Forest Service
Grain Inspection, Packers and Stockyards Administration
Rural Utilities Service
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
National Institutes of Health
Coast Guard
National Communications System
U.S. Immigration and Customs Enforcement
Fish and Wildlife Service
Indian Affairs Bureau
National Park Service
Antitrust Division
Drug Enforcement Administration
Juvenile Justice and Delinquency Prevention Office
Employee Benefits Security Administration
Employment and Training Administration
Mine Safety and Health Administration
Federal Procurement Policy Office
Agency for Toxic Substances and Disease Registry
Federal Aviation Administration
Federal Railroad Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Office of the Secretary, DHS.
Final rule; technical amendment.
Citizens and eligible nationals of participating Visa Waiver Program countries may apply for admission to the United States at U.S. ports of entry as nonimmigrant aliens for a period of ninety days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements. On March 4, 2010, the Secretary of Homeland Security, in consultation with the Secretary of State, designated Greece as a country that is eligible to participate in the Visa Waiver Program. Accordingly, this rule updates the list of countries authorized to participate in the Visa Waiver Program by adding Greece.
This final rule is effective on April 5, 2010.
Gianfranco Corti, Department of Homeland Security, Office of Policy, (202) 282-8732.
Pursuant to section 217 of the Immigration and Nationality Act (INA), 8 U.S.C. 1187, the Secretary of Homeland Security (the Secretary), in consultation with the Secretary of State, may designate certain countries as Visa Waiver Program (VWP) countries if certain requirements are met. Those requirements include, without limitation: (1) Meeting the statutory rate of nonimmigrant visa refusal for nationals of the country; (2) a government certification that it issues machine-readable passports that comply with internationally accepted standards; (3) a U.S. government determination that the country's designation would not negatively affect U.S. law enforcement and security interests; (4) an agreement to report, or make available through other designated means, to the U.S. government information about the theft or loss of passports; (5) government acceptance for repatriation any citizen, former citizen, or national not later than three weeks after the issuance of a final order of removal; and (6) an agreement with the United States to share information regarding whether citizens or nationals of the country represent a threat to the security or welfare of the United States or its citizens.
The INA also sets forth requirements for continued eligibility and, where appropriate, probation and/or termination of program countries.
The designated countries in the VWP include Andorra, Australia, Austria, Belgium, Brunei, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Japan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Monaco, the Netherlands, New Zealand, Norway, Portugal, Republic of Korea, San Marino, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom.
Citizens and eligible nationals of VWP countries may apply for admission to the United States at U.S. ports of entry as nonimmigrant visitors for a period of ninety days or less for business or pleasure without first obtaining a nonimmigrant visa, provided that they are otherwise eligible for admission under applicable statutory and regulatory requirements. To travel to the United States under the VWP, an alien must be from a participating country and must satisfy the following:
(1) Be seeking entry as a tourist for ninety days or less;
(2) Be a national of a program country;
(3) Present an electronic passport or a machine-readable passport issued by a designated VWP participant country to the air or vessel carrier before departure;
(4) Execute the required immigration forms;
(5) If arriving by air or sea, arrive on an authorized carrier;
(6) Not represent a threat to the welfare, health, safety or security of the United States;
(7) Have not violated U.S. immigration law during a previous admission under the VWP;
(8) Possess a round-trip ticket;
(9) Waive the right to review or appeal a decision regarding admissibility or to contest, other than on the basis of an application for asylum, any action for removal; and
(10) Obtain an approved travel authorization via the Electronic System for Travel Authorization (ESTA) in advance of travel. For more information about the ESTA, please see the interim final rule at 73 FR 32440 (June 9, 2008), and implementing notice at 73 FR 67354 (November 13, 2008).
DHS, in consultation with the Department of State, has evaluated the country of Greece for VWP designation to ensure that it meets the requirements set forth in section 217 of the INA, as amended by section 711 of the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). The Secretary has determined that Greece has satisfied the statutory requirements to be a VWP country; therefore, the Secretary, in consultation with the Secretary of State, has designated Greece as a program country.
This final rule adds Greece to the list of countries authorized to participate in
Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. The final rule merely lists a country that the Secretary of Homeland Security, in consultation with the Secretary of State, has designated as a VWP eligible country in accordance with 8 U.S.C. 1187(c). This amendment is a technical change simply updating the list of VWP eligible countries. Therefore, notice and comment for this rule are unnecessary and contrary to the public interest because the rule has no substantive impact, is technical in nature, and relates only to management, organization, procedure, and practice. For the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.
This final rule is also excluded from the rulemaking provisions of 5 U.S.C. 553 as a foreign affairs function of the United States, because it advances the President's foreign policy goals, involves a bilateral agreement that the United States has entered into with Greece, and directly involves relationships between the United States and its alien visitors. Accordingly, DHS is not required to provide public notice and an opportunity to comment before implementing the requirements under this final rule.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 603(b)), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBREFA), requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of a proposed rule on small entities (i.e., small businesses, small organizations, and small governmental jurisdictions) when the agency is required “to publish a general notice of proposed rulemaking for any proposed rule.” Because this rule is being issued as a final rule, on the grounds set forth above, a regulatory flexibility analysis is not required under the RFA.
DHS has considered the impact of this rule on small entities and has determined that this rule will not have a significant economic impact on a substantial number of small entities. The individual aliens to whom this rule applies are not small entities as that term is defined in 5 U.S.C. 601(6). Accordingly, there is no change expected in any process as a result of this rule that would have a direct effect, either positive or negative, on a small entity.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This amendment does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.
The rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, DHS has determined that this final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
Air carriers, Aliens, Maritime carriers, Passports and visas.
8 U.S.C. 1103, 1187; 8 CFR part 2.
(a) * * *
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Prohibited Area 49 (P-49) Crawford, TX. While the United States Secret Service (USSS) recognizes the ongoing security
Effective date 0901 UTC, June 3, 2010.
Colby Abbott, Airspace and Rules Group, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone: (202) 267-8783.
On October 5, 2009, the Department of the Treasury, USSS, notified the FAA that while the security requirements for establishing P-49 Crawford, TX (66 FR 16391) remain valid, consideration of a modification of the existing prohibited area was appropriate. After a six-month security review of P-49, the USSS determined the dimensions (boundary and altitude) of the prohibited area could be reduced. This action responds to that notification.
This action amends Title 14 Code of Federal Regulations (14 CFR) part 73 by revising the legal description for P-49 Crawford, TX. After conducting a security review of P-49, the USSS notified the FAA to reduce the boundary and altitude dimensions of the prohibited area. This action reduces the boundary from a 3 NM radius to a 2 NM radius of lat. 31°34′45″ N., 97°32′00″ W., and lowers the designated altitude from “Surface to but not including 5,000 feet MSL” to “Surface to but not including 2,000 feet MSL.”
Because this action restores previously prohibited airspace to public use, I find that notice and public procedures under 5 U.S.C. 553(b) are unnecessary as it would only delay the return of the airspace to public use.
Section 73.89 of Title 14 CFR part 73 was republished in FAA Order 7400.8S, effective February 16, 2010.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends prohibited airspace in Crawford, Texas.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with paragraph 311c, FAA Order 1050.1E, Environmental Impacts: Policies and Procedures. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Prohibited areas, Restricted areas.
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Boundaries. That airspace within a 2 NM radius of lat. 31°34′45″ N., long. 97°32′00″ W.
Designated altitudes. Surface to 2,000 feet MSL.
Time of designation. Continuous.
Using agency. United States Secret Service, Washington, DC.
Consumer Product Safety Commission.
Final interpretative rule.
The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) requires the Consumer Product Safety Commission (“Commission”) to issue a final rule providing its interpretation of the civil penalty factors found in the Consumer Product Safety Act (“CPSA”), the Federal Hazardous Substances Act (“FHSA”), and the Flammable Fabrics Act (“FFA”), as amended by section 217 of the CPSIA. These statutory provisions require the Commission to consider certain factors in determining the amount of any civil penalty to seek. The Commission published an interim final rule on September 1, 2009, providing its interpretation of the statutory factors and seeking public comment. The Commission is now issuing a final rule interpreting the statutory factors.
This rule is effective March 31, 2010.
Melissa V. Hampshire, Assistant General Counsel, Division of Enforcement and Information, Office of the General Counsel, Consumer Product Safety Commission, 4330 East-West Highway, Bethesda, Maryland 20814, telephone: 301-504-7631, e-mail:
The CPSIA specified that the Commission, by August 14, 2009, issue a final regulation providing its interpretation of civil penalty factors in section 20(b) of the CPSA, section 5(c)(3) of the FHSA, and section 5(e)(2) of the FFA.
The statutory factors the Commission is required to consider in determining the amount of a civil penalty to seek are the same factors identified in section 20(c) of the CPSA, section 5(c)(4) of the FHSA, and section 5(e)(3) of the FFA for determining whether a civil penalty may be compromised by the Commission. These statutory provisions instruct the Commission to consider the following factors in determining the amount of a compromised penalty, whether it should be remitted or mitigated by the Commission, and, in what amount: The nature, circumstances, extent and gravity of the violation, including the nature of the product defect,
As set forth in section 217(a)(4) of the CPSIA, new penalty amounts specified in section 217(a) of the CPSIA became effective on August 14, 2009 (one year after the date of enactment of the CPSIA). Under the amendments, the maximum penalty amounts increase from $8,000 to $100,000 for each knowing violation under the CPSA, FHSA, and FFA. Maximum penalty amounts for any related series of violations increase from $1,825,000 to $15,000,000.
On July 12, 2006, the Commission published a proposed interpretative rule (71 FR 39248) that identified additional factors to be considered in assessing and compromising civil penalties under sections 20(b) and (c) of the CPSA. The comment period closed August 11, 2006. The Commission received four comments.
The enactment of the CPSIA superseded the proposed rule by requiring that the Commission provide its interpretation of the enumerated statutory factors under section 20(b) of the CPSA, section 5(c)(3) of the FHSA, and section 5(e)(2) of the FFA. The CPSIA also indicated that under the CPSA, FHSA, and FFA, the Commission should consider the nature, circumstances, extent, and gravity of the violation in determining the appropriate penalty amount. The statute provides examples of elements that should go into that consideration. The CPSIA modified the factor of appropriateness of the penalty in relation to the size of the business of the person charged by requiring that this factor include a consideration of how to mitigate undue adverse economic impacts on small businesses. This small business analysis element was added to the CPSA and FHSA but not added to the FFA factor. The Commission will consider the undue adverse economic impacts on small businesses as another appropriate factor under the FFA. The CPSIA also added to the CPSA, FHSA, and FFA a new catch-all statutory factor “other factors as appropriate.” The effect of the CPSIA amendments was noted in the Fall 2008 Current Regulatory Plan and the Unified Agenda (RIN: 3041-AC40) by stating that the proposed July 2006 rule would be withdrawn. In the
On November 18, 2008, the Commission staff posted a notice on the Commission Web site inviting comment on information the Commission should address in considering the amended statutory factors under the CPSA, FHSA, and FFA. The Commission staff also invited comment on what other factors are appropriate to consider in penalty determinations including: (1) A previous record of compliance; (2) timeliness of response; (3) safety and compliance monitoring; (4) cooperation and good faith; (5) economic gain from noncompliance; (6) product failure rate; and (7) what information the Commission should consider in determining how to mitigate the adverse economic impact of a particular penalty on a small business. The Commission staff also invited comment on whether it should develop a formula or matrix for weighing any or all of the various factors and what criteria it should use in any weighting formula or matrix. The Commission received 16 comments in response to the 2008 Web site notice and considered the comments in issuing the interim final rule.
On September 1, 2009, the Commission published an interim final interpretative rule setting forth the Commission's interpretation of the statutory factors under the CPSA, FHSA, and FFA, for seeking and compromising civil penalties. The Commission sought comments on the interim final rule. The Commission received 10 comments in response to the September 1, 2009 notice. Some commenters responded on behalf of their trade or industry associations.
The determination of the amount of any civil penalty to seek and/or compromise should allow for maximum flexibility within an identified framework. The CPSIA requirement for the Commission to interpret the civil penalty factors gives transparency to the regulated community about the framework the Commission will use to guide its penalty calculations in the enforcement process and may provide incentives for greater compliance. The changes made by various CPSIA provisions to the CPSA, FHSA, and FFA, including those to the CPSA's prohibited acts and the addition of new prohibited acts, present the regulated community with many new compliance challenges and responsibilities.
Any proposed civil penalty determination is based first on a violation of a prohibited act under the CPSA, FHSA, or FFA. Civil penalties may then be sought against any person who “knowingly violates” section 19 of the CPSA, section 4 of the FHSA, or a regulation or standard under section 4 of the FFA. The term “knowingly” is defined in section 20(d) of the CPSA, 15 U.S.C. 2069(d), section 5(c)(5) of the FHSA, 15 U.S.C. 1264(c)(5), and section 5(e)(1) of the FFA, 15 U.S.C. 1194(e)(1), to mean the having of actual knowledge or the presumed having of knowledge deemed to be possessed by a “reasonable man” who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations. Since its enactment in 1973, the CPSA always contained a civil penalty provision; however, until 1990, the FHSA and FFA did not contain comparable provisions for civil penalties. Under the FFA, the Commission had to seek civil penalties under the Federal Trade Commission Act, using the authorities under that act. The FHSA had no civil penalty provision. The Consumer Product Safety Improvement Act of 1990, Public Law 101-608, 104 Stat. 3110, November 16, 1990, amended section 5 of the FHSA and section 5 of the FFA giving the Commission authority to seek civil penalties for knowing violations of those acts. If a penalty settlement cannot be negotiated between the Commission and a person, the Commission may seek an action in Federal court to obtain a penalty.
In the past, the majority of civil penalties for prohibited acts were imposed either for a knowing failure to furnish information required by section 15(b) of the CPSA, or for regulatory violations under the CPSA, FHSA, or FFA. The interim final rule described how the CPSIA amended these three statutes to strengthen the Commission's enforcement ability and allow for more uniform enforcement under the CPSA.
The new amendments expand the acts prohibited under the CPSA and give the Commission the ability to enforce violations of the FHSA, FFA, and other acts enforced by the Commission as prohibited acts under the CPSA. Thus, the amended CPSA now prohibits the sale, offer for sale, distribution in commerce, or importation into the United States of any consumer product, or other product or substance that is regulated under the CPSA or any other act enforced by the Commission, that is not in conformity with an applicable consumer product safety rule under the CPSA, or any similar rule, regulation, standard, or ban under any other act enforced by the Commission. 15 U.S.C. 2068(a)(1).
The CPSA, as amended, adds a new prohibited act for the sale, manufacture, distribution, or importation of products subject to a voluntary corrective action taken by the manufacturer, in consultation with the Commission, and publicly announced by the Commission, or if the seller, distributor, or manufacturer knew or should have known of such voluntary corrective action. 15 U.S.C. 2068(a)(2)(B).
The CPSA, as amended, broadens the prohibited act for the sale, offer for sale, manufacture for sale, or distribution or importation of any consumer product or other product or substance subject to a section 15 mandatory recall order to include products subject to a section 12 order. A section 15 order is imposed in an adjudicative proceeding to declare a product a “substantial product hazard” under section 15 of the CPSA, 15 U.S.C. 2064. A section 12 order, which may include a mandatory order requiring notification to purchasers, and repair, replacement, or refund, is one imposed by a District Court after an “imminent hazard” proceeding under section 12 of the CPSA, 15 U.S.C. 2061.
The amended prohibited acts section of the CPSA is also broadened to include the sale, offer for sale, manufacture for sale, distribution in commerce, or importation into the United States of a banned hazardous substance under the FHSA as an act prohibited under the CPSA. 15 U.S.C. 2068(a)(2)(D).
The prohibited act in section 19(a)(6) of the CPSA relating to certification under section 14 of the CPSA is newly expanded to make the failure to furnish a certificate required by any other act enforced by the Commission a prohibited act under the CPSA. This prohibited act now also references a new tracking label requirement of CPSA section 14(a)(5) by specifying that the failure to comply with any requirement of section 14 includes the failure to comply with the requirement for tracking labels or any rule or regulation promulgated under section 14.
The CPSA statutory language has also been expanded to include a new prohibited act for the sale, offer for sale, distribution in commerce, or importation into the United States of any consumer product containing an unauthorized third-party certification mark. 15 U.S.C. 2068(a)(12).
Any misrepresentation to Commission officers or employees about the scope of consumer products subject to recall or material misrepresentation in the course of an investigation under any act enforced by the Commission also is a new prohibited act under the CPSA. 15 U.S.C. 2068(a)(13).
In addition, the CPSA now contains a new prohibited act for the exercise or attempt to exercise undue influence on a third-party conformity assessment body that tests products for compliance under laws administered by the Commission.
The CPSIA adds to the Commission's export prohibition authority section 19(a)(15) of the CPSA, making it illegal to export from the United States for purposes of sale any consumer product or other product or substance (other than the export of a product or substance permitted by the Secretary of the Treasury under section 17(e) of the CPSA) that is subject to court- or Commission-ordered recall or that is banned under the FHSA or subject to a voluntary recall announced by the Commission. 15 U.S.C. 2068(a)(15).
The CPSIA also adds a new prohibited act that makes it illegal to violate a Commission order issued under new section 18(c) of the CPSA, which allows the Commission to prohibit export for sale of any consumer product not in conformity with an applicable consumer product safety rule.
The comments that the Commission received on the Interim Final Rule and the Commission's responses are discussed in this section of the preamble.
Some commenters stated that the Commission should reserve seeking the highest penalties only for those violations involving actual knowledge where death or serious injury is likely. The commenters suggested that penalties involving presumed knowledge and circumstances where no injury or only minor injury occurred should result in lower or no penalties. Some commenters also suggested that technical violations should not involve a penalty at all. These commenters sought clarification of these concepts in the rule.
The CPSA, FHSA, and FFA define “knowingly” as the having of actual knowledge, or the presumed having of knowledge deemed to be possessed by a “reasonable man” who acts in the circumstances, including knowledge obtainable upon the exercise of due care to ascertain the truth of representations. Thus, the knowledge requirements in the CPSA, FHSA, and FFA include presumed knowledge, as well as actual knowledge. Only in section 20(a)(2) is a distinction made and this limits the civil penalty liability of certain persons without actual knowledge to those who are not the manufacturer, private labeler or distributor of the products involved. Aside from this limitation, actual and presumed knowledge are treated equally under the statutes, and both could have the same consequence for civil penalty liability. Thus, the Commission declines to follow the commenters' suggestion to seek a higher penalty only where there is evidence of actual knowledge and serious injury or death, or a lower or no penalty where there is evidence of presumed knowledge. To follow the commenters' position would treat the “presumed knowledge” element differently than it is treated in the statute. However, the presence or absence of actual knowledge could reflect on a person's culpability and affect the size of the penalty. Moreover, the adoption of the distinction sought by the commenters would be a formulaic approach to penalty determinations. Almost all the commenters opposed the idea that the Commission adopt such a formulaic approach. However, the Commission has attempted to further clarify in the final rule its guidance about what factors may influence the Commission's determination under the various statutory and other factors. Importantly, in an individual case, the Commission would review the facts and circumstances surrounding the violations and the proposed assessment of penalties in light of the factors and framework described in the rule. Specific comments relating to each factor are discussed below. The CPSIA has greatly expanded the number of prohibited acts. Accordingly the Commission intends to use its civil penalty authority in a manner best designed to promote the underlying goals of the CPSA—specifically that of protecting the public against unreasonable risks of injury associated with consumer products. In so doing, the Commission may reserve the highest civil penalty for more serious or extensive violations.
Section 1119.1 describes the purpose of new Part 1119 “Civil Penalty Factors,” explaining that it is the Commission's interpretation of the statutory civil penalty factors set forth in the Consumer Product Safety Act (15 U.S.C. 2051-2089), the Federal Hazardous Substances Act (15 U.S.C. 1261-1278), and the Flammable Fabrics Act (15 U.S.C. 1191-1204). The Commission has revised the interim final rule's text in the final rule to add clarification on the underlying goals and policies of civil penalties.
Section 1119.2 explains that the part applies to all civil penalty determinations that the Commission proposes to seek or compromise for knowing violations of the CPSA, the FHSA, or the FFA.
Section 1119.3 defines certain terms used in the rule. The Commission has revised the definition of the term “product defect” from that in the interim final rule. The term is defined in the final rule to have the same meaning as the term “defect” referenced in the CPSA and the Commission's definition of “defect” at 16 CFR 1115.4. The term “violator” has been revised to reflect the statutory terminology that any “person” is subject to civil penalties. As noted in the rule, “person” includes any legally responsible party who committed a knowing violation of the CPSA, FHSA or FFA. The rule explains that the definitions apply for purposes of the rule.
The Commission believes that this factor allows the Commission to consider the totality of the circumstances surrounding a violation while recognizing that depending upon the case, the significance and importance of each factor may vary. The Commission also believes that this particular factor allows for consideration of the seriousness and extent of a particular violation that may not otherwise be considered with respect to the other enumerated statutory factors. Therefore, in each case, the Commission will continue to look at the enumerated statutory factors, as well as other factors (described in section 1119.4(b) below) that the Commission may determine are appropriate, and consider all of the factors in determining the civil penalty amount.
The interim final rule indicated that the Commission would consider, under this provision, where appropriate and applicable in each particular case, the nature of the hazard presented by the product for which a penalty is sought. The Commission construed this factor as applying broadly to products or substances that may in fact contain a defect which could create a substantial product hazard (as defined and explained in 16 CFR 1115.4), to products which present a hazard because of a violation of a rule, regulation, standard, or ban under the CPSA, FHSA, and FFA, as well as to any other violation and how the nature of those violations relate to the underlying products or substances.
A number of commenters addressed the definition of “product defect” in section 1119.3 of the interim final rule as overly broad and unnecessarily expansive and inconsistent with the Commission's interpretation of defect as used in 16 CFR 1115.4. The commenters pointed out that defining “product defect” beyond the definition in section 1115.4 as a product or substance “associated with a prohibited act” had no basis in the statutory language of the CPSA and that the definition should be clarified to refer only to the Commission's definition in 16 CFR 1115.4.
The Commission agrees that the definition of “product defect” in the interim final rule should be revised. The Commission agrees that certain CPSA violations may not involve a “product defect” or a “defective product.” For example, failure to supply a required General Conformity Certification that a product complies with an applicable consumer product safety rule may not necessarily involve a product defect or a defective product. Thus, “product defect” may not be a relevant consideration in such a circumstance. Therefore, the Commission has revised the final rule to clarify that where “product defect” or “defective product” does not apply, in such circumstances, the other statutory factors will be considered.
Several commenters noted that penalties should not be sought for violations where the products presented risks of minor or moderate injury.
The Commission declines to follow this suggestion. However, the Commission notes that minor or moderate injury is considered as a factor in the determination of the overall penalty. The Commission refers to the discussion of 16 CFR 1115.12 which specifies that severity of the risk includes a consideration of the likelihood of an injury occurring, the intended or reasonably foreseeable use or misuse of the product, and the population group exposed. The Commission retains these references in the final rule. The Commission also notes that the interim final rule has been modified in the final rule to further clarify that the Commission will consider “illness” along with injury and death as a consideration under this factor. The Commission believes that consideration of illness is consistent with the statutory direction which defines a “risk of injury” in section 3(a)(14) of the CPSA to mean a risk of death, personal injury, or serious or frequent illness.
The Commission received several comments suggesting that it should not seek a penalty where the information the Commission evaluates reveals that the violation involved no injury or only minor injuries have occurred.
The Commission declines to follow this suggestion because a violative product, a product about which a person did not report as required, or another type of violation, may present a serious risk to consumers even though no injuries have occurred. However, the final rule is further clarified to state that the Commission would consider under this factor whether illnesses or deaths have occurred, in addition to considering whether injuries have or have not occurred. The rule is further clarified to explain that this consideration will also involve the number and nature of such injuries, illnesses, or deaths. Finally, the Commission has pointed out that both acute and the likelihood for chronic illness will be considered.
The Commission is required to consider the number of defective products or amount of substances distributed in commerce. The Commission recognizes, as some commenters pointed out, that the number of defective products in consumers' hands may be different from the number of defective products distributed. However, the statutory language makes no distinction between those defective products distributed in commerce that consumers received, and those defective products distributed in commerce that consumers have not received. Therefore both could be considered in appropriate cases. With respect to the number of defective products or amount of substances involved in a recall, the Commission clarifies in the rule that the Commission does not intend to penalize a person's decision to conduct a wider-than-necessary recall undertaken out of an abundance of caution. This would not include situations where such a recall is conducted due to a person's uncertainty concerning how many or which products may need to be recalled.
The Commission is required to consider the size of a business in relation to the amount of the penalty. This factor reflects the relationship between the size of the business of the person charged and the deterrent effect of, and other policies underlying, civil penalties. In considering business “size,” the Commission may look to several factors including but not limited to the number of employees, net worth, and annual sales. The Commission may be guided, where appropriate, by any relevant financial factors to help determine a person's ability to pay a penalty including but not limited to:
• Liquidity factors—factors that help measure a person's ability to pay its short-term obligations;
• Solvency factors—factors that help measure a person's ability to pay its long-term obligations; and
• Profitability factors— factors that measure a person's level of return on investment.
The Commission is aware that penalties may have adverse economic consequences on persons, including small businesses. The statute requires the Commission to consider how to mitigate the adverse economic consequences on small businesses only if those consequences would be “undue.” What the Commission considers in determining what is “undue” may include, but is not limited to, the business's size and financial factors relating to its ability to pay. The interim final rule is modified in the final rule to explain that the burden to present clear, reliable, relevant, and sufficient evidence relating to a business's size and ability to pay rests on the business. When considering how to mitigate undue adverse economic consequences, the Commission will, as appropriate, follow its Small Business Enforcement Policy set forth at 16 CFR 1020.5. In determining a small business's ability to pay a proposed penalty, the Commission may be guided, where appropriate, by the financial factors set forth above. The Commission recognizes that on occasion its announced civil penalty amounts do not seem to reflect the seriousness of the violations due to the Commission's mitigation of the amount of the penalty based on ability to pay. While the Commission, unlike certain other federal agencies, has never publicized the amount it would have sought absent the mitigation, it acknowledges that it has that authority and may exercise that authority in appropriate circumstances.
Some commenters suggested that the Commission should identify other factors that will be considered in penalty determinations. The factors the commenters suggested included previous record of compliance, good faith, efforts taken to respond to the violations, duration of the violations, and compliance with mandatory and/or voluntary standards. The Commission has determined that some of these factors would already be evaluated in the context of the enumerated statutory factors to consider, such as the nature, circumstances, extent, and gravity of the violation. Therefore, it is not necessary to separately enumerate these factors.
Congress clarified in the CPSIA that the Commission has the ability to consider factors in addition to the ones enumerated in the act in individual cases, as appropriate. However, the Commission retains the concept from the interim final rule in the final rule that in any penalty matter the Commission and the person are free to raise any other factors they believe are relevant in determining an appropriate civil penalty amount. Factors not identified below could therefore be raised in a penalty matter. The Commission has determined that the factors listed below should remain with changes and other clarifications as noted:
•
•
•
•
A person will be notified of any factors beyond those enumerated in the statutes that the Commission relies on as aggravating factors for purposes of determining a civil penalty amount.
Section 1119.5 of the rule sets forth a notification provision whereby, if it is believed that a person has violated the law and a penalty is sought, the person will be so advised. This provision has been informally followed by the Commission in determining the amount of a civil penalty to seek or compromise for knowing violations. The Commission has provided further clarification of this process in the rule.
The Commission issued an interim final rule, in accordance with the procedures set forth at 5 U.S.C. 553 of the Administrative Procedure Act, on September 1, 2009, providing its interpretation of the penalty factors in section 20(b) of the CPSA, section 5(c)(3) of the FHSA, and section 5(e)(2) of the FFA. Maximum civil penalty amounts have increased for violations that occurred on or after August 14, 2009. This final rule is effective upon publication. The rule is interpretative and does not impose obligations on regulated parties beyond those imposed by the CPSA, FHSA, and FFA. Therefore, there is no need to provide a delayed effective date in order to allow for regulated parties to prepare for the rule.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, directs agencies to consider the potential impact of regulations on small business and other small entities. However, the RFA does not apply to rulemaking that is not subject to the notice and comment requirement of the Administrative Procedure Act, 5 U.S.C. 553. Interpretative rules, such as the one issued by this notice, are not subject to the notice and comment requirement. Accordingly, neither an initial nor a final regulatory flexibility analysis is required for this rule.
The rule does not impose any information collection requirements. Rather, it describes the statutory civil penalty factors and how the Commission interprets those factors. Accordingly, it is not subject to the Paperwork Reduction Act, 44 U.S.C. 3501-3520.
The Commission's regulations at 16 CFR 1021.5(a) provide that there are no CPSC actions that ordinarily produce significant environmental effects. The rule does not fall within the categories in 16 CFR 1021.5(b) of CPSC actions that have the potential for producing environmental effects. The rule does not have any potential for adversely affecting the quality of the human environment. Council of Environmental Quality regulations at 40 CFR 1508.18(a) provide that agency actions subject to environmental review “do not include bringing judicial or administrative enforcement actions.” Therefore, no environmental assessment or environmental impact statement is required.
Administrative practice and procedure, Business and Industry, Consumer protection, Reporting and recordkeeping requirements.
15 U.S.C. 2058, 2063, 2064, 2067(b), 2068, 2069, 2076(e), 2084, 1261, 1263, 1264, 1270, 1273, 1278, 1191, 1192, 1193, 1194, 1195, 1196.
This part sets forth the Consumer Product Safety Commission's (Commission) interpretation of the statutory factors considered in determining the amount of civil penalties that the Commission may seek or compromise. The policies behind, and purposes of, civil penalties include the following: Deterring violations; providing just punishment; promoting respect for the law; promoting full compliance with the law; reflecting the seriousness of the violation; and protecting the public.
This part applies to all civil penalty determinations the Commission may seek or compromise under the Consumer Product Safety Act (CPSA) (15 U.S.C. 2051-2089), the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261-1278), and the Flammable Fabrics Act (FFA) (15 U.S.C. 1191-1204). Any person who knowingly violates section 19 of the CPSA, section 4 of the FHSA, or section 5(e) of the FFA, is subject to a civil penalty.
For purposes of this rule, the following definitions apply:
(a)
(b)
(c)
(a)
(i)
(A) The nature of the product defect;
(B) The severity of the risk of injury;
(C) The occurrence or absence of injury;
(D) The number of defective products distributed;
(E) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses; and
(F) Such other factors as appropriate.
(ii)
(A) The nature of the substance;
(B) Severity of the risk of injury;
(C) The occurrence or absence of injury;
(D) The amount of substance distributed;
(E) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses; and
(F) Such other factors as appropriate.
(iii)
(A) The severity of the risk of injury;
(B) The occurrence or absence of injury;
(C) The appropriateness of such penalty in relation to the size of the business of the person charged; and
(D) Such other factors as appropriate.
(2)
(3)
(4)
(5)
(6)
(7) The appropriateness of such penalty in relation to the size of the business of the person charged, including how to mitigate undue adverse economic impacts on small businesses.
(i) The Commission is required to consider the size of the business of the person charged in relation to the amount of the penalty. This factor reflects the relationship between the size of a business and the policies behind, and purposes of, a penalty (as noted above in § 1119.1). In considering business size, the Commission may look to several factors including, but not limited to, the number of employees, net worth, and annual sales. A business's size and a business's ability to pay a penalty are separate considerations. In some cases for small businesses, however, these two considerations may relate to each other. The Commission will be guided, where appropriate, by relevant financial factors to determine a small business's ability to pay a penalty, including, but not limited to, liquidity, solvency, and profitability. The burden to present clear, reliable, relevant, and sufficient evidence relating to a business's size and ability to pay rests on the business.
(ii) The statute requires the Commission to consider how to mitigate the adverse economic impacts on small businesses only if those impacts would be undue. What the Commission considers in determining what is undue may include, but is not limited to, the business's size and financial factors relating to its ability to pay. When considering how to mitigate undue
(b)
(1)
(2)
(3)
A person will be informed in writing if it is believed that the person has violated the law and if the Commission intends to seek a civil penalty. Any person who receives such a writing will have an opportunity to submit evidence and arguments that it should not pay a penalty or should not pay a penalty in the amount sought by the Commission.
In Title 20 of the Code of Federal Regulations, Part 500 to End, revised as of April 1, 2009, on page 466, remove § 655.0 and correctly reinstate it to read as follows:
(a)
(2)
(3)
(b)
(c)
(d)
(e)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is removing portions of a regulation that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete or redundant. The portions of the regulation being removed are provisions listing certain feed use combinations for oxytetracycline and neomycin in the tables contained in that regulation. This rule does not finalize the provisions of the proposed rule regarding removing the remainder of the regulation.
This rule is effective April 30, 2010.
William T. Flynn, Center for Veterinary Medicine (HFV-50), 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail:
In the
In the same issue of the
FDA received hearing requests regarding two products owned by Pennfield Oil Co. (Pennfield). One is a bacitracin methylene disalicylate (BMD) Type A medicated article, NADA 141-137, that is listed in the table in § 558.15(g)(1). This listing is under Fermenta Animal Health Co., which is a predecessor in interest to Pennfield. The other is a two-way, fixed-combination Type A medicated article containing oxytetracycline and neomycin sulfate, NADA 138-939, that is listed in the table in § 558.15(g)(2).
The agency received only one set of comments on the 2003 proposed rule, from Pennfield. The comment objected to the removal of § 558.15 until the issues in the NOOH are addressed. It argued that the BMD listing in § 558.15 provides evidence of Pennfield's approval, and that removal of that section, without updating the BMD listing in part 558, subpart B, would result in a lack of recognition in the regulations of the approval that Pennfield currently has.
In 2006, FDA finalized portions of the 2003 proposed rule. In that final rule (71 FR 16219, March 31, 2006), FDA removed from the tables in § 558.15(g) products and use combinations that were not approved, and products and use combinations whose approval was reflected in part 558, subpart B. FDA retained only the listings for NADA 141-137 and NADA 138-939 in those tables. In addition, FDA retained § 558.15(a) through (f). FDA stated it intended to finalize the proposed rule to remove all of § 558.15 once, as part of the DESI program, either the approvals for NADA 141-137 and NADA 138-939 have been withdrawn or part 558, subpart B has been amended to reflect their approvals.
Subsequently, Pennfield filed a supplement to NADA 138-939 for its fixed-combination oxytetracycline/neomycin Type A medicated articles. The supplemental NADA, which provided labeling conforming to the relevant findings of effectiveness announced in the NOOH, was approved on July 2, 2009, and the regulations were amended in § 558.455 of subpart B to reflect that approval (74 FR 40723, August 13, 2009).
This oxytetracycline/neomycin use combination is listed in the table in § 558.15(g)(2) and is the only use combination listed in this provision. Because this use combination's approval is now reflected in § 558.455, FDA is removing § 558.15(g)(2) as obsolete or redundant. As in the 2006 final rule, FDA is retaining the sole listing in the table in § 558.15(g)(1) for NADA 141-137 as well as § 558.15(a) through (f), and intends to continue to finalize the proposed rule to remove all of § 558.15.
The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-602), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.
FDA proposed the removal of § 558.15 on August 8, 2003, because it was obsolete or redundant. The original purpose of § 558.15, requiring the submission of the results of studies on the long-term administration of then-marketed antimicrobial drugs in animal feed on the occurrence of multiple drug-resistant bacteria associated with these animals, was obsolete as FDA had a new strategy and concept for assessing the safety of antimicrobial new animal drugs, including subtherapeutic use of antimicrobials in animal feed, with regard to their microbiological effects on bacteria of human health concern. This final rule would delete the only animal drug use combination listed in § 558.15(g)(2) which is redundant because its approved conditions of use are now listed in § 558.455.
Only one set of comments on the proposal was received by FDA. Because these comments did not question the benefits as described in the proposed rule, we retain the benefits for the final rule. This final rule is expected to provide greater clarity in the regulations for new animal drugs for use in animal feeds by deleting obsolete provisions in § 558.15. We do not expect this final rule to result in any direct human or animal health benefit. Rather, this final rule would remove regulations that are no longer necessary.
We do not expect the final rule that revokes § 558.15(g)(2) to have a substantive effect on any approved new animal drugs, or to cause any approved new animal drug to lose its marketing ability or experience a loss of sales.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. FDA has determined that this final rule does not impose compliance costs on the sponsors of any products that are currently marketed. Further, it does not cause any drugs that are currently marketed to lose their marketing ability. We therefore certify that this final rule would not have a significant economic effect on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $133 million, using the most current (2008) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
FDA concludes that this rule does not have information collection requirements.
Animal drugs, Animal feeds.
21 U.S.C. 360b, 371.
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the regulations that govern the operation of the U.S. Highway 101 bascule bridge across the Chehalis River, mile 0.1, at Aberdeen, Washington. At least one-hour notice by telephone will be required at all times for draw openings. The change is necessary to allow the bridge owner to reduce the staffing requirements of the bridge in light of the infrequent openings requested for the bridge.
This rule is effective April 30, 2010.
Comments and related materials received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2009-0959 and are available online by going to
If you have questions on this rule, call or
On December 4, 2009, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Chehalis River, Aberdeen, WA, Schedule Change in the
This rule enables the Washington State Department of Transportation, the owner of the Chehalis River Bridge, to operate the draw only if at least one-hour notice is provided at all times. This notice will be given by telephone to 360-533-9360. A marine radio will also be maintained at the bridge, but will only be monitored when a draw tender is present. Previously, one-hour notice was only required between 9 p.m. and 5 a.m.
Over the years ship traffic has dwindled on this reach of the Chehalis River. From June through September 2009 the draw did not open for large oceangoing vessels. The former ship traffic is now focused seaward of the bridge following the recent closure of timber terminals above the bridge. The bridge averages only seven openings a month during those daylight hours when a draw operator is present. The Washington State Department of Transportation requested this change to reduce unnecessary staffing of the drawbridge in light of the infrequent openings requested for the bridge.
No comments were received on the proposed rule and no changes were made to the proposed rule.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard has made this determination based on the fact that vessel operators will not be significantly impacted since they will still be able to transit under the bridge by giving one-hour notice.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities because all vessel operators will not be significantly impacted since they will still be able to transit under the bridge by giving one-hour notice.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required.
Bridges.
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
The draw of the U.S. 101 highway bridge, mile 0.1, at Aberdeen shall open on signal if at least one-hour notice is given at all times by telephone to the Washington State Department of Transportation.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Fifth Coast Guard District, has issued a temporary deviation from the regulations governing the operation of the SR170 Centerville Turnpike Bridge across the Atlantic Intracoastal Waterway, Albemarle and Chesapeake Canal, mile 15.7, at Chesapeake, VA. The deviation is necessary to facilitate structural repairs to the swing span. This deviation allows the drawbridge to remain in the closed to navigation position.
This deviation is effective from 8 a.m. on April 10, 2010 to 6 p.m. on April 18, 2010.
Documents mentioned in this preamble as being available in the docket USCG-2010-0185 and are available online by going to
If you have questions on this rule, call or e-mail Mr. Bill H. Brazier, Bridge Management Specialist, Fifth Coast Guard District; telephone (757) 398-6422, e-mail
The City of Chesapeake, who owns and operates this swing-type bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.997(i), to facilitate structural repairs.
The SR170 Centerville Turnpike Bridge has a vertical clearance in the closed position to vessels of four feet above mean high water.
Under this temporary deviation, the drawbridge will be maintained in the closed to navigation position to facilitate repairs to structural support stringers on two separate closures. The first closure period will begin at 8 a.m. April 10, 2010, until and including 6 p. m. April 11, 2010; and the second closure period scheduled to begin at 8 a.m. on April 17, 2010, until and including 6 p.m. on April 18, 2010. Openings will be provided during the closure periods at the following times: on Saturdays at 8 a.m., 10 a.m., noon, 2 p.m., 4 p.m., 6 p.m., 8 p.m., and 10 p.m., and on Sundays at midnight, 2 a.m., 4 a.m., 6 a.m., 8 a.m., 10 a.m., noon, 2 p.m., 4 p.m., and 6 p.m.
The Atlantic Intracoastal Waterway caters to a variety of vessels from tug and barge traffic to recreational vessels traveling from Florida to Maine. The Coast Guard has carefully coordinated the restrictions with commercial and recreational waterway users. Additionally, the Coast Guard will inform unexpected users of the waterway through our local and broadcast Notices to Mariners of the closure periods for the bridge so that vessels can arrange their transits to minimize any impacts caused by the temporary deviation. The Atlantic Ocean is the alternate route for vessels and the bridge will be able to open in the event of an emergency.
In accordance with 33 CFR 117.35(e), the draw must return to its original operating schedule immediately at the end of the designated time period. This
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the drawbridge operation regulation for the Coos Bay Railroad Bridge, Coos Bay, mile 9.0, at North Bend, Oregon to delete the requirement for special sound signals used in foggy weather and to change the name of the owner. The change is necessary to make the sound signals used at the bridge consistent with other bridges in the area and to eliminate the unnecessary special sound signals.
This rule is effective April 30, 2010.
Comments and related materials received from the public, as well as documents mentioned in this preamble as being available in this docket are part of docket USCG-2009-0840 and are available online by going to
If you have questions on this rule, call or email Austin Pratt, Chief, Bridge Section, Waterways Management Branch, 13th Coast Guard; telephone 206-220-7282, e-mail
On November 16, 2009, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Port of Coos Bay Railroad Bridge, Coos Bay, North Bend, OR, in the
This rule will remove the requirements at the Port of Coos Bay Railroad Bridge, Coos Bay, mile 9.0, at North Bend, Oregon for a bell to be rung continuously in foggy weather and that a siren be sounded in foggy weather when the swingspan is closed. The movable span is normally kept in the open position except for the passage of trains or maintenance work. The rule will also change the regulation to reflect the bridge's current owner as the Port of Coos Bay.
The bell and siren at this drawbridge are not standard requirements at drawbridges and there is nothing specific to this bridge that currently warrants the continuance of these signals. Vessel traffic through the swingspan includes tugs and tows and a variety of recreational craft. Oceangoing ship traffic has diminished greatly in recent decades.
The operating regulations currently in effect for the bridge are found at 33 CFR 117.871. These state that the bridge be maintained normally in the open position except for the passage of trains or maintenance. The aforementioned sound signals are also prescribed.
No comments on the proposed rule were received and no changes were made to it.
We developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard has made this finding based on the fact that the rule will have no known impact on the maritime public.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities because it will have no known impact on any vessel traffic.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the proposed rule so that they can better evaluate its effects on them and participate in the rulemaking process.
This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of Information and Regulatory Affairs has not designated this as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
Bridges.
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.2.
The draw of the Port of Coos Bay railroad bridge, mile 9.0 at North Bend, shall be maintained in the fully open position, except for the crossing of trains or maintenance.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Eleventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the I Street Drawbridge across the Sacramento River, mile 59.4, at Sacramento, CA. The deviation is necessary to allow the bridge owner to make bridge repairs.
This deviation is effective from 8 a.m. to 6 p.m. on March 30, 2010.
Documents mentioned in this preamble as being available in the docket are part of the docket USCG-2010-0152 and are available online by going to
If you have questions on this rule, call or e-mail David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516, e-mail
Union Pacific Railroad Company requested a temporary change to the operation of the I Street Drawbridge, mile 59.4, over Sacramento River, at Sacramento, CA. The I Street Drawbridge navigation span provides 109 feet vertical clearance above Mean High Water in the full open-to-navigation position, and 30 feet vertical clearance above Mean High Water when closed. The draw opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other times the draw shall open on signal if at least four hours notice is given, as required by 33
The drawspan will be secured in the closed-to-navigation position from 8 a.m. to 6 p.m. on March 30, 2010, to allow the bridge owner to remove and replace the oil in the operating machinery for the drawspan. This temporary deviation has been coordinated with waterway users. There are no scheduled river boat cruises or anticipated levee maintenance during this deviation period. No objections to the proposed temporary deviation were raised. The drawspan can be opened with 2 hours advance notice for emergencies requiring the passage of waterway traffic.
Vessels that can transit the bridge, while in the closed-to-navigation position, may continue to do so at any time.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the regulation governing the operation of the LA 75 pontoon bridge, mile 38.4, in Iberville Parish, Louisiana. The Iberville Parish School Board requested that the operating regulation of the LA 75 pontoon bridge be changed to add an additional 30 minutes to the end of the morning scheduled closure period to provide more time for school buses to transit across the bridge. The additional time is needed as a result of school redistricting.
This rule is effective April 30, 2010.
Comments and related materials received from the public, as well as documents mentioned in this preamble as being available in the docket, are part of docket USCG-2009-0686 and are available online by going to
On November 10, 2009, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Lower Grand River, Iberville Parish, LA in the
The Iberville Parish School Board requested a change in the operation regulation for the LA 75 pontoon and the LA 77 swing bridge across the Lower Grand River, mile 38.4 and 47.0, respectively, in Iberville Parish, Louisiana. The change would add an additional 30 minutes to the end of each scheduled closure period to provide more time for school buses to transit across the bridge. Extra time is now needed because one of Iberville Parish's high schools has been closed. School bus lines have been rerouted, creating the need to have more time to transit the students over the bridges.
Presently, 33 CFR 117.478(a) and (b) states: The draw of the LA 75 bridge, mile 38.4 (Alternate Route) at Bayou Sorrel and the draw of the LA 77 bridge, mile 47.0 (Alternate Route) at Grosse Tete, shall open on signal; except that, from about August 15 to about June 5 (the school year), the draw of the LA 75 bridge need not be opened from 6 a.m. to 7:30 a.m. and from 3 p.m. to 4:30 p.m. and the draw of the LA 77 bridge need not be opened from 6 a.m. to 8 a.m. and from 2:30 p.m. to 4:30 p.m., Monday through Friday except Federal holidays. The draws shall open on signal at any time for an emergency aboard the vessel.
Concurrent with the publication of the notice of proposed rulemaking, a test deviation [USCG-2009-0686] was issued to allow the Iberville Parish School Board to test the proposed schedule and to obtain data and public comments. The test deviation allowed the bridges to operate as follows: The draw of the LA 75 bridge, mile 38.4 (Alternate Route) at Bayou Sorrel and the draw of the LA 77 bridge, mile 47.0 (Alternate Route) at Grosse Tete, shall open on signal; except that, from about August 15 to about June 5 (the school year), the draw of the LA 75 bridge need not be opened from 6 a.m. to 8 a.m. and from 3 p.m. to 5 p.m. and the draw of the LA 77 bridge need not be opened from 6 a.m. to 8:30 a.m. and from 2:30 p.m. to 5 p.m., Monday through Friday except Federal holidays. The draws shall open on signal at any time for an emergency aboard the vessel. The test period was in effect from November 25, 2009 until December 28, 2009.
One comment was received on November 11, 2009, before the test deviation went into effect, from a mariner expressing concern about the curfew changes. He is concerned because he believes there is already a congestion problem on the waterway during the closure periods and the additional 30 minutes would make the congestion worse. We did not receive any comments during or after the test deviation.
The Coast Guard has reviewed bridge tender logs from before, during, and after the test deviation became effective. The logs do not indicate an appreciable difference in the number of openings with the additional 30 minute closure period. The Coast Guard also reviewed the school buses crossing the bridges during the test deviation. The report indicated that the only time extension needed for the school buses is the morning closure for LA 75 pontoon bridge at Bayou Sorrel. Based on the research and data that was reviewed and the comment that was received, the Coast Guard has determined that the permanent change to the operating regulation for the Bayou Sorrel, LA 75 pontoon bridge morning closure period is warranted. The LA 75 pontoon bridge at Bayou Sorrel afternoon bridge closure and the LA 77 swing bridge at Grosse Tete morning and afternoon closures will remain as they are presently regulated.
The Coast Guard received one comment from a mariner on November 11, 2009. Although he recognizes the importance of getting children to school at the proper times, he is worried about the increase in the duration of time that the bridges would be closed because it would add to a current congestion issue during those periods of closure. The Coast Guard has analyzed the data and research on the impact of the time
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. The changes have a minimal impact on maritime traffic transiting the bridge. Mariners can plan their trips in accordance with the scheduled bridge openings. The changes to the regulatory text published in the NPRM will be less restrictive than what was published. The afternoon closure at the LA 75 pontoon bridge at Bayou Sorrel and both the morning and afternoon closures at the LA 77 swing bridge at Grosse Tete will remain unchanged to what is currently published in the operating regulations.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels that would be transiting the bridge during that 30 minute increment of time. Because the amount of time that would be added to the current bridge closure period is minimal, this rule will not affect a substantial number of small entities and therefore will not have a substantial economic impact.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM (SNPRM) we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
Bridges.
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The draw of the LA 75 bridge, mile 38.4 (Alternate Route) at Bayou Sorrel, shall open on signal; except that from about August 15 to about June 5 (the school year), the draw need not be opened from 6 a.m. to 8 a.m. and from 3 p.m. to 4:30 p.m., Monday through Friday except holidays. The draw shall open on signal at any time for an emergency aboard a vessel.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Route 6 New Bedford Fairhaven Bridge across the Acushnet River, mile 0.0, between New Bedford and Fairhaven, Massachusetts. This temporary deviation is necessary to facilitate a public event, the Greater New Bedford Community Health Center 5K Road Race, by allowing the bridge to remain in the closed position for two hours during the running of the 5K Road Race.
This deviation is effective from 10 a.m. through 12 p.m. on May 30, 2010.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2010-0167 and are available online at
If you have questions on this rule, call or e-mail Mr. John McDonald, Project Officer, First Coast Guard District, telephone (617) 223-8364,
The Route 6 New Bedford Fairhaven Bridge, across the Acushnet River at mile 0.0, between New Bedford and Fairhaven, Massachusetts, has a vertical clearance in the closed position of 6 feet at mean high water and 10 feet at mean low water. The Drawbridge Operation Regulations are listed at 33 CFR 117.585. The bridge opens on the hour from 6 a.m. through 10 a.m. and at a quarter past the hour between 11:15 a.m. and 6:15 p.m. The bridge opens on signal at all other times.
The owner of the bridge, Massachusetts Department of Transportation, requested this temporary deviation to facilitate a public event, the Greater New Bedford Community Health Center 5K Road Race.
Under this deviation, the Route 6 New Bedford Fairhaven Bridge may remain in the closed position between 10 a.m. and 12 p.m. on May 30, 2010. The 10 a.m. and 11:15 a.m. openings will be missed as a result of this temporary deviation. Vessels able to pass under the closed draw may do so at any time.
In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Route 1 & 9 (Lincoln Highway) Bridge, mile 1.8, across the Hackensack River at Jersey City, New Jersey. This deviation allows the bridge owner to require a two hour advance notice for bridge openings April through September and several bridge closures to facilitate bridge painting operations. Vessels that can pass under the draw without a bridge opening may do so at all times.
This deviation is effective from April 1, 2010 through September 15, 2010.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2010-0029 and are available online at
If you have questions on this rule call Joe Arca, Project Officer, First Coast Guard District, at (212) 668-7165. If you have questions on viewing the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826.
The Route 1 & 9 (Lincoln Highway) Bridge across the Hackensack River at mile 1.8, at Jersey City, New Jersey, has a vertical clearance in the closed position of 35 feet at mean high water and 40 feet at mean low water. The bridge opens on signal as required by 33 CFR 117.723(a)(5).
The bridge owner, the New Jersey Department of Transportation, requested a temporary deviation to require at least a two hour advance notice for bridge openings to allow workers sufficient time to clear painting equipment from the lift span in order to provide bridge openings.
In addition, several bridge closures will be necessary during the effective time period for this temporary deviation in order to facilitate various phases of this bridge painting project that must be completed with the bridge closed.
The exact times and dates for the bridge closures could not be determined prior to publication of this temporary deviation. They will be announced in the Local Notice to Mariners two weeks prior to their implementation. A broadcast notice to mariners will also be initiated twenty four hours in advance to further inform mariners of the proposed bridge closures.
Under this deviation the Route 1 & 9 (Lincoln Highway) Bridge shall require at least a two hour advance notice for bridge openings from April 1, 2010 through September 15, 2010. In addition, several bridge closures to be announced as stated above, will occur during the effective period of this temporary deviation from April 1, 2010 and September 15, 2010.
Vessels able to pass under the closed draw may do so at all times.
The waterway is primarily used by deep draft tankers, tugs and barge units. Waterway users were advised of the requested bridge closure period and offered no objection.
In accordance with 33 CFR 117.35(e), the bridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard Captain of the Port (COTP), Marine Safety Unit Duluth, MN is establishing a temporary safety zone on the waters of the Red River, MN. This safety zone is being established to ensure the safety of the public. The safety zone will prevent individuals from entering all navigable waters of the Red River in the State of Minnesota north of a line drawn across latitude 46°20′00″ N, including those portions of the river in Wilkin, Clay, Norman, Polk, Marshall and Kittson counties, to the United States-Canada international border.
Documents indicated in this preamble as being available in the docket are part of docket USCG-2010-0198 and are available online by going to
If you have questions on this temporary rule, call or e-mail Aaron L. Gross, Chief of Port Operations, Marine Safety Unit Duluth, Coast Guard; telephone 218-720-5286 ext 111, e-mail
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is necessary to provide for the safety of life and property on navigable waters.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
Flooding conditions along the Red River have created serious dangers to the boating public. The strong currents and floating debris associated with the flooding of the Red River necessitate the Coast Guard limiting access to the portions of the river affected by this rule in order to protect the public.
This temporary safety zone is necessary to ensure the safety of the public from hazards involved with the flooding of the Red River. Restricted access to the Red River by the public will help ensure the safety of persons and property along the Red River.
The Coast Guard is establishing a temporary safety zone to encompass certain waters of the Red River in the Duluth Captain of the Port (COTP) Zone. The safety zone will prevent individuals from entering all navigable waters of the Red River in the State of Minnesota north of a line drawn across latitude 46°20′00″ N, including those portions of the river in Wilkin, Clay, Norman, Polk, Marshall and Kittson counties, to the United States-Canada international border.
The COTP may stop enforcement of this safety zone before 5 p.m. on April
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the portions of the Red River affected by this safety zone.
This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: Few small business entities operate on the affected portion of the river and this rule will be enforced for a limited time, only until the Red River is deemed safe to transit.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Duluth or his designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
(4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Duluth or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Duluth or his on-scene representative.
Environmental Protection Agency (EPA).
Final rule.
In this final action, EPA is issuing a stay for 18 months of the inclusion of fugitive emissions requirements in the federal Prevention of Significant Deterioration (PSD) program published in the
The amendments to 40 CFR parts 51 and 52 in this rule are effective from April 1, 2010 through October 3, 2011. Effective April 1, 2010, the following Code of Federal Regulations sections are administratively stayed until October 3, 2011: 40 CFR 51.165(a)(1)(v)(G), (a)(1)(vi)(C)(3), (a)(1)(ix), (a)(1)(xxviii)(B)(2), (a)(1)(xxviii)(B)(4), (a)(1)(xxxv)(A)(1), (a)(1)(xxxv)(B)(1), (a)(1)(xxxv)(C), (a)(1)(xxxv)(D), (a)(2)(ii)(B), (a)(6)(iii), (a)(6)(iv), and (f)(4)(i)(D); 40 CFR 51.166, (a)(7)(iv)(b), (b)(2)(v), (b)(3)(iii)(c), (b)(3)(iii)(d), (b)(20), (b)(40)(ii)(b), (b)(40)(ii)(d), (b)(47)(i)(a), (b)(47)(ii)(a), (b)(47)(iii), (b)(47)(iv), (r)(6)(iii) and (r)(6)(iv), and (w)(4)(i)(d); 40 CFR part 51, Appendix S, paragraphs II.A.5(vii), II.A.6(iii), II.A.9, II.A.24(ii)(b), II.A.24(ii)(d), II.A.30(i)(a), II.A.30(ii)(a), II.A.30(iii), II.A.30(iv), IV.I.1(ii), IV.J.3, IV.J.4, and IV.K.4(i)(d); and 40 CFR 52.21, (a)(2)(iv)(b), (b)(2)(v), (b)(3)(iii)(b), (b)(3)(iii)(c), (b)(20), (b)(41)(ii)(b), (b)(41)(ii)(d), (b)(48)(i)(a), (b)(48)(ii)(a), (b)(48)(iii), (b)(48)(iv), (r)(6)(iii), (r)(6)(iv), and (aa)(4)(i)(d).
Ms. Carrie Wheeler, Air Quality Policy Division, (C504-03), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number (919) 541-9771; fax
Entities potentially affected by this action include sources in all industry groups. The majority of sources potentially affected are expected to be in the following groups.
Entities potentially affected by the subject rule for this proposed action also include state, local, and tribal governments.
In addition to being available in the docket, an electronic copy of this final rule is also be available on the World Wide Web in the regulations and standards section of our NSR home page located at
On December 19, 2008, the EPA (“we”) issued a final rule revising our requirements of the major NSR programs regarding the treatment of fugitive emissions (“Fugitive Emissions Rule”). 73 FR 77882. The final rule required fugitive emissions to be included in determining whether a physical or operational change results in a major modification only for sources in industries that have been designated through rulemaking under section 302(j) of the CAA. The final rule amended all portions of the major NSR program regulations: Permit requirements, the PSD program, and the emission offset interpretive ruling.
On February 17, 2009, the Natural Resources Defense Council submitted a petition for reconsideration of the December 2008 final rule as provided for in CAA 307(d)(7)(B).
On April 24, 2009, we responded to the February 17, 2009 petition by letter indicating that we were convening a reconsideration proceeding for the inclusion of fugitive emissions challenged in the petition and granting a 3-month administrative stay of the rule contained in the federal PSD program at 40 CFR parts 51 and 52. The letter also indicated that we would publish a notice of proposed rulemaking “in the near future” to address the specific issues for which we are granting reconsideration.
The administrative stay of the Fugitive Emissions Rule became effective on September 30, 2009.
In this final rule we are staying the Fugitive Emissions Rule for 18 months. As described above, the same provisions were administratively stayed for 3 months; however, that stay ended on December 30, 2009. To avoid a gap between the end of the stay and the proposed additional stay, an interim final determination was made to provide an additional stay for 3 months, ending on March 31, 2010. We believe the 18 month additional stay is needed and will provide adequate time for EPA to propose, take comment on, and issue a final action on issues that are associated with the inclusion of fugitive emissions. Therefore, we are issuing this stay of the final Fugitive Emissions Rule in the federal PSD program at 40 CFR 51
When we proposed this stay on February 11, 2010, we did not take comment on any substantive issues concerning the inclusion of fugitive emissions in the NSR program as stated in the Fugitive Emissions Rule. Comments sought were to be limited to the issue of whether to establish this additional stay and how long this stay would be. [75 FR 6823 at 6825].
We received three comments on the proposal for this additional stay of the Fugitive Emissions Rule. The first commenter supported the additional stay for “18 months, 24 months, or however long it takes for the current administration to reverse the rule and return to EPA's longstanding, lawful, and more protective approach.”
One industry coalition commenter opposed the additional 18 month stay to “take substantive action and facilitate resolution of this significant permit applicability issue.” Further, the commenter suggested that any delay “makes compliance with already complex PSD and NSR rules just that more difficult.” No additional detail is provided regarding the difficulties with compliance for these rules. We agree with the industry coalition commenter that EPA should take substantive action to facilitate resolution of this applicability issue. However, we believe that 18 months is necessary to allow EPA sufficient time to propose, take public comment on, and issue a final action concerning the inclusion of fugitive emissions in the federal PSD program. The commenter does not provide further details to demonstrate how this stay negatively impacts compliance. In our view, it is imperative the Fugitive Emissions Rule continue to be stayed while we undergo the reconsideration process to reduce confusion. If it is effective during this process and the Rule is ultimately changed, it would only further complicate compliance with PSD and NSR rules, an issue of concern for the commenter.
The final commenter did not comment specifically on the proposed additional stay, but instead stated that “further reconsideration is unnecessary.” We believe this comment addresses the underlying substance of the Fugitive Emissions rule, which is beyond the scope of this action.
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any new requirements on small entities. We have determined that small businesses will not incur any adverse impacts because EPA is taking this action to propose an additional stay to the regulations at 40 CFR parts 51 and 52 concerning the inclusion of fugitive emissions. No costs are associated with this amendment.
This action does not contain a federal mandate under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for state, local, and tribal governments, in the aggregate, or the private sector in any one year. This action only proposes to put in place an additional stay of the regulations at 40 CFR parts 51 and 52 concerning the inclusion of fugitive emissions. Thus, this rule is not subject to the requirements of sections 202 or 205 of the Unfunded Mandates Reform Act (UMRA).
This final rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments.
This final rule does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in EO 13132. This action only stays the regulations at 40 CFR parts 51 and 52 concerning the inclusion of fugitive emissions.
This action does not have tribal implications, as specified in EO 13175 (65 FR 67249, November 9, 2000). This action will not impose any new obligations or enforceable duties on tribal governments. Thus, EO 13175 does not apply to this action.
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because this proposal only proposes to put in place an additional stay of the regulations at 40 CFR parts 51 and 52 concerning the inclusion of fugitive emissions.
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the Executive Order.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This final rulemaking does not involve technical standards. Therefore, EPA is not using any voluntary consensus standards.
Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority and/or low income populations. This rule stays the regulations at 40 CFR parts 51 and 52 concerning the inclusion of fugitive emissions.
Pursuant to sections 307(d)(1)(J) and 307(d)(1)(V) of the CAA, the Administrator determines that this action is subject to the provisions of section 307(d). Section 307(d)(1)(V) provides that the provisions of section 307(d) apply to “such other actions as the Administrator may determine.”
The Congressional Review Act, 5 U.S.C. 801
Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. 553(b), generally provides that rules may not take effect earlier than 30 days after they are published in the
“The provisions of section 553 through 557 * * * of Title 5 shall not, except as expressly provided in this section, apply to actions to which this subsection applies.”
The statutory authority for this action is provided by section 301(a) of the CAA as amended (42 U.S.C. 7601(a)). This notice is also subject to section 307(d) of the CAA (42 U.S.C. 7407(d)).
Administrative practices and procedures, Air pollution control, Carbon monoxide, Fugitive emissions, Intergovernmental relation, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Transportation, Volatile organic compounds.
Administrative practices and procedures, Air pollution control, Carbon monoxide, Fugitive emissions, Incorporation by reference, Intergovernmental relation, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Transportation, Volatile organic compounds.
23 U.S.C. 101; 42 U.S.C. 7401- 7671q.
2. Effective April 1, 2010, 40 CFR 51.165(a)(1)(v)(G), (a)(1)(vi)(C)(3), (a)(1)(ix), (a)(1)(xxviii)(B)(2), (a)(1)(xxviii)(B)(
3. Effective April 1, 2010 through October 3, 2011, amend 40 CFR 51.165 to add paragraph (a)(4) to read as follows:
(a) * * *
(4) Each plan may provide that the provisions of this paragraph do not apply to a source or modification that would be a major stationary source or major modification only if fugitive emission to the extent quantifiable are considered in calculating the potential to emit of the stationary source or modification and the source does not belong to any of the following categories:
(i) Coal cleaning plants (with thermal dryers);
(ii) Kraft pulp mills;
(iii) Portland cement plants;
(iv) Primary zinc smelters;
(v) Iron and steel mills;
(vi) Primary aluminum ore reduction plants;
(vii) Primary copper smelters;
(viii) Municipal incinerators capable of charging more than 250 tons of refuse per day;
(ix) Hydrofluoric, sulfuric, or citric acid plants;
(x) Petroleum refineries;
(xi) Lime plants;
(xii) Phosphate rock processing plants;
(xiii) Coke oven batteries;
(xiv) Sulfur recovery plants;
(xv) Carbon black plants (furnace process);
(xvi) Primary lead smelters;
(xvii) Fuel conversion plants;
(xviii) Sintering plants;
(xix) Secondary metal production plants;
(xx) Chemical process plants—The term chemical processing plant shall not include ethanol production facilities that produce ethanol by natural fermentation included in NAICS codes 325193 or 312140;
(xxi) Fossil-fuel boilers (or combination thereof) totaling more than 250 million British thermal units per hour heat input;
(xxii) Petroleum storage and transfer units with a total storage capacity exceeding 300,000 barrels;
(xxiii) Taconite ore processing plants;
(xxiv) Glass fiber processing plants;
(xxv) Charcoal production plants;
(xxvi) Fossil fuel-fired steam electric plants of more than 250 million British thermal units per hour heat input;
(xxvii) Any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act.
(i) * * *
(1) * * *
(ii) The source or modification would be a major stationary source or major modification only if fugitive emissions, to the extent quantifiable, are considered in calculating the potential to emit of the stationary source or modification and such source does not belong to any following categories:
(a) Coal cleaning plants (with thermal dryers);
(b) Kraft pulp mills;
(c) Portland cement plants;
(d) Primary zinc smelters;
(e) Iron and steel mills;
(f) Primary aluminum ore reduction plants;
(g) Primary copper smelters;
(h) Municipal incinerators capable of charging more than 250 tons of refuse per day;
(i) Hydrofluoric, sulfuric, or nitric acid plants;
(j) Petroleum refineries;
(k) Lime plants;
(l) Phosphate rock processing plants;
(m) Coke oven batteries;
(n) Sulfur recovery plants;
(o) Carbon black plants (furnace process);
(p) Primary lead smelters;
(q) Fuel conversion plants;
(r) Sintering plants;
(s) Secondary metal production plants;
(t) Chemical process plants—The term chemical processing plant shall not include ethanol production facilities that produce ethanol by natural fermentation included in NAICS codes 325193 or 312140;
(u) Fossil-fuel boilers (or combination thereof) totaling more than 250 million British thermal units per hour heat input;
(v) Petroleum storage and transfer units with a total storage capacity exceeding 300,000 barrels;
(w) Taconite ore processing plants;
(x) Glass fiber processing plants;
(y) Charcoal production plants;
(z) Fossil fuel-fired steam electric plants of more than 250 million British thermal units per hour heat input;
(aa) Any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act; or
F.
(1) Coal cleaning plants (with thermal dryers);
(2) Kraft pulp mills;
(3) Portland cement plants;
(4) Primary zinc smelters;
(5) Iron and steel mills;
(6) Primary aluminum ore reduction plants;
(7) Primary copper smelters;
(8) Municipal incinerators capable of charging more than 250 tons of refuse per day;
(9) Hydrofluoric, sulfuric, or nitric acid plants;
(10) Petroleum refineries;
(11) Lime plants;
(12) Phosphate rock processing plants;
(13) Coke oven batteries;
(14) Sulfur recovery plants;
(15) Carbon black plants (furnace process);
(16) Primary lead smelters;
(17) Fuel conversion plants;
(18) Sintering plants;
(19) Secondary metal production plants;
(20) Chemical process plants—The term chemical processing plant shall not include ethanol production facilities that produce ethanol by natural fermentation included in NAICS codes 325193 or 312140;
(21) Fossil-fuel boilers (or combination thereof) totaling more than 250 million British thermal units per hour heat input;
(22) Petroleum storage and transfer units with a total storage capacity exceeding 300,000 barrels;
(23) Taconite ore processing plants;
(24) Glass fiber processing plants;
(25) Charcoal production plants;
(26) Fossil fuel-fired steam electric plants of more than 250 million British thermal units per hour heat input;
(27) Any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act.
42 U.S.C. 7401
(i) * * *
(1) * * *
(vii) The source or modification would be a major stationary source or major modification only if fugitive emissions, to the extent quantifiable, are considered in calculating the potential to emit of the stationary source or modification and the source does not belong to any of the following categories:
(a) Coal cleaning plants (with thermal dryers);
(b) Kraft pulp mills;
(c) Portland cement plants;
(d) Primary zinc smelters;
(e) Iron and steel mills;
(f) Primary aluminum ore reduction plants;
(g) Primary copper smelters;
(h) Municipal incinerators capable of charging more than 250 tons of refuse per day;
(i) Hydrofluoric, sulfuric, or nitric acid plants;
(j) Petroleum refineries;
(k) Lime plants;
(l) Phosphate rock processing plants;
(m) Coke oven batteries;
(n) Sulfur recovery plants;
(o) Carbon black plants (furnace process);
(p) Primary lead smelters;
(q) Fuel conversion plants;
(r) Sintering plants;
(s) Secondary metal production plants;
(t) Chemical process plants—The term chemical processing plant shall not include ethanol production facilities that produce ethanol by natural fermentation included in NAICS codes 325193 or 312140;
(u) Fossil-fuel boilers (or combination thereof) totaling more than 250 million British thermal units per hour heat input;
(v) Petroleum storage and transfer units with a total storage capacity exceeding 300,000 barrels;
(w) Taconite ore processing plants;
(x) Glass fiber processing plants;
(y) Charcoal production plants;
(z) Fossil fuel-fired steam electric plants of more than 250 million British thermal units per hour heat input;
(aa) Any other stationary source category which, as of August 7, 1980, is being regulated under section 111 or 112 of the Act; or
Environmental Protection Agency (EPA).
Final rule.
EPA is amending 40 CFR 180.560 to add a reference to the active ingredient flucarbazone-sodium (wheat only) to the tolerance for the inert ingredient cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) on wheat forage, wheat grain, wheat hay, and wheat straw. Arysta LifeScience North America, LLC requested this tolerance amendment under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective March 31, 2010. Objections and requests for hearings must be received on or before June 1, 2010, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0714. All documents in the docket are listed in the docket index available at
Karen Samek, Registration division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 347-8825; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR cite at
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0714 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 1, 2010.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in
•
•
•
EPA has received a petition from Arysta LifeScience North America, LLC, 15401 Weston Parkway, Cary, NC 27513, requesting an amendment to the existing tolerances for the inert ingredient (safener) (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinolinoxyacetic acid). For ease of reading this document, acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester will be referred to as cloquintocet-mexyl. EPA published two final rules to establish tolerances for the safener under 40 CFR 180.560 in the
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the chemical. The Agency’s decision document for this action is available on EPA's Electronic Docket at
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by cloquintocet-mexyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rules published on March 5, 2008, December 16, 2005, and June 22, 2000. In these final rules, the Agency reviewed the available information on cloquintocet-mexyl submitted by the petitioners as well as additional information available to EPA. The toxicity database is sufficient for cloquintocet-mexyl and has not changed since the time of those publications. Therefore, only a brief summary is provided here.
Cloquintocet-mexyl has a low order of acute oral, dermal, and inhalation toxicity. It is slightly irritating to the eyes and non-irritating to the skin. Cloquintocet-mexyl is a skin sensitizer. The chemical is not genotoxic and is not a reproductive and developmental toxicant. There is no evidence of neurotoxicity in the available studies. Cloquintocet-mexyl is classified as “not likely to be a human carcinogen.” The main metabolite for cloquintocet-mexyl is 5-chloro-8-quin-linoxyacetic acid, and testing on the metabolite is part of the toxicology database for cloquintocet-mexyl. For additional information on the human health toxicity data for cloquintocet-mexyl and its metabolite, see EPA's Electronic Docket at
In examining aggregate exposure, the FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found cloquintocet-mexyl to share a common mechanism of toxicity with any other substances, and cloquintocet-mexyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cloquintocet-mexyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for cloquintocet-mexyl is complete, except for immunotoxicity and neurotoxicity studies. EPA began requiring these studies on December 26, 2009. In the absence of specific immunotoxicity studies, EPA has evaluated the available toxicity data for cloquintocet-mexyl and determined that an additional database uncertainty factor is not needed to account for potential immunotoxicity. EPA's determination is based on the following considerations.
There was some indication of possible immunotoxicity in the form of lymphoid hyperplasia of the thymus in male rats (without any histopathology changes in the study) at the LOAEL of 73.5 milligrams/kilogram/day (mg/kg/day) in the combined chronic/oncogenicity study in rats (with a NOAEL of 36.4 mg/kg/day). This effect was observed only in males. No blood parameters were affected. In addition, cloquintocet-mexyl does not belong to a class of chemicals that would be expected to be immunotoxic. A clear NOAEL was established for these effects (36.4 mg/kg/day), and the regulatory endpoint of 4.3 mg/kg/day (the NOAEL from the combined chronic/oncogenicity study) is nearly 10X below the NOAEL for the possible immunotoxic effect. Therefore, based on the considerations in this unit, EPA does not believe that conducting immunotoxicity testing will result in a NOAEL significantly less than the NOAEL of 4.3 mg/kg/day already established for cloquintocet-mexyl, and an additional factor (UFDB) for database uncertainties is not needed to account for potential immunotoxicity. A confirmatory immunotoxicity study will be required as a condition of the registration.
No acute and subchronic neurotoxicity studies are available, however, there is no evidence of neurotoxicity in the toxicology database on cloquintocet-mexyl. Therefore, based on the considerations in this unit, the Agency does not believe that conducting acute and subchronic neurotixicty studies will result in a NOAEL less than the NOAEL of 4.3 mg/kg/day. Therefore, there is no need for additional uncertainty factors (UF). Confirmatory acute and subchronic neurotoxicity studies will be required as a condition of registration.
ii. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to
iii. There is no indication that cloquinocet-mexyl is a neurotoxic chemical and thus there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iv. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of cloquintocet-mexyl (currently there are no proposed residential uses and therefore non-occupational exposure is not expected).
For additional information on the Safety Factor determination for infants and children for cloquintocet-mexyl, see the docket and the
EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate safty factors (SFs). EPA calculates the aPAD and cPAD by dividing the point of departure (POD) by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded.
In the 2005 and 2008 rulemakings for cloquintocet-mexyl, EPA concluded that aggregate risks from exposure to cloquintocet-mexyl did not exceed 1% of the aPAD or cPAD for the most exposed population groups. (73 FR 11819); (70 FR 74685). These findings are applicable to this tolerance amendment.
Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to cloquintocet-mexyl and its acid metabolite (5-chloro-8-quinolinoxyacetic acid).
Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Enviromental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; e-mail address: residuemethods@epa.gov. For the complete description of Analytical Methods for cloquintocet-mexyl, see the docket and the
There are no Codex tolerances for cloquintocet-mexyl.
Therefore, 40 CFR 180.560 is amended by establishing a tolerance for the combined residues of cloquintocet-mexyl (acetic acid [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester; CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) when used as an inert ingredient (safener) in pesticide formulations containing the active ingredients flucarbazone-sodium (wheat only), pinoxaden (wheat or barley), clodinafop-propargyl (wheat only), or pyroxsulum (wheat only) in or on barley, grain at 0.1 ppm; barley, hay at 0.1 ppm; barley, straw at 0.1 ppm; wheat, forage at 0.2 ppm; wheat, grain at 0.1 ppm; wheat, hay at 0.5 ppm; and wheat, straw at 0.1 ppm.
This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
(a)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; modification of a closure.
NMFS is opening directed fishing for pollock in the West Yakutat District of the Gulf of Alaska (GOA). This action is necessary to fully use the 2010 total allowable catch (TAC) of pollock in the West Yakutat District of the GOA.
Effective 1200 hrs, Alaska local time (A.l.t.), March 26, 2010, through 2400 hrs, A.l.t., December 31, 2010. Comments must be received at the following address no later than 4:30 p.m., A.l.t., April 12, 2010.
Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by RIN 0648-XV61, by any one of the following methods:
• Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal:
• Mail: P.O. Box 21668, Juneau, AK 99802.
• Fax: (907) 586-7557.
• Hand delivery to the Federal Building: 709 West 9th Street, Room 420A, Juneau, AK.
All comments received are a part of the public record. No comments will be posted to
NMFS will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). You may submit attachments to electronic comments in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
NMFS closed directed fishing for pollock in the West Yakutat District of the GOA under § 679.20(d)(1)(iii) on March 23, 2010 (75 FR 14498, March 26, 2010).
As of March 25, 2010, NMFS has determined that approximately 681 metric tons of pollock remain in the directed fishing allowance for pollock in the West Yakutat District of the GOA. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2010 TAC of pollock in the West Yakutat District of the GOA, NMFS is terminating the previous closure and is reopening directed fishing for pollock in the West Yakutat District of the GOA. The Administrator, Alaska Region (Regional Administrator) considered the following factors in reaching this decision: (1) the current catch of pollock in the West Yakutat District of the GOA and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of pollock in the West Yakutat District of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 25, 2010.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
Without this inseason adjustment, NMFS could not allow the fishery for pollock in the West Yakutat District of the GOA to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until April 12, 2010.
This action is required by § 679.20 and § 679.25 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: The installation of TU250 CS boards, however, has resulted in a few occurrences of erratic engine behaviour, in the form of unexpected N1 variations and/or illumination of the “GOV” warning light. The conclusions from an investigation by Turboméca are that these malfunctions are due to a lapse of quality control in the varnishing process applied to the boards, and that only boards in a specific serial number range, as defined under “Applicability” and referred to below as the “suspect batch,” are affected.
We are proposing this AD to prevent loss of automatic engine control during flight due to an uncommanded engine roll-back, which could result in the inability to continue safe flight.
We must receive comments on this proposed AD by April 30, 2010.
You may send comments by any of the following methods:
•
•
•
•
Contact Turbomeca, 40220 Tarnos, France; telephone 33 05 59 74 40 00; fax 33 05 59 74 45 15, for the service information identified in this proposed AD.
You may examine the AD docket on the Internet at
Kevin Dickert, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2009-0090, dated April 28, 2009 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
The installation of TU250 CS boards, however, has resulted in a few occurrences of erratic engine behaviour, in the form of unexpected N1 variations and/or illumination of the “GOV” warning light. The conclusions from an investigation by Turbomeca are that these malfunctions are due to a lapse of quality control in the varnishing process applied to the boards, and that only boards in a specific serial number range, as defined under “Applicability” and referred to below as the “suspect batch,” are affected.
Turbomeca S.A. has issued Mandatory Service Bulletins No. 298 73 0809, Version A, dated February 12, 2008; and No. 298 73 0810, Version B, dated April 27, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of France, and is approved for operation in the United States. Pursuant to our bilateral agreement with France, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated
Based on the service information, we estimate that this proposed AD would affect about 10 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $3,500 per product. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $35,850.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by April 30, 2010.
(b) None.
(c) This AD applies to Turbomeca S.A. Makila 1A and 1A1 turboshaft engines with a comparator/selector (CS) board, part number (P/N) 0 177 99 716 0, and a serial number (S/N) between 241EL and 1192EL (inclusive) installed. These engines are installed on, but not limited to, Eurocopter AS 332 C, AS 332 C1, AS 332 L, and AS 332 L1 helicopters.
(d) The EASA AD 2009-0090, dated April 28, 2009, states that this AD results from the following:
(1) The installation of TU250 CS boards, however, has resulted in a few occurrences of erratic engine behaviour, in the form of unexpected N1 variations and/or illumination of the “GOV” warning light. The conclusions from an investigation by Turboméca are that these malfunctions are due to a lapse of quality control in the varnishing process applied to the boards, and that only boards in a specific serial number range, as defined under “Applicability” and referred to below as the “suspect batch”, are affected.
(2) We are issuing this AD to prevent loss of automatic engine control during flight due to an uncommanded engine roll-back, which could result in the inability to continue safe flight.
(e) Unless already done, do the following actions.
(1) Within 50 operating hours from the effective date of this AD, replace any CS board, P/N 0 177 99 716 0, with an S/N from 241EL to 1192EL (inclusive), that has fewer than 200 hours-since-new (HSN). Use paragraph 2 of Turbomeca S.A. Mandatory Service Bulletin (MSB) No. 298 73 0809 Version A, dated February 12, 2008, to replace the boards.
(2) During the next 500-hour inspection, replace any CS board, P/N 0 177 99 716 0, with a S/N from 241EL to 1192EL (inclusive), that has 200 HSN or more. Use paragraph 2 of Turbomeca S.A. MSB No. 298 73 0810 Version B, dated April 27, 2009, to replace the boards.
(f) This AD differs from the Mandatory Continuing Airworthiness Information (MCAI) and/or service information as follows:
(1) This AD requires replacing within 50 operating hours after the effective date of this AD, all comparator/selector boards, P/N 0 177 99 716 0, with an S/N from 241EL to 1192EL (inclusive) that have fewer than 200 HSN.
(2) This AD requires replacing at the next 500-hour routine inspection after the effective date of this AD, all comparator/selector boards, P/N 0 177 99 716 0, with a S/N from 241EL to 1192EL (inclusive) that have 200 HSN or more.
(g)
(h) Refer to MCAI EASA Airworthiness Directive 2009-0090, dated April 28, 2009, and Turbomeca S.A. Mandatory Service Bulletins No. 298 73 0809, Version A, dated February 12, 2008; and No. 298 73 0810, Version B, dated April 27, 2009, for related information. Contact Turbomeca, 40220 Tarnos, France; telephone 33 05 59 74 40 00; fax 33 05 59 74 45 15, for a copy of this service information.
(i) Contact Kevin Dickert, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify the Norton Sound Low and Control 1234L Offshore Airspace Areas in Alaska. This action would lower the airspace floors to provide controlled airspace beyond 12 miles from the coast of the United States given that there is a requirement to provide Instrument Flight Rules (IFR) en route Air Traffic Control (ATC) services and within which the United States is applying domestic ATC procedures.
Comments must be received on or before May 17, 2010.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: (202) 366-9826. You must identify FAA Docket No. FAA-2010-0071 and Airspace Docket No. 10-AAL-1 at the beginning of your comments. You may also submit comments through the Internet at
Ken McElroy, Airspace and Rules Group, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone: (202) 267-8783.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2010-0071 and Airspace Docket No. 10-AAL-1) and be submitted in triplicate to the Docket Management Facility (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2010-0071 and Airspace Docket No. 10-AAL-1.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to modify the Norton Sound Low and Control 1234L Offshore Airspace Areas in Alaska.
The Norton Sound Low Offshore Airspace Area would be modified by lowering the offshore airspace floor to 1,200 feet mean sea level (MSL) at the following airports; within 73 miles of Clarks Point, King Salmon, Kivalina, Kwethluk, Napakiak, Scammon Bay, Shaktooklik, and Tooksook Bay; within 74 miles of Elim and Manokotak, and within 72.5 miles of Red Dog.
The Control 1234L Offshore Airspace Area would be modified by lowering the offshore airspace floor to 1,200 feet above the surface within 73 miles of Nikolski, and Toksook Bay Airports.
Offshore airspace areas are published in paragraph 2003 of FAA Order 7400.9T dated August 27, 2009 and effective September 15, 2009, which is incorporated by reference in 14 CFR 71.1. The offshore airspace areas listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies offshore airspace areas in Alaska.
As part of this proposal relates to navigable airspace outside the United States, this notice is submitted in accordance with the International Civil Aviation Organization (ICAO) International Standards and Recommended Practices.
The application of International Standards and Recommended Practices by the FAA, Office of System Operations Airspace and AIM, Airspace and Rules Group, in areas outside the United States domestic airspace, is governed by the Convention on International Civil Aviation. Specifically, the FAA is governed by Article 12 and Annex 11, which pertain to the establishment of necessary air navigational facilities and services to promote the safe, orderly, and expeditious flow of civil air traffic. The purpose of Article 12 and Annex 11 is to ensure that civil aircraft operations on international air routes are performed under uniform conditions.
The International Standards and Recommended Practices in Annex 11 apply to airspace under the jurisdiction of a contracting state, derived from ICAO. Annex 11 provisions apply when air traffic services are provided and a contracting state accepts the responsibility of providing air traffic services over high seas or in airspace of undetermined sovereignty. A contracting state accepting this responsibility may apply the International Standards and Recommended Practices that are consistent with standards and practices utilized in its domestic jurisdiction.
In accordance with Article 3 of the Convention, state-owned aircraft are exempt from the Standards and Recommended Practices of Annex 11. The United States is a contracting state to the Convention. Article 3(d) of the Convention provides that participating state aircraft will be operated in international airspace with due regard for the safety of civil aircraft. Since this action involves, in part, the designation of navigable airspace outside the United States, the Administrator is consulting with the Secretary of State and the Secretary of Defense in accordance with the provisions of Executive Order 10854.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and effective September 15, 2009, is to be amended as follows:
That airspace extending upward from 14,500 feet MSL within an area bounded by a line beginning at lat. 56°42′59″ N., long. 160°00′00″ W., north by a line 12 miles from and parallel to the U.S. coastline to the intersection with 164°00′00″ W., longitude near the outlet to Kotzebue Sound, then north to the intersection with a point 12 miles from the U.S. coastline, then north by a line 12 miles from and parallel to the shoreline to lat. 68°00′00″ N., to lat. 68°00′00″ N., long. 168°58′23″ W., to lat. 65°00′00″ N., long. 168°58′23″ W., to lat. 62°35′00″ N., long. 175°00′00″ W., to lat. 59°59′57″ N., long. 168°00′08″ W., to lat. 57°45′57″ N., long. 161°46′08″ W., to lat. 58°06′57″ N., long. 160°00′00″ W., to the point of beginning; and that airspace extending upward from 1,200 feet MSL north of the Alaska Peninsula and east of 160° W. longitude within 73 miles of the Port Heiden NDB/DME, AK, and north of the Alaska Peninsula and east of 160° W. longitude within an 81.2-mile radius of the Perryville Airport, AK, and north of the Alaska Peninsula and east of 160° W. longitude within a 72.8-mile radius of the Chignik Airport, AK, and within a 35-mile radius of lat. 60°21′17″ N., long. 165°04′01″ W., and within a 73-mile radius of the Chevak Airport, AK, and within a 73-mile radius of the Clarks Point Airport, AK, and within a 73-mile radius of the Elim Airport, AK, and within a 45-mile radius of the Hooper Bay Airport, AK, and within a 73-mile radius of the King Salmon Airport, AK, and within a 73-mile radius of the Kivalina Airport, AK, and within a 74-mile radius of the Kotzebue VOR/DME, AK, and within a 73-mile radius of the Kwethluk Airport, AK, and within a 74-mile radius of the Manokotak Airport, AK, and within a 73-mile radius of the Napakiak Airport, AK, and within a 77.4-mile radius of the Nome VORTAC, AK, and within a 71NM radius of the New Stuyahok Airport, AK, and within a 73-mile radius of the Noatak Airport, AK, and within a 72.5-mile radius of the Red Dog Airport, AK, and within a 73-mile radius of the Scammon Bay Airport, AK, and within a 73-mile radius of the Shaktoolik Airport, AK, and within a 74-mile radius of the Selawik Airport, AK, and within a 73-mile radius of the St. Michael Airport, AK, and within a 73-mile radius of the Toksook Bay Airport, AK, and within a 30-mile radius of lat. 66°09′58″ N., long. 166°30′03″ W., and within a 30-mile radius of lat. 66°19′55″ N., long. 165°40′32″ W., and that airspace extending upward from 700 feet MSL within 8 miles west and 4 miles east of the 339° bearing from the Port Heiden NDB/DME, AK, extending from the Port Heiden NDB/DME, AK, to 20 miles north of the Port Heiden NDB/DME, AK, and within a 25-mile radius of the Nome Airport, AK.
That airspace extending upward from 2,000 feet above the surface within an area bounded by a line beginning at lat. 58°06′57″ N., long. 160°00′00″ W., then south along 160°00′00″ W. longitude, until it intersects the Anchorage Air Route Traffic Control Center (ARTCC) boundary; then southwest, northwest, north, and northeast along the Anchorage ARTCC boundary to lat. 62°35′00″ N., long. 175°00′00″ W., to lat. 59°59′57″ N., long. 168°00′08″ W., to lat. 57°45′57″ N., long. 161°46′08″ W., to the point of beginning; and that airspace extending upward from 1,200 feet above the surface within a 26.2-mile radius of Eareckson Air Station, AK, within an 11-mile radius of Adak Airport, AK, and within 16 miles of Adak Airport, AK, extending clockwise from the 033° bearing to the 081° bearing from the Mount Moffett NDB, AK, and within a 10-mile radius of Atka Airport, AK, and within a 10.6-mile radius from Cold Bay Airport, AK, and within 9 miles east and 4.3 miles west of the 321° bearing from Cold Bay Airport, AK, extending from the 10.6-mile radius to 20 miles northwest of Cold Bay Airport, AK, and 4 miles each side of the 070° bearing from Cold Bay Airport, AK, extending from the 10.6-mile radius to 13.6 miles northeast of Cold Bay Airport, AK, and within a 26.2-mile radius of Eareckson Air Station, AK, and west of 160° W. longitude within an 81.2-mile radius of Perryville Airport, AK, and within a 73-mile radius of the Nikolski Airport, AK, within a 74-mile radius of the Manokotak Airport, AK, and within a 73-mile radius of the Clarks Point Airport, AK and west of 160° W. longitude within a 73-mile radius of the Port Heiden NDB/DME, AK, and within a 10-mile radius of St. George Airport, AK, and within a 73-mile radius of St. Paul Island Airport, AK, and within a 20-mile radius of Unalaska Airport, AK, extending clockwise from the 305° bearing from the Dutch Harbor NDB, AK, to the 075° bearing from the Dutch Harbor NDB, AK, and west of 160° W. longitude within a 25-mile radius of the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of North Dakota on April 6, 2009. Specifically, EPA is proposing approval of revisions to the North Dakota air pollution control rules regarding prevention of significant deterioration of air quality, and partial approval of the SIP revision “Interstate Transport of Air Pollution” addressing the requirements of Clean Air Act section 110(a)(2)(D)(i) for the 1997 PM
Comments must be received on or before April 30, 2010.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2009-0282, by one of the following methods:
•
•
•
•
•
Domenico Mastrangelo, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303) 312-6436,
For the purpose of this document, we are giving meaning to certain words or initials as follows:
(i) The words or initials
(ii) The words
(iii) The initials
(iv) The words
What should I consider as I prepare my comments for EPA?
1.
2.
a. Identify the rulemaking by docket number and other identifying information (subject heading,
b. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
c. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
d. Describe any assumptions and provide any technical information and/or data that you used.
e. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
f. Provide specific examples to illustrate your concerns, and suggest alternatives.
g. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
h. Make sure to submit your comments by the comment period deadline identified.
EPA is proposing approval of revisions to the State provisions on the prevention significant deterioration (PSD) of air quality in subsection 33-15-15-01.2 of the North Dakota Administrative Code (NDAC), and is also proposing partial approval of the North Dakota Interstate Transport of Air Pollution SIP for the 1997 PM
Section 110(k) of the CAA addresses EPA's rulemaking action on SIP submissions by states. The CAA requires states to observe certain procedural requirements in developing SIP revisions for submittal to EPA. Section 110(a)(2) of the CAA requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a state to EPA.
The North Dakota Department of Health (NDDH) held a public hearing on October 7, 2008 for revisions to subsection 33-15-15-01.02 of the NDAC and for the addition to the North Dakota SIP of the Interstate Transport non-regulatory provisions. The NDDH adopted the provisions on April 1, 2009 and submitted them to EPA on April 6, 2009.
In a March 2, 2010 email, EPA requested that the North Dakota Air Quality Division clarify the State commitment, stated in the Interstate Transport SIP submitted to EPA April 6, 2009, to EPA's interim policy on the use of PM
We have evaluated the submittal by the NDDH and have determined that the State met the requirements of section 110(a)(2) of the CAA for reasonable notice and public hearing.
The revisions to subsection 33-15-15-01.2 updated to August 1, 2007 the baseline date for incorporation by reference of the Federal requirements at 40 CFR 52.21. In addition, various administrative corrections and clarifications were made. As these revisions were made to make the PSD provisions consistent with Federal requirements, they are approvable.
The interstate transport provisions at CAA section 110(a)(2)(D)(i), also referred to as the “good neighbor”
To demonstrate that its SIP satisfies the requirements for significant contribution to nonattainment, North Dakota relies on a combination of: (a) EPA modeling analysis results published in Federal Register notices as part of the Clean Air Interstate Rule (CAIR) rulemaking process;
Section 110(a)(2)(D)(i) provides that EPA cannot approve a state's SIP for a new or revised NAAQS unless it contains adequate measures to prohibit emissions from sources within the state from contributing significantly to nonattainment of the NAAQS in another state. EPA's August 15, 2006, guidance to states concerning section 110(a)(2)(D)(i) recommended various methods by which states might evaluate whether or not its emissions significantly contribute to violations of the 1997 PM
Although significant contribution must be measured not just against nonattainment areas, but against areas with monitors showing violations of the NAAQS, nonattainment areas are a convenient starting point for the analysis. For the 1997 annual PM
A number of considerations provide evidence that North Dakota emissions are unlikely to contribute significantly to the violations of the 1997 annual PM
The fact that monitors located between North Dakota and Libby are not registering violations of the NAAQS does not conclusively establish that emissions from North Dakota could not contribute in the aggregate to violations
Similarly, available information indicates that North Dakota emissions are unlikely to contribute significantly to the violations of the 1997 annual PM
As mentioned above, EPA must consider not only significant contribution to nonattainment areas, but also to areas with monitors showing violations of the NAAQS. A review of the AQS monitoring data for adjacent downwind states shows that it is highly unlikely that emissions from North Dakota contribute significantly to downwind areas that have monitors showing violations of the 1997 24-hour and annual PM
In South Dakota, monitors in Minnehaha and Brookings Counties had the highest design values for 1997 24-hour PM
In Minnesota, during 1999-2008, the highest design values for 1997 24-hour PM
In Iowa, the highest 24-hour PM
The data and weight of evidence analysis presented above support the conclusion of the North Dakota Interstate Transport SIP (adopted April 1, 2009 and submitted April 6, 2009) that emissions from North Dakota do not contribute significantly to nonattainment in any other state for the 1997 PM
As noted above, Section 110(a)(2)(D)(i) provides that EPA cannot approve a state's SIP for a new or revised NAAQS unless it contains adequate measures to prohibit emissions from sources within the state from contributing significantly to nonattainment of the NAAQS in another state. EPA's August 15, 2006, guidance to states concerning section 110(a)(2)(D)(i) recommended various methods by which states might evaluate whether or not its emissions significantly contribute to violations of the 1997 ozone standards in another state. Among other methods, EPA recommended consideration of available EPA modeling conducted in conjunction with CAIR, or in the absence of such EPA modeling, consideration of other information such as the amount of emissions, the geographic location of violating areas, meteorological data, or various other forms of information that would be relevant to assessing the likelihood of significant contribution to violations of the NAAQS in another state. The assessment of significant contribution to nonattainment is not restricted to impacts upon areas that are formally designated nonattainment. Consistent with EPA's approach in CAIR, this impact must be evaluated with respect to monitors showing a violation of the NAAQS (70 FR 25172, May 12, 2005, and 63 FR 57371, October 27, 1998). Furthermore, although relevant information other than modeling may be considered in assessing the likelihood of significant contribution to violations of the 1997 8-hour ozone standard in another state, EPA notes that no single piece of information in the following discussion is by itself dispositive of the issue. Instead, the total weight of all the evidence taken together supports the conclusion that emissions from North Dakota sources are unlikely to contribute significantly to violations in another state of the 1997 8-hour ozone standard.
Although significant contribution must be measured not just against nonattainment areas, but against areas with monitors showing violations of the NAAQS, nonattainment areas are a convenient starting point for the analysis. For the 1997 8-hour ozone NAAQS, the North Dakota Interstate Transport SIP revision identifies the Denver Metro Area/North Front Range (DMA/NFR) in Colorado, and the Illinois and Wisconsin counties along the southwestern shores of Lake Michigan as the closest designated nonattainment areas.
The DMA/NFR nonattainment area is approximately 550 miles southwest of Bismarck, North Dakota.
Another transport factor is wind direction. Research for North Dakota and states immediately to the south and east shows that in North Dakota both surface and regional transport winds from the northeast, needed to transport ozone to the DMA/NFR area, are generally rare. Thirty years of data collected by the United States Geological Survey (USGS) on surface wind direction for several North Dakota locations show that there was much variability by location and time of the year, with the exception of northeasterly winds, which were very infrequent.
The Illinois/Wisconsin counties along the southwestern shores of Lake Michigan (which make up the other nonattainment area within possible transport distance of North Dakota) are approximately 700 miles east-southeast from Bismarck. The CAIR modeling domain for 8-hour ozone transport analysis included only the eastern half of North Dakota, and the CAIR modeling analysis did not determine whether NO
Additional ozone transport factors specific to North Dakota are distance from the nonattainment area and prevailing orientation of the winds. As noted above, Bismarck is approximately 700 miles from the Illinois/Wisconsin nonattainment area, a distance which does not exclude the realistic possibility that significant ozone transport might occur. Research on surface wind direction in North Dakota, reflected in the USGS data referenced earlier, shows a great variability depending on location and time of the year. Northwesterly winds are more frequent than southwesterly or southeasterly winds considered separately, but less frequent
This conclusion is supported by the recent attainment demonstration developed for the nonattainment counties along the western shores of Lake Michigan by the Wisconsin Department of Natural Resources (WDNR). The WDNR analysis identifies heavy industrial activity and dense urbanization as the major local contributors to the high ozone concentrations in the Illinois and Wisconsin Counties along the southwestern shores of Lake Michigan. Regional ozone transport is thought to contribute from 40 to 60% of the maximum ozone concentrations in the Lake Michigan airshed, and the contributing transport is estimated to originate from south-southwesterly areas, within a span of 160 to 270 degrees. Any ozone transport from North Dakota would fall outside this span. The WDNR finding, in combination with the results of the analysis for other transport factors presented above, strengthens the conclusion that it is unlikely that emissions from North Dakota sources contribute significantly to the nonattainment of the Illinois/Wisconsin Counties on the southwestern shores of Lake Michigan.
Finally, by 2008, the 8-hour ozone design values for the Illinois and Wisconsin nonattainment counties along the shores of Lake Michigan fell below the level of the NAAQS, a reduction attributed to the implementation of State and Federal control measures since the designation of these counties as nonattainment in 2004. In other words, were there emissions from North Dakota sources reaching the Illinois and Wisconsin counties along the western rim of Lake Michigan, they would no longer be significantly contributing to violations of the NAAQS in that area.
As mentioned above, EPA must consider not only significant contribution to nonattainment areas, but also to areas with monitors showing violations of the NAAQS. A review of the AQS monitoring data for adjacent downwind states shows that it is highly unlikely that emissions from North Dakota contribute significantly to downwind areas that have monitors showing violations of the 1997 8-hour ozone NAAQS. Between 1999 and 2008 there were no violations of the 1997 8-hour ozone NAAQS at any of the monitors in adjacent downwind states, such as Minnesota, South Dakota and Iowa.
The design values for Minnesota, South Dakota and Iowa during the 1999-2008 years remained substantially below the 1997 NAAQS in most counties, as shown by the highest design values. In South Dakota, the highest design values were in Custer and Jackson Counties, where they peaked, respectively, at 71 and at 68 ppb. In Minnesota, the highest design values were in Anoka and Washington Counties, where they peaked at 75 ppb. In Iowa, the highest design values were in Clinton and Scott Counties, where they reached levels between 78 and 80 ppb in the early part of the 1999-2008 period, and decreased to levels, respectively, between 67 and 72, and 65 and 70 ppb during 2006-2008. The decrease of Iowa ozone levels between 1998 and 2008 can be gauged by comparing the peak levels of 79-80 ppb in 2000-2003 with peak levels of 70-75 ppb in 2006-2008.
The data and weight of evidence analysis presented above support the conclusion of the North Dakota Interstate Transport SIP (adopted April 1, 2009 and submitted April 6, 2009) that emissions from North Dakota do not contribute significantly to nonattainment in any other state for the 1997 8-hour ozone NAAQS, consistently with the requirements of element (1) of CAA section 110(a)(2)(D)(i).
The third element of section 110(a)(2)(D)(i) requires a SIP to contain adequate provisions prohibiting emissions that interfere with any other state's required measures to prevent significant deterioration of its air quality. The State of North Dakota interstate transport SIP is consistent with the 2006 guidance. The SIP indicates in Section 7.8.1, subsection C, “Impact on Prevention of Significant Deterioration (PSD),” that the State's SIP provisions include an EPA-approved PSD program applicable to all regulated pollutants. North Dakota's regulations for its PSD program were federally-approved and made part of the SIP on November 2, 1979 (44 FR 63103). On July 19, 2007, EPA approved the North Dakota PSD revisions incorporating EPA's December 31, 2002 NSR Reforms into the State's regulations (72 FR 39564). North Dakota does not have nonattainment areas for any of the criteria pollutants and therefore does not have a Nonattainment New Source Review (NNSR) program.
Consistent with EPA's November 29, 2005 Phase II rule for the 1997 8-hour ozone standard (70 FR 71612), the State updated, effective April 1, 2009, its PSD provisions by incorporating by reference most of the federal provisions at 52.21, including the definition of regulated NSR pollutant at 52.21(b)(50), listing NO
For PM
On the basis of the data and analysis presented above, EPA concludes that the North Dakota Interstate Transport
EPA is proposing approval of revisions, submitted by the Governor of North Dakota with a letter dated April 6, 2009, to the prevention of significant deterioration provisions in subsection 33-15-15 of the NDAC, and partial approval of the addition to the State SIP of the “Interstate Transport of Air Pollution” SIP addressing the requirements of Clean Air Act section 110(a)(2)(D)(i) for the 1997 PM
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing partial approval of the State Implementation Plan (SIP) revisions “State of Colorado Implementation Plan to Meet the Requirements of Clean Air Act Section 110(a)(2)(D)(i)(I)—Interstate Transport Regarding the 1997 8-Hour Ozone Standard” submitted by the State of Colorado on June 18, 2009. The Colorado Interstate Transport SIP revisions submitted June 18, 2009 address the requirements of Clean Air Act section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS). In this
Comments must be received on or before April 30, 2010.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2007-1032, by one of the following methods:
•
•
•
•
•
Domenico Mastrangelo, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303) 312-6436,
For the purpose of this document, we are giving meaning to certain words or initials as follows:
(i) The words or initials
(ii) The words
(iii) The initials
(iv) The words
1.
2.
a. Identify the rulemaking by docket number and other identifying information (subject heading,
b. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
c. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
d. Describe any assumptions and provide any technical information and/or data that you used.
e. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
f. Provide specific examples to illustrate your concerns, and suggest alternatives.
g. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
h. Make sure to submit your comments by the comment period deadline identified.
Section 110(a)(2)(D)(i) of the CAA requires that a state's SIP must contain adequate provisions prohibiting any source or other type of emissions activity within the state from emitting any air pollutant in amounts which will: (1) Contribute significantly to nonattainment of the NAAQS in any other state; (2) interfere with maintenance of the NAAQS by any other state; (3) interfere with any other state's required measures to prevent significant deterioration of air quality; or (4) interfere with any other state's required measures to protect visibility. On June 11, 2008, the State of Colorado submitted to EPA an Interstate Transport SIP addressing the interstate transport requirements of CAA section 110(a)(2)(D)(i) for the 1997 PM
EPA is proposing partial approval of the Colorado Interstate Transport of Air Pollution SIP addressing the requirements of CAA section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone NAAQS. On December 30, 2008, the Colorado Air Quality Control Commission (AQCC) adopted the “State of Colorado Implementation Plan to Meet the Requirements of the Clean Air Act Section 110(a)(2)(d)(i)(I)—Interstate Transport Regarding the 1997 8-Hour Ozone Standard.” Colorado submitted the December 30, 2008 SIP revision to EPA on June 18, 2009. In this
Section 110(k) of the CAA addresses EPA's rulemaking action on SIP submissions by states. The CAA requires states to observe certain procedural requirements in developing SIP revisions for submittal to EPA. Section 110(a)(2) of the CAA requires that each SIP revision be adopted after reasonable notice and public hearing. This must occur prior to the revision being submitted by a state to EPA.
The Colorado AQCC held a public hearing in December 2008 for the interstate transport SIP revision: “State of Colorado Implementation Plan to Meet the Requirements of Clean Air Act Section 110(a)(2)(D)(i)(I)—Interstate Transport Regarding the 1997 8-Hour Ozone Standard.” The AQCC adopted this revision on December 30, 2008, and the State submitted it to EPA on June 18, 2009.
On November 18, 2009, the AQCC provided EPA with an exact color duplicate of the SIP adopted by the AQCC on December 30, 2008 and included in the June 18, 2009 submittal to EPA. In the original submittal, AQCC provided a black and white copy. The SIP's color duplicate, available for review as part of the Docket, makes it easier to understand modeling results reported in several graphs that are part of the SIP technical demonstration.
EPA has reviewed the submittal from the State of Colorado and has determined that the State met the requirements for reasonable notice and public hearing under section 110(a)(2) of the CAA.
The interstate transport provisions at CAA section 110(a)(2)(D)(i), also referred to as the “good neighbor” provisions, require that each state's SIP contain adequate provisions prohibiting emissions that adversely affect any other state's air quality through interstate transport of air pollutants. As discussed in the Background Information section of this notice, a state's SIP must contain provisions that satisfy the four elements of section 110(a)(2)(D)(i). On August 15, 2006, EPA issued guidance for SIP submissions addressing the requirements of section 110(a)(2)(D)(i) for the 1997 PM
To demonstrate that emissions from Colorado do not contribute significantly to nonattainment of the 1997 8-hour ozone NAAQS in any other state, the Colorado Interstate Transport SIP relies on a combination of: (a) Modeling analysis done by the State as part of the attainment demonstration SIP for the Denver Metropolitan Area/North Front Range (DMA/NFR) nonattainment area for the 1997 8-hour ozone standard; (b) monitoring data gathered by states and reported to EPA in the Air Quality System (AQS) database; and (c) considerations of geographical and meteorological factors. In this action, EPA expands on the analysis of geographical and meteorological factors, and of ozone concentration levels reflecting AQS monitoring data.
Section 110(a)(2)(D)(i) provides that EPA cannot approve a state's SIP for a new or revised NAAQS unless it contains adequate measures to prohibit emissions from sources within the state from contributing significantly to nonattainment of the NAAQS in another state. EPA's August 15, 2006 guidance to states concerning section 110(a)(2)(D)(i) recommended various methods by which states might evaluate whether or not its emissions significantly contribute to violations of the 1997 ozone standards in another state. Among other methods, EPA recommended consideration of available EPA modeling conducted in conjunction with CAIR,
The Colorado Interstate Transport SIP uses results from Colorado's 2009 “8-Hour Ozone Attainment Plan” for the DMA/NFR nonattainment area, and a report from the Western States Air Resource (WESTAR) Council to underscore that: (a) Local anthropogenic ozone contribution to high ozone concentrations in Denver is only about 25%; and (b) on days of highest ozone concentrations (reflecting a design value of 84.9 ppb) in the DMA/NFR area, the projected design values decrease to 63 ppb or less for all downwind Colorado counties east of an imaginary north-south line approximately 70 miles east from Denver.
In addition, significant contribution should be measured not just against nonattainment areas, but also against areas with monitors showing violations of the NAAQS. That said, nonattainment areas are a convenient starting point for EPA's analysis. For the 1997 8-hour ozone NAAQS, the St. Louis area and the Illinois and Wisconsin Counties along the southwestern shore of Lake Michigan (Illinois/Wisconsin area) are the designated downwind nonattainment areas closest to Colorado.
The Illinois/Wisconsin nonattainment area is approximately 900 miles east/northeast from the Colorado DMA/NFR area. Distance per se is not an obstacle to long range transport of ozone and/or its precursors, as discussed in the January 30, 2004 notice proposing CAIR (69 FR 4599). NOx, the primary ozone precursor that was the object of the CAIR transport study, may be transported for long distances, contributing significantly to high ozone concentrations in other states. However, with increasing distance there are greater opportunities for ozone or NO
Another transport factor is wind direction. For long range transport winds, a modeling analysis of ozone dispersion during the summer months (June to August) of the five-year period 1991-1995 shows that on high local ozone days the prevailing long range transport winds in States immediately to the east and north of Colorado (Kansas, Nebraska, South Dakota, Iowa, Minnesota, and North Dakota) had a southerly direction. On high regional ozone days, during the same period, regional transport winds in the same States were southwesterly, but with a westerly component so weak that a greater portion of NO
Additional circumstantial evidence supporting this conclusion is found in technical documentation developed in recent years by the States of Kansas and Wisconsin. To support its Interstate Transport SIP, the State of Kansas submitted to EPA Region 7 technical documentation that includes back trajectory analyses gauging the pathway of air masses impacting the Illinois/Wisconsin nonattainment area on the four days with highest ozone concentrations during each of the years 2005-2007. The back trajectory analyses in Appendix G of the technical support section show that, for the four days with the highest ozone readings, none of the pathways followed by air masses moving into the Chicago Metropolitan Statistical Area (MSA) or into several of the Wisconsin nonattainment counties came from Colorado. Since these back trajectories refer to the pathways of air masses and not specifically to ozone transport, the results of this analysis cannot be considered determinative as to the significant contribution of ozone or NO
Further support is given by a recent attainment demonstration by the Wisconsin Department of Natural Resources (WDNR) for the nonattainment counties along the southwestern shores of Lake Michigan.
Finally, by 2008, the 8-hour ozone design values for the Illinois and Wisconsin nonattainment counties along the shores of Lake Michigan fell below the level of the NAAQS, a reduction attributed to the implementation of State and Federal control measures since the designation of these counties as nonattainment in 2004. In other words, were there emissions from Colorado sources reaching the Illinois and Wisconsin counties along the western rim of Lake Michigan, they would no longer be significantly contributing to violations of the NAAQS in that area.
The other nonattainment area, St. Louis and adjacent counties, is approximately 800 miles straight east from the Colorado DMA/NFR area. This substantial distance does not, in and by itself, exclude the possibility of significant contribution from Colorado's NO
The impact of wind direction on ozone transport from Colorado to the St. Louis area is gauged through the results of several findings. Kansas, immediately east of Colorado and west of Missouri, is characterized by strong southerly surface winds that match prevailing regional transport winds, which have a southerly orientation during days of elevated ozone concentration. Throughout 2005 its winds averaged daily speeds slightly over 9 mph.
Results from other studies are consistent with these tentative conclusions. In a study published by OTAG in 1997, the St. Louis area showed higher ozone concentrations (70 as compared with 55 ppb) on days with winds from the south or the east than on days with winds from the west (the general direction from Colorado) or southwest.
As mentioned above, EPA must consider not only significant contribution to nonattainment areas, but also to areas with monitors showing violations of the NAAQS. A review of the AQS monitoring data for adjacent downwind states shows that it is highly unlikely that emissions from Colorado contribute significantly to downwind areas that have monitors showing violations of the 1997 8-hour ozone NAAQS. Between 1999 and 2008 there were no violations of the 1997 8-hour ozone NAAQS at any of the monitors in adjacent downwind states, such as Kansas, Nebraska and Wyoming.
Design values for the years 2005-2007
The historical trend over the period 1998-2008 for the 1997 8-hour ozone design values in these states places the 2005-2007 data reviewed above in context. In Nebraska, ozone design values were consistently low throughout the period. In Wyoming, design values were also constant in most of the monitored areas, where ozone monitoring only began between 2003 and 2005. Kansas design values show a clear trend of declining ozone levels from the late 1990s to the most recent years. In Linn, Sedgwick, and Sumner Counties, design values decreased from highs ranging between 77 and 82 ppb during 2000-2003 to levels ranging between 66 and 75 ppb in 2006-2008.
The data and weight of evidence analysis presented above support the conclusion of the Colorado Interstate Transport SIP (adopted into the State SIP on December 30, 2008 and submitted to EPA June 18, 2009) that emissions from Colorado do not contribute significantly to nonattainment in any other state for the 1997 8-hour ozone NAAQS, consistently with the requirements of element (1) of CAA section 110(a)(2)(D)(i).
EPA is proposing partial approval of the Colorado SIP to meet the requirements of Section 110(a)(2)(D)(i)(I) regarding the 1997 ozone standard. Specifically, in this action EPA is proposing to approve only the language and demonstration that, in this SIP revision, address the requirements of element (1): Prohibition of significant
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile Organic Compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule and request for comment.
EPA is proposing to grant a petition submitted by Tokusen USA, Inc. (called just Tokusen hereinafter) to exclude (or delist) a wastewater treatment plant (WWTP) sludge filter cake (called just sludge hereinafter) generated by Tokusen in Conway, AR from the lists of hazardous wastes. EPA used the Delisting Risk Assessment Software (DRAS) in the evaluation of the impact of the petitioned waste on human health and the environment.
EPA bases its proposed decision to grant the petition on an evaluation of waste-specific information provided by the petitioner. This proposed decision, if finalized, would exclude the petitioned waste from the requirements of hazardous waste regulations under the Resource Conservation and Recovery Act (RCRA).
If finalized, EPA would conclude that Tokusen's petitioned waste is non-hazardous with respect to the original listing criteria. EPA would also conclude that Tokusen's process minimizes short-term and long-term threats from the petitioned waste to human health and the environment.
We will accept comments until April 30, 2010. We will stamp comments postmarked after the close of the comment period as “late.” These “late” comments may not be considered in formulating a final decision.
Submit your comments, identified by Docket ID No. EPA-R06-RCRA-2009-0549 by one of the following methods:
1.
2.
3.
4.
For technical information regarding the Tokusen, contact Youngmoo Kim at 214-665-6788 or by e-mail at
Your requests for a hearing must reach EPA by April 15, 2010. The request must contain the information described in § 260.20(d).
The information in this section is organized as follows:
(1) To grant Tokusen's delisting petition to have its WWTP sludge excluded, or delisted, from the definition of a hazardous waste; and subject to certain verification and monitoring conditions.
(2) To use the Delisting Risk Assessment Software (DRAS) to evaluate the potential impact of the petitioned waste on human health and the environment. The Agency used this model to predict the concentration of hazardous constituents released from the petitioned waste, once it is disposed.
Tokusen's petition requests an exclusion from the F006 waste listing pursuant to 40 CFR 260.20 and 260.22. Tokusen does not believe that the petitioned waste meets the criteria for which EPA listed it. Tokusen also believes no additional constituents or factors could cause the waste to be hazardous. EPA's review of this petition included consideration of the original listing criteria and the additional factors required by the Hazardous and Solid Waste Amendments of 1984 (HSWA).
If the sludge is delisted, the WWTP sludge from Tokusen will be disposed at a RCRA Subtitle D landfill: The Waste Management Industrial Landfill, North Little Rock, Arkansas.
RCRA section 3001(f) specifically requires EPA to provide a notice and an opportunity for comment before granting or denying a final exclusion. Thus, EPA will not grant the exclusion until it addresses all timely public comments (including those at public hearings, if any) on this proposal.
RCRA section 3010(b)(1) at 42 USCA 6930(b)(1), allows rules to become effective in less than six months when the regulated facility does not need the six-month period to come into compliance. That is the case here, because this rule, if finalized, would reduce the existing requirements for persons generating hazardous wastes.
EPA believes that this exclusion should be effective immediately upon final publication because a six-month deadline is not necessary to achieve the purpose of section 3010(b), and a later effective date would impose unnecessary hardship and expense on this petitioner. These reasons also provide good cause for making this rule effective immediately, upon final publication, under the Administrative Procedure Act, 5 U.S.C. 553(d).
Because EPA is issuing this exclusion under the Federal RCRA delisting program, only states subject to Federal RCRA delisting provisions would be affected. This would exclude states which have received authorization from EPA to make their own delisting decisions.
EPA allows states to impose their own non-RCRA regulatory requirements that are more stringent than EPA's, under section 3009 of RCRA, 42 U.S.C. 6929. These more stringent requirements may include a provision that prohibits a Federally issued exclusion from taking effect in the state. Because a dual system (that is, both Federal (RCRA) and state (non-RCRA programs) may regulate a petitioner's waste, EPA urges petitioners to contact the state regulatory authority to establish the status of their wastes under the state law.
EPA has also authorized some states (for example, Louisiana, Oklahoma, Georgia, Illinois) to administer a RCRA delisting program in place of the Federal program, that is, to make state delisting decisions. Therefore, this exclusion does not apply in those authorized states unless that state makes the rule part of its authorized program. If Tokusen transports the petitioned waste to or manages the waste in any state with delisting authorization, Tokusen must obtain delisting authorization from that state before it can manage the waste as non-hazardous in the state.
EPA published an amended list of hazardous wastes from non-specific and specific sources on January 16, 1981, as part of its final and interim final regulations implementing section 3001 of RCRA. EPA has amended this list several times and published it in 40 CFR 261.31 and 261.32.
EPA lists these wastes as hazardous because: (1) The wastes typically and frequently exhibit one or more of the characteristics of hazardous wastes identified in Subpart C of Part 261 (that is, ignitability, corrosivity, reactivity, and toxicity), (2) the wastes meet the criteria for listing contained in § 261.11(a)(2) or (a)(3), or (3) the wastes are mixed with or derived from the treatment, storage or disposal of such characteristic and listed wastes and which therefore become hazardous under § 261.3(a)(2)(iv) or (c)(2)(i), known as the “mixture” or “derived-from” rules, respectively.
Individual waste streams may vary, however, depending on raw materials, industrial processes, and other factors. Thus, while a waste described in these regulations or resulting from the operation of the mixture or derived-from rules generally is hazardous, a specific waste from an individual facility may not be hazardous.
For this reason, 40 CFR 260.20 and 260.22 provide an exclusion procedure, called delisting, which allows persons to prove that EPA should not regulate a specific waste from a particular generating facility as a hazardous waste.
A delisting petition is a request from a facility to EPA or an authorized state to exclude wastes from the list of hazardous wastes. The facility petitions EPA because it does not consider the wastes hazardous under RCRA regulations.
In a delisting petition, the petitioner must show that wastes generated at a particular facility do not meet any of the criteria for which the waste was listed. The criteria for which EPA lists a waste are in part 261 and further explained in the background documents for the listed waste.
In addition, under 40 CFR 260.22, a petitioner must prove that the waste does not exhibit any of the hazardous waste characteristics (that is, ignitability, reactivity, corrosivity, and toxicity) and present sufficient information for EPA to decide whether factors other than those for which the waste was listed warrant retaining it as a hazardous waste. (
Generators remain obligated under RCRA to confirm whether their waste remains non-hazardous based on the hazardous waste characteristics even if EPA has “delisted” the waste.
Besides considering the criteria in 40 CFR 260.22(a) and section 3001(f) of RCRA, 42 U.S.C. 6921(f), and in the background documents for the listed wastes, EPA must consider any factors (including additional constituents) other than those for which EPA listed the waste, if a reasonable basis exists that these additional factors could cause the waste to be hazardous.
EPA must also consider as hazardous waste mixtures containing listed hazardous wastes and wastes derived from treating, storing, or disposing of listed hazardous waste.
On March 25, 2009, Tokusen petitioned EPA to exclude from the lists of hazardous wastes contained in § 261.31, WWTP sludge (F006) generated from its facility located in Conway, Arkansas. The waste falls under the classification of listed waste pursuant to § 261.31. Specifically, in its petition, Tokusen requested that EPA grant a standard exclusion for 2,000 cubic yards per year of the WWTP sludge.
The Tokusen USA, Inc. facility produces high-carbon steel tire cord for use in radial tire manufacturing. The steel cord is produced from steel rod which has been reduced in size and electroplated with copper and zinc to produce a brass coating. The facility generates F006 filter cake by the dewatering of wastewater sludge generated at the on-site wastewater treatment plants. This waste is stored on-site less than 90 days and is then transported from the site to the RCRA Subtitle C facility, Chemical Waste Management in Sulphur, LA 70556.
To support its petition, Tokusen submitted:
(1) Historical information on waste generation and management practices;
(2) Analytical results from four samples for total concentrations of compounds of concern (COCs);
(3) Analytical results from four samples for Toxicity Characteristic Leaching Procedure (TCLP) extract values of COCs; and
(4) Multiple pH testing for the petitioned waste.
EPA believes that the descriptions of the Tokusen analytical characterization provide a reasonable basis to grant Tokusen's petition for an exclusion of the WWTP sludge. EPA believes the data submitted in support of the petition show the WWTP sludge is non-hazardous. Analytical data for the
For this delisting determination, EPA used such information gathered to identify plausible exposure routes (
EPA believes that the EPACMTP fate and transport model represents a reasonable worst-case scenario for possible groundwater contamination resulting from disposal of the petitioned waste in a landfill, and that a reasonable worst-case scenario is appropriate when evaluating whether a waste should be relieved of the protective management constraints of RCRA Subtitle C. The use of some reasonable worst-case scenarios resulted in conservative values for the compliance-point concentrations and ensures that the waste, once removed from hazardous waste regulation, will not pose a significant threat to human health or the environment.
The DRAS also uses the maximum estimated waste volumes and the maximum reported total concentrations to predict possible risks associated with releases of waste constituents through surface pathways (
In most cases, because a delisted waste is no longer subject to hazardous waste control, EPA is generally unable to predict, and does not presently control, how a petitioner will manage a waste after delisting. Therefore, EPA currently believes that it is inappropriate to consider extensive site-specific factors when applying the fate and transport model. EPA does control the type of unit where the waste is disposed. The waste must be disposed in the type of unit the fate and transport model evaluates.
The DRAS results which calculate the maximum allowable concentration of chemical constituents in the waste are presented in Table I. Based on the comparison of the DRAS and TCLP Analyses results found in Table I, the petitioned waste should be delisted
EPA concluded, after reviewing Tokusen's processes that no other hazardous constituents of concern, other than those for which tested, are likely to be present or formed as reaction products or by-products in the waste. In addition, on the basis of explanations and analytical data provided by Tokusen, pursuant to § 260.22, EPA concludes that the petitioned waste do not exhibit any of the characteristics of ignitability, corrosivity, reactivity or toxicity.
During the evaluation of Tokusen's petition, EPA also considered the potential impact of the petitioned waste via non-groundwater routes (
The descriptions of Tokusen's hazardous waste process and analytical characterization provide a reasonable basis for EPA to grant the exclusion. The data submitted in support of the petition show that constituents in the waste are below the leachable concentrations (
Thus, EPA believes Tokusen should be granted an exclusion for the WWTP sludge. EPA believes the data submitted in support of the petition show Tokusen's WWTP sludge is non-hazardous. The data submitted in support of the petition show that constituents in Tokusen's waste are presently below the compliance point concentrations used in the delisting decision and would not pose a substantial hazard to the environment. EPA believes that Tokusen has successfully demonstrated that the WWTP sludge is non-hazardous.
EPA therefore, proposes to grant an exclusion to Tokusen in Conway, Arkansas, for the WWTP sludge described in its petition. EPA's decision to exclude this waste is based on descriptions of the treatment activities associated with the petitioned waste and characterization of the WWTP sludge.
If EPA finalizes the proposed rule, EPA will no longer regulate the petitioned waste under Parts 262 through 268 and the permitting standards of Part 270. Tokusen must comply with the LDR requirements before disposing of the delisted waste because the LDR attaches at the point of generation of the waste. The delisting, if granted, will absolve the generator from his obligation of handling the waste as hazardous. The appropriate waste code for this waste is F006. The LDR treatment standard for F006 is found in 40 CFR 268.40.
The petitioner, Tokusen, must comply with the requirements in 40 CFR Part 261, Appendix IX, Table 1. The text below gives the rationale and details of those requirements.
(1)
This paragraph provides the levels of constituents for which Tokusen must test the WWTP sludge, below which these wastes would be considered non-hazardous. EPA selected the set of inorganic and organic constituents specified in paragraph (1) of 40 CFR Part 261, Appendix IX, Table 1, (the exclusion language) based on information in the petition. EPA compiled the inorganic and organic constituents list from the composition of the waste, descriptions of Tokusen's treatment process, previous test data provided for the waste, and the respective health-based levels used in delisting decision-making. These delisting levels correspond to the allowable levels measured in the TCLP concentrations.
(2)
The purpose of this paragraph is to ensure that Tokusen manages and disposes of any WWTP sludge that contains hazardous levels of inorganic and organic constituents according to Subtitle C of RCRA. Managing the WWTP sludge as a hazardous waste until initial verification testing is performed will protect against improper handling of hazardous material. If EPA determines that the data collected under this paragraph do not support the data provided for in the petition, the exclusion will not cover the petitioned waste. The exclusion is effective upon publication in the
(3)
Tokusen must complete a rigorous verification testing program on the WWTP sludge to assure that the sludge does not exceed the maximum levels specified in paragraph (1) of the exclusion language. This verification program operates on two levels. The first part of the verification testing program consists of testing the WWTP sludge for specified indicator parameters as per paragraph (1) of the exclusion language. If EPA determines that the data collected under this paragraph do not support the data provided for the petition, the exclusion will not cover the generated wastes. If the data from the initial verification testing program demonstrate that the leachate meets the delisting levels, Tokusen may request quarterly testing. EPA will notify Tokusen in writing, if and when it may replace the testing conditions in paragraph (3)(A) with the testing conditions in (3)(B) of the exclusion language.
The second part of the verification testing program is the quarterly testing of representative samples of WWTP sludge for all constituents specified in paragraph (1) of the exclusion language. EPA believes that the concentrations of the constituents of concern in the WWTP sludge may vary over time. Consequently this program will ensure that the sludge is evaluated in terms of variation in constituent concentrations in the waste over time.
The proposed subsequent testing would verify that Tokusen operates a treatment facility where the constituent concentrations of the WWTP sludge do not exhibit unacceptable temporal and spatial levels of toxic constituents. EPA is proposing to require Tokusen to analyze representative samples of the WWTP sludge quarterly during the first year of waste generation. Tokusen would begin quarterly sampling 60 days after the final exclusion as described in paragraph (3)(B) of the exclusion language.
EPA, per paragraph 3(C) of the exclusion language, is proposing to end the subsequent testing conditions after
(4)
Paragraph (4) of the exclusion language would allow Tokusen the flexibility of modifying its processes (for example, changes in equipment or change in operating conditions) to improve its treatment process. However, Tokusen must prove the effectiveness of the modified process and request approval from EPA. Tokusen must manage wastes generated during the new process demonstration as hazardous waste until it has obtained written approval and paragraph (3) of the exclusion language is satisfied.
(5)
To provide appropriate documentation that Tokusen's WWTP sludge is meeting the delisting levels, Tokusen must compile, summarize, and keep delisting records on-site for a minimum of five years. It should keep all analytical data obtained through paragraph (3) of the exclusion language including quality control information for five years. Paragraph (5) of the exclusion language requires that Tokusen furnish these data upon request for inspection by any employee or representative of EPA or the State of Arkansas.
If the proposed exclusion is made final, it will apply only to 2,000 cubic yards per year of wastewater treatment sludge generated at Tokusen after successful verification testing.
EPA would require Tokusen to file a new delisting petition under any of the following circumstances:
(a) If it significantly alters the manufacturing process treatment system except as described in paragraph (4) of the exclusion language;
(b) If it uses any new manufacturing or production process(es), or significantly changes from the current process(es) described in their petition; or
(c) If it makes any changes that could affect the composition or type of waste generated.
Tokusen must manage waste volumes greater than 2,000 cubic yards per year of WWTP waste as hazardous until EPA grants a new exclusion. When this exclusion becomes final, Tokusen's management of the wastes covered by this petition would be relieved from Subtitle C jurisdiction, and the WWTP sludge from Tokusen will be disposed to the RCRA Subtitle D landfill of Waste Management Industrial Subtitle D landfill in North Little Rock, AR.
(6)
The purpose of paragraph (6) of the exclusion language is to require Tokusen to disclose new or different information related to a condition at the facility or disposal of the waste, if it is pertinent to the delisting. Tokusen must also use this procedure if the waste sample in the annual testing fails to meet the levels found in paragraph (1). This provision will allow EPA to reevaluate the exclusion, if a source provides new or additional information to EPA. EPA will evaluate the information on which EPA based the decision to see if it is still correct, or if circumstances have changed so that the information is no longer correct or would cause EPA to deny the petition, if presented.
This provision expressly requires Tokusen to report differing site conditions or assumptions used in the petition in addition to failure to meet the annual testing conditions within 10 days of discovery. If EPA discovers such information itself or from a third party, it can act on it as appropriate. The language being proposed is similar to those provisions found in RCRA regulations governing no-migration petitions at § 268.6.
EPA believes that it has the authority under RCRA and the Administrative Procedures Act (APA), 5 U.S.C. 551 (1978)
EPA believes a clear statement of its authority in delistings is merited in light of EPA's experience.
(7)
In order to adequately track wastes that have been delisted, EPA is requiring that Tokusen provide a one-time notification to any state regulatory agency through which or to which the delisted waste is being carried. Tokusen must provide this notification 60 days before commencing this activity.
If Tokusen violates the terms and conditions established in the exclusion, EPA will start procedures to withdraw the exclusion. Where there is an immediate threat to human health and the environment, EPA will evaluate the need for enforcement activities on a case-by-case basis. EPA expects Tokusen to conduct the appropriate waste analysis and comply with the criteria explained above in paragraph (1) of the exclusion.
EPA is requesting public comments on this proposed decision. Please send three copies of your comments. Send two copies to Ben Banipal, Section Chief of the Corrective Action and Waste Minimization Section (6PD-C), Multimedia Planning and Permitting Division, Environmental Protection Agency (EPA), 1445 Ross Avenue, Dallas, Texas 75202. Send a third copy to the Hazardous Waste Division, Arkansas Department of Environmental Quality, P.O. Box 8913, Little Rock, AR 72118. Identify your comments at the top with this regulatory docket number: “EPA-R06-RCRA-2009-0549.” You may submit your comments electronically to Youngmoo Kim at
You should submit requests for a hearing to Ben Banipal, Section Chief of the Corrective Action and Waste Minimization Section (6PD-C), Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, 1445 Ross Avenue, Dallas, Texas 75202.
You may review the RCRA regulatory docket for this proposed rule at the
Under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), this rule is not of general applicability and therefore is not a regulatory action subject to review by the Office of Management and Budget (OMB). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The Agency's risk assessment did not identify risks from management of this material in a Subtitle D landfill. Therefore, EPA does not believe that any populations in proximity of the landfills used by this facility should not be adversely affected by common waste management practices for this delisted waste.
Environmental protection, Hazardous Waste, Recycling, Reporting and recordkeeping requirements.
Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).
For the reasons set out in the preamble, 40 CFR part 261 is proposed to be amended as follows:
1. The authority citation for part 261 continues to read as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.
2. In Table 1 of Appendix IX of part 261 add the following waste stream in alphabetical order by facility to read as follows:
Fish and Wildlife Service, Interior.
Proposed rule; reopening of comment period, notice of availability of draft economic analysis, and amended required determinations.
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our July 9, 2009, proposed listing and critical habitat designation for Casey's June beetle (
We will consider comments that we receive on or before April 30, 2010.
You may submit comments by one of the following methods:
• Federal eRulemaking Portal:
• U.S. mail or hand-delivery: Public Comments Processing, Attn: FWS-R8-ES-2009-0019; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, Suite 222; Arlington, VA 22203.
We will post all comments on
Jim Bartel, Field Supervisor, U.S. Fish and Wildlife Service, Carlsbad Fish and Wildlife Office, 6010 Hidden Valley Road, Suite 101, Carlsbad, CA 92011; telephone (760) 431-9440; facsimile (760) 431-5901. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at (800) 877-8339.
We intend that any final action resulting from the proposed rule will be based on the best scientific data available and will be as accurate and as effective as possible. Therefore, we request comments or information from the public, other concerned government agencies, the scientific community, industry, or other interested party during this reopened comment period on the proposed rule to list the Casey's June beetle (
(1) Any available information on known or suspected threats and proposed or ongoing projects with the potential to threaten Casey's June beetle, specifically:
(a) The present or threatened destruction, modification or curtailment of its habitat or range;
(b) Overutilization for commercial, recreational, scientific, or educational purposes;
(c) Disease or predation;
(d) The inadequacy of existing regulatory mechanisms; and
(e) Other natural or manmade factors affecting its continued existence.
(2) Additional information concerning the range, distribution, and population size of this species, including the locations of any additional populations of this species.
(3) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531
(4) Specific information on areas that provide habitat for Casey's June beetle that we did not discuss in the proposed rule, whether such areas contain the physical and biological features essential to the conservation of Casey's June beetle, and what special management considerations or protections may be required to maintain or enhance the essential features.
(5) Land-use designations and current or planned activities in the subject areas and their possible impacts on proposed critical habitat.
(6) Any foreseeable economic, national security, or other relevant impact that may result from designating particular areas as critical habitat, and, in particular, any impacts to small entities (such as small businesses or small governments), and the benefits of including or excluding areas from the proposed designation that exhibit these impacts.
(7) Whether any particular area being proposed as critical habitat should be excluded under section 4(b)(2) of the Act, and whether the benefits of potentially excluding any particular area outweigh the benefits of including that area under section 4(b)(2) of the Act.
(8) Whether inclusion of tribal lands of the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation, California (preferred name “Agua Caliente Band of Cahuilla Indians”), in Riverside County is appropriate and why.
(9) The likelihood of adverse social reactions to the designation of critical habitat, and how the consequences of such reactions, if they occur, would relate to the conservation of the species and regulatory benefits of the proposed critical habitat designation.
(10) Information on the extent to which the description of potential economic impacts in the DEA is complete and accurate.
(11) The potential effects of climate change on this species and its habitat and whether the critical habitat may adequately account for these potential effects.
(12) Whether our approach to designating critical habitat could be improved or modified in any way to provide an opportunity for greater public participation and understanding, or to assist us in accommodating public concerns and comments.
If you submitted comments or information on the proposed rule (74 FR 32857) during the initial comment period from July 9, 2009, to September 8, 2009, please do not resubmit them. These comments are included in the public record for this rulemaking, and
You may submit your comments and materials concerning the proposed rule and the DEA associated with the proposed critical habitat designation by one of the methods listed in the
If you submit a comment via
Comments and materials we receive, as well as supporting documentation used to prepare this notice, will be available for public inspection on
It is our intent to discuss only those topics directly relevant to the proposed designation of critical habitat for Casey's June beetle in this document. For more detailed information on the taxonomy, biology, and ecology of Casey's June beetle, please refer to the 90-day finding on the petition to list the species under the Act, published in the
Section 3 of the Act defines critical habitat as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed in accordance with... [the Act], on which are found those physical or biological features (I) essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed . . . upon a determination by the Secretary that such areas are essential for the conservation of the species” (16 USC 1532(5)(A)). If the proposed rule is made final, section 7 of the Act will prohibit destruction or adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions that may affect critical habitat must consult with us on the effects of their proposed actions, under section 7(a)(2) of the Act.
Section 4(b)(2) of the Act requires that we designate critical habitat based upon the best scientific and commercial data available, after taking into consideration the economic impact, impact on national security, or any other relevant impact of specifying any particular area as critical habitat.
We prepared a DEA (Industrial Economics Inc. 2010) that identifies and analyzes the potential impacts associated with the proposed designation of critical habitat for Casey's June beetle that we published in the
The primary intended benefit of critical habitat is to support the conservation of endangered and threatened species, such as the Casey's June beetle. Thus, attempts to develop monetary estimates of the benefits of this proposed critical habitat designation would focus on the public's willingness to pay to achieve the conservation benefits to the beetle resulting from this designation. Quantification and monetization of species conservation benefits requires information on the incremental change in the probability of Casey's June beetle conservation that is expected to result from the designation. No studies exist that provide such information for this species. Even if this information existed, the published valuation literature does not support monetization of incremental changes in conservation probability for this species. Because it is not possible to determine the probability that benefits will occur in this instance, the Service has decided not to include such estimates in the DEA. Rather than rely on economic measures, the Service believes that the direct benefits of the proposed rule are best expressed in biological terms that can be weighed against the expected cost impacts of the rulemaking.
The DEA (made available with the publication of this notice and referred to throughout this document unless otherwise noted) estimates the foreseeable economic impacts of the proposed critical habitat designation for Casey's June beetle. The economic analysis identifies potential incremental
Baseline economic impacts are those impacts that result from listing and other conservation efforts for Casey's June beetle. Conservation efforts related to development activities constitute the majority of total baseline costs (approximately 80 percent) in areas of proposed critical habitat. Impacts to flood control activities comprise the remaining approximately 20 percent of impacts. Total future baseline impacts are estimated to be $12,703,600 ($1,182,600 annualized) in present value terms using a 7 percent discount rate over the next 20 years (2010 to 2029) in areas proposed as critical habitat (Industrial Economics Inc. 2010, pp. ES-7).
Almost all incremental impacts attributed to the proposed critical habitat designation are expected to be related to development activities (approximately 100 percent). The DEA estimates total potential incremental economic impacts in areas proposed as critical habitat over the next 20 years (2010 to 2029) to be $9,792,270 ($924,131 annualized) in present value terms using a 7 percent discount rate (Industrial Economics Inc. 2010, p. ES-8). This value is based on an assumption of total avoidance of designated areas and thus represents the upper-bound potential cost for each project. As such, it likely overstates the expected absolute cost of future actions to protect critical habitat.
The DEA considers both economic efficiency and distributional effects. In the case of habitat conservation, efficiency effects generally reflect the “opportunity costs” associated with the commitment of resources to comply with habitat protection measures (such as lost economic opportunities associated with restrictions on land use). The DEA also addresses how potential economic impacts are likely to be distributed, including an assessment of any local or regional impacts of habitat conservation and the potential effects of conservation activities on government agencies, private businesses, and individuals. The DEA measures lost economic efficiency associated with residential and commercial development and public projects and activities, such as economic impacts on water management and transportation projects, Federal lands, small entities, and the energy industry. Decision-makers can use this information to assess whether the effects of the critical habitat designation might unduly burden a particular group or economic sector.
In our proposed rule that published in the
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
According to the Small Business Administration, small entities include small organizations, such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under the proposed designation as well as types of project modifications that may result. In general, the term significant economic impact is meant to apply to a typical small business firm's business operations.
To determine if the proposed designation of critical habitat for Casey's June beetle would affect a substantial number of small entities, we consider the number of small entities affected within particular types of economic activities, such as residential and commercial development. In order to determine whether it is appropriate for our agency to certify that this rule would not have a significant economic impact on a substantial number of small entities, we considered each industry or category individually. If we finalize this proposed listing and proposed critical habitat designation, Federal agencies must consult with us under section 7 of the Act if their activities may affect the species or the designated critical habitat. Incremental impacts to small entities may occur as a direct result of a required consultation under section 7 of the Act. Additionally, even in the absence of a Federal nexus, indirect incremental impacts may still result because, for example, a city may request project modifications due to the designation of critical habitat via its review under the California Environmental Quality Act (CEQA).
In the DEA of the proposed critical habitat designation, we evaluate the
As discussed in Appendix A of the DEA, the only impacts of the proposed rule on small businesses would potentially result from lost land values associated with the identified development projects. In the 20-year timeframe for the analysis, three developers may experience impacts. The potential incremental costs are expected to vary by project, depending on the size and the value of the land. The total annualized incremental impacts are forecast at approximately $965,000 (discounted at 7 percent). The SBREFA analysis estimates that three small businesses may be affected by the designation of critical habitat (Industrial Economics, Inc. 2010, pp. A-3-A-6). Because only three small businesses may be affected, we do not find that the number of small entities that would be significantly affected is substantial.
In summary, we considered whether the proposed rule would result in a significant economic impact on a substantial number of small entities. For the above reasons and based on currently available information, we certify that, if adopted, the proposed critical habitat would not have a significant economic impact on a substantial number of small entities. Therefore, an initial regulatory flexibility analysis is not required.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501), we make the following findings:
(a) This rule would not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or Tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or Tribal governments,” with two exceptions. It excludes “a condition of federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and Tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding” and the State, local, or Tribal governments “lack authority” to adjust accordingly. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance; or (ii) a duty arising from participation in a voluntary Federal program.”
The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. Designation of critical habitat may indirectly impact non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action may be indirectly impacted by the designation of critical habitat. However, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above on to State governments.
(b) As discussed in the DEA of the proposed designation of critical habitat for Casey's June beetle, we do not believe that the rule would significantly or uniquely affect small governments because it would not produce a Federal mandate of $100 million or greater in any year; that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The DEA concludes incremental impacts may occur due to project modifications that may need to be made for development and flood control activities; however, these are not expected to affect small governments. Incremental impacts stemming from various species conservation and development controls are expected to be borne by the Riverside County Flood Control and Water Conservation District (FCWCD), which is not considered a small government based on the county's population. Consequently, we do not believe that the critical habitat designation would significantly or uniquely affect small government entities. As such, a Small Government Agency Plan is not required.
On May 18, 2001, the President issued E.O. 13211 on regulations that significantly affect energy supply, distribution, and use. Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. The OMB's guidance for implementing this Executive Order outlines nine outcomes that may constitute “a significant adverse effect” when compared to no regulatory action. As discussed in Appendix A, the DEA finds that none of these criteria are relevant to this analysis. The DEA identified no potentially affected entities involved in the production of energy, and a Statement of Energy Effects is therefore not required.
A complete list of all references we cited in the proposed rule and in this document is available on the Internet at
The primary authors of this notice are the staff members of the Carlsbad Fish and Wildlife Office (see
The authority for this action is the Endangered Species Act of 1973 as amended (16 U.S.C. 1531
Fish and Wildlife Service, Interior.
Notice of 12-month petition finding.
We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the Tucson shovel-nosed snake (
The finding announced in this document was made on March 31, 2010.
This finding is available on the Internet at
Steve Spangle, Field Supervisor, Arizona Ecological Services Office (see
Section 4(b)(3)(B) of the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531
We received a petition, dated December 15, 2004, from the Center for Biological Diversity requesting that we list the Tucson shovel-nosed snake as threatened or endangered throughout its range and designate critical habitat within its range in the United States. The petition, which was clearly identified as such, contained detailed information on the natural history, biology, current status, and distribution of the Tucson shovel-nosed snake. It also contained information on what the petitioner reported as potential threats to the subspecies from urban development, agricultural practices, collecting, inadequacy of existing regulations, drought, and climate change. In response to the petitioner's requests, we sent a letter to the petitioner, dated September 7, 2005, explaining that, due to funding constraints in fiscal year 2005, we would not be able to address the petition in a timely manner. On February 28, 2006, the petitioner filed a 60-day notice of intent to sue (NOI) the Department of the Interior for failure to issue 90-day and 12-month findings, and a proposed listing rule, as appropriate, in response to the petition as required by 16 U.S.C. 1533(b)(3)(A) and (B). In response to the NOI, we agreed to submit a 90-day finding to the
On July 29, 2008, we made our 90-day finding that the petition presented substantial scientific information indicating that listing the Tucson shovel-nosed snake (
This notice constitutes the 12-month finding on the December 15, 2004, petition to list the Tucson shovel-nosed snake as threatened or endangered.
The Tucson shovel-nosed snake is a small snake (250-425 millimeters (mm) (9.84-16.73 inches (in) total length) in the family Colubridae, with a shovel-shaped snout, an inset lower jaw, and coloring that mimics coral snakes (Mahrdt
In considering taxonomic data, the Service relies “on standard taxonomic distinctions and the biological expertise of the Department and the scientific community concerning the relevant taxonomic group” (50 CFR §424.11(a)) and “on the basis of the best scientific and commercial information” (50 CFR §424.11(b)). The Service, not any professional organization or expert, bears the responsibility for deciding what taxonomic entities are to be protected under the Act. We address any conflicting information or expert opinion by carefully evaluating the underlying scientific information and weighing its reliability and adequacy according to the considerations of the Act and our associated policies and procedures and using the best scientific information available.
Taxonomic nomenclature for the Tucson shovel-nosed snake has changed over time. The snake was first described as a subspecies,
In our 90-day finding for this petition (73 FR 43905), we determined that a recent study of genetic variation of mitochondrial DNA (Wood
Additionally, the petition requested that the Service consider an “intergrade zone” between the Tucson shovel-nosed snake and the Colorado Desert shovel-nosed snake as part of the Tucson shovel-nosed snake's range. An intergrade zone is an area of overlap between the ranges of two subspecies where individuals may possess intermediate characters (attributes or features that distinguish a subspecies, such as coloration) or traits of both subspecies. It is generally recognized and accepted by practitioners of subspecies taxonomy that intergrade zones may exist between the ranges of two subspecies where the diagnostic characters of both subspecies may be found (Mayr 1942, p. 107; Huxley 1943, p. 210-211; Mayr 1963, p. 368; Mayr 1969, pp. 193-196; Mayr 1970, pp. 219-226; Wake 1997, pp. 7761-7762; Rodri
In order to be compliant with 50 CFR 424.11(a) and to understand the taxonomic entity to consider for listing, the Service requested review and input on the issue of taxonomic classification and distribution of the Tucson shovel-nosed snake from nine individuals with biological and taxonomic expertise and background in this issue. Of the nine, six provided comments and input on specific questions we asked regarding the issue of determining species and subspecies, taxonomic classification, and geographical ranges (including the location of the boundary between the Tucson shovel-nosed snake and the intergrade zone) based on recent and historical studies and publications related to Tucson shovel-nosed snake taxonomic classification.
We considered publications by Collins and Taggart (2009), Crother (2008a), Wood
The two species experts believed that there is some agreement between morphological and mitochondrial DNA data, and supported acknowledging
According to most phylogenetic species concepts, the taxonomists (Boundy 2008, Burbrink 2008, Crother 2008b, Frost 2008) are using a criterion for species, not subspecies, and all four of these reviewers acknowledge that, following this reasoning, they do not believe subspecies are real biological units and that the concept of subspecies is antiquated. However, the Act recognizes conservation concern below the level of species by defining “species” to include subspecies and vertebrate Distinct Population Segments. Published lists of reptile and amphibian taxa, including those authored by our taxonomic peer reviewers (for example, Crother 2008a, Collins and Taggart 2009 (F. Burbrink is an author on the snake section)), still include subspecies, and the International Code of Zoological Nomenclature (ICZN), a universally accepted system of nomenclature (Frost
Additionally, mitochondrial DNA, as analyzed by Wood
For the available information we considered, we find that uncertainty exists in both the taxonomic entity and subspecies range of
The diet of shovel-nosed snakes consists of a variety of invertebrates, including scorpions, beetle larvae, spiders, crickets, centipedes, native roaches, and ants, (Mattison 1989, p. 25; Rosen
Like the other three subspecies of the western shovel-nosed snake, the Tucson shovel-nosed snake uses “sand swimming” as its primary locomotion. The snake moves using a sideways swaying motion while it is either on or under the sand or loose soil (Stebbins 2003, p. 393). Klauber (1951, p. 192) suggests that shovel-nosed snakes rarely move more than 30.5 m (100 ft) in one night, as they do not normally move great distances below the sand surface; however, Rorabaugh (2002, p. 42) documented one shovel-nosed snake (
Reproductive studies have not been conducted specific to
Limited information suggests the existence of four age classes in the Western shovel-nosed snake, based on snout-to-vent length (SVL): 0.5, 1.5, 2.5, and 3.5 years and older (Rosen
Klauber (1951, p. 185) indicates that scattered sand hummocks, crowned with mesquite or other desert shrubs, are favorite refuges for shovel-nosed snakes. Rosen (2003, p. 8) suggests that the Tucson shovel-nosed snake is found in more productive creosote-mesquite floodplain environments, differing from the habitats preferred by other subspecies of the Western shovel-nosed snake. Rosen (2003, p. 8) describes the associated soils of the Tucson shovel-nosed snake as soft, sandy loams, with sparse gravel.
The subspecies was historically known from Pima County in the Avra and Santa Cruz valleys (Rosen 2003, p. 4) and from western Pinal and a portion of eastern Maricopa counties (Klauber 1951, p. 196).
As of 2001, over one-third of the range of the Tucson shovel-nosed snake (Mardt
Survey efforts on the Florence Military Reservation (Mixan and Lowery
In 2006, the Arizona Game and Fish Department coordinated attempts to collect shovel-nosed snake tissues for genetic analyses. Based on these efforts, populations are persisting in areas dominated by creosote flats along State Route 79, north of Florence and south of Florence Junction; along Maricopa Road (including State Route 238) between Maricopa and Gila Bend (likely including much of the Rainbow Valley and lower Vekol Wash); east of the San Tan Mountains; along State Route 349 between Maricopa and Casa Grande; south of Interstate 8 near the northern boundary of the Tohono O'odham Reservation; and in the vicinity of the Santa Cruz Flats near Eloy and Picacho (Arizona Game and Fish Department 2008, p. 2).
Section 4 of the Act (16 U.S.C. 1533), and implementing regulations at 50 CFR 424, set forth procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. A species, subspecies, or distinct population segment of vertebrate taxa may be determined to be endangered or threatened due to one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Below we provide a summary of our analysis of the threats to the Tucson shovel-nosed snake.
As of 2001, more than 20 percent of the area within the range of the Tucson shovel-nosed snake had been converted to urban development (U.S. Geological Survey National Gap Analysis Program 2004). The effects of urban and rural development are expected to increase as human populations increase. The human population in Arizona increased by 394 percent from 1960 to 2000 (Social Science Data Analysis Network 2000, p. 1) and another 26.7 percent from 2000 to 2008 (U.S. Census Bureau 2008, p. 1). Since 2000, population growth rates in Arizona counties where the Tucson shovel-nosed snake historically occurred or may still occur have varied by county but are no less remarkable: Maricopa (28.7 percent); Pima (19.9 percent); and Pinal (82.1 percent) (U.S. Census Bureau 2008, p. 1). Increasing human populations threaten the Tucson shovel-nosed snake as further modification and loss of habitat is required to accommodate this growth.
Human population growth trends in Arizona are expected to continue into the future. By 2030, projections estimate the population in Arizona will have more than doubled when compared to the 2000 population estimate (U.S. Census Bureau 2005, p. 1). In particular, a wide swath (called the Sun Corridor “Megapolitan”) from the international border in Nogales, through Tucson, Phoenix, and north past the Prescott area is predicted to house eight million people by 2030 (Gammage
In response to our 90-day finding on the Tucson shovel-nosed snake, we received information stating that the prospect of continuing development is no longer a threat to the snake because of current economic conditions, and that these conditions have not only halted most real estate projects in central Arizona, but have also eliminated the demand for State Trust land in central Arizona to be sold for development (James 2008, p. 10). We acknowledge that development pressure across Arizona has slowed due to the recent economic downturn and housing market collapse. However, this does not negate the fact that development likely still will continue in the future, although perhaps at a slower pace than in the earlier part of this century. For instance, the most recent draft Pinal County Comprehensive Plan (February 2009) acknowledges that the county is in the middle of the Sun Corridor Megapolitan (Tucson, Phoenix, and the corridor between them), and proposes four shorter-term Growth Areas to define areas where development will occur or be encouraged to develop over the next decade, although it does not mean to discourage growth outside of these areas (Pinal County Comprehensive Plan 2009, p. 109). These four Growth Areas (Gateway/Superstition Vistas, West Pinal, Red Rock, and Tri-Communities) fall either completely or partially within the range of the Tucson shovel-nosed snake. The Gateway/Superstition Vistas Growth Area alone encompasses 71,225 hectares (176,000 acres, or 275 square miles) of State Trust land, at least two-thirds of which falls within the range of the snake, and it is anticipated that more than 800,000 to more than 1,000,000, people will one day live in this development (Pinal County Comprehensive Plan 2009, p. 115). The Comprehensive Plan (2009, p. 117) identifies many kilometers (miles) of new freeways and principal arterials in this Growth Area at buildout, which the plan acknowledges may take over a half century to realize (p. 115). Roads can have a negative effect on reptiles in general, and snakes specifically, and pose a threat to the Tucson shovel-nosed snake, as well. This is discussed in more detail in the Road Construction, Use, and Maintenance section below.
Additionally, the Maricopa County Comprehensive Plan calls for Growth Areas to the south and east of the Chandler and Mesa areas, which are within the range of the Tucson shovel-nosed snake (Maricopa County Comprehensive Plan 2002 (revised), p. 92). City comprehensive plans within the range of the snake also call for future Growth Areas; for example, the City of Eloy has designated six Growth Areas encompassing 15,520 acres mostly along the Interstate 10 corridor (City of Eloy General Plan 2004, pp. 7-6 through 7-10), of which more than half fall within the range of the snake. These Growth Areas include the locations of some of the most recent sightings of the snake (Rosen 2008b, p. 8). While much of this area has already been impacted by development or irrigated agriculture, any remaining habitat for the Tucson shovel-nosed snake will likely be negatively affected as development and
James (2008, p. 9) also stated that, as a consequence of restrictions imposed on both agricultural and municipal uses of groundwater by Arizona law, development within the range of the Tucson shovel-nosed snake, particularly in Pinal County, has primarily involved the conversion of agricultural land to municipal uses. Although James (2008, p. 9) considers the actual impact of development on suitable habitat for the Tucson shovel-nosed snake to be exaggerated, we did not find evidence to support this claim. As of 2001, more than one third of the area within the range of the snake was in agricultural use or under development (U.S. Geological Survey National Gap Analysis Program 2004). We acknowledge that the conversion of agricultural land to municipal uses has occurred and continues to occur within the range of the Tucson shovel-nosed snake (as noted above). Much of the land in the western half of Pinal County is primarily used for irrigated agriculture because of low desert valleys (Arizona Department of Agriculture 2009, p. 1), which includes a large portion of the range of the Tucson shovel-nosed snake. However, the above-mentioned Gateway/Superstition Vistas Growth Area occurs on 71,225 hectares (176,000 acres, or 275 square miles) of Arizona State Trust land that, while portions of it are moderately grazed, are not currently in irrigated agriculture. Additionally, conversion from agriculture to residential development involves building additional roadways and transportation corridors, which may negatively affect the snake, even in pockets of remaining habitat (see Road Construction, Use, and Maintenance section below). Therefore, while development may be occurring on lands that were already compromised by a previous use, it still poses a threat, as areas of remaining habitat (especially within the Sun Corridor Megapolitan) are expected to be developed for residential and commercial use over the next decade and beyond.
As noted in the previous section, roadways and transportation corridors are expected to increase over the next decade and beyond as counties within the range of the Tucson shovel-nosed snake, and particularly in Pinal County, continue to develop residential and commercial infrastructure. Roads pose unique threats to herpetofauna and specifically to the Tucson shovel-nosed snake, its prey base, and the habitat where it occurs through: (1) fragmentation, modification, and destruction of habitat; (2) increased genetic isolation; (3) alteration of movement patterns and behaviors; (4) facilitation of the spread of non-native species via human vectors; (5) increased recreational access and the likelihood of subsequent, decentralized urbanization; (6) interference with or inhibition of reproduction; and (7) population sinks through direct mortality (resulting in unnaturally high death rates that exceed birth rates within a population) (Rosen and Lowe 1994, pp. 146-148; Carr and Fahrig 2001, pp. 1074-1076; Hels and Buchwald 2001, p. 331; Smith and Dodd 2003, pp. 134-138; Angermeier
Roe
Off-highway vehicle (OHV) use has grown considerably in Arizona. As of 2007, 385,000 OHVs were registered in Arizona (a 350 percent increase since 1998) and 1.7 million people (29 percent of the Arizona's public) engaged in off-road activity from 2005 to 2007 (Sacco 2007, pers. comm.). Over half of OHV users reported that merely driving off-road was their primary activity, versus using the OHV for the purpose of hunting, fishing, or hiking (Sacco 2007, pers. comm.). Given the pervasive use of OHVs on the landscape, OHV-related mortalities are likely a threat to Tucson shovel-nosed snakes. Ouren
Solar radiation levels in the Southwest, including Arizona, are some of the highest in the world, and interest in tapping into this source of potential energy is growing. Of the solar technologies available to harness this energy, Concentrating Solar Power (CSP) technologies are the most likely to be used, although photovoltaic cells could be used in some cases. CSP technologies use mirrors to reflect and concentrate sunlight onto receivers that collect solar energy and convert it to heat. This thermal energy can then be used to produce electricity via a steam turbine or heat engine driving a generator.
Within Arizona, the Bureau of Land Management (BLM) has received 35 solar right-of-way applications, including one that is pending on 850 hectares (2,100 acres) approximately 19 kilometers (12 miles) south of Eloy, which is within the range of the Tucson shovel-nosed snake (BLM 2009b, p. 1 and map). Additionally, within Arizona, the Arizona State Land Department is considering solar projects on some of the lands under its jurisdiction. These potential sites are mostly west of Phoenix and Gila Bend, but one project could be located along Interstate 10 in the vicinity of Red Rock, which is within the range of the Tucson shovel-nosed snake. Little information is available about these projects, so we do not know the exact location or extent of each project (Scott 2009, p. 29).
Solar energy development and transmission corridors pose similar threats to the Tucson shovel-nosed snake as development and roadway projects (see Rural and Urban Development and Road Construction, Use, and Maintenance sections above). An average utility-scale solar facility to generate 250 megawatts of electricity would occupy about 506 hectares (1,250 acres) of land (BLM 2009a, p. 1), and would involve removal of all vegetation within this area. Additionally, CSP facilities employ liquids such as oils or molten salts to create steam to power conventional turbines and generators, as
While the number of farms in Arizona has almost doubled since 1997, the total amount of farmed area has decreased (U.S. Department of Agriculture 2009, p. 7). Within Maricopa, Pima, and Pinal counties, the amount of irrigated farmland decreased from 2002 to 2007 by 13.5 percent (58,724 hectares (145,109 acres)), 4.1 percent (3,327 hectares (8,222 acres), and 0.7 percent (2,366 hectares (5,846 acres)), respectively (U.S. Department of Agriculture 2009, p. 273). This decrease in irrigated farmland is likely due to the conversion of agricultural areas to urban development. As of 2001, more than 10 percent of the area within the range of the Tucson shovel-nosed snake had been converted to agriculture (U.S. Geological Survey National Gap Analysis Program 2004).
Pinal County is the county with the most agricultural production within the range of the Tucson shovel-nosed snake. In 2007, the amount of farmland still in production in Pinal County was 125,420 hectares (309,920 acres), or approximately nine percent of the entire county (U.S. Department of Agriculture 2009, p. 273). Much of this land, however, is in the western half of the county (Arizona Department of Agriculture 2009, p. 1), which is within the range of the Tucson shovel-nosed snake. Conversion of low desert valleys to farmland renders habitats unsuitable for the Tucson shovel-nosed snake. Agricultural practices can impact this subspecies in a number of ways. Farmers typically use pesticides and herbicides to maintain high agricultural yields, but because arthropods are the primary food for the snake (Mattison 1989, p. 25; Rosen
Fire has become an increasingly significant threat in the Sonoran Desert. Esque and Schwalbe (2002, pp. 180-190) discuss the effect of wildfires in the Arizona Upland and Lower Colorado River subdivisions of Sonoran desertscrub, both of which are found in the range of the Tucson shovel-nosed snake. The widespread invasion of non-native annual grasses appears to be largely responsible for altered fire regimes that have been observed in these communities, which are not adapted to fire (Esque and Schwalbe 2002, p. 165). In areas comprised entirely of native species, ground vegetation density is mediated by barren spaces that do not allow fire to carry across the landscape. However, in areas where non-native grasses have become established, the fine fuel load is continuous, and fire is capable of spreading quickly and efficiently (Esque and Schwalbe 2002, p. 175). Non-native annual grasses prevalent within the range of the Tucson shovel-nosed snake include brome grasses (
After disturbances such as fire, non-native grasses may exhibit dramatic population explosions, which hasten their effect on native vegetation communities. Additionally, with increased fire frequency, these population explosions may lead to a type-conversion of the vegetation community from desert scrub to grassland (Esque and Schwalbe 2002, pp. 175-176; Overpeck and Weiss 2005, p. 2075). Fires carried by the fine fuel loads created by non-native grasses often burn at unnaturally high temperatures, which may result in soils becoming hydrophobic (water repelling), exacerbating sheet erosion, and contributing large amounts of sediment to receiving drainages and water bodies (Esque and Schwalbe 2002, pp. 177-178). Buffelgrass, in particular, is acknowledged as one of the most serious invasive weeds in the Sonoran Desert due to its ability to spread exponentially (Buffelgrass Working Group 2007, p. 2). It has the potential to invade much of southern and central Arizona, which can lead to recurring grassland fires and the destruction of native desert vegetation (Buffelgrass Working Group 2007, p. 2). These changes can negatively affect the habitat and prey base of the Tucson shovel-nosed snake, although precisely how snake populations would respond is unknown.
Much of the habitat within the range of the Tucson shovel-nosed snake already has been converted to development or agriculture, and remaining habitat continues to be threatened by both these land uses, as well as the construction of large-scale solar power facilities and transmission lines. By the year 2030, the human population in Arizona is expected to be more than double the 2000 population, particularly in the Sun Corridor Megapolitan, which is an area completely encompassing the range of the Tucson shovel-nosed snake. Road construction, maintenance, and use have been documented to affect this subspecies directly through mortality and indirectly through habitat loss and fragmentation, the impacts of which will likely increase with new development and an increasing human population. The need for alternative energy sources is continuing to rise, which will lead to construction of solar energy facilities and transmission corridors in the State of Arizona, some of which will likely be sited within the range of the Tucson shovel-nosed snake. Agricultural use within the range of the snake has been decreasing, a trend that will probably continue as land use converts from agriculture to residential and commercial development. Agriculture that persists will continue to impact the snake by reducing the available prey base and fragmenting habitat. The threat of wildfire due to non-native plants is expected to rise, given the prevalence of Mediterranean grasses, brome grasses, and especially buffelgrass within the range of the Tucson shovel-nosed snake and the invasive nature of these grasses. How snakes would respond to vegetation community change brought about by increasing fire frequency is unknown. The best available information indicates shovel-nosed snakes travel only short distances (37 m (121 ft)), which likely makes the subspecies particularly susceptible to habitat fragmentation as barriers formed by the above-mentioned threats isolate small populations from one another. Therefore, we find that the present or threatened destruction, modification, or curtailment of its habitat or range is a threat to the Tucson shovel-nosed snake within the foreseeable future.
Based on the information available, overutilization of the Tucson shovel-nosed snake does not appear to pose a threat to this subspecies. Shovel-nosed snakes in general, and Tucson shovel-nosed snakes in particular, are not regularly seen in the pet trade (Arizona Game and Fish Department 2008). There have been few scientific or educational studies of Tucson shovel-nosed snakes over the years, and most recently they have been limited largely to surveys (Arizona Game and Fish Department 2008). Few animals have been collected for these studies other than animals found on highways, where their survival was already likely compromised. Additionally, Arizona State University and the University of Arizona recently began to accept photographic vouchers, versus physical specimens, in their respective museum collections, which may reduce the amount of collection. We believe these measures reduce the necessity for field biologists to collect physical specimens (unless discovered postmortem) for locality voucher purposes and, therefore, further reduce impacts to vulnerable populations of the Tucson shovel-nosed snake. Based on this information, we find that overutilization for commercial, recreational, scientific, or educational purposes is not a threat to the Tucson shovel-nosed snake.
Disease in Tucson shovel-nosed snakes has not yet been documented as a specific threat. However, little is known about disease in wild snakes. Predation on
The Tucson shovel-nosed snake is considered a “Tier 1b Species of Greatest Conservation Need” in the Arizona Game and Fish Department draft document, Arizona's Comprehensive Wildlife Conservation Strategy (CWCS) (Arizona Game and Fish Department 2006, pp. 32 and 723). The purpose of the CWCS is to provide a foundation for the future of wildlife conservation and a stimulus to conservation partners to strategically think about their roles in prioritizing conservation efforts (Arizona Game and Fish Department 2006, p. 2). A Tier 1b species is one that requires immediate conservation actions aimed at improving conditions through intervention at the population or habitat level (Arizona Game and Fish Department 2006, p. 32). The CWCS, however, does not provide regulatory protection for the snake. It serves only to prioritize funds and guide implementation of conservation activities for Arizona's vulnerable wildlife (Arizona Game and Fish Department 2006, p. 9). The Arizona Game and Fish Department does not have specified or mandated recovery goals for the Tucson shovel-nosed snake, but it continues as a strong partner in research and survey efforts that further our understanding of current populations within Arizona.
With a valid hunting license, the Arizona Game and Fish Department allows for take of up to four Tucson shovel-nosed snakes per person per year as specified in Commission Order Number 43. The Arizona Game and Fish Department defines “take” as “pursuing, shooting, hunting, fishing, trapping, killing, capturing, snaring, or netting wildlife or the placing or using any net or other device or trap in a manner that may result in the capturing or killing of wildlife.” If more than four are to be collected (e.g., for research purposes), a scientific collecting permit must be obtained. It is illegal to commercially sell, barter, or trade any native Arizona wildlife.
While we are aware that the Arizona Game and Fish Department enforces these laws to the extent that it can, encounters between humans and Tucson shovel-nosed snakes can result in the capture, injury, or death of the snake due to the lay person's fear or dislike of snakes, and the snake's resemblance to venomous coral snakes (Rosen and Schwalbe 1988, p. 43; Ernst and Zug 1996, p. 75; Green 1997, pp. 285-286; Nowak and Santana-Bendix 2002, p. 39). We believe that unregulated take may occur, but it is likely infrequent because Tucson shovel-nosed snakes generally are difficult to locate in the wild.
The majority of currently known populations of Tucson shovel-nosed snakes occur on lands managed by the Arizona State Land Department, which at present has no regulations or programs to protect the subspecies. State Trust Land is distinguished from public land (such as Federal land administered by the BLM or U.S. Forest Service) in that all uses of the land must benefit the 13 Trust beneficiaries, the largest of which are the Common Schools (Arizona State Land Department 2009a, p. 1). Arizona State Trust Lands are managed to enhance value and optimize economic return for the Trust beneficiaries (Arizona State Land Department 2009b, p. 1), which can include the sale or long-term lease of lands for commercial or residential development. Although State lands currently provide open space within the range of the Tucson shovel-nosed snake, there are no known plans to require protection of habitat on State lands, and no other protections are afforded the snake on State lands.
BLM manages some lands within the range of the Tucson shovel-nosed snake. BLM currently has no regulations to protect the Tucson shovel-nosed snake, and does not survey for the snake or its habitat. BLM lands usually are secure from agricultural and urban development; however, BLM may dispose of lands identified under its land use planning through the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701
Some lands within the range of the Tucson shovel-nosed snake are owned by county, city, or private entities. These lands may provide habitat for the Tucson shovel-nosed snake if they are maintained as natural open space; however, there are no regulatory mechanisms in place to protect the snake should the land use change.
We are aware of three habitat conservation plans currently being developed that include the Tucson shovel-nosed snake as a covered species: the Pima County Multi-species Conservation Plan, the Town of Marana Habitat Conservation Plan, and the City of Tucson's Avra Valley Habitat Conservation Plan. As none of these plans have been finalized, we will not explore the adequacies of these plans as possible regulatory mechanisms for the snake.
The Gila River Indian Community owns lands within the range of the Tucson shovel-nosed snake. We are not aware of any mechanisms in place to protect the snake on their lands.
Currently, there are no regulatory mechanisms in place that specifically target the conservation of the Tucson shovel-nosed snake or its habitat. Regulations protecting the quantity and quality of open space are inadequate to protect the habitat of the Tucson shovel-nosed snake, particularly in the face of the significant population growth expected within the historical range of the snake discussed under Factor A. Therefore, we consider the inadequacy of existing regulatory mechanisms a threat to the Tucson shovel-nosed snake.
Seager
Temperatures in the desert Southwest are expected to rise in the next two decades and likely throughout the 21
In our review of the status of the Tucson shovel-nosed snake, we carefully examined the best scientific and commercial information available. We identified a number of potential threats to this species, including: urban and rural development; road construction, use, and maintenance; concentrating solar power facilities and transmission corridors; agriculture; wildfires; and lack of adequate management and regulation.
Limited surveys have been conducted only in small parts of its range, so information on rangewide population size and trends for the Tucson shovel-nosed snake is not available. As of 2001, over one-third of the area within the range of the snake had been converted to either urban development or agriculture. There are indications that in the Avra Valley, where the snake was once present, it has now disappeared or persists in such low numbers that it is difficult to locate. In other areas (e.g., Florence Military Reservation), the snake appears to be persisting. Therefore, based on the best available information, we find that the only information we have indicates that populations in the Avra Valley have declined, which is near development and agriculture; while in areas with little or no development or agriculture, the population is persisting.
We evaluated existing and potential threats to the Tucson shovel-nosed snake to determine what effects on the subspecies are currently occurring, whether these threats are likely to increase or decrease in the future, and which of the impacts may be expected to rise to the level of a threat to the subspecies, either rangewide or at the population level. We examined threats posed by urban and rural development; road construction, use, and maintenance; solar power facilities and transmission corridors; agricultural uses; wildfires; overutilization; disease and predation; the inadequacy of existing regulatory mechanisms; and climate change. We did not find that overutilization, disease, or predation are currently threatening the Tucson shovel-nosed snake. We also found it likely that the threat of agricultural uses will decrease in the future, as farmland is and will continue to be converted to residential and commercial uses.
Next we considered whether any of the potential threats are likely to increase within the foreseeable future. Data suggest that urban and rural development in most of the snake's range is likely to increase in the future. Comprehensive Plans encompassing the entire range of the snake encourage large Growth Areas in the next 20 years and beyond, portions of which occur in Tucson shovel-nosed snake habitat not already impacted by development or agriculture. These Plans also call for an increase in roads and transportation corridors, which have been documented to impact the snake through direct mortality. Additionally, development of solar energy facilities and transmission corridors throughout the State is being pursued, and demand for these facilities will likely increase. Some of these facilities are being considered within the range of the Tucson shovel-nosed snake and have the potential to degrade
Climate change is likely to continue for the next century, but there is uncertainty as to how climate change, described under Factor E, will affect the Tucson shovel-nosed snake and its habitat. Predictions are that temperatures in the Southwestern United States will continue to increase, with extreme weather events (such as heat waves, drought, and flooding) occurring with more frequency. How summer precipitation may be affected is less certain. Current models suggest that a 10- to 20-year (or longer) drought is anticipated, and some models predict dramatic changes in Southwestern vegetation communities as a result of climate change, although trajectories of vegetation change are difficult to predict because of variability in warm season precipitation and fire frequency. These changes could affect the habitat of the Tucson shovel-nosed snake, but because of the lack of specific modeling data within the range of the snake, we cannot predict how climate change will impact the Tucson shovel-nosed snake now or in the foreseeable future.
We next considered whether the existing level of threats causes us to conclude that the species is in danger of extinction now or in the foreseeable future. The threats discussed above, particularly those that lead to a loss of habitat, are likely to reduce the population of Tucson shovel-nosed snakes across its entire range. Given the limited geographic distribution of this snake and the fact that its entire range lies within the path of future development, we believe the subspecies is likely to become in danger of extinction within the foreseeable future. Therefore, we find that listing the Tucson shovel-nosed snake throughout its range is warranted.
We have reviewed the available information to determine if the existing and foreseeable threats pose an emergency. We have determined that an emergency listing is not warranted for this subspecies at this time because, within the current distribution of the subspecies throughout its range, there are at least some populations of the Tucson shovel-nosed snake that exist in relatively natural conditions that are unlikely to change in the short-term. However, if at any time we determine that emergency listing of the Tucson shovel-nosed snake is warranted, we will initiate an emergency listing.
The Service adopted guidelines on September 21, 1983 (48 FR 43098) to establish a rational system for allocating available appropriations to the highest priority species when adding species to the Lists of Endangered or Threatened Wildlife and Plants or reclassifying threatened species to endangered status. The system places greatest importance on the immediacy and magnitude of threats, but also factors in the level of taxonomic distinctiveness by assigning priority in descending order to monotypic genera, full species, and subspecies (or equivalently, distinct population segments of vertebrates). We assigned the Tucson shovel-nosed snake an LPN of 3, based on our finding that the subspecies faces imminent and high-magnitude threats from the present or threatened destruction, modification, or curtailment of its habitat and the inadequacy of existing regulatory mechanisms. One or more of the threats discussed above is occurring or is expected to occur throughout the entire range of this subspecies. These threats are on-going and, in some cases (e.g., loss of habitat through urban development), considered irreversible. While we conclude that listing the Tucson shovel-nosed snake is warranted, an immediate proposal to list this subspecies is precluded by other higher priority listing, which we address below.
The Act defines an endangered species as one ‘‘in danger of extinction throughout all or a significant portion of its range,'' and a threatened species as one ‘‘likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.'' The term ‘‘significant portion of its range'' is not defined by the statute. For the purposes of this finding, a significant portion of a species' range is an area that is important to the conservation of the species because it contributes meaningfully to the representation, resiliency, or redundancy of the species. The contribution must be at a level such that its loss would result in a decrease in the ability to conserve the species.
If an analysis of whether a species is threatened or endangered in a significant portion of its range is appropriate, we engage in a systematic process that begins with identifying any portions of the range of the species that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose in analyzing portions of the range that are not reasonably likely to be significant and threatened or endangered. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (i) the portions may be significant and (ii) the species may be in danger of extinction there or likely to become so within the foreseeable future. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are essentially uniform throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats applies only to portions of the range that are unimportant to the conservation of the species, such portions will not warrant further consideration.
On the basis of an analysis of factors that may threaten the Tucson shovel-nosed snake, we have determined that listing is warranted throughout its range. Therefore, it is not necessary to conduct further analysis with respect to the significance of any portion of its range at this time. We will further analyze whether threats may be disproportionate and warrant further consideration as a significant portion of its range at such time that we develop a proposed listing determination.
Preclusion is a function of the listing priority of a species in relation to the resources that are available and competing demands for those resources. Thus, in any given fiscal year (FY), multiple factors dictate whether it will be possible to undertake work on a proposed listing regulation or whether promulgation of such a proposal is warranted but precluded by higher-priority listing actions.
The resources available for listing actions are determined through the annual Congressional appropriations process. The appropriation for the Listing Program is available to support work involving the following listing actions: proposed and final listing rules;
We cannot spend more than is appropriated for the Listing Program without violating the Anti-Deficiency Act (see 31 U.S.C. § 1341(a)(1)(A)). In addition, in FY 1998 and for each fiscal year since then, Congress has placed a statutory cap on funds which may be expended for the Listing Program, equal to the amount expressly appropriated for that purpose in that fiscal year. This cap was designed to prevent funds appropriated for other functions under the Act (for example, recovery funds for removing species from the Lists), or for other Service programs, from being used for Listing Program actions (see House Report 105-163, 105
Recognizing that designation of critical habitat for species already listed would consume most of the overall Listing Program appropriation, Congress also put a critical habitat subcap in place in FY 2002 and has retained it each subsequent year to ensure that some funds are available for other work in the Listing Program: “The critical habitat designation subcap will ensure that some funding is available to address other listing activities” (House Report No. 107 - 103, 107
Thus, through the listing cap, the critical habitat subcap, and the amount of funds needed to address court-mandated critical habitat designations, Congress and the courts have in effect determined the amount of money available for other listing activities. Therefore, the funds in the listing cap, other than those needed to address court-mandated critical habitat for already listed species, set the limits on our determinations of preclusion and expeditious progress.
Congress also recognized that the availability of resources was the key element in deciding, when making a 12-month petition finding, whether we would prepare and issue a listing proposal or instead make a “warranted but precluded” finding for a given species. The Conference Report accompanying Public Law 97-304, which established the current statutory deadlines and the warranted-but-precluded finding, states (in a discussion on 90-day petition findings that by its own terms also covers 12-month findings) that the deadlines were “not intended to allow the Secretary to delay commencing the rulemaking process for any reason other than that the existence of pending or imminent proposals to list species subject to a greater degree of threat would make allocation of resources to such a petition [that is, for a lower-ranking species] unwise.”
In FY 2010, expeditious progress is that amount of work that can be achieved with $10,471,000, which is the amount of money that Congress appropriated for the Listing Program (that is, the portion of the Listing Program funding not related to critical habitat designations for species that are already listed). However these funds are not enough to fully fund all our court-ordered and statutory listing actions in FY 2010, so we are using $1,114,417 of our critical habitat subcap funds in order to work on all of our required petition findings and listing determinations. This brings the total amount of funds we have for listing action in FY 2010 to $11,585,417. Starting in FY 2010, we are also using our funds to work on listing actions for foreign species since that work was transferred from the Division of Scientific Authority, International Affairs Program to the Endangered Species Program. Our process is to make our determinations of preclusion on a nationwide basis to ensure that the species most in need of listing will be addressed first and also because we allocate our listing budget on a nationwide basis. The $11,585,417 is being used to fund work in the following categories: compliance with court orders and court-approved settlement agreements requiring that petition findings or listing determinations be completed by a specific date; section 4 (of the Act) listing actions with absolute statutory deadlines; essential litigation-related, administrative, and listing program-management functions; and high-priority listing actions for some of our candidate species. The allocations for each specific listing action are identified in the Service's FY 2010 Allocation Table (part of our administrative record).
In FY 2007, we had more than 120 species with an LPN of 2, based on our September 21, 1983, guidance for assigning an LPN for each candidate species (48 FR 43098). Using this guidance, we assign each candidate an LPN of 1 to 12, depending on the magnitude of threats (high vs. moderate to low), immediacy of threats (imminent or nonimminent), and taxonomic status of the species (in order of priority: monotypic genus (a species that is the sole member of a genus); species; or part of a species (subspecies, distinct population segment, or significant portion of the range)). The lower the listing priority number, the higher the listing priority (that is, a species with an LPN of 1 would have the highest listing priority). Because of the large number of
To be more efficient in our listing process, as we work on proposed rules for these species in the next several years, we are preparing multi-species proposals when appropriate, and these may include species with lower priority if they overlap geographically or have the same threats as a species with an LPN of 2. In addition, available staff resources are also a factor in determining high-priority species provided with funding. Finally, proposed rules for reclassification of threatened species to endangered are lower priority, since as listed species, they are already afforded the protection of the Act and implementing regulations.
We assigned the Tucson shovel-nosed snake an LPN of 3, based on our finding that the subspecies faces immediate and high-magnitude threats from the present or threatened destruction, modification, or curtailment of its habitat; predation; and the inadequacy of existing regulatory mechanisms. One or more of the threats discussed above are occurring in each known population in the United States and throughout historically occupied habitats in Mexico. These threats are on-going and, in some cases (e.g., nonnative species), considered irreversible. Pursuant to the 1983 Guidelines, a “species” facing imminent high-magnitude threats is assigned an LPN of 1, 2, or 3 depending on its taxonomic status. Because the Tucson shovel-nosed snake is a subspecies, we assigned it an LPN of 3 (the highest category available for a subspecies). Therefore, work on a proposed listing determination for the Tucson shovel-nosed snake is precluded by work on higher priority candidate species (i.e., species with LPN of 2); listing actions with absolute statutory, court-ordered, or court-approved deadlines; and final listing determinations for those species that were proposed for listing with funds from previous fiscal years. This work includes all the actions listed in the tables below under expeditious progress.
As explained above, a determination that listing is warranted but precluded must also demonstrate that expeditious progress is being made to add or remove qualified species to and from the Lists of Endangered and Threatened Wildlife and Plants. (Although we do not discuss it in detail here, we are also making expeditious progress in removing species from the list under the Recovery program, which is funded by a separate line item in the budget of the Endangered Species Program. As explained above in our description of the statutory cap on Listing Program funds, the Recovery Program funds and actions supported by them cannot be considered in determining expeditious progress made in the Listing Program.) As with our “precluded” finding, expeditious progress in adding qualified species to the Lists is a function of the resources available and the competing demands for those funds. Given that limitation, we find that we are making progress in FY 2010 in the Listing Program. This progress included preparing and publishing the following determinations:
Our expeditious progress also includes work on listing actions that we funded in FY 2010 but have not yet been completed to date. These actions are listed below. Actions in the top section of the table are being conducted under a deadline set by a court. Actions in the middle section of the table are being conducted to meet statutory timelines, that is, timelines required under the Act. Actions in the bottom section of the table are high-priority listing actions. These actions include work primarily on species with an LPN of 2, and selection of these species is partially based on available staff resources, and when appropriate, include species with a lower priority if they overlap geographically or have the same threats as the species with the high priority. Including these species together in the same proposed rule results in considerable savings in time and funding, as compared to preparing separate proposed rules for each of them in the future.
We have endeavored to make our listing actions as efficient and timely as possible, given the requirements of the relevant law and regulations, and constraints relating to workload and personnel. We are continually considering ways to streamline processes or achieve economies of scale, such as by batching related actions
The Tucson shovel-nosed snake will be added to the list of candidate species upon publication of this 12-month finding. We will continue to monitor the status of this species as new information becomes available. This review will determine if a change in status is warranted, including the need to make prompt use of emergency listing procedures.
We intend that any proposed listing action for the Tucson shovel-nosed snake will be as accurate as possible. Therefore, we will continue to accept additional information and comments from all concerned governmental agencies, the scientific community, industry, or any other interested party concerning this finding.
A complete list of all references cited in this document is available on the Internet at http://www.regulations.gov and upon request from the Field Supervisor at the Arizona Ecological Services Office (see
The primary author of this notice is the Arizona Ecological Services Office (see
The authority for this action is section 4 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Rural Utilities Service, USDA.
Notice and request for comments.
The Rural Utilities Service (RUS), in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended), invites comments on the following information collections for which the Agency intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by June 1, 2010.
Michele Brooks, Director, Program Development and Regulatory Analysis, U.S. Department of Agriculture, Rural Utilities Service, 1400 Independence Ave., SW., STOP 1522, Room 5162, South Building, Washington, DC 20250-1522. Telephone: (202) 690-1078. Fax: (202) 720- 8435.
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. This notice identifies information collections that RUS is submitting to OMB for extension.
USDA Rural Development administers rural utilities programs through the Rural Utilities Service (Agency). Agency applicants provide environmental documentation, as prescribed by the rule, to assure that policy contained in NEPA is followed. The burden varies depending on the type, size, and location of each project, which then prescribes the type of information collection involved. The collection of information is only that information that is essential for the Agency to provide environmental safeguards and to comply with NEPA as implemented by the CEQ regulations.
Copies of this information collection can be obtained from MaryPat Daskal, Program Development and Regulatory Analysis, United States Department of Agriculture, Rural Utilities Service, at (202) 720-7853. FAX: (202) 720-8435.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designation of the following organizations to provide official services under the United States Grain Standards Act, as amended (USGSA): Champaign-Danville Grain Inspection Departments, Inc. (Champaign); Detroit Grain Inspection Service, Inc. (Detroit); Eastern Iowa Grain Inspection and Weighing Service, Inc. (Eastern Iowa); Enid Grain Inspection Company, Inc. (Enid); Keokuk Grain Inspection Service (Keokuk); Michigan Grain Inspection Services, Inc. (Michigan); and Omaha Grain Inspection Service, Inc. (Omaha).
William A. Ashley, Acting Branch Chief, Review Branch, Compliance Division, GIPSA, USDA, STOP 3604, Room 1647-S, 1400 Independence Avenue, SW., Washington, DC 20250-3604.
William A. Ashley, 202-720-8262 or
In the September 4, 2009,
Champaign, Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha were the sole applicants for
GIPSA evaluated all available information regarding the designation criteria in section 7(f)(1) of the USGSA (7 U.S.C. 79(f)) and determined that Champaign, Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha are able to provide official services in the geographic areas specified in the September 4, 2009
Interested persons may obtain official services by calling the telephone numbers listed below:
Section 7(f)(1) of the USGSA authorizes GIPSA's Administrator to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)(1)).
Under section 7(g)(1) of the USGSA, designations of official agencies are effective for 3 years unless terminated by the Secretary; however, designations may be renewed according to the criteria and procedures prescribed in section 7(f) of the Act.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
The designations of the official agencies listed below will end on September 30, 2010. We are asking persons or governmental agencies interested in providing official services in the areas presently served by these agencies to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agencies: Amarillo Grain Exchange, Inc. (Amarillo); Cairo Grain Inspection Agency, Inc. (Cairo); Louisiana Department of Agriculture and Forestry (Louisiana); North Carolina Department of Agriculture (North Carolina); and D. R. Schaal Agency, Inc. (Schaal).
Applications and comments must be received by April 30, 2010.
Submit applications and comments concerning this notice using any of the following methods:
•
•
•
•
•
William A. Ashley, 202-720-8262 or
Section 7(f)(1) of the United States Grain Standards Act (USGSA) (7 U.S.C. 71-87k) authorizes GIPSA's Administrator to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services. Under section 7(g)(1) of the USGSA, designations of official agencies are effective for 3 years unless terminated by the Secretary, but may be renewed according to the criteria and procedures prescribed in section 7(f) of the Act.
Pursuant to Section 7(f)(2) of the Act, the following geographic areas, in the States of Oklahoma and Texas are assigned to this official agency:
• Armstrong (north of Prairie Dog Town Fork of the Red River), Carson, Childress, Collingsworth, Dallam, Deaf Smith (east of U.S. Route 385), Donley, Gray, Hansford, Hall (east of U.S. Route 287), Harley, Hemphill, Hutchinson, Lipscomb, Moore, Ochiltree, Oldham, Potter, Randall (north of Prairie Dog Town Fork of the Red River, State Route 217 and FM 1062), Roberts, Sherman, and Wheeler Counties in Texas.
• Beaver, Cimarron, and Texas Counties in Oklahoma.
Pursuant to Section 7(f)(2) of the Act, the following geographic areas, in the States of Illinois, Kentucky, and Tennessee are assigned to this official agency:
• Alexander, Jackson County (south of State Route 3, State Route 149, and State Route 13; west of U.S. Route 51), Johnson, Hardin, Massac, Pope, Pulaski, Randolph County (south of State Route 150 and south of State Route 3), and Union Counties in Illinois.
• Ballard, Calloway, Carlisle, Fulton, Graves, Hickman, Livingston, Lyon, Marshall, McCracken, and Trigg Counties in Kentucky.
• Benton, Dickson, Henry, Houston, Humphreys, Lake, Montgomery, Obion, Stewart, and Weakley Counties in Tennessee.
The Cargill, Inc., grain elevator in Tiptonville, Lake County, Tennessee, which is located within Cairo's assigned areas, is currently serviced, and will continue to be serviced by Midsouth Grain Inspection Service.
Pursuant to Section 7(f)(2) of the Act, the entire State of Louisiana, except those export port locations within the State which are serviced by GIPSA, is assigned to this official agency.
Pursuant to Section 7(f)(2) of the Act, the entire State of North Carolina, except those export port locations within the State which are serviced by GIPSA, is assigned to this official agency.
Pursuant to Section 7(f)(2) of the Act, the following geographic areas, in the States of Iowa, Minnesota, New Jersey, and New York are assigned to this official agency:
• Butler (north of County Road C23 and County Road C33, east of County Road T47, and west of State Highway 188/County Road T64), Cerro Gordo, Floyd (west of County Road T64 and north of County Road B60), Franklin (north of County Road C55, County Road C25, and County Road C23 and west of U.S. Route 65, County Road S41, and County Road S56), Hancock, Kossuth (east of U.S. Route 169), Mitchell, Winnebago, Worth, Wright (north of State Route 3 and Interstate 35 and east of State Route 17 and U.S. Route 65) Counties in Iowa.
The following grain elevators, located within Schaal's assigned geographic areas in the State of Iowa, are not serviced by Schaal: (1) Agvantage F.S., Chapin, Franklin County; (2) Five Star Coop, Rockwell, Cerro Gordo County (both serviced by Central Iowa Grain Inspection Service, Inc.); and (3) West Bend Elevator Co., Algona, Kossuth County; Stateline Coop, Burt, Kossuth County; Gold-Eagle, Goldfield, Wright County; and North Central Coop, Holmes, Wright County (serviced by Sioux City Inspection and Weighing Service Company).
• Faribault, Freeborn, and Mower Counties in Minnesota.
• The entire States of New Jersey and New York, except those export port locations within the States which are serviced by GIPSA.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 7(f) of the USGSA and 7 CFR 800.196(d). Designation in the specified geographic areas is for the period beginning October 1, 2010, and ending September 30, 2013. To apply for designation or for more information, contact William A. Ashley at the address listed above or visit GIPSA's Web site at
We are publishing this notice to provide interested persons the opportunity to comment on the quality of services provided by the Amarillo, Cairo, Louisiana, North Carolina, and Schaal official agencies. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicants. Submit all comments to William A. Ashley at the above address or at
We consider applications, comments, and other available information when determining which applicant will be designated.
7 U.S.C. 71-87k.
Forest Service, USDA.
Notice of meeting.
Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000, as amended, (Pub. L. 110-343), the Umatilla National Forest, Southeast Washington Resource Advisory Committee will conduct a business meeting. The meeting is open to the public.
Wednesday, April 7, 2010, beginning at 6:30 p.m.
Pomeroy Ranger District Office, 71 West Main Street, Pomeroy, Washington.
Agenda topics will include review and approval of project proposals, and is an open public forum.
Monte Fujishin, Designated Federal Official, at (509) 843-1891 or e-mail
Forest Service, USDA.
Notice of meeting.
The Alpine County Resource Advisory Committee (RAC) will hold a meeting.
The meeting will be held on April 20, 2010, and will begin at 6 p.m.
The meeting will be held in Alpine County at the Alpine Early Learning Center, 100 Foothill Road, Markleeville, CA 96120.
Marnie Bonesteel, RAC Coordinator,
USDA, Humboldt-Toiyabe National Forest, Carson Ranger District, 1536 S. Carson Street, Carson City, NV 89701 (775) 352-1240; E-MAIL
Agenda items to be covered include: (1) Congratulate new members (2) Discuss and vote on committee bylaws and elect a chairperson (3) Review Title II projects and recommend projects for funding (4) Public Comment. The meeting is open to the public. Public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.
Forest Service, USDA.
Notice of meeting.
Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000, as amended, (Pub. L. 110-343), the Boise, Payette, and Sawtooth National Forests' Southwest Idaho Resource Advisory Committee will conduct a business meeting. The meeting is open to the public.
Thursday, April 15, 2010, beginning at 10:30 a.m.
Idaho Counties Risk Management Program Building, 3100 South Vista Avenue, Boise, Idaho.
Agenda topics will include review and approval of project proposals, and is an open public forum.
Dale Olson, Designated Federal Official, at (208) 347-0322 or e-mail
United States Commission on Civil Rights.
Notice of meeting cancellation.
On March 18, 2010 (75 FR 13076) the U.S. Commission on Civil Rights announced a business meeting to be held on Friday, March 26, 2010 at the Commission's headquarters. On Thursday, March 25, 2010, the meeting was cancelled. The decision to cancel the meeting was too close in time to the day of the meeting for the publication of a cancellation notice to appear in advance of the scheduled meeting date. The details of the cancelled meeting are:
Friday, March 26, 2010; 11:30 a.m. EDT.
Via Teleconference. Public Dial in: 1-800-597-7623. Conference ID # 63007474.
Meeting open to public.
This meeting is open to the public, except where noted otherwise.
The Commission's next scheduled meeting is Friday, April 16, 2010, the details of which will be published in the
Lenore Ostrowsky, Acting Chief, Public Affairs Unit (202) 376-8591. TDD: (202) 376-8116.
Persons with a disability requiring special services, such as an interpreter for the hearing impaired, should contact Pamela Dunston at least seven days prior to the meeting at 202-376-8105. TDD: (202) 376-8116.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
Projects under the 2010 CPEX will guide future census design as well as benefit other ongoing programs conducted by the Census Bureau, such as the American Community Survey.
As with previous decennial censuses dating back to 1950, the Census Bureau conducts a formal program to assess the census and experimental tests that examine methodologies, techniques, and strategies that will potentially improve the way the Census Bureau conducts the next decennial census. For experimental studies, the actual decennial census environment is required because it provides the necessary conditions to learn the true effects of new ideas within the context of the actual effects of national advertising, outreach partnerships, and other events that occur only during a census.
The 2010 CQS seeks to build on previous Internet data collection research in order to set the stage for the Internet testing cycle for the 2020 Census. The main objective is to estimate measurement errors, such as simple response variance and bias of responses from a census mail questionnaire compared to those from a census Internet questionnaire. The reinterviews will be conducted with a sample of 2010 Census mail respondents in order to provide estimates of measurement errors associated with the design and content of a self-administered census Internet questionnaire. Since the measurement error structure may differ depending on whether a respondent has only one response mode option (
The data from the Internet reinterview will be compared with the data from the mail reinterview to provide additional information for estimating measurement errors associated with responses from each of the data collection modes as well as response option strategies. Internet reinterview data will also be compared to 2010 Census mail questionnaire data for the same households to estimate gross difference rates. A similar comparison will be made for the mail reinterview to estimate gross difference rates for the mail mode. These gross difference rates will be compared to estimate the measurement error that arises from Internet versus census mail questionnaires. In addition to estimating measurement errors, a key objective of the evaluation is to collect data related to respondent interaction with a census Internet questionnaire such as break-off rates and completion times. Laboratory usability testing will also provide data (
The Internet and mail reinterviews will be conducted in late summer of 2010, after the census enumeration activities have been completed, to minimize the risk to the 2010 Census data collection. However, the reinterviews will be conducted as close to the census enumeration as feasible to effectively compare reinterview results to the 2010 Census self-administered mail questionnaire. Presumably, the results collected within the census environment will reflect a more generalizable measurement error structure than results from a mid-decade census test instrument. In addition, we hope to capitalize on respondents' awareness of the 2010 Census to obtain a higher response to the reinterviews than would be possible in the absence of the 2010 Census environment. However, for the Internet reinterview, compliance may suffer from public messaging informing potential respondents that there is no Internet response option in the 2010 Census.
As with all CPEX experiments and evaluations, the 2010 CQS is primarily designed for use by the Census Bureau to inform early 2020 Census testing and planning. The intent is to use the 2010 CQS quantitative results, in combination with the usability laboratory results, to focus the Census Bureau's Internet development/design resources for early decade testing. This questionnaire design work will be integrated with response option and contact strategy research within the 2020 testing cycle to establish the optimal Internet data collection strategy for the 2020 Census.
The 2010 CQS is intended to provide estimates of measurement error associated with the design and content of a self-administered census Internet questionnaire. The overall goal is to design the most effective census Internet questionnaire, given the time and resource constraints, and then evaluate its associated measurement error and usability issues. The Internet instrument is not intended to simply replicate the 2010 Census mail questionnaire in an electronic mode. Rather, the goal is to evaluate measurement error associated with an Internet questionnaire that exploits the advantages of the electronic technology, while still retaining the meaning and intent of the questions and response options from the mail form. Likewise, this evaluation is not intended to evaluate public compliance (as measured by unit-level response rates). An Internet response strategy study within the 2010 Census production cycle (or shortly after) would be limited by the 2010 Integrated Communication Program (ICP) messages stating that there is no Internet data collection for the 2010 Census.
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Brian Harris-Kojetin, OMB Desk Officer either by fax (202-395-7245) or e-mail (
Import Administration, International Trade Administration, Department of Commerce.
On December 11, 2009, the United States Court of International Trade (CIT) sustained the Department of Commerce's (the Department) remand determination in
March 31, 2010.
John Conniff, AD/CVD Operations, Office 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave., NW., Washington, DC 20230; telephone: 202/482-1009.
On November 24, 2008, the Department published its affirmative countervailing duty determination in
In
The Department issued its remand redetermination on October 20, 2009.
On December 11, 2009, the CIT sustained the Department's remand redetermination in its entirety.
Because there is now a final and conclusive decision in the court proceeding, we are further amending
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, Department of Commerce.
Announcement of availability of Federal financial assistance.
NMFS announces the availability of long-term direct loans made under the Fisheries Finance Program (FFP). The FFP provides financing for the purchase of used vessels or the reconstruction of vessels (limited to reconstructions that do not add to fishing capacity); refinancing for existing debt obligations; financing or refinancing fisheries shoreside facilities or aquacultural facilities; and the purchase or refinancing of Individual Fishing Quota (IFQ) in the North Pacific. FFP loans are not issued for purposes which could contribute to over capitalization of the fishing industry.
All loan funds available for FY 2010 must be obligated before September 30, 2010.
Applicants may obtain information and send loan applications to the nearest Financial Services Branch (FSB). FSB locations and contact information are:
1. Northwest Financial Services Branch, F/MB53, National Marine Fisheries Service, National Oceanic and Atmospheric Administration, 7600 Sand Point Way NW, (BIN C15700), Seattle, WA 98115, Branch Chief: Scott Houghtaling, Phone: (206) 526-6122.
2. Northeast Financial Services Branch, F/MB51, National Marine Fisheries Service, National Oceanic and Atmospheric Administration, 55 Great Republic Drive, Suite 02-700, Gloucester, MA 01930-2209, Branch Chief: Ron Linsky, Phone: (978) 281-9154.
3.Southeast Financial Services Branch, National Marine Fisheries Service, F/MB52, National Oceanic and Atmospheric Administration, 263 13th Avenue South, St. Petersburg, FL 33702-2432, Branch Chief: Shawn Berry, Phone: (727) 824-5342.
In addition, information is available at
The FFP's primary statutory authority is found in Title XI of the Merchant Marine Act, 1936, as amended and now recodified at 46 U.S.C. 53701,
Title XI is the credit authority under which NMFS will make these loans. This authority is subject to the Federal Credit Reform Act of 1990 (FCRA) (2 U.S.C. 661) which requires estimated net loan losses (FCRA cost) to be appropriated at the time Congress authorizes annual loan ceilings.
The amount of annual FCRA credit authority available is a ratio of the FCRA cost rate and the FCRA cost appropriated. The current cost rate estimate based on the historical performance of FFP's loan programs is zero. Consequently, no loan subsidy is required. For Fiscal Year 2010 (FY10),
It is estimated that these credit authorities will fund approximately 31 traditional loans and 54 IFQ loans. Applications will generally be reviewed in the order they are received. The FFP's traditional priorities are:
1. Aquacultural facilities construction, reconstruction, reconditioning, and acquisition
2. Fisheries shoreside facilities construction, reconstruction, reconditioning, and acquisition;
3. Fishing vessel reconstruction, reconditioning and acquisition. The FFP rule, however, prohibits loans that increase existing harvesting capacity, as does the FFP's loan authority appropriations language. FFP loans may not consequently originally finance either vessel construction or reconstruction that increases vessel harvesting capacity. The FFP will not make vessel loans in fisheries listed as overfished or subject to overfishing in the recent Status of the U.S. Fisheries, published by the National Marine Fisheries Service, at the time of application.
The FFP is listed in the “Catalog of Federal Domestic Assistance” under number 11.415: Fisheries Finance Program.
An applicant, either an individual or a business entity must be a citizen of the United States as described in 46 U.S.C. 104, or an entity who is a citizen for the purpose of documenting a vessel in the coastwise trade under 46 U.S.C. 50501.
Applicants for an IFQ loan must be eligible to hold the IFQ in the North Pacific fishery that is subject of the loan.
1.
2.
3.
4.
5.
6.
7.
1. In accordance with the provisions of the Debt Collection Improvement Act of 1996, a person may not obtain any Federal financial assistance in the form of a loan (other than a disaster loan) or loan guarantee if the person has an outstanding debt (other than a debt under the Internal Revenue Code of 1986) with any Federal agency which is in a delinquent status, as determined under standards prescribed by the Secretary of the Treasury.
2. Applicants may be subject to a name-check review process. Name checks are intended to reveal if any key individuals associated with the applicant have been convicted of or are presently facing such criminal charges as fraud, theft, perjury, or other matters which significantly reflect on the applicant's management honesty or financial integrity.
3. A false statement on an application is grounds for denial or termination of funds and grounds for possible punishment by a fine or imprisonment as provided in 18 U.S.C. 1001.
4. Applicants must submit a completed Form CD-511, “Certifications Regarding Debarment, Suspension and Other Responsibility Matters; Drug-Free Workplace Requirements and Lobbying,” and the following explanations are hereby provided:
i.
ii.
5. An applicant classified for tax purposes as in individual, partnership, proprietorship, corporation, or medical corporation is required to submit a taxpayer identification number (TIN) (either social security number, employer identification number as applicable, or registered foreign organization number) on Form W-9, “Payers Request for Taxpayer Identification Number.” Tax-exempt organizations and corporations (with the exception of medical corporations) are excluded from this requirement. Recipients who either fail to provide their TIN or provide an incorrect TIN may have funding suspended until the requirement is met.
Disclosure of a Recipient's TIN is mandatory for Federal income tax reporting purposes under the authority of 26 U.S.C., Section 6011 and 6109(d), and 26 CFR, Section 301.6109-1. This is to ensure the accuracy of income computation by the IRS. This information will be used to identify an individual who is compensated with DOC funds or paid interest under the Prompt Payment Act.
6. An audit of a Program loan may be conducted at any time. Auditors, selected at the discretion of the Department of Commerce's Office of
Neither the Administrative Procedure Act nor any other law requires prior notice and opportunity for public comment about this document (which concerns loans). Consequently, the Regulatory Flexibility Act does not require a regulatory flexibility analysis.
This notice is not significant for purposes of E.O. 12866.
This notice contains and refers to collection-of-information requirements subject to the Paperwork Reduction Act. The application requirements contained in the Notice have been approved under OMB control number 0648-0012. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice and request for applications.
The ONMS is seeking applications for the following vacant seats on the Monterey Bay National Marine Sanctuary Advisory Council: Conservation alternate and Education primary. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen for the Education primary should expect to serve until February 2011 and applicants who are chosen for the Conservation alternate should expect to serve until February 2013.
Applications are due by April 30, 2010.
Application kits may be obtained from 299 Foam Street, Monterey, CA 93940 or online at
Nicole Capps, 299 Foam Street, Monterey, CA 93940, (831) 647-4206,
The MBNMS Advisory Council was established in March 1994 to assure continued public participation in the management of the Sanctuary. Since its establishment, the Advisory Council has played a vital role in decisions affecting the Sanctuary along the central California coast.
The Advisory Council's twenty voting members represent a variety of local user groups, as well as the general public, plus seven local, state and federal governmental jurisdictions. In addition, the respective managers or superintendents for the four California National Marine Sanctuaries (Channel Islands National Marine Sanctuary, Cordell Bank National Marine Sanctuary, Gulf of the Farallones National Marine Sanctuary and the Monterey Bay National Marine Sanctuary) and the Elkhorn Slough National Estuarine Research Reserve sit as non-voting members.
Four working groups support the Advisory Council: The Research Activity Panel (“RAP”) chaired by the Research Representative, the Sanctuary Education Panel (“SEP”) chaired by the Education Representative, the Conservation Working Group (“CWG”) chaired by the Conservation Representative, and the Business and Tourism Activity Panel (“ETAP”) chaired by the Business/Industry Representative, each dealing with matters concerning research, education, conservation and human use. The working groups are composed of experts from the appropriate fields of interest and meet monthly, or bi-monthly, serving as invaluable advisors to the Advisory Council and the Sanctuary Superintendent.
The Advisory Council represents the coordination link between the Sanctuary and the state and federal management agencies, user groups, researchers, educators, policy makers, and other various groups that help to focus efforts and attention on the central California coastal and marine ecosystems.
The Advisory Council functions in an advisory capacity to the Sanctuary Superintendent and is instrumental in helping develop policies, program goals, and identify education, outreach, research, long-term monitoring, resource protection, and revenue enhancement priorities. The Advisory Council works in concert with the Sanctuary Superintendent by keeping him or her informed about issues of concern throughout the Sanctuary, offering recommendations on specific issues, and aiding the Superintendent in achieving the goals of the Sanctuary program within the context of California's marine programs and policies.
16 U.S.C. 1431,
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice and request for applications.
The ONMS is seeking applications for the following vacant seat on the Flower Garden Banks National Marine Sanctuary Advisory Council: Conservation. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the
Applications are due by May 28, 2010.
Application kits may be obtained from Jennifer Morgan, NOA-Flower Garden Banks National Marine Sanctuary, 4700 Avenue U, Bldg. 216, Galveston, TX 77551 or downloaded from the sanctuary Web site
Jennifer Morgan, NOAA-Flower Garden Banks National Marine Sanctuary, 4700 Avenue U, Bldg. 216, Galveston, TX 77551, 409-621-5151 ext. 103,
Located in the northwestern Gulf of Mexico, the Flower Garden Banks National Marine Sanctuary includes three separate areas, known as East Flower Garden, West Flower Garden, and Stetson Banks. The Sanctuary was designated on January 17, 1992. Stetson Bank was added to the Sanctuary in 1996. The Sanctuary Advisory Council will consist of no more than 21 members; 16 non-governmental voting members and 5 governmental non-voting members. The Council may serve as a forum for consultation and deliberation among its members and as a source of advice to the Sanctuary manager regarding the management of the Flower Garden Banks National Marine Sanctuary.
16 U.S.C. Sections 1431,
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice and request for applications.
The ONMS is seeking applications for the following vacant seats on the Fagatele Bay National Marine Sanctuary Advisory Council: Research, Education, Commercial Fishing, Ocean Recreation, Youth, Tutuila: East Side, Tutila: West Side, and Manua Islands. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members should expect to serve 3-year terms, pursuant to the council's Charter.
Applications are due by April 30, 2010.
Application kits may be obtained from Emily Gaskin, Fagatele Bay National Marine Sanctuary, American Samoa Department of Commerce Office, Executive Office Building, Utulei. Completed applications should be returned to the same address.
Emily Gaskin at (684) 633-5155 ext. 271 or
The Fagatele Bay National Marine Sanctuary Advisory Council was established in 1986 pursuant to Federal law to ensure continued public participation in the management of the sanctuary. The Sanctuary Advisory Council brings members of a diverse community together to provide advice to the Sanctuary Manager (delegated from the Secretary of Commerce and the Under Secretary for Oceans and Atmosphere) on the management and protection of the Sanctuary, or to assist the National Marine Sanctuary Program in guiding a proposed site through the designation or the periodic management plan review process.
16 U.S.C. 1431,
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) has received requests for new shipper reviews of the antidumping duty order on certain preserved mushrooms from the People's Republic of China (PRC).
Fred Baker, Scott Hoefke, or Robert James, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-2924, (202) 482-4947, or (202) 482-0649, respectively.
On February 19, 1999, the Department published the antidumping duty order on certain preserved mushrooms from the PRC.
Pursuant to the requirements set forth in section 751(a)(2)(B)(i) of the Act and 19 CFR 351.214(b)(2), Tongfa and Fengyu certified that (1) they did not export subject merchandise to the United States during the POI (
Based on information on the record and in accordance with section 751(a)(2)(B) of the Act and section 351.214(d) of the Department's regulations, we find that the requests Tongfa and Fengyu submitted meet the statutory and regulatory requirements for initiation of new shipper reviews.
In cases involving non-market economies, the Department requires that a company seeking to establish eligibility for an antidumping duty rate separate from the country-wide rate provide evidence of
We will instruct the CBP to allow, at the option of the importer, the posting, until the completion of the review, of a bond or security in lieu of a cash deposit for certain entries of the subject merchandise produced and exported by Tongfa and produced and exported by Fengyu in accordance with section 751(a)(2)(B)(iii) of the Act and 19 CFR 351.214(e). Because Tongfa and Fengyu certified that they both produce and export the subject merchandise, the sales of which form the basis for their new shipper review requests, we will instruct CBP to permit the use of a bond only for entries of subject merchandise which Tongfa and Fengyu both produced and exported.
Interested parties may submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 351.306.
These initiations and this notice are issued and published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Sea World LLC, 9205 South Park Center Loop, Suite 400, Orlando, FL 32819, has applied in due form for a permit to import one beluga whale (
Written or telefaxed comments must be received on or before April 30, 2010.
The application and related documents are available for review upon written request or by appointment in the following offices:
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 713-2289; fax (301) 713-0376; and
Southeast Region, NMFS, 263 13th Avenue South, Saint Petersburg, FL 33701; phone (727) 824-5312; fax (727) 824-5309.
Written comments on this application should be submitted to the Chief, Permits, Conservation and Education Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits, Conservation and Education Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Jennifer Skidmore or Kristy Beard, (301) 713-2289.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
The applicant requests authorization to import one male adult beluga whale from the Vancouver Aquarium Marine Science Center, British Columbia, Canada to Sea World of Texas. The applicant requests this import for the purpose of public display. The receiving facility, Sea World of Texas, 10500 SeaWorld Drive, San Antonio, TX 78251 is: (1) open to the public on regularly scheduled basis with access that is not limited or restricted other than by charging for an admission fee; (2) offers an educational program based on professionally accepted standards of the Association of Zoos and Aquariums and the Alliance for Marine Mammal Parks and Aquariums; and (3) holds an Exhibitor's License, number 58-C-0077, issued by the U.S. Department of Agriculture under the Animal Welfare Act (7 U.S.C. §§ 2131 - 59).
In addition to determining whether the applicant meets the three public display criteria, NMFS must determine whether the applicant has demonstrated that the proposed activity is humane and does not represent any unnecessary risks to the health and welfare of marine mammals; that the proposed activity by itself, or in combination with other activities, will not likely have a significant adverse impact on the species or stock; and that the applicant's expertise, facilities and resources are adequate to accomplish successfully the objectives and activities stated in the application.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that the Louisville Zoological Garden, 1100 Trevilian Way, P.O. Box 37250, Louisville, KY 40233, has applied in due form for a permit to import one South African fur seal (
Written or telefaxed comments must be received on or before April 30, 2010
The application and related documents are available for review upon written request or by appointment in the following offices:
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 713-2289; fax (301) 713-0376; and
Southeast Region, NMFS, 263 13th Avenue South, Saint Petersburg, FL 33701; phone (727) 824-5312; fax (727) 824-5309.
Written comments on this application should be submitted to the Chief, Permits, Conservation and Education Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits, Conservation and Education Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Jennifer Skidmore or Kristy Beard, (301) 713-2289.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
The applicant requests authorization to import one female adult South African fur seal from the Toronto Zoo, Ontario, Canada to the Louisville Zoological Garden. The applicant requests this import for the purpose of public display. The receiving facility, the Louisville Zoological Garden is: (1) open to the public on regularly scheduled basis with access that is not limited or restricted other than by charging for an admission fee; (2) offers an educational program based on professionally accepted standards of the Association of Zoos and Aquariums; and (3) holds an Exhibitor's License, number 61-C-0106, issued by the U.S. Department of Agriculture under the Animal Welfare Act (7 U.S.C. §§ 2131 - 59).
In addition to determining whether the applicant meets the three public display criteria, NMFS must determine whether the applicant has demonstrated that the proposed activity is humane and does not represent any unnecessary risks to the health and welfare of marine mammals; that the proposed activity by itself, or in combination with other activities, will not likely have a significant adverse impact on the species or stock; and that the applicant's expertise, facilities and resources are adequate to accomplish successfully the objectives and activities stated in the application.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
International Trade Administration, DOC.
Notice of Federal advisory committee meeting.
This notice sets forth the schedule and proposed agenda of the
The meeting is scheduled for: Thursday, April 15, 2010, from 1 p.m. to 4 p.m. Eastern Daylight Time (EDT).
The meeting will be held in Room 4830, U.S. Department of Commerce, Herbert Clark Hoover Building, 1401 Constitution Ave, NW., Washington, DC 20230.
Mr. Frank Caliva, Office of Energy & Environmental Industries, International Trade Administration, Room 4053, 1401 Constitution Ave, NW., Washington, DC 20230. (Phone: 202-482-8245; Fax: 202-482-5665; e-mail:
1. Welcome & introduction of members attending for the first time.
2. Discussion of civil nuclear trade priority issues.
A limited amount of time will be available for pertinent brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Caliva and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5 p.m. EST on Friday, April 9, 2010. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration (ITA) may conduct a lottery to determine the speakers. Speakers are requested to bring at least 20 copies of their oral comments for distribution to the participants and public at the meeting.
Any member of the public may submit pertinent written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to the Civil Nuclear Trade Advisory Committee, Office of Energy & Environmental Industries, Room 4053, 1401 Constitution Ave NW., Washington, DC 20230. To be considered during the meeting, comments must be received no later than 5 p.m. EST on Friday, April 9, 2010, to ensure transmission to the Committee prior to the meeting. Comments received after that date will be distributed to the members but may not be considered at the meeting.
Copies of CINTAC meeting minutes will be available within 90 days of the meeting.
Bureau of the Census, Department of Commerce.
Notice of public meeting.
The Bureau of the Census (U.S. Census Bureau) is giving notice of a meeting of the Census Scientific Advisory Committee (C-SAC). The Committee will address policy, research, and technical issues relating to a full range of Census Bureau programs and activities, including communications, decennial, demographic, economic, field operations, geographic, information technology, and statistics. Last minute changes to the agenda are possible, which could prevent giving advance public notice of schedule adjustments.
April 22-23, 2010. On April 22, the meeting will begin at approximately 8:30 a.m. and adjourn at approximately 5 p.m. On April 23, the meeting will begin at approximately 8:30 a.m. and adjourn at approximately 12 p.m.
The meeting will be held at Hilton Crystal City Hotel, 2399 Jefferson Davis Highway, Arlington, Virginia 22202.
Jeri Green, Committee Liaison Officer, Department of Commerce, U.S. Census Bureau, Room 8H182, 4600 Silver Hill Road, Washington, DC 20233, telephone 301-763-6590. For TTY callers, please use the Federal Relay Service 1-800-877-8339.
Members of the C-SAC are appointed by the Director, U.S. Census Bureau. The Committee provides scientific and technical expertise, as appropriate, to address Census Bureau program needs and objectives. The Committee has been established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2, Section 10).
The meeting is open to the public, and a brief period is set aside for public comments and questions. Persons with extensive questions or statements must submit them in writing at least three days before the meeting to the Committee Liaison Officer named above. Seating is available to the public on a first-come, first-served basis.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should also be directed to the Committee Liaison Officer as soon as known, and preferably two weeks prior to the meeting.
Bureau of the Census, Department of Commerce.
Notice of advisory committee reestablishment.
Notice is hereby given that the Secretary of Commerce has determined that the reestablishment of an advisory committee of technical advisors is necessary and in the public interest. Accordingly, the Bureau of the Census (Census Bureau) has chartered the Census Scientific Advisory Committee (CSAC), which succeeds the Census Advisory Committee of Professional Associations (CACPA). The charter for the CACPA expired on February 1, 2010.
Contact Jeri Green, Chief, Census Advisory Committee Office, U.S. Census Bureau, Washington, DC 20233, telephone 301-763-2075,
The CSAC will advise the Census Bureau's Director on the full range of Census Bureau programs and activities. The CSAC will provide scientific and technical expertise from the following disciplines: Demography, economics, geography, psychology, statistics, survey methodology, social and behavioral sciences, Information Technology and computing, marketing and other fields of expertise, as appropriate, to address Census Bureau program needs and objectives.
The CSAC will function solely as an advisory body and in compliance with provisions of the Federal Advisory Committee Act. Copies of the charter will be filed with the appropriate Committees of the Congress and with the Library of Congress.
Import Administration, International Trade Administration, Department of Commerce.
To help in its analysis, the Department is inviting the public to comment on the issue and the specific points raised by the conferees as well as identify additional issues or considerations that it believes are deserving of the Department's attention as it prepares its report. The Department is also notifying the public that it will hold a public hearing on April 27, 2010.
All comments will be available for public inspection at Import Administration's Central Records Unit, Room 1117, between the hours of 8:30 a.m. and 5 p.m. on business days. In addition, all comments will be made available to the public in Portable Document Format (PDF) on the Internet at the Import Administration Web site at the following address:
Comments may be submitted electronically or in writing. Electronic comments should be submitted to
Kelly Parkhill at (202) 482-3791.
Department of the Navy, DoD.
Notice.
In accordance with Section 102(2)(c) of the National Environmental Policy Act (NEPA)of 1969 (42 U.S.C. 4332 (2) (c)), as implemented by the Council on Environmental Quality Regulations (40 CFR Parts 1500-1508), the Department of the Navy intends to prepare an Environmental Impact Statement (EIS) and conduct a public scoping meeting for the proposed replacement of the Stuart Mesa Bridge and installation and operation of water infrastructure improvements throughout Marine Corps Base Camp Pendleton (MCBCP) in San Diego County, California.
The Department of the Navy will review all comments received during the 30-day public scoping period, which starts with the publication of this Notice of Intent. A public scoping meeting, using an informal open house format, will be held in the San Clemente Community Center, 100 North Calle Seville, San Clemente, California 92672, from 6 p.m. to 8 p.m. on April 16, 2010. The meeting will be announced by notices published in the North County Times and San Clemente Sun Post News. The public is invited to attend the meeting at their convenience during the meeting hours and can view project-related displays and speak with Department of the Navy and MCBCP representatives and resource staff. A court reporter will be available at the meeting to accept oral comments.
Written comments on the scope of the MCBCP Basewide Water Infrastructure and Stuart Mesa Bridge Replacement EIS should be directed to: Mr. Jesse Martinez, Naval Facilities Engineering Command (NAVFAC) Southwest, 1220 Pacific Highway, San Diego, California 92132. Written comments may also be submitted via fax at 619-532-4160, or e-mailed to
Mr. Jesse Martinez, NAVFAC Southwest at telephone 619-532-3844, fax 619-532-4160, or e-mail:
In the case of the roadway system, the Stuart Mesa Bridge, together with nearby roadway segments and the adjacent intersection of Stuart Mesa Road and Vandegrift Boulevard, represents a critical roadway connection on the main internal north-south connector in the southern and western portions of MCBCP. The roadway link has been severed in the past by flooding, underscoring the need for an all-weather solution.
The purpose of the proposed action is to enhance the ability of MCBCP to efficiently meet its mission by developing new or upgraded, reliable, and compliant infrastructure systems necessary to sustain military training and operations and quality of life services on MCBCP. The purpose is to provide (1) secure and more effective use of water resources, improved potable water quality and capacity, treatment and delivery capabilities, and water system redundancy necessary to reliably and efficiently deliver potable water in the northern region of MCBCP; (2) improved delivery of Basewide water services during periods of scheduled, unscheduled, and emergency system interruption; and (3) roadway improvements necessary to maintain efficient all-weather traffic accessibility to key areas in the southern portion of MCBCP that are now severed during periodic flooding in the vicinity of the Stuart Mesa Bridge.
The water infrastructure projects were initially included in the November 12, 2008, Notice of Intent (NOI) for MCBCP's Basewide Utilities Infrastructure project (73 FR 66879). These two water infrastructure projects were removed from that EIS for potential re-design and to develop additional alternatives for analysis. These two water infrastructure projects are independent of the Basewide Utilities Infrastructure projects and meet different needs.
The EIS will address the proposed alternative sites, alignments, and construction methods as described below.
Four alternatives involving a combination of two AWT sites and two pipeline routes are being evaluated. All alternatives include construction of a 54,000-square-foot AWT facility, 80,000 linear feet (LF) of new and replacement water lines, pump stations with emergency generators, connection to existing reservoirs and distribution system, a brine disposal system, and plant access improvements. The proposed AWT facility would process up to 7.5 million gallons per day (mgd) and would include micro-filtration, granulated activated carbon, and reverse osmosis. The facility would be designed in modular form for ease of expandability; however there are no current plans for expansion.
Following water treatment at the AWT, brine would be disposed via ocean outfall and/or injection wells. The brine disposal line would extend from the AWT facility to the south to connect to the proposed injection wells east of Interstate 5 (I-5) and/or to the existing Unit 1 ocean intake pipeline at San Onofre Nuclear Generating Station (SONGS). The line to SONGS would extend beneath I-5 via HDD. Brine disposal would make up approximately 8 to 10 percent of the capacity of the proposed AWT or a maximum volume of approximately 0.6 to 0.75 mgd. The ocean outfall disposal would use the existing SONGS former Unit 1, 12-foot-diameter, 3,200-foot-long cooling water intake structure located on the Pacific Ocean floor. Deep injection wells (approximately 1,000 feet deep) would be located south and east of the existing San Onofre percolation ponds.
Four alternatives involving different pipeline routes are being evaluated.
The pipelines would be HDD under or suspended over San Onofre Creek, Las Flores Creek, Aliso Canyon drainage, French Creek, and two locations on the Santa Margarita River to avoid impacts to these areas.
The project would also include the construction and operation of three pump stations along the alignment. One pump station would be located within the footprint of the AWT North and a second pump station would be located within a developed parking lot at the AWT South. A third pump station would be located in an existing parking area on the southwest side of the intersection of El Camino Real and Las Pulgas Road. Bicycle lanes and/or pedestrian trails could also be included over proposed water lines where feasible.
Alternative 2. The proposed north-south pipeline would start at the new AWT North facility (P-1044) and extend south in El Camino Real to Las Pulgas Road and run north in Las Pulgas Road to Basilone Road. The water line would then extend along Basilone Road to Vandegrift Boulevard and run east to connect to the AWT South at Haybarn Canyon as well as several reservoirs along a ridge above the AWT South (Reservoirs 13151, 13154, 24140, 24174, and 240173). This alternative would require two additional pump stations, for a total of five pump stations.
Four alternatives including a combination of two flood control methods and the use of a temporary bridge during construction are being evaluated. All alternatives include demolition of the existing Stuart Mesa Bridge and construction of a new four lane bridge and flood protection measures.
The project includes “100-year storm” flood protection control measures to protect Stuart Mesa Road and Vandegrift Boulevard. They consist of levees; toe scour protection along the levee; a storm water drain system consisting of culverts, inlets, outlets, headwalls, channels, and earth and concrete ditches. Supporting activities would include the construction and relocation of utilities (electrical, communications/information lines, water main) during the demolition and construction of the new bridge. Under this alternative, no temporary replacement bridge would be constructed over the Santa Margarita River and traffic would need to utilize alternate routes during this time.
The EIS will evaluate the potential environmental effects associated with each of the alternatives. Issues to be addressed include, but are not limited to; geology, topography and soils, hydrology and water quality, biological resources, cultural resources, land use, visual resources, socioeconomics and environmental justice, traffic, air quality, noise, public health and safety, services and utilities, and coastal zone management. Relevant and reasonable measures that could alleviate environmental effects will be considered.
Comments on the scope of this EIS must be received by April 30, 2010. The Department of the Navy will publish a Notice of Availability (NOA) in the
The Department of the Navy will undertake appropriate consultations with regulatory entities pursuant to the Endangered Species Act, Clean Water Act, National Historic Preservation Act, and any other applicable law or regulation. Consultation will include but is not limited to the following Federal, State, and local agencies: U.S. Fish and Wildlife Service; National Oceanic and Atmospheric Administration Fisheries; State Historic Preservation Officer; American Indian Tribes; U.S. Army Corps of Engineers; U.S. Environmental Protection Agency; all local Historic Site Boards and Heritage organizations; California Regional Water Quality Control Board; California Coastal Commission; San Diego Air Pollution Control District; and the County of San Diego, Department of Environmental Health.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.215L.
Office of Elementary and Secondary Education, Department of Education.
Notice of proposed priorities, requirements, definition, and selection criteria.
The Assistant Secretary for Elementary and Secondary Education proposes priorities, requirements, a definition, and selection criteria under the Smaller Learning Communities (SLC) program. The Assistant Secretary will use these priorities, requirements, definition, and selection criteria, in addition to any other previously established priorities and requirements, for a competition using fiscal year (FY) 2009 funds and may use them in later years. We take this action to focus Federal financial assistance on an identified national need. We intend these priorities, requirements, definition, and selection criteria to enhance the effectiveness of SLC projects in improving academic achievement and helping to prepare students for postsecondary education and careers.
We must receive your comments on or before April 30, 2010.
Address all comments about the proposed priorities, requirements, definition, and selection criteria to Angela Hernandez-Marshall, U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Room 3E308, Washington, DC 20202-6200.
If you prefer to send your comments through the Internet, use the following address:
Angela Hernandez-Marshall.
If you use a telecommunications device for the deaf (TDD), call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
We invite you to assist us in complying with the specific requirements of Executive Order 12866 and its overall requirement of reducing regulatory burden that might result from the proposed priorities, requirements, definition, and selection criteria. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about this notice in room 3E308, 400 Maryland Avenue, SW., Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.
20 U.S.C. 7249.
However, evaluation data have not shown that these structural changes and personalization strategies, by themselves, improve student academic achievement and readiness for postsecondary education and careers. Student learning gains have been seen only in those schools that also have made considerable changes in curriculum and instruction (Bernstein,
For these reasons, we are proposing priorities and selection criteria that are specifically intended to promote the close integration of SLC implementation with systematic efforts to improve curriculum and instruction. We also propose certain other requirements and a definition to clarify statutory provisions, improve the management of grant activities, facilitate the review of applications, and promote the equitable distribution of limited SLC grant funds.
As used in this notice, the terms
For these reasons, we propose a priority to allow grantees to use SLC funds to pay the necessary personnel and other costs associated with increasing common planning time for teachers. Under the proposed priority, applicants could, for example, propose to use grant funds to hire additional teachers, pay substitute teachers, or extend the school day in order to provide teachers with more time for common planning and collaboration.
Under the proposed priority, we would not require that grantees increase common planning time for all teachers within a school. Instead, grantees could choose to focus on a single grade level, such as ninth grade, or on particular content areas.
We believe that this proposed priority will help enhance the effectiveness of SLC projects in improving academic achievement and the preparation of students for postsecondary education and careers by ensuring that students receive the academic and personal supports they need to achieve.
This proposed priority would support projects that increase the amount of time regularly provided to teachers who share the same students or teach the same academic subject for common planning and collaboration during or immediately following the school day without decreasing the amount of time provided to teachers for individual planning and preparation. To meet this priority, the common planning time must be used for one or more of the following activities:
(1) Structured examination of student work and outcome data.
(2) Collaborative professional development and coaching, including classroom observation.
(3) Identifying instructional and other interventions for struggling students.
(4) Curriculum and assessment development.
The SLC program can be an important source of funding to support turnaround efforts in a State's persistently lowest-achieving high schools. For this reason, we propose to establish a priority for SLC projects that include one or more schools that have been identified by a State as a persistently lowest-achieving school.
This proposed priority would support SLC projects that include one or more schools that have been identified by a
For the purpose of this priority, the term “persistently lowest-achieving school” is defined as it is under the Department's State Fiscal Stabilization Fund Program (
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
These proposed requirements would be in addition to the application requirements required under title V, part D, subpart 4, section 5441(b) of the ESEA, and the following requirements established in the 2005 SLC NFP and the 2007 SLC NFP:
In its application, the applicant must provide detailed, yearly budget information for the total grant period requested.
In addition, we are proposing to reduce the number of schools that an LEA may apply on behalf of in a single application from eight to five because, in the past, many grantees have experienced great difficulties managing and overseeing project activities at more than five schools. In such cases, implementation progress has been slow and uneven and several grantees decided to remove one or more schools from their grants.
Finally, through this requirement, we are proposing that applications requesting more funds than the maximum amounts specified for any school or for the total grant will not be read as part of the regular application process. In previous SLC competitions, some applicants requested more funds than the amount that we indicated would be available for a grant. These applications included activities that could only be implemented if the applicants received a funding amount that exceeded the maximum amount specified by the Department. This strategy put at a competitive disadvantage other applicants that requested funds within the Department's specified funding range and proposed a less extensive set of activities. For this reason, we propose to review only those applications that request an amount that does not exceed the maximum amounts specified for the grants.
The following chart provides the ranges of awards per high school size:
An LEA may include up to five schools in a single application for a SLC grant. Therefore, an LEA applying on behalf of a group of eligible schools would be able to receive up to $12,500,000 for its SLC grant.
Applications requesting more funds than the maximum amounts specified for any school or for the total grant will not be read as part of the regular application process. However, if, after the Secretary selects applications to be funded, it appears that additional funds remain available, the Secretary has the option of reviewing applications that requested funds exceeding the maximum amounts specified. Under this requirement, if the Secretary chooses to fund any of the additional applications, selected applicants will be required to work with the Department to revise their proposed budgets to fit within the appropriate funding range.
In order to ensure that SLC projects ultimately achieve these important outcomes, we must ensure that each funded SLC project measures its progress in improving student academic achievement and related outcomes. For this reason, we propose to continue to measure the progress of grantees using two indicators: (1) Student performance on reading/language arts and mathematics assessments and (2) high school graduation rates (these two indicators are reflected in paragraphs (1) and (2) of the Performance Indicators included in the 2007 SLC NFP). These are the same indicators used by States to measure the progress of LEAs and high schools under Part A of Title I of the ESEA. We propose that performance objectives for these indicators equal or exceed the annual measurable objectives established by the State in its approved accountability plan for Part A of Title I of the ESEA. Because school-level data for these indicators are now available to the Department through using the EDEN Submission System (ESS), it is unnecessary for the Department to continue to collect them directly from grantees.
We also propose to continue measuring the extent to which the graduates of each school included in an SLC grant enter postsecondary education in the semester following high school graduation. Because enrolling in postsecondary education is a nearly universal aspiration among high school students and their parents, we believe that this measurement continues to be useful and we believe that grantees should be held accountable for helping them achieve this goal. We propose that performance objectives for this indicator exceed the baseline level of performance and give particular emphasis to narrowing any gaps between students in general and economically disadvantaged students, students from major racial and ethnic groups, students with disabilities, and students with limited English proficiency. Because data for this indicator are not reported by SEAs through ESS (an electronic system that facilitates the efficient and timely transmission of data from SEAs to the Department), we propose to continue to require grantees to provide these data on an annual basis. We further propose to require grantees to use administrative records that document student enrollment in postsecondary education as the principal source of data for this indicator because these data are likely to be more accurate and less costly to obtain than information gathered through student and parent surveys. Because these administrative records may not provide data on all of a school's graduates (
(a) The percentage of students who score at or above the proficient level on the reading/language arts and mathematics assessments used by the State to determine whether a school has made adequate yearly progress under Part A of Title I of the ESEA, as well as these percentages disaggregated by subject matter and the following subgroups:
(1) Major racial and ethnic groups.
(2) Students with disabilities.
(3) Students with limited English proficiency.
(4) Economically disadvantaged students.
(b) The school's graduation rate, as defined in the State's approved accountability plan for Part A of Title I of the ESEA, as well as the graduation rates for the following subgroups:
(1) Major racial and ethnic groups.
(2) Students with disabilities;
(3) Students with limited English proficiency; and
(4) Economically disadvantaged students; and
(c) The percentage of all graduates who enroll in postsecondary education in the semester following high school graduation, as well as the percentage disaggregated by the following subgroups:
(1) Major racial and ethnic groups.
(2) Students with disabilities.
(3) Students with limited English proficiency.
(4) Economically disadvantaged students.
Each applicant must identify in its application its performance objectives for each of these indicators for each year of the project period and provide baseline data for the third indicator (postsecondary enrollment). The Department will obtain baseline data for the first and second performance indicators (student performance on reading/language arts and mathematics assessments and the graduation rate) and data on the extent to which each school included in a grant achieves its annual performance objectives for each year of the project period from the data that are now reported to the Department by SEAs using the EDEN Submission System (ESS). Grantees are not required to provide these data.
Each grantee must report to the Department annually on the extent to which each school in its grant achieves its performance objectives for the third proposed indicator (postsecondary enrollment).
Finally, grantees must use administrative records maintained by State, national, or regional entities that already collect data on student enrollment in postsecondary education as the principal source of data for this performance indicator. These administrative records include, for example, data available through State longitudinal databases or other sources. Grantees may supplement these records with data collected through surveys administered to students or parents after graduation.
(a) The school's name, postal mailing address, and the 12-digit identification number assigned the school by the National Center for Education Statistics; and
(b) Evidence that, during the current school year or the most recently completed school year, the school is a large public high school (
To meet this requirement, the enrollment figures provided in the evidence must be based upon data from the current school year or the most recently completed school year. In addition, this evidence must include a copy of either:
(a) The form or report that the LEA submits to the SEA to report the school's student enrollment (or student membership, as it is sometimes described) on or around October 1 of each year.
(b) A document provided by the SEA that identifies the school's enrollment on or around October 1 of each year.
Each grantee must ensure that its designated project director—for a grant that includes one school—be not less than fifty percent of a full-time equivalent (FTE) position and that the time commitment of a project director
In addition to the definitions set out in the authorizing statute, 34 CFR 77.1, and the 2005 SLC NFP, we propose that the following definition also apply to this program:
The Assistant Secretary for Elementary and Secondary Education proposes the following selection criteria for evaluating an application under this program. We may apply one or more of these criteria in any year in which this program is in effect. These proposed selection criteria are intended to replace the selection criteria established for the SLC program in the 2005 SLC NFP and the 2007 SLC NFP.
In the notice inviting applications or the application package or both we will announce the maximum possible points assigned to each criterion.
(a)
(1) Teachers, school administrators, parents, and community stakeholders support the proposed project and have been and will continue to be involved in its development and implementation;
(2) The applicant has carried out sufficient planning and preparatory activities to enable it to implement the proposed project during the school year in which the grant award will be made;
(3) School administrators, teachers, and other school employees will receive effective, ongoing technical assistance and professional development in implementing structural and instructional reforms and providing effective instruction; and
(4) The applicant demonstrates that the proposed project is aligned with and advances a coordinated, district-wide strategy to improve student academic achievement and preparation for postsecondary education and careers without need for remediation.
(b)
(1) Creating an environment in which multiple teachers and other adults within the school know the needs, interests, and aspirations of each student well, closely monitor each student's progress, and provide the academic and other support each student needs to succeed;
(2) Equipping all students with the reading/English language arts, mathematics, and science knowledge and skills they need to succeed in postsecondary education and careers without need for remediation;
(3) Helping students who enter high school with reading/English language arts or mathematics skills that are significantly below grade-level to “catch up” and attain, maintain and exceed proficiency by providing supplemental instruction and supports to these students during the ninth grade and, to the extent necessary, in later grades;
(4) Increasing the amount of time regularly provided to teachers for common planning and collaboration during or immediately following the school day, without decreasing the amount of time provided to teachers for individual planning and preparation;
(5) Ensuring, through technical assistance, professional development, and other means, that teachers use opportunities for common planning and collaboration effectively to improve instruction and student academic achievement;
(6) Increasing the participation of students, particularly low-income students, in Advanced Placement, International Baccalaureate, or dual credit courses (such as dual enrollment or early college programs) that offer students the opportunity to earn simultaneously both high school and college credit; and
(7) Increasing the percentage of students who enter postsecondary education in the semester following high school graduation by delivering comprehensive guidance and academic advising to students and their parents that includes assistance in selecting courses and planning a program of study that will provide the academic preparation needed to succeed in postsecondary education, early and ongoing college awareness and planning activities, and help in identifying and applying for financial aid for postsecondary education.
(c)
(1) The management plan is likely to achieve the objectives of the proposed project on time and within budget and includes clearly defined responsibilities and detailed timelines and milestones for accomplishing project tasks; and
(2) The project director and other key personnel are qualified and have sufficient authority to carry out their responsibilities, and their time commitments are appropriate and adequate to implement the SLC project effectively.
(d)
We will announce the final priorities, requirements, definition, and selection criteria in a notice in the
This notice does not solicit applications. In any year in which we choose to use one or more of these priorities, requirements, definition, and selection criteria, we invite applications through a notice in the
The potential costs associated with this proposed regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.
In assessing the potential costs and benefits—both quantitative and qualitative—of this proposed regulatory action, we have determined that the benefits of the proposed priorities, requirements, definition, and selection criteria justify the costs.
We have determined, also, that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
Certain sections of the proposed priorities, requirements, definition, and selection criteria for the SLC grant program contain changes to information collection requirements already approved by the Office of Management and Budget (OMB) under OMB control number 1810-0676 (1890-0001). We will be publishing a separate notice in the
This document provides early notification of our specific plans and actions for this program.
The official version of this document is the document published in the
U.S. Election Assistance Commission (EAC).
Notice and request for public comment on Proposed Information Quality Guidelines Policy.
The U.S. Election Assistance Commission (EAC) seeks public comment on the Proposed Information Quality Guidelines policy. The policy outlines the EAC's directives and required procedures to implement the OMB Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies, 67 FR 8452 (“OMB Guidelines”). The EAC developed the Proposed Information Quality Guidelines to meet its obligations under the OMB Guidelines and to codify its high standards of quality in the production of information disseminated outside the agency.
Written comments must be submitted on or before 4 p.m. EDT on April 30, 2010.
Ms. Tamar Nedzar, Ms. Karen Lynn-Dyson or Ms. Shelly Anderson at (202) 566-3100.
United States Election Assistance Commission.
Request for public comment on proposed requirements for the testing of
The U.S. Election Assistance Commission (EAC) is publishing for public comment a set of proposed requirements for the testing of pilot voting systems to be used by jurisdictions to serve Uniformed and Overseas voters.
UOCAVA legislation was enacted before the advent of today's global electronic communications technology. Consequently it relied on U.S. domestic and military mail systems as well as foreign postal systems for the worldwide distribution of election materials. By the mid-1990s it became apparent that the mail transit time and unreliable delivery posed significant barriers for many UOCAVA citizens, preventing them from successfully exercising their right to vote. At the same time the Internet was being widely adopted by businesses, governments and the general public. Therefore it was a natural development for FVAP and states to consider the potential of the Internet as an alternative to the “by-mail” UOCAVA process.
FVAP sponsored Voting Over the Internet (VOI), a small pilot project for the November 2000 general election, to examine the feasibility of using Internet technology. Four states participated in this experiment, which enabled voters to use their own personal computers to securely register to vote, request and receive absentee ballots, and return their voted ballots. Following the successful completion of the VOI project, in the Fiscal Year 2002 National Defense Authorization Act (section 1604 of Pub. L. 107-107:115 Stat. 1277), Congress instructed the Secretary of Defense to carry out a larger demonstration project for the November 2002 general election. This project was to be “carried out with participation of sufficient numbers of absent uniformed services voters so that the results are statistically significant”.
Since there was not sufficient time to define and implement a large project for 2002, the project was planned for implementation for the November 2004 election. Seven states agreed to participate and worked with FVAP to develop system requirements and operating procedures. However, the Secure Electronic Registration and Voting Experiment (SERVE) was cancelled before it was deployed due to concerns raised by several computer scientists. These individuals contended that the use of personal computers over the Internet could not be made secure enough for voting and consequently called for the project to be terminated. The Department of Defense, citing a lack of public confidence in the SERVE system, decided the project could not continue under these circumstances.
In response to this development, the Fiscal Year 2005 National Defense Authorization Act (section 567 of Pub. L. 108-375;118 Stat. 119) repealed the requirement for the Secretary of Defense to conduct an electronic voting demonstration project “until the first regularly scheduled general election for federal office which occurs after the Election Assistance Commission (EAC) notifies the Secretary that the Commission has established electronic absentee voting guidelines and certifies that it will assist the Secretary in carrying out the project”. Pursuant to this legislation, in September 2005, the EAC requested its voting system advisory group, the Technical Guidelines Development Committee (TGDC), to add this subject on their research agenda; however the request was declined.
Since that time legislation dealing with a number of UOCAVA voting issues were under consideration by Congress. Ultimately, passed as part of the Fiscal Year 2010 National Defense Authorization Act (NDAA) (section 581 of Pub. L. 111-84), the Military and Overseas Voters Empowerment Act contains a provision allowing the Secretary of Defense to establish one or more pilot programs to test the feasibility of new election technology for UOCAVA voters. This provision requires the EAC and the National Institute of Standards and Technology (NIST) to provide best practices or standards to support these pilot programs, “in accordance with electronic absentee voting guidelines established under” the earlier FY2005 NDAA. In December 2009, the EAC directed the TGDC to begin this work as a top research priority. The EAC expects this work to result in the comprehensive set of remote electronic voting system guidelines as mandated by the FY2005 NDAA. The TGDC has been tasked to consider the full range of remote voting architectures, including instances where the voter can use his own personal computer for voting. The pilot testing requirements, that the EAC is currently developing, will be provided to the TGDC as the basis and starting point for their research and deliberations.
The EAC UOCAVA Working Group has taken much the same approach as the state pilot project working groups. The source materials drawn on for this effort included: the Voluntary Voting System Guidelines (VVSG) 1.0 ; the VVSG 1.1; the VVSG 2.0; the VOI, SERVE; FIPS; and NIST Special Publications. One significant difference in the EAC Working Group approach was the technology scope covered by the requirements. The VOI, SERVE and Okaloosa system requirements were tailored specifically for the particular system implementations developed for those projects. However, since many different types of remote voting systems could be submitted to the EAC certification program, the EAC Working Group defined generic system requirements to provide for system design flexibility.
Pilot projects are small in scale and short in duration. Consequently, certification for pilot systems needs to be quicker and less expensive than the regular process currently used for conventional systems with an expected life of more than 10 years. Nevertheless, since actual votes will be cast using the voting systems utilized in the pilot project, the certification process must retain sufficient rigor to provide reasonable assurance that the pilot systems will operate correctly and securely.
There is a fundamental dichotomy in complexity in remote voting architectures: those where the voting
The UOCAVA Pilot requirements document contains testable requirements for the following areas:
(1) Functional Requirements.
(2) Usability.
(3) Software.
(4) Security.
(5) Quality Assurance.
(6) Configuration Management.
(7) Technical Data Package.
(8) Systems Users Manual.
Comments must be received on or before 4 p.m. EST on April 15, 2010.
In order to allow efficient and effective review of comments the EAC requests that:
(1) Comments refer to the specific section that is the subject of the comment.
(2) General comments regarding the entire document or comments that refer to more than one section be made as specifically as possible so that EAC can clearly understand to which portion(s) of the documents the comment refers.
(3) To the extent that a comment suggests a change in the wording of a requirement or section of the guidelines, please provide proposed language for the suggested change.
All comments submitted will be published at the end of the comment period on the EAC's Web site at
An electronic copy of the proposed guidance may be found on the EAC's Web site at
Matthew Masterson, Phone (202) 566-3100, e-mail
On March 8, 2010, Symbiotics, LLC (transferor) and AG Hydro, LLC (transferee) filed an application for transfer of license of the Applegate Dam Project, located on the Applegate River in Jackson County, Oregon.
Applicants seek Commission approval to transfer the license for the Applegate Dam from the transferor to the transferee.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c
d.
e
f.
g.
h.
i.
j.
Comments, Motions to Intervene, and Protests may be filed electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions
The Commission's Rules of Practice and Procedure require all interveners filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o. Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers.
p.
On March 8, 2010, Glen Falls Hydro, LLC (transferor) and Essex Energy Partners, LLC (transferee) filed an application for transfer of license of the Glen Falls Project, located on the Moosup River in Windham County, Connecticut.
Applicants seek Commission approval to transfer the license for the Glen Falls Project from the transferor to the transferee.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Comments, Motions to Intervene, and Protests may be filed electronically via the Internet. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
The Commission's Rules of Practice and Procedure require all interveners filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o. Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers.
p.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions is 60 days from the issuance of this notice; reply comments are due 105 days from the issuance date of this notice.
All documents (original and eight copies) may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now is ready for environmental analysis.
l
The Upper Pacolet development would consist of: (1) An existing 315-foot-long by 18-foot-high concrete and rubble masonry dam, with the addition of 3-foot-high flashboards; (2) an existing 30-acre reservoir, with a useable storage capacity of 90 acre-feet at elevation 519.0 feet North American Vertical Datum 1988 (NAVD 88); (3) new vertical slide intake gates with rack and pinion operators, sluice gates, and trashracks having a 1-inch clear bar spacing with a trash rake; (4) a new 24-foot-wide by 40-foot-long concrete powerhouse that would contain a vertical Kaplan turbine with an estimated generating capacity of 1,100 kilowatts (kW); (5) a tailrace with a 40-foot-long guide wall; (6) a new 200-foot-long, 34 kilovolt (kV) transmission line; (7) a proposed substation; and (8) appurtenant facilities.
The Lower Pacolet development (all existing facilities) would consist of: (1) A 347-foot-long by 24-foot-high concrete and rubble masonry dam, with 4-foot-high flashboards; (2) three sand gates; (3) an 11-acre reservoir, with a useable storage capacity of 44-acre feet at an elevation of 492.0 feet NAVD 88 ; (4) an intake structure equipped with trashracks having a 1.375-inch clear bar spacing and a trash rake; (5) a 100-foot-long by 10-foot-diameter penstock; (6) a 67-foot-long by 32-foot-wide concrete powerhouse, integral with the dam, containing two vertical Leffel Type Z turbines, each generating 400 kilowatts (kW); (7) a tailrace with a 340-foot-long curved training wall; (8) a 250-foot-long, 34.5-kV transmission line; and (9) appurtenant facilities.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
You may also register online at
o. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing motions to intervene and protests, comments, recommendations, and preliminary terms and conditions (terms and conditions for transmission line routes only), is 60 days from the issuance of this notice; reply comments are due 105 days from the issuance date of this notice. All documents may be filed electronically via the Internet.
Please include the project numbers (P-12597-021 and P-12598-019) on any comments, motions, recommendations,
k.
Additionally, at the Lower Turnbull Drop Project, the applicant proposes to (1) change the entire transmission line to 69 kV and eliminate the remote electrical substation and (2) change the length and location of the 69 kV transmission line. At the Upper Turnbull Drop Project, the applicant proposes to (1) change the entire transmission line to 69 kV and eliminate the remote electrical substation and (2) change the length and location of the 69 kV transmission line. The filing of terms and conditions (see section “o” below) are only being requested by this notice for the applicant's proposal regarding changes to the transmission line routes.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
On March 17, 2010, Upper Peninsula Power Company (transferor) and North American Hydro Holdings, LLC (transferee) filed an application for transfer of license of the AuTrain Project, located on the Upper AuTrain River in Alger County, Michigan.
Applicants seek Commission approval to transfer the license for the AuTrain Project from the transferor to the transferee.
Deadline for filing comments and motions to intervene: 30 days from the issuance of this notice. Comments and motions to intervene may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii)(2008) and the instructions on the Commission's website under the “e-Filing” link. If unable to be filed electronically, documents may be paper-filed. To paper-file, an original and eight copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For more information on how to submit these types of filings please go to the Commission's Web site located at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following open access transmission tariff filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that on March 23, 2010, pursuant to section 206 of the Rules and Practice and Procedure, 18 CFR 385.206 and sections 206 of the Federal Power Act, 16 U.S.C. 824(e), New England Power Generators Association Inc. (Complainant) filed a formal complaint against ISO New England Inc. (Respondent) alleging that, the Respondent's current and proposed tariffs governing the Forward Capacity market (FCM) are unjust and unreasonable.
The Complainant certifies that copies of the complaint were served on the contacts for the Respondent and the New England Power Pool as listed on the Commission's list of Corporate Officials and on parties and regulatory agencies the Complainant reasonably expects to be affected by this Complaint, including all of the parties that have intervened in Docket ER10-787-000.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed South Carolina Electric and Gas Company's application for license for the Saluda Hydroelectric Project (FERC Project No. 516), located on Saluda River in Richland, Lexington, Saluda, and Newberry counties, near Columbia, South Carolina. The project does not occupy any Federal lands.
Staff prepared a draft environmental assessment (EA), which analyzes the potential environmental effects of relicensing the project, and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Any comments should be filed within 45 days from the date of this notice and be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Please affix Project No. 516 to all comments. Comments may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
For further information, contact Lee Emery by telephone at (202) 502-8379, or by e-mail at
This is a supplemental notice in the above-referenced proceeding of NFI Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 5, 2010.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
This is a supplemental notice in the above-referenced proceeding of Southern Turner Cimarron I, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 13, 2010.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
This is a supplemental notice in the above-referenced proceeding of Patriot Power LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 13, 2010.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
This is a supplemental notice in the above-referenced proceeding of Reliable Power, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability, is April 13, 2010.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the following hydroelectric proceeding has been initiated by the Commission:
a.
b.
c.
d.
e.
f.
g.
h.
i.
Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper;
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
j.
k.
The Director of Hydropower Licensing issued a 50-year license to A. W. Brown, Co. for the Sunshine Power Project on March 20, 1987 (38 FERC ¶ 62,282). The project was transferred to Mr. Jerry McMillan and Ms. Christine Smith by order on February 23, 1996 (74 FERC ¶ 62,092). On January 26, 2006, Ms. Smith informed the Commission that in August of 2005, Mr. McMillan deeded Ms. Smith his interest in the Sunshine Project. In response, on April 6, 2006, Commission staff requested Ms. Smith file an application for transfer of license with the Secretary of the Commission. Ms. Smith failed to file a transfer application.
On August 13, 2007, Commission staff received a letter from Ms. Smith stating that she had sold the project to Ms. Claudia Burkhart. Commission staff wrote to Ms. Burkhart on August 21, 2008, stating that she needed to file a transfer of license application with the Commission's Secretary. Once again, no transfer application was filed. According to Commission records, the project has not operated since October 1, 2008, and the owner does not intend to bring the project back into operation. On October 19, 2009, Commission staff wrote Ms. Burkhart requesting she file either a detailed plan and schedule to resume generation at the project along with a transfer of license application, or a request to voluntarily surrender the license. No response was filed. On January 13, 2010, Commission staff sent a letter to Mr. McMillan and Ms. Smith, with a copy to Ms. Burkhart, requesting them to show cause why the Commission should not initiate a proceeding for terminating the license based upon implied surrender. No response was filed to the show cause letter.
l. This notice is available for review and reproduction at the Commission in the Public Reference Room, Room 2A, 888 First Street, NE., Washington, DC 20426. The filing may also be viewed on the Web at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
p.
The staff of the Federal Energy Regulatory Commission (Commission) will hold three workshops to provide a forum for interested participants to ask questions on the interpretation and application of the Policy Statement on Penalty Guidelines, which the Commission recently issued on March 18, 2010.
Staff will also hold similar workshops in Houston, Texas on April 14, 2010, and in San Francisco, California on April 15, 2010. The times and locations of these later workshops will be provided in a subsequent notice. These workshops will not be webcast.
The purpose of the workshops will be to have staff discuss how the Penalty Guidelines will be applied and to answer questions about the Penalty Guidelines. In that regard, questions are being solicited from the public in advance of the workshops. Please submit questions on the Penalty Guidelines to Jeremy Medovoy, Attorney-Advisor, Office of Enforcement, Division of Investigations, by e-mail at
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an e-mail to
Questions about the workshops may be directed to Jeremy Medovoy by e-mail at
Environmental Protection Agency (EPA).
Notice.
EPA has established registration review dockets for the pesticides listed in the table in Unit III.A. With this document, EPA is opening the public comment period for these registration reviews. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Registration review dockets contain information that will assist the public in understanding the types of information and issues that the Agency may consider during the course of registration reviews. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
Comments must be received on or before June 1, 2010.
Submit your comments identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit III.A., by one of the following methods:
•
•
•
All documents in the docket are listed in the docket index available at
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farmworker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
EPA is initiating its reviews of the pesticides identified in this document pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA section 3(a), a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.
As directed by FIFRA section 3(g), EPA is reviewing the pesticide registrations identified in the table in this unit to assure that they continue to satisfy the FIFRA standard for registration—that is, they can still be used without unreasonable adverse effects on human health or the environment. A pesticide's registration review begins when the Agency establishes a docket for the pesticide's registration review case and opens the docket for public review and comment. At present, EPA is opening registration review dockets for the cases identified in the following table.
1.
• An overview of the registration review case status.
• A list of current product registrations and registrants.
•
•
• Risk assessments.
• Bibliographies concerning current registrations.
• Summaries of incident data.
• Any other pertinent data or information.
Each docket contains a document summarizing what the Agency currently knows about the pesticide case and a preliminary work plan for anticipated data and assessment needs. Additional documents provide more detailed information. During this public comment period, the Agency is asking that interested persons identify any additional information they believe the Agency should consider during the registration reviews of these pesticides. The Agency identifies in each docket the areas where public comment is specifically requested, though comment in any area is welcome.
2.
3.
• To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
• The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
• Submitters must clearly identify the source of any submitted data or information.
• Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
• As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.
Environmental protection, Antimicrobials, Pesticides and pests, Decyl isononyl dimethyl ammonium chloride, Dowicil 100, Thymol (5-methyl-2-isopropyl-1-phenol), 1,3,5-Triazine-2,4-diamine, N-cyclopropyl-N'-(1,1-dimethylethyl)-6-(methylthio)-.
Environmental Protection Agency (EPA).
Notice.
EPA has received a specific exemption request from the Michigan Department of Agriculture to use the pesticide kasugamycin (CAS No. 6980-18-3 to treat up to 10,000 acres of apples to control fire blight. The applicant proposes the use of a new chemical which has not been registered by EPA. EPA is soliciting public comment before making the decision whether or not to grant the exemption.
Comments must be received on or before April 15, 2010.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0179, by one of the following methods:
•
•
•
Keri Grinstead, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; fax number: (703) 605-0781; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
Under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the Administrator determines that emergency conditions exist which require the exemption. Michigan Department of Agriculture has requested the Administrator to issue a specific exemption for the use of kasugamycin on apples to control fire blight.
As part of this request, the applicant asserts that kasugamycin is needed to control streptomycin-resistant strains of
The Applicant proposes to make no more than three applications of Kasumin 2L on 10,000 acres of apples between April 20, 2010 and May 31, 2010 in Berrien, Cass, Ionia, Kent, Montcalm, Newaygo, Oceana, Ottawa, and Van Buren counties in Michigan. As currently proposed, the maximum amount of product to be applied would be 15,000 gallons.
This notice does not constitute a decision by EPA on the application itself. The regulations governing section 18 of FIFRA require publication of a notice of receipt of an application for a specific exemption proposing use of a new chemical (i.e., an active ingredient) which has not been registered by EPA.
The Agency will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the Michigan Department of Agriculture.
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice.
This notice announces the availability of EPA's final registration review decision for the pesticide Bromine, case 4015. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, that the pesticide can perform its intended function without causing unreasonable adverse effects on human health or the environment. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the pesticide specific contact person listed under
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0167. Publicly available docket materials are available either in the electronic docket at
Pursuant to 40 CFR 155.58(c), this notice announces the availability of EPA's final registration review decision for bromine, case 4015. Bromine is a bromide releasing antimicrobial pesticide that is registered as a mildewstat/mildewcide, bactericide, fungistate, fungicide, virucide, and insecticide. Bromine is registered for use to control bacteria and fungi on surfaces of agricultural, commercial, institutional, industrial, residential, and public access premises and equipment. It is also registered for use to treat/disinfect potable water (examples of potable water system treatment sites include, but are not restricted to, aboard ships and on oil and gas drilling/production platforms).
Pursuant to 40 CFR 155.57, a registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA. EPA has considered bromine in light of the FIFRA standard for registration. The Final Decision document in the docket describes the Agency's rationale for issuing a registration review final decision for this pesticide.
In addition to the final registration review decision document, the registration review docket for bromine also includes other relevant documents related to the registration review of this case. The combined final work plan and proposed registration review decision was posted to the docket and the public was invited to submit any comments or new information. During the 60-day comment period, no public comments were received.
Pursuant to 40 CFR 155.58(c), the registration review case docket for bromine will remain open until all actions required in the final decision have been completed.
Background on the registration review program is provided at:
Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide authority for this action.
Environmental protection, Registration review, Pesticides and pests, Antimicrobials, Bromine.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's order for the label amendment, which was voluntarily requested by the registrant and accepted by the Agency, to terminate use on carrots for pesticide registrations listed in Table 1 in Unit II. pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows a December 2, 2009 (74 FR 63151)
The cancellations are effective as published in the
James Parker, Pesticides Re-evaluation Division (7508P) , Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 306-0469; fax number: (703) 308-7070; e-mail address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0265. Publicly available docket materials are available either in the electronic docket at
This notice announces the amendment to terminate use on carrots, as requested by registrants, of products registered under section 3 of FIFRA. The affected registrations are listed in sequence by registration number in Table 1 of this unit.
Table 2 of this unit includes the names and addresses of record for the registrant of the products in Table 1 of this unit, in sequence by EPA company number.
During the public comment period provided, EPA received no comments in response to the December 2, 2009
Pursuant to FIFRA section 6(f), EPA hereby approves the requested amendment to terminate the carrot use of dicloran registrations identified in Table 1 in Unit II. Accordingly, the Agency for product registrations identified in Table 1 in Unit II. Any distribution, sale, or use of existing stocks of the products identified in Table 1 in Unit II. in a manner inconsistent with any of the Provisions for Disposition of Existing Stocks set forth in Unit VI. will be considered a violation of FIFRA.
Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
EPA’s existing stocks policy (56 FR 29362) provides that: “If a registrant requests to voluntarily cancel a registration where the Agency has identified no particular risk concerns, the registrant has complied with all applicable conditions of reregistration, conditional registration, and data call ins, and the registration is not subject to a Registration Standard, Label
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action. The effective date of this use cancellation is November 2, 2010. The cancellation order that is the subject of this notice includes the following existing stock provisions:
The registrant may sell and distribute existing stocks of products listed in Table 1 in Unit II. until November 2, 2010. Persons other than the registrant may sell and distribute existing stocks of products listed in Table 1 in Unit II. until exhausted. Use of the products listed in Table 1 in Unit II. may be exhausted, provided that such use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled product.
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice of Public Comment Period and Listening Session.
EPA is announcing a 60-day public comment period and a public listening session for the external review draft human health assessment titled, “Toxicological Review of Dichloromethane: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-10/003). The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD). The public comment period and external peer review meeting, which will be scheduled at a later date and announced in the
EPA is also announcing a listening session to be held on May 11, 2010, during the public comment period for this draft assessment. This listening session is a step in EPA's revised IRIS process, announced on May 21, 2009, for developing human health assessments for inclusion in the IRIS database. The purpose of the listening session is to allow all interested parties to present scientific and technical comments on draft IRIS health assessments to EPA and other interested parties during the public comment period and before the peer review meeting. EPA welcomes the comments that will be provided to the Agency by the listening session participants. The comments will be considered by the Agency as it revises the draft assessment in response to the independent SAB peer review and the public comments. All presentations submitted to EPA according to the instructions below will become part of the official public record.
EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination.
The public comment period begins March 31, 2010, and ends June 1, 2010. Comments should be in writing and must be received by EPA by June 1, 2010.
The listening session on the draft assessment for dichloromethane will be held on May 11, 2010, beginning at 9 a.m. and ending at 4 p.m., Eastern Daylight Time. If you would like to attend the listening session, you should register by May 4, 2010. If you would like to make a presentation at the listening session, you should register by May 4, 2010, indicate that you wish to make oral comments at the session, and indicate the length of your presentation. When you register, please indicate if you will need audio-visual aid (
Listening session participants who want EPA to share their comments with the external peer reviewers should also submit written comments during the public comment period using the detailed and established procedures described in the
The draft “Toxicological Review of Dichloromethane: In Support of Summary Information on the Integrated Risk Information System (IRIS)” is available primarily via the Internet on the NCEA home page under the Recent Additions and Publications menus at
Comments may be submitted electronically via
The listening session on the draft Dichloromethane assessment will be held at the EPA offices at Potomac Yard
A teleconference line will also be available for registered attendees/speakers. The teleconference number is 866-299-3188 and the access code is 926-378-7897, followed by the pound sign (#). The teleconference line will be activated at 8:45 a.m., and you will be asked to identify yourself and your affiliation at the beginning of the call.
For information on the public comment period, please contact the Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail:
For information on the public listening session, please contact Christine Ross, IRIS Staff, National Center for Environmental Assessment (Mail Code: 8601P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone: 703-347-8592; facsimile: 703-347-8689; or e-mail:
If you have questions about the assessment, please contact Glinda S. Cooper, National Center for Environmental Assessment, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., 8601P, Washington, DC 20460, telephone: 703-347-8636; facsimile: 703-347-8689; or e-mail:
EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to specific chemical substances found in the environment. Through the IRIS Program, EPA provides the highest quality science-based human health assessments to support the Agency's regulatory activities. The IRIS database contains information for more than 540 chemical substances that can be used to support the first two steps (hazard identification and dose-response evaluation) of the risk assessment process. When supported by available data, IRIS provides oral reference doses (RfDs) and inhalation reference concentrations (RfCs) for chronic noncancer health effects and cancer assessments. Combined with specific exposure information, government and private entities use IRIS to help characterize public health risks of chemical substances in a site-specific situation and thereby support risk management decisions designed to protect public health.
Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2010-0224, by one of the following methods:
•
•
•
•
•
EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment and cannot contact you for clarification, EPA may not be able to consider your comment.
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office announces two public meetings of the SAB Trichloroethylene (TCE) Review Panel: a teleconference and a face-to-face meeting to review EPA's
There will be a public teleconference on April 20, 2010 from 2:30 p.m. to 4:30 p.m. (Eastern Time). The public meeting will be held on May 10, 2010 from 9 a.m. to 5 p.m. (Eastern Time), May 11, 2010 from 9 a.m. to 5 p.m. and May 12, 2010 from 9 a.m. to 3 p.m. (Eastern time).
The teleconference will be conducted by phone only. The face-to-face meeting on May 10-12, 2010 will be held at The Hilton Embassy Row Hotel, 2015 Massachusetts Avenue, NW., Washington, DC 20036; telephone (202) 265-1600.
Any member of the public wishing to obtain information concerning the public teleconference and/or public meeting may contact Dr. Marc Rigas, Designated Federal Officer (DFO), EPA Science Advisory Board Staff Office (1400F), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; by telephone/voice mail at (202) 343-9978 or at
Pursuant to the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2, notice is hereby given that the SAB Trichloroethylene Review Panel will hold a public teleconference to discuss the plans for the subsequent public face-to-face meeting to conduct a peer review of the EPA's
In 2001, ORD developed a draft IRIS Toxicological Assessment for TCE, which was released for public comment and external peer review. In 2002, the Environmental Health Committee of the SAB reviewed the draft TCE Assessment and made several recommendations to strengthen the dose-response assessment. In 2004, in preparation for development of a new TCE assessment, the National Research Council (NRC) was requested to provide a scientific consultation on key scientific issues related to assessing the human health risks of TCE, including those relevant to hazard characterization/mode of action, physiologically-based pharmacokinetic (PBPK) modeling, and dose-response assessment. ORD has taken the recommendations and conclusions included in the NRC's report, which was released in 2006, into account as it developed a new revised draft IRIS Toxicological Assessment for TCE. ORD has requested that the SAB review its revised draft assessment.
In response to ORD's request, the SAB Staff Office solicited nominations of experts and formed a review panel for TCE [
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of applications to register new antimicrobial pesticide products containing new active ingredients, pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is publishing this notice of such applications, pursuant to section 3(c)(4) of FIFRA.
Comments must be received on or before April 30, 2010.
Submit your comments, identified by docket identification (ID) number specified for the pesticide of interest as shown in Unit II., by one of the following methods:
•
•
•
A contact person is listed at the end of each registration application summary and may be contacted by telephone or e-mail. The mailing address for each contact person listed is: Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA received applications as follows to register new antimicrobial pesticide products containing new active ingredients pursuant to the provisions of section 3(c) of FIFRA, and is publishing this notice of such applications pursuant to section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications.
1.
2.
3.
4.
5.
6.
7.
8.
Environmental protection, Antimicrobial pesticides and pest.
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of applications to register new uses for pesticide products containing currently registered active ingredients, pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is publishing this notice of such applications, pursuant to section 3(c)(4) of FIFRA.
Comments must be received on or before April 30, 2010.
Submit your comments, identified by docket identification (ID) number specified within the table below, by one of the following methods:
•
•
•
A contact person is listed at the end of each registration application summary and may be contacted by telephone or e-mail. The mailing address for each contact person listed is: Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA received applications as follows to register new uses of pesticide products containing currently registered active ingredients pursuant to the provisions of section 3(c) of FIFRA, and is publishing this notice of such applications pursuant to section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
Environmental protection, Antimicrobial pesticides and pest.
Environmental Protection Agency (EPA).
Notice.
This notice announces the availability of EPA’s final registration review decision for the pesticide
This action is directed to the public in general, and may be of interest to a
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-1026. Publicly available docket materials are available either in the electronic docket at
In accordance with 40 CFR 155.58(c), this notice announces the availability of EPA’s final registration review decision for
In accordance with 40 CFR 155.57, a registration review decision is the Agency’s determination whether a pesticide meets, or does not meet, the standard for registration in FIFRA. EPA has considered
In addition to the final registration review decision document, the registration review docket for
In accordance with 40 CFR 155.58(c), the registration review case docket for
Background on the registration review program is provided at:
Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide authority for this action.
Environmental protection, Bacillus subtilis, Pesticide and pest, Registration review.
Environmental Protection Agency (EPA).
Notice.
EPA has established registration review dockets for the pesticides listed in the table in Unit III.A. With this document, EPA is opening the public comment period for these registration reviews. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Registration review dockets contain information that will assist the public in understanding the types of information and issues that the Agency may consider during the course of registration reviews. Through this program, EPA is ensuring that each
Comments must be received on or before June 1, 2010.
Submit your comments identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit III.A., by one of the following methods:
•
•
•
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farmworker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
EPA is initiating its reviews of the pesticides identified in this document in accordance with section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.
As directed by FIFRA section 3(g), EPA is reviewing the pesticide registrations identified in the table in this unit to assure that they continue to satisfy the FIFRA standard for registration—that is, they can still be used without unreasonable adverse effects on human health or the environment. A pesticide's registration review begins when the Agency establishes a docket for the pesticide's registration review case and opens the docket for public review and comment. At present, EPA is opening registration review dockets for the cases identified in the following table.
1.
• An overview of the registration review case status.
• A list of current product registrations and registrants.
•
•
• Risk assessments.
• Bibliographies concerning current registrations.
• Summaries of incident data.
• Any other pertinent data or information.
Each docket contains a document summarizing what the Agency currently knows about the pesticide case and a preliminary work plan for anticipated data and assessment needs. Additional documents provide more detailed information. During this public comment period, the Agency is asking that interested persons identify any additional information they believe the Agency should consider during the registration reviews of these pesticides. The Agency identifies in each docket the areas where public comment is specifically requested, though comment in any area is welcome.
2.
3.
• To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
• The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
• Submitters must clearly identify the source of any submitted data or information.
• Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.
Environmental protection, Pesticides and pests, Vegetable and flower oils, Menthol and Agrobacterium radiobacter.
Environmental Protection Agency (EPA).
Notice.
EPA has established registration review dockets for the pesticides listed in the table in Unit III.A. With this document, EPA is opening the public comment period for these registration reviews. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. Registration review dockets contain information that will assist the public in understanding the types of information and issues that the Agency may consider during the course of registration reviews. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment. This document also announces the Agency's intent not to open a registration review docket for pirimicarb. This pesticide does not currently have any actively registered pesticide products and is therefore not scheduled for review under the registration review program.
Comments must be received on or before June 1, 2010.
Submit your comments identified by the docket identification (ID) number for the specific pesticide of interest provided in the table in Unit III.A., by one of the following methods:
•
•
•
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farmworker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
3.
EPA is initiating its reviews of the pesticides identified in this document pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.
As directed by FIFRA section 3(g), EPA is reviewing the pesticide registrations identified in the table in this unit to assure that they continue to satisfy the FIFRA standard for registration—that is, they can still be used without unreasonable adverse effects on human health or the environment. A pesticide's registration review begins when the Agency establishes a docket for the pesticide's registration review case and opens the docket for public review and comment. At present, EPA is opening registration review dockets for the cases identified in the following table.
EPA is also announcing that it will not be opening a docket for pirimicarb because this pesticide is not included in any products actively registered under FIFRA section 3. The Agency will take separate actions to cancel any remaining FIFRA section 24(c) Special Local Needs registrations with this active ingredient and to propose revocation of any affected tolerances that are not supported for import purposes only.
1.
• An overview of the registration review case status.
• A list of current product registrations and registrants.
•
•
• Risk assessments.
• Bibliographies concerning current registrations.
• Summaries of incident data.
• Any other pertinent data or information.
Each docket contains a document summarizing what the Agency currently knows about the pesticide case and a preliminary work plan for anticipated data and assessment needs. Additional documents provide more detailed information. During this public comment period, the Agency is asking that interested persons identify any additional information they believe the Agency should consider during the registration reviews of these pesticides. The Agency identifies in each docket the areas where public comment is specifically requested, though comment in any area is welcome.
2.
3.
• To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
• The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
• Submitters must clearly identify the source of any submitted data or information.
• Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.
Environmental protection, Pesticides and pests.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 - 3520. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before June 1, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202-395-5167 or via the Internet at Nicholas_A._Fraser@omb.eop.gov and to the Federal Communications Commission via email to PRA@fcc.gov.
Judith B. Herman, Office of Managing Director, (202) 418-0214. For additional information, contact Judith B. Herman, 202-418-0214, judth-b.herman@fcc.gov.
OMB Control Number: 3060-0710.
Title: Policy and Rules Under Parts 1 and 51 Concerning Implementation of the Local Competition Provisions in the Telecommunications Act of 1996, CC Docket No. 96-98.
Form No.: N/A.
Type of Review: Extension of a currently approved collection.
Respondents: Business or other for profit.
Number of Respondents and Responses: 15,282 responses; 1,067,987 responses.
Estimated Time Per Response: .50 - 2,880 hours.
Frequency of Response: On occasion reporting requirement, recordkeeping requirement and third party disclosure requirements.
Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. sections 1 - 4, 201 - 205, 214, 224, 251, 252, 303(r) and 601.
Total Annual Burden: 645,798 hours.
Total Annual Cost: N/A.
Privacy Act Impact Assessment: N/A.
Nature and Extent of Confidentiality: The Commission is not requesting respondents to submit confidential information to the Commission. If the respondents wish to submit information which they believe is confidential, they may request confidential treatment of
Needs and Uses: The Commission will submit this expiring information collection to the Office of Management and Budget (OMB) after this comment period in order to obtain the full three year clearance from them. There is no change in the reporting, recordkeeping and/or third party disclosure requirements. However, there is a significant decrease of 409,352 total annual burden hours and a $625,000 decrease in annual costs. This is due to several reasons including 1) re-calculations of each burden estimate; 2) re-estimate of the estimated time burden for some of the information collection categories; and 3) less time per response due to familiarity gained over the years of performing these functions.
The Commission adopted rules and regulations to implement parts of Sections 251 and 252 that affect local competition. Incumbent local exchange carriers (LECs) are required to offer interconnection, unbundled network elements, transport and termination and wholesale rates for certain services to new entrants. Incumbent LECs must price such services at rates that are cost-based and just and reasonable and provide access to right-of-way as well as establish reciprocal compensation arrangements for the transport and termination of telecommunications traffic.
Federal Accounting Standards Advisory Board.
Notice.
The Exposure Draft is available on the FASAB home page
Respondents are encouraged to comment on any part of the exposure draft. Written comments are requested by April 22, 2010, and should be sent to:
Wendy M. Payne, Executive Director, Federal Accounting Standards Advisory Board, 441 G Street, NW., Suite 6814, Mail Stop 6K17V, Washington, DC 20548.
Wendy Payne, Executive Director, at (202) 512-7350.
Federal Advisory Committee Act, Pub. L. 92-463.
Board of Governors of the Federal Reserve System.
The following information collections, which are being handled under this delegated authority, have received initial Board approval and are hereby published for comment. At the end of the comment period, the proposed information collections, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected; and
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments must be submitted on or before June 1, 2010.
You may submit comments, identified by FR 2046, FR 2060, FR 2572, FR 4006, FR 4008, FR 4010, FR 4011, FR 4012, FR 4017, FR 4019, FR 4023, FR 4013, or FR 4014 by any of the following methods:
•
•
•
•
•
Additionally, commenters should send a copy of their comments to the OMB Desk Officer by mail to the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street, NW., Washington, DC 20503 or by fax to 202-395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at:
Michelle Shore, Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device for the Deaf (TDD) users may contact (202-263-4869).
1.
2.
3.
4.
The FR 4011 is voluntary and is authorized under Sections 4(j) and 4(k) of the BHC Act, 12 U.S.C. 1843(j) through (k); and sections 225.88, and 225.89, of Regulation Y, 12 CFR 225.88, and 225.89.
The FR 4012 is mandatory and is authorized under Section 4(l)(1) and 4(m) of the BHC Act, 12 U.S.C. 1843(l)(1) and (m); section 8(a) of the International Banking Act, 12 U.S.C. 3106(a); and sections 225.83 and 225.93 of Regulation Y, 12 CFR 225.83 and 225.93.
The FR 4017 is required to obtain a benefit and is authorized under Section 9 of the Federal Reserve Act, 12 U.S.C. 335; and section 208.76 of Regulation H, 12 CFR 208.76.
The FR 4019 is required to obtain a benefit and is authorized under Section 4(k)(7) of the BHC Act, 12 U.S.C. 1843(k)(7); and sections 225.171(e)(3), 225.172(b)(4), and 225.173(c)(2) of Regulation Y, 12 CFR 225.171(e)(3), 225.172(b)(4), and 225.173(c)(2).
The FR 4023 is mandatory and is authorized under Section 4(k)(7) of the BHC Act, 12 U.S.C. 1843(k)(7); and sections 225.171(e)(4) and 225.175 of Regulation Y, 12 CFR 225.171(e)(4) and 225.175.
For the FR 4010, FR 4011, FR 4017, FR 4019, and information related to a failure to meet capital requirements on the FR 4012, a company may request confidential treatment of the information contained in these information collections pursuant to section (b)(4) and (b)(6) of the Freedom of Information Act (FOIA)(5 U.S.C. 552 (b)(4) and (b)(6)). Information related to a failure to meet management requirements on the FR 4012 is confidential and exempt from disclosure under section (b)(4), because the release of this information would cause substantial harm to the competitive position of the entity, and (b)(8) if the information is related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions. Since the Federal Reserve does not collect the FR 4023, no issue of confidentiality under the FOIA arises. FOIA will only be implicated if the Board's examiners retained a copy of the records in their examination or supervision of the institution, and would likely be exempt from disclosure pursuant to FOIA (5 U.S.C. 552(b)(4), (b)(6), and (b)(8)).
There are no formal reporting forms for these collections of information, which are event generated, though in each case the type of information required to be filed is described in the Board's regulations. These collections of information are required pursuant to amendments made by the GLB Act to the BHC Act or the Federal Reserve Act, or Board regulations issued to carry out the GLB Act.
5.
6.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 26, 2010.
Board of Governors of the Federal Reserve System, March 26, 2010.
Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order — embodied in the consent agreement — that would settle these allegations.
Comments must be received on or before April 26, 2010.
Interested parties are invited to submit written comments electronically or in paper form. Comments should refer to “Dave & Buster’s, File No. 082 3153” to facilitate the organization of comments. Please note that your comment — including your name and your state — will be placed on the public record of this proceeding, including on the publicly accessible FTC website, at (
Because comments will be made public, they should not include any sensitive personal information, such as an individual’s Social Security Number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential. . . .,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing
Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please consider submitting your comments in electronic form. Comments filed in electronic form should be submitted by using the following weblink: (
A comment filed in paper form should include the “Dave & Buster’s, File No. 082 3153” reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission, Office of the Secretary, Room H-135 (Annex D), 600 Pennsylvania Avenue, NW, Washington, DC 20580. The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.
The Federal Trade Commission Act (“FTC Act”) and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments received will be available to the public on the FTC website, to the extent practicable, at (
Katrina Blodgett (202-326-3158), Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for March 25, 2010), on the World Wide Web, at (
Public comments are invited, and may be filed with the Commission in either paper or electronic form. All comments should be filed as prescribed in the
The Federal Trade Commission has accepted, subject to final approval, a consent agreement from Dave & Buster’s, Inc. (“Dave & Buster’s”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement’s proposed order.
Dave & Buster’s owns and operates 53 restaurant and entertainment complexes in the United States. Consumers may pay for purchases at these locations with credit and debit cards (collectively, “payment cards”) or cash. In conducting its business, Dave & Buster’s routinely collects information from consumers to obtain authorization for payment card purchases, including the credit card account number, expiration date, and an electronic security code for payment authorization. This information is particularly sensitive because it can be used to facilitate payment card fraud and other consumer fraud.
The Commission’s complaint alleges that since at least April 2007, Dave & Buster’s engaged in a number of practices that, taken together, failed to provide reasonable and appropriate security for personal information on its computer networks. Among other things, Dave & Buster’s: (a) failed to employ sufficient measures to detect and prevent unauthorized access to computer networks or to conduct security investigations, such as by employing an intrusion detection system and monitoring system logs; (b) failed to adequately restrict third-party access to its networks, such as by restricting connections to specific IP addresses or granting temporary, limited access; (c) failed to monitor and filter outbound traffic from its networks to identify and block export of sensitive personal information without authorization; (d) failed to use readily available security measures to limit access between in-store networks, such as by using firewalls or isolating the payment card system from the rest of the corporate network; and (e) failed to use readily available security measures to limit access to its computer networks through wireless access points on the networks.
The complaint further alleges that between April 30, 2007 and August 28, 2007, an intruder, exploiting some of these vulnerabilities, connected to Dave & Buster’s networks numerous times without authorization, installed unauthorized software, and intercepted personal information in transit from in-store networks to its credit card processing company. The breach compromised approximately 130,000 unique payment cards used by consumers in the United States.
The proposed order applies to personal information Dave & Buster’s collects from or about consumers. It contains provisions designed to prevent Dave & Buster’s from engaging in the future in practices similar to those alleged in the complaint.
Part I of the proposed order requires Dave & Buster’s to establish and maintain a comprehensive information
• Designate an employee or employees to coordinate and be accountable for the information security program.
• Identify material internal and external risks to the security, confidentiality, and integrity of personal information that could result in the unauthorized disclosure, misuse, loss, alteration, destruction, or other compromise of such information, and assess the sufficiency of any safeguards in place to control these risks.
• Design and implement reasonable safeguards to control the risks identified through risk assessment, and regularly test or monitor the effectiveness of the safeguards’ key controls, systems, and procedures.
• Develop and use reasonable steps to select and retain service providers capable of appropriately safeguarding personal information they receive from respondents, and require service providers by contract to implement and maintain appropriate safeguards.
• Evaluate and adjust its information security program in light of the results of the testing and monitoring, any material changes to its operations or business arrangements, or any other circumstances that it knows or has reason to know may have a material impact on the effectiveness of its information security program.
Part II of the proposed order requires that Dave & Buster’s obtain within 180 days, and on a biennial basis thereafter for ten (10) years, an assessment and report from a qualified, objective, independent third-party professional, certifying, among other things, that it has in place a security program that provides protections that meet or exceed the protections required by Part I of the proposed order; and its security program is operating with sufficient effectiveness to provide reasonable assurance that the security, confidentiality, and integrity of consumers’ personal information is protected.
Parts III through VII of the proposed order are reporting and compliance provisions. Part III requires Dave & Buster’s to retain documents relating to its compliance with the order. For most records, the order requires that the documents be retained for a five-year period. For the third-party assessments and supporting documents, Dave & Buster’s must retain the documents for a period of three years after the date that each assessment is prepared. Part IV requires dissemination of the order now and in the future to principals, officers, directors, and managers at corporate headquarters, regional offices, and at each store having responsibilities relating to the subject matter of the order. Part V ensures notification to the FTC of changes in corporate status. Part VI mandates that Dave & Buster’s submit an initial compliance report to the FTC, and make available to the FTC subsequent reports. Part VII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.
The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.
By direction of the Commission.
Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office of Healthcare Quality.
Notice.
The U.S. Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), Office for Healthcare Quality (OHQ) announces the opportunity to collaborate with the U.S. Department of Health and Human Services (HHS). HHS invites public and private professional health related organizations to participate as collaborating co-sponsors in the development and implementation of an innovative program that advances the goals enumerated in the HHS Action Plan to prevent Healthcare-Associated Infections.
Expressions of interest for FY 2010-11 must be received no later than cob April 15, 2010.
Expressions of interest, comments, and questions may be submitted by e-mail to
Daniel Gallardo via electronic mail to
Healthcare-associated infections (HAIs) exact a significant toll on human life. They are among the leading causes of preventable death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002. In hospitals, they are a significant cause of morbidity and mortality. In addition to the substantial human suffering caused by healthcare-associated infections, the financial burden attributable to the infections is staggering. It is estimated that healthcare-associated infections cause $28 to $33 billion in excess healthcare costs each year. For these reasons, the prevention and reduction of healthcare-associated infections is a top priority for the U.S. Department of Health and Human Services (HHS).
The HHS Steering Committee for the Prevention of Healthcare-Associated Infections, led by Dr. Don Wright, Deputy Assistant Secretary for Healthcare Quality, was established in July 2008. The Steering Committee was charged with developing a comprehensive strategy to prevent and reduce healthcare-associated infections and issuing a plan which establishes national goals for healthcare-associated infection prevention and outlines key actions for achieving identified short- and long-term objectives. The plan, released in January 2009 as the HHS Action Plan, is also intended to enhance collaboration with external stakeholders to strengthen coordination and impact of national efforts.
Therefore, OHQ is interested in establishing partnerships with private and public professional health organizations in order to further the efforts in the prevention of Healthcare-Associated Infections. As partners with OHQ, professional health related organizations can bring their ideas, expertise, administrative capabilities, and resources in the development of a program(s) that promotes the reduction and prevention of Healthcare-
Given OHQ's objective, entities which have similar goals and consistent interests, appropriate expertise and resources, and which would like to pursue a Co-Sponsorship opportunity with OHQ, are encouraged to reply to this notice with a program proposal. Working together, these partnerships will provide opportunities to promote the prevention and reduction of healthcare-associated infections.
Office of the National Coordinator for Health Information Technology, HHS.
Notice of meeting.
This notice announces a forthcoming meeting of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The meeting will be open to the public.
Persons attending ONC's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Judy Sparrow at least seven (7) days in advance of the meeting.
ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2).
Office of the National Coordinator for Health Information Technology, HHS.
Notice of meeting.
This notice announces a forthcoming meeting of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The meeting will be open to the public.
Persons attending ONC's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Judy Sparrow at least seven (7) days in advance of the meeting.
ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2).
Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services.
Notice.
Executive Order 13251, dated November 24, 2009. The Presidential Commission for the Study of Bioethical Issues will be governed by provisions of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of advisory committees.
The U.S. Department of Health and Human Services announces establishment of the Presidential Commission for the Study of Bioethical Issues (the “Commission”), as directed by Executive Order 13521.
Ms. Diane M. Gianelli, Acting Executive Director, Presidential Commission on the Study of Bioethical Issues; Department of Health and Human Services; and/or Ms. Judith E. Crawford, Administrative Director, Presidential Commission on the Study of Bioethical Issues; Department of Health and Human Services. Both Ms. Gianelli and Ms. Crawford work in the Commission's office located at: 1425 New York Avenue, NW., Suite C100; Washington, DC 20005; Telephone: (202) 233-3960; Fax: (202) 233-3990.
Under Executive Order 13521, the President directed that the Commission shall be established within the Department of Health and Human Services (HHS). To comply with the authorizing directive and guidelines under the Federal Advisory Committee Act (FACA), a charter has been filed with the Committee Management Secretariat in the General Services Administration (GSA), the appropriate committees in the Senate and U.S. House of Representatives, and the Library of Congress to establish the Commission as a non-discretionary Federal advisory committee. The charter was filed on March 10, 2010.
The Commission has been established to replace the President's Council on Bioethics. The Council was established by Executive Order 13237, dated November 28, 2001. Council operations were terminated on September 30, 2009. The authorizing directive for the Commission, Executive Order 13521, supersedes Executive Order 13237.
A copy of the Commission charter can be obtained from the designated contacts or by accessing the FACA database that is maintained by the GSA Committee Management Secretariat. The Web site for the FACA database is
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to
Evaluation of Childhood Obesity Prevention and Control Initiative: New York City Health Bucks Program —New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Childhood obesity is a major public health concern. One out of every five children is affected by overweight or obesity in the United States, making it the most prevalent nutritional disease of this population. Although increased consumption of fruits and vegetables has been found to reduce long-term obesity risk, as well as risk of heart disease and some cancers, relatively few children and adolescents consume the USDA recommended minimum standard of five servings a day of fruits and vegetables.
In response to this growing public health crisis, the Division of Nutrition, Physical Activity, and Obesity (DNPAO) at the Centers for Disease Control and Prevention (CDC), is working to identify promising local programs and policies designed to prevent childhood obesity. Priority is being given to programs and policies targeting improved eating habits and physical activity levels among children in low-income communities.
The New York City Health Bucks program, operated by the New York City Department of Health and Mental Hygiene (DOHMH), is one example of this type of initiative. The program operates in three high-need, underserved New York City neighborhoods: The South Bronx, North and Central Brooklyn, and East and Central Harlem. Through the program, targeted neighborhood residents are provided with $2 “Health Bucks” that can be redeemed at local farmers' markets for the purchase of fresh, locally-grown fruits and vegetables. The Health Bucks program is intended to increase fresh fruit and vegetable purchases and consumption, and to increase access at the community level by attracting local farmers to these underserved areas.
CDC plans to sponsor an evaluation of the NYC Health Bucks program in 2010. Information will be collected from five groups of respondents: Local community organizations involved in distributing Health Bucks to individuals (200 respondents); farmers' market managers operating New York City farmers' markets (90 respondents); farmers' market vendors selling at New York City farmers' markets (474 respondents); farmers' market consumers at New York City farmers' markets (2,348 respondents); and residents of neighborhoods in which the NYC Health Bucks program operates (1,000 respondents).
The evaluation plan calls for local community organizations to complete a web-based questionnaire at the conclusion of the farmers' market season. Farmers' market managers will complete a written survey during the farmers' market season, with in-person follow up by trained interviewers on site at farmers' markets for managers who do not respond to the initial mailing. Farmers' market vendors will complete a written survey administered by trained interviewers on site at farmers' markets, and trained interviewers will also conduct written point-of-purchase intercept surveys with farmers' market consumers. Finally, telephone interviews will be conducted with a random sample of residents in neighborhoods in which the NYC Health Bucks program operates, and in-depth information will be collected from farmers' market consumers and vendors through focus groups.
The results of the evaluation study will be used to: Assess the program's ability to improve nutrition behaviors among targeted participants; identify factors serving as barriers and facilitators to program implementation and expected outcomes; provide feedback to the DOHMH for the purposes of program improvement; and share results with other entities interested in implementing similar programs.
Information collection will be conducted in English and Spanish. There are no costs to respondents other than their time, and participation is voluntary. The total estimated annualized burden hours are 660.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Studying the Implementation of a Chronic Care Toolkit and Practice Coaching In Practices Serving Vulnerable Populations.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
This proposed information collection was previously published in the
Comments on this notice must be received by April 30, 2010.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at
An important part of AHRQ's mission is to disseminate information and tools that can support improvement in quality and safety in the U.S. health care community. This proposed information collection supports that part of AHRQ's mission by further refining the practice coaching delivered in conjunction with a previously developed toolkit, Implementing Integrating Chronic Care and Business Strategies in the Safety Net: A Toolkit for Primary Care Practices and Clinics. AHRQ requests that the Office of Management and Budget approve, under the Paperwork Reduction Act of 1995, AHRQ's intention to collect information needed to determine whether practice coaching is effective in facilitating adoption of the Chronic Care Model (CCM) for improving treatment and management of chronic medical conditions by primary care physicians, especially those who care for underserved populations. This project is being conducted pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to quality measurement and improvement and with respect to clinical practice, including primary care and practice-oriented research. 42 U.S.C. 299a(a)(2) and (4). This project will be conducted by AHRQ through a contract with the University of Minnesota.
Although 1,500 physician practices in the U.S. and internationally have been involved in CCM quality improvement efforts, most patients still do not receive their chronic care in accordance with CCM. One factor affecting CCM implementation has been that having teams attend collaborative meetings (three two-day meetings over a nine-month period) is burdensome, especially for under-resourced providers. An attempt to use the Internet as a virtual collaborative met with disappointing results. Another barrier to adoption of the CCM in settings that serve vulnerable populations is the scarcity of resources to implement and sustain the CCM. In 2006 AHRQ contracted with the RAND Corporation, Group Health's MacColl Institute, and the California Health Care Safety Net Institute (SNI) to develop a toolkit that informs safety net providers on how to redesign their systems of care along the lines of the Chronic Care Model while attending to their financial realities. The result was Implementing Integrating Chronic Care and Business Strategies in the Safety Net: A Toolkit for Primary Care Practices and Clinics. The Toolkit was piloted in two California safety net clinics. Recognizing that merely distributing the Toolkit was unlikely to foster adoption of CCM, the intervention included six months of practice coaching delivered by the MacColl Institute. Practice Coaches (PC) are health care or related professionals who help primary care practices in a variety of quality improvement and research activities. PCs made two site visits to each site and participated in weekly team meetings by phone. They also interacted with the sites through e-mail and phone contact.
The lack of documentation available on coaching led to the development of a practice coaching manual, which was funded by AHRQ through a contract with the RAND Corporation. Development of the Coaching Manual entailed conducting a literature review, interviewing practice coaching experts, and incorporating evaluation results from the coaching provided in conjunction with the Toolkit. The Coaching Manual was published in the winter of 2009. The literature review and interviews revealed that there are a number of different models of practice coaching. However, knowledge is scant about how practice coaching is best performed, under what conditions practice coaching is most successful, and the costs of coaching and being coached. Pilot testing the Toolkit with a low-intensity practice coaching strategy proved insufficient to encourage practices to use the Toolkit independently. The Toolkit was subsequently streamlined based on pilot sites' reports that the initial Toolkit was not easy to use. This project will explore the implementation of the revised Toolkit along with a more intensive practice coaching strategy, providing lessons on methods to improve chronic care in clinical practices that serve vulnerable populations.
This project will include the following data collections:
(1) Key Informant Interviews with providers, staff and practice coaches from 20 safety net practices that participate in the practice coaching intervention. These will be used to describe the process and content of practice coaching, perceived changes from the coaching intervention at the practice, provider and patient levels, factors that impeded or facilitated the coaching intervention and implementation of practice changes
(2) Primary Care Practice Profile (PCPP). This questionnaire will be completed by a single individual at each site, either the medical director or chief administrator, and will provide an overview of each replication site that will help place intervention activities and outcomes in context for each site. It covers demographics of patients served, patient flow, disease health outcomes, most frequent diagnoses, most frequent referrals, number of staff by discipline, staff and patient satisfaction, processes of care, and organizational processes.
(3) Physician Practice Connections-Readiness Survey (PPC-RS)—This questionnaire asks about the presence of 53 practice systems in 5 of the 6 domains of the Chronic Care Model: Clinical information systems (information systems, presence of registry or organized database, and systematic monitoring of patient population); decision support (clinician reminders and alerts for lab tests, and visits or guidelines related to individual patient care), delivery system redesign (services for managing patients with chronic illness involving multiple clinicians and care between visits), health care organization (performance tracking and feedback, process of using clinical information systems to aggregate and report on key indicators, and use of data for benchmarking performance and informing QI activities), and clinical quality improvement (presence of formal processes to assess care, develop interventions, and use data to monitor the effects).
(4) Assessment of Chronic Illness Care (ACIC)—The ACIC is contained in the Toolkit and yields subscale scores and a total score. Subscale scores reflect CCM components and include: Community linkages, self-management support, decision support, delivery system design, information systems, and organization of care.
(5) Change Process Capability Questionnaire (CPCQ)—The CPCQ assesses 30 factors and strategies that experienced quality improvement leaders ranked as most important for successful implementation. A recent validation study found good predictive validity. Items correlating with the PPC-RS were eliminated after the initial validation study so there is little to no overlap across the two measures. In addition to changes in the content of care (CCM components), these also include organizational will for change (Priority) and capacity and skill in the conduct of the actual change processes and strategies.
(6) Patient Assessment of Chronic Illness Care (PACIC)—The 20-item PACIC consists of five subscales which assess components of the CCM: Patient activation, delivery system design/decision support, goal setting, problem-solving/contextual counseling, and followup and coordination.
(7) Consumer Assessment of Healthcare Providers and Systems—Primary Care Adult—This questionnaire assesses patient experiences in three areas: Getting appointments and healthcare when needed; how well doctors communicate, and courteous and helpful office staff.
(8) Primary Care Staff Satisfaction Survey—This questionnaire assesses staff satisfaction with their work environment. It consists of 8 4-point likert scale items and 2 open-ended questions, and was developed by the Institute for Healthcare Improvement.
(9) Chart Audits—Chart audits will be conducted at baseline, the end of the 10-month coaching intervention, and at 3-month follow-up to assess changes in patient care quality over the course of the intervention. A chart abstraction form will be developed to collect these data. This data collection will be performed by the project staff and will not impose a burden on the participating sites. Therefore, OMB clearance is not required for this data collection.
Clinic staff will be provided with a paper version of the surveys as well as the option to complete the surveys on line using a secure on-line survey program. With the exception of the staff surveys, no special information technology will be used to collect information, since many of the data collection forms are standardized instruments available in hard-copy form, and special permission from the developers would be required to create electronic versions of these forms. The information collection is a one-time only project; thus, there would be little benefit in reduced burden from automated information collection tools for the other instruments.
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this two-year study. Key informant interviews will be conducted with practice coaches at midpoint in the intervention and again at the end of the intervention. Key informant interviews will also be conducted with up to 3 primary care providers and 2 other staff members from each of the 20 practices (10 per year) prior to start of the intervention, and again at 3-month follow-up after the intervention is completed. Each interview takes about 1 hour.
The Primary Care Practice Profile will be administered once and will be completed by one staff person from each practice and takes 30 minutes to complete. The Physician Practice Connections-Readiness Survey (PPC-RS) will be completed pre, post and at 3-month follow-up by three individuals from each of the 20 practices (individuals with the appropriate knowledge to complete the survey will be identified by the medical director of each site). It takes 90 minutes to complete. The Assessment of Chronic Illness Care (ACIC) will be completed by 4 staff and 4 primary care providers per practice at pre, post and 3-month follow-up and takes 30 minutes to complete. The Change Process Capability Questionnaire (CPCQ) will be completed by 4 staff and 4 primary care providers per practice at pre, post and 3-month follow-up and takes 15 minutes to complete. The Primary Care Staff Satisfaction Survey (PCSSS) will be completed by 4 staff and 4 primary care providers per practice at pre, post and 3-month follow-up and takes 15 minutes to complete. The Patient Assessment of Chronic Illness Care (PACIC) will be completed by 3,000 adult patients (1,500 annually) with chronic illness and requires 15 minutes to complete. The Consumer Assessment of Healthcare Providers and Systems—Primary Care Adult (CAHPS) will be completed by 3,000 adult patients (1,500 annually) with chronic illness and requires 45 minutes to complete. Both patient surveys will be administered to adult patients with a chronic disease who receive care at the practices during a 2-day data collection period immediately before, immediately after, and at 3-month follow-up. The surveys will be administered during the post visit period in the wait room, by a bi-lingual Spanish-English research assistant. The total annualized burden hours are estimated to be 1,984 hours.
Exhibit 2 shows the estimated annualized cost burden associated with the respondent's time to participate in this study. The total annualized cost burden is estimated to be $60,714.
Exhibit 3 shows the estimated total and annualized cost to conduct this research. The total cost over two years is estimated to be $600,000.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Reductions of Infection Caused by Carbapenem Resistant Enterobacteriaceae (KPC) Producing Organisms through the Application of Recently Developed CDC/HICPAC Recommendations.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Comments on this notice must be received by June 1, 2010.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at
Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths among the 2.1 million people who acquired infections while hospitalized in 2000, and HAI rates have risen relentlessly since then. On March 20, 2009, the Centers for Disease Control (CDC) and the Healthcare Infections Control Practices Advisory Committee (HICPAC) developed infection control (IC) guidance for Klebsiella pneumonia carbapenemase-producing (KPC) isolates, as they have been rapidly emerging as a significant challenge in healthcare settings. The danger of these bacteria is that they are resistant to carbapenem (a class of beta-lactam antibiotics with a broad spectrum of antibacterial activity) and cannot be treated by the most commonly prescribed antibiotics. Limited treatment options mean that infections caused by carbapenem resistant bacteria result in substantial mortality and morbidity.
The CDC and HICPAC recommendations draw on infection control strategies which have been applied to these pathogens in other settings, and other evidence based strategies in infection control. There has been little research, however, on the implementation of control strategies to prevent the spread of these KPC infections. The goal of this project is to understand how these recommendations can best be implemented and how effective these recommendations will be in practice. This research will advance private and public efforts to improve health care quality by improving measures to control the spread of a dangerous organism. This research will also provide data for the development of an implementation toolkit that hospitals can use to prevent the spread of carbapenem resistant bacteria. The toolkit may include the following types of resources: General information about the implementation of evidenced-based clinical practices, resource materials, and tools and methods that users can adopt to conduct point prevalence surveys, protocols and tools that users can adopt to specify when active KPC surveillance is needed, and resources for approaching the problem as a team-based quality-improvement effort.
OMB clearance will be sought for this toolkit once it is developed.
This study is being conducted by AHRQ through its contractor, Boston University, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
This project will include the following data collections from the intensive care unit (ICU) staff within each of three participating hospitals:
(1) Pre-intervention focus groups will be conducted separately with managers and staff. The purpose of these focus groups is to identify potential problems in the implementation that can be addressed through various means (
(2) Clinical staff survey. Factors identified in the pre-intervention focus groups will be used to inform the development of a self-administered survey of staff knowledge of and attitudes toward KPC surveillance and infection control procedures. Respondents will be health care workers on the units where these new guidelines have been implemented. Findings from the survey will be used to assess barriers perceived by the staff, potential differences across units, and potential differences by employee/occupational group.
(3) Post-intervention focus groups (6 months after implementation of new KPC IC guidelines) will be conducted separately with managers and staff. The purpose of these focus groups is to identify actual problems experienced in the initial implementation and possible measures to address, and to identify successful practices to include in a toolkit that hospitals can use to implement the CDC and HICPAC recommendations.
In addition to developing a toolkit, AHRQ plans to disseminate the lessons
The estimated annualized burden hours for respondents to participate in this two year research project are presented in Exhibit 1. Pre-intervention focus groups with clinical staff will be conducted with 18 staff members (an average of 9 per year for 2 years) from each of the 3 participating hospitals and will take about 1 hour. Pre-intervention focus groups with also be conducted with 2 managers (an average of 1 per year for 2 years) from each hospital and will take about an hour to complete.
The clinical staff survey will be administered to 20 clinical staff (an average of 10 per year for 2 years) from each hospital and will take 15 minutes to complete.
Finally, respondents from the pre-intervention focus groups will participate in post-intervention focus groups approximately four months after the initiation of the intervention. They will not last more than an hour each. The total annualized burden hours are estimated to be 68 hours.
Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this research. The total annualized cost burden is estimated to be $3,108.
Exhibit 3 shows the annualized and total cost to the federal government for this two year research project. Project development covers steps taken to revise the research plan and begin implementation. The total cost is estimated to be $500,001.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Health Plan Survey Comparative Database.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
This proposed information collection was previously published in the
Comments on this notice must be received by April 30, 2010.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at
Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database
The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database for Health Plans. The CAHPS Health Plan Database consists of data from the AHRQ CAHPS Health Plan Survey.
Health plans in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The CAHPS Database was developed by AHRQ in 1998 in response to requests from health plans, purchasers, and the Centers for Medicare & Medicaid Services (CMS) to provide comparative data to support public reporting of health plan ratings, health plan accreditation and quality improvement.
The CAHPS Health Plan Survey is a tool for collecting standardized information on enrollees' experiences with health plans and their services. The development of the CAHPS Health Plan Survey began in 1995, when AHRQ awarded the first set of CAHPS grants to Harvard, RTI, and RAND. In 1997 the CAHPS 1.0 survey was released by the CAHPS Consortium. The CAHPS Consortium refers to the research organizations involved in the development, dissemination, and support of CAHPS products. The current Consortium includes AHRQ, CMS, RAND, Yale School of Public Health, and Westat.
Since that time, the Consortium has clarified and updated the survey instrument to reflect field test results; feedback from industry experts; reports from health plan participants, data collection vendors, and other users; and evidence from cognitive testing and focus groups. In November 2006, the CAHPS Consortium released the latest version of the instrument: The CAHPS Health Plan Survey 4.0. The development of this update to the Health Plan Survey has been part of the “Ambulatory CAHPS (A-CAHPS) Initiative,” which arose as a result of extensive research conducted with users. AHRQ released the CAHPS Health Plan Survey 4.0, along with guidance on how to customize and administer it. The National Quality Forum endorsed the 4.0 version of the Health Plan Survey in July 2007.
The CAHPS Health Plan Database uses data from AHRQ's standardized CAHPS Health plan survey to provide comparative results to health care purchasers, consumers, regulators and policy makers across the country. The Database also provides data for AHRQ's annual National Healthcare Quality and National Healthcare Disparities Reports. Voluntary participants include public and private employers, State Medicaid agencies, State Children's Health Insurance Programs (SCHIP), CMS, and individual health plans.
The collection of information for the CAHPS Database for Health Plans is being conducted pursuant to AHRQ's statutory authority to conduct and support research on health care and systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services.
Information for the CAHPS Health Plan Database has been collected by AHRQ through its contractor Westat on an annual basis since 1998. Health plans are asked to voluntarily submit their data to the comparative database in June of each year. The data are cleaned with standardized programs, then aggregated and used to produce comparative results for commercial (adult and child), Medicaid (adult and child), and Medicare (adult) populations for the two most recent years. In addition, individual participant reports are produced that display the participating organizations' own results compared to appropriate comparisons derived from the National, regional and product-type distributions on a password-protected section of the online reporting system.
The CAHPS Health Plan Database receives the data from three sources. First, commercial health plan data is purchased by the CAHPS Health Plan Database directly from the National Committee for Quality Assurance (NCQA). The data is collected by NCQA from those who participate in its accreditation program. Second, Medicare data is provided by CMS through an agency data use agreement. The Medicare data is collected by CMS
Each year State Medicaid agencies and individual health plans decide whether to participate in the database and prepare their materials and dataset for submission to the CAHPS Health Plan Database. Participating organizations are typically State Medicaid agencies with multiple health plans. However, individual health plans are also encouraged to submit their data to the CAHPS Database. The number of data submissions per registrant varies from participant to participant and year to year because some participants submit data for multiple health plans, while others may only submit survey data for one plan.
Each organization that decides to participate in the database must have their POC complete a registration form providing their contact information for access to the on-line data submission system, sign and submit a data use agreement (DUA), and provide health plan characteristics such as health plan name, product type, type of population surveyed, health plan state, and plan name to appear in the reporting of their results.
Each vendor that submits files on behalf of a Medicaid agency or individual health plan must also complete the registration form in order to obtain access to the on-line submission system. The vendor, on behalf of their client, may also complete additional information about survey administration (CAHPS survey version used, mode of survey administration, total enrollment count, description of how the sample was selected), submit a copy of the questionnaire used, and submit one data file per health plan. Commercial health plan data is received directly from NCQA. Medicare health plan data is received from CMS.
The burden hours and costs below pertain only to the collection of Medicaid data from State Medicaid agencies and individual Medicaid health plans because those are the only entities that submit data through the data submission process (other data are obtained directly from NCQA and CMS as noted earlier in Section 2). In 2009, a total of 60 participants, representing 45 individual organizations and 15 vendors, submitted data for 244 health plans (an average of about 4 health plans per participant).
Exhibits 1 and 2 are based on the estimated number of individual participants (participating organizations and/or vendors) who will complete the database submission steps and forms in the coming years, and is not based on the total number of health plans that are submitted. The number of respondents and burden hours are based on an estimated slight increase in the number of participants to 70 in 2010 and 2011.
In Exhibit 1, the 70 participants that will complete the registration form and submit information to the CAHPS Health Plan Database are a combination of an estimated 50 State Medicaid agencies and individual health plans, and 20 estimated vendors. The 50 State Medicaid agencies or individual health plans will sign and submit a DUA. Vendors do not sign or submit DUAs. Health plan information and data files are submitted for each health plan. Exhibit 1 shows an estimated total of 280 health plans (70 estimated participants with 4 health plans per participant). The total burden hours for completing the registration, DUA and data submission process are estimated to be 722 hours.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete the submission process. The cost burden is estimated to be $31,046 annually.
Exhibit 3 shows the estimated annualized cost to the government for developing, maintaining and managing the Health Plan Database and analyzing the data and reporting results. The cost is estimated to be $260,000 annually. Annualized costs for collecting and processing the CAHPS Health Plan Database are based upon 10 years of historical project costs. Start-up costs were present in the early years of the database only.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443-1129.
The Health Education Assistance Loan (HEAL) program provided federally-insured loans to students in schools of allopathic medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, allied health, or chiropractic, and graduate students in health administration or clinical psychology through September 30, 1998. Eligible lenders, such as banks, savings and loan associations, credit unions, pension funds, State agencies, HEAL schools, and insurance companies, made new refinanced HEAL loans which are insured by the Federal Government against loss due to borrower's death, disability, bankruptcy, and default. The basic purpose of the program was to assure the availability of funds for loans to eligible students who needed to borrow money to pay for their educational loans. Currently, the program monitors the federal liability, and assists in default prevention activities.
The HEAL borrower, the borrower's physician, and the holder of the loan completes the Physician's Certification form to certify that the HEAL borrower meets the total and permanent disability provisions. The Department uses this form to obtain detailed information about disability claims which includes the following: (1) The borrower's consent to release medical records to the Department of Health and Human Services and to the holder of the borrower's HEAL loans, (2) pertinent information supplied by the certifying physician, (3) the physician's certification that the borrower is unable to engage in any substantial gainful activity because of a medically determinable impairment that is expected to continue for a long and indefinite period of time or to result in death, and (4) information from the
The estimate of burden for the Physician's Certification form is as follows:
E-mail comments to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by June 1, 2010.
Submit electronic comments on the collection of information to
Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3794,
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
In April 1996, a law entitled “The FDA Export Reform & Enhancement Act of 1996” (FDAERA) amended sections 801(e) and 802 of the act (21 U.S.C. 381(e) and 382). It was designed to ease restrictions on exportation of unapproved pharmaceuticals, biologics, and devices regulated by FDA. Section 801(e)(4) of the FDAERA provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of 801(e) and 802 or other requirements of the act. This section of the law requires FDA to issue certification within 20 days of receipt of the request and to charge firms up to $175 for the certifications.
This new section of the act authorizes FDA to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the act. FDA has developed five types of certificates that satisfy the requirements of section 801(e)(4)(B) of the act: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, (4) Non-Clinical Research Use Only Certificates, and (5) Certificates of Free Sale. Table 1 of this document lists the different certificates and details their use:
FDA will continue to rely on self-certification by manufacturers for the first three types of certificates listed in table 1 of this document. Manufacturers are requested to self-certify that they are in compliance with all applicable requirements of the act, not only at the time that they submit their request to the appropriate center, but also at the time that they submit the certification to the foreign government.
The appropriate FDA centers will review product information submitted by firms in support of their certificate and any suspected case of fraud will be referred to FDA's Office of Criminal Investigations for followup. Making or submitting to FDA false statements on any documents may constitute violations of 18 U.S.C. 1001, with penalties including up to $250,000 in fines and up to 5 years imprisonment.
FDA estimates the burden of this collection of information as follows:
Comments and questions about the information collection described above should be directed to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ACF, Office of Management and Budget, Paperwork Reduction Project, 725 17th Street NW., Washington, DC 20503, FAX (202) 395-6974.
Indian Health Service, HHS.
Notice.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the
National health care standards developed by the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration), the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), and other accrediting organizations require health care facilities to review, evaluate and verify the credentials, training and experience of medical staff applicants prior to granting medical staff privileges. In order to meet these standards, IHS health care facilities require all medical staff applicants to provide information concerning their education, training, licensure, and work experience and any adverse disciplinary actions taken against them. This information is then verified with references supplied by the applicant and may include: Former employers, educational institutions, licensure and certification boards, the American Medical Association, the Federation of State Medical Boards, the National Practitioner Data Bank, and the applicants themselves.
In addition to the initial granting of medical staff membership and clinical privileges, JCAHO standards require that a review of the medical staff be conducted not less than every two years. This review evaluates the current competence of the medical staff and verifies whether they are maintaining the licensure or certification requirements of their specialty.
The medical staff credentials and privileges records are maintained at the health care facility where the health care provider is a medical staff member. The establishment of these records at IHS health care facilities is not optional; such records must be established and accredited by JCAHO. Prior to the establishment of this JCAHO requirement, the degree to which medical staff applications were
The application process has been streamlined and is using information technology to make the application electronically available on the Internet.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Notice of Availability—Common Formats Version 1.1.
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the
Ongoing public input.
The Common Formats Version 1.1 can be accessed electronically at the following HHS Web site:
Marcy Opstal, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403-3697;
The Patient Safety Act and Patient Safety Rule establish a framework by which doctors, hospitals, and other healthcare providers may voluntarily report information regarding patient safety events and quality of care. Information that is assembled and developed by providers for reporting to PSOs and the information received and analyzed by PSOs—called “patient safety work product”—is privileged and confidential. Patient safety work product is used to identify events, patterns of care, and unsafe conditions that increase risks and hazards to patients. Definitions and other details about PSOs and patient safety work product are included in the Patient Safety Rule.
The Patient Safety Act and Patient Safety Rule require PSOs, to the extent practical and appropriate, to collect patient safety work product from providers in a standardized manner in order to permit valid comparisons of similar cases among similar providers. The collection of patient safety work product allows the aggregation of sufficient data to identify and address underlying causal factors of patient safety problems. Both the Patient Safety Act and Patient Safety Rule can be accessed electronically at
In order to facilitate standardized data collection, the Secretary of HHS authorized AHRQ to develop and maintain the Common Formats to improve the safety and quality of healthcare delivery. In August 2008, AHRQ issued the initial release of the formats, Version 0.1 Beta. The second release of the Common Formats, Version 1.0, was announced in the
The term “Common Formats” is used to describe clinical definitions and technical requirements developed for the uniform collection and reporting of patient safety data, including all supporting material. The Common Formats are not intended to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system. The scope of Common Formats applies to all patient safety concerns including:
• Incidents—patient safety events that reached the patient, whether or not there was harm,
• Near misses or close calls—patient safety events that did not reach the patient, and
• Unsafe conditions—circumstances that increase the probability of a patient safety event.
Common Formats Version 1.1 is currently limited to patient safety reporting for acute care hospitals and is designed to support the first stage in the improvement cycle. Version 1.1 includes two general types of formats, generic and event specific. The generic Common Formats pertain to all patient safety concerns. The three generic formats are: Healthcare Event Reporting Form, Patient Information Form, and Summary of Initial Report. The event-specific Common Formats pertain to frequently-occurring and/or serious patient safety events. The eight event-specific formats are: Blood or Blood Product, Device or Medical/surgical Supply, Fall, Healthcare-Associated Infection, Medication or Other Substance, Perinatal, Pressure Ulcer, and Surgery or Anesthesia.
The Common Formats Version 1.1 has a defined focus on patient safety reporting for acute care hospitals. It should be noted, however, that the privilege and confidentiality protections of the Patient Safety Act and Patient Safety Rule apply to patient safety work product developed under the aegis of a PSO with respect to healthcare in any setting. Future versions of the Common Formats are being developed for other settings such as: Skilled nursing facilities (SNFs), ambulatory surgery centers, and physician and practitioner offices.
AHRQ's Common Formats Version 1.1 includes:
• Descriptions of patient safety events and unsafe conditions to be reported (event descriptions),
• Specifications for patient safety aggregate reports and individual event summaries,
• Delineation of data elements to be collected for specific types of events,
• A user's guide and quick guide, and
• Technical specifications for electronic data collection and reporting.
In anticipation of the need for Common Formats, AHRQ began their development in 2005 by creating an inventory of functioning private and public sector patient safety reporting systems. This inventory provides an evidence base that informs construction of the Common Formats. The inventory now numbers 69 and includes many systems from the private sector, including prominent academic settings, hospital systems, and international reporting systems (
Since February 2005, AHRQ has coordinated an interagency Federal Patient Safety Work Group (PSWG) to assist AHRQ with developing and maintaining the Common Formats. The PSWG includes major health agencies within the HHS CDC, Centers for Medicare & Medicaid Services, FDA, Health Resources and Services Administration, the Indian Health Service, the National Institutes of Health, the National Library of Medicine, the Office of the National Coordinator for Health Information Technology, the Office of Public Health and Science, the Substance Abuse and Mental Health Services Administration—as well as the DoD and the VA.
The PSWG assists AHRQ with assuring the consistency of definitions/formats with those of relevant government agencies as refinement of the Common Formats continues. To the extent practicable, the Common Formats are also aligned with World Health Organization (WHO) concepts, framework, and definitions, contained in their draft International Classification for Patient Safety (ICPS).
The technical specifications promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. The specifications also provide direction to software developers, so the Common Formats can be implemented electronically, and to PSOs, so the Common Formats can be submitted electronically to the PSO Privacy Protection Center (PPC) for data de-identification and transmission to the Network of Patient Safety Databases (NPSD).
The technical specifications consist of the following:
• Data dictionary—defines data elements and their attributes (data element name, answer values, field length, guide for use, etc.) included in Common Formats Version 1.1;
• Clinical document architecture (CDA) implementation guide—provides instructions for developing a Health Level Seven (HL7) CDA Extensible Markup Language (XML) file to transmit the Common Formats patient safety data from the PSO to the PPC using the Common Formats;
• Validation rules and errors document—specifies and defines the validation rules that will be applied to the Common Formats data elements submitted to the PPC;
• Common Formats flow charts—diagrams the valid paths to complete generic and event specific formats (a complete event report);
• Local specifications—provides specifications for processing, linking and reporting on events and details specifications for reports; and
• Metadata registry—includes descriptive facts about information contained in the data dictionary to illustrate how such data corresponds with similar data elements used by other Federal agencies and standards development organizations [
To allow for greater participation by the private sector in the subsequent development of the Common Formats, AHRQ engaged the National Quality Forum (NQF), a non-profit organization focused on healthcare quality, to solicit comments and advice to guide the further refinement of the Common Formats. The NQF began this process with feedback on AHRQ's 0.1 Beta release of the Common Formats. The NQF also convened an expert panel to review the comments received on Common Formats Version 1.0 and provide feedback to AHRQ. Based upon the expert panel's feedback, AHRQ, in conjunction with the PSWG, has further revised and refined the Common Formats that are now available as Version 1.1.
AHRQ is committed to continuing refinement of the Common Formats. The Agency is specifically interested in obtaining feedback from both the private and public sectors, particularly from those who use the Common Formats, to guide their improvement. Although AHRQ's Version 1.1 has been developed based on evidence, consensus of the PSWG, public comments and input, and feedback from the NQF expert panel, the formats do not fully reflect the refinement that comes from large-scale use and repeated revision. The process for updating and refining the formats will be an iterative one.
More information on the Common Formats Version 1.1, including the feedback process, can be obtained through AHRQ's PSO Web site:
The Indian Health Service (IHS) is accepting grant applications for the FY 2010 Special Diabetes Program for Indians (SDPI) Community-Directed grant program. This competitive grant announcement is open to all existing SDPI grantees that have an active grant in place and are in compliance with the previous terms and conditions of the grant. This program is authorized under H.R. 6331 “Medicare Improvement for Patients and Providers Act of 2008” (Section 303 of Pub. L. 110-275) and the Snyder Act, 25 U.S.C. 13. The program is described in the Catalog of Federal Domestic Assistance (CDFA) under 93.237.
The SDPI seeks to support diabetes treatment and prevention activities for American Indian/Alaska Native (AI/AN) communities. Grantees will implement programs based on identified diabetes-related community needs. Activities will be targeted to reduce the risk of diabetes in at-risk individuals, provide services that target those with new onset diabetes, provide high quality care to those with diagnosed diabetes, and/or reduce the complications of diabetes.
The purpose of the FY 2010 SDPI Community-Directed grant program is to support diabetes treatment and prevention programs that have a program plan which integrates at least one IHS Diabetes Best Practice and that have a program evaluation plan in place which includes tracking outcome measures.
This is not an application for continued funding as was previously available for Community-Directed grant programs.
During the past 50 years, type 2 diabetes has become a major public health issue in many AI/AN communities, and it is increasingly recognized that AI/AN populations have a disproportionate burden of diabetes (Ghodes, 1995). In 2006, 16.1% of AI/ANs age 20 years or older had diagnosed diabetes (unpublished IHS Diabetes Program Statistics, 2006) compared to 7.8% for the non-Hispanic white population (CDC, 2007). In addition, AI/AN people have higher rates of diabetes-related morbidity and mortality than the general U.S. population (Carter, 1996; Harris, 1995; Gilliland, 1997). Strategies to address the prevention and treatment of diabetes in AI/AN communities are urgently needed.
Under the Balanced Budget Act of 1997, Congress authorized the IHS to administer the SDPI grant program. SDPI grants are programmatically directed by the IHS Division of Diabetes Treatment and Prevention (DDTP).
The SDPI is a $150 million per year grant program. Over 330 programs have received SDPI Community-Directed grants annually since 1998. In addition, 66 demonstration projects have been funded annually since 2004 to address prevention of type 2 diabetes or cardiovascular disease risk reduction. A Congressional re-authorization in 2008 extended the SDPI through FY 2011.
Grants.
The total amount of funding identified for FY 2010 SDPI
Approximately 150 awards will be issued for Budget Cycle IV. Applications will be accepted from grantees whose current SDPI FY 2009 grants end on May 31, 2010. Additionally, applicants from Budget Cycles I, II or III that were deemed ineligible due to incomplete applications or that possessed delinquent OMB A-133 financial audits can resubmit applications under the timelines for Budget Cycle IV.
The project period for grants made under this announcement is 24 months, subject to the availability of funds.
Eligible applicants include the following:
•
•
•
•
Current SDPI grantees are eligible to apply for competing continuation funding under this announcement and must demonstrate that they have complied with previous terms and conditions of the SDPI grant in order to receive funding under this announcement.
Non-profit Tribal organizations and national or regional health boards are not eligible, consistent with past Tribal consultation. Applicants that do not meet these eligibility requirements will have their applications returned without further consideration.
Under this announcement, only one SDPI Community-Directed diabetes grant will be awarded per entity. If a Tribe submits an application, their local IHS facility cannot apply; if the Tribe does not submit an application, the IHS facility can apply. Tribes that are awarded grant funds may sub-contract with local IHS facilities to provide specific clinical services. In this case, the Tribe would be the primary SDPI grantee and the Federal entity would have a sub-contract within the Tribe's SDPI grant.
Tribes are encouraged to collaborate with any appropriate local entities including IHS facilities. If a Tribe seeks to provide specific clinical or support services, it may implement sub-contracts with these entities in order to transfer funds. The amount of SDPI funding that the Tribe receives remains the same. The Tribe, as the primary grantee, arranges with the entity to provide specified services that support the program's plan. The entity may request direct costs only.
When a Tribe sub-contracts with the local IHS facility, application requirements for collaborative arrangements include:
• A signed Memorandum of Agreement (MOA) must be submitted with the SDPI application. The MOA must include the scope of work assigned to the sub-contracting IHS facility.
• The IHS Area Director and the Tribal Chairperson must give signed approval of the MOA.
• The Tribe's application must include additional SF-424 and SF-424A forms that are completed by the IHS facility which includes a budget narrative and a face page that is signed by the Chief Executive Officer (CEO).
Programs that submit one application on behalf of multiple organizations (sub-grantees) must submit copies of selected application forms and documents for each of their sub-grantees. (
The FY 2010 Special Diabetes Program for Indians (SDPI) Community-Directed grant program does not require matching funds or cost sharing.
Provide information about the SDPI Program Coordinator on the “Key Contacts Form” which is included in the application package. The Program Coordinator must meet the following requirements:
• Have relevant health care education and/or experience.
• Have experience with program management and grants program management, including skills in program coordination, budgeting, reporting and supervision of staff.
• Have a working knowledge of diabetes.
Existing SDPI grantees must submit a current, signed and dated Tribal resolution or Tribal letter of support from all Indian Tribe(s) served by the project. Applications from each Tribal organization must include specific resolutions or letters of support from all Tribes affected by the proposed project activities.
If the Tribal resolution or Tribal letter of support is not submitted with the application, it must be received in the Division of Grants Operations (DGO) by June 15, 2010. This date is prior to the objective review dates, June 21-24, 2010.
Urban Indian health programs must submit a letter of support from the organization's board of directors. Urban Indian health programs are non-profit organizations and must also submit a copy of the 501(c)(3) Certificate. All letters of support must be included in the application or submitted to the DGO by June 15, 2010. This date is prior to the objective review dates, June 21-24, 2010.
IHS facilities must submit a letter of support from the CEO. The documentation must be received in the DGO by June 15, 2010. This date is prior to the objective review dates, June 21-24, 2010.
The application package and instructions may be found at
Mandatory documents for all applicants include:
• Application forms:
○ SF-424.
○ SF-424A.
○ SF-424B.
○ Key Contacts Form.
• Budget Narrative.
• Project Narrative.
• Tribal Resolution or Tribal Letter of Support (Tribal Organizations only).
• Letter of Support from Organization's Board of Directors (Title V Urban Indian Health Programs only).
• 501(c)(3) Certificate (Title V Urban Indian Health Programs only).
• CEO Letters of Support (IHS facilities only).
• 2008 and 2009 IHS Diabetes Care and Outcomes Audit Report.
• Biographical sketches for all Key Personnel.
• Disclosure of Lobbying Activities (SF-LLL) (if applicable).
• Documentation of OMB A-133 required Financial Audit for FY 2007 and FY 2008. Acceptable forms of documentation include:
○ E-mail confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or
○ Face sheets from audit reports. These can be found on the FAC Web site:
The primary grantee for applications that propose sub-grantees must submit all of the mandatory documents listed above. In addition, they must submit the following documents for each sub-grantee:
• SF-424, SF-424A, SF-424B and Key Contacts Form.
• Project Narrative.
• Budget Narrative.
• 2008 and 2009 IHS Diabetes Care and Outcomes Audit Reports.
A separate budget is required for each sub-grantee, but the primary grantee's application must reflect the total budget for the entire cost of the project.
Programs that propose sub-contracts with IHS facilities to provide clinical services must submit the documents noted below for the sub-contractor:
• MOA that is signed by the primary grantee, the sub-contractor, the IHS Area Director and the Tribal Chairperson.
• SF-424 and SF-424A forms completed by the IHS facility (in addition to the primary applicant's SF-424 forms).
A separate budget is required for the sub-contract, but the primary grantee's application must reflect the total budget for the entire cost of the project.
A.
Section 1: Community Needs Assessment
A1.1 Describe the burden of diabetes in your community. Include estimates of the number of people diagnosed with diabetes and the total number of people. Describe how you calculated these estimates.
A1.2 Briefly describe the top diabetes-related health issues in your community.
A1.3 Briefly describe the unique challenges your program experiences related to prevention and treatment of diabetes.
Section 2: Leadership Support
A2.1 Question: Has at least one organization administrator or Tribal leader agreed to be actively involved in your program's work? (Yes or No).
A2.2 Provide the name and role or position that this leader holds.
A2.3 Describe how this leader will be involved with your program.
Section 3: Personnel
Using the table format that is in the application instructions, provide the following information for each person who will be paid with SDPI funds:
A3.1 Name.
A3.2 Title.
A3.3 Brief description of tasks/activities.
A3.4 Is this person already on staff with your SDPI or diabetes program?
A3.5 What percent FTE of this person's salary will be paid using SDPI funds?
Section 4: Diabetes Audit Review
Obtain copies of your local IHS Diabetes Care and Outcomes Audit Reports for 2008 and 2009. Review and compare the results for these two years. Work with your local audit coordinator or Area Diabetes Consultant (ADC) if you need help.
A4.1 Provide a list of results for three to five items/elements (e.g., A1c, eye exam, education, etc.) that improved from 2008 to 2009.
A4.2 Provide a list of three to five items/elements that need to be improved.
A4.3 Describe how your program will address these three to five items/elements that need to be improved or describe how your program will work with your local health care facility to address these areas.
Section 5: Collaboration
A5.1 Describe existing partnerships and collaborations that your program has in place.
A5.2 Describe new partnerships and collaboration that your program is planning to implement.
Section 1: Overview
Each 2009 IHS Diabetes Best Practice includes two specific measures that are called “key measures.” Programs may track additional measures based on local priorities. A list of all Best Practices is located in the application instructions. This list provides a short description of the contents and key measures for each Best Practice.
B1.1 List which IHS Diabetes Best Practice(s) your program will implement in order to address the needs that were identified in your community assessment.
Section 2: Program Planning
Provide the information requested below separately for each Best Practice that will be implemented:
B2.1 Target Population: What population will you target?
B2.2 Goal: Describe the goal that your program wants to achieve as a result of implementing the selected Best Practice.
B2.3 Objectives/Measures: List the objective(s) your program will work to accomplish, with at least one measure
B2.4 Activities: List the activities that your program will do to meet the selected Best Practice objectives. These could be events you will organize, services you will offer, materials you will develop and implement, or other activities.
Section 3: Evaluation
B3.1 Describe how your program will track activities for the selected Best Practice(s).
B3.2 Describe how your program will collect and track data on all measures (listed in Section 2 above) for the selected Best Practice(s).
B3.3 Describe how your program will collect stories about individual participants, community events, program staff, and other aspects of your program.
Section 1: Major Accomplishments and Activities
C1.1 Describe three major accomplishments that your SDPI program achieved in the past 12 months.
C1.2 Describe three to five major accomplishments that your SDPI program has achieved since it began.
C1.3 Describe one story that exemplifies a major program accomplishment from the past year.
C1.4 Describe your SDPI program's primary activities during the past 12 months.
C1.5 Describe your SDPI program`s primary activities since it began.
Section 2: Challenges
C2.1 Describe the two or three biggest challenges that your SDPI program encountered in the past 12 months.
C2.2 Describe how your SDPI program addressed these challenges.
C2.3 Indicate if you successfully addressed these challenges. (If so, why; if not, why not.)
Section 3: Dissemination
C3.1 Describe three to five major lessons that your SDPI program has learned since it began.
C3.2 Describe how your SDPI program has shared the lessons that you have learned with other diabetes programs.
C3.3 Describe materials or products your SDPI program has developed.
Section 4: Other Information
C4.1 Provide any additional information about your SDPI program.
B. Budget Narrative (no more than 4 pages)
The budget narrative should explain why each budget item on the SF-424A is necessary and relevant to the proposed project.
Applications are to be submitted electronically through Grants.gov by April 30, 2010 at 12 midnight Eastern Standard Time (EST). Any application received after the application deadline will not be accepted for processing, and it will be returned to the applicant(s) without further consideration for funding.
If technical challenges arise and the applicants need help with the electronic application process, contact Grants.gov Customer Support via e-mail to
If an applicant needs to submit a paper application instead of submitting electronically via Grants.gov, prior approval must be requested and obtained (see information under Subsection 6 ” Electronic Submission Requirements” for additional information). The waiver must be documented in writing (e-mails are acceptable), before submitting a paper application. After a waiver is received, the application package must be downloaded by the applicant from Grants.gov. Once completed and printed, the original application and two copies must be sent to Denise E. Clark, Division of Grants Operations (DGO) (denise.clark@ihs.gov), 801 Thompson Avenue, TMP, Suite 360, Rockville, MD 20852. Paper applications that are submitted without a waiver will be returned to the applicant without review or further consideration.
Executive Order 12372 requiring intergovernmental review is not applicable to this program.
A. Pre-award costs are allowable pending prior approval from the awarding agency. However, in accordance with 45 CFR Part 74 and 92, pre-award costs are incurred at the applicant's risk. The awarding office is under no obligation to reimburse such costs if for any reason the applicant does not receive an award or if the award is less than anticipated.
B. The available funds are inclusive of direct and appropriate indirect costs (see Section VI, Subsection 3).
C. Only one grant will be awarded per applicant.
Use the
Applicants that receive a waiver to submit paper application documents must follow the rules and timelines that are noted below. The applicant must seek assistance at least ten days prior to the application deadline.
Applicants that do not adhere to the timelines for Central Contractor Registry (CCR) and/or Grants.gov registration and/or request timely assistance with technical issues will not be considered for a waiver to submit a paper application.
Please be aware of the following:
• Paper applications are not the preferred method for submitting applications.
• If you have problems electronically submitting your application on-line, contact Grants.gov Customer Support via e-mail to
• Upon contacting Grants.gov, obtain a tracking number as proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver to submit a paper application must be obtained.
• If it is determined that a waiver is needed, the applicant must submit a request in writing (e-mails are acceptable) to
• Upon entering the Grants.gov site, there is information that outlines the requirements to the applicant regarding electronic submission of an application through Grants.gov, as well as the hours of operation.
• Applicants are strongly encouraged not to wait until the deadline date to begin the application process through Grants.gov as the registration process for CCR and Grants.gov could take up to fifteen working days.
• In order to use Grants.gov, the applicant must have a Dun and Bradstreet (DUNS) Number and register in the Central Contractor Registration (CCR). A minimum of ten working days should be allowed to complete CCR registration.
• All documents must be submitted electronically, including all information typically included on the SF-424 and all necessary assurances and certifications.
• Please use the optional attachment feature in Grants.gov to attach additional documentation that may be requested by IHS.
• The application must comply with any page limitation requirements described in the Funding Announcement.
• After you electronically submit your application, you will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The DGO will download your application from Grants.gov and provide necessary copies to the DDTP. Neither the DGO nor the DDTP will notify applicants that the application has been received.
• You may access the electronic application package and instructions for this Funding Opportunity Announcement on http://www.Grants.gov.
• You may search for the application package on Grants.gov either with the CFDA number or the Funding Opportunity Number. Both numbers are identified in the heading of this announcement.
• The applicant must provide the Funding Opportunity Number: HHS-2010-IHS-SDPI-0004.
Applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Many organizations may already have a DUNS number. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number or to find out if your organization already has a DUNS number, access
Applicants must also be registered with the CCR. A DUNS number is required before an applicant can complete their CCR registration. Registration with the CCR is free of charge. Applicants may register online at
Criteria that will be used to evaluate the application are divided into three categories. They include:
• Project Narrative
The project narrative is divided into three parts: Part A—Program Information; Part B—Program Planning/Evaluation; and Part C—Project Report. Required information includes topics such as: Community needs assessment, leadership support, use of Diabetes Audit results, selected Best Practice(s), overall evaluation plan and project accomplishments. For each Best Practice that will be implemented, address: target population, goal, objectives/measures, review of key measures, and activities (
• Budget Narrative
The budget narrative provides additional explanation to support the information provided on the SF-424A form. Budget categories to address include: Personnel, fringe benefits, travel, equipment and supplies, contractual/consultant and constructions/alterations/renovations. In addition to a line item budget, provide a brief justification of each budget item and how they support project objectives.
• Key Contacts Form
This form seeks to obtain contact information about only one person: the project's SDPI Program Coordinator.
Points will be assigned in each category adding up to a total of 100. A minimum score of 60 points is required for funding. Points will be assigned as follows:
•
•
Each application will be prescreened by DGO staff for eligibility and completeness as outlined in this Funding Opportunity Announcement. Applications from entities that do not meet eligibility criteria or that are incomplete will not be reviewed. Applicants will be notified by the DGO that their application did not meet minimum requirements.
After being prescreened by the DGO, applications will be reviewed by an Objective Review Committee (ORC) and assigned a score. The ORC is an objective review group that will be convened by the DDTP in consultation with the DGP as required by Department of Health and Human Services (HHS) Grants Policy.
To obtain a minimum score for funding, applicants must address all program requirements and provide all required documentation. Applicants that receive less than a minimum score will be informed via e-mail of their application's deficiencies. (
When an application is submitted on behalf of multiple organizations (sub-grantees), the review score will be a combined score that is based on information provided by all of these organizations.
Funded applicants (grantees) must meet the following programmatic requirements:
Grantees must implement recommended services and activities from at least one 2009 IHS Diabetes Best Practice. They should implement recommendations based on program need, strengths, and resources. Program activities, services and key measures from the selected Best Practice(s) must be documented in the project narrative (
Grantees must follow the plans submitted with their application when implementing each selected Best Practice and their evaluation processes. A minimum evaluation requirement is to monitor the key measures over time. Programs may track additional measures based on local priorities.
Grantees must participate in SDPI training sessions and peer-to-peer learning activities. Training sessions will be primarily conference calls or combined WebEx/conference calls. Grantees will be expected to:
• Participate in interactive discussion during conference calls.
• Share activities, tools and results.
• Share problems encountered and how barriers are broken down.
• Share materials presented at conferences and meetings.
• Participate and share in other relevant activities.
Sessions, which will be led by DDTP, DGO, or their agents, will address clinical and other topics. Topics will include: program planning and evaluation, enhancing accountability through data management, and improvement of principles and processes. Grantees will integrate information and ideas in order to enhance effectiveness. Anticipated outcomes from participating in the learning sessions are improved communication and sharing among grantees, increased use of data for improvement, and enhanced accountability.
If an application does not receive a minimum score for funding from the ORC, the applicant will be informed via a summary statement that will be sent to the AOR via e-mail. The applicant then has two opportunities to submit revisions to their application. Before application revisions can be submitted, the AOR must have received a summary statement from the previous review that outlines the weaknesses of the initial application.
Applicants will have five business days from the date that the summary statement is sent via e-mail to submit hard copies of their application revisions. Along with the revised application documents, applicants must prepare and submit an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must also include responses to the criticism and issues raised in the summary statement.
The Introduction and revised application documents must be mailed directly to the DGO to the attention of Denise Clark, Lead Grants Management Specialist
Technical assistance will be available to applicants as they prepare resubmission documentation.
An Ad Hoc Review Committee will be convened specifically to review the initial application revisions. If the revised application receives the minimum score for funding or above, the applicant will be informed via a Notice of Award (NoA). If the Review Committee determines that the application with revisions still does not receive a fundable score, the applicant will be informed of their application's deficiencies via a second summary statement that will be e-mailed to the AOR.
Applicants will have five business days from the date that the second summary statement is sent via e-mail to submit hard copies of their application revisions. Along with the revised application documents, applicants must prepare and submit an Introduction of not more than three pages that summarizes the substantial additions, deletions, and changes. The Introduction must also include responses to the criticism and issues raised in the summary statement.
The Introduction and revised application documents must, again, be mailed directly to the DGO to the attention of Denise Clark, Lead Grants Management Specialist
A second Ad Hoc Review Committee will be convened to review the second application revisions. If the application with revisions receives the minimum score for funding or above, the applicant will be informed via a NoA.
If the Review Committee determines that the application with revisions still does not receive a fundable score, applicants will be informed in writing of their application's deficiencies.
Technical Assistance from Area Diabetes Consultants (ADCs) is available to all applicants in all cycles that did not/do not receive fundable scores. These applicants are encouraged to contact the ADC for their area to obtain assistance. Contact information for ADCs can be found on the Division of Diabetes Web site
Grantees that receive a fundable score will be notified of their approval for funding via the NoA.
The NoA will be prepared by the DGO and sent via postal mail to each applicant that is approved for funding under this announcement. This document will be sent to the person who is listed on the SF-424 as the AOR. The NoA will be signed by the Grants Management Officer. The NoA is the authorizing document for which funds are dispersed to the approved entities. The NoA serves as the official notification of the grant award and reflects the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period. The NoA is the legally binding document. Applicants who are disapproved based on the ORC score will receive a copy of the summary statement which identifies the weaknesses and strengths of the application submitted. The AOR serves as the business point of contact for all business aspects of the award.
The anticipated NoA date for all applicants that score well in the ORC review for Cycle IV is July 15, 2010.
Grants are administered in accordance with the following regulations, policies, and Office of Management and Budget (OMB) cost principles:
A. The criteria as outlined in this Funding Opportunity Announcement.
B. Administrative Regulations for Grants:
• 45 CFR Part 92—Uniform Administrative Requirements for Grants
• 45 CFR Part 74—Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Non-Profit Organizations, and Commercial Organizations.
C. Grants Policy:
• HHS Grants Policy Statement, Revised 01/2007.
D. Cost Principles:
• OMB Circular A-87—State, Local, and Indian Tribal Governments (Title 2 Part 225).
• OMB Circular A-122—Non-Profit Organizations (Title 2 Part 230).
E. Audit Requirements
• OMB Circular A-133—Audits of States, Local Governments, and Non-Profit Organizations.
This section applies to all grant recipients that request reimbursement of indirect costs in their grant application. In accordance with HHS Grants Policy Statement, Part II-27, IHS requires applicants to obtain a current indirect cost rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award's budget period. If the current rate is not on file with the DGO at the time of award, the indirect cost portion of the budget will be restricted. The restrictions remain in place until the current rate is provided to the DGO.
Generally, indirect costs rates for IHS grantees are negotiated with the HHS Division of Cost Allocation
The DDTP and the DGO have requirements for progress reports and financial reports based on the terms and conditions of this grant as noted below.
Program progress reports are required semi-annually. These reports must include at a minimum: Reporting of Best Practice measures; and a brief comparison of actual accomplishments to the goals established for the budget period or provide sound justification for the lack of progress.
Annual financial status reports are required until the end of the project period. Reports must be submitted annually no later than 30 days after the end of each specified reporting period. The final financial status report is due within 90 days after the end of the 24 month project period. Standard Form 269 (long form for those reporting program income; short form for all others) will be used for financial reporting.
Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports (FSR). According to SF-269 instructions, the final SF-269 must be verified from the grantee records to support the information outlined in the FSR.
Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) The imposition of special award provisions; and (2) the non-funding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports.
Applicants who have an active SDPI grant are required to be up-to-date in the submission of required audit reports. These are the annual financial audit reports required by OMB A-133, audits of state, local governments, and non-profit organizations that are submitted. Documentation of (or proof of submission) of current FY 2007 and FY 2008 Financial Audit Reports is mandatory. Acceptable forms of documentation include: e-mail confirmation from FAC that audits were submitted; or face sheets from audit reports. Face sheets can be found on the FAC Web site:
Telecommunication for the hearing impaired is available at: TTY (301) 443-6394.
• For Grants Budget Management, contact:
• Denise Clark, Lead Grants Management Specialist, DGO
• For Grants.gov electronic application process, contact:
• Tammy Bagley, Grants Policy, DGP
• For programmatic questions, contact:
• Bonnie Bowekaty, Program Assistant, DDTP
• Lorraine Valdez, Deputy Director, DDTP
• Area Diabetes Consultants Web site:
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Minh Doan at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
With this correction notice, the Agency for Healthcare Research and Quality (AHRQ) informs the public of an amendment made to the notice subject mentioned above published on March 18, 2010 Vol. 75, No. 52, Second paragraph of pages 13 135-13136.
The revised should read: “DATE: April 15-16, 2010 (Open on April 15 from 8 a.m. to 8:15 am. and closed for the remainder of the meeting)”.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS); Employee Benefits Security Administration (EBSA), Department of Labor (DOL).
Notice.
This notice announces the first meeting of the Medicaid, Children's Health Insurance Program (“CHIP”), and Employer-Sponsored Coverage Coordination Working Group (referred to as the “CHIP Working Group”). The CHIP Working Group will meet to address objectives specified under section 311(b)(1)(C) of the Children's Health Insurance Program Reauthorization Act of 2009. This meeting is open to the public.
Stacey Green, DFO, Centers for Medicare & Medicaid Services, DHHS at (410) 786-6102, or Amy Turner,
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA), this notice announces the first meeting of the Medicaid, CHIP, and Employer-Sponsored Coverage Coordination Working Group (“CHIP Working Group”). The Secretary of Health and Human Services and the Secretary of Labor are required under section 311(b)(1)(C) of the Children's Health Insurance Program Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3), enacted February 4, 2009, to jointly establish a CHIP Working Group. The membership of the group is based on nominations submitted in response to a
Not later than August 5, 2010, the CHIP Working Group must submit to the Secretary of Labor and the Secretary of Health and Human Services the model coverage coordination disclosure form and the report containing recommendations for appropriate measures for addressing the impediments to the effective coordination of coverage.
The CHIP Working Group consists of 22 individuals, including 2 Co-Chairs. Members of the CHIP Working Group are composed of representatives of the Department of Labor (DOL); the Department of Health and Human Services (DHHS); State directors of the Medicaid Program under title XIX of the Act; State directors of the State Children's Health Insurance Program under title XXI of the Act; employers, including owners of small businesses and their trade or industry representatives and certified human resource and payroll professionals; plan administrators and plan sponsors of group health plans as defined in section 607(1) of the Employee Retirement Income Security Act of 1974, as amended; health insurance issuers; and representatives of children and other beneficiaries of medical assistance under title XIX of the Act or child health assistance or other health benefits coverage under title XXI of the Act. Members serve for the duration of the committee.
The current members are:
• Department of Labor: Phyllis Borzi;
• Department of HHS: Victoria Wachino;
• State Representatives, including Medicaid and CHIP Directors: Mari Spaulding-Bynon, Rhonda Medows, Howard “Rocky” King, Ann Clemency Kohler; Janet Olszewski, Linda Sheppard, and Anita Smith;
• Employers, Plan Sponsors, and Plan Administrators: Emma Bennett-Williams, Barbara Caress, Roberta Casper Watson, Greta Cowart, Kaye Pestaina, and Mark Stember;
• Health Insurance Issuers: Terry Bayer, Ellyn Fuchsteiner, and Kevin Hayden; and
• Representatives of Children and Other Beneficiaries of Medical Assistance: Joan Alker, George Askew, Miguel Carranza, and Karen Pollitz.
The meeting will commence with welcoming remarks for the CHIP Working Group by Departmental representatives. In addition, the agenda will focus on the following:
• Opening statements from the Co-Chairs, as well as introductions and remarks by other CHIP Working Group members;
• Swearing in of members;
• An overview of FACA requirements;
• An overview by DOL and HHS staff of the deliverables that the CHIP Working Group is responsible for under CHIPRA:
+ A model coverage coordination disclosure form for plan administrators of group health plans.
+ A report containing recommendations for appropriate measures for addressing the impediments to the effective coordination of coverage between group health plans and title XIX and XXI State plans.
• An opportunity for public comment and testimony.
For additional information and clarification on these topics, contact the DFO as provided in the
The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the
Individuals requiring sign language interpretation or other special accommodations must contact the DFO via the contact information specified in the
Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Paul Tran at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Scientific Management Review Board.
The meeting will be open to the public, with attendance limited to space available. Registration is required since space is limited. Please visit the conference Web site for information on meeting logistics and to register for the meeting
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. For additional information about the Federal Advisory Committee meeting, please contact Circle Solutions at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, April 7, 2010, 8 a.m. to April 8, 2010, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held April 14, 2010 to April 15, 2010. The meeting time and location remain the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Neurological Disorders and Stroke, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Request for comments on the proposed substances to be evaluated for Set 24 toxicological profiles.
This notice announces the list of proposed substances that will be evaluated for Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) Set 24 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public comments on the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, substances, not on this list, that may have public health implications.
Nominations must be submitted within 30 days of the publication of this notice.
Nominations may be submitted electronically. Refer to the section
For further information, contact: Commander Jessilynn B. Taylor, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, F-62, Atlanta, GA, 30333; telephone: (770) 488-3313; or e-mail:
The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601
Each year, ATSDR develops a list of substances to be considered for toxicological profile development. This list is compiled from ATSDR's Priority List of Hazardous Substances and from previously nominated substances of public health concern. The following list of 240 proposed substances will be considered for Set 24 Toxicological Profile development.
ATSDR will evaluate all data and information associated with nominated substances and will determine the final list of substances to be chosen for toxicological profile development. Substances will be chosen according to ATSDR's specific guidelines for selection, found in the
Please ensure that your comments are submitted within the specified nomination period. Nominations received after the closing date will be marked as late and may be considered only if time and resources permit.
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing a public workshop entitled “2010 PDA/FDA Pharmaceutical Supply Chain Workshop—Enough Talk: Let's Find and Implement Solutions.” The workshop, cosponsored with the Parenteral Drug Association (PDA), will focus on solutions to reduce the risk to product quality in the pharmaceutical supply chain.
The cost of registration is as follows:
If you need special accommodations due to a disability, please contact Wanda Neal, PDA (see
A reliable supply of high quality, safe, and effective drug products and drug ingredients depends upon a series of controls across the entire supply chain from sourcing of incoming starting materials to distribution controls to marketing. Recent experiences in the market have highlighted the need for effective controls across the supply chain. There is a surge in global cooperation and efforts toward harmonization of good manufacturing practices (GMPs) and good distribution practices (GDPs) and controls pertaining to the supply chain among members of industry and regulatory agencies. Understanding and securing the entire ingredient manufacturing and distribution chain helps to ensure the quality and safety of medicines for patients.
Through a series of plenary sessions and working group breakout sessions, the workshop will provide participants the opportunity to:
• Hear from senior FDA personnel on the current regulatory environment.
• Share improvements in programs and technology.
• Identify any barriers to securing the entire ingredient manufacturing and distribution chain and associated actions to implement effective solutions.
Personnel with experience related to supply chain issues, including quality and technical functions, will find this level of information exchange with members of industry and regulatory agencies useful to their specific areas.
30-Day notice of information collection for review; Form G-79A, Information Relating to Beneficiary of Private Bill; OMB Control No. 1653-0026.
The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted for thirty days April 30, 2010. Written comments and suggestions from the public and affected agencies regarding items contained in this notice and especially with regard to the estimated public burden and associated response time should be directed to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to OMB Desk Officer, for U. S. Immigration and Customs Enforcement, Department of Homeland Security, and sent via electronic mail to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Overview of This Information Collection:
(1)
(2)
(3)
(4)
(5)
(6)
Requests for a copy of the proposed information collection instrument, with instructions; or inquiries for additional information should be requested via e-mail to:
Coast Guard, DHS.
Notice of recertification.
The purpose of this notice is to inform the public that the Coast Guard has recertified the Prince William Sound Regional Citizens' Advisory Council (PWSRCAC) as an alternative voluntary advisory group for Prince William Sound, Alaska. This certification allows the PWSRCAC to monitor the activities of terminal facilities and crude oil tankers under the Prince William Sound Program established by statute.
This recertification is effective for the period from March 1, 2010 through February 28, 2011.
LCDR Ken Phillips, Seventeenth Coast Guard District (dpi), by telephone at (907) 463-2821, or by mail at P.O. Box 25517, Juneau, Alaska 99802.
As part of the Oil Pollution Act of 1990, Congress passed the Oil Terminal and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among industry, government, and local communities in overseeing compliance with environmental concerns in the operation of crude oil terminals and oil tankers.
On October 18, 1991, the President delegated his authority under 33 U.S.C 2732(o) to the Secretary of Transportation in Executive Order 12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of certifying advisory councils, or groups, subject to the Act. On March 3, 1992, the Secretary redelegated that authority to the Commandant of the Coast Guard (see 57 FR 8582; March 11, 1992). The Commandant redelegated that authority to the Chief, Office of Marine Safety, Security and Environmental Protection (G-M) on March 19, 1992 (letter #5402).
On July 7, 1993, the USCG published a policy statement, 58 FR 36504, to clarify the factors that shall be considered in making the determination as to whether advisory councils, or groups, should be certified in accordance with the Act.
The Assistant Commandant for Marine Safety and Environmental Protection (G-M), redelegated recertification authority for advisory councils, or groups, to the Commander, Seventeenth Coast Guard District on February 26, 1999 (letter #16450).
On September 16, 2002, the Coast Guard published a policy statement, 67 FR 58440, which changed the recertification procedures such that applicants are required to provide the USCG with comprehensive information every three years (triennially). For each of the two years between the triennial application procedures, applicants submit a letter requesting recertification that includes a description of any substantive changes to the information provided at the previous triennial recertification. Further, public comment is not solicited prior to recertification during streamlined years, only during the triennial comprehensive review.
The Alyeska Pipeline Service Company pays the PWSRCAC $2.9 million annually in the form of a long-term contract. In return for this funding, the PWSRCAC must annually show that it “fosters the goals and purposes” of OPA 90 and is “broadly representative of the communities and interests in the vicinity of the terminal facilities and Prince William Sound.” The PWSRCAC is an independent, nonprofit organization founded in 1989. Though it receives Federal oversight like many independent, non-profit organizations, it is not a Federal agency. The PWSRCAC is a local organization that predates the passage of OPA 90. The existence of the PWSRCAC was specifically recognized in OPA 90 where it is defined as an “alternate voluntary advisory group.”
Alyeska funds the PWSRCAC, and the Coast Guard makes sure the PWSRCRC operates in a fashion that is broadly consistent with OPA 90.
By letter dated February 24, 2010, the Commander, Seventeenth Coast Guard District, certified that the PWSRCAC qualifies as an alternative voluntary advisory group under 33 U.S.C. 2732(o). This recertification terminates on February 28, 2011.
National Communications System, DHS.
Notice of open advisory committee meeting.
The President's National Security Telecommunications Advisory Committee (NSTAC) will hold its annual meeting on May 6, 2010. The meeting will be open to the public.
May 6, 2010, from 2:30 p.m. until 5:30 p.m.
The meeting will take place at the U.S. Chamber of Commerce, 1615 H Street, NW., Washington, DC. If you desire meeting materials, please contact Ms. Sue Daage at (703) 235-4964 or by e-mail at
•
•
•
•
Ms. Sue Daage, Government Industry Planning and Management Branch, at (703) 235-4964, e-mail:
The NSTAC advises the President on issues and problems related to implementing national security and emergency preparedness telecommunications policy. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), Public Law 92-463 (1972), as amended appearing in 5 U.S.C. App. 2. At the upcoming meeting, the NSTAC Principals will receive Government stakeholder comments and updates on the progress of the Communications Resiliency Task Force and the Cybersecurity Collaboration Task Force.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name/or OMB Control number and should be sent to: Leroy McKinney, Jr., Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Room 4178, Washington, DC 20410-5000; telephone 202.402.8048 (this is not a toll-free number), or e-mail Mr. McKinney at
Dacia Rogers, Office of Policy, Programs and Legislative Initiatives, PIH, Department of Housing and Urban Development, 451 7th Street, SW., Room 4116, Washington, DC 20410; telephone 202-402-3374 (this is not a toll-free number).
The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology,
This Notice also lists the following information:
Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended.
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Reports Liaison Officer, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street, SW., Room 8228, Washington, DC 20410-6000.
Susan Brunson, 202-708-3061, ext. 3852 (this is not a toll-free number), for copies of the proposed forms and other available documents.
The Department of Housing and Urban Development will submit the proposed extension of information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).
This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
This Notice also lists the following information:
Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice of proposed information collection.
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name/or OMB Control number and should be sent to: Leroy McKinney, Jr., Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Room 4178, Washington, DC 20410-5000; telephone 202-402-8048 (this is not a toll-free number), or e-mail Mr. McKinney at
Dacia Rogers, Office of Policy, Programs and Legislative Initiatives, PIH, Department of Housing and Urban Development, 451 7th Street, SW., Room 4116, Washington, DC 20410; telephone 202-402-3374 (this is not a toll-free number).
The Department will submit the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology; e.g., permitting electronic submission of responses.
This notice also lists the following information:
Section 3506 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
The Department of Housing and Urban Development (HUD) gives notice to the public, agencies, and Indian Tribes that the Seattle Housing Authority and the City of Seattle Human Services Department (Community Development Block Grant (CDBG) Administration Unit) intend to prepare an Environmental Impact Statement (EIS) for the Yesler Terrace Redevelopment Project, located in the City of Seattle, King County, WA. The project proponent is the Seattle Housing Authority. The City of Seattle Human Services Department and the Seattle Housing Authority, acting jointly as lead agencies, will prepare the EIS under the authority of the City of Seattle Human Services Department as the Responsible Entity for compliance with the National Environmental Policy Act (NEPA) in accordance with 42 U.S.C. 5304(g) and 42 U.S.C. 1437x and HUD regulations at 24 CFR 58.4, and under the Seattle Housing Authority's role as lead agency in accordance with the Washington State Environmental Policy Act (SEPA). The EIS will be a joint NEPA and SEPA document. The EIS will satisfy requirements of SEPA (RCW 43.21C) and the SEPA Rules (WAC 197-11) which require that all State and local government agencies consider the environmental consequences of projects over which they have discretionary authority before acting on those projects. The proposed action is subject to compliance with NEPA, because funds from the public housing programs under Title I of the United States Housing Act of 1937 (HOPE VI, Capital Funds, Demolition/Disposition) will used for this project (24 CFR 58.1(b)(6)(i)). This notice is given in accordance with the Council on Environmental Quality regulations at 40 CFR parts 1500-1508. All interested Federal, State, and local agencies, Indian Tribes, groups, and the public are invited to comment on the scope of the EIS. If you are an agency with jurisdiction by law over natural or other public resources affected by the project, the Seattle Housing Authority and the City of Seattle Human Services Department need to know what environmental information germane to your statutory responsibilities should be included in the EIS.
Comments relating to the scope of the EIS are requested and will be accepted by the contact persons listed below until May 17, 2010. Any person or agency interested in receiving a notice and wishing to make comment on the scope of the EIS should contact the persons listed below.
Stephanie Van Dyke, Development Director of the Seattle Housing Authority,
For additional background information on the project proposal, please see the Seattle Housing Authority Web site:
The meeting/open house will be held at the Yesler Terrace Gym (835 Yesler Way, Seattle, WA 98122) on April 29, 2010. An open house will be held from 6-7 p.m. and public comments on the scope will be taken at 7 p.m. For accommodations and translation services in conjunction with the public meeting please contact Collette Frazier, (p) (206) 615-3556.
The Seattle Housing Authority and the City of Seattle Human Services Department will consider a proposal for a phased redevelopment of the existing Yesler Terrace residential community to a mixed-use residential community on a 28-acre site on the southern slope of First Hill in Seattle, WA. The proposed project is generally bounded by Interstate 5 on the west, Alder Street and Fir Street on the north, 12th Avenue on the east, and Washington Street on the south.
The proposed project would include development of a mix of affordable and market-rate housing, office and retail uses, as well as parks and open space, enhanced landscaping, improved streets and a system of pedestrian and bike improvements. All existing residential structures on the site would be demolished under the Proposed Action; other structures on the site may also be demolished. The existing Yesler Terrace
The proposed actions may involve the following: Comprehensive Plan Amendment, text amendment to the Land Use Code to allow a new zone for Yesler Terrace, street vacation, preliminary and final plat approval, adoption of a Planned Action Ordinance, Development Agreement approval, other construction and building permits and other Federal, State and local approvals for redevelopment of the Yesler Terrace community.
The EIS is also intended to fulfill SEPA requirements for a Planned Action environmental review for the portion of the site west of Boren Avenue, per RCW 43.21C.031, SMC 25.05.164 [
This is to be a combined document—an EIS under the State of Washington State Environmental Policy Act (RCW 43.21C. and WAC 197-11) and an EIS under NEPA (42 U.S.C. 4321) and implementing regulations of the Council on Environmental Quality (40 CFR parts 1500-1508) and HUD (24 CFR part 58).
As a lead agency, the City of Seattle, through its Human Services Department, is the responsible entity (RE) for this project in accordance with 24 CFR part 58, “Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities.” As a RE, the City of Seattle Human Services Department assumes the responsibility for environmental review, decision-making, and action that would otherwise apply to HUD under NEPA.
In addition, the Seattle Housing Authority is the State Environmental Policy Act (SEPA) lead agency responsible for preparing an Environmental Impact Statement (EIS).
Questions may be directed to the individuals named in this notice under the heading
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
This Notice announces a debenture recall of certain Federal Housing Administration (FHA) debentures, in accordance with authority provided in the National Housing Act.
Yong Sun, FHA Financial Reporting Division, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 5148, Washington, DC 20410, telephone (202) 402-4778. This is not a toll-free number.
Pursuant to section 207(j) of the National Housing Act, 12 U.S.C. 1713(j), and in accordance with HUD's regulation at 24 CFR 207.259(e)(3), the Assistant Secretary for Housing—Federal Housing Commissioner, with the approval of the Secretary of the Treasury, announces the call of all FHA debentures, with a coupon rate of 5 percent or above, except for those debentures subject to “debenture lock agreements,” that have been registered on the books of the Bureau of the Public Debt, Department of the Treasury, and are, therefore, “outstanding” as of March 31, 2010. The date of the call is July 1, 2010.
The debentures will be redeemed at par plus accrued interest. Interest will cease to accrue on the debentures as of the call date. At redemption, final interest on any called debentures will be paid along with the principal. Payment of final principal and interest due on July 1, 2010 will be made automatically to the registered holder.
During the period from the date of this notice to the call date, debentures that are subject to the call may not be used by the mortgagee for a special redemption purchase in payment of a mortgage insurance premium.
No transfer of debentures covered by the foregoing call will be made on the books maintained by the Treasury Department on or after June 14, 2010. This debenture call does not affect the right of the holder of a debenture to sell or assign the debenture on or after this date.
Office of Public and Indian Housing, HUD.
Announcement of funding awards.
In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department for funding under the FY 2008 and FY 2009 HUD-VASH program. This announcement contains the consolidated names and addresses of those award recipients selected for funding under both the Consolidated Appropriations Act, 2008 (Pub. L. 110-161) and the Omnibus Appropriations Act, 2009 (Pub. L. 111-8).
Danielle Bastarache, Director, Housing Voucher Programs, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 Seventh
The Consolidated Appropriations Act, 2008 (Pub. L. 110-161) (“2008 Appropriations Act”) made $75 million available for HUD-VASH, an initiative that combines HUD Housing Choice Voucher (HCV) rental assistance for homeless veterans with case management and clinical services provided by the Department of Veterans Affairs (VA) at its medical centers and in the community. The HCV program is authorized under section 8(o)(19) of the United States Housing Act of 1937. The Omnibus Appropriations Act, 2009 (Pub. L. 111-8) (“2009 Appropriations Act”) made an additional $75 million available to HUD-VASH. Both the 2008 and 2009 Appropriations Acts require HUD to distribute assistance without competition, to public housing agencies (PHAs) that partner with eligible Veterans Affairs Medical Centers (VAMCs) or other entities as designated by the VA. As required by statute, selection was based on geographical need for such assistance as identified by the VA, public housing agency performance, and other factors as specified by the HUD in consultation with the VA. On May 6, 2008 (73 FR 25026), HUD published in the
As required by the FY 2008 and FY 2009 Appropriations Acts, the VA identified VAMCs to participate in the program taking into account the population of homeless veterans needing services in the area, the number of homeless veterans recently served by the homeless programs at each VAMC, geographic distribution, and the VA's case management resources. After considering location and administrative performance of PHAs in the jurisdiction of each VAMC, HUD invited PHAs to apply for HUD-VASH vouchers. In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), today's
Office of the Chief Information Officer, HUD.
Notice of modification of Existing Computer Matching Program.
Pursuant to the Computer Matching and Privacy Protection Act of 1988, as amended, and the Office of Management and Budget's (OMB) Guidance on the statute (5 U.S.C. 552a, as amended), HUD is providing notice of its intent to modify an existing computer matching program with SSA to include the Disaster Housing Assistance Program (DHAP) as a covered HUD rental assistance program for the purpose of income verifications and computer matching.
Interested persons are invited to submit comments regarding this notice to the Rules Docket Clerk, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Communications should refer to the above docket number and title. Comments sent by facsimile are not acceptable. A copy of each communication submitted will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address.
For Privacy Act inquires: Office of the Chief Information Officer, contact Donna Robinson-Staton, Departmental Privacy Act Officer, HUD, 451 Seventh Street, SW., Room 2256, Washington, DC 20410, telephone number (202) 402-8073. For program information: Office of Public and Indian Housing, contact Nicole Faison, Program Advisor for the Office of Public Housing and Voucher Programs, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 4214, Washington, DC 20410, telephone number (202) 402-4267; Office of Housing, contact Gail Williamson, Director of the Housing Assistance Policy Division, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 6138, Washington, DC 20410, telephone number (202) 402-2473. (These are not toll free telephone numbers). A telecommunications device for hearing- and speech-impaired individuals (TTY) is available at (800) 877-8339 (Federal Information Relay Service).
This Notice supersedes a similar notice published in the
Administrators of HUD rental assistance programs rely upon the accuracy of tenant-reported income to determine participant eligibility for and level of, rental assistance. The computer matching program will provide indicators of potential under-reported tenant income that will require additional verification to identify inappropriate (excess or insufficient) rental assistance, and perhaps administrative or legal actions. The matching program will be carried out to detect inappropriate (excessive or insufficient) rental assistance under sections 221(3), 221(d)(5), and 236 of the National Housing Act, the United States Housing Act of 1937, section 101 of the Housing and Community Development Act of 1965, section 202 of the Housing Act of 1959, section 811 of the Cranston-Gonzalez National Affordable Housing Act, the Native American Housing Assistance and Self-Determination Act of 1996, and the Quality Housing and Work Responsibility Act (QHWRA) of 1998. The program will also provide for verification of Social Security numbers (SSNs) for tenants participating in covered rental assistance programs, and borrowers and co-borrowers applying for mortgage insurance for FHA loans through HUD. This Notice provides an overview of computer matching for HUD's rental assistance programs. Specifically, the Notice describes HUD's program for computer matching of its tenant data to SSA's death data, Social
The Computer Matching and Privacy Protection Act (CMPPA) of 1988, an amendment to the Privacy Act of 1974 (5 U.S.C. 552a), OMB's guidance on this statute entitled “Final Guidance Interpreting the Provisions of Public Law 100-503, the CMPPA of 1988” (OMB Guidance), and OMB Circular No. A-130 requires publication of notices of computer matching programs. Appendix I to OMB's Revision of Circular No. A-130, “Transmittal Memorandum No. 4, Management of Federal Information Resources,” prescribes Federal agency responsibilities for maintaining records about individuals. In compliance with the CMPPA and Appendix I to OMB Circular No. A-130, copies of this notice are being provided to the Committee on Government Reform and Oversight of the House of Representatives, the Committee of Homeland Security and Governmental Affairs of the Senate, and OMB's Office of Information and Regulatory Affairs.
This matching program is being conducted pursuant to the Privacy Act of 1974 (5 U.S.C. 552a); 542(b) of the 1998 Appropriations Act (Pub. L. 105-65); section 904 of the Stewart B. McKinney Homeless Assistance Amendments Act of 1988, as amended (42 U.S.C. 3544); section 165 of the Housing and Community Development Act of 1987 (42 U.S.C. 3543); the National Housing Act (12 U.S.C. 1701-1750g); the United States Housing Act of 1937 (42 U.S.C. 1437-1437z); section 101 of the Housing and Community Development Act of 1965 (12 U.S.C. 1701s); the Native American Housing Assistance and Self-Determination Act of 1996 (25 U.S.C. 4101
This Notice of computer matching program applies to the following rental assistance programs:
This Notice does not apply to the Low Income Housing Tax Credit (LIHTC) or the Rural Housing Services Section 515 without Section 8 programs.
HUD's primary objective in implementing the computer matching program is to verify the income of individuals participating in the rental assistance programs identified in section II above to determine the appropriate level of rental assistance, and to detect, deter, reduce and correct fraud and abuse in rental assistance programs. In meeting this objective, HUD also is carrying out its responsibility under 42 U.S.C. 1437f(K) to ensure that income data provided to POAs by household members is complete and accurate. HUD's various assisted housing programs, administered through POAs, require that applicants and participants meet certain income and other criteria to be eligible for rental assistance. In addition, tenants generally are required to report the amounts and sources of their income at least annually. However, under the QHWRA of 1998, PHAs must offer public housing tenants the option to pay a flat rent, or an income-based rent annually. Those tenants who select a flat rent will be required to recertify income at least every three years. In addition, the Changes to the Admissions and Occupancy Final Rule (March 29, 2000; 65 FR 16692) specified that household composition must be recertified annually for tenants who select a flat rent or income-based rent.
Other objectives of this computer matching program include: (1) Increasing the availability of rental assistance to individuals who meet the requirements of the rental assistance programs; (2) after removal of personal identifiers, conducting analyses of the Social Security death data and benefit information, and income reporting of program participants; and (3) measure improper payments due to under-reporting of income and/or overpayment of subsidy on behalf of deceased program participants (single member households).
In this computer matching program, tenant-provided information included in HUD's automated systems of records known as
Any match (i.e., a “hit”) will be further reviewed by HUD, the POAs, or the HUD Office of Inspector General (OIG) to determine whether the income reported by tenants to the program administrator is correct and complies with HUD and program administrator requirements. Specifically, current or prior SS and SSI benefit information and other data will be sought directly from tenants. For public housing and Section 8 tenant-based HCV programs, tenants will be required to provide PHAs with original SSA benefit verification letters dated within the last 60 days for comparison to computer matching results for accuracy. For multifamily housing programs, tenants must provide O/As with SSA benefit verification letters dated within the last 120 days. For SS and SSI benefit information for prior years, the tenant may be required to provide POAs with an original benefit history document from SSA if there is a dispute regarding historical income information obtained through the computer matching program.
Regarding all the matching described in this notice, POAs will take appropriate action in consultation with tenants to: (1) Resolve income disparities between tenant-reported and SSA-reported data; and (2) Use correct income amounts in determining rental assistance.
POAs must compute the rent in full compliance with all applicable statutes, regulations and administrator policies. POAs must ensure that they use the correct income and correctly compute the rent. In order to protect any individual whose records are used in this matching program, POAs may not suspend, terminate, reduce, or make a final denial of any rental assistance to any tenant, or take other adverse action against the tenant as a result of information produced by this matching program until: (a) The tenant has received notice from the POA of its findings and has been informed of the opportunity to contest such findings; (b) The POA has independently verified the information; and (c) either the notice period provided in applicable regulations of the program, or 30 days, whichever is later, has expired. “Independently verified” in item (b) means the specific information relating to the tenant that is used as a basis for an adverse action has been investigated and confirmed by the POA. (5 U.S.C. 552a) As such, POAs must resolve income discrepancies in consultation with tenants. Additionally, serious violations, which POAs, HUD Program staff, or the HUD OIG verify, should be referred for full investigation and appropriate civil and/or criminal proceedings.
With respect to SSA-provided error messages regarding HUD-provided tenant, and matched borrower or co-borrower personal identifiers, the POA and FHA administrator/agent will confirm its file and system documentation to confirm accuracy of data elements, and make any necessary corrections. If there is no error in the documentation, the POAs and FHA administrators/agents will notify the individual of the error and request that the individual contact the SSA to correct any SSA data errors. POAs and FHA administrators/agents cannot correct such errors.
SSA will conduct the matching of tenant SSNs and additional identifiers (surnames and dates of birth) to tenant data that HUD supplies from its systems of records known as the
SSA will match the tenant records included in HUD/H-11 and HUD/PIH-4 to their systems of records known as SSA's
HUD data will also be matched to the
The computer matching program will be conducted according to the computer matching agreement between HUD and the SSA. The computer matching agreement for the planned matches will terminate either when the purpose of the computer matching program is accomplished, or 18 months from the date the original agreement was signed, whichever comes first. The agreement may be extended for one 12-month period, with the mutual agreement of all involved parties, if the following conditions are met:
(1) Within three months of the expiration date, all Data Integrity Boards review the agreement, find that the program will be conducted without change, and find a continued favorable examination of benefit/cost results; and (2) All parties certify that the program has been conducted in compliance with the agreement.
The agreement may be terminated, prior to accomplishment of the computer matching purpose or 18 months from the date the agreement is signed (whichever comes first), by the mutual agreement of all involved parties within 30 days of written notice.
Bureau of Indian Affairs, Interior.
Notice of submission to the Office of Management and Budget.
As required by the Paperwork Reduction Act, the Office of Indian Energy and Economic Development (IEED), in the Office of the Assistant Secretary—Indian Affairs, is submitting the information collection titled “Tribal Energy Resource Agreements (TERAs)” to the Office of Management and Budget (OMB) for renewal. The information collection is currently authorized by OMB Control Number 1076-0167, which expires March 31, 2010. The information collection requires Indian tribes interested in entering into a TERA or who already have a TERA to provide certain information, including information as part of the application for, and implementation, reassumption, and rescission of the TERA.
Interested persons are invited to submit comments on or before April 30, 2010.
You may submit comments on the information collection to the Desk Officer for Department of the Interior at the Office of Management and Budget, by facsimile to (202) 395-5806 or you may send an e-mail to:
Darryl Francois, Department of the Interior, Office of Indian Energy and Economic Development, Room 20—South Interior Building, 1951 Constitution Avenue, NW., Washington, DC 20245, fax (202) 208-4564;
The Energy Policy Act of 2005 (Pub. L. 109-58) authorizes the Secretary to approve individual TERAs. The intent of these agreements is to promote tribal oversight and management of energy and mineral resource development on tribal lands and further the goal of Indian self-determination. A TERA offers a tribe an alternative for developing energy-related business agreements and awarding leases and granting rights-of-way for energy facilities without having to obtain further approval from the Secretary.
This information collection conducted under TERA regulations at 25 CFR part 224 will allow IEED to determine the capacity of tribes to manage the development of energy resources on tribal lands. Information collected:
• Enables IEED to engage in a consultation process with tribes that is designed to foster optimal pre-planning of development proposals and speed up the review and approval process for TERA agreements;
• Provides wide public notice and opportunity for review of TERA agreements by the public, industry, and government agencies;
• Ensures that the public has an avenue for review of the performance of tribes in implementing a TERA;
• Creates a process for preventing damage to sensitive resources as well as ensuring that the public has fully communicated with the tribe in the petition process;
• Ensures that a tribe is fully aware of any attempt by the Department of the Interior to resume management authority over energy resources on tribal lands; and
• Ensures that the tribal government fully endorses any relinquishment of a TERA.
IEED requests that you send your comments on this collection to the location listed in the
Please note that an agency may not sponsor or conduct, and an individual need not respond to, a collection of information unless it has a valid OMB Control Number. Response to the information collection is required to obtain a benefit.
It is our policy to make all comments available to the public for review at the following location, during the hours of 9 a.m.-5 p.m., Eastern Daylight Savings Time, Monday through Friday except for legal holidays: Department of the Interior, Office of Indian Energy and Economic Development, Room 20—South Interior Building, 1951 Constitution Avenue, NW., Washington, DC 20245. Before including your address, phone number, e-mail address or other personally identifiable information, be advised that your entire comment—including your personally identifiable information—may be made public at any time. While you may request that we withhold your personally identifiable information, we cannot guarantee that we will be able to do so.
OMB has up to 60 days to make a decision on the submission for renewal, but may make the decision after 30 days. Therefore, to receive the best consideration of your comments, you should submit them closer to 30 days than 60 days.
Bureau of Indian Affairs, Interior.
Notice of submission to the Office of Management and Budget.
As required by the Paperwork Reduction Act, the Bureau of Indian Affairs (BIA) is submitting the information collection, titled “Navajo Partitioned Lands Grazing Permits, 25 CFR 161” to the Office of Management and Budget (OMB) for renewal. The information collection is currently authorized by OMB Control Number 1076-0162, which expires March 31, 2010. The information collection requires the Navajo Nation, members of the Navajo Nation, and tribal organizations authorized by the Navajo Nation to submit certain information in order to obtain, modify, or assign a grazing permit.
Interested persons are invited to submit comments on or before April 30, 2010.
You may submit comments on the information collection to the Desk Officer for Department of the Interior at the Office of Management and Budget, by facsimile to (202) 395-5806 or you may send an e-mail to:
You may request further information or obtain copies of the information collection request submission from David Edington,
The BIA is seeking renewal of the approval for the information collection conducted under 25 CFR part 161, implementing the Navajo-Hopi Settlement Act of 1974, 24 U.S.C. 640d-6402-31, as amended by the Navajo-Hopi Indian Relocation Amendments Acts of 1980, 94 Stat. 929, and the Federal court decisions of
This information collection allows BIA to receive the information necessary to determine whether an applicant to obtain, modify, or assign a grazing permit on Navajo-partitioned lands is eligible and complies with all applicable grazing requirements. No third party notification or public disclosure burden is associated with this collection.
The BIA requests that you send your comments on this collection to the locations listed in the
Please note that an agency may not sponsor or conduct, and an individual need not respond to, a collection of information unless it has a valid OMB Control Number.
It is our policy to make all comments available to the public for review at the location listed in the
OMB has up to 60 days to make a decision on the submission for renewal, but may make the decision after 30 days. Therefore, to receive the best consideration of your comments, you should submit them closer to 30 days than 60 days.
As required under 5 CFR 1320.8(d), a
National Park Service, Interior.
Notice.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects in the possession of the Museum of Cultural and Natural History, Central Michigan University, Mt. Pleasant, MI. The human remains and associated funerary objects were removed from Arenac, Isabella, and Saginaw Counties, MI.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Museum of Cultural and Natural History professional staff and physical anthropologists from Western Michigan University, Kalamazoo, MI, and the University of Western Ontario, Canada, and in consultation with representatives of the Little Traverse Bay Bands of
In 1970, human remains representing a minimum of two individuals were removed from Point Lookout, 20AC18, in Arenac County, MI. Students from Central Michigan University and amateur archeologists excavated the site and the material was immediately turned over to the Museum of Cultural and Natural History. No known individuals were identified. The 11 associated funerary objects are 2 (reconstructed) ceramic vessels, 1 piece of worked bone, 1 small sheet of copper, 1 bag of ochre sand, 1 stone object, 1 bag of ceramic sherds, 1 group of copper beads and bead fragments, 1 stone tool, 1 bone needle, and 1 tooth from an unknown animal.
Archeological evidence dates the material from the Early Late Woodland Era, and the determination is supported by publications of the State Archaeologist's Office of Michigan. The human remains were identified as being of Native American ancestry based on archeological dating and osteological examination.
In 1970-1971, human remains representing a minimum of 18 individuals were removed from Indian Mound Park, 20IB1, in Isabella County, MI. Faculty and students from Central Michigan University excavated the site and the material was immediately turned over to the Museum of Cultural and Natural History. No known individuals were identified. The five associated funerary objects are one celt, one projectile point, and three ceramic sherds.
Archeological evidence dates the material from the Early Late Woodland Era, and the determination is supported by publications of the State Archaeologist's Office of Michigan. The human remains were identified as being of Native American ancestry based on archeological dating and osteological examination.
From 1968 to 1970, and in 1972, human remains representing a minimum 124 individuals were removed from the Frazier-Tyra site, 20SA9, in Saginaw County, MI. Amateur archeologists excavated the site from 1968 to 1970, and turned over the material to the Anthropology Department of Central Michigan University, which transferred it to the Museum of Cultural and Natural History in the early 1990s. Students from Central Michigan University excavated the site again in 1972, and immediately turned over the materials they found to the Museum of Cultural and Natural History. No known individuals were identified. The 372 associated funerary objects are 285 ceramic sherds, 76 pieces of lithic debitage, 4 scrapers, 1 piece of copper, 1 abrading stone, 1 projectile point, 1 piece of conch, 1 bag of ochre, 1 pipe and 1 pipe fragment.
Archeological evidence dates the material from the Early Late Woodland Era, and the determination is supported by publications of the State Archaeologist's Office of Michigan. The human remains were identified as being of Native American ancestry based on archeological dating and osteological examination.
The area of Arenac, Isabella, and Saginaw Counties in mid-Michigan has a long established history of Native American occupation before European encroachment in the early 17th century. The Anishnaabek, which is comprised of the Odawa/Ottawa, Ojibwe/Chippewa and Potawatomi, have long called this area home. Officials of the Museum of Cultural and Natural History have reasonably determined that the individuals described above from Arenac, Isabella, and Saginaw Counties are Native American, however, officials of the Museum of Cultural and Natural History have determined that the evidence is insufficient to determine cultural affiliation with any present-day Indian tribe.
Officials of the Museum of Cultural and Natural History have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of 144 individuals of Native American ancestry. Officials of the Museum of Cultural and Natural History also have determined that, pursuant to 25 U.S.C. 3001 (3)(A), the 388 objects described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony. Lastly, officials of the Museum of Cultural and Natural History have determined that, pursuant to 25 U.S.C. 3001 (2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and associated funerary objects and any present-day Indian tribe.
The Native American Graves Protection and Repatriation Review Committee (Review Committee) is responsible for recommending specific actions for disposition of culturally unidentifiable human remains. In February 2009, the Museum of Cultural and Natural History requested that the Review Committee recommend disposition of the 144 culturally unidentifiable human remains and associated funerary objects to the Little Traverse Bay Bands of Odawa Indians, Michigan, and the Saginaw Tribe of Chippewa Indians of Michigan, as the aboriginal occupants of the lands encompassing the present-day Arenac, Isabella, and Saginaw Counties, MI. The Review Committee considered the proposal at its May 23 - 24, 2009 meeting and recommended disposition of the human remains and associated funerary objects to the Little Traverse Bay Bands of Odawa Indians, Michigan, and the Saginaw Tribe of Chippewa Indians of Michigan. A September 16, 2009, letter on behalf of the Secretary of Interior from the Designated Federal Official transmitted the authorization for the museum to effect disposition of the culturally unidentifiable human remains and associated funerary objects to the two Indian tribes listed above contingent on the publication of a Notice of Inventory Completion in the
Representatives of any other Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects should contact Dr. Pamela Gates, NAGPRA Representative, Museum of Cultural and Natural History, 103 Rowe Hall, Central Michigan University, Mt. Pleasant, MI 48859, telephone (989) 774-3341, before April 30, 2010. Disposition of the human remains and associated funerary objects to the Little Traverse Bay Bands of Odawa Indians, Michigan, and the Saginaw Tribe of Chippewa Indians of Michigan may proceed after that date if no additional claimants come forward.
The Museum of Cultural and Natural History is responsible for notifying the Little Traverse Bay Bands of Odawa Indians, Michigan, and the Saginaw Tribe of Chippewa Indians of Michigan that this notice has been published.
Notice is hereby given that on March 1, 2010, a proposed Consent Decree in the case of
The United States and the Coeur d'Alene Tribe (“Tribe”) filed a complaint against Sidney Resources Corp. (“Sidney”) alleging that Sidney is liable pursuant to Section 107(a) of CERCLA for response costs and natural resources damages in connection with Operable Unit Three of the Bunker Hill Mining and Metallurgical Complex Superfund Site in northern Idaho. The U.S. Environmental Protection Agency has incurred response costs and the U.S. Department of the Interior, U.S. Department of Agriculture and the Tribe are trustees of injured natural resources for the Site. The proposed Consent Decree is based on a financial analysis that Sidney has no ability to pay. Sidney does not currently own property within the Site. The Decree requires Sidney to assign its interests in insurance policies to a trust, for the benefit of EPA and the natural resource trustees. The Decree grants Sidney a covenant not to sue for response costs and natural resource damages in connection with the Site.
For thirty (30) days after the date of this publication, the Department of Justice will receive comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to
During the comment period, the Consent Decree may be examined on the following Department of Justice Web site:
Pursuant to Department of Justice policy, notice is hereby given that, on March 26, 2010, a proposed First Material Modification to Consent Decree (“First Decree Modification”) in
The Department of Justice will receive comments relating to the First Decree Modification for a period of thirty (30) days from the date of this publication. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and mailed either electronically to
The First Decree Modification may be examined at: (1) The offices of the United States Attorney, 10 West Market Street, Suite 2100, Indianapolis, Indiana; and (2) the offices of the U.S. Environmental Protection Agency, 77 West Jackson Boulevard, 14th Floor, Chicago, Illinois. During the public comment period, the First Decree Modification may also be examined on the following Department of Justice Web site:
Coordinating Council on Juvenile Justice and Delinquency Prevention.
Notice of meeting.
The Coordinating Council on Juvenile Justice and Delinquency Prevention (Council) announces its April 2010 meeting.
Friday, April 16, 2010 from 11 a.m. to 12:30 p.m.
The meeting will take place in the third floor main conference room at the U.S. Department of Justice, Office of Justice Programs, 810 7th St. NW., Washington, DC 20531.
Visit the Web site for the Coordinating Council at
The Coordinating Council on Juvenile Justice and Delinquency Prevention, established pursuant to Section 3(2)A of the Federal Advisory Committee Act (5 U.S.C. App. 2) will meet to carry out its advisory functions under Section 206 of the Juvenile Justice and Delinquency Prevention Act of 2002, 42 U.S.C. 5601,
Although designated agency representatives may attend, the Council membership is composed of the Attorney General (Chair), the Administrator of the Office of Juvenile Justice and Delinquency Prevention (Vice Chair), the Secretary of Health and Human Services (HHS), the Secretary of Labor, the Secretary of Education, the Secretary of Housing and Urban Development, the Director of the Office of National Drug Control Policy, the Chief Executive Officer of the Corporation for National and Community Service, and the Assistant Secretary of Homeland Security for U.S. Immigration and Customs Enforcement. Up to nine additional members are appointed by the Speaker of the House of Representatives, the Senate Majority Leader, and the President of the United States. Other federal agencies take part in Council activities including the Departments of Agriculture, Defense, the Interior, and the Substance Abuse and Mental Health Services Administration of HHS.
The agenda for this meeting will include: (a) Reports from the Council's Operations Committee and Issue Team; (b) presentations on juvenile information systems work and children's exposure to violence and c) update on and discussion of reconstruction of the Juvenile Justice system in New Orleans.
For security purposes, members of the public who wish to attend the meeting must pre-register online at
Photo identification will be required for admission to the meeting.
Notice is hereby given that, on February 25, 2010, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and the participants intend to file additional written notifications disclosing all changes in membership.
On September 10, 2007, Cooperative Research Group on Integrated Investigation of Faulting in Carbonate Strata filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
Notice is hereby given that, on February 18, 2010, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Pursuant to Section 6(b) of the Act, the identities of the parties to the venture are: Konarka Technologies, Inc., Lowell, MA; and Cambridge Major Laboratories, Inc., Germantown, WI. The general area of Cambridge and Konarka 00-00-7749's planned activity is to
Mine Safety and Health Administration (MSHA), Labor.
Notice of affirmative decisions on petitions for modification granted in whole or in part.
The Mine Safety and Health Administration (MSHA) enforces mine operator compliance with mandatory safety and health standards that protect miners and improve safety and health conditions in U.S. mines. This
Copies of the final decisions are posted on MSHA's Web Site at
Roslyn B. Fontaine, Acting Deputy Director, Office of Standards, Regulations and Variances at 202-693-9475 (Voice),
Under section 101 of the Federal Mine Safety and Health Act of 1977, a mine operator may petition and the Secretary of Labor (Secretary) may modify the application of a mandatory safety standard to that mine if the Secretary determines that: (1) An alternative method exists that will guarantee no less protection for the miners affected than that provided by the standard; or (2) that the application of the standard will result in a diminution of safety to the affected miners.
MSHA bases the final decision on the petitioner's statements, any comments and information submitted by interested persons, and a field investigation of the conditions at the mine. In some instances, MSHA may approve a petition for modification on the condition that the mine operator complies with other requirements noted in the decision.
On the basis of the findings of MSHA's investigation, and as designee of the Secretary, MSHA has granted or partially granted the following petitions for modification:
•
•
•
•
•
Employment and Training Administration, Labor.
Notice.
This Notice announces allotments for PY 2010 for WIA Title I Youth, Adults and Dislocated Worker Activities programs; final allotments for Employment Service (ES) activities under the Wagner-Peyser Act for PY 2010 and Workforce Information Grants allotments for PY 2010. Allotments for the Work Opportunity Tax Credits will be announced separately.
The WIA allotments for States and the State final allotments for the Wagner-Peyser Act are based on formulas defined in their respective statutes. The WIA allotments for the outlying areas are based on a formula determined by the Secretary. As required by WIA section 182(d), on February 17, 2000, a Notice of the discretionary formula for allocating PY 2000 funds for the outlying areas (American Samoa, Guam, Marshall Islands, Micronesia, Northern Marianas, Palau, and the Virgin Islands) was published in the
Comments on the formula used to allot funds to the outlying areas must be received by April 30, 2010.
Submit written comments to the Employment and Training Administration, Office of Financial and Administrative Management, 200 Constitution Ave., NW., Room N-4702, Washington, DC 20210, Attention: Mr. Kenneth Leung, (202) 693-3471 (phone), (202) 693-2859 (fax), e-mail:
WIA Youth Activities allotments—Evan Rosenberg at (202) 693-3593 or LaSharn Youngblood at (202) 693-3606; WIA Adult and Dislocated Worker Activities and ES final allotments—Mike Qualter at (202) 693-3014; Workforce Information Grant allotments—Anthony Dais at (202) 693-2784.
The Department of Labor (DOL or Department) is announcing WIA allotments for PY 2010 for Youth Activities, Adults and Dislocated Worker Activities, and Wagner-Peyser Act PY 2010 final allotments. This notice provides information on the amount of funds available during PY 2010 to States with an approved WIA Title I and Wagner-Peyser Act Strategic Plan for PY 2010, and information regarding allotments to the outlying areas.
The allotments are based on the funds appropriated in the Consolidated Appropriations Act, 2010, Public Law 111-117, December 16, 2009. Included below are tables listing the PY 2010 allotments for programs under WIA Title I Youth Activities (Table I), Adult and Dislocated Workers Employment and Training Activities (Tables II and III, respectively), and the PY 2010 Wagner-Peyser Act final allotments (Table IV). Also attached is the PY 2010 Workforce Information Grant table (Table V).
The Department of Education's appropriations now include funding for these supplemental grants; therefore, WIA Title I funds are no longer being provided for these two areas. The Compact, as amended by Section 309 of Division D of Public Law 111-117, the Consolidated Appropriations Act, 2010 (in the Department of Education's General Provisions), extends the availability of programs previously available to Palau through September 2010, including WIA Title I funding provisions.
The methodology for distributing funds to all outlying areas is not specified by WIA, but is at the Secretary's discretion. The methodology used is the same as used since PY 2000, i.e., funds are distributed among the remaining areas by formula based on relative share of number of unemployed, a 90 percent hold-harmless of the prior year share, a $75,000 minimum, and a 130 percent stop-gain of the prior year share. As in PY 2009, data for the relative share calculation in the PY 2010 formula were from 2000 Census data for all outlying areas, obtained from the Bureau of the Census (Bureau) and are based on 2000 Census surveys for those areas conducted either by the Bureau or the outlying areas under the guidance of the Bureau. The total amount available for Native Americans is 1.5 percent of the total amount for Youth Activities, in accordance with WIA section 127. After determining the amount for the outlying areas and Native Americans, the amount available for allotment to the States for PY 2010 is $907,897,792. This total amount was below the required $1 billion threshold specified in section 127(b)(1)(C)(iv)(IV); therefore, as in PY 2009, the WIA additional minimum provisions were not applied, and, instead, as required by WIA, the Job Training Partnership Act (JTPA) section 202(a)(3) (as amended by section 701 of the Job Training Reform Amendments of 1992) minimums of 90 percent hold-harmless of the prior year allotment percentage and 0.25 percent State minimum floor were used. Also, as required by WIA, the provision applying a 130 percent stop-gain of the prior year allotment percentage was used. The three formula factors required in WIA use the following data for the PY 2010 allotments:
(1) Number of unemployed for Areas of Substantial Unemployment (ASUs), averages for the 12-month period, July 2008 through June 2009;
(2) Number of excess unemployed individuals or the ASU excess (depending on which is higher), averages for the same 12-month period used for ASU unemployed data; and
(3) Number of economically disadvantaged youth (age 16 to 21, excluding college students and military), from special 2000 Census calculations.
As done beginning with the PY 2006 allotments, the ASU data for the PY 2010 allotments was identified by the States using special 2000 Census data based on households, obtained under Employment and Training Administration contract with the Census Bureau and provided to States by the Bureau of Labor Statistics.
(1) Number of unemployed, averages for the 12-month period, October 2008 through September 2009;
(2) Number of excess unemployed, averages for the 12-month period, October 2008 through September 2009; and
(3) Number of long-term unemployed, averages for the 12-month period, October 2008 through September 2009.
Since the Dislocated Worker Activities formula has no floor amount or hold-harmless provisions, funding changes for States directly reflect the impact of changes in the number of unemployed.
Under section 7 of the Wagner-Peyser Act, 10 percent of the total sums allotted to each State shall be reserved for use by the Governor to provide performance incentives for ES offices, services for groups with special needs, and for the extra costs of exemplary models for delivering job services.
Mine Safety and Health Administration (MSHA), Labor.
Notice of petitions for modification of existing mandatory safety standards.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR Part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification filed by the parties listed below to modify the application of existing mandatory safety standards published in Title 30 of the Code of Federal Regulations.
All comments on the petitions must be received by the Office of Standards, Regulations and Variances on or before April 30, 2010.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
4.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments. Individuals who submit comments by hand-delivery are required to check in at the receptionist desk on the 21st floor.
Individuals may inspect copies of the petitions and comments during normal
Barbara Barron, Office of Standards, Regulations and Variances at 202-693-9447 (Voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary determines that: (1) An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or (2) that the application of such standard to such mine will result in a diminution of safety to the miners in such mine. In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
The Legal Services Corporation Board of Directors will meet on April 7, 2010 at 12 p.m., Eastern Time.
Legal Services Corporation, 3333 K Street, NW., Washington, DC 20007, 3rd Floor Conference Center.
For all meetings and portions thereof open to public observation, members of the public who are unable to attend but wish to listen to the proceedings may do so by following the telephone call-in directions given below. You are asked to keep your telephone muted to eliminate background noises. From time to time the Chairman may solicit comments from the public.
• Call toll-free number: 1-(866) 451-4981;
• When prompted, enter the following numeric pass code: 5907707348;
• When connected to the call, please “MUTE” your telephone immediately.
1. Approval of agenda;
2. Consider and act on nominations for the Chairman of the Board of Directors;
3. Consider and act on nominations for the Vice Chairman of the Board of Directors;
4. Consider and act on delegation to Chairman of authority to make Committee assignments;
5. Public comment;
6. Consider and act on other business;
7. Consider and act on motion to adjourn meeting.
Katherine Ward, Executive Assistant to the Vice President & General Counsel, at (202) 295-1500. Questions may be sent by electronic mail to
Upon request, meeting notices will be made available in alternate formats to accommodate visual and hearing impairments. Individuals who have a disability and need an accommodation to attend the meeting may notify Katherine Ward, at (202) 295-1500 or
Office of Management and Budget, Office of Federal Procurement Policy.
Notice of proposed policy letter.
The Office of Federal Procurement Policy (OFPP) in the Office of Management and Budget (OMB) is issuing a proposed policy letter to provide guidance to Executive Departments and agencies on circumstances when work must be reserved for performance by Federal government employees. The Presidential Memorandum on Government Contracting, issued on March 4, 2009, directs OMB to clarify when governmental outsourcing of services is, and is not, appropriate, consistent with section 321 of the National Defense Authorization Act (NDAA) for FY 2009. Section 321 requires OMB to (i) create a single definition for the term “inherently governmental function” that addresses any deficiencies in the existing definitions and reasonably applies to all agencies; (ii) establish criteria to be used by agencies to identify “critical” functions and positions that should only be performed by federal employees; and (iii) provide guidance to improve internal agency management of functions that are inherently governmental or critical. The Presidential Memorandum is available at
Memorandum-for-the-Heads-of-Executive-Departments-and-Agencies-Subject-Government/.
Section 321 may be found at
Comments may be submitted by any of the following methods:
•
•
•
Mathew Blum, OFPP, (202) 395-4953 or
OFPP is issuing a proposed policy letter to provide guidance addressing when work must be reserved for performance by federal employees. The policy letter is intended to implement direction in the President's March 4, 2009,
•
•
•
After public comment is considered and the policy letter is finalized, appropriate changes will be made to the Federal Acquisition Regulation (FAR).
The Presidential Memorandum on Government Contracting requires the Director of OMB to develop guidance addressing when governmental outsourcing of services is, and is not, appropriate. The Memorandum states that the line between inherently governmental activities that should not be outsourced and commercial activities that may be subject to private-sector performance has become blurred, which may have led to the performance of inherently governmental functions by contractors and, more generally, an overreliance on contractors by the government. It directs OMB to clarify when outsourcing is, and is not, appropriate, consistent with section 321 of the NDAA for FY 2009.
Section 321 directed OMB to: (1) Create a single, consistent definition for the term “inherently governmental function” that addresses any deficiencies in the existing definitions and reasonably applies to all agencies; (2) develop criteria for identifying critical functions with respect to the agency's missions and structure; (3) develop criteria for determining positions dedicated to critical functions which should be reserved for federal employees to ensure the department or agency maintains control of its mission and operations; (4) provide criteria for identifying agency personnel with responsibility for (a) maintaining sufficient organic expertise and technical capability within the agency, and (b) issuing guidance for internal activities associated with determining when work is to be reserved for performance by Federal employees; and (5) solicit the views of the public regarding these matters.
OMB's OFPP reviewed current laws, regulations, policies, and reports addressing the definition of inherently governmental functions and the reservation of work for government employees. The review was conducted with the assistance of an interagency team that included representatives from the Chief Acquisition Officers Council and the Chief Human Capital Officers Council. As part of this effort, OFPP reviewed the definition of inherently governmental functions in the Federal Activities Inventory Reform Act (FAIR Act), Public Law 105-270, section 2383 of title 10 (which cites to definitions in the Federal Acquisition Regulation (FAR)), the FAR, OMB Circular A-76, OFPP Policy Letter 92-1,
To supplement this review, OMB held a public meeting and solicited comments from the public last spring and summer to inform the development of guidance. Comments were specifically sought regarding the definition of inherently governmental functions and criteria for identifying critical functions. See 74 FR 25775 (May 29, 2009) for a copy of the notice. OMB received 11 comments addressing these issues. For a copy of public comments, go to
Respondents generally favored the definition of “inherently governmental function” found in the FAIR Act. Some concern was raised regarding changes made to the definition by OMB Circular A-76 when the Circular was revised in 2003.
Some respondents recommended that the criteria OMB develops to identify critical functions and positions reserved for federal employees be tied to mission performance. Some cautioned that these criteria should also guard against the contracting out of a function if such action poses too great a risk of creating a single point of mission failure. However, at least one commenter expressed the view that, as long as the overall function is managed by a federal employee, not every position performing a critical function needs to be performed by federal employees in order to protect the government's interest and prevent mission failure. Another commenter stated that tasks closely associated with governmental decision-making should not be contracted out unless the government can effectively guard against or otherwise mitigate conflicts of interest.
Based on this review and consideration of the public comments, OFPP has: (1) Developed a proposed policy letter and (2) formulated a list of tailored questions to elicit feedback on specific issues that will help inform its deliberations in shaping final guidance.
OFPP has developed a proposed policy letter to improve the rules addressing the proper roles of the public and private sectors in performing work for the government. The policy letter is designed to address a number of weaknesses with existing rules that are affecting the efficiency and effectiveness of government performance. These weaknesses are summarized below along with a brief description of how they would be addressed.
There are three main sources for definitions and guidance addressing inherently governmental function: (1) The FAIR Act, (2) the FAR, and (3) OMB Circular A-76.
a.
The proposed policy letter adopts the FAIR Act definition as the single, government-wide definition. This definition reflects longstanding OFPP guidance that had been set out in OFPP Policy Letter 92-1. 57 FR 45096 (September 30, 1992). Most public commenters expressed general satisfaction with the statutory definition in the FAIR Act, while also acknowledging uncertainties as to its construction and application in particular circumstances.
b.
OFPP seeks to clarify and reinforce that agencies have both pre-award and post-award responsibilities for evaluating whether a function is inherently governmental and taking steps to avoid transferring inherently governmental authority to a contractor, such as through inadequate attention to contract administration. For proposed work, a determination that the work is not inherently governmental should be made prior to issuance of the
Policy guidance addressing inherently governmental functions must also address functions closely associated with inherently governmental functions to properly ensure that work that is intimately related to the public interest is performed by Federal employees. Closely associated functions approach the status of inherently governmental work because of the nature of these functions and the risk that their performance, if not appropriately managed, may materially limit Federal officials' performance of inherently governmental functions.
The proposed policy letter retains an illustrative list of functions closely associated with inherently governmental functions from current FAR coverage. The guidance requires agencies to take a number of steps related to these functions. First, the proposed policy letter reiterates the requirement set forth in section 736 of Division D of the Omnibus Appropriations Act, 2009, Public Law 111-8, to give special consideration to reserving these functions to performance by federal employees. Second, the proposed policy letter lays out the responsibilities agencies must perform if they determine that contractor performance of a function closely associated with an inherently governmental function is appropriate. These responsibilities include pre-establishing in the contract specified ranges of acceptable decisions, subjecting the contractor's discretionary decision to final approval by an agency official, assigning a sufficient number of qualified federal employees with appropriate expertise to administer the work, and taking steps to avoid or mitigate conflicts of interest. Each of these actions is designed to help ensure that the contractor's activities do not expand to include inherently governmental responsibilities. Although these actions should currently be taken, they are not enumerated in one guidance document and often are given insufficient management attention (see paragraph 5, below, for additional discussion on new agency responsibilities for management and monitoring).
Since at least the early 1990s, government-wide policy addressing when work must be reserved for Federal employees has focused almost exclusively on the definition of “inherently governmental” functions and functions closely associated with inherently governmental functions. This narrow focus has been cited as a cause of inadequate attention to maintaining a residual Federal core capability when considering contractor performance of critical functions that are tied to an agency's mission. The Acquisition Advisory Panel, established by Congress in 2003 to review the federal acquisition system, concluded in its 2007 report that the consequences of this inattention to contractor performance of critical functions include “the loss of institutional memory, the inability to be certain whether the contractor is properly performing the specified work at a proper price and the inability to be sure that decisions are being made in the public interest rather than in the interest of the contractors performing the work.” Following the issuance of the Panel's report, Congress, in the FY 2009 NDAA, directed OMB to develop criteria for agencies to use in identifying “critical” functions and in determining when such functions, or parts thereof, must be retained for performance by federal employees.
Consistent with section 321 of the FY 2009 NDAA, the proposed policy letter provides guidance to address the handling of critical functions and the maintenance of a core capability by Federal employees. The proposed policy letter would define critical function to mean a function whose importance to the agency's mission and operation requires that at least a portion of the function must be reserved to federal employees in order to ensure the agency has sufficient internal capability to effectively perform and maintain control of its mission and operations. Agencies would be held responsible for ensuring a sufficient number of positions performing critical work are filled by federal employees with appropriate training, experience, and expertise to understand the agency's requirements, formulate alternatives, manage the work product, and manage any contractors used to support the Federal workforce. The proposed guidance would also require agencies to evaluate whether they have sufficient internal capability on a case-by-case basis, taking into account factors such as the agency's mission, the complexity of the function and need for specialized skill, and the effect of contractor default on mission performance. The proposed guidance is built around the general principle that the more critical a function is, the greater the need for internal capability to maintain control of the agency's mission and operations. This is most obviously the case where the function is critical to achievement of the agency's core mission, but even for functions that may not be viewed as critical, such as functions that are not directly involved in performing the core mission, the agency may determine that the function is, nonetheless, sensitive enough as to require that many, most, or, in some situations, all positions be filled by Federal employees.
Finally, if an agency determines that it has sufficient internal capability to control its mission and operations, the proposed policy would require the consideration of cost to establish the extent to which additional critical work is performed by Federal employees, unless performance and risk considerations in favor of Federal employee performance would clearly outweigh cost considerations.
A clear understanding of responsibilities and heightened management attention will be required to ensure that work that should be performed by Federal employees is reserved for performance by them.
The proposed policy letter lays out the determinations that must be documented by the agency head or designated requirements official before a contract solicitation is issued to show that functions to be acquired by contract are not inherently governmental. It would also require agencies to determine (also before issuing a solicitation) that they have sufficient internal capability to control their mission and operations. During contract performance, agencies would be required to (1) monitor how contractors are performing contracts, especially those involving work closely associated with inherently governmental functions or professional and technical services, and (2) take appropriate action where internal control of mission and operations is at risk due to inappropriate or excessive reliance on contractors to perform critical functions.
Finally, the proposed policy letter would require agencies to strengthen internal agency management. Each agency with 100 or more full-time federal employees in the prior fiscal year would be required to identify one
OFPP welcomes comments on the proposed policy letter. Respondents are also encouraged to offer their views on the following questions, many of which are designed to help elicit feedback on specific aspects of the draft guidance.
a. If the FAIR Act definition of “inherently governmental” is adopted, what additional definitional clarification is needed, if any?
b. What additional guidance should be provided to make clear that identifying “critical” work is driven by mission and circumstance, which will differ between agencies and within agencies over time? Is there a term other than “critical” that might be used to more clearly convey this principle?
c. What, if any, additional guidance should be provided to address what is meant by the term “public interest”?
a. Does the “discretion” test (which is derived from OMB Circular A-76, Attachment A and, before that, OFPP Policy Letter 92-1) help or hinder identification of inherently governmental functions? How might the language in the proposed policy letter be improved to make it more useful?
b. Does the proposed “nature of the function” test help in the identification of inherently governmental functions? How might the coverage of this test in the proposed policy letter be improved to make it more useful?
c. Should consideration be given to establishing a “principal-agent” test that would require agencies to identify functions as inherently governmental where serious risks could be created by the performance of these functions by those outside government, because of the difficulty of ensuring sufficient control over such performance?
d. What, if any, additional guidance might help agencies differentiate between circumstances where contractors are being used appropriately to inform government officials and those where contractors are limiting or constraining government exercise of inherently governmental responsibilities?
e. What, if any, changes should be made to existing laws that currently deem specific functions or the work performed by specific organizations to be inherently governmental?
a. Should the policy letter set out a presumption, or a requirement, in favor of performance of “closely associated” and/or critical functions by federal employees?
b. What, if any, additional guidance may help agencies differentiate between critical functions and functions that are closely associated with the performance of inherently governmental functions?
c. Should these categories be merged and treated in identical fashion? Why or why not?
d. What, if any, additional guidance might be provided to help agencies identify the extent to which a critical function may be performed by a contractor?
e. Should the policy clarify whether determinations regarding criticality are to be made at the departmental or component level?
a. What, if any, additional guidance may help agencies differentiate between functions that are critical and those that are not?
b. Should guidance allow agency heads to identify categories of service contracts that may be presumed to be non-critical? Why or why not?
a. What functions, in particular, are the most difficult to properly classify as inherently governmental, closely associated with inherently governmental, critical, or non-critical—and why? What specific steps should be taken to address this challenge?
b. What should guidance say—in place of, or in addition to, the draft guidance or currently existing federal regulations or policies—to address the use (if any) of contractors performing any of the following functions?
i. Pre-award acquisition support, such as acquisition planning, market research, development of independent government cost estimates, and preparation of documentation in support of contract award, including preparation of: price negotiation memoranda and price reasonableness determinations, technical evaluations, determinations of responsibility, determinations and findings, and justifications;
ii. Post-award acquisition support, such as functions involving the use of contractors to manage other contractors, the development of contractor performance assessments, review of contract claims, and the preparation of termination settlement proposals;
iii. Procurement management reviews;
iv. Management of Federal grantees;
v. Strategic planning;
vi. Lead systems integration;
vii. Physical security involving:
A. Guard services, convoy security services, pass and identification services, plant protection services, the operation of prison or detention facilities;
B. Security services other than those described in A; or
C. The use of deadly force, including combat, security operations performed in direct support of combat, and security that could evolve into combat;
viii. Cyber security, including IT network security;
ix. Support for intelligence activities, such as covert operations;
x. The assistance, reinforcement or rescue of individuals who become engaged in hostilities or offensive responses to hostile acts or demonstrated hostile intentions; and
xi. Intelligence interrogation of detainees, including interrogations in connection with hostilities.
c. Should the guidance provide an illustrative list of functions that are presumed to be critical? Why or why not? If so, what functions should be included on the list?
a. How, if at all, should this guidance address the problem of limitations on the number of authorized Federal positions and the impact of such limitations on decisions about reserving work for Federal employees?
b. How, if at all, should this guidance address the potential nexus between decisions regarding reserving work for Federal employees and the unavailability of certain capabilities and expertise among Federal employees (e.g., “hard to fill” labor categories), and the impact of Federal salary limits on hiring people with those capabilities and expertise?
c. Should the guidance address when it is appropriate to temporarily contract for performance of work that is generally reserved for Federal employees?
d. How, if at all, should this guidance address situations where there is no basis to reserve work for Federal
e. What, if any, additional guidance might be provided to help an agency analyze whether it has the best mix of private and public sector labor? Are there benchmarks that exist to help agencies make this determination? Can the concept of “overreliance” be effectively understood without also providing guidance on “underreliance”? Why or why not?
a. How, if at all, should the draft guidance address advisory and assistance services? What, if any, changes should be considered to FAR Subpart 37.2 to improve how agencies draw upon the skills of the public and private sectors?
b. How, if at all, should the draft guidance address personal services contracting? What, if any, changes should be considered to FAR Subpart 37.104 to improve how agencies draw upon the skills of the public and private sectors?
c. What additional guidance, if any, would be beneficial to improve understanding and implementation of policies addressing functions that must be reserved for performance by Federal employees?
d. What additional guidance, if any, would be beneficial to improve understanding and implementation of policies addressing functions that may be performed by contractors?
Is an OFPP policy letter an effective vehicle to serve as the main document for consolidated policy guidance on the subject of work reserved for Federal employees and maintaining certain critical capability levels in-house? Does it effectively address the affected stakeholder communities? If not, which communities are not properly addressed and what form should the guidance take and why?
a. What best practices (e.g., flowcharts, decision trees, checklists, handbooks) exist to help agencies identify which functions should be reserved for performance by Federal employees?
b. What questions arise most frequently that might be suitably addressed in a question and answer format? Examples of questions might include the following:
• What steps should contractor employees be required to take when working on a government site to ensure their status is clearly understood?
• Under what, if any, circumstances may a contractor attend a policy-making meeting?
• Under what, if any, circumstances may a contractor represent an agency at a policy-making meeting?
What, if any, additional guidance should be provided to ensure the policies and practices discussed in the draft guidance are given appropriate management attention?
a. What is the best way to optimize the value of Federal employee inventories that agencies prepare under the FAIR Act and OMB Circular A-76 to support policies for identifying work to be reserved for performance by Federal employees?
b. What is the best way to optimize the value of the contractor employee inventory required by section 743 of Division C of the FY 2010 Consolidated Appropriations Act, Public Law 111-117 (for civilian agencies) and section 807 of the National Defense Authorization Act for FY 2008, Public Law 110-181 (for defense agencies), to support policies for identifying work to be reserved for performance by Federal employees and those that may continue to be performed by contractors?
1. Purpose. This guidance establishes Executive Branch policy addressing when work must be reserved for performance by federal employees. The policy is intended to assist agency officers and employees in ensuring that only federal employees perform work that is inherently governmental or otherwise needs to be reserved to the public sector.
Nothing in this guidance is intended to discourage the appropriate use of contractors. Contractors can provide expertise, innovation, and cost-effective support to federal agencies for a wide range of services. Reliance on contractors is not, by itself, a cause for concern, provided that the work that they perform is not work that should be reserved for federal employees and that federal officials are appropriately managing contractor performance.
2. Authority. This policy letter is issued pursuant to section 6(a) of the Office of Federal Procurement Policy Act, 41 U.S.C. 405(a), the President's March 4, 2009,
3. Definitions.
“
(a) The term includes functions that require either the exercise of discretion in applying Federal Government authority or the making of value judgments in making decisions for the Federal Government, including judgments relating to monetary transactions and entitlements. An inherently governmental function involves, among other things, the interpretation and execution of the laws of the United States so as—
(1) To bind the United States to take or not to take some action by contract, policy, regulation, authorization, order, or otherwise;
(2) To determine, protect, and advance United States economic, political, territorial, property, or other interests by military or diplomatic action, civil or criminal judicial proceedings, contract management, or otherwise;
(3) To significantly affect the life, liberty, or property of private persons;
(4) To commission, appoint, direct, or control officers or employees of the United States; or
(5) To exert ultimate control over the acquisition, use, or disposition of the property, real or personal, tangible or intangible, of the United States, including the collection, control, or disbursement of appropriations and other Federal funds.
(b) The term does not normally include—
(1) Gathering information for or providing advice, opinions, recommendations, or ideas to Federal Government officials; or
(2) Any function that is primarily ministerial and internal in nature (such as building security, mail operations, operation of cafeterias, housekeeping, facilities operations and maintenance, warehouse operations, motor vehicle fleet management operations, or other routine electrical or mechanical services).
”
4. Policy. It is the policy of the Executive Branch to ensure that government action is taken as a result of informed, independent judgments made by government officials. Adherence to this policy will ensure that the act of governance is performed, and decisions of significant public interest are made, by officials who are ultimately accountable to the President and bound by laws controlling the conduct and performance of Federal employees that are intended to protect or
(a)
(1) Ensure that service contractors do not perform inherently governmental functions (see section 5-1);
(2) Give special consideration to federal employee performance of functions closely associated with inherently governmental functions and, when such work is performed by contractors, provide greater attention and an enhanced degree of management oversight of the contractors' activities to ensure that contractors' duties do not expand to include performance of inherently governmental functions (see section 5-2a); and
(3) Ensure that federal employees perform critical functions to the extent necessary for the agency to operate effectively and maintain control of its mission and operations (see section 5-2b).
(b)
(c)
(i) Dedicate a sufficient amount of work on critical functions to performance by federal employees in order to build competencies (both knowledge and skills), provide for continuity of operations, and retain institutional knowledge of government operations, including those unique to the agency's mission;
(ii) Ensure that sufficient personnel is available to manage and oversee the contractor's performance and evaluate and approve or disapprove the contractor's work products and services, recruiting and retaining the necessary federal talent where it is lacking; and
(iii) Consider the impact of decisions to establish a specified level of government employee authorizations (or military end strength) or available funding on the ability to use Federal employees for work that should be reserved for performance by such employees.
(2) Agencies' annual Human Capital Plan for Acquisition shall identify specific strategies and goals for addressing both the size and capability of the acquisition workforce, including program managers and contracting officer technical representatives. The number of personnel required to administer a particular contract is a management decision to be made after analysis of a number of factors. These include, among others:
(i) The scope of the activity in question;
(ii) The technical complexity of the project or its compontents;
(iii) The technical capability, numbers, and workload of federal mangement officials;
(iv) The inspection techniques available;
(v) The proven adequacy and reliability of contractor project management;
(vi) The sophistication and track record of contract administration organizations within the agency; and
(vii) The importance and criticality of the function.
5. Implementation guidelines and responsibilities. Agencies shall use the guidelines below to determine (1) whether their requirements involve the performance of inherently government functions, functions closely associated with inherently governmental functions, or critical functions; and (2) the type and level of management attention necessary to ensure that functions that should be reserved for federal performance are not materially limited by or effectively transferred to contractors. The latter determination typically requires agencies to consider the totality of circumstances surrounding how, where, and when work is to be performed.
5-1. Inherently governmental functions. Agencies shall ensure that inherently governmental functions are reserved exclusively for performance by federal employees.
(a)
(1) The nature of the function. Functions which involve the exercise of sovereign powers—that is, powers that are uniquely governmental—are inherently governmental by their very nature. Examples of functions that, by their nature, are inherently governmental are an ambassador representing the United States, a police officer arresting a person, and a judge sentencing a person convicted of a crime to prison. A function may be classified as inherently governmental based strictly on its uniquely governmental nature and without regard to the type or level of discretion associated with the function.
(2) The exercise of discretion. (i) A function requiring the exercise of discretion shall be deemed inherently governmental if the exercise of such discretion commits the government to a course of action where two or more alternative courses of action exist and decision making is not already limited or guided by existing policies, procedures, directions, orders, and other guidance that:
(A) Identify specified ranges of acceptable decisions or conduct concerning the overall policy or direction of the action; and
(B) Subject the discretionary authority to final approval or regular oversight by agency officials.
(ii) The fact that decisions are made, and discretion exercised, by a contractor in performing its duties under the contract—such as how to allocate the contractor's own or subcontract resources, what conclusions to emphasize and, unless specified in the contract, what techniques and procedures to employ, whether and whom to consult, what research alternatives to explore given the scope of the contract, or how frequently to test—is not determinative of whether the contractor is performing an inherently government function. A function involving the exercise of discretion may be appropriately performed consistent with the restrictions in this section where the contractor does not have the authority to decide on the overall course of action, but is tasked to develop options or implement a course of action, and the agency official has the ability to countervail the contractor's action. By contrast, contractor performance would be inappropriate where the contractor's involvement is or would be so extensive, or the contractor's work product so close to a final agency product, as to effectively preempt the federal officials' decision-making process, discretion or authority.
(b)
(i) The function to be contracted does not appear on the list in Appendix A;
(ii) A statute, such as an annual appropriations act, does not identify the function as inherently governmental or otherwise require it to be performed by Federal employees; and
(iii) The proposed role for the contractor is not so extensive that the ability of senior agency management to develop and consider options is or would be preempted or inappropriately restricted.
(2)
5-2. Other work that must be reserved for federal employees. In some cases, work that is not inherently governmental must also be reserved for performance by federal employees. Such reservation will be required under certain circumstances for functions that are closely associated with the performance of inherently governmental functions and critical functions.
5-2a. Functions closely associated with the performance of inherently governmental functions. Agencies shall give special consideration to federal employee performance of functions closely associated with inherently governmental functions.
(a)
(b)
(1) If the agency determines the function is closely associated with the performance of an inherently governmental function, section 736 of Division D of the Omnibus Appropriations Act, 2009, Public Law 111-8, requires civilian agencies subject to the FAIR Act to give special consideration to using federal employees to perform the function. Civilian agencies shall refer to OMB Memorandum M-09-26, Managing the Multi-Sector Workforce (July 29, 2009), Attachment 3 for criteria addressing the in-sourcing of work under Public Law 111-8. Memorandum M-09-26 explains that federal employee performance would be expected if either contractor performance causes the agency to lack sufficient internal expertise to maintain control of its mission and operations or analysis suggests that public sector performance is more cost effective and it is feasible to hire federal employees to perform the function. The OMB Memorandum is available at
(2) The Department of Defense shall—
(i) Ensure special consideration is given to federal employee performance consistent with the requirements of 10 U.S.C. 2463; and
(ii) To the maximum extent practicable, minimize reliance on contractors performing functions closely associated with inherently governmental functions consistent with 10 U.S.C. 2330a.
(c)
(1) Limit or guide a contractor's exercise of discretion and retain control of government operations by both—
(i) Pre-establishing in the contract specified ranges of acceptable decisions and/or conduct; and
(ii) Pre-establishing a process for subjecting the contractor's discretionary decisions and/or conduct to final approval by the agency official;
(2) Assign a sufficient number of qualified government employees, with expertise to administer or perform the work, to give heightened management attention to the contractor's activities, in particular, to ensure that they do not expand to include inherently governmental functions, are not performed in ways not contemplated by the contract so as to become inherently governmental, do not undermine the integrity of the government's decision-making process, and do not interfere with federal employees' performance of the closely-associated inherently governmental functions (see section 5-1(b)(2) for guidance on steps to take where a determination is made that the contract is being used to fulfill responsibilities that are inherently governmental);
(3) Ensure that a reasonable identification of contractors and contractor work products is made whenever there is a risk that Congress, the public, or other persons outside of the government might confuse contractor personnel or work products with government officials or work products, respectively; and
(4) Take appropriate steps to avoid or mitigate conflicts of interest, such as by:
(i) Conducting pre-award conflict of interest reviews, to ensure contract performance is in accordance with objective standards and contract specifications, and developing a conflict of interest mitigation plan, if needed, that identifies the conflict and specific actions that will be taken to lessen the potential for conflict of interest or reduce the risk involved with a potential conflict of interest;
(ii) Physically separating contractor personnel from government personnel at the worksite;
(iii) Ensuring contractors are clearly identified as such in work product and on work support systems, such as in electronic mail systems and phone messaging systems, and on signature blocks, security and other identification badges, and office name plates;
(iv) Having contractor personnel work off-site, if cost-effective and without derogation to the work to be performed;
(v) Excluding contractors from subsequent competitions if conflicts cannot be avoided; or
(vi) Performing work with federal employees if (A) contractor conflicts cannot be satisfactorily resolved or (B) decision-making would be at risk of being transferred to the private sector because contractors have such influence and insight into government decision making or government officials would rely too heavily on contractor inputs (or rely almost exclusively on contractor fact-finding or memory).
(5) Make a written determination concurrent with transmittal of the statement of work (or any modification thereof) to the contracting officer that
(i) The function is closely associated with an inherently governmental function;
(ii) Private sector performance of the function is appropriate and the most cost effective source of support for the agency; and
(iii) The agency has sufficient internal capability to control its missions and operations, oversee the contractor's performance of the contract, limit or guide the contractor's exercise of discretion, ensure reasonable identification of contractors and contractor work products, and avoid or mitigate conflicts of interest and unauthorized personal services.
5-2b. Critical functions. Agencies shall dedicate a sufficient number of federal employees to the performance of critical functions so that federal employees may maintain control of agencies' mission and operations.
(a)
(1) Sufficient internal capability—
(i) Generally requires that an agency have an adequate number of positions filled by federal employees with appropriate training, experience, and expertise (organic and technical) to understand the agency's requirements, formulate alternatives, take other appropriate actions to properly manage and be accountable for the work product, and continue critical operations in the event of contractor default; and
(ii) Further requires that an agency have the ability and internal expertise to manage any contractors used to support the federal workforce and evaluate their work product.
(2) Determinations concerning what constitutes sufficient internal capability must be made on a case-by-case basis taking into account, among other things:
(i) The agency's mission;
(ii) The complexity of the function and the need for specialized skill;
(iii) The current strength of the agency's in-house organic and technical expertise;
(iv) The current strength (capability and capacity) of the agency's acquisition workforce;
(v) The effect of contractor default on mission performance; and
(vi) The enforceability of criminal sanctions for crimes performed by contractors as compared to those applicable to federal employees.
(b)
(ii) If an agency has sufficient internal capability to control its mission and operations, the extent to which additional work is performed by federal employees should be determined consistent with the parameters set forth in subsection (2)(ii) below.
(2)
(ii) If an agency has sufficient internal capability to control its mission and operations, the extent to which additional work is performed by federal employees should be based on cost considerations unless performance and risk considerations in favor of federal employee performance will clearly outweigh cost considerations. Supporting cost analysis should address the full costs of government and private sector performance and provide like comparisons of costs that are of a sufficient magnitude to influence the final decision on the most cost effective source of support for the organization.
6. Additional agency responsibilities. (a)
(b)
(c)
(d)
(e)
7. Federal Acquisition Regulatory Council. Pursuant to subsections 6(a) and 25(f) of the Office of Federal Procurement Policy Act, 41 U.S.C. 405(a) and 421(f), the Federal Acquisition Regulatory Council shall ensure that the policies established herein that pertain to the acquisition of services are incorporated in the FAR in a timely manner.
8. Judicial review. This policy letter is not intended to provide a constitutional or statutory interpretation of any kind and it is not intended, and should not be construed, to create any right or benefit, substantive or procedural, enforceable at law by a party against the United States, its agencies, its officers, or any person. It is intended only to provide policy guidance to agencies in the exercise of their discretion concerning federal contracting. Thus, this policy letter is not intended, and should not be construed, to create any substantive or procedural basis on which to challenge any agency action or inaction on the ground that such action or inaction was not in accordance with this policy letter.
9. Effective date. This policy letter is effective [insert date 30 days after issuance of final policy letter]
The following is an illustrative list of functions considered to be inherently governmental.
1. The direct conduct of criminal investigation.
2. The control of prosecutions and performance of adjudicatory functions (other than those relating to arbitration or other methods of alternative dispute resolution).
3. The command of military forces, especially the leadership of military personnel who are members of the combat, combat support or combat service support role.
4. The conduct of foreign relations and the determination of foreign policy.
5. The determination of agency policy, such as determining the content and application of regulations, among other things.
6. The determination of Federal program priorities or budget requests.
7. The direction and control of Federal employees.
8. The direction and control of intelligence and counter-intelligence operations.
9. The selection or non-selection of individuals for Federal Government employment.
10. The approval of position descriptions and performance standards for Federal employees.
11. The determination of what Government property is to be disposed of and on what terms (although an agency may give contractors authority to dispose of property at prices with specified ranges and subject to other reasonable conditions deemed appropriate by the agency).
12. In Federal procurement activities with respect to prime contracts:
(a) determining what supplies or services are to be acquired by the Government (although an agency may give contractors authority to acquire supplies at prices within specified ranges and subject to other reasonable conditions deemed appropriate by the agency);
(b) participating as a voting member on any source selection boards;
(c) approval of any contractual documents, to include documents defining requirements, incentive plans, and evaluation criteria;
(d) awarding contracts;
(e) administering contracts (including ordering changes in contract performance or contract quantities, taking action based on evaluations of contractor performance, and accepting or rejecting contractor products or services);
(f) terminating contracts;
(g) determining whether contract costs are reasonable, allocable, and allowable; and
(h) participating as a voting member on performance evaluation boards.
13. The approval of agency responses to Freedom of Information Act requests (other than routine responses that, because of statute, regulation, or agency policy, do not require the exercise of judgment in determining whether documents are to be released or withheld), and the approval of agency responses to the administrative appeals of denials of Freedom of Information Act requests.
14. The conduct of administrative hearings to determine the eligibility of any person for a security clearance, or involving actions that affect matters of personal reputation or eligibility to participate in government programs.
15. The approval of federal licensing actions and inspections.
16. The determination of budget policy, guidance, and strategy.
17. The collection, control, and disbursement of fees, royalties, duties, fines, taxes and other public funds, unless authorized by statute, such as title 31 U.S.C. 952 (relating to private collection contractors) and title 31 U.S.C. 3718 (relating to private attorney collection services), but not including:
(a) collection of fees, fines, penalties, costs or other charges from visitors to or patrons of mess halls, post or base exchange concessions, national parks, and similar entities or activities, or from other persons, where the amount to be collected is easily calculated or predetermined and the funds collected can be easily controlled using standard cash management techniques, and
(b) routine voucher and invoice examination.
18. The control of the Treasury accounts.
19. The administration of public trusts.
20. The drafting of Congressional testimony, responses to Congressional correspondence, or agency responses to audit reports from the Inspector General, the Government Accountability Office, or other federal audit entity.
The following is an illustrative list is of functions that are closely associated with the performance of inherently governmental functions.
1. Services that involve or relate to budget preparation, including workforce modeling, fact finding, efficiency studies, and should-cost analyses.
2. Services that involve or relate to reorganization and planning activities.
3. Services that involve or relate to analyses, feasibility studies, and strategy options to be used by agency personnel in developing policy.
4. Services that involve or relate to the development of regulations.
5. Services that involve or relate to the evaluation of another contractor's performance.
6. Services in support of acquisition planning.
7. Assistance in contract management (particular where a contractor might influence official evaluations of other contractors' offers).
8. Technical evaluation of contract proposals.
9. Assistance in the development of statements of work.
10. Support in preparing responses to Freedom of Information Act requests.
11. Work in any situation that permits or might permit access to confidential business information and/or any other sensitive information (other than situations covered by the National Industrial Security Program described in FAR 4.402(b)).
12. Dissemination of information regarding agency policies or regulations, such as attending conferences on behalf of an agency, conducting community relations campaigns, or conducting agency training courses.
13. Participation in any situation where it might be assumed that participants are agency employees or representatives.
14. Participation as technical advisors to a source selection board or as nonvoting members of a source evaluation board.
15. Service as arbitrators or provision of alternative dispute resolution (ADR) services.
16. Construction of buildings or structures intended to be secure from electronic eavesdropping or other penetration by foreign governments.
17. Provision of inspection services.
18. Drafting of legal advice and interpretations of regulations and statutes to government officials.
19. Provision of special non-law-enforcement security activities that do not directly involve criminal investigations, such as prisoner detention or transport and non-military national security details.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council Space Operations Committee.
Tuesday, April 13, 2010, 3-5 p.m. CDT.
NASA Johnson Space Center's Gilruth Center, Lone Star
Mr. Jacob Keaton, Space Operations Mission Directorate, National Aeronautics and Space Administration Headquarters, Washington, DC 20546, 202/358-1507,
The agenda for the meeting includes the following topics:
The meeting will be open to the public up to the seating capacity of the room. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. They authorize the preservation of records of continuing value in the National Archives of the United States and the destruction, after a specified period, of records lacking administrative, legal, research, or other value. Notice is published for records schedules in which agencies propose to destroy records not previously authorized for disposal or reduce the retention period of records already authorized for disposal. NARA invites public comments on such records schedules, as required by 44 U.S.C. 3303a(a).
Requests for copies must be received in writing on or before April 30, 2010. Once the appraisal of the records is completed, NARA will send a copy of the schedule. NARA staff usually prepare appraisal memorandums that contain additional information concerning the records covered by a proposed schedule. These, too, may be requested and will be provided once the appraisal is completed. Requesters will be given 30 days to submit comments.
You may request a copy of any records schedule identified in this notice by contacting the Life Cycle Management Division (NWML) using one of the following means:
Requesters must cite the control number, which appears in parentheses after the name of the agency which submitted the schedule, and must provide a mailing address. Those who desire appraisal reports should so indicate in their request.
Laurence Brewer, Director, Life Cycle Management Division (NWML), National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001. Telephone: 301-837-1539. E-mail:
Each year Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval, using the Standard Form (SF) 115, Request for Records Disposition Authority. These schedules provide for the timely transfer into the National Archives of historically valuable records and authorize the disposal of all other records after the agency no longer needs them to conduct its business. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
The schedules listed in this notice are media neutral unless specified otherwise. An item in a schedule is media neutral when the disposition instructions may be applied to records regardless of the medium in which the records are created and maintained. Items included in schedules submitted to NARA on or after December 17, 2007, are media neutral unless the item is limited to a specific medium. (See 36 CFR 1225.12(e).)
No Federal records are authorized for destruction without the approval of the Archivist of the United States. This approval is granted only after a thorough consideration of their administrative use by the agency of origin, the rights of the Government and of private persons directly affected by the Government's activities, and whether or not they have historical or other value.
Besides identifying the Federal agencies and any subdivisions requesting disposition authority, this public notice lists the organizational unit(s) accumulating the records or indicates agency-wide applicability in the case of schedules that cover records that may be accumulated throughout an agency. This notice provides the control number assigned to each schedule, the total number of schedule items, and the number of temporary items (the records proposed for destruction). It also includes a brief description of the temporary records. The records schedule itself contains a full description of the records at the file unit level as well as their disposition. If NARA staff has prepared an appraisal memorandum for the schedule, it too includes information about the records. Further information about the disposition process is available on request.
1. Department of Agriculture, Office of Procurement and Property (N1-16-09-4, 1 item, 1 temporary item). Master files of an electronic information system used to track and manage property assets and related financial information.
2. Department of Agriculture, Food and Nutrition Service (N1-462-09-6, 1 item, 1 temporary item). Master files of an electronic information system that serves as a central repository of product information relating to the Women, Infants, and Children program.
3. Department of Agriculture, Food and Nutrition Service (N1-462-09-8, 1 item, 1 temporary item). Master files of an electronic information system that contains information on recipients or potential recipients of supplemental nutrition assistance who have been or are disqualified from receiving benefits.
4. Department of Defense, Defense Commissary Agency (N1-506-09-2, 2 items, 2 temporary items). Master files and outputs of an electronic information system that tracks sales and receipts, products, pricing, ordering, and inventories at military commissaries.
5. Department of Defense, Defense Commissary Agency (N1-506-09-3, 4
6. Department of Defense, Defense Commissary Agency (N1-506-09-4, 2 items, 2 temporary items). Master files and outputs of electronic information systems that maintain data on processed meat products sold by military commissaries.
7. Department of Defense, Defense Commissary Agency (N1-506-09-6, 2 items, 2 temporary items). Master files and outputs of an electronic information system used in connection with the pricing and promotion of products at military commissaries.
8. Department of Defense, Defense Security Service (N1-446-09-5, 12 items, 12 temporary items). Records relating to contractor facilities involved in the National Industrial Security Program. Records pertain to such matters as security clearance of facilities, cancellation of clearances, security agreements, and related administrative actions.
9. Department of Education, Office of Management (N1-441-09-21, 2 items, 2 temporary items). Case files relating to complaints by borrowers in connection with Federal student loans. An electronic case tracking system is also included.
10. Department of Education, Office of Management (N1-441-09-20, 1 item, 1 temporary item). Master files of an electronic information system that contains data concerning student loans, including name of recipient, type of loan, loan period, and loan amount.
11. Department of Energy, Southwestern Power Administration (N1-387-10-1, 2 items, 2 temporary items). Records relating to power accounting and billing invoices.
12. Department of Health and Human Services, Centers for Medicare & Medicaid Services (N1-440-09-5, 1 item, 1 temporary item). Master files of an electronic information system that contains information concerning appeals of fee-for-service and managed care decisions under the Medicare program.
13. Department of Homeland Security, U.S. Customs and Border Protection (N1-568-09-1, 1 item, 1 temporary item). Master files of an electronic information system used to manage and track importer compliance audits.
14. Department of the Interior, Office of the Secretary (N1-48-08-22, 22 items, 17 temporary items). Records relating to management and administration, including such records as development files, planning files, audit records, records inventories, records relating to budget matters, committee records, and paperwork reduction files. Also included is the agency web site. Proposed for permanent retention are such records as Indian Fiduciary Trust management and reform records, Freedom of Information Act appeals related to the Indian Fiduciary Trust, and executive committee and board membership records.
15. Department of the Interior, Office of Planning and Performance Management (N1-48-09-10, 8 items, 1 temporary item). Records of the office other than those proposed for permanent retention. Proposed for permanent retention are such records as strategic planning files, performance and accountability report files, budgets and associated performance information relating to agency components, and performance management governance files.
16. Department of Justice, Criminal Division (N1-60-07-2, 3 items, 1 temporary item). Organized Crime Drug Enforcement Task Force case files that have been incorporated into an electronic management information system. Proposed for permanent retention are master files of the electronic information system containing case information as well as older case files, which have not been incorporated into the system.
17. Department of Justice, Executive Office for United States Attorneys (N1-60-10-10, 2 items, 2 temporary items). Master files and outputs of an electronic information system containing emergency contact information for employees.
18. Department of Justice, United States Attorney's Office for the District of South Carolina (N1-118-09-1, 19 items, 8 temporary items). Records relating to a pilot project for intermodal and maritime security at the Port of Charleston. Included are such records as electronic information systems used for situational awareness and property asset tracking, intelligence working files, vessel arrival files, and routine reference and research photographs. Proposed for permanent retention are such records as organizational records, briefing materials, operating manuals, public relations records, subject files, and photographs of significant activities.
19. Department of State, Bureau of Public Affairs (N1-59-09-4, 4 items, 2 temporary items). Web site records that contain information duplicated in other agency recordkeeping systems. Also included are records that relate to management and operation of the Web site. Proposed for permanent retention are the agency's official blog and snapshots of the entire public Web site taken at the end of each Presidential administration.
20. Department of the Treasury, Internal Revenue Service (N1-58-09-48, 3 items, 3 temporary items). Master files, outputs, and system documentation for an electronic information system which is used to store data from estate tax returns and generate estate tax closing letters.
21. Department of the Treasury, Internal Revenue Service (N1-58-09-90, 2 items, 2 temporary items). Master files and system documentation for an electronic information system which is used to disclose tax return information to participating state and local governments.
22. Department of the Treasury, Internal Revenue Service (N1-58-09-91, 4 items, 4 temporary items). Master files and system documentation for an electronic information system which is used to monitor upcoming legal actions, media interest, and outreach activities related to criminal investigations.
23. Department of the Treasury, Internal Revenue Service (N1-58-09-93, 2 items, 2 temporary items). Master files and system documentation for an electronic information system which is used to provide account transcripts to state tax collection agencies.
24. Department of the Treasury, Internal Revenue Service (N1-58-09-94, 2 items, 2 temporary items). Master files and system documentation for an electronic information system which is used to assist agency employees in processing taxpayer penalty relief requests.
25. Department of the Treasury, Internal Revenue Service (N1-58-09-98, 3 items, 3 temporary items). Master files, inputs, and system documentation for an electronic information system which is used to transmit electronically filed tax returns to the appropriate tax processor.
26. Department of the Treasury, Internal Revenue Service (N1-58-09-99, 6 items, 6 temporary items). Master files, outputs, and system documentation for an electronic information system which is used to track remittances that cannot be credited to the taxpayer and are considered excess collections.
27. Department of the Treasury, Internal Revenue Service (N1-58-09-100, 6 items, 6 temporary items). Master files, outputs, and system documentation for an electronic information system which is used to track remittances that cannot be immediately credited because the taxpayer has not been positively identified.
28. Department of the Treasury, Internal Revenue Service (N1-58-09-102, 4 items, 4 temporary items). Master files, inputs, outputs, and system documentation for an electronic information system which is used to maintain information concerning applicants for and participants in the Health Coverage Tax Credit program.
29. Central Intelligence Agency, Agency-wide (N1-263-06-3, 14 items, 13 temporary items). Records relating to records and information management activities. Included are such records as security classified records control and tracking logs, library services files, forms files, subject files relating to records management, indexes to temporary records, and records disposition schedules. Proposed for permanent retention are indexes to records scheduled for permanent retention.
30. Export-Import Bank of the United States, Chief Information Office (N1-275-09-4, 3 items, 3 temporary items). Master files of an electronic information system used to facilitate the Bank's loan pre-approval process.
31. Federal Maritime Commission, Office of the Secretary (N1-358-09-6, 2 items, 2 temporary items). Informal complaints and dispute resolution case files relating to shipping disputes. Also included are master files of an electronic information system that is used to assign cases to staff and monitor their status.
32. Federal Maritime Commission, Bureau of Certification and Licensing (N1-358-09-4, 1 item, 1 temporary item). Master files of an electronic information system that contains data about passenger vessels and their insurance coverage against potential claims.
33. Federal Maritime Commission, Bureau of Certification and Licensing (N1-358-09-5, 1 item, 1 temporary item). Master files of an electronic information system that contains data about potentially unlicensed ocean transportation intermediaries.
U.S. Nuclear Regulatory Commission (NRC).
Notice of pending NRC action to submit an information collection request to the Office of Management and Budget (OMB) and solicitation of public comment.
The NRC invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the
Information pertaining to the requirement to be submitted:
1.
2.
3.
4.
5.
6.
7.
Submit, by June 1, 2010, comments that address the following questions:
1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?
2. Is the burden estimate accurate?
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room, One White Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville, Maryland 20852. OMB clearance requests are available at the NRC worldwide Web site:
For the Nuclear Regulatory Commission.
FPL Energy Point Beach, LLC (FPLE, the licensee) is the holder of Renewed Facility Operating License Nos. DPR-24 and DPR-27, which authorize operation of the Point Beach Nuclear Plant, Units 1 and 2 (PBNP). The licenses provide, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC, the Commission) now or hereafter in effect.
The facility consists of two pressurized water reactors located in Manitowoc County, Wisconsin.
Title 10 of the
By letter dated February 26, 2010, which was superseded by letter dated March 11, 2010, the licensee requested an exemption in accordance with 10 CFR 73.5, “Specific exemptions.” Enclosures 1 to the February 26, and March 11, 2010, letters contain security-related information and, accordingly, are not available to the public. Redacted versions of the licensee's exemption requests dated February 26, and March 11, 2010, are publicly available in the Agencywide Documents Access and Management System (ADAMS) Accession Nos. ML100600565 and ML100710739, respectively. The licensee has requested an exemption from the March 31, 2010, compliance date stating that it must accommodate unforeseen delays such as adverse weather, material delivery delays, and testing constraints that could result in non-compliance with the March 31, 2010, compliance deadline. Specifically, the request is for one requirement that would be met by May 28, 2010, versus the March 31, 2010, deadline. Granting this exemption for the one item would afford the licensee additional time to perform necessary upgrades to meet or exceed the regulatory requirements.
Pursuant to 10 CFR 73.55(a)(1), “By March 31, 2010, each nuclear power reactor licensee, licensed under 10 CFR Part 50, shall implement the requirements of this section through its Commission-approved Physical Security Plan, Training and Qualification Plan, Safeguards Contingency Plan, and Cyber Security Plan referred to collectively hereafter as `security plans.' ” Pursuant to 10 CFR 73.5, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR Part 73 when the exemptions are authorized by law, and will not endanger life or property or the common defense and security, and are otherwise in the public interest.
NRC approval of this exemption, as noted above, would allow an extension from March 31, 2010, until May 28, 2010, for the implementation date for one specific requirement of the new rule. As stated above, 10 CFR 73.5 allows the NRC to grant exemptions from the requirements of 10 CFR 73. The NRC staff has determined that granting of the licensee's proposed exemption would not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Therefore, the exemption is authorized by law.
In the draft final Power Reactor Security rule sent to the Commission, the NRC staff proposed that the requirements of the new regulation be met within 180 days. The Commission directed a change from 180 days to approximately 1 year for licensees to fully implement the new requirements. This change was incorporated into the final rule. From this, it is clear that the Commission wanted to provide a reasonable timeframe for licensees to reach full compliance.
As noted in the final rule, the Commission also anticipated that licensees would have to conduct site-specific analyses to determine what changes were necessary to implement the rule's requirements, and that changes could be accomplished through a variety of licensing mechanisms, including exemptions. Since issuance of the final rule, the Commission has rejected a request generically to extend the rule's compliance date for all operating nuclear power plants, but noted that the Commission's regulations provide mechanisms for individual licensees, with good cause, to apply for relief from the compliance date, as documented in the letter from R. W. Borchardt (NRC) to M. S. Fertel (Nuclear Energy Institute) dated June 4, 2009. The licensee's request for an exemption is therefore consistent with the approach set forth by the Commission and discussed in the June 4, 2009, letter.
The licensee provided detailed information in Enclosure 1 of its letter dated March 11, 2010, requesting an exemption. The licensee is requesting additional time to perform necessary upgrades to the PBNP security system due to unforeseen delays such as adverse weather, material delivery delays, and testing constraints, and provides a timeline for achieving full compliance with the new regulation. Enclosure 1 to the licensee's letter contains security-related information regarding the site security plan, details of the specific requirement of the regulation for which the site cannot be in compliance by the March 31, 2010, deadline, justification for the exemption request, the required changes to the site's security configuration, and a timeline with critical path activities that will bring the licensee into full compliance by May 28, 2010. The timeline provides dates indicating when the critical equipment will be installed, tested, and become operational.
Notwithstanding the schedular exemptions for these limited requirements, the licensee will continue to be in compliance with all other applicable physical security requirements as described in 10 CFR 73.55 and reflected in its current NRC-approved physical security program. By May 28, 2010, PBNP will be in full compliance with all the regulatory
The staff has reviewed the licensee's submittals and concludes that the licensee has justified its request for an extension of the compliance date with regard to one specified requirement of 10 CFR 73.55 until May 28, 2010.
Accordingly, the Commission has determined that pursuant to 10 CFR 73.5, “Specific exemptions,” an exemption from the March 31, 2010, compliance date is authorized by law and will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the Commission hereby grants the requested exemption.
The long-term benefits that will be realized when the PBNP security modifications are complete justifies exceeding the full compliance date in the case of this particular licensee. The security measure for which PBNP needs additional time to implement is a new requirement imposed by March 27, 2009, amendments to 10 CFR 73.55, and is in addition to those required by the security orders issued in response to the events of September 11, 2001. Therefore, the NRC concludes that the licensee's actions are in the best interest of protecting the public health and safety through the security changes that will result from granting this exemption.
As per the licensee's request and the NRC's regulatory authority to grant an exemption from the March 31, 2010, deadline for the one item specified in Enclosure 1 of PBNP letter dated March 11, 2010, the licensee is required to be in full compliance with 10 CFR 73.55 by May 28, 2010. In achieving compliance, the licensee is reminded that it is responsible for determining the appropriate licensing mechanism (
Pursuant to 10 CFR 51.32, “Finding of no significant impact,” the Commission has previously determined that the granting of this exemption will not have a significant effect on the quality of the human environment [75 FR 14206; March 24, 2010].
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission (NRC).
Notice of availability.
The NRC staff is issuing its Final Interim Staff Guidance (ISG) DC/COL-ISG-017 titled “Ensuring Hazard-Consistent Seismic Input for Site Response and Soil Structure Interaction Analyses,” (Agencywide Documents Access and Management System (ADAMS) Accession No. ML100570203). This ISG supplements the guidance provided to the NRC staff in Sections 2.5 and 3.7 of NUREG-0800, “Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants,” March 2007, and DC/COL-ISG-01, “Interim Staff Guidance on Seismic Issues Associated with High Frequency Ground Motion in Design Certification and Combined License Applications,” issued May 19, 2008 (ADAMS Accession No. ML081400293). The NRC staff issues DC/COL-ISGs to facilitate timely implementation of current staff guidance and to facilitate activities associated with review of applications for design certifications and combined licenses by the Office of New Reactors. The NRC staff intends to incorporate the final approved DC/COL-ISG-017 into the next revision of SRP Sections 2.5 and 3.7 and Regulatory Guide 1.206, “Combined License Applications for Nuclear Power Plants (LWR Edition),” June 2007.
The NRC maintains ADAMS, which provides text and image files of NRC's public documents. These documents may be accessed through the NRC's Public Electronic Reading Room on the Internet at
Dr. Kimberly A. Hawkins, Chief, Structural Engineering Branch 2, Division of Engineering, Office of the New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;
The agency posts its issued staff guidance in the agency external web page (
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of Issuance and Availability of Regulatory Guide (RG) 1.126, Revision 2, “An Acceptable Model and Related Statistical Methods for the Analysis of Fuel Densification.”
John C. Voglewede, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 251-7555 or e-mail
The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision to an existing guide in the agency's “Regulatory Guide” series. This series was developed to describe and make
Revision 2 of RG 1.126 was issued with a temporary identification as Draft Regulatory Guide, DG-1189. This guide describes an analytical model and related assumptions and procedures that the staff of the NRC considers acceptable for predicting the effects of fuel densification in light-water-cooled nuclear power reactors. To meet these objectives, the guide describes statistical methods related to product sampling that will ensure that this and other approved analytical models will adequately describe the effects of densification for each initial core and reload fuel quantity produced.
In December 2008, DG-1189 was published with a public comment period of 60 days from the issuance of the guide. No formal comments were received and the public comment period closed on February 9, 2009. Electronic copies of RG 1.126 are available through the NRC's public Web site under “Regulatory Guides” at
In addition, regulatory guides are available for inspection at the NRC's Public Document Room (PDR) located at Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852-2738. The PDR's mailing address is USNRC PDR, Washington, DC 20555-0001. The PDR can also be reached by telephone at (301) 415-4737 or (800) 397-4209, by fax at (301) 415-3548, and by e-mail to
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on the U.S. Evolutionary Power Reactor (EPR) will hold a meeting on April 20-21, 2010, at 11545 Rockville Pike, T2-B1, Rockville, Maryland.
The entire meeting will be open to public attendance, with the exception of a portion that may be closed to protect information that is proprietary to AREVA NP, pursuant to 5 U.S.C. 552b(c)(4).
The proposed agenda for the subject meeting shall be as follows:
The Subcommittee will review Chapters 4, 5 and 17 of the Safety Evaluation Report with Open Items associated with the staff's review of the Calvert Cliff's Unit 3 Combined License Application (COLA).
The Subcommittee will review Chapter 12 of the Safety Evaluation Report with Open Items associated with the staff's review of the Calvert Cliff's Unit 3 COLA, and complete review of Chapter 19 of the Safety Evaluation Report with Open Items associated with the staff's review of the U.S. EPR Design Certification application.
The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Mr. Derek Widmayer (Telephone 301-415-7366, E-mail:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
The ACRS Subcommittee on Power Uprates will hold a meeting on April 23, 2010, at 11545 Rockville Pike, Rockville, Maryland, Room T2 B3.
The meeting will be open to public attendance, with the exception of a portion that may be closed to protect fuel design information that is proprietary to General Electric Hitachi (GEH) and Global Nuclear Fuels (GNF), pursuant to 5 U.S.C. 552b(c)(4).
The agenda for the subject meeting shall be as follows:
The Subcommittee will review Supplement 3 to Topical Report NEDC-33173P-A, “Applicability of GE Methods to Expanded Domains.” This supplement extends the GEH/GNF computational methods to include GNF-2 fuel design.
The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
Small Business Administration.
Notice of reporting requirements submitted for OMB review.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before April 30, 2010. If you intend to comment but cannot prepare comments promptly, please advise the OMB Reviewer and the Agency Clearance Officer before the deadline.
Address all comments concerning this notice to:
Jacqueline White, Agency Clearance Officer, (202) 205-7044.
U.S. Small Business Administration.
Notice of open Federal advisory committee meeting.
The SBA is issuing this notice to announce the location, date, time, and agenda for the next meeting of the Region II Buffalo District Advisory Council. The meeting will be open to the public.
The meeting will be held on April 14, 2010 from approximately 9:30 a.m. to 11:30 a.m. Eastern Standard Time.
The meeting will be held at the Canisius College Amherst Conference Center, 300 Corporate Parkway, Amherst, New York 14226.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Region II Buffalo District Advisory Council. The Region II Buffalo District Advisory Council is tasked with providing information of public interest.
The purpose of the meeting is so the council can provide advice and opinions regarding the effectiveness of and need for SBA programs, particularly the local districts which members represent. The agenda will include: District office, SBA programs and services, ARRA, government contracting, disaster updates, lending
The meeting is open to the public however advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation to the Region II Buffalo District Advisory Council must contact Franklin J. Sciortino, District Director, Buffalo District Office by October 8, by fax or email in order to be placed on the agenda. Franklin J. Sciortino, District Director, Buffalo District Office, U.S. Small Business Administration, 540 Niagara Center, 130 S. Elmwood Avenue, Buffalo, New York 14202; telephone (716) 551-4301 or fax (716) 551-4418.
Additionally, if you need accommodations because of a disability or require additional information, please contact Kelly Lotempio, BDS/PIO, Buffalo District Office, U.S. Small Business Administration, 540 Niagara Center, 130 S. Elmwood Avenue, Buffalo, New York 14202; telephone (716) 551-4301,
For more information, please visit our Web site at
Securities and Exchange Commission (“Commission”).
Notice of application for an order pursuant to Section 26(c) of the Investment Company Act of 1940 (the “Act”) approving certain substitutions of securities and an order of exemption pursuant to Section 17(b) of the Act from Section 17(a) of the Act.
The Insurance Companies and the Separate Accounts are referred to as the “Substitution Applicants.” The Insurance Companies, the Separate Accounts and the Investment Companies are referred to as the “Section 17 Applicants.”
Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090. Applicants c/o Paul G. Cellupica, Chief Counsel—Securities Regulation and Corporate Services, MetLife Group, 1095 Avenue of the Americas, 40th Floor, New York, NY 10036 and Robert N. Hickey, Esq., Sullivan & Worcester LLP, 1666 K Street, NW., Washington, DC 20006.
Alison T. White, Senior Counsel, or Joyce M. Pickholz, Branch Chief, Office of Insurance Products, Division of Investment Management, at (202) 551-6795.
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. MetLife of CT is a stock life insurance company organized in 1863 under the laws of Connecticut. MetLife Investors is a stock life insurance company organized on August 17, 1981 under the laws of Missouri. First MetLife Investors is a stock life insurance company organized on
2. Separate Account Eleven, Fund UL, VA Account One, VL Account One, First VA Account One, Separate Account A, Separate Account UL, SE Separate Account Twenty-Six, SE Separate Account Twenty-Seven, Separate Account 13S, GA Separate Account Twenty-Eight, and GA Separate Account Twenty-Nine are registered under the Act as unit investment trusts for the purpose of funding the Contracts. Security interests under the Contracts have been registered under the Securities Act of 1933.
3. Separate Account QPN is exempt from registration under the Act. Security interests under the Contracts have been registered under the Securities Act of 1933.
4. VL Account Eight, Separate Account DCVL and Separate Account 485 serve as separate account funding vehicles for certain Contracts that are exempt from registration under Section 4(2) of the Securities Act of 1933 and Regulation D thereunder.
5. Although Separate Account QPN, VL Account Eight, Separate Account DCVL and Separate Account 485 are exempt from registration under the Act, they would be subject to the investment limitations of Section 12 but for the exclusion contained in Section 12(d)(1)(E) of the Act. To rely on such exclusion, an investment company that is not a registered investment company must, among other things, agree to refrain from substituting a security unless the Commission approves the substitution in the manner provided in Section 26 of the Act.
6. MIST and Met Series Fund are each registered under the Act as open-end management investment companies of the series type, and their securities are registered under the Securities Act of 1933. Metlife Advisers, LLC serves as investment adviser to MIST and Met Series Fund.
7. The annuity contracts permit the Insurance Companies to substitute shares of one fund with shares of another, including a fund of a different registered investment company. The prospectuses for the Contracts and the Separate Accounts contain the appropriate disclosures of this right.
8. Each Insurance Company, on its behalf and on behalf of the Separate Accounts proposes to make certain substitutions of shares of 11 funds (the “Existing Funds”) held in sub-accounts of its respective Separate Accounts for certain series (the “Replacement Funds”) of MIST and Met Series Fund.
9. The proposed substitutions are as follows: (a) BlackRock Money Market Portfolio for AIM V.I. Money Market Fund and Legg Mason Western Asset Variable Money Market Portfolio; (b) RCM Technology Portfolio for AIM V.I. Technology Fund and DWS Technology VIP; (c) Oppenheimer Global Equity Portfolio for DWS Global Opportunities VIP; (d) Met/Artisan Mid Cap Value Portfolio for Janus Aspen Perkins Mid Cap Value Portfolio; (e) Met/Templeton Growth Portfolio for Legg Mason Batterymarch Variable Global Equity Portfolio; (f) MetLife Stock Index Portfolio for Legg Mason Batterymarch S&P 500 Index Portfolio; (g) BlackRock High Yield Portfolio for Pioneer High Yield VCT Portfolio; (h) Lord Abbett Growth and Income Portfolio for Putnam VT Growth and Income Fund; (i) Met/AIM Small Cap Growth Portfolio for UIF Small Company Growth Portfolio.
10. The following is a summary of the investment objectives and policies of each Existing Fund and its corresponding Replacement Fund. Additional information including asset sizes, risk factors and comparative performance history for each Existing Fund and Replacement Fund can be found in the Application.
11. The management fees, 12b-1 fees (if applicable), other expenses and total operating expenses for each Existing and Replacement Fund are as follows:
12. MetLife Advisers, LLC is the adviser of each of the Replacement Funds. Each Replacement Fund currently offers up to four classes of shares, three of which, Class A, Class B and Class E are involved in the substitutions.
13. The Applicants believe the substitutions will provide significant benefits to Contract owners, including improved selection of sub-advisers and simplification of fund offerings through the elimination of overlapping offerings.
14. As a result of the substitutions, the number of investment options offered under substantially all of the Contracts will not change (currently ranges in number from 3 to 122). For a limited number of Contracts which currently have at least 21 investment options available, after the substitutions there will be available at least 20 investment options.
15. Those substitutions which replace investment options advised by investment advisers that are not affiliated with the Substitution Applicants with funds for which MetLife Advisers, LLC acts as investment adviser will permit each adviser, under the Multi-Manager Order, [IC-22824 (1997) and IC-23859 (1999)], to hire, monitor and replace sub-advisers as necessary to achieve optimal performance.
16. Contract owners with sub-account balances invested (through the separate account) in shares of the Replacement Funds, except for the Legg Mason Batterymarch Variable Global Equity Portfolio/Met/Templeton Growth Portfolio, will have lower total expense ratios taking into account fund expenses and current fee waivers.
17. In the following substitutions, the management fee and/or applicable Rule 12b-1 fee of the Replacement Fund are either currently higher, or, at certain management fee breakpoints, may be higher than those of the respective Existing Fund: Legg Mason Western Asset Variable Money Market Portfolio/BlackRock Money Market Portfolio; AIM V. I. Technology Fund/RCM Technology Portfolio; DWS Technology VIP/RCM Technology Portfolio; DWS Global Opportunities VIP/Oppenheimer Global Equity Portfolio; Putnam VT Growth and Income Portfolio/Lord Abbett Growth and Income Portfolio; UIF Small Company Growth Portfolio/Met/AIM Small Cap Growth Portfolio; and Janus Aspen Perkins Mid Cap Value Portfolio/Met/Artisan Mid Cap Value Portfolio.
18. The Substitution Applicants propose to limit Contract charges attributable to Contract value invested in the Replacement Funds following the proposed substitutions to a rate that would offset the difference in the expense ratio between each Existing Fund's net expense ratio and the net expense ratio for the respective Replacement Fund.
19. Except for the Legg Mason Batterymarch Variable Global Equity Portfolio/Met/Templeton Growth Portfolio substitution where there is an increase in net expenses after waivers of 0.05%, the substitutions will result in decreased net expense ratios ranging from 2 basis points to 57 basis points. Moreover, there will be no increase in Contract fees and expenses, including mortality and expense risk fees and administration and distribution fees charged to the Separate Accounts as a result of the substitutions.
20. The Substitution Applicants believe that the Replacement Funds have investment objectives, policies and risk profiles that are either substantially the same as, or sufficiently similar to, the corresponding Existing Funds to make those Replacement Funds appropriate candidates as substitutes.
21. In addition, after the substitutions, neither MetLife Advisers, LLC nor any of their affiliates will receive compensation from the charges to the Separate Accounts related to the Contracts or from Rule 12b-1 fees or revenue sharing from the Replacement Funds in excess of the compensation currently received from the investment advisers or distributors of the Existing Funds.
22. The share classes of the Replacement Funds are either identical to or less than the share classes of the Existing Funds with respect to the imposition of Rule 12b-1 fees currently imposed, except with respect to the substitution of BlackRock Money Market Portfolio for Legg Mason Western Asset Variable Money Market Portfolio.
23. Each MIST and Met Series Fund Replacement Fund's Class B and Class E Rule 12b-1 fees can be raised to 0.50% of net assets by the Replacement Fund's Board of Directors/Trustees without shareholder approval. However, Met Series Fund and MIST represent that Rule 12b-1 fees of the Class B and Class E shares of the Replacement Funds issued in connection with the proposed substitutions will not be raised above the current rate without approval of a majority in interest of the respective Replacement Funds' shareholders after the substitutions.
24. The distributors of the Existing Funds pay to the Insurance Companies, or their affiliates, any 12b-1 fees associated with the class of shares sold to the Separate Accounts. Similarly, the distributors for MIST and Met Series Fund will receive from the applicable class of shares held by the Separate Accounts Rule 12b-1 fees in the same amount or a lesser amount than the amount paid by the Existing Funds, except as described above.
25. Further, in addition to any Rule 12b-1 fees, the investment advisers or distributors of the Existing Funds pay the Insurance Companies or one of their affiliates from 0 to 43 basis points for the Existing Funds' classes of shares involved in the substitutions. Following the substitutions, these payments will not be made on behalf of the Replacement Funds. Rather, the Insurance Companies or their affiliates will have available both the 25 and 15 basis points in Rule 12b-1 fees from the Replacement Funds (with respect to Class B and Class E shares, respectively) and, as owners of the Replacement Funds' adviser, profit distributions from the adviser. These profits from investment advisory fees may be more or less than the fees being paid by the Existing Funds.
1. The Substitution Applicants request that the Commission issue an order pursuant to Section 26(c) of the Act approving the proposed substitutions.
2. Applicants represent that the Contracts permit the applicable Insurance Company, subject to compliance with applicable law, to substitute shares of another investment company for shares of an investment company held by a sub-account of the Separate Accounts. The prospectuses for the Contracts and the Separate Accounts contain appropriate disclosure of this right.
3. By a supplement to the prospectuses for the Contracts and the Separate Accounts, each Insurance Company has notified all owners of the Contracts of its intention to take the necessary actions, including seeking the order requested by this Application, to substitute shares of the funds as described herein. The supplement has advised Contract owners that from the date of the supplement until the date of the proposed substitution, owners are permitted to make one transfer of Contract value (or annuity unit exchange) out of the Existing Fund sub-account to one or more other sub-accounts without the transfer (or exchange) being treated as one of a limited number of permitted transfers (or exchanges) or a limited number of transfers (or exchanges) permitted without a transfer charge. The supplement also has informed Contract
4. The proposed substitutions will take place at relative net asset value with no change in the amount of any Contract owner's Contract value, cash value, or death benefit or in the dollar value of his or her investment in the Separate Accounts.
5. The process for accomplishing the transfer of assets from each Existing Fund to its corresponding Replacement Fund will be determined on a case-by-case basis. In most cases, it is expected that the substitutions will be effected by redeeming shares of an Existing Fund for cash and using the cash to purchase shares of the Replacement Fund. In certain other cases, it is expected that the substitutions will be effected by redeeming the shares of an Existing Fund in-kind; those assets will then be contributed in-kind to the corresponding Replacement Fund to purchase shares of that Fund. All in-kind redemptions from an Existing Fund of which any of the Substitution Applicants is an affiliated person will be effected in accordance with the conditions set forth in the Commission's no-action letter issued to
6. Contract owners will not incur any fees or charges as a result of the proposed substitutions, nor will their rights or an Insurance Company's obligations under the Contracts be altered in any way. All expenses incurred in connection with the proposed substitutions, including brokerage, legal, accounting, and other fees and expenses, will be paid by the Insurance Companies. In addition, the proposed substitutions will not impose any tax liability on Contract owners. The proposed substitutions will not cause the Contract fees and charges currently being paid by existing Contract owners to be greater after the proposed substitutions than before the proposed substitutions. No fees will be charged on the transfers made at the time of the proposed substitutions because the proposed substitutions will not be treated as a transfer for the purpose of assessing transfer charges or for determining the number of remaining permissible transfers in a Contract year.
7. In addition to the prospectus supplements distributed to owners of Contracts, within five business days after the proposed substitutions are completed, Contract owners will be sent a written notice informing them that the substitutions were carried out and that they may make one transfer of all Contract value or cash value under a Contract invested in any one of the sub-accounts on the date of the notice to one or more other sub-accounts available under their Contract at no cost and without regard to the usual limit on the frequency of transfers from the variable account options to the fixed account options. The notice will also reiterate that (other than with respect to “market timing” activity) the Insurance Company will not exercise any rights reserved by it under the Contracts to impose additional restrictions on transfers or to impose any charges on transfers until at least 30 days after the proposed substitutions. The Insurance Companies will also send each Contract owner current prospectuses for the Replacement Funds involved to the extent that they have not previously received a copy.
8. Each Insurance Company also is seeking approval of the proposed substitutions from any State insurance regulators whose approval may be necessary or appropriate.
9. The Substitution Applicants agree that for those who were Contract owners on the date of the proposed substitutions, the Insurance Companies will reimburse, on the last business day of each fiscal period (not to exceed a fiscal quarter) during the twenty-four months following the date of the proposed substitutions, those Contract owners whose sub-account invests in the Replacement Fund such that the sum of the Replacement Fund's net operating expenses (taking into account fee waivers and expense reimbursements) and sub-account expenses (asset-based fees and charges deducted on a daily basis from sub-account assets and reflected in the calculation of sub-account unit values) for such period will not exceed, on an annualized basis, the sum of the Existing Fund's net operating expenses taking into account fee waivers and expense reimbursements and sub-account expenses for fiscal year 2009, except with respect to the AIM V.I. Technology Fund/RCM Technology Portfolio, DWS Technology VIP/RCM Technology Portfolio, DWS Global Opportunities VIP/Oppenheimer Global Equity Portfolio, Janus Aspen Perkins Mid Cap Value Portfolio/Met/Artisan Mid Cap Value Portfolio, Legg Mason Western Asset Variable Money Market Portfolio/BlackRock Money Market Portfolio, Putnam VT Growth and Income Portfolio/Lord Abbett Growth and Income Portfolio, and UIF Small Company Growth Portfolio/Met/AIM Small Cap Growth Portfolio substitutions.
10. With respect to the AIM V.I. Technology Fund/RCM Technology Portfolio, DWS Technology VIP/RCM Technology Portfolio, DWS Global Opportunities VIP/Oppenheimer Global Equity Portfolio, Janus Aspen Perkins Mid Cap Value Portfolio/Met/Artisan Mid Cap Value Portfolio, Legg Mason Western Asset Variable Money Market Portfolio/BlackRock Money Market Portfolio, Putnam VT Growth and Income Portfolio/Lord Abbett Growth and Income Portfolio and UIF Small Company Growth Portfolio/Met/AIM Small Cap Growth Portfolio substitutions, the reimbursement agreement with respect to the Replacement Fund's operating expenses and sub-account expenses, will extend for the life of each Contract outstanding on the date of the proposed substitutions.
11. The Substitution Applicants further agree that, except with respect to the AIM V.I. Technology Fund/RCM Technology Portfolio, DWS Technology VIP/RCM Technology Portfolio, DWS Global Opportunities VIP/Oppenheimer Global Equity Portfolio, Janus Aspen Perkins Mid Cap Value Portfolio/Met/Artisan Mid Cap Value Portfolio, Legg Mason Western Asset Variable Money Market Portfolio/BlackRock Money Market Portfolio, Putnam VT Growth and Income Portfolio/Lord Abbett Growth and Income Portfolio, and UIF Small Company Growth Portfolio/Met/AIM Small Cap Growth Portfolio substitutions, the Insurance Companies will not increase total separate account charges (net of any reimbursements or waivers) for any existing owner of the Contracts on the date of the substitutions for a period of two years from the date of the substitutions.
12. With respect to the AIM V.I. Technology Fund/RCM Technology Portfolio, DWS Technology VIP/RCM Technology Portfolio, DWS Global Opportunities VIP/Oppenheimer Global Equity Portfolio, Janus Aspen Perkins Mid Cap Value Portfolio/Met/Artisan Mid Cap Value Portfolio, Legg Mason
13. In each case, the applicable Insurance Companies believe that it is in the best interests of the Contract owners to substitute the Replacement Fund for the Existing Fund. The Insurance Companies believe that in cases where the Replacement Fund has a new sub-adviser, the new sub-adviser will, over the long term, be positioned to provide at least comparable performance to that of the Existing Fund's sub-adviser.
14. The Substitution Applicants anticipate that Contract owners will be better off with the array of sub-accounts offered after the proposed substitutions than they have been with the array of sub-accounts offered prior to the substitutions.
15. The Substitution Applicants submit that none of the proposed substitutions is of the type that Section 26(c) was designed to prevent.
16. The Substitution Applicants request an order of the Commission pursuant to Section 26(c) of the Act approving the proposed substitutions by the Insurance Companies.
17. The Section 17 Applicants request an order under Section 17(b) exempting them from the provisions of Section 17(a) to the extent necessary to permit the Insurance Companies to carry out each of the proposed substitutions.
18. Section 17(a)(1) of the Act, in relevant part, prohibits any affiliated person of a registered investment company, or any affiliated person of such person, acting as principal, from knowingly selling any security or other property to that company. Section 17(a)(2) of the Act generally prohibits the persons described above, acting as principals, from knowingly purchasing any security or other property from the registered company.
19. Because shares held by a separate account of an insurance company are legally owned by the insurance company, the Insurance Companies and their affiliates collectively own of record substantially all of the shares of MIST and Met Series Fund. Therefore, MIST and Met Series Fund and their respective funds are arguably under the control of the Insurance Companies notwithstanding the fact that Contract owners may be considered the beneficial owners of those shares held in the Separate Accounts. If MIST and Met Series Fund and their respective funds are under the control of the Insurance Companies, then each Insurance Company is an affiliated person or an affiliated person of an affiliated person of MIST and Met Series Fund and their respective funds. If MIST and Met Series Fund and their respective funds are under the control of the Insurance Companies, then MIST and Met Series Fund and their respective funds are affiliated persons of the Insurance Companies.
20. Regardless of whether or not the Insurance Companies can be considered to control MIST and Met Series Fund and their respective funds, because the Insurance Companies own of record more than 5% of the shares of each of them and are under common control with each Replacement Fund's investment adviser, the Insurance Companies are affiliated persons of both MIST and Met Series Fund and their respective funds. Likewise, their respective funds are each an affiliated person of the Insurance Companies.
21. The Insurance Companies, through their separate accounts in the aggregate own more than 5% of the outstanding shares of the following Existing Funds: Legg Mason Batterymarch Variable Global Equity Portfolio, Legg Mason Western Asset Variable Money Market Portfolio, Legg Mason Batterymarch S&P 500 Index Portfolio, Pioneer High Yield VCT Portfolio, UIF Small Company Growth Portfolio. Therefore, each Insurance Company is an affiliated person of those funds.
22. Because the substitutions may be effected, in whole or in part, by means of in-kind redemptions and purchases, the substitutions may be deemed to involve one or more purchases or sales of securities or property between affiliated persons. The proposed transactions may involve a transfer of portfolio securities by the Existing Funds to the Insurance Companies; immediately thereafter, the Insurance Companies would purchase shares of the Replacement Funds with the portfolio securities received from the Existing Funds. Accordingly, as the Insurance Companies and certain of the Existing Funds listed above, and the Insurance Companies and the Replacement Funds, could be viewed as affiliated persons of one another under Section 2(a)(3) of the Act, it is conceivable that this aspect of the substitutions could be viewed as being prohibited by Section 17(a).
23. Section 17(b) of the Act provides that the Commission may, upon application, grant an order exempting any transaction from the prohibitions of Section 17(a) if the evidence establishes that: (a) The terms of the proposed transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned; (b) the proposed transaction is consistent with the policy of each registered investment company concerned, as recited in its registration statement and records filed under the Act; and (c) the proposed transaction is consistent with the general purposes of the Act.
24. The Section 17 Applicants submit that for all the reasons stated above the terms of the proposed in-kind purchases of shares of the Replacement Funds by the Insurance Companies, including the consideration to be paid and received, as described in this Application, are reasonable and fair and do not involve overreaching on the part of any person concerned. The Section 17 Applicants also submit that the proposed in-kind purchases by the Insurance Companies are consistent with the policies of: (a) MIST and of its RCM Technology, Met/Templeton Growth, BlackRock High Yield, Lord Abbett Growth and Income and Met/AIM Small Cap Growth Portfolios; and (b) Met Series Fund and of its BlackRock Money Market, Oppenheimer Global Equity, Met/Artisan Mid Cap Value and MetLife Stock Index Portfolios, as recited in the current registration statements and reports filed by each under the Act. Finally, the Section 17 Applicants submit that the proposed substitutions are consistent with the general purposes of the Act.
25. To the extent that the in-kind purchases by the Insurance Company of the Replacement Funds' shares are deemed to involve principal transactions among affiliated persons, the procedures described below should be sufficient to assure that the terms of the proposed transactions are reasonable and fair to all participants. The Section 17 Applicants maintain that the terms of the proposed in-kind purchase transactions, including the consideration to be paid and received by each fund involved, are reasonable, fair and do not involve overreaching principally because the transactions will conform with all but one of the conditions enumerated in Rule 17a-7. The proposed transactions will take place at relative net asset value in conformity with the requirements of Section 22(c) of the Act and Rule 22c-1 thereunder with no change in the
26. The boards of MIST and Met Series Fund have adopted procedures, as required by paragraph (e)(1) of Rule 17a-7, pursuant to which the series of each may purchase and sell securities to and from their affiliates. The Section 17 Applicants will carry out the proposed Insurance Company in-kind purchases in conformity with all of the conditions of Rule 17a-7 and each series' procedures thereunder, except that the consideration paid for the securities being purchased or sold may not be entirely cash. Nevertheless, the circumstances surrounding the proposed substitutions will be such as to offer the same degree of protection to each Replacement Fund from overreaching that Rule 17a-7 provides to them generally in connection with their purchase and sale of securities under that Rule in the ordinary course of their business. In particular, the Insurance Companies (or any of their affiliates) cannot effect the proposed transactions at a price that is disadvantageous to any of the Replacement Funds. Although the transactions may not be entirely for cash, each will be effected based upon (1) the independent market price of the portfolio securities valued as specified in paragraph (b) of Rule 17a-7, and (2) the net asset value per share of each fund involved valued in accordance with the procedures disclosed in its respective investment company registration statement and as required by Rule 22c-1 under the Act. No brokerage commission, fee, or other remuneration will be paid to any party in connection with the proposed in kind purchase transactions.
27. The sale of shares of Replacement Funds for investment securities, as contemplated by the proposed Insurance Company in-kind purchases, is consistent with the investment policies and restrictions of the Investment Companies and the Replacement Funds because (a) the shares are sold at their net asset value, and (b) the portfolio securities are of the type and quality that the Replacement Funds would each have acquired with the proceeds from share sales had the shares been sold for cash. To assure that the second of these conditions is met, MetLife Advisers, LLC and the sub-adviser, as applicable, will examine the portfolio securities being offered to each Replacement Fund and accept only those securities as consideration for shares that it would have acquired for each such fund in a cash transaction.
28. The Section 17 Applicants submit that the proposed Insurance Company in-kind purchases are consistent with the general purposes of the Act as stated in the Findings and Declaration of Policy in Section 1 of the Act and that the proposed transactions do not present any of the conditions or abuses that the Act was designed to prevent.
29. The Section 17 Applicants represent that the proposed in-kind purchases meet all of the requirements of Section 17(b) of the Act and request that the Commission issue an order pursuant to Section 17(b) of the Act exempting the Separate Accounts, the Insurance Companies, MIST, Met Series Fund and each Replacement Fund from the provisions of Section 17(a) of the Act to the extent necessary to permit the Insurance Companies on behalf of the Separate Accounts to carry out, as part of the substitutions, the in-kind purchase of shares of the Replacement Funds which may be deemed to be prohibited by Section 17(a) of the Act.
Applicants assert that for the reasons summarized above that the proposed substitutions and related transactions meet the standards of Section 26(c) of the Act and are consistent with the standards of Section 17(b) of the Act and that the requested orders should be granted.
For the Commission, by the Division of Investment Management pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 23(c)(3) of the Investment Company Act of 1940 (the “Act”) for an exemption from section 23(c) of the Act.
Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090. Applicant, c/o Steven F. Tunney, President and Chief Executive Officer, MCG Capital Corporation, 1100 Wilson Boulevard, Suite 3000, Arlington, Virginia 22209.
Barbara T. Heussler, Senior Counsel, at (202) 551-6990, or Jennifer L. Sawin, Branch Chief, at (202) 551-6821, (Division of Investment Management, Office of Investment Company Regulation).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Applicant is an internally managed, non-diversified, closed-end management investment company that has elected to be regulated as a business development company (“BDC”) under the Act. The Plans authorize the Applicant to issue Restricted Stock to the Participants in accordance with the terms and conditions of the Prior Order. The Applicant seeks to amend the Prior Order to permit the Applicant to withhold shares of the Applicant's common stock or purchase shares of the Applicant's common stock from the Participants to satisfy tax withholding obligations related to the vesting of Restricted Stock that were or will be granted pursuant to the Plans or the Amended Plans. The Applicant will continue to comply with all of the terms and conditions of the Prior Order.
2. The Plans and the Amended Plans authorize the Applicant to issue shares of Restricted Stock; at the time of issuance these shares are subject to certain forfeiture restrictions. On the date that any Restricted Stock vests, such vested shares of the Restricted Stock are released to the Participant and are available for sale or transfer. For Participants who are employees, the value of the vested shares is deemed to be wage compensation for the employee. Applicant states that any compensation income recognized by an employee is generally subject to Federal withholding for income and employment tax purposes.
3. The Amended Plans will be subject to approval by the Applicant's board of directors as well as the required majority of the Applicant's directors within the meaning of section 57(o) of the Act. The Amended Plans explicitly permit the Applicant to withhold shares of the Applicant's common stock or purchase shares of the Applicant's common stock from the Participants to satisfy tax withholding obligations related to the vesting of Restricted Stock.
1. Section 23(c) of the Act, which is made applicable to BDCs by section 63 of the Act, generally prohibits a BDC from purchasing any securities of which it is the issuer except in the open market, pursuant to tender offers or under other circumstances as the Commission may permit to ensure that the purchase is made on a basis that does not unfairly discriminate against any holders of the class or classes of securities to be purchased. Applicant states that the withholding of the Applicant's common stock or purchase of shares of Applicant's common stock to satisfy tax withholding obligations related to the vesting of Restricted Stock might be deemed to be purchases by the Applicant of its own securities within the meaning of section 23(c), and that section 23(c) of the Act may therefore prohibit these transactions.
2. Section 23(c)(3) of the Act permits a BDC to purchase securities of which it is the issuer “under such * * * circumstances as the Commission may permit by * * * orders for the protection of investors in order to insure that such purchases are made in a manner or on a basis which does not unfairly discriminate against any holders of the class or classes of securities to be purchased.” Applicant believes that the requested relief meets the standards of section 23(c)(3) of the Act.
3. The Applicant states that any such purchases will be made in a manner that does not unfairly discriminate against the Applicant's other stockholders because any shares that the Participants deliver to the Applicant to satisfy tax withholding obligations will be valued at the closing sales price of Applicant's shares of common stock on the NASDAQ Global Select Market (or any other such exchange on which its shares of common stock may be traded in the future) as of the date of the transaction. Applicant further states that no transaction will be conducted pursuant to the requested order on days when there are no reported market transactions involving the Applicant's shares. Applicant submits that because all of the transactions between the Applicant and the Participants with respect to the Amended Plans will take place at the public market price for the Applicant's common stock, these transactions will not be significantly different than could be achieved by any stockholder selling in a market transaction.
4. Applicant submits that the withholding provisions in the Amended Plans do not raise concerns about preferential treatment of the Applicant's insiders because the Amended Plans are a bona fide compensation plan of the type that is common among corporations generally. Further, the vesting schedule is determined at the time of the initial grant of the Restricted Stock. Applicant represents that that the transactions may be made only as permitted by the Amended Plans. The Applicant believes that its request for the order is consistent with the policies underlying the provisions of the Act permitting the use of equity compensation as well as prior exemptive relief granted by the Commission for relief under section 23(c) of the Act.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing this proposed rule change to amend BX Rule 3121 to reflect recent changes to a corresponding rule of the Financial Industry Regulatory Authority (“FINRA”). The Exchange will implement the proposed rule change thirty days after the date of the filing. Proposed new language is in italics and proposed deletions are in brackets.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Many of BX's rules are based on rules of FINRA (formerly the National Association of Securities Dealers (“NASD”)). During 2008, FINRA embarked on an extended process of moving rules formerly designated as “NASD Rules” into a consolidated FINRA rulebook. In most cases, FINRA has renumbered these rules, and in some cases has substantively amended them. Accordingly, BX also proposes to initiate a process of modifying its rulebook to ensure that BX rules corresponding to FINRA rules continue to mirror them as closely as practicable. In some cases, it will not be possible for the rule numbers of BX rules to mirror corresponding FINRA rule numbers, because existing or planned BX rules make use of those numbers. However, wherever possible, BX plans to update its rules to reflect changes to corresponding FINRA rules.
This filing addresses BX Rule 3121, which formerly corresponded to NASD 3121. In SR-FINRA-2009-080,
BX is adopting the new FINRA rule in full, and redesignating BX Rule 3121 to be BX Rule 4570, so as to correspond to the new FINRA rule number.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A) of the Act
In its guidance on the proposed rules of Self-Regulatory Organizations (“SROs”),
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-BX-2010-020 and should be submitted on or before April 21, 2010.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change amends NSCC's rules regarding the eligibility of securities processed through the ID Net Service (“ID Net”).
In its filing with the Commission, NSCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. NSCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
On June 2, 2008, the Commission approved a rule change that provided for the settlement of institutional transactions through a joint service of NSCC and The Depository Trust Company (“DTC”) called ID Net. ID Net enables subscribers to the service to net all eligible affirmed institutional transactions at DTC against Continuous Net Settlement (“CNS”) transactions
Participation in ID Net is voluntary. Eligibility for ID Net requires that a
Since the implementation of ID Net, the service has operated with minimal disruption, thus allaying the concerns regarding the addition of certain securities previously excluded from the service. In order to enhance processing efficiency and at the request of its members, NSCC is expanding ID Net to allow NSCC at its discretion from time to time to make eligible for ID Net any security that is eligible for CNS processing.
NSCC will announce by “Important Notice” particular securities or classes of securities are made eligible for processing through ID Net.
The proposed rule change is consistent with Section 17A of the Act,
NSCC does not believe that the proposed rule change will have any impact or impose any burden on competition.
Written comments relating to the proposed rule change were not and are not intended to be solicited or received. NSCC will notify the Commission of any written comments received by NSCC.
The foregoing proposed rule change has become effective upon filing pursuant to Section 19(b)(3)(A)(iii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change amends DTC's rules in order to update its Settlement Service Guide as it relates to the ID Net Service (“ID Net”).
In its filing with the Commission, DTC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. DTC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
On June 2, 2008, the Commission approved a rule change that provided for the settlement of institutional transactions through a service called ID Net. ID Net enables subscribers to the service to net all eligible affirmed institutional transactions at DTC against Continuous Net Settlement (“CNS”) transactions at the National Securities Clearing Corporation (“NSCC”). ID Net accepts affirmed institutional transactions from clearing agencies, entities exempt from clearing agency registration with the Commission, and “qualified vendors,”
Participation in ID Net is voluntary. Eligibility for ID Net requires that a broker-dealer be a DTC participant and an NSCC member eligible for CNS processing. The custodian bank must be a DTC participant. In addition, eligibility for ID Net processing is based on the underlying security being processed, the type of transaction submitted for processing, and the timing of affirmation. Most equity securities that are eligible for CNS are eligible for ID Net processing. However, DTC initially excluded the following securities from ID Net: (1) Corporate and municipal bonds and unit investment trust issues; (2) new issue securities; (3) securities that are IPO tracked (because the use of omnibus accounts will bypass the tracking system); (4) trades in issues that are currently undergoing a mandatory or voluntary reorganization; (5) trades in CUSIPs with a CNS buy-in; and (6) trades in securities appearing on the SEC's Regulation SHO list. At its inception, DTC noted that because ID Net was a new service, it was excluding certain securities that could potentially have a relatively high rate of delivery failure or disrupt normal processing of transactions in ID Net in order to ensure that the system ran smoothly. DTC also noted that as its experience with ID Net grew, it would revaluate the exclusion of certain issues.
Since the implementation of ID Net, the service has operated with minimal disruption, thus allaying the concerns regarding the addition of certain securities previously excluded from the service. In order to enhance processing efficiency and at the request of its participants, DTC is expanding ID Net to allow at DTC's discretion from time to time to make eligible for ID Net any security that is eligible for CNS processing.
DTC will notify its participants by “Important Notice” of the effective date of this change.
The proposed rule change is consistent with Section 17A of the Act,
DTC does not believe that the proposed rule change will have any impact or impose any burden on competition.
Written comments relating to the proposed rule change were not and are not intended to be solicited or received. DTC will notify the Commission of any written comments received by DTC.
The foregoing proposed rule change has become effective upon filing pursuant to Section 19(b)(3)(A)(iii) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange, through its wholly-owned subsidiary NYSE Arca Equities, Inc. (“NYSE Arca Equities”), proposes to list and trade shares (“Shares”) of the following fund of the ProShares Trust (“Trust”): ProShares Ultra MSCI Mexico Investable Market. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to list and trade the Shares of the following fund under NYSE Arca Equities Rule 5.2(j)(3), the Exchange's listing standards for Investment Company Units (“ICUs”):
The Fund is an “index fund” that seeks to provide daily investment results that, before fees and expenses, correspond to twice (200%) of the daily performance of the MSCI Mexico Investable Market Index (“Index”). The Fund does not seek to achieve its stated objective over a period of time greater than one day.
According to the Trust's Registration Statement,
The Exchange is submitting this proposed rule change because the Index for the Fund does not meet all of the “generic” listing requirements of Commentary .01(a)(B) to NYSE Arca Equities Rule 5.2(j)(3) applicable to listing of ICUs based on international or
Detailed descriptions of the Fund, the Index, procedures for creating and redeeming Shares, transaction fees and expenses, dividends, distributions, taxes, risks, and reports to be distributed to beneficial owners of the Shares can be found in the Trust's Registration Statement or on the Web site for the Fund (
The proposed rule change is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The Commission notes that the Index fails to meet only one of the requirements set forth in Commentary .01(a)(B)(3) to NYSE Arca Equities Rule 5.2(j)(3) by only a small amount and that the Exchange has represented that the Shares of the Fund currently satisfy all of the other generic listing standards under NYSE Arca Equities Rule 5.2(j)(3) and all other requirements applicable to ICUs, as set forth in Exchange rules and prior Commission orders approving the generic listing rules applicable to the listing and trading of ICUs. Therefore, the Commission believes that the listing and trading of the Shares do not present any novel or significant issues or impose any significant burden on competition, and that waiving the 30-day operative delay will benefit the market and investors by providing market participants with additional investing choices. For these reasons, the Commission designates the proposed rule change as operative under upon filing.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-NYSEArca-2010-17 and should be submitted on or before April 21, 2010.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to extend its sponsored access rule for a pilot period ending on September 15, 2010. The current pilot expires on March 15, 2010.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to attract additional business by extending its sponsored access rule, which is similar to that of other exchanges. During the previous pilot program, very few member organizations availed themselves of the program, but the Exchange seeks to make it available for an additional pilot period expiring September 15, 2010.
A Sponsored Participant is a non-member of the Exchange, such as an institutional investor, that gains access to the Exchange and trades under a Sponsoring Member's execution and clearing identity pursuant to a sponsorship arrangement between such non-member and a member organization. Specifically, the Exchange proposes to permit Sponsored Participants to be sponsored by Sponsoring Member Organizations, and thereby access the Exchange, subject to certain requirements. These requirements are intended to confirm that the Sponsored Participant is required to and had procedures in place to comply with Exchange rules, and that the Sponsoring Member Organization takes responsibility for the Sponsored Participant's activity on the Exchange.
First, the Sponsored Participant and its Sponsoring Member Organization must have entered into and maintained an Access Agreement with the Exchange. The Sponsoring Member Organization must designate the Sponsored Participant by name in an addendum to the Access Agreement.
Second, there must be a Sponsored Participant Agreement between the Sponsoring Member Organization and the Sponsored Participant that contains the following sponsorship provisions, enumerated in full in Rule 1094(b)(ii):
(i) The orders of the Sponsored Participant are binding in all respects on the Sponsoring Member Organization;
(ii) The Sponsoring Member Organization is responsible for the actions of the Sponsored Participant;
(iii) In addition to the Sponsoring Member Organization being required to comply with the Exchange Certificate of Incorporation, By-laws, Rules and procedures of the Exchange, the
(iv) The Sponsored Participant shall maintain, keep current and provide to the Sponsoring Member Organization a list of individuals authorized to obtain access to the Exchange on behalf of the Sponsored Participant;
(v) The Sponsored Participant shall familiarize its authorized individuals with all of the Sponsored Participant's obligations under this Rule and will assure that they receive appropriate training prior to any use or access to the Exchange;
(vi) The Sponsored Participant may not permit anyone other than authorized individuals to use or obtain access to the Exchange;
(vii) The Sponsored Participant shall take reasonable security precautions to prevent unauthorized use or access to the Exchange, including unauthorized entry of information into the Exchange, and agrees that it is responsible for any and all orders, trades and other messages and instructions entered, transmitted or received under identifiers, passwords and security codes of authorized individuals, and for the trading and other consequences thereof;
(viii) The Sponsored Participant acknowledges its responsibility to establish adequate procedures and controls that permit it to effectively monitor its employees', agents' and Participants' use and access to the Exchange for compliance with the terms of this agreement;
(ix) The Sponsored Participant shall pay when due all amounts, if any, payable to Sponsoring Member Organization, the Exchange, or any other third parties that arise from the Sponsored Participant's access to and use of the Exchange. Such amounts include, but are not limited to applicable exchange and regulatory fees.
Third, the Sponsoring Member Organization must provide the Exchange with a Sponsored Participant Addendum to its Access Agreement acknowledging its responsibility for the orders, executions and actions of its Sponsored Participant at issue.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under 19b-4(f)(6) normally may not become operative prior to 30 days after the date of filing.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
NASDAQ is filing with the Securities and Exchange Commission (“SEC” or “Commission”) a proposal for the NASDAQ Options Market (“NOM” or “Exchange”) to amend: Chapter IV, Section 6 (Series of Options Contracts Open for Trading) to establish strike-price intervals for options on Index-Linked Securities;
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The purpose of this proposal is to amend Chapter IV, Section 6 and Chapter VI, Section 2 to establish strike price intervals and trading hours for options on Index-Linked Securities (“ILS”), also known as exchange-traded notes (“ETN”), prior to the Exchange proposing to list and trade these new products.
The Commission has approved the Exchange's proposal, as well as the proposals of other options exchanges, to enable the listing and trading of options on ILS (ETN).
Prior to the commencement of trading options on Index-Linked Securities, the Exchange is proposing to establish that strike price intervals of $1 will be permitted where the strike price is less than $200. Where the strike price is greater than $200, $5 strikes will be permitted. These proposed changes are reflected by the addition of Chapter IV, Section 6, Supplementary Material .01(c) to Section 6.
The Exchange is seeking to establish $1 strikes for ILS (ETN) options where the strike price is less than $200 because the Exchange believes the marketplace and investors will be expecting these types of options to trade in a similar manner to options on exchange-traded funds (“ETFs”).
The Exchange proposes to amend Chapter VI, Section 2(b) to provide that options contracts on exchange-traded notes including Index-Linked Securities, as defined in Chapter IV, Section 3(l), may be traded on the Exchange until 4:15 p.m. each business day. This will establish similar trading hours for ILS (ETN) options as the currently-established trading hours for ETF options.
The Exchange has analyzed its capacity and believes the Exchange and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the additional traffic associated with the listing and trading
The Exchange expects that other option exchanges that have adopted rules providing for the listing and trading of options on Index-Linked Securities will submit similar proposals.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
Written comments were neither solicited nor received.
Within 35 days of the date of publication of this notice in the
(A) By order approve the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes new Rule 905NY regarding the Exchange's liability for system outages. The text of the proposed rule change is attached as Exhibit 5 to the 19b-4 form. A copy of this filing is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change
The purpose of this filing is to clarify that that [sic] the Exchange will generally not be held liable for any losses, expenses, damages or claims arising out of the use of its facilities, except to the extent that such losses, expenses, damages or claims are attributable to the willful misconduct, gross negligence, bad faith or fraudulent or criminal acts of the Exchange or its officers, employees or agents acting within the scope of their authority.
Currently, NYSE Amex Rule 60 limits the liability of the Exchange for claims arising out of use of NYSE Amex's Post Execution Reporting (“PER”) and NYSE Alternext Options Switch (“AMOS”) systems. NYSE Amex Rule 63 describes the Exchange's liability in general. These rules were intended to cover both the options and equities trading platforms of NYSE Amex. However, neither of these rules were revised following adoption of the Section 900NY rules governing the trading of options contracts.
The Exchange now proposes to adopt new NYSE Amex Rule 905NY to clarify that the Exchange (i) is generally not liable for losses, expenses, damages, or claims, arising out of the use of its facilities, but (ii) will assume some limited liability for damages arising out of the use of the NYSE Amex options trading platform under certain prescribed circumstances and capped at certain prescribed amounts. The proposed rule is substantially similar in scope to NYSE Amex Rules 60 and 63, but is modeled off NYSE Arca options Rule 14.2, Liability of Exchange. To the extent that a conflict may arise between the proposed Rule 905NY and either Rule 60 or 63, the new rule would take precedence. The Exchange is in the process of reviewing Rules 60 and 63 for possible revision or deletion. NYSE Arca Rule 14.2 offers a comprehensive and clear approach regarding liability, thus the Exchange seeks to harmonize its approach regarding liability with that of NYSE Arca.
The Exchange believes the proposed rule change is consistent with Section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) Impose any significant burden on competition; and
(iii) Become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange requested that the Commission waive the 30-day operative delay period. The Commission notes that the proposal is nearly identical to the rule of another self-regulatory organization,
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange is filing this proposed rule change to delay the application of NASDAQ Rule 4611(d) until 180 days following its approval. The text of the proposed rule change is available at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
On January 13, 2010, the Commission approved SR-NASDAQ-2008-104 which established new standards for sponsored access as set forth in NASDAQ Rule 4611(d), NASDAQ's Market Access Rule.
Nasdaq believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On March 24, 2010, the Department of State notified Congress that it had withdrawn Mexico's certification under United States Public Law 101-162, Section 609, because Mexico's turtle excluder device (TED) program was not currently comparable to the United States program as required by the statute. Withdrawal of Mexican certification is primarily a compliance and environmental issue, but it does have trade implications. The United States government is providing the Government of Mexico with detailed technical recommendations and capacity-building support with a view to strengthening Mexico's sea turtle protection program. Both governments will continue to actively seek further engagement opportunities to ensure renewal of Mexican certification within the shortest period of time consistent with the requirements of U.S. law.
James J. Hogan, III, Office of Marine Conservation, Bureau of Oceans and International Environmental and Scientific Affairs, Department of State, Washington, DC 20520-7818; telephone: (202) 647-2252.
Section 609 of Public Law 101-162 prohibits imports of certain categories of shrimp unless the President certifies to the Congress not later than May 1 of each year either: (1) That the harvesting nation has adopted a program governing the incidental capture of sea turtles in its commercial shrimp fishery comparable to the program in effect in the United States and has an incidental take rate comparable to that of the United States; or (2) that the fishing environment in the harvesting nation does not pose a threat of the incidental taking of sea turtles. The President has delegated the authority to make this certification to the Department of State. Revised State Department guidelines for making the required certifications were published in the
The Department of State has communicated this decision under Section 609 to the Office of Field Operations of U.S. Customs and Border Protection.
This decision regarding withdrawal of Mexico's certification means that wild-harvest shrimp from Mexico's commercial trawl fisheries may not be imported into the United States until Section 609 certification for Mexico can be reinstated. A Department of State DS-2031 form signed by the exporter and importer must accompany all shrimp imports into the United States. If shrimp products are from a non-certified country, a government official of the harvesting nation must also certify the shrimp was caught without harming sea turtles. Users should check boxes 7(A)(1) for aquaculture shrimp products or 7(A)(3) for artisanal shrimp products. Users should note that exception 7.A.(2) on the form “Harvested Using TEDs,” while a currently valid exception to the prohibition on imports from nations not certified under Public Law 101-162, is only available once the Department of State determines in advance that a country wishing to use this exception has in place an enforcement and catch segregation system for making such individual shipment certifications. Presently, only Brazil and Australia have shown that they have a system in place for specific fisheries. Exception 7(A)(4) is for other case-by-case, special circumstance determinations made by the Department of State in advance. For these reasons exceptions 7(A)(2) and 7(A)(4) are not applicable to imports of wild-caught shrimp from Mexico.
The OAS CIDIP Study Group will hold another public meeting to continue the discussion that began at the December 15, 2009 and continued at two additional meeting. This is not a meeting of the full Advisory Committee.
In the context of the Seventh Inter-American Specialized Conference on Private International Law (CIDIP-VII), the Committee on Juridical and Political Affairs (CJAP) of the Permanent Council of the OAS is carrying out work on consumer rights as part of its program on private international law. Three proposals have been put forward: A revised Brazilian draft convention on applicable law that has recently been expanded to include jurisdiction, a Canadian draft model law on applicable law and jurisdiction, and a United States proposal (with several components) for legislative guidelines/model laws/rules to promote consumer redress mechanisms such as small claims tribunals, collective procedures, on-line dispute resolution, and
The United States is also considering whether to pursue ratification of the Inter-American Convention on the Law Applicable to International Contracts (known as the Mexico City Convention), which was adopted at the Fifth Inter-American Specialized Conference on Private International Law (CIDIP-V). The United States is exploring the process for obtaining official corrections to the English text of the Convention to conform to the Spanish version. Copies of proposed corrections to the English text can be obtained through the contact points listed below. Other developments which may be relevant to work at the OAS include the proposal at UNCITRAL for future work on on-line dispute resolution and the establishment by the Permanent Bureau of the Hague Conference on Private International Law of an experts group to consider development of a non-binding instrument on choice of law in international commercial contracts.
Pursuant to section 7086(c)(2) of the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2010 (Division F, Pub. L. 111-117) (“the Act”), and Department of State Delegation of Authority Number 245-1, I hereby determine that it is important to the national interest of the United States to waive the requirements of section 7086(c)(1) of the Act with respect to the Government of Libya, and I hereby waive such restriction.
This determination shall be reported to the Congress, and published in the
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (
The following Agreements were filed with the Department of Transportation under sections 412 and 414 of the Federal Aviation Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing proceedings to enforce these provisions. Answers may be filed within 21 days after the filing of the application.
National Highway Traffic Safety Administration (NHTSA), DOT.
Request for public comment on proposed collection of information.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.
Comments must be submitted on or before June 1, 2010.
Direct all written comments to the U.S. Department of Transportation Dockets, 1200 New Jersey Ave., SE., Washington, DC 20590. Docket No. NHTSA-2010-0037.
Randolph Atkins, Ph.D., Contracting Officer's Technical Representative, Office of Behavioral Safety Research (NTI-131), National Highway Traffic Safety Administration, 1200 New Jersey Ave., SE., W46-500, Washington, DC 20590. Dr. Atkins' phone number is 202-366-5597 and his e-mail address is
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must publish a document in the
(i) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(ii) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(iii) How to enhance the quality, utility, and clarity of the information to be collected; and
(iv) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In compliance with these requirements, NHTSA asks public comment on the following proposed collection of information:
44 U.S.C. 3506(c)(2)(A).
Federal Railroad Administration, DOT.
Notice.
In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking re-approval of the following information collection activities that were previously approved by OMB under Emergency Clearance Procedures. Before submitting these information collection requirements for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.
Comments must be received no later than June 1, 2010.
Submit written comments on any or all of the following proposed activities by mail to either: Mr. Robert Brogan, Office of Safety, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590, or Ms. Kimberly Toone, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA to acknowledge receipt of their respective comments must include a self-addressed stamped postcard stating, “Comments on OMB control number 2130-0587.” Alternatively, comments may be transmitted via facsimile to (202) 493-6216 or (202) 493-6497, or via e-mail to Mr. Brogan at
Mr. Robert Brogan, Office of Safety, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone: (202) 493-6292) or Ms. Kimberly Toone, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to provide 60 days' notice to the public for comment on information collection activities before seeking approval of such activities by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested respondents to comment on the following summary of proposed information collection activities regarding (i) Whether the information collection activities are necessary for FRA to properly execute its functions, including whether the activities will have practical utility; (ii) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (iii) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (iv) ways for FRA to minimize the burden of information collection activities on the public by automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Below is a brief summary of the information collection activities that FRA will submit for renewed clearance by OMB as required under the PRA:
As part of the RSIA, Congress provided $50 million to FRA to award, in one or more grants, to eligible projects by passenger and freight rail carriers, railroad suppliers, and State and local Governments. Funds will be awarded to projects that have a public benefit of improved railroad safety and efficiency, with priority given to projects that make PTC technologies interoperable between railroad systems; projects that accelerate the deployment of PTC technology on high-risk corridors, such as those that have high volumes of hazardous material shipments; and for projects over which commuter or passenger trains operate, or that benefit both passenger and freight safety and efficiency.
Funds provided under this grant program may constitute a maximum of 80 percent of the total cost of a selected project, with a minimum of 20 percent of costs funded from other sources. The funding provided under these grants will be made available to grantees on a reimbursement basis. FRA anticipates awarding grants to multiple eligible participants. FRA may choose to award a grant or grants within the available funds in any amount. Funding made available through grants provided under this program, together with funding from other sources that is committed by a grantee as part of a grant agreement, must be sufficient to complete the funded project and achieve the anticipated technology development. FRA will begin accepting grant applications 10 days after publication of the separate Notice of Funds Availability, which will be published on March 29, 2010, in the
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b), 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
Federal Transit Administration (FTA), DOT.
Notice of Availability of Final Circular.
The Federal Transit Administration (FTA) is issuing Circular 9030.1D to provide comprehensive assistance to grantees in implementing the Urbanized Area Formula Program (Section 5307) for capital, planning, and some operating grants in urbanized areas.
The effective date of this circular is May 1, 2010.
A copy of the circular and comments and material received from the public, as well as any documents indicated in the preamble as being available in the docket, are part of docket FTA-2009-0010 and are available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor, Room W12-140, Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
You may also review the circular, comments, and supporting documents online through the Federal Document Management System (FDMS) at Web site:
This notice does not include the final circular. Electronic versions of the final circular will be posted on
Henrika Buchanan-Smith, Office of Program Management, Federal Transit Administration, 1200 New Jersey Ave., SE., East Building, Fourth Floor, Washington, DC 20590, phone: (202) 366-5080, fax: (202) 366-7951, or e-mail,
This notice provides a summary of changes to FTA Circular 9030.1C, Urbanized Area Formula Program: Program Guidance and Grant Application Instructions and addresses comments received in response to FTA's September 30, 2009
Seven commenters responded to the notice of availability, including a public transportation trade association, a vanpool operator, two large metropolitan transit agencies, a member of the public, and one who wished to remain anonymous.
One commenter asked that FTA extend the comment period for an additional 45 to 60 days. FTA declined this request, as FTA specified in the Notice of Availability that “[l]ate-filed comments will be considered to the extent practicable,” and FTA has considered all comments received after the November 20, 2009, deadline. Several commenters asked that FTA withhold publication of the circular until new surface transportation reauthorization legislation had been enacted. FTA believes that such an approach is not feasible, given uncertainty concerning the reauthorization process and the need to implement changes mandated by the 2005 reauthorization bill.
One commenter objected to the language in section 6 of the title page where FTA reserved the right to update the circular to reflect changes in revised or new guidance or regulation. FTA disagrees with this objection, noting that FTA is already obligated to include an opportunity for notice and comment when revising a circular or regulation, and there is no need to duplicate that effort when updating each circular affected by that revision.
Chapter I of the revised circular is the introductory chapter containing general information about FTA, including contact information. It briefly addresses the current authorizing legislation for the Urbanized Area Formula program (a.k.a. “Section 5307 program”), provides information about Grants.gov, includes definitions applicable to the program and provides a brief program history. A “Definitions” section has been added to this circular, defining common terms used in the Section 5307 program.
Chapter I contains a number of topics that have been reorganized in the new circular. The former section “Other Funds Available for Transit Projects” is now renamed “Relationship to Other Programs” to be consistent with other FTA circulars, and moved to Chapter II. We have also moved the section titled “Flexible Funds” to the “Relationship to Other Programs” section in Chapter II, and transferred information on apportionments and local and Federal share to Chapter III. In addition, we have incorporated the information in the section titled “Grant Application Process” into other sections of the revised circular.
Several commenters suggested that the term “direct recipient” be deleted in favor of the term “designated recipient.” FTA declines to adopt that change, as the two terms are not identical. A “designated recipient” is an entity officially designated by the Governor through the planning process to receive and apportion funds. A direct recipient, in contrast, is any entity that receives funds directly from FTA. In some cases, the designated recipient may also be a direct recipient, although a direct recipient may not necessarily be the designated recipient.
One commenter suggested that content be added to address the National Transit Database (NTD) and the Uniform System of Accounts (USOA). FTA has accepted and incorporated those changes in Chapter I, under the section titled “Definitions.” Another suggested that administrative costs be defined and addressed in the Circular, which FTA has done in Chapter III, section 6, “Eligible Capital Projects.” One commenter asked FTA to address force account plans, which FTA has done in Appendix E, “Preventive Maintenance.”
Chapter II of the former circular, “Applicant Eligibility” has been augmented to contain additional detail about the Urbanized Area Formula program. Chapter II addresses the statutory authority for the Urbanized Area Formula program, followed by the goals of the program, recipient designation, the respective roles of the
One commenter, a large metropolitan transportation agency, objected to FTA's attempt to meet GPRA (Government Performance and Results Act) requirements by setting performance targets, using program measures to determine grant funding levels, or using those measures in a punitive manner. The commenter suggested that FTA provide additional clarification in the final circular as to the measurement of fleet condition and specifically recommends that FTA require recipients to report “average fleet age” information. FTA acknowledges the commenter's concerns, but ridership and condition data are long-standing national data measures and submitted to the National Transit Database on a regular basis. With regard to their use as determinants, formulas such as the fixed guideway tier of the 5307 formula are determined by Congress and implemented by FTA. Finally, FTA believes that comprehensive fleet age and condition statistics are necessary for FTA to estimate fleet condition on a national level with a reasonable degree of accuracy.
Chapter III continues to address eligible capital, operating and planning activities, as well as advance capital project authority, reflecting changes made by Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for users (SAFETEA-LU). Transportation development credits (formerly referred to as toll revenue credits) have been added to Chapter III to provide a calculation method that is consistent with the method used by the Federal Highway Administration (FHWA). FTA has moved and supplemented information about “Preventive Maintenance” into a new Appendix E due to the length and complexity of the topic. FTA has moved pre-award authority and letters of no prejudice to Chapter IV. Additional information addressed in Chapter III includes apportionments, funds availability, and local and Federal share. All of these sections have been updated to be consistent with the law and with the format of other recently revised FTA circulars.
One commenter asked FTA to support a definition of Mobility Management that included employer-oriented Transportation Management Organizations. FTA has included language in Chapter III, section 6f(5) to implement this request. The same commenter asked that FTA revise Chapter III to address eligibility that takes into account emissions benefits for purposes of compliance with the Clean Air Act. Emissions benefits, while a factor under the Congestion Management and Air Quality (CMAQ) program, are not statutory factors for consideration under the section 5307 program. Finally the same commenter asked that the circular include stronger provisions to include private providers and operators in the local planning and programming process. FTA does not get involved in the details of the local public participation process, and instead defers to the local Metropolitan Planning Organizations (MPOs) to determine their locally-developed processes and procedures.
The sections of former Chapter IV, “Apportionments,” describing how funds are apportioned under the urbanized area formula program and apportionments are transferred to other eligible programs, are now in the first sections of Chapter III. FTA has added a new Chapter IV, “Program Development,” to address the role of the designated recipient and the metropolitan planning organization (MPO), applicants other than designated recipients; pass-through arrangements (formerly found in Chapter II); subarea allocation and transfer of funds for highway projects (formerly found in Chapter IV); planning requirements (formerly in Appendix A); program of projects and public participation requirements; certifications and assurances (formerly found in Chapter V); undertaking projects in advance; a catch-all section for pre-award authority; and letters of no prejudice (formerly found in Chapter III).
FTA has revised each of these sections to reflect changes in statutes, regulations, and FTA policy. We are also streamlining some sections, such as planning, while expanding others, such as certifications and assurances, to provide more detailed guidance to our recipients.
One commenter noted that the draft circular did not account for the various roles of designated recipients vis-à-vis Metropolitan Planning Organizations (MPO) throughout the country. Given the wide variation of these roles among the various urbanized areas (UZA), the commenter stated that the circular must be flexible. The commenter perceived that Chapter IV of the draft assumes a Metropolitan Planning Organization (MPO) is the sole designated recipient for the UZA. This structure is impractical in some communities where the Metropolitan Planning Organization (MPO) is not staffed sufficiently to undertake the duties of a designated recipient or others where the independence of local governments is more pronounced and, as a result, a single Metropolitan Planning Organization (MPO) function is primarily to coordinate the activities of multiple designated recipients. FTA agrees with this commenter and has revised Chapter IV accordingly to clarify the relationship between Metropolitan Planning Organization (MPO), Designated Recipient and other recipients. Chapter IV has also been revised to clarify that the Metropolitan Planning Organization (MPO) and the designated recipient can be two separate entities.
Another commenter, a large metropolitan transportation agency operating across state boundaries, asked that the circular specifically address transit agencies that must work with multi-state Metropolitan Planning Organization (MPO)s, acknowledging them as designated recipients. Consistent with statute, however, designated recipients are determined by local officials, not FTA, and FTA believes language in a circular would have no effect on that process.
One commenter asked why “toll revenue credits” had been renamed “transportation development credits” in the revised circular. FTA is making this change to reflect statutory changes in the 2005 reauthorization law.
Several commenters suggested that the planning justification be removed from the Transportation Electronic Award Management (TEAM) system as redundant, because by virtue of their inclusion in a Statewide Transportation Improvement Plan (STIP), they already have been through the Metropolitan Planning Organization (MPO) planning process. FTA does not agree with this
Finally, one commenter suggested that the discussion of joint development address private investment and provide additional guidance on how retail space can qualify as incidental space. FTA believes that FTA's publication “Final Agency Guidance on the Eligibility of Joint Development Improvements Under Federal Transit Law” (72 FR 5788, Feb. 7, 2007) provides adequate direction, but interested parties may contact FTA's headquarters or regional offices for specific questions not addressed by the Final Agency Guidance document.
The revised Chapter V addresses the coordinated planning process required under the Section 5310, Elderly Individuals and Individuals with Disabilities formula program; the Section 5316, Job Access and Reverse Commute (JARC) program; and the Section 5317, New Freedom program. Often the designated recipient for the Urbanized Area Formula program will also be the designated recipient for one or more of these human services transportation programs. The revised Chapter V contains substantially the same information as that found in FTA Circular 9040.1F, Nonurbanized Area Formula Program Guidance and Grant Application Instructions.
The information found in the former Chapter V, “Requirements Associated with Urbanized Area Formula Program Grants” has been reorganized into other chapters. For example, the section, “National Transit Database Reporting System” has been updated and moved to the new Chapter VI. We are also providing a link to the FTA Web site as well as to the TEAM system, where applicants can find the instructions. FTA has moved the section titled “Certification Procedures” to the rewritten Chapter IV. The section titled “FTA Oversight” has been updated and moved to the new Chapter II. The section titled “Certifications Particular to the Urbanized Area Formula Program” has been renamed “Certifications Required by 49 U.S.C. 5307” and moved to Chapter IV. Updated information on program of projects and public participation requirements have also been moved to Chapter IV. Finally, FTA is eliminating the “Alphabetical List of Other Requirements” as the content of that section is already addressed in other chapters. Updated information related to “Associated Capital Maintenance Items,” “New Technology Introduction” and “Lease vs. Buy Considerations” can be found in Chapter III under “Capital Projects;” updated information on “Buses,” “Bus Facilities,” and “Fixed Guideway Rolling Stock,” has been consolidated into Chapter IV's section titled, “Requirements Related to Rolling Stock and Equipment.” The section on “New Starts” has been removed because information on the relationship between the New Starts program and the Urbanized Area Formula program is already addressed in Chapter II. Other provisions in the former Chapter V can be found in the revised Chapter VII, “Other Provisions.”
The content of the former Chapter VI, “Application Instructions,” has been updated, streamlined, and moved to Appendix A. The revised Chapter VI contains information on the TEAM system, Electronic Clearing House Operation (ECHO) system, and, as previously discussed, information on the National Transit Database, requirements related to vehicles and equipment, and requirements related to facilities. The information in this chapter is consistent with that found in other recently updated FTA circulars.
Several commenters stated that the estimation of useful service life in Chapter VI, section 5, for facilities was impractical, given variations in climate, geography, and usage. They claimed that such an exercise would result in additional investments of time and costs on transit agencies and FTA alike with no practical benefit. FTA does not agree with these commenters—by establishing a standard useful life for facilities, FTA can ensure consistency across projects and regions.
Chapter VII of the former circular contained instructions for preparing a project budget. This information has been updated and moved to Appendix B, consistent with other recently revised FTA circulars. The revised Chapter VII conforms to the “Other Provisions” chapters in other FTA circulars, and addresses common Federal requirements that FTA grantees are held to in addition to the program-specific requirements. As previously stated, some of the information has been relocated from the former Chapter V's “Alphabetical Listing of Other Requirements.” Other sections, such as the Presidential Coin Act, are new to this circular. Recipients should use this chapter, in conjunction with FTA's Master Agreement and the current fiscal year Certifications and Assurances to assure that they have met all requirements. Recipients may contact FTA HQ or Regional Counsel if they have additional questions concerning these requirements.
Once commenter asked FTA to include explicit language excluding vanpool drivers from FTA's drug and alcohol testing requirements. Consistent with prior legal opinions from FTA's Chief Counsel, FTA has included specific language in Chapter VII, section 7 of the revised circular.
The appendices are intended as tools for developing a grant application. Appendix A specifically addresses steps and instructions for preparing a grant application, including pre-application and application stages. This information is comparable to Chapter VI, “Application Instructions,” in the former circular, although it has been updated and reorganized. Appendix A also includes an application checklist. Appendix B provides budgetary information, including a sample budget, replacing the information formerly found in Chapter VII, “Instructions for Preparing a Project Budget.” Appendix C consists of the content of the former Appendix D, “Operating Assistance Projects.” Appendix D contains the content of the former Appendix F, “Forms and Representative Documents,” with the exception of documents we have removed that are now readily available online. Appendix E contains a description of the preventive maintenance program, and is new to this circular. Appendix F contains updated contact information for FTA's regional and metropolitan offices, which was previously contained in Chapter VIII of the former circular.
Several commenters opined that the “Engineering Review” required in the revised Appendix A would unnecessarily add time and costs without likely improvement of project management. One commenter claimed that this proposal raises the bar for new projects and will increase the cost of project development, grant management, and FTA oversight. Another commenter added that state of good repair projects and routine replacement investments should not be subjected to more extensive oversight. FTA responds that this is not a new requirement, but rather, is currently required under Chapter VI, section 9c, of the outgoing FTA Circular 9030.1C,
Drug Enforcement Administration (DEA), Department of Justice.
Interim Final Rule with Request for Comment.
The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are in addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.
This rule has been classified as a major rule subject to Congressional review. The effective date is June 1, 2010. However, at the conclusion of the Congressional review, if the effective date has been changed, the Drug Enforcement Administration will publish a document in the
The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of June 1, 2010.
Written comments must be postmarked and electronic comments must be submitted on or before June 1, 2010. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after Midnight Eastern Time on the last day of the comment period.
To ensure proper handling of comments, please reference “Docket No. DEA-218” on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be sent to DEA by sending an electronic message to
Please note that DEA is requesting that electronic comments be submitted before midnight Eastern Time on the day the comment period closes because
Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone (202) 307-7297.
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.
Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the
DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1399. These regulations are designed to ensure an adequate supply of controlled substances for legitimate medical, scientific, research, and industrial purposes, and to deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity.
Controlled substances are drugs and other substances that have a potential for abuse and psychological and physical dependence; these include opioids, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances. DEA lists controlled substances in 21 CFR part 1308. The substances are divided into five schedules: Schedule I substances have a high potential for abuse and have no currently accepted medical use in treatment in the United States. These substances may only be used for research, chemical analysis, or manufacture of other drugs. Schedule II-V substances have currently accepted medical uses in the United States, but also have potential for abuse and psychological and physical dependence that necessitate control of the substances under the CSA. The vast majority of Schedule II, III, IV, and V controlled substances are available only pursuant to a prescription issued by a practitioner licensed by the State and registered with DEA to dispense the substances. Overall, controlled substances constitute between 10 percent and 11 percent of all prescriptions written in the United States.
The CSA provides that a controlled substance in Schedule II may only be dispensed by a pharmacy pursuant to a “written prescription,” except in emergency situations (21 U.S.C. 829(a)). In contrast, for controlled substances in Schedules III and IV, the CSA provides that a pharmacy may dispense pursuant to a “written or oral prescription.” (21 U.S.C. 829(b)). Where an oral prescription is permitted by the CSA, the DEA regulations further provide that a practitioner may transmit to the pharmacy a facsimile of a written, manually signed prescription in lieu of an oral prescription (21 CFR 1306.21(a)).
Under longstanding Federal law, for a prescription for a controlled substance to be valid, it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice (
The Controlled Substances Act is unique among criminal laws in that it stipulates acts pertaining to controlled substances that are permissible. That is, if the CSA does not explicitly permit an action pertaining to a controlled substance, then by its lack of explicit permissibility the act is prohibited. Violations of the Act can be civil or criminal in nature, which may result in administrative, civil, or criminal proceedings. Remedies under the Act can range from modification or revocation of DEA registration, to civil monetary penalties or imprisonment, depending on the nature, scope, and extent of the violation.
Specifically, it is unlawful for any person knowingly or intentionally to manufacture, distribute, or dispense, a controlled substance or to possess a controlled substance with the intent of manufacturing, distributing, or dispensing that controlled substance, except as authorized by the Controlled Substances Act (21 U.S.C. 841(a)(1)).
Further, it is unlawful for any person knowingly or intentionally to possess a controlled substance unless such substance was obtained directly, or pursuant to a valid prescription or order, issued for a legitimate medical purpose, from a practitioner, while acting in the course of the practitioner's professional practice, or except as otherwise authorized by the CSA (21 U.S.C. 844(a)). It is unlawful for any person to knowingly or intentionally acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge (21 U.S.C. 843(a)(3)).
It is unlawful for any person knowingly or intentionally to use a DEA registration number that is fictitious, revoked, suspended, expired, or issued to another person in the course of dispensing a controlled substance, or for the purpose of acquiring or obtaining a controlled substance (21 U.S.C. 843(a)(2)).
Beyond these possession and dispensing requirements, it is unlawful for any person to refuse or negligently fail to make, keep, or furnish any record (including any record of dispensing) that is required by the CSA (21 U.S.C. 842(a)(5)). It is also unlawful to furnish any false or fraudulent material information in, or omit any information from, any record required to be made or kept (21 U.S.C. 843(a)(4)(A)).
Within the CSA's system of controls, it is the individual practitioner (
Thus, a prescription is much more than the mere method of transmitting dispensing information from a practitioner to a pharmacy. The prescription serves both as a record of the practitioner's determination of the legitimate medical need for the drug to be dispensed, and as a record of the dispensing, providing the pharmacy with the legal justification and authority to dispense the medication prescribed by the practitioner. The prescription also provides a record of the actual dispensing of the controlled substance to the ultimate user (the patient) and, therefore, is critical to documenting that controlled substances held by a pharmacy have been dispensed legally. The maintenance by pharmacies of complete and accurate prescription records is an essential part of the overall CSA regulatory scheme established by Congress.
On January 13, 2010, HHS published two rules to implement the provisions of the HITECH ACT. The Centers for Medicare and Medicaid Services published a notice of proposed rulemaking entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program” (75 FR 1844) [CMS-0033-P, RIN 0938-AP78]. The proposed rule would specify the initial criteria an eligible professional and eligible hospital must meet to qualify for the incentive payment; calculation of the incentive payment amounts; and other payment and program participation issues.
The Office of the National Coordinator for Health Information Technology published an interim final rule entitled “Health Information Technology; Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” (75 FR 2014) [RIN 0991-AB58]. The interim final rule became effective February 12, 2010. The certification criteria adopted in the interim final rule establish the capabilities and related standards that certified electronic health record technology will need to include in order to, at a minimum, support the achievement of the proposed meaningful use Stage 1 (beginning in 2011) by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR incentive programs. The comment period for both rules ended March 15, 2010.
The Office of the National Coordinator for Health Information Technology also published a notice of proposed rulemaking entitled “Proposed Establishment of Certification Programs for Health Information Technology” (75 FR 11328, March 10, 2010) (RIN 0991-AB59) which proposes the establishment of certification programs for purposes of testing and certifying health information technology. The proposed rule specifies the processes the National Coordinator for Health Information Technology would follow to authorize organizations to perform the certification of health information technology.
Electronic prescription applications may be stand-alone applications (
The existing electronic prescription applications allow practitioners to create a prescription electronically, but accommodate different means of transmitting the prescription to the pharmacy. Practitioners may print the prescription for manual signature; the prescription may then be given to the patient or the practitioner's office may fax it to a pharmacy. Some applications will automatically transmit an image of the prescription as a facsimile. True
Because of the large number of electronic prescription and pharmacy applications and the current lack of a mature standard for the formatting of prescription data, most electronic prescriptions are routed from the electronic prescription or EHR application through intermediaries, at least one of which determines whether the prescription file needs to be converted from one software version to another so that the receiving pharmacy application can correctly import the data. There are generally three to five intermediaries that route prescriptions between practitioners and pharmacies. For example, a prescription may be routed to the application provider, then to a hub that converts the prescription from one software version to another to meet the requirements of the receiving pharmacy, then to the pharmacy application provider or chain pharmacy server before reaching the dispensing pharmacy. Some application providers further route prescriptions through aggregators who direct the prescription to a hub or to a pharmacy. For closed healthcare systems, where the practitioners and pharmacies are part of the same system, intermediaries are not needed.
One intermediary, SureScripts/RxHub, certifies electronic prescription and pharmacy applications for compliance with the SCRIPT standard; SureScripts/RxHub determines whether the electronic prescription application creates a prescription that conforms to the SCRIPT standard and whether the pharmacy application is able to open and read a SCRIPT prescription correctly.
The Certification Commission for Healthcare Information Technology (CCHIT) is a private, nonprofit organization recognized by the Secretary of HHS as a certification body for EHRs under the exception to the physician self-referral prohibition and safe harbor under the anti-kickback statute, respectively, for certain arrangements involving the donation of interoperable EHR software to physicians and other health care practitioners or entities (71 FR 45140 and 71 FR 45110, respectively, August 8, 2006). CCHIT develops criteria for electronic medical records (EMRs or EHRs) and certifies applications against these criteria. Although electronic prescribing is addressed in the CCHIT ambulatory certification criteria, these criteria do not address all elements with which DEA has concern, such as the particular information required in a prescription. The CCHIT criteria do address security issues, such as access control and audit logs. CCHIT is developing standards for stand-alone electronic prescription applications. DEA has not been able to identify any organization that sets standards for or certifies pharmacy applications for security issues or even for the ability to record and retain information such as dispensing data.
Most of the applications appear to rely on passwords to identify a user of the application. Passwords are often described as the weakest link in security because they are easily guessed or, in healthcare settings, where multiple people use the same computers, easily observed. Where longer, more complex passwords are required by applications as a means to increase their effectiveness, this can actually be counterproductive, as it often causes users to write down their passwords, which weakens overall security.
Even if there are logical access controls, they may not limit who can perform functions such as approving a prescription or signing it. At medical practices and even more so at hospitals and clinics, many staff members may use the same computers. The person who logged onto the application may not be the person entering prescription information later or the person who transmits the prescription. Some applications have internal audit trail functions, but whether these are active and reviewed is at the practitioner's discretion. In addition, with multiple people using computers, it is unclear that the audit trail can accurately identify who is performing actions. Except for those Federal electronic prescription applications that require practitioners to digitally sign prescriptions, none of the applications transmit any indication that a prescription was actually signed.
With multiple intermediaries moving prescriptions between practitioners and pharmacies, there is no assurance that a prescription may not be altered or added during transmission. Some intermediaries have good security, but there is no requirement for them to do so and practitioners and pharmacies have no control over which intermediaries are used. The pharmacy has no way to verify that the prescription was sent by the practitioner whose name is on the prescription or that if it was, that it was not altered after the practitioner issued it. The evidence of forgery and alteration that pharmacies use to identify illegitimate paper prescriptions do not exist in an electronic record—not only because electronic prescriptions contain no handwritten signatures, but also because electronic prescriptions are typically created from drop-down menus, which prevent or reduce the likelihood of misspelled drug names, inappropriate dosage forms and units, and other indicators of possible forgery.
The existing processes used for electronic prescriptions for noncontrolled substances, therefore, make it easy for every party to repudiate the prescription. A practitioner can claim that someone outside the practice issued a prescription in his name, that someone else in the practice used his password to issue a prescription, or that it was altered after he issued it either in transmission or at the pharmacy. Proving or disproving any of these claims would be very difficult with the existing processes. DEA and other law enforcement agencies might not be able to prove a case against someone issuing illegitimate prescriptions; equally important, practitioners might have trouble proving that they were not responsible for illegitimate prescriptions issued in their name.
Because regulations do not currently exist permitting the use of electronic prescriptions for controlled substances, there is naturally no evidence of diversion related to electronic prescriptions of these substances. That there is no evidence that other noncontrolled prescription drugs have been diverted through electronic prescriptions is not relevant for several reasons. First, there is a very limited, if any, black market for other prescription medications. Second, there is no reason for law enforcement to investigate diversion of these medications, if it occurs, because such diversion may not be illegal (this would depend on State law). Finally, the number of electronic prescriptions, including refill requests, has not been great (4 percent in 2008, according to SureScripts/RxHub).
In contrast, prescription controlled substances have always carried a significant inherent risk of diversion, both because they are addictive and because they can be sold for significantly higher prices than their retail price. The recent studies showing increasing levels of abuse of these drugs throughout the United States heightens the cause for concern. Accordingly, with controlled substances there is a considerable incentive for individuals and criminal organizations to exploit any vulnerabilities that exist to obtain these substances illegally.
The National Survey on Drug Use and Health (NSDUH) (formerly the National Household Survey on Drug Abuse) is an annual survey of the civilian, non-institutionalized, population of the United States aged 12 or older. The survey is conducted by the Office of Applied Studies, Substance Abuse and Mental Health Services Administration, of the Department of Health and Human Services. Findings from the 2008 NSDUH are the latest year for which information is currently available. The 2008 NSDUH
The consequences of prescription drug abuse are seen in the data collected by the Substance Abuse and Mental Health Services Administration on emergency room visits. In the latest data, Drug Abuse Warning Network (DAWN), 2006: National Estimates of Drug-Related Emergency Department Visits,
People dependent on the drugs are willing to pay a high premium to obtain them, creating a black market for these drugs. The problem of illegitimate prescriptions, which exists with paper prescriptions, is exacerbated by the speed of electronic transmissions and the difficulty of identifying an electronic prescription as invalid. A single prescription can be sent to multiple pharmacies; multiple practitioners' identities can be stolen and each identity used to issue a limited number of prescriptions to prevent a pharmacy or a State prescription monitoring program from noticing an unusual pattern. DEA's goal in the proposed rule was to address these vulnerabilities and ensure that before controlled substance prescriptions are issued electronically, the process is adequately secure to protect both DEA registrants and society.
Based on DEA's concerns, certain requirements must exist for any system to be used for the electronic prescribing of controlled substances:
• Only DEA registrants may be granted the authority to sign controlled substance electronic prescriptions. The approach must, to the greatest extent possible, protect against the theft of registrants' identities.
• The method used to authenticate a practitioner to the electronic prescribing system must ensure to the greatest extent possible that the practitioner cannot repudiate the prescription. Authentication methods that can be compromised without the practitioner being aware of the compromise are not acceptable.
• The prescription records must be reliable enough to be used in legal actions (enforcing laws relating to controlled substances) without diminishing the ability to establish the relevant facts and without requiring the calling of excessive numbers of witnesses to verify records.
• The security systems used by any electronic prescription application must, to the greatest extent possible, prevent the possibility of insider creation or alteration of controlled substance prescriptions.
Most commenters, however, raised a substantial number of issues about various provisions of the proposed rule; their comments are addressed in detail in section IV of this preamble. On a general level, they expressed concern that the proposed requirements would prove too burdensome and would create a barrier to the adoption of electronic prescribing. They also raised two overarching issues that have affected the approach that DEA has adopted in this interim final rule.
First, the commenters noted that DEA's proposed approach addressed primarily one model for electronic prescription applications, application service providers (ASPs). In this model, the practitioner subscribes to a service and accesses, usually over the Internet, an electronic prescription application that is maintained on the ASP's servers. The ASP controls access to the application, has access to all of the records, and maintains security. The practitioner does not need to install the application or maintain servers that archive the records. Many electronic prescription application providers, particularly those that develop EHRs and hospital applications, install their software on the practitioner's computers. Once the application is installed, the electronic prescription application provider's role is limited to providing technical assistance when needed. Access control, records, and security are handled by the practitioners or their staff. Some of the proposed provisions did not work when the electronic prescription application provider is not involved in logical access control.
Second, many commenters pointed out that the technology continues to evolve, the EHR applications are still changing, and that the standards for electronic prescriptions are not mature. A number of commenters indicated that the current transmission system, which relies on a series of intermediaries to provide interoperability, may not be needed when both technology and the standards evolve. These commenters wanted DEA to provide more flexibility to be able to adjust to advancements as they occur.
This section provides an overview of the interim final rule. As noted above, commenters raised a number of issues related to specific proposed provisions. DEA has revised the rule to address commenters' concerns and to recognize the variations in how electronic prescription applications are implemented. In arriving at an interim final rule, DEA has balanced a number of considerations. Chief among these is DEA's obligation to ensure that the regulations minimize, to the greatest extent possible, the potential for diversion of controlled substances resulting from nonregistrants gaining access to electronic prescription applications and electronic prescriptions. At the same time, DEA has sought to streamline the rules to reduce the burden on registrants.
In response to commenters' concerns, DEA is adopting an approach to identity proofing (verifying that the user is who he claims to be) and logical access control (verifying that the authenticated user has the authority to perform the requested operation) that is different from the approach that it proposed. The interim final rule provisions related to these two steps are based on the concept of separation of duties: No single individual will have the ability to grant access to an electronic prescription application or pharmacy application. For individual practitioners in private practice (as opposed to practitioners associated with an institutional practitioner registrant), identity proofing will be done by an authorized third party that will, after verifying the identity, issue the authentication credential to a registrant. As some commenters suggested, DEA is requiring registrants to apply to certain Federally approved credential service providers (CSPs) or certification authorities (CAs) to obtain their authentication credentials or digital certificates. These CSPs or CAs will be required to conduct identity proofing at National Institute of Standards and Technology (NIST) SP 800-63-1 Assurance Level 3, which allows either in-person or remote identity proofing. Once a Federally approved CSP or CA has verified the identity of the practitioner, it will issue the necessary authentication credential.
The successful issuance of the authentication credentials will be necessary to sign electronic controlled substance prescriptions, but possession of the credential will not be sufficient to gain access to the signing function. The electronic prescription application must allow the setting of logical access controls to ensure that only DEA registrants or persons exempted from the requirement of registration are allowed to indicate that prescriptions are ready to be signed and sign controlled substance prescriptions. Logical access controls may be by user or role-based; that is, the application may allow permissions to be assigned to individual users or it may associate permissions with particular roles (
DEA is allowing, but not requiring, institutional practitioners to conduct identity proofing in-house as part of their credentialing process. At least two people within the credentialing office must sign any list of individuals to be granted access control. That list must be sent to a separate department (probably the information technology department), which will use it to issue authentication credentials and enter the logical access control data. As with private practices, two individuals will be required to enter and approve the logical access control information. Institutional practitioners may require registrants and those exempted from registration under § 1301.22 to obtain identity proofing and authentication credentials from the same CSPs or CAs that individual practitioners use. The institutional practitioner may also conduct the identity proofing in-house, then provide the information to these CSPs or CAs to obtain the authentication credentials. In this last case, the institutional practitioners would be acting as trusted agents for the CSPs or CAs, under rules that those organizations set. Because DEA has made extensive changes to the requirements related to identity proofing and logical access control, DEA is seeking further comments on these issues.
As proposed, DEA is requiring in this interim final rule that the authentication credential be two-factor. Two-factor authentication (two of the following—something you know, something you have, something you are) protects the practitioner from misuse of his credential by insiders as well as protecting him from external threats because the practitioner can retain control of a biometric or hard token. Authentication based only on knowledge factors is easily subverted because they can be observed, guessed, or hacked and used without the practitioner's knowledge. In the interim final rule DEA is allowing the use of a biometric as a substitute for a hard token or a password. If a hard token is used, it must meet FIPS 140-2 Security Level 1 for cryptographic devices or one-time-password devices and must be stored on a device that is separate from the computer being used to access the application. The CSPs and CAs may issue a new hard token or register and provide credentials for an existing token. Regardless of whether a new token is provided and activated or an existing token is registered for the signing of controlled substances prescriptions, communications between the CSP or CA and practitioner applicant must occur through two channels (
However, while DEA is requiring in this interim final rule that the authentication credential be two-factor, DEA is seeking further comments on this issue. Specifically, DEA seeks comments in response to the following question:
• Is there an alternative to two-factor authentication that would provide an equally safe, secure, and closed system for electronic prescribing of controlled substances while better encouraging adoption of electronic prescriptions for controlled substances? If so, please describe the alternative(s) and indicate how, specifically, it would better encourage adoption of electronic prescriptions for controlled substances without diminishing the safety and security of the system.
DEA is establishing standards with which any biometric being used as one factor to sign controlled substance prescriptions must comply; however, DEA is not specifying the types of biometrics that may be used to allow for the greatest flexibility and adaptation to new technologies in the future. DEA consulted extensively with NIST in the development of these standards and has relied on their recommendations for this aspect of the rule. If a biometric is used, it may be stored on a computer, a hard token, or the biometric reader. Storage of biometric data, whether in raw or template format, has implications for data protection and maintenance. These are considerations that should be weighed by application providers and implementers when choosing where and how biometric data may be stored. Additionally, application providers and implementers may wish to consider using open standard biometric data formats when available, to provide interoperability where more than one application provider may be providing biometric capabilities (
DEA is requiring that the application display a list of controlled substance prescriptions for the practitioner's review before the practitioner may authorize the prescriptions. A separate list must be displayed for each patient. All information that the DEA regulations require to be included in a prescription for a controlled substance, except the patient's address, must appear on the review screen along with a notice that completing the two-factor authentication protocol is legally signing the prescription. A separate key stroke will not be required for this statement. Registrants must indicate that each controlled substance prescription shown is ready to be signed. When the registrant indicates that one or more prescriptions are to be signed, the application must prompt him to begin the two-factor authentication protocol. Completion of the two-factor authentication protocol legally signs the prescriptions. When the two-factor authentication protocol is successfully completed, the application must digitally sign and archive at least the DEA-required information. If the practitioner is digitally signing the prescription with his own private key,
The electronic prescription application must generate a monthly log of controlled substance prescriptions issued by a registrant, archive a record of those logs, and provide the logs to the practitioner. The practitioner is not required to review the monthly log.
Because the prescription information will be digitally signed when the practitioner completes the two-factor authentication protocol, the prescription need not be transmitted immediately. Information other than the information that must be digitally signed may be added to the file (
DEA has clarified that the application may print copies of an electronically transmitted prescription if they are clearly labeled as copies, not valid for dispensing. If a practitioner is notified by an intermediary or pharmacy that a transmission failed, he may print a copy of the transmitted prescription and manually sign it. The prescription must indicate that it was originally transmitted to a specific pharmacy and that the transmission failed. The pharmacy is responsible for checking to ensure that the prescription was not received electronically and no controlled substances were dispensed pursuant to the electronic prescription prior to filling the paper prescription.
DEA has also clarified that the requirement that the DEA-required contents of the prescription not be altered during transmission applies only to changes to the content (not format) by intermediaries, not to changes that may lawfully be made at a pharmacy after receipt. Pharmacy changes to electronic prescriptions for controlled substances are governed by the same statutory and regulatory limitations that apply to paper prescriptions. Intermediaries may not convert an electronic controlled substance prescription into a fax. Once a prescription is created electronically, all records of the prescription must be retained electronically.
Unless the prescription is being transmitted with a digital signature, either the last intermediary or the pharmacy must digitally sign the prescription; the pharmacy must archive the digitally signed prescription. Both the electronic prescription application and the pharmacy application must maintain an internal audit trail that records any modifications, annotations, or deletions of an electronic controlled substance prescription or when a functionality required by the rule is interfered with; the time and date of the action; and the person taking the action. The application provider and the registrants must develop a list of auditable events; auditable events should be occurrences that indicate a potential security problem. For example, an unauthorized person attempting to sign or alter a prescription would be an auditable event; a pharmacist annotating a record to indicate a change to a generic version of a drug would not be. The applications must run the internal audit function daily to identify any auditable events. When one occurs, the application must generate a readable report for the practitioner or pharmacist. If a practitioner or pharmacy determines that there is a potential security problem, they must report it to DEA within one business day.
Application providers must obtain a third-party audit before the application may be used to create, sign, transmit, or process controlled substance prescriptions and whenever a functionality related to controlled substance prescription requirements is altered, or every two years after the initial audit, whichever occurs first. If one or more certification organizations establish procedures to review applications and determine whether they meet the requirements set forth in the DEA regulations, DEA may allow this certification to replace the third-party audit. DEA will notify registrants of any such approvals of organizations to conduct these third-party certifications through its Web site. At this time, no such certification exists for either electronic prescription or pharmacy applications, but the Certification Commission for Healthcare Information Technology (CCHIT) has developed a program for electronic prescription applications.
All records must be maintained for two years from the date on which they were created or received. Pharmacy records must be backed up daily; DEA is not specifying where back-up files must be stored.
Because DEA is allowing any registrant to use the public key infrastructure (PKI) option proposed for Federal healthcare systems, the interim final rule does not include separate requirements for these systems.
When a prescription is transmitted (outside of a closed system), it moves through three to five intermediaries between practitioners and pharmacies. Although prescriptions could be altered, added, or deleted during transmission, DEA is not regulating transmission. Registrants have no control over the string of intermediaries. A practitioner might be able to determine from his
Some commenters on the NPRM claimed that the security practices of intermediaries were sufficient to protect electronic prescriptions. These practices, which are voluntary, do not address the principal threats of diversion, which occur before and after transmission. Maintaining the integrity of the record during transmission is of little value if there is no assurance that a registrant created and transmitted the prescription or that pharmacy staff did not alter it after receipt.
DEA wishes to emphasize that the electronic prescribing of controlled substances is in addition to, not a replacement of, existing requirements for written and oral prescriptions for controlled substances. This rule provides a new option to prescribing practitioners and pharmacies. It does not change existing regulatory requirements for written and oral prescriptions for controlled substances. Prescribing practitioners will still be able to write, and manually sign, prescriptions for Schedule II, III, IV, and V controlled substances, and pharmacies will still be able to dispense controlled substances based on those written prescriptions and archive those records of dispensing. Further, nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription application that does not comply with the interim final rule to prepare a controlled substance prescription, so that EHR and other electronic prescribing functionality may be used, and print the prescription for manual signature by the practitioner. Such prescriptions are paper prescriptions and subject to the existing requirements for paper prescriptions.
This section summarizes the 194 comments received to the NPRM by issue and provides DEA's responses. For each issue, DEA first summarizes the proposed rule, then presents the comments and DEA's responses. The subjects are presented in an order that tracks the process of issuing and dispensing a prescription from practitioner to pharmacy. Issues that apply to both types of applications (
DEA proposed that practitioners would be required to undergo in-person identity proofing, with DEA-registered hospitals, State licensing boards, or law enforcement agencies checking the identification documents. The record of the identity proofing would then have been sent to the electronic prescription application provider, which would use the information to set access controls to ensure that only practitioners eligible to issue controlled substance prescriptions were allowed to sign these prescriptions.
In response to comments on whether this requirement will reduce diversion, DEA is well aware of the vulnerabilities of the paper-based prescription system, but that such vulnerabilities exist does not mean that DEA should allow similar or greater vulnerabilities with electronic prescriptions for controlled substances. A forged paper prescription provides forensic evidence of who committed the forgery and can exonerate a practitioner based on that evidence; an electronic prescription issued in a practitioner's name provides no such evidence, making it difficult for law enforcement to identify the person who issued it and difficult for the practitioner to prove that he did not. Restricting access to the CSA database would not solve the problem of patients, medical office staff,
DEA recognizes that identity proofing and logical access controls (discussed below) will not stop all misuse of electronic prescription applications. Identity proofing will not prevent a registrant from issuing invalid prescriptions or allowing a staff member to issue prescriptions in his name, and it is not intended to prevent such activity. The purpose of identity proofing is to limit to as great an extent as possible the ability of nonregistrants to obtain an authentication credential and issue electronic controlled substance prescriptions under a practitioner's name.
A long-term care facility (LTCF) organization, several information technology organizations, and an application provider suggested that DEA use existing certification authorities (CAs) that issue digital certificates and routinely conduct identity proofing as part of the enrollment process. An information technology firm suggested that DEA establish a set of common criteria under which credential issuers can become accredited, citing the Department of Defense External Certification Authority program as an example. The commenter also suggested that DEA specify that firms qualified as shared service providers by the Federal Bridge Certification Authority (FBCA) could serve as CSPs. A few commenters associated with application providers or information technology organizations asked DEA to consider remote identity proofing systems.
DEA's objective is to ensure that identity proofing and the provision of two-factor authentication credentials will be done by a third party that is not involved in any other part of the electronic prescribing process. This approach is based on the concept of separation of duties, to ensure that the ability to sign controlled substance prescriptions will not depend on the action of a single entity or person. A registrant will need the two-factor authentication credential before he will be able to sign electronic prescriptions for controlled substances, but the possession of the token or tokens associated with the credential will not, itself, authorize a registrant to access the application to sign controlled substances prescriptions. Logical access control will be granted separately. Without the two-factor authentication credential, a practitioner will not be able to sign controlled substance prescriptions even if granted access.
For practitioners who are obtaining a two-factor authentication credential that does not include a digital certificate, DEA is requiring that they obtain their authentication credential from a credential service provider (CSP) that has been approved by the General Services Administration Office of Technology Strategy/Division of Identity Management to conduct identity proofing that meets NIST Sp 800-63-1 Assurance Level 3 or above. For practitioners obtaining a digital certificate, DEA is requiring that they obtain the digital certificate from a certification authority that is cross-certified with the Federal Bridge Certification Authority (FBCA) at a basic assurance level or higher and that conducts identity proofing at NIST SP 800-63-1 Assurance Level 3 or above. DEA believes that shared service providers would be too restrictive and believes that the approach it is implementing provides greater flexibility for the regulated industry.
DEA is not dictating how a CSP or CA conducts identity proofing. The standards for identity proofing are set by the Federal Bridge Certification Authority (FBCA) or the General Services Administration in their certificate policies and frameworks and in NIST SP 800-63-1. Level 3 requires either in-person identity proofing based on checking government-issued photographic identification or remote identity proofing. For in-person identity proofing, Level 3 requires the examination of a government-issued photographic identification, which must be verified with either the issuing agency, credit bureaus, or other similar databases. The verification must confirm that the name, date of birth, and address listed in the application for the credential are consistent with the information in other records checked. The person checking the identification must compare the person with the photograph, record the identification number, address (if listed), and date of birth. If the identification is valid, the issuing organization may authorize or issue the credential and send notice to the address of record; if the identification or other records checked do not confirm the address listed in the application (as may happen if the person has recently moved), the organization must issue credentials in a manner that confirms the address of record (the address of record is the address listed in the application).
For remote identity proofing, Level 3 requires a valid government-issued identification number and a financial account number. These numbers must be confirmed via record checks with either the issuing agency or institution or through credit bureaus or similar databases. The check must confirm that the name, address, date of birth, and other personal information in the records are consistent with the application and sufficient to identify a unique individual. The address or telephone number must be confirmed by issuing the credential in a manner that
DEA is not requiring the CSP or CA to check DEA registrations or State authorizations to practice or dispense controlled substances as part of the identity-proofing process; these will be checked as part of logical access control, as discussed in the next section. DEA decided to have checks for the DEA registration, authorization to practice, and authorization to dispense controlled substances for individual practitioners handled separately from identity proofing for three reasons. First, the information that is used to verify identity may not be the information associated with a DEA registration. Government-issued photographic identifications and credit cards usually are associated with home addresses and, perhaps, Social Security numbers; DEA registrations are usually associated with business locations and, in some cases, taxpayer identification numbers. In addition, the registration database that DEA makes available through the National Technical Information Service does not include this personal information, so that a CA or CSP would have to contact DEA for each applicant. Second, some practices or application providers may want some or all of the nonregistrants on the staff to obtain authentication credentials so that there will be only one method of authenticating to the application. The possession of a two-factor authentication credential would not, in these cases, distinguish between those who can sign controlled substance prescriptions and those who cannot. Third, the decision to grant access to the functions that allow a practitioner to indicate that a prescription is ready for signing and to sign controlled substance prescriptions is based on whether the person is a DEA registrant, not on the possession of a two-factor authentication credential. The two-factor authentication credential is a necessary, but not a sufficient, condition for signing a controlled substance prescription. It is logical, therefore, to require the people who set logical access controls, rather than those who conduct identity proofing, to check the DEA and State authorizations to practice and, where applicable, authorizations to dispense controlled substances of prescribing practitioners.
The rule only allows institutional practitioners to conduct in-person identity proofing, not remote identity proofing. There are two reasons for this limitation. First, the practitioners will be visiting the institution on a regular basis so the burden should be relatively low. Second, most institutional practitioners may not have the ability or desire to conduct the credit and other background checks that are part of remote identity proofing at NIST Levels 2 and 3. DEA recognizes that in some large systems, the credentialing office may be at a central location and many staff may work at other locations. In those cases, the institutional practitioner can decide whether to have the staff visit the central location or send someone from the credentialing office to the other locations to conduct the identity proofing. DEA notes that this issue will arise only during the initial enrollment of previously credentialed practitioners. After that, practitioners being newly credentialed by an institution can undergo identity proofing when and where they are credentialed. The rule also requires that the credentialing office check the DEA and State authorizations to practice and, where applicable, authorizations to dispense controlled substances because this check should be part of their standard credentialing process.
Under the rule, the institutional practitioner may issue the two-factor authentication credentials itself or obtain them from a third party, which will have to be a CSP or CA that meets the criteria specified above. In the latter case, the institutional practitioner could have each practitioner apply for the two-factor credential himself, which would entail undergoing identity proofing by the CSP or CA. Alternatively, the institutional practitioner can serve as a trusted agent for the third party. Trusted agents conduct part of the identity proofing on behalf of the CSP or CA and submit the information for each person along with a signed agreement that specifies the trusted agent's responsibilities. DEA emphasizes that institutional practitioners are allowed, but not required, to conduct identity proofing. If an institutional practitioner (
In the NPRM, DEA proposed that the identity proofing document had to be submitted to the application provider, which would then check the DEA registration and State authorizations to practice, and set access controls. DEA also proposed that the application providers check DEA registration status weekly and revoke authentication credentials if practitioners' registrations had been terminated, revoked, or suspended.
Access is the ability to do something with a computer resource. This usually refers to a technical ability (
NIST SP 800-12 further states:
Access control is the means by which the ability is explicitly enabled or restricted in some way (usually through physical and system-based controls). Computer-based access controls are called logical access controls. Logical access controls can prescribe not only who or what (
DEA has revised its approach to access control to remove the application provider and its staff from direct involvement in the process. Instead, the interim final rule will require that the application must have the capability to set logical access controls that limit access to the functions for indicating a prescription is ready for signing and for signing the prescription to DEA registrants. The interim final rule will also limit access to setting these logical access controls. The application may set logical access controls on an individual basis or on roles. If the logical access controls are role-based, one or more roles will have to be limited to individuals authorized to prescribe controlled substances. This role may be labeled “DEA registrant” or physician, dentist, nurse practitioner, etc., provided the role is limited to those authorized to issue controlled substance prescriptions. For an individual practitioner who is an agent or employee of an institutional practitioner, and who has been authorized to prescribe controlled substances under the registration of the institutional practitioner pursuant to 21 CFR 1301.22(c), if logical access controls are role-based, one role will have to be “authorized to sign controlled substance prescriptions.” (Other methods of setting logical access controls that NIST cites—location or time—do not appear to be relevant, although applications or users may add such limits based on their own concerns.)
The application logical access control capability must require that data entry of authorizations for setting logical access controls and the functions limited to registrants (indicating that a controlled substance prescription is ready for signing and signing a controlled substance prescription) involve two people. The requirement for two people to be involved in such data entry is frequently used to protect applications from internal security threats. If a person is able, through the use of false identity documents, to obtain a two-factor authentication credential in a registrant's name, he will still not be able to sign controlled substance prescriptions unless he is granted access, by two people (one of whom is a registrant). The interim final rule does not specify in detail how the application must be structured to ensure that two people concur with the data entry; rather, the rule simply requires that the application must not accept these logical access controls without the action of two parties. For example, a small practice with two registrants neither of whom is expecting to leave may decide that only the registrants will perform this function, which may occur only at the initial installation or upgrade of an electronic prescription application to comply with controlled substance
The interim final rule requires that at least one of the people assigned the role of administering logical access control must verify that any registrant granted authorization to indicate that a prescription is ready for signing and to sign controlled substance prescriptions has a valid DEA registration, a State authorization to practice and, where applicable, a State controlled substance authorization. In small practices, this verification may require nothing more than checking expiration dates on the practitioners' DEA Certificate of Registration and State authorization(s), unless there is reason to question the current validity. In larger practices, verification may take more time. Individual registrations can be checked online at DEA's Web site at
Once DEA registration and State authorization to practice and State authorization to dispense controlled substances have been verified, two people must be involved in entering the data to the application to identify those people authorized to indicate that a prescription is ready for signing and to sign controlled substance prescriptions; those two people are also involved in entering data to the application to identify people whose authorization has been revoked. The first person must enter the data. A registrant must then use his two-factor authentication credential to provide the second approval. The application must ensure that until the second approval occurs, logical access controls for controlled substance prescription functions cannot be activated or altered. DEA recognizes that some solo practitioners may not have other employees although it seems unlikely that they do not have at least part-time help for office management and back office functions. DEA is not requiring that the second person be an employee, simply that there be two people involved and that the persons involved be specifically designated by the practitioner(s). For such solo practitioners and for many small practices, logical access controls may need to be set only once because they will usually be set or changed only with staff turnover.
All entries and changes to the logical access controls for setting the controls and for the controlled substance prescription functions must be defined as auditable events and a record of the changes retained as part of the internal audit trail. DEA is seeking comment on this approach to logical access control for individual practitioners.
Logical access must be revoked whenever any of the following occurs: A DEA registration expires without renewal, or is terminated, revoked, or suspended; the registrant reports that a token associated with the two-factor authentication credential has been lost or compromised; or the registrant is no longer authorized to use the practice's application. DEA anticipates that for most practices, logical access controls will be set and changed infrequently, usually when a new registrant joins the practice or a registrant leaves. Even in larger practices, changes to authorizations are likely to occur relatively infrequently.
DEA recognizes that application service providers (ASPs) may currently set access controls, to the extent that they do, at the ASP level and that the interim final rule may require them to reprogram some of their security controls. DEA believes these steps are necessary to ensure that a registrant is involved in the process of setting logical access controls and that these cannot be set or changed without the concurrence of a registrant. If registrants submitted a list of people to be authorized to perform the controlled substance prescription functions to an ASP, there would need to be a process to ensure that the list was from a legitimate source (
For institutional practitioners, the setting of logical access controls will necessarily be somewhat different because the registrant is not an individual. The principle, however, is the same. Identity proofing must be separate from setting logical access controls; two individuals must be involved in each step. The interim final rule therefore requires that two individuals from the credentialing office provide the part of the institution that controls the computer applications with the names of practitioners authorized to issue controlled substance prescriptions. The entry of the data will also require the involvement of two individuals. The institutional registrant is responsible for designating and documenting individuals or roles that can perform these functions. Logical access must be revoked whenever any of the following occurs: The institutional practitioner's or, where applicable, individual practitioner's DEA registration expires without renewal, or is terminated, revoked, or suspended; the practitioner reports that a token associated with the two-factor authentication credential has been lost or compromised; or the individual practitioner is no longer authorized to use the institutional practitioner's application. DEA is seeking comment on this approach to logical access control for institutional practitioners.
DEA recognizes that this approach will not prevent a registrant in solo practice from continuing to issue controlled substances prescriptions under an expired, terminated, suspended, or revoked registration. However, it is already clear under existing law and regulations that a practitioner who prescribes or otherwise dispenses controlled substances beyond the scope of his registration is committing a violation of the CSA and subject to potential criminal prosecution, civil fine, and loss of registration. Any practitioner who would use his two-factor authentication credential to issue prescriptions after he is legally barred from doing so would be creating evidence of such criminal activity. As discussed above, the purpose of identity proofing and access control is to prevent nonregistrants from gaining the ability to issue controlled substance prescriptions.
Authentication protocols are classified by the number of factors they require. NIST and others recognize three factors: something you know, something you have, and something you are. Combinations of user IDs and passwords are one-factor because they require only information that you know. A standard ATM uses two-factor—something you know (a personal identification number (PIN)) and something you have (bank card). DEA proposed that practitioners be required to use a two-factor authentication protocol to access the electronic prescription application to sign controlled substance prescriptions. DEA proposed that one factor would have to be a hard token that met NIST SP 800-63 Level 4 and that the cryptographic module would have to be validated at Federal Information Processing Standard (FIPS) 140-2 Security Level 2 overall and Level 3 security.
As commenters indicated, single-factor authentication usually means passwords alone or in combination with user IDs. NIST states in its special publication SP 800-63-1: “* * * the ability of humans to remember long, arbitrary passwords is limited, so passwords are often vulnerable to a variety of attacks including guessing, use of dictionaries of common passwords, and brute force attacks of all possible password combinations. * * * all password authentication mechanisms are vulnerable to keyboard loggers and observation of the password when it is entered.” NIST also states that “* * * many users, left to choose their own passwords will choose passwords that are easily guessed and even fairly short[.]”
Organizations should be aware of the drawbacks of using password-based authentication. There are many types of threats against passwords, and most of these threats can only be partially mitigated. Also, users are burdened with memorizing and managing an ever-increasing number of passwords. However, although the existing mechanisms for enterprise password management can somewhat alleviate this burden, they each have significant usability disadvantages and can also cause more serious security incidents because they permit access to many systems through a single authenticator. Therefore, organizations should make long-term plans for replacing or supplementing password-based authentication with stronger forms of authentication for resources with higher security needs.
DEA remains convinced that single-factor authentication is insufficient to ensure that a practitioner will not be able to repudiate a prescription he signed.
A practitioner organization, a hospital organization, a pharmacy association, a health information technology organization, a healthcare system, other medical associations, and a number of application providers asked DEA to allow the use of biometrics as an alternative to a hard token. The practitioner organization stated that a
DEA is establishing several requirements for the use of biometrics, and for the testing of the software used to read the biometrics. DEA is establishing these standards after extensive consultation with NIST, and based on NIST recommendations. A discussion of these requirements follows.
• The biometric subsystem must operate at a false match rate of 0.001 or lower.
The term “false match rate” is similar to the term “false accept rate”—it is the rate at which an impostor's biometric is falsely accepted as being that of an authorized user. DEA is not establishing a false non-match (rejection) rate; while users may be interested in this criterion, DEA does not have an interest in setting a requirement for a tolerance level for false rejections for electronic prescription applications.
• The biometric subsystem must use matching software that has demonstrated performance at the operating point corresponding with the required false match rate specified (0.001) or a lower false match rate. This testing must be performed by the National Institute of Standards and Technology (NIST) or another DEA-approved (government or non-government) laboratory.
This criterion is designed to ensure that an independent third-party has tested the software and has determined its effectiveness on a sequestered data set that is large enough for high confidence in the results, which will be made publicly available for consumers. DEA believes that the requirement to have the biometric software tested by an independent third party, as discussed further below, will provide greater assurance to electronic prescription application providers and practitioners that the biometric subsystem being used, in fact, meets DEA's requirements. NIST currently lists technologies which it has tested and their rates of performance at the following URLs:
• The biometric subsystem must conform to Personal Identity Verification authentication biometric acquisition specifications, pursuant to NIST Special Publication 800-76-1, if they exist for the biometric modality of choice.
This requirement specifies minimum requirements for the performance of the device that is used to acquire biometric data (usually an image), whereas the prior requirements relate to the software used to compare biometric samples to determine if a user is who he claims to be. NIST Special Publication 800-76-1
DEA wishes to emphasize that the use of SP 800-76-1 does not imply that all requirements related to Federally mandated Personal Identity Verification cards apply in this context, only those specified for biometric acquisition for the purposes of authentication. PIV goes beyond this application, in that it has additional requirements for fingerprint registration (or enrollment) suitable for a Federal Bureau of Investigation background check, and the PIV credential has interoperability requirements that will not necessarily apply to users of controlled substance electronic prescription applications.
• The biometric subsystem must either be co-located with a computer or PDA that the practitioner uses to issue electronic prescriptions for controlled substances, where the computer or PDA is located in a known, controlled location, or be built directly into the practitioner's computer or PDA that he uses to issue electronic prescriptions for controlled substances.
This criterion is intended to add to the security of the biometric factor by physically controlling access to the biometric device to reduce the potential for spoofing.
• The biometric subsystem must store device ID data at enrollment (i.e., biometric registration) with the biometric data and verify the device ID at the time of authentication.
Within this context, enrollment is the process of collecting a biometric sample from a new user and storing it (in some format) locally, on a network, and/or on a token. These enrolled data are stored
• The biometric subsystem must protect the biometric data (raw data or templates), match results, and/or non-match results when authentication is not local.
• If sent over an open network, biometric data (raw data or templates), match results, and/or non-match results must be:
○ Cryptographically source authenticated;
○ Combined with a random challenge, a nonce, or a timestamp to prevent replay;
○ Cryptographically protected for integrity and confidentiality;
○ Sent only to authorized systems.
The above requirements are to ensure the security and integrity for this authentication factor (a biometric), ensuring any data related to the biometric subsystem (biometric patterns and results of comparisons) are sent from an authorized source to an authorized destination and that the message was not tampered with in transit. Additionally, cryptographic protection of the biometric data addresses an aspect of the user's interests in confidentiality of personal data.
The easiest way to meet the above requirements when authentication is not local is to run a client authenticated TLS connection or a similar protocol between the endpoints of any remote communication carrying data subject to the above requirements. Another possible solution that may be used is server authenticated TLS in combination with a secure HTTP cookie at the client that contains at least 64 bits of entropy.
DEA also recognizes that biometrics application providers have a vested interest in either selling their applications directly to practitioners or electronic prescription application providers, or partnering with those electronic prescription application providers to market their applications. Therefore, as discussed above, to provide practitioners and electronic prescription application providers with an objective appraisal of the biometrics applications they may purchase and use, DEA is requiring independent testing of those applications. This testing is similar to the third-party audits or certifications of the electronic prescription and pharmacy applications DEA is also requiring. Testing of the biometric subsystem must have the following characteristics:
• The test is conducted by a laboratory that does not have an interest in the outcome (positive or negative) of performance of a submission or biometric.
DEA wishes to ensure that the testing body is independent and neutral. As noted previously, tests may be conducted by NIST, or DEA may approve other government or nongovernment laboratories to conduct these tests.
• Test data are sequestered.
• Algorithms are provided to the testing laboratory (as opposed to scores).
To the extent possible, independent testing should provide an unbiased evaluation of its object of study, which should yield repeatable, generalizable results. The above two requirements reflect the principle behind independent testing. If test participants had access to the test data used in an evaluation, they would have the opportunity to tune or augment their algorithms to maximize accuracy on that data set, but would likely fail to give a fair assessment of the algorithm's performance. Therefore, test data should not be made public before the testing period closes, and if test data are sequestered, algorithms must be provided to the independent testing laboratory for the experiment(s) to be conducted. Additionally, the latter requirement permits the independent testing laboratory to produce the results itself that are ultimately used to characterize performance.
• The operating point(s) corresponding with the false match rate specified (0.001), or a lower false match rate, is tested so that there is at least 95% confidence that the false match and non-match rates are equal to or less than the observed value.
As discussed above, testing should yield results that are repeatable. The resulting measurements of an evaluation should have a reasonably high degree of reliability. A confidence level of 95% or greater will characterize the values from an evaluation as reliable for this context.
• Results are made publicly available.
The provision of testing results to the public, either through a Web site or other means, will help to ensure transparency of the testing process and of the results. Such transparency will provide greater opportunity for interested electronic prescription application providers and others to compare results between biometrics application providers to find the biometric application that best meets their needs.
DEA recognizes the need for assurance that a captured biometric sample is obtained from a genuine user—and not a spoofed copy, particularly in unattended applications such as electronic prescriptions for controlled substances, where many users may have access to computers that contain electronic prescription applications. Liveness detection is a tool that some biometric vendors have developed to address this issue. However, since this is an active area of research that has not been standardized, DEA is not setting a specific requirement for liveness detection at this time, but will reconsider this tool in the future as industry standards and specifications are developed.
DEA emphasizes that the use of biometrics as one factor in the two-factor authentication protocol is strictly voluntary, as is all electronic prescribing of controlled substances. As noted previously, DEA wishes to emphasize that these standards do not specify the types of biometrics that may be acceptable. Any biometric that meets the criteria specified above may be used as the biometric factor in a two-factor authentication credential used to indicate that prescriptions are ready to be signed and sign controlled substance prescriptions. DEA, after extensive consultation with NIST, has written these criteria to be as flexible as possible to emerging technologies, allowing new biometrics systems to develop in the future that meet these criteria.
Because the use of biometrics and the standards related to their use were not discussed in the notice of proposed rulemaking, DEA is seeking further comment on these issues. Specifically, DEA is seeking comments in response to the following questions:
• What effect will the inclusion of biometrics as an option for meeting the two-factor authentication requirement have on the adoption rate of electronic prescriptions for controlled substances, using the proposed requirements of a password and hard token as a baseline? Do you expect the adoption rate to significantly increase, slightly increase, or be about the same? Please also indicate why.
• Is there an alternative to the option of biometrics which could result in greater adoption by medical practitioners of electronic prescriptions for controlled substances while also providing a safe, secure, and closed system for prescribing controlled substances electronically? If so, please describe the alternative(s) and indicate
Also, based on the comments received, it appears that a number of commenters may have already implemented biometrics as an authentication credential to electronic applications. DEA is seeking information from commenters on their experiences implementing biometric authentication. DEA seeks the following information:
• Why was the decision made to adopt biometrics as an authentication credential? Why was the decision made to adopt biometrics as opposed to another option? What other options were considered?
• What are biometrics as an authentication credential used for (
• How many people in the practice/institution use biometric authentication (number and percentage, type of employee—practitioners, nurses, office staff, etc.)?
• What types of biometric authentication credentials are used (
• How are the biometrics read, and what hardware is necessary (
• Is biometric authentication used by itself or in combination with a user ID or password?
• How are biometric readers distributed (
• Was the adoption of biometrics part of installation of a new system or an addition to existing applications?
• How long did the implementation process take? Was the time related to implementing biometrics or other application installation issues?
• Which parts of the biometric implementation were completed without difficulty?
• What challenges were encountered and how were they overcome?
• Were workflows affected during or after implementation and, if so, how were they affected and for how long?
• How do the users feel about the use of biometrics as an authentication credential?
• Has the use of biometric authentication improved or slowed workflows? If so, how?
• Has the use of biometric authentication improved data and/or network security?
• What other benefits have been realized?
Other commenters objected to the requirement for Level 4 security for the hard token. They noted that relatively few devices that are validated by Federal Information Processing Standards (FIPS) meet Level 4. One application provider stated that DEA's description in the proposed rule is more like Level 3 with a hard token. It asserted that Level 4 would mean that any user of the application, not just practitioners signing controlled substance prescriptions, would need Level 4 tokens. Some commenters further asserted that few devices meet FIPS 140-2 Security Level 3 for physical security. An intermediary stated the current NIST SP 800-63-1 draft definition is different from the original SP 800-63 definition; the commenter indicated that SP 800-63-1 does not require that approved cryptographic algorithms must be implemented in a cryptographic module validated under FIPS 140-2. Thus, the commenter believed, the requirements according to this new draft SP 800-63-1 could be implemented more easily.
Contrary to the intermediary's statement, NIST SP 800-63-1 does require that cryptographic modules be FIPS 140-2 validated. NIST SP 800-63-1 requires the following for one-time-password devices: “Must use approved block cipher or hash function to combine a symmetric key stored on device with a nonce to generate a one-time password. The cryptographic module performing this operation shall be validated at FIPS 140-2 Level 1 or higher.” For single-factor and multi-factor cryptographic tokens at Assurance Level 2 or 3, NIST SP 800-63-1 requires: “The cryptographic module shall be validated at FIPS 140-2 Level 1 or higher.”
DEA believes that NIST 800-63-1 Assurance Level 3 as described will meet its security concerns. As discussed above, DEA continues to believe that reliance on passwords alone, as a few commenters suggested, would not provide sufficient security in healthcare settings where computers are accessed and shared by staff. Many staff may be able to watch passwords being entered, and computers may be accessible to patients or other outsiders. In addition, DEA notes that practitioners might find strong passwords more burdensome than a biometric or token over the long run. Strong passwords generally need to be long (
Based on the comments received, it appears that a number of commenters have already implemented a variety of hard tokens (
• Why was the decision made to adopt hard token(s) as an authentication credential? Why was the decision made to adopt hard tokens as opposed to another option? What other options were considered?
• What are hard token(s) as an authentication credential used for (
• How many people in the practice/institution use hard tokens for authentication (number and percentage, type of employee—practitioners, nurses, office staff, etc.)?
• What types of hard tokens are used (
• Are the hard tokens used by themselves or in combination with user IDs or passwords?
• How are the hard tokens read (where applicable), and what hardware is necessary (
• How are hard token readers distributed (
• Was the adoption of hard tokens part of installation of a new system or an addition to existing applications?
• How long did the implementation process take? Was the time related to implementing hard tokens or other application installation issues?
• Which parts of the implementation were completed without difficulty?
• What challenges were encountered and how were they overcome?
• Were workflows affected during or after implementation and, if so, how were they affected and for how long?
• How do the users feel about the use of hard tokens as an authentication credential?
• Has the use of hard tokens as an authentication credential improved or slowed workflows? If so, how?
• Has the use of hard tokens as an authentication credential improved data and/or network security?
• What other benefits have been realized?
Electronic prescription application downtime is not specific to tokens; any electronic prescription application may experience downtime regardless of the authentication method used. Practitioners will always have the option of writing controlled substance prescriptions manually.
DEA proposed that controlled substance prescriptions must contain the same data elements required for paper prescriptions. DEA proposed that, as with paper prescriptions, practitioners or their agents would be able to create a prescription. When the prescription was complete, DEA proposed that the application require the practitioner to complete the two-factor authentication protocol. The application would then present at least the DEA-required elements for review for each controlled substance prescription and the practitioner would have to positively indicate his approval of each prescription. Prior to signing, the proposed rule would have required the practitioner to indicate, with another keystroke, agreement with an attestation that he had reviewed the prescription information and understood that he was signing the prescription. The practitioner would then have signed the prescription for immediate transmission. If there was no activity for more than two minutes after two-factor authentication, the application would have been required to lock out the practitioner and require reauthentication to the signing function. The first intermediary that received the prescription would have been required to digitally sign and archive the prescription.
DEA proposed that the application present to the practitioner certain prescription information including the patient's name and address, the drug name, strength, dosage form, quantity prescribed, directions for use, and the DEA registration number under which the prescription would be authorized. DEA further proposed to require the practitioner to indicate those prescriptions that were ready to be signed.
DEA proposed allowing practitioners to indicate that prescriptions for multiple patients were ready for signing and allow a single signing to cover all approved prescriptions.
A practitioner organization expressed agreement with the requirement in the proposed rule that prior to the transmission of the electronic prescription, the application should show a summary of the prescription. It noted that while National Council for Prescription Drug Programs (NCPDP) SCRIPT provides fields and codes for all required data, not all are mandatory. In addition, this commenter indicated some applications do not show all of the DEA-required prescription information. The commenter asked how applications will be updated and/or modified to meet the specifications required in the proposed rule. Another commenter, an application provider, stated that developers will have to redesign the applications at the screen level and at the user permission level, which will add costs. An insurance organization stated that the current NCPDP standards do not accommodate the described process and will have to be revised to conform next generation electronic prescribing software to the DEA requirements. The commenter believed that this would create another delay in the eventual use of electronic prescribing for controlled substances.
DEA realizes that many application providers will have to update their applications, but it notes that most perform regular updates and upgrades. They may choose to incorporate the changes required by these regulations as part of a regular revision cycle.
Astrand, B.
DEA proposed that the practitioner would use his two-factor authentication credential to access the review screen. The practitioner would indicate those prescriptions ready to be signed. Prior to signing, DEA proposed that the practitioner indicate agreement with the following statement: “I, the prescribing practitioner whose name and DEA registration number appear on the controlled substance prescription(s) being transmitted, have reviewed all of the prescription information listed above and have confirmed that the information for each prescription is accurate. I further declare that by transmitting the prescription(s) information, I am indicating my intent to sign and legally authorize the prescription(s).” If there was no activity for two or more minutes, the application would have to lock him out; he would have to reauthenticate to the application before being able to continue reviewing or signing prescriptions.
Commenters generally expressed concern about the additional keystrokes required to take these steps, stating that each new keystroke adds to the burden of creating an electronic prescription and discourages use of electronic prescriptions. An insurance organization stated that the process DEA proposed would require at least three practitioner confirmations of the electronic prescription. The commenter asserted that the more steps in the process, the less the workflow integration with current electronic prescribing workflow, and the increased potential for the reversion to written prescriptions. Another insurance organization stated the process of reviewing and signing should be streamlined. The commenter believed the process proposed by DEA seemed to have five steps with three confirmations.
Commenters were particularly concerned about the 2-minute lockout period. They were unsure whether it applied to the initial access to the application or to access to the signing function. A number of application providers stated that requiring two-factor authentication to sign the prescription would be more effective and eliminate the need for a lockout; that is, they advocated making the use of the two-factor authentication synonymous with signing a controlled substance prescription. One practitioner organization stated that the authentication and lockout could interrupt work flows; access to other functions of the electronic medical record must be available with the authentication. The application providers also noted that lockouts are easy to implement.
Those commenters who addressed the attestation statement expressed opposition to it. They emphasized that a practitioner must comply with the Controlled Substances Act and its implementing regulations in the prescribing of any controlled substance. Some were of the view that the statement did not serve any new purpose or address any new requirement. They emphasized that such a statement is not required for written prescriptions. Commenters
A number of organizations stated that they believed a better approach would be to present a simple dialog box with a clear and short warning that a prescription for a controlled substance is about to be signed. Some suggested this dialog could have three buttons: Agree, Cancel, and Check Record. Some commenters also noted that when prescribers get prescription renewal requests (for noncontrolled substances) in their electronic medical record applications now they have to minimize or temporarily “cancel” the request, check the chart for appropriateness, and then click yes or no. Commenters believed that the proposed rule does not seem to include this necessary capability.
As discussed previously, DEA has revised the rule to limit the required data displayed for the practitioner on the screen where the practitioner signs the controlled substance prescription to the patient's name, drug information, refill/fill information, and the practitioner information. The requirement in the proposed rule that the patient's address be displayed on the screen at this step of the process has been eliminated. (However, consistent with longstanding requirements for controlled substance prescriptions, the patient's address must be included in the prescription data transmitted to the pharmacy.) Because DEA is requiring that the application digitally sign the information required by the DEA regulations at the time the practitioner signs the prescription, additional non-DEA-required information (
DEA has revised the rule to eliminate a separate keystroke for an attestation statement and adopted the suggestion of some of the commenters that the statement be included on the screen with the prescription review list. Further, DEA has revised the statement displayed. The statement will read: “By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.” The practitioner will not be required to take any action with regard to the statement. Rather, the statement is meant to be informative and thereby eliminate the possibility of any uncertainty as to the significance of completing the two-factor authentication protocol at that time and the limitation on who may do so. The only keystrokes that the practitioner will have to take will be to indicate approval of the prescription and affix a legal signature to the prescription by execution of the two-factor authentication protocol. DEA notes that some applications already present practitioners with a list of prescriptions ready to be signed and require their approval. For these applications, only the two-factor authentication will be a new step.
Because the National Council for Prescription Drug Programs SCRIPT standard does not currently contain a field for the signature of a prescription, DEA proposed that the prescription record transmitted to the pharmacy must include an indication that the practitioner signed the prescription. This indication could be a single character.
The required contents for an electronic prescription for a controlled substance set forth in the interim final rule are the same contents that have long been required under the DEA regulations for all paper and oral prescriptions for controlled substances. As with all regulations issued by any agency, the DEA regulations are publicly available, every standards organization and application provider has access to them, and all persons subject to the regulations are legally
DEA proposed that only one DEA number should be associated with a controlled substance prescription.
DEA is aware of the issue of internal code numbers held by individual practitioners prescribing controlled substances as agents or employees of hospitals or other institutions under those institutions' registrations pursuant to § 1301.22(c). DEA published an Advance Notice of Proposed Rulemaking (74 FR 46396, September 9, 2009) to seek information that can be used to standardize these data and to require institutions to provide their lists of practitioners eligible to prescribe controlled substances under the registration of the hospital or other institution to pharmacies on request.
The problem with special codes for individual practitioners prescribing controlled substances using the institutional practitioner's registration and the DEA-issued identification number for certain substances used for detoxification and maintenance treatment is that SCRIPT does not currently have a code to identify them. Codes exist that identify DEA numbers and State authorization numbers; the fields are then defined to limit them to the acceptable number of characters. The general standard for the identification number field, however, is 35 characters. It should, therefore, be possible for NCPDP to add a code for an institution-based DEA number that allows up to 35 characters, with the first nine characters in the standard DEA format; the remaining characters should be sufficient to accommodate most institutional coding systems until DEA and the industry can standardize the format. Similarly, NCPDP should be able to add a code for the identification number for maintenance of detoxification treatment. Free text fields may also need to be used to incorporate other information required on certain prescriptions; for example, part 1306 requires that prescriptions for gamma hydroxybutyric acid the practitioner must indicate the medical need for the prescription; for certain medications being used for maintenance or detoxification treatment, the practitioner must include an identification number in addition to his DEA number.
On the issue of the inability of pharmacies to validate the special code assigned by an institutional practitioner to individual practitioners permitted to prescribe controlled substances using the institution's DEA registration, DEA notes that the “validation” that some pharmacy applications conduct simply confirms that the DEA number is in the standard format and conforms to the formula used to generate the DEA registration numbers. The validation does not confirm that the number is associated with the prescriber listed on the prescription or that the registration is current and in good standing. To confirm the actual validity of the DEA number, the pharmacy would have to check the DEA registration database using the Registration Validation tool available at the Office of Diversion Control Web site (
DEA recognizes that revisions to the SCRIPT standard to accommodate identification codes for individual practitioners prescribing controlled substances using the institutional practitioner's registration, identification numbers for maintenance or detoxification treatment, and dates before which a Schedule II prescription may not be filled may not occur immediately as they have to be incorporated into a revision to the standard that is subject to the standards development process. Application providers will then have to incorporate the new codes into their applications.
Because DEA does not want to delay implementation of electronic prescribing of controlled substances for any longer than is necessary to accommodate the main provisions of the rule, DEA has added provisions to §§ 1311.102 (“Practitioner responsibilities.”), 1311.200 (“Pharmacy responsibilities.”), and 1311.300 (“Third-party audits.”) to address the short-term inability of applications to handle information such as this accurately and consistently. DEA is requiring that third-party auditors or certification organizations determine whether the application being tested can record, store, and transmit (for an electronic prescription application) or import, store, and display (for a pharmacy application) the basic information required under § 1306.05(a) for every controlled substance prescription, the indication that the prescription was signed, and the number of refills. Any application that cannot perform these functions must not be approved, certified, or used for
DEA proposed that the electronic prescription would have to be transmitted immediately upon signing. DEA proposed that the first recipient of the electronic prescription would have to digitally sign the record as received and archive the digitally signed copy. The digital signature would not be transmitted to the other intermediaries or the pharmacy.
A standards organization recommended extending to long-term care facilities (LTCFs) the option allowed to Federal health care agencies where the prescription may be digitally signed and “locked” after being signed by the practitioner, while allowing other facility-determined information, such as resident unit/room/bed, times of administration, and pharmacy routing information to be added prior to transmission. The commenter noted that these additional data elements are distinct from the prescription data required by § 1306.05(a). The commenter explained that this digitally signed version would be archived and available for audit. The organization stated that its recommended process matches a key aspect of the accepted LTCF order workflow, where the nursing facility reviews each physician order in the context of the resident's full treatment regimen and adds related nursing and administration notes. The commenter explained that after review and nursing annotation, the prescription is forwarded to the appropriate LTC pharmacy. By requiring that the prescription be digitally signed immediately after the physician's signature (or upon receipt if the facility system is the first recipient of the electronic prescription), this rule could appropriately be extended to non-Federal nursing facilities, enabling them to meet existing regulations requiring review of resident medication orders by facility nursing staff prior to transmission to the pharmacy. A pharmacist organization, whose members work in LTCFs and similar facilities, stated that the rule may be impossible to put into operation without
On the issue of having the first recipient digitally sign the DEA-required information, some commenters asked about the identity of the first recipient. One application provider expressed the view that unless the application provider is the first recipient, it cannot be held responsible for the digital signing and archiving. Where the first processor is a third-party aggregator, this commenter asserted, it should be responsible for complying. An application provider organization stated that adding a digital signature will greatly increase the storage cost of transaction data.
One application provider stated that if the prescription is created on an Internet-based application, such as one on which the prescriber uses an Internet browser to access the application, the prescription would actually be digitally signed on the Internet-based application provider's servers by the prescriber. Therefore, the initial digital signature archived on the Internet-based prescribing application would be that of the prescriber, created using the hardware cryptographic key, rather than that of the application provider. The commenter indicated that in this case, the application network provider, rather than the electronic prescription application provider, should digitally sign the prescription with its own digital signature and archive the digitally signed version of the prescription as received. The commenter asserted that for true ASP applications (Web-based applications), the prescriber is actually digitally signing the prescription at the server. It is not necessary, this commenter indicated, for the Web-based electronic prescription application provider to sign also. Some commenters thought that every intermediary would be required to digitally sign and archive a copy. A State board of pharmacy said the first recipient should not have to digitally sign the prescription unless the first recipient is the pharmacy. The responsible pharmacist should have to digitally sign the prescription.
An application provider stated that the combination of authentication mechanisms, combined with reasonable security measures by the practice (
DEA does not believe that the security mechanisms that the application provider cited at a practitioner's office would sufficiently provide for non-repudiation. DEA disagrees with the State Board of Pharmacy that the first recipient or the electronic prescription application need not digitally sign the record. Unless the record is digitally signed before it moves through the transmission system, practitioners would be able to repudiate prescriptions by claiming that they had been altered during transmission (inadvertently or purposefully). The only way to prove otherwise would be to obtain (by subpoena or otherwise) all of the audit log trails from the intermediaries, assuming that they retained them. As DEA is not requiring the intermediaries to retain records or audit trails, it might not be possible to obtain them. In addition, unless a practitioner was transmitting prescriptions to a single pharmacy, the number of intermediaries involved could be substantial; although the practitioner's application might use the same routers to reach SureScripts/RxHub or its equivalent, each of the recipient pharmacies may rely on different intermediaries.
DEA proposed an alternative approach, limited to Federal healthcare facilities, that would be based on public key infrastructure (PKI) and digital signature technology. Under this approach, practitioners would obtain a digital certificate from a certification authority (CA) cross-certified with the Federal Bridge CA (FBCA) and use the associated private key to digitally sign prescriptions for controlled substances. DEA proposed this approach based on requests from Federal health care agencies that have implemented PKI systems. Those agencies noted that the option DEA proposed for all health care practitioners did not meet the security needs of Federal health care agencies.
Some commenters noted that although the current system, based on intermediaries, makes use of digital signatures difficult, changes in technology may make it feasible in the future. In addition, for healthcare systems with their own pharmacies, a PKI-based approach would be feasible now. An intermediary stated that NCPDP SCRIPT could not accommodate a digital signature, but other IT organizations argued that this is not necessarily true. One information technology security firm stated that companion standards to NCPDP SCRIPT standard in XML and HL7, which ought to be considered, include the W3C's XML digital signature standard (XML-DSig) and the Document Digital Signature (DSG) Profile. Several application providers stated:
The prescription should be digitally signed using encapsulated XML Digital Signature with XADES profile. The specific profile is recognized for optional use by CCHIT [the Certification Commission for Healthcare Information Technology] in S28. This is fully specified in HITSP C26 for documents, which points at the IHE DSG profile. HITSP C26 and IHE DSG profile uses detached signatures on managed documents. This might be preferred as it would have the least impact on the existing data flow, or further profiling could support encapsulation if necessary. CCHIT S28 is not fully clear and has not yet been tested.
An information technology organization stated that DEA should require PKI. The government has a highly secure, interoperable digital identity system for Federal agencies and cross-certified entities through FBCA. The commenter asserted that this system should provide the framework for DEA's rule for electronic prescribing of controlled substances. The commenter believed that it is a widely available and supported system that provides the level of security, non-repudiability, interoperability, and auditability required by legislation covering the prescribing of controlled substances. The commenter stated that such a system would provide strong evidence that the original prescription was signed by a DEA-registered practitioner, that it was not altered after it was signed and transmitted, and that it was not altered after receipt by the pharmacist.
An information technology provider suggested the application allow the end users to choose credential types, including PKI and/or One Time Password (OTP) credentials, and recommended end users be permitted to use their existing PKI credentials if their digital certificates met Federal Medium Assurance requirements and are issued from a CA that is cross-certified with the Federal Bridge. The commenter asserted that it is expected that there will be a number of service providers who will offer a turnkey PKI service to issue digital certificates for non-Federal entities that meet these requirements. This would lower costs for the overall system and would foster a stronger adoption curve for end users because they may be able to use a device they already possess to secure online accounts.
A PKI system designer noted that digital signatures can be used for any data. Once prescription and pharmacy applications are using the same version of SCRIPT the commenter believed there will be no need for conversion of prescriptions from one software version to another. The commenter further asserted that:
An intermediary further stated that the FIPS 186-2 Digital Signature Standard published in January 2000 has some shortcomings that are addressed in the current draft version FIPS 186-3 of the standard. The commenter believed these shortcomings relate to the signature schemas. The commenter asserted that FIPS 186-2 does not support RSA signature schemes according to Public Key Cryptography Standard (PKCS) #1 version 2.1, which is a widely used industry standard. The commenter indicated that PKCS#1 is added to the FIPS 186-3 draft for the Digital Signature Standard. Therefore, the commenter asserted, signatures according to PKCS#1 version 2.1 (RSASSA-PKCS1-v1_5 and RSASSA-PSS) should also be considered as appropriate for electronic prescriptions for controlled substances. This same commenter asserted that the minimum key sizes for digital signatures should meet the requirements specified in NIST SP 800-57 Part 1.
Under the interim final rule, using a private key to sign controlled substance prescriptions will be an option provided that the associated digital certificate is obtained from a certification authority that is cross-certified with the Federal PKI Policy Authority at a basic assurance level or above. The electronic prescription application will have to support the use of digital signatures, applying the same criteria as proposed for Federal systems. The private key associated with the digital certificate will have to be stored on a hard token (separate from the computer being accessed) that meets the requirements for FIPS 140-2 Security Level 1 or higher. If a practitioner digitally signs a prescription with his own private key and transmits the prescription with the digital signature attached, the pharmacy will have to validate the prescription, but no other digital signatures will need to be applied. (If the practitioner uses his own private key to sign a prescription, the electronic prescribing application will not have to apply an application digital signature.) If the
As noted in other parts of this rulemaking, DEA has updated the incorporation by reference to FIPS 186-3, June 2009.
DEA proposed that an application provider must audit its records and applications daily to identify if any security incidents had occurred and report such incidents to DEA.
Although practitioners are not expressly required under the DEA regulations to report suspected diversion of controlled substances to DEA, all DEA registrants have a duty to provide effective controls and procedures to guard against theft and diversion of controlled substances.
DEA recognizes the concern about reporting incidents before the practitioner or application provider has had a chance to investigate. DEA's experience with theft and loss reporting, however, indicates that waiting for investigation may delay reporting for long periods and make it difficult to collect evidence. DEA believes that one business day is sufficient. DEA notes that this is the same length of time required under the regulations for reporting of thefts or significant losses of controlled substances.
DEA proposed that all records related to controlled substance electronic prescriptions be maintained for five years. DEA also proposed that the electronic records must be easily readable or easily rendered into a format that a person can read.
With respect to the issue of placing certain recordkeeping responsibilities on application providers, which are nonregistrants, the following considerations should be noted. While the express recordkeeping requirements of the CSA (set forth in 21 U.S.C. 827) apply only to registrants, DEA has authority under the Act to promulgate “any rules, regulations, and procedures [that the agency] may deem necessary and appropriate for the efficient execution of [the Act].” (21 U.S.C. 871(b)). DEA also has authority under the Act “to promulgate rules and regulations * * * relating to the * * * control of the * * * dispensing of controlled substances.” (21 U.S.C. 821). The requirements set forth in the interim final rule relating to recordkeeping by nonregistrant application providers are being issued pursuant to this statutory authority. As stated in the interim final rule, for the purpose of electronic prescribing of controlled substances, DEA registrants may only use those applications that comply fully with the requirements of the interim final rule.
It should also be noted that DEA is not requiring practitioners to create a copy of a prescription or a new record; it is requiring the practitioner to use an application that stores a copy of the digitally signed record and retains the record for two years. These records will be stored on an application service provider's servers if the practitioner is using an application service provider to prescribe or on the practitioner's computers for installed applications. DEA further notes that the electronic prescribing of controlled substances is voluntary; no practitioner is required to issue controlled substance prescriptions electronically.
Although DEA had proposed having the first intermediary store the record, after taking into consideration the comments received to the NPRM, DEA decided that this approach risked losing the records. The practitioner can determine, through audit or certification reports, whether an electronic prescribing application meets DEA's requirements, but it may be difficult for the prescribing practitioner to ensure that an intermediary meets DEA's requirements if the first intermediary is a different firm, as it often is. Intermediaries may change or go out of business, destroying any records stored; intermediaries may also subcontract out some of the functions, further attenuating controls.
DEA proposed that the electronic prescription application would have to generate, on a monthly basis, a log of all controlled substance prescriptions issued by a practitioner and provide the log to the practitioner for his review. DEA further proposed that the practitioner would be required to review the log, but would not be expected to cross-check it with other records. As DEA explained in the NPRM, the purpose of the log review was to provide a chance for the practitioner to spot obvious anomalies, such as prescriptions for patients he did not see, for controlled substances he did not prescribe, unusual numbers of prescriptions, or high quantity of drugs. The practitioner would have to indicate that he had reviewed the log.
Other practitioner groups and application providers opposed the requirement that the practitioner review the monthly log check because such review is not required for paper prescriptions and because, these commenters asserted, it would be difficult to do without cross-checking patient records. An application provider stated that DEA does not have the authority to require the monthly log as 21 U.S.C. 827(c)(1) exempts practitioners from keeping prescription records. Some commenters mistakenly assumed that pharmacies would be generating the logs and that practitioners would have to review multiple logs each month; they opposed the requirement on that basis. An application provider and a State agency expressed doubt about the benefits of the requirement given the number of prescriptions that might be in an individual practitioner's monthly log. A few commenters suggested that DEA should enhance the log requirement to require the electronic prescription application to generate the logs every week (rather than every month, as was proposed). One application provider said that any log requirement would discourage electronic prescribing. Several commenters stated that the check would not enhance non-repudiation. A practitioner organization and a practitioner said that many providers would be worried about their liability if they fail to detect fraud. These commenters suggested that the regulations should protect unintentional failure to detect fraud and the purpose of the logs should be exclusively to help physicians recognize fraud if they are able to do so, but without penalty for failures to catch errors if a good faith review and signature were performed. Another practitioner organization stated that DEA did not detail the practitioner's ultimate responsibility to review and approve the information in the logs, the manner and timeframe in which the review must be completed, or the practitioner's liability for failing to review the log. The commenter asserted that this obligation, as well as the other requirements, seems to create a new practice standard that places more responsibility, and thus increased liability, for proper implementation of the law on practitioners. In addition, this commenter expressed the view that there is a need to specify the confidentiality of all such records,
A State board of pharmacy said that a review of prescription monitoring records should be accepted as a substitute. Several commenters asked that the review be done electronically. A State agency stated that DEA should prohibit the practitioner from delegating the review to members of his staff.
DEA is also maintaining in the interim final rule the requirement that the application be able to generate a log, upon request by the practitioner, of all electronic prescriptions for controlled substances the practitioner issued using the application over at least the preceding two years. As was proposed, the interim final rule requires that this log, as well as the monthly logs, be sortable at least by patient name, drug name, and date of issuance.
With respect to 21 U.S.C. 827, it is true that this provision sets forth the statutorily mandated recordkeeping requirements for DEA registrants. However, this provision does not preclude DEA from requiring that practitioners who elect to prescribe controlled substances electronically use applications that meet certain standards designed to reduce the likelihood of diversion. In this same vein, nothing in 21 U.S.C. 827 precludes DEA from requiring that practitioners, when electronically prescribing controlled substances, use applications that, among other things, maintain records that the agency reasonably concludes are necessary to ensure proper accountability. As stated at the outset of this preamble, DEA has broad statutory authority to promulgate any rules and regulations that the agency deems necessary and appropriate to controlled against diversion of controlled substances or to otherwise efficiently execute the agency's functions under the CSA.
DEA proposed that the information required under part 1306 including the full name and address of the patient, drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner must not be altered during transmission; it could be reformatted.
DEA proposed that if a prescription is transmitted electronically, it could not be printed. If it was printed, it could not be transmitted electronically.
DEA has also added a provision that the application may print a prescription for signing and dispensing if transmission fails. DEA will require that these original prescriptions include a note to the pharmacy that the prescription was originally transmitted to a specific pharmacy, but that the transmission failed. DEA considers this warning necessary because it is possible that the practitioner will be notified of a failure while the application is still attempting to transmit the prescription. The warning will alert the pharmacy to check its records to be certain a later transmission attempt had not succeeded. If the printed prescription is to be used for dispensing, it must be manually signed by the prescribing practitioner pursuant to § 1306.05(a). As the printed prescription contains information regarding the prior transmission, this information will be retained by the pharmacy.
DEA proposed that intermediaries could not convert an electronic prescription into a fax if transmission failed. They would be required to notify the practitioner, who would then have to print and manually sign the prescription.
One State Board of Pharmacy stated that it had found many problems with electronic prescriptions. Among the problems this State Board reported was that even when pharmacies are able to receive electronic prescriptions, their applications do not necessarily read electronic prescriptions accurately. Data entered by a practitioner may be truncated in the pharmacy application or moved to another field. These statements were echoed by a State pharmacist association.
One application provider asked if faxed electronic prescriptions can continue to be treated as oral prescriptions.
None of the security measures that are used for transmission address the threat of someone stealing a practitioner's identity to issue prescriptions or of office staff being able to issue prescriptions in a practitioner's name because of inadequate access controls or authentication protocols. None of the measures address the threat of pharmacy staff altering records to hide diversion. Some commenters indicated that they anticipate the elimination of intermediaries once the SCRIPT standard is mature and interoperability exists without the need for converting a data file from one software version to another so that it can be read correctly.
Although DEA is concerned about the possibility that controlled substances prescriptions could be altered or created during transmission, it has chosen to address those issues by requiring that the controlled substance prescription is digitally signed when the practitioner executes the two-factor authentication protocol and when the pharmacy receives the prescription. The only transmission issues that DEA is addressing in the interim final rule concern one common practice—the conversion of prescriptions from one software version to another—and one possible practice—the facsimile transmission of prescriptions by intermediaries to pharmacies. As discussed above, DEA will permit intermediaries to convert controlled substances prescriptions from one software version to another; DEA will not allow intermediaries to transform an electronic prescription for a controlled substance into a facsimile as many of them do. DEA is also explicitly stating that any DEA-required information may not be altered during transmission.
DEA proposed that either the pharmacy or the last intermediary routing an electronic prescription should digitally sign the prescription and the pharmacy would archive the digitally signed record as proof of the prescription as received.
The interim final rule requires the pharmacy or the last intermediary to digitally sign the prescription and the
About a third of registered pharmacies already have the ability to digitally sign electronic controlled substance orders through DEA's Controlled Substances Ordering System; the private key used for these electronic orders could be used to sign prescriptions upon receipt. Similarly, most applications that move files through virtual private networks or that conduct business over the Internet have digital signature capabilities. DEA has not imposed any requirements for the source of the digital signatures because pharmacies and intermediaries may already have signing modules that can be used. Pharmacies that have a Controlled Substance Ordering System digital certificate obtained it from DEA. In response to the comment on validating the digital signature, the pharmacy or intermediary will be signing the record; DEA sees no need to ask them to validate their own certificate. DEA does not believe that it is necessary to provide an alternative to the digital signature because it should be possible for either the intermediary or pharmacy to apply a digital signature within a reasonable time.
On the issue of direct exchanges between a practitioner and a pharmacy, two digital signatures (the electronic prescription application's or practitioner's and the pharmacy's) would be required unless the practitioner's digital signature is transmitted to the pharmacy and validated. Even when intermediaries are not involved, there is the possibility that an electronic prescription could be intercepted and altered during transmission. When it becomes feasible for practitioners to transmit electronic prescriptions directly to pharmacies, without conversion from one software version to another, the PKI option that DEA is making available under the interim final rule may be an alternative that more applications and practitioners choose to use. The primary barrier to this option is the current need to convert prescription information from one software version to another during transmission because of interoperability issues; conversion of the prescription information from one software version to another makes it impossible to validate the digital signature on receipt. When interoperability issues have been resolved, transmitting a digital signature and validating the digital signature may be more cost-effective for some pharmacies. Because of the alternatives DEA is providing for practitioner issuance of electronic prescriptions for controlled substances, DEA does not believe it is necessary to develop alternative approaches that would apply only to those few truly closed systems. DEA notes that it has also made a number of changes to the proposed rule that are consistent with the practices described by the commenters from closed systems; for example, DEA is allowing institutional practitioners to conduct identity proofing in-house.
DEA proposed that pharmacies would be required to check the CSA database to confirm that the DEA registration of the prescriber was valid at the time of signing.
DEA proposed that pharmacy applications have an internal electronic audit trail that recorded each time a controlled substance prescription was opened, annotated, altered, or deleted and the identity of the person taking the action. The pharmacy or the application provider would establish and implement a list of auditable events that, at a minimum, would include attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with application operations in the pharmacy application. The application would have to analyze the audit logs at least once every 24 hours and generate an incident report that identifies each auditable event. Security incidents would need to be reported within one business day.
DEA does not believe it is feasible to define or list every conceivable event that would constitute an auditable event for all pharmacies. The extent to which a particular event might raise concern at one pharmacy is not necessarily the same at other pharmacies. For example, a community pharmacy may want to set different triggers for changes to opioid prescriptions than a pharmacy that serves a large cancer center or a pharmacy that services LTCFs would. A community pharmacy that is closed overnight may want to identify any change that occurs during the hours when it is closed—an event that is not a consideration for a pharmacy that is open 24 hours a day. The auditable events must, at a minimum, include attempted or successful unauthorized access, modification, or destruction of information or interference with application operations in the pharmacy application. DEA has dropped the unauthorized “use or disclosure” from its list of auditable events. These events are included in the CCHIT standards for electronic health records and may be important to pharmacies, but are not directly relevant to DEA's concerns.
DEA expects that application providers and developers will work with pharmacies to identify other auditable events. DEA emphasizes that application providers should define auditable events to capture potential security threats or diversion. Changes from brand name drug to a generic version of the same drug, for example, do not represent potential security issues.
DEA proposed that back-up records be stored at a separate offsite location. DEA proposed that the electronic record be easily readable or easily rendered into a format that a person could read and must be readily retrievable.
DEA believes that daily backup of prescription records is an acceptable length of time to ensure the integrity of pharmacy records.
In the NPRM, DEA confirmed existing regulations regarding the transfer of prescriptions for Schedule III, IV, and V controlled substances. Specifically, under § 1306.25(a) a pharmacy is allowed to transfer an original unfilled electronic prescription to another pharmacy if the first pharmacy is unable to or chooses not to fill the prescription. Further, a pharmacy is also allowed to transfer an electronic prescription for a Schedule III, IV, or V controlled substance with remaining refills to another pharmacy for filling provided the transfer is communicated between two licensed pharmacists. The pharmacy transferring the prescription would have to void the remaining refills in its records and note in its records to which pharmacy the prescription was transferred. The notations may occur electronically. The pharmacy receiving the transferred prescription would have to note from whom the prescription was received and the number of remaining refills.
DEA proposed that both electronic prescription applications and the prescription processing module in pharmacy applications should be subject to a third-party audit that met the requirements of SysTrust or WebTrust audits (or for pharmacies, SAS 70). The standards for these audits are established and maintained by the American Institute of Certified Public Accountants.
DEA proposed third-party audits as a way to provide registrants with an objective appraisal of the applications they purchase and use. As a number of commenters stated, except for registrants associated with very large practices, large healthcare systems, or chain pharmacies, any of which may have their own information technology departments, the majority of registrants cannot be expected to determine, on their own, whether an application meets DEA's requirements. If they are to have assurance that the application they are using is in compliance with DEA regulatory requirements, that assurance must come from another source.
As commenters noted, DEA essentially had to choose among four possibilities for determining whether an application meets the requirements of part 1311: The application provider could self-certify the application; DEA could review and certify applications; an independent certification organization could take on that role; or the application provider could obtain a third-party audit from a qualified independent auditor. DEA believes that self-certification would not provide any assurance to registrants as non-compliant application providers would have an incentive to misrepresent their compliance with DEA regulatory requirements, and registrants would have few ways to determine the truth. For example, an application provider could claim that its application required the setting of logical access controls when the application, in fact, allowed anyone access regardless of the logical access controls. Until a practitioner or pharmacy discovered that prescriptions were being written or altered by unauthorized persons there would be no reason to suspect a problem with the application.
DEA does not have the expertise or the resources to conduct technical reviews of electronic prescription or pharmacy applications. Even if DEA elected to obtain such expertise, the time required for it to do so and then to review all of the existing applications would delay adoption.
DEA believes that a third-party audit approach allows application providers to seek a review as soon as their applications are compliant, which should make applications available for electronic prescribing of controlled substances sooner than relying on DEA. Third-party audits, while perhaps new to some prescription and pharmacy application providers, are a common approach used by the private sector to ensure compliance with both government regulations and private sector standards. For example, the International Standards Organization (ISO) frequently requires companies to obtain a third-party audit to gain certification for compliance with its standards (
The fourth approach would be to rely on an independent certification organization, such as CCHIT, to test and certify electronic prescription and pharmacy applications. Under the interim final rule, DEA will allow the certifications of such independent organizations to substitute for a third-party audit if the certification process clearly determines that the application being tested is compliant with DEA regulatory requirements and clearly distinguishes between applications that are compliant with part 1311 and those that are not. DEA notes, for example, that CCHIT currently tests and certifies EHRs against a set of published standards and plans to test and certify stand-alone electronic prescribing applications. However, at this time, CCHIT does not evaluate pharmacy applications. Once any certification
A pharmacy organization stated application vulnerabilities should be addressed through technology and that they should not create extra paperwork. It also stated that DEA should ensure that the cost of these audits is reasonable for small practices and pharmacies. A pharmacy organization and an information technology organization stated that the audit requirement is a burden financially and logistically. These commenters noted that some clinics that serve as both practitioners and pharmacies will bear the costs of both sides of the transaction.
DEA has taken a number of steps to reduce the cost of the third-party audit. First, recognizing that the electronic prescribing and prescription processing functions DEA is requiring may not change every year, DEA has revised the rule to require an audit whenever an application is altered in a way that could affect the functionalities within the electronic prescription or pharmacy application related to controlled substance prescription requirements or every two years, whichever occurs first. Second, DEA has clarified that the purpose of the third-party audit is to determine whether the application meets DEA's requirements, that is, that the application is capable of performing the functions DEA requires and does so consistently. Where the application is installed on practice or pharmacy computers, the audit will not need to address the application provider's physical security nor will it need to address physical security at the practice or pharmacy because that will vary with each installation and is beyond the control of the application provider. For application service providers, the physical security of the ASP will need to be audited.
Third, as discussed above, if independent certification organizations develop programs that certify applications for part 1311 compliance, DEA will review their processes to determine whether such certifications can substitute for a third-party audit.
Finally, DEA has expanded the kinds of third-party auditors beyond those who perform SysTrust, WebTrust, or SAS 70 audits to include certified information system auditors (CISA) who perform compliance audits as a regular ongoing business activity. The CISA certification is sponsored by the Information Systems Audit and Control Association (ISACA)
As discussed above, if a certification organization decides to incorporate, as part of its certification, a determination that the application meets the requirements of part 1311, DEA will review the process used to determine whether the certification can be used as a substitute for a third-party audit. Based on a review of the information available on its Web site,
DEA would be willing to evaluate a request from a pharmacy board to carry out a third-party audit or review of an audit, but as no State Board offered to take on this role in its comments to the NPRM, DEA doubts that this approach is feasible.
As discussed above, if an organization develops a program to certify electronic prescription or pharmacy applications, DEA will review the processes for certification of applications proposed by that organization to determine if the certification standards adequately evaluate compliance with part 1311. DEA will provide a list of those organizations whose certification processes adequately address compliance with DEA's requirements and allow such certifications to take the place of third-party audits. This should reduce the cost to application providers. As for the concern about the availability of third-party auditors, DEA notes that there are a limited number of applications, which are unlikely all to be ready for audits at the same time. DEA, however, has expanded the range of potential auditors by including those who have CISA credentials.
In the NPRM, DEA provided a detailed risk assessment, applying the criteria of OMB M-04-04, a guidance document for assessing risks for Federal agencies. (
In
The information technology firm stated that Level 4 token technology is significantly more costly to distribute, manage, and operate than multi-token Level 3 technologies. The commenter asserted that cell phone-based multi-factor one-time-password devices require the distribution of code that is unique to each cell phone platform. Consequently, the commenter asserted, the cost and complexity for the end-users is significant. The logistical management of the software and cryptographic solutions for multi-factor cryptographic hardware devices make their cost untenable in a large scale, heterogeneous deployment. The application provider asserted that Level 4 requires that every system user use a Level 4 token to access the system, not just practitioners accessing select functions in a single application. Both commenters suggested that DEA require Level 3 tokens that are stored on a device “separate from the computer gaining access,” citing OMB memorandum M-07-16 on safeguarding personal information.
The primary purpose of the higher level of physical security for Level 4 is to prevent tampering with the device. Given the technical expertise needed to tamper with a device without making it nonfunctional, DEA does not consider that such tampering is enough of a risk in healthcare settings to justify imposing the higher costs associated with such devices. DEA believes that the other steps it is implementing regarding identity proofing and logical access control are sufficient to mitigate the risk to allow for Level 3 rather than Level 4 tokens. By requiring that two factors are used to access the controlled substance functions in the application, DEA is limiting the threat from stolen or tampered-with tokens.
DEA also disagrees with the commenter's suggestion for different requirements for Schedule II prescriptions. As DEA has discussed, electronic prescriptions are written prescriptions. Requirements for written prescriptions are uniform, regardless of the schedule of the controlled substance. Further, to establish differing requirements for Schedule II controlled substance prescriptions as compared with Schedule III, IV, and V prescriptions would add unnecessary complexity to the electronic prescription application. The commenter's suggestion appears to be based on the assumption that Schedule II substances, and their related prescriptions, are more likely to be diverted; however, DEA notes that both Schedule III and Schedule IV substances, and their related prescriptions, are regularly diverted for nonlegitimate use. DEA believes that a single approach more accurately reflects the statutory and regulatory requirements for written prescriptions, is more appropriate, and will be easier for application providers and practitioners to implement.
DEA has adopted some of the second factors that the commenter suggested, specifically the biometric and any hard token that meets NIST Level 3, which could include proximity cards and thumb drives that contain a cryptographic module. DEA does not believe that associating a prescription with a particular IP address will provide a pharmacy any assurance of the identity of the person who signed the prescription; any prescription generated on a practice's computers may have the same IP address. This suggestion also assumes that every pharmacy to which a practitioner may transmit would have the ability to determine whether the source IP address was whitelisted.
As to the claim that pharmacists will prevent wide-spread diversion, it is difficult to see how this could be the case. If someone issues multiple prescriptions to a patient and transmits them to multiple pharmacies, the pharmacists will have no ability to identify the problem, just as a single pharmacist will not be able to identify fraudulent prescriptions issued to multiple patients. Unlike paper prescriptions, electronic prescriptions lack many of the indications of a forged prescription that pharmacists use to identify a forged paper prescription. Electronic prescribing applications make it difficult for the person diverting to misspell a drug name or to select dosage forms that do not exist; they provide no indication of alterations.
The commenter assumes that such problems will be discovered through data mining and that data mining will reduce diversion. DEA, however, has no authority to collect data on all prescriptions issued and, therefore, no ability to conduct data mining. Even if DEA had the authority to collect prescription data, data mining would only work if all prescription data were available (electronic prescriptions, paper, fax, and oral) and in a common electronic format. If the per-prescription transaction fee charged by the commenter for transmission is any indication of the cost of that one step in data mining, the cost of data mining for controlled substance prescriptions to DEA could be high.
Data mining, were it legally possible and economically feasible, is based on being able to identify patterns of unusual activities. Data mining might detect individuals diverting controlled substances for themselves or registrants issuing large numbers of prescriptions potentially other than for legitimate medical purposes. It would not identify the organized diverters who would easily determine what patterns would trigger investigation and avoid those patterns. One problem with poorly controlled or uncontrolled electronic prescription issuance is that it would be easy for criminals to steal practitioner identities, issue a limited number of prescriptions under each identity to a limited number of patients, and move on to the next set of stolen identities. Nothing in the pattern would trigger investigation, regardless of whether data mining was being conducted.
Finally, data mining, even in real time if that were to be possible, would not prevent many of the injuries and deaths diversion causes because the drugs would have been obtained and used or sold before law enforcement could act. To claim that the risk to personal safety is low is to ignore the reality of the consequences of drug diversion. DEA considers it critical that electronic prescribing applications for controlled substance prescriptions be designed to limit the possibility of diversion to as great an extent as possible rather than assume that the problems will not occur. Fixing the problem after electronic prescribing applications are widely deployed, as the commenter suggested, could be done, would be far more difficult and more disruptive than implementing reasonable controls in the early stages of the applications' use.
Because of DEA's statutory responsibilities and the magnitude of the harm to the public health and safety that would result if an insufficiently secure system were to cause an increase in diversion of controlled substances, any regulations authorizing the use of electronic prescriptions for controlled substances must contain adequate security measures from the outset. DEA cannot, consistent with its obligations, set the bar lower than it believes necessary with an eye toward increasing the security requirements at some later date should the vulnerabilities be exploited. Regulatory changes take significant time—time during which there could be continuing harm to the public health and safety.
In the NPRM, DEA proposed to move all of the existing definitions in part 1311 to a new section in part 1300 (§ 1300.03) and to add new definitions to that section. The proposed definitions included “audit,” “audit trail,” “authentication,” “authentication protocol,” “electronic prescription,” “hard token,” “identity proofing,” “intermediary,” “NIST SP 800-63,” “paper prescription,” “PDA,” “SAS 70 audit,” “service provider,” “SysTrust,” “token,” “valid prescription,” and “WebTrust.”
Definition of “Service provider.” In the NPRM, DEA proposed to define a service provider as follows:
(1) Issues or registers practitioner tokens and issues electronic credentials to practitioners.
(2) Provides the technology system (software or service) used to create and send electronic prescriptions.
(3) Provides the technology system (software or service) used to receive and process electronic prescriptions at a pharmacy.
An intermediary recommended modifying the definition of service provider to recognize that some prescribers and the entities for which they work have created their own electronic prescribing applications. The intermediary noted that some prescribers, as well as some pharmacies, have their own proprietary applications and do not connect to intermediaries through third-party service providers, but rather connect directly. Accordingly, some entities in fact act as both a prescriber or pharmacy, on the one hand, and an application provider, on the other hand. The intermediary also noted that the addition of the word “trusted” to the definition of service provider adds a subjective element that is not defined anywhere in the NPRM. While the word “trusted” is a term of art used in the industry, since it is not defined in the NPRM, the intermediary stated that DEA should delete the word “trusted” from the definition of service provider to avoid any ambiguity in the future. The intermediary argued that if an entity complies with the requirements as imposed by the rule, then that entity is and should be considered a trusted entity, and there is no need to introduce an undefined and subjective word such as “trusted” into the definition.
The definition of “intermediary” is unchanged from the NPRM: “
DEA believes that these revisions will clarify the rule and allow DEA to make the distinction between application service providers, who host and manage the electronic prescription applications on an ongoing basis, and those providers that develop, market, or install software, but do not manage the application once it is installed. In the case of a closed system, a single entity may manage both the electronic prescription application and the pharmacy application and, therefore, would be considered to be the provider of both. Based on the inclusion of these new definitions, DEA has removed the term “service provider” from the interim final rule.
Similarly, DEA does not believe it appropriate for DEA itself to maintain a list of pharmacies that accept electronic prescriptions for controlled substances. Again, whether a pharmacy chooses to accept such prescriptions is a business decision left to that pharmacy. DEA is not in a position to proactively and continually monitor pharmacies' involvement in this arena, nor is DEA in a position to continually receive updates from its approximately 65,000 pharmacy registrants regarding their involvement. The electronic prescribing of controlled substances by prescribing practitioners, and the dispensing of those electronic prescriptions by DEA-registered pharmacies, is strictly voluntary. DEA notes that electronic prescription application providers maintain databases of pharmacies that accept electronic prescriptions for routing or other purposes. DEA believes that application providers and/or intermediaries are better suited to the task of maintaining these listings. This is particularly necessary as, due to potential interoperability issues, a pharmacy that can process prescriptions from one application provider may not be able to process prescriptions from other application providers.
A pharmacy organization stated that it is receiving many reports of errors occurring in electronic prescriptions. The commenter indicated that the prescriptions are quite legible, but, occasionally, quite wrong. Pharmacists are reporting that many prescriptions are being received by the pharmacy with the drug names and directions for use truncated. In other cases, the directions are incorrect in the space allocated for directions, while the intended instructions are placed in the “comments” section. In other situations, the wrong drug, wrong strength, or totally incorrect directions are transmitted. Occasionally, the quantity of drug is incorrect. There have been a few instances where a computer application, according to anecdotal reports, actually “shuffled” prescriptions in the application, such that the drug intended for one patient appeared on screen for another patient. The organization asserted that errors have been caused by practitioner software and pharmacy software, as well as practitioner keying errors.
It should also be noted that the required elements of a prescription for a controlled substance (those set forth in 21 CFR 1306.05(a)) are the same for all prescriptions for controlled substances, and this same approach is followed in the interim final rule with respect to electronic prescriptions. Further, DEA believes that disallowing the electronic prescribing of Schedule II controlled substances could significantly hinder adoption of electronic prescribing of controlled substances in other schedules, as it would potentially create separate application requirements for separate schedules, causing confusion among practitioners, pharmacies, and application providers as to which requirements should be followed for which substances.
• Promoting scalability and nationwide adoption of electronic prescribing by enabling all prescribers, regardless of the volume of controlled substances prescribed, to create and transmit prescriptions for controlled substances via the same electronic media as prescriptions for noncontrolled substances;
• Reducing and eliminating additional costs and administrative burden on pharmacists and prescribers;
• Ensuring compliance and consistency with the uniform standards relating to the requirements for electronic prescription drug programs;
• Improving patient safety and quality of care; and
• Allowing for the expeditious adoption of technological advances and innovation.
As has been discussed previously, nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription application that does not comply with the interim final rule to prepare a controlled substance prescription, so that EHR and other electronic prescribing functionality may be used, and print the prescription for manual signature by the practitioner. Such prescriptions are paper
Similarly, DEA does not believe it prudent to delay the effective date of this rule for any length of time. DEA wishes to encourage adoption of electronic prescriptions for controlled substances as rapidly as industry is willing and able to comply with the requirements of this rule. DEA recognizes that some health care entities, particularly Federal healthcare facilities, may be more prepared to begin electronically prescribing controlled substances in compliance with this rule than others. To delay the effective date of this rule may unnecessarily hinder those organizations from electronically prescribing controlled substances as quickly as they are able.
DEA notes that 38 States have implemented prescription monitoring programs that are based on the submission of data from pharmacies after the prescriptions have been filled. These programs may be used to identify patients who are obtaining prescriptions from multiple practitioners at one time or practitioners who are issuing an unusual number of controlled substance prescriptions.
As this interim final rule is a
A number of commenters raised issues that are beyond the scope of this rulemaking (
In view of the comments that DEA received, the interim final rule contains a number of changes to the proposed rule. For the most part, the changes are logical outgrowths of the proposed rule and comments. In some instances, however, DEA has determined that the changes from the proposed rule warrant additional public comment. To assist the reader in understanding the changes, this section summarizes the major revisions. Commenters made a variety of recommendations on each issue. Where DEA determined that it could accept recommendations without lessening the security and integrity of controlled substance prescriptions, it has done so to provide more flexibility and lessen the burden on practitioners and pharmacies.
DEA wishes to emphasize that the electronic prescribing of controlled substances is in addition to, not a replacement of, existing requirements for written and oral prescriptions for controlled substances. This rule provides a new option to prescribing practitioners and pharmacies. It does not change existing regulatory requirements for written and oral prescriptions for controlled substances. Prescribing practitioners will still be able to write, and manually sign, prescriptions for Schedule II, III, IV, and V controlled substances, and pharmacies will still be able to dispense controlled substances based on those written prescriptions and archive those records of dispensing. Further, nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription application that does not comply with the interim final rule to prepare a controlled substance prescription electronically, so that EHR and other electronic prescribing functionality may be used, and print the prescription for manual signature by the practitioner. Such prescriptions are paper prescriptions and subject to the existing requirements for paper prescriptions.
In Part 1300, DEA is adding a new § 1300.03 (“Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.”) The definitions currently in § 1311.02 are moved to § 1300.03. Definitions of the following are established without revision from the NPRM: “audit trail,” “authentication,” “electronic prescription,” “identity proofing,” “intermediary,” “paper prescription,” “PDA,” “SAS 70,” “SysTrust,” “token,” “valid prescription,” and “WebTrust.” Based on comments received, DEA is establishing the definition of “hard token,” with changes as discussed above. Based on comments received, DEA is adding definitions of the terms “application service provider,” “electronic prescription application provider,” “installed electronic prescription application,” “installed pharmacy application,” “pharmacy application provider,” and “signing function.” DEA is updating the proposed definition of “NIST SP 800-63” to reflect the most current version of this document.
To address the use of a biometric as one possible factor in a two-factor authentication credential, DEA is adding definitions specific to that subject. Specifically, DEA is adding definitions of “biometric subsystem,” “false match rate,” “false non-match rate,” “NIST SP 800-76-1,” and “operating point.” While DEA is adding a definition of “password” to mean “a secret, typically a character string (letters, numbers, and other symbols), that a person memorizes and uses to authenticate his identity,” DEA is not establishing any regulations regarding password strength, length, format, or character usage.
In the definition of authentication protocol, DEA revised the language slightly to read: “Authentication protocol means a well specified message exchange process that verifies possession of a token to remotely authenticate a person to an application.” The proposed language had read “to remotely authenticate a prescriber.”
As discussed elsewhere in this rule, DEA is revising certain recordkeeping requirements. To ensure that terms used regarding recordkeeping are understood, DEA has repeated the definition of “readily retrievable” from 21 CFR 1300.01(b)(38). This definition is longstanding and is well understood by the regulated industry. DEA does not believe that this definition will cause the regulated industry any difficulty. Since the inception of the CSA, the DEA regulations have defined the term as follows: “
In its NPRM, DEA proposed to define the term “audit” as follows: “
DEA has added definitions of credential and credential service provider based on the NIST definitions in NIST SP 800-63-1.
DEA has added definitions for the updated NIST FIPS standards. Finally, DEA is defining the term “trusted agent” to provide greater specificity regarding identity proofing conducted by institutional practitioners.
In Part 1304, § 1304.04 is revised to limit records that cannot be maintained at a central location to paper order forms for Schedule I and II controlled substances and paper prescriptions. In paragraph (b)(1), DEA is removing the reference to prescriptions; all prescription requirements are moved to paragraph (h). Paragraph (h), which details pharmacy recordkeeping, is revised to limit the current requirements to paper prescriptions and to state that electronic prescriptions must be retrievable by prescriber's name, patient name, drug dispensed, and date filled. The electronic records must be in a format that will allow DEA or other law enforcement agencies to read the records and manipulate them; preferably the data should be downloadable to a spreadsheet or database format that allows DEA to sort the data. The data extracted should only include the items DEA requires on a prescription. Records are required to be capable of being printed upon request.
DEA is adding a new § 1304.06 (“Records and reports for electronic prescriptions.”) This section does not create new recordkeeping requirements, but rather simply consolidates and references in one section requirements that exist in other parts of the rule. This new section is intended to make it easier for registrants and application providers to understand the records and reports they are required to maintain. Practitioners who issue electronic prescriptions for controlled substances must use electronic prescription applications that retain the record of the digitally signed prescription information and the internal audit trail and any auditable event identified by the internal audit trail. Institutional practitioners must retain a record of identity proofing and issuance of the two-factor authentication credential, where applicable, as required by § 1311.110. Pharmacies that process electronic prescriptions for controlled substances must use a pharmacy application that retains all prescription and dispensing information required by DEA regulations, the digitally signed record of the prescription as received by the pharmacy, and the internal audit trail and any auditable event identified by the internal audit trail. Registrants and application service providers must retain a copy of any security incident report filed with the Administration. Application providers must retain third-party audit or certification reports and any adverse audit or certification reports filed with the Administration regarding problems identified by the third-party audit or certification. All records must be retained for two years unless otherwise specified. DEA is not establishing any recordkeeping requirements for credential service providers or certification authorities because they are already subject to such requirements under the terms of certificate policies or frameworks they must meet to gain Federal approval.
In Part 1306 (“Prescriptions”) § 1306.05 is amended to state that electronic prescriptions must be created and signed using an application that meets the requirements of part 1311 and to limit some requirements to paper prescriptions (
Section 1306.08 is added to state that practitioners may sign and transmit controlled substance prescriptions electronically if the applications used are in compliance with part 1311 and all other requirements of part 1306 are met. Pharmacies are allowed to handle electronic prescriptions if the pharmacy application complies with part 1311 and the pharmacy meets all other applicable requirements of parts 1306 and 1311.
As proposed, §§ 1306.11, 1306.13, and 1306.15 are revised to clarify how the requirements for Schedule II prescriptions apply to electronic prescriptions.
As proposed, § 1306.21 is revised to clarify how the requirements for Schedule III, IV, and V prescriptions apply to electronic prescriptions.
As proposed, § 1306.22 is revised to clarify how the requirements for Schedule III and IV refills apply to electronic prescriptions and to clarify that requirements for electronic refill records for paper, fax, or oral prescriptions do not apply to electronic refill records for electronic prescriptions. Pharmacy applications used to process and retain electronic controlled substance prescriptions are required to comply with the requirements in part 1311. In addition, DEA is breaking up the text of the existing section into shorter paragraphs to make it easier to read.
As proposed, § 1306.25 is revised to include separate requirements for transfers of electronic prescriptions. These revisions are needed because an electronic prescription could be transferred without a telephone call between pharmacists. Consequently, the transferring pharmacist must provide, with the electronic transfer, the information that the recipient transcribes when accepting an oral transfer. DEA notes that the NPRM contained language proposing to permit an electronic prescription to be transferred more than once, in conflict with the requirements for paper and oral prescriptions. DEA has removed this proposed requirement; all transfer requirements for electronic prescriptions are consistent with those for paper and oral prescriptions.
Finally, DEA notes that it had proposed a new § 1306.28 to state the basic recordkeeping requirements for pharmacies for all controlled substance prescriptions. Those requirements are present in § 1304.22. Although DEA initially believed that including these requirements in part 1306 would be beneficial, after further consideration DEA believes that they would be redundant and could, in fact, create confusion. Therefore, DEA is not finalizing proposed 21 CFR 1306.28.
DEA is revising the title of part 1311 as proposed.
Section 1311.08 is revised to include the incorporations by reference of FIPS 180-3, Secure Hash Standard; FIPS 186-3, Digital Signature Standard; and NIST SP 800-63-1 Draft Electronic Authentication Guideline.
Subpart C is being added by this interim final rule. DEA has revised the content of proposed subpart C, as discussed above, and has reorganized the subpart. The following describes each of the sections in the interim final subpart C.
Section 1311.100 provides the general requirements for issuing electronic controlled substance prescriptions. It clarifies that the rules apply to all controlled substance prescriptions; the same electronic prescription requirements apply to Schedule II prescriptions as apply to other controlled substance prescriptions. DEA notes that the statutory prohibition on refilling Schedule II prescriptions remains in effect regardless of whether the prescription is issued electronically or on paper (21 U.S.C. 829(a), 21 CFR 1306.12(a)). Only a practitioner registered or exempt from registration and authorized to issue the prescription may do so; the prescription must be created on an application that meets all of the requirements of part 1311 subpart C. A prescription is not valid if the application does not meet the requirements of the subpart or if any of the required application functions were disabled when it was created. A pharmacy may process electronic controlled substance prescriptions only if its application meets the requirements of the subpart.
Section 1311.102 specifies the practitioner's responsibilities. A practitioner must retain sole control of the hard token, where applicable, and must not share the password or other knowledge factor or biometric information. The practitioner must notify the individuals designated to set logical access controls within one business day if the hard token has been lost, stolen, or compromised, or the authentication protocol has otherwise been compromised.
If the practitioner is notified by an intermediary or pharmacy that an electronic prescription was not successfully delivered, he must ensure that any paper or oral prescription (where permitted) issued as a replacement of the original electronic prescription indicates that the prescription was originally transmitted electronically to a particular pharmacy and that the transmission failed.
As discussed previously, if the third-party auditor or certification organization finds that an electronic prescription application does not accurately and consistently record, store, and transmit the information related to the name, address, and registration number of the practitioner, patient name and address, and prescription information (drug name, strength, quantity, directions for use), the indication of signing, and the number of refills, the practitioner must not use the application to sign and transmit electronic prescriptions for the controlled substances.
Further, if the third-party auditor or certification organization finds that an electronic prescription application does not accurately and consistently record, store, and transmit other information required for prescriptions, the practitioner must not sign and transmit electronic prescriptions for controlled substances that are subject to the additional information requirements.
In most cases, this will not be an issue as the SCRIPT standard supports the standard information required for a prescription. A limited number of prescriptions, however, require special information. Prescriptions for GHB require a note on medical need; prescriptions for drugs used for detoxification and maintenance treatment require an additional DEA identification number. Schedule II prescriptions may be issued with written instructions indicating the earliest date that the prescription may be filled. DEA is not certain that the existing SCRIPT standard accommodates the additional information or that existing pharmacy applications accurately and consistently capture and display such information. Because there are relatively few prescriptions with these requirements, DEA decided to place the onus on the third-party auditors or certification organizations to determine whether applications can create, transmit, import, display, and store all of the information needed for these prescriptions. If an electronic
Section 1311.102 also states that a practitioner must not use the application for controlled substance prescriptions if any of the functions have been disabled or is not working properly. Finally, if the application provider notifies him that the third-party audit indicated that the application does not meet the requirements of part 1311, or that the application provider has identified a problem that makes the application non-compliant, the practitioner must immediately cease to issue controlled substance prescriptions using the application and must ensure that access for signing controlled substance prescriptions is terminated. The practitioner must not use the application to issue controlled substance prescriptions until it is notified that the application is again compliant and all relevant updates to the application have been installed.
Sections 1311.105 and 1311.110 specify the requirements for obtaining an authentication credential for individual practitioners and practitioners using an institutional practitioner's application, as discussed above.
Section 1311.115 specifies the requirements for two-factor authentication. It allows the authentication protocol to use any two of the three authentication factors (something you know, something you are, and something you have) and sets the requirements that hard tokens must meet.
Section 1311.116 specifies the requirements that biometric subsystems must meet.
Section 1311.120 provides the electronic prescription application requirements.
Section 1311.120(b)(1) requires an electronic prescription application to link each registrant, by name, with a DEA registration number. For practitioners exempt from the requirement of registration under § 1301.22(c), the application must link each practitioner to the institutional practitioner's DEA registration number and the specific internal code number required under § 1301.22(c)(5).
Section 1311.120(b)(2) requires an electronic prescription application to allow setting of logical access controls for indicating that prescriptions are ready to be signed and signing controlled substance prescriptions. It also requires the application to allow the setting and changing of logical access controls.
Section 1311.120(b)(3) states that logical access controls must be set by user name or role. If the application uses role-based access controls, it must not allow an individual to be assigned the role of registrant unless the individual is linked to a DEA registration number.
Section 1311.120(b)(4) requires that setting and changing of logical access controls must take the actions of two individuals, as discussed above.
Section 1311.120(b)(5) states that the application must accept two-factor authentication credentials and require their use for approving logical access controls and signing prescriptions.
Section 1311.120(b)(6) states that an electronic controlled substance prescription must contain all of the information required under part 1306. As commenters pointed out, although the SCRIPT standard has fields for most of this information, the use of these fields is not always mandated. Some of the required information may have to be put in free text fields (
Section 1311.120(b)(7) states that the application must require the practitioner or his agent to select the DEA number to be used for the prescription where the practitioner issues prescriptions under more than one DEA number. This provision is intended to prevent the application from automatically filling in the DEA number field when a practitioner uses more than one number.
Section 1311.120(b)(8) states that the electronic prescription application must have a time application that is within five minutes of the official National Institute of Standards and Technology time source.
Section 1311.120(b)(9) specifies the information that must appear on the review screen. As explained above, if a practitioner has written several prescriptions for a single patient, the practitioner's and patient's information may appear only once on the review screen.
Section 1311.120(b)(10) states that the application must require the practitioner to indicate that each controlled substance prescription is ready for signing. If any of the information required under part 1306 is altered after the practitioner has indicated that it is ready for signing, the application must remove the indication that it is ready for signing and require another indication before allowing it to be signed. The application must not allow the signing or transmission of a prescription that was not indicated as ready to be signed.
Section 1311.120(b)(11) provides the requirement that the practitioner use the two-factor authentication protocol to sign the prescription.
Section 1311.120(b)(12) states that the application must not allow a practitioner to sign a prescription if his two-factor authentication credential is not associated with the prescribing practitioner's DEA number listed on the prescription (or an institutional practitioner's DEA number and the prescriber's extension data). The application will have to associate each two-factor authentication credential with the registrant's DEA number(s) (or institutional practitioner's DEA number plus the individual practitioner's extension data) and ensure that only the authentication credentials associated with the number on the prescription can indicate the prescription as ready for signing and sign it. This provision is needed to prevent one registrant in a practice from reviewing and signing prescriptions written by other registrants. DEA recognizes that with paper prescriptions, DEA numbers for every member of a practice may be printed on a prescription pad; only the signature indicates which practitioner issued the prescription. For electronic prescriptions, however, only one prescribing practitioner's name will appear and one DEA number. Although the authentication credential will be associated with only one practitioner, it
Section 1311.120(b)(13) states that where a practitioner seeks to prescribe more than one controlled substance at one time for a particular patient, the electronic prescription application may allow the practitioner to sign multiple prescriptions for a single patient at one time using a single invocation of the two-factor authentication protocol provided that the practitioner has individually indicated that each controlled substance prescription is ready to be signed while all the prescription information and the statement described in § 1311.140 are displayed.
Section 1311.120(b)(14) states that the application must time and date stamp the prescription on signing.
Section 1311.120(b)(15) states that when the practitioner executes the two-factor authentication protocol, the application must digitally sign and electronically archive at least the information required by DEA. If the practitioner is signing the prescription with his own private key, the application must electronically archive the digitally signed prescription, but need not digitally sign the prescription a second time.
Section 1311.120(b)(16) specifies the requirements for a digital signature. The cryptographic module must be validated at FIPS 140-2 Security Level 1. The digital signature application and hash function must comply with FIPS 186-3 and FIPS 180-3. The electronic prescription application's private key must be stored encrypted on a FIPS 140-2 Security Level 1 validated cryptographic module using a FIPS-approved encryption algorithm. For software implementations, when the signing module is deactivated, the application must clear the plain text password from the application memory to prevent the unauthorized access to, or use of, the private key.
Section 1311.120(b)(17) states that the prescription transmitted to the pharmacy must include an indication that the prescription was signed unless the prescription is being transmitted with the practitioner's digital signature.
Section 1311.120(b)(18) states that a prescription must not be transmitted unless the signing function was used.
Section 1311.120(b)(19) states that the information required under part 1306 must not be altered after the prescription is digitally signed. If any of the required information is altered, the prescription must be canceled.
Section 1311.120(b)(20) through (22) specify the requirements for printing transmitted prescriptions.
Section 1311.120(b)(23) states that the application must maintain an audit trail related to the following: The creation, alteration, indication of readiness for signing, signing, transmission, or deletion of a controlled substance prescription; the setting or changing of logical access controls related to controlled substance prescriptions; and any notification of failed transmission. Section 1311.120(b)(24) specifies the information that must be maintained in the audit trail: Date and time of the action, type of action, identity of the person taking the action, and outcome.
Section 1311.120(b)(25) states that the application must be capable of conducting an internal audit and generating a report on auditable events.
Section 1311.120(b)(26) states that the application must protect audit trail records from unauthorized deletion, and must prevent modifications to the records.
Section 1311.120(b)(27) specifies the requirements for the monthly log.
Section 1311.120(b)(28) specifies that all records that the application is required to generate and archive must be retained electronically for at least two years.
Sections 1311.125 and 1311.130 specify the requirements for setting and changing logical access controls at an individual practitioner's practice and at an institutional practitioner, respectively.
Section 1311.135 sets the basic application requirements for creating an electronic controlled substance prescription. It states that either a practitioner or his agent may enter prescription information. If a DEA registrant holds more than one registration that he uses to issue prescriptions, the application must require him to select the registration number for each prescription. The application cannot set a default or pre-fill the field if the practitioner has more than one registration. If a practitioner has only one registration, as most practitioners do, the application could automatically fill that field. If required by State law, a supervisor's name and DEA number may be listed on a prescription, provided the prescription clearly indicates who is the supervisor and who is the prescribing practitioner.
Section 1311.140 provides the application requirements for signing an electronic prescription for a controlled substance. It requires that the screen displaying the prescription information for review include the statement that completing the two-factor authentication protocol signs the prescription and that only the practitioner whose name and DEA number are on the prescription may sign it. After the practitioner has indicated that one or more controlled substance prescriptions for a single patient are ready for signing, the application must prompt the practitioner to execute the two-factor authentication protocol. The completion of the two-factor authentication protocol must apply the application's (or practitioner's) digital signature to the DEA-required information and electronically archive the digitally signed record. The application must clearly label as the signing function the function that applies the digital signature. Any controlled substance prescription not signed in this manner must not be transmitted.
Section 1311.145 specifies the requirements for the use of a practitioner's digital certificate and the associated private key. The digital certificate must have been obtained in accordance with the requirements of § 1311.105. The digitally signed record must be electronically archived. The section specifies that if the prescription is transmitted without the digital signature attached, the application must check the Certificate Revocation List to ensure that the certificate is valid and must not transmit the prescription if the certificate has expired. The section also clarifies that if a practitioner uses his own private key, the application need not apply its private key to sign the record.
Section 1311.150 specifies the requirements for auditable events for electronic prescription applications. Auditable events must include at least the following: attempted or successful unauthorized access to the application; attempted or successful unauthorized deletion or modification of any records required by part 1311; interference with application operations related to prescriptions; any setting of or changes to logical access controls related to controlled substance prescriptions; attempted or successful interference with audit trail functions; and, for application service providers, attempted or successful creation, modification, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee
Section 1311.170 requires that the application transmit the prescription as soon as possible after signature by the practitioner. The section requires that the electronic prescription application not allow the printing of an electronic prescription that has been transmitted unless the pharmacy or intermediary notifies the practitioner that the electronic prescription could not be delivered to the pharmacy designated as the recipient or was otherwise rejected. If a practitioner is notified that an electronic prescription was not successfully delivered to the designated pharmacy, the application may print the prescription for the practitioner's manual signature. The prescription must include information noting that the prescription was originally transmitted electronically to [name of specific pharmacy] on [date/time], and that transmission failed.
The section indicates that the application may print copies of the transmitted prescription if they are clearly labeled as copies not valid for dispensing. Data on the prescription may be electronically transferred to medical records and a list of prescriptions written may be printed for patients if the list indicates that it is for informational purposes only. The section clarifies that the electronic prescription application must not allow the transmission of an electronic prescription if a prescription was printed for signature prior to attempted transmission.
Finally, the section specifies that the contents of the prescription required under part 1306 must not be altered during transmission between the practitioner and pharmacy. Any change to this required content during transmission, including truncation or removal of data, will render the prescription invalid. The contents may be converted from one software version to another; conversion includes altering the structure of fields or machine language so that the receiving pharmacy application can read the prescription and import the data into its application. At no time may an intermediary convert an electronic controlled substance prescription data file to another form (
Section 1311.200 specifies the pharmacy's responsibility to process controlled substance electronic prescriptions only if the application meets the requirements of part 1311. The section also requires the pharmacy to determine which employees may access functions for annotating, altering, and deleting prescription information (to the extent such alteration is permitted by the CSA and its implementing regulations) and for implementing those logical access controls. As discussed previously, if the third-party auditor or certification organization finds that a pharmacy application does not accurately and consistently import, store, and display the information related to the name, address, and registration number of the practitioner, patient name and address, and prescription information (drug name, strength, quantity, directions for use), the indication of signing, and the number of refills, the pharmacy must not accept electronic prescriptions for the controlled substance. If the third-party auditor or certification organization finds that a pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions, the pharmacy must not accept electronic prescriptions for controlled substances that are subject to the additional information requirements.
The section specifies that if a prescription is received electronically, all annotations and recordkeeping related to that prescription must be retained electronically. The section reiterates the responsibility of the pharmacy to dispense controlled substances only in response to legitimate prescriptions.
Section 1311.205 provides the requirements for pharmacy applications.
Section 1311.205(b)(1) states that the application must allow the pharmacy to set access controls to limit access to functions that annotate, alter, or delete prescription information, and to the setting or changing of logical access controls.
Section 1311.205(b)(2) states that logical access controls must be set by name or role.
Section 1311.205(b)(3) specifies that the application must digitally sign and archive an electronic prescription upon receipt or be capable of receiving and archiving a digitally signed record.
Section 1311.205(b)(4) specifies the requirements for the digital signature functionality for pharmacy applications that digitally sign prescription records upon receipt.
Section 1311.205(b)(5) states that the pharmacy application must validate a practitioner's digital signature if the pharmacy accepts prescriptions digitally signed by the practitioner and transmitted with the digital signature.
Section 1311.205(b)(6) states that if a practitioner's digital signature is not sent with the prescription, either the application must check for the indication that the prescription was signed or the application must display the indication for the pharmacist to check.
Section 1311.205(b)(7) states that the application must read and retain the entire DEA number including the specific internal code number assigned to an individual practitioner prescribing controlled substances using the registration of the institutional practitioner.
Section 1311.205(b)(8) states that the application must read and store, and be capable of displaying, all of the prescription information required under part 1306.
Section 1311.205(b)(9) states that the pharmacy application must read and store in full the information required under § 1306.05(a). Either the pharmacist or the application must verify all the information is present.
Section 1311.205(b)(10) states that the application must allow the pharmacy to add information on the number/volume of the drug dispensed, the date dispensed, and the name of the dispenser.
Section 1311.205(b)(11) specifies that the application must be capable of retrieving prescription information by practitioner name, patient name, drug name, and date dispensed.
Section 1311.205(b)(12) states that the application must allow downloading of prescription data into a form that is readable and sortable.
Section 1311.205(b)(13) states that the application must maintain an audit trail related to the following: The receipt, annotation, alteration, or deletion of a controlled substance prescription; and the setting or changing of logical access controls related to controlled substance prescriptions.
Section 1311.205(b)(14) specifies the information that must be maintained in the audit trail: Date and time of the action, type of action, identity of the person taking the action, and outcome.
Section 1311.205(b)(15) states that the application must generate a daily report of auditable events (if they have occurred).
Section 1311.205(b)(16) states that the application must protect the audit trail
Section 1311.205(b)(17) states that the application must back up files daily.
Section 1311.205(b)(18) states that the application must retain records for two years from the date of their receipt or creation.
Section 1311.210 sets the requirements for digitally signing the prescription as received and archiving the record. It also sets the requirements for validating a prescription that has the practitioner's digital signature attached.
Section 1311.215 specifies the requirements for auditable events for pharmacy applications. Auditable events must include at least the following: Attempted or successful unauthorized access to the application; attempted or successful unauthorized deletion or modification of any records required by part 1311; interference with application operations related to prescriptions; any setting of or changes to logical access controls related to controlled substance prescriptions; attempted or successful interference with audit trail functions; and, for application service providers, attempted or successful annotation, alteration, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee of the application service provider. The application must run the internal audit once every calendar day and generate a report that identifies any auditable event. This report must be reviewed by the pharmacy. If the auditable event compromised or could have compromised the integrity of the records, this must be reported to DEA and the application service provider, if applicable, within one business day of discovery.
Section 1311.300 specifies the requirements for third-party audits discussed above and includes the option of substituting a certification from an organization and certification program approved by DEA. Audits or certifications must occur before the application may be used to create, sign, transmit, or process electronic controlled substance prescriptions, and whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first. Audits must be conducted by a person qualified to conduct a SysTrust, WebTrust, or SAS 70 audit, or a Certified Information System Auditor who performs compliance audits as a regular ongoing business activity. DEA is seeking comment regarding the use of Certified Information System Auditors.
Application providers must make audit reports available to any practitioner or pharmacy that uses or is considering using the application to handle controlled substance prescriptions. The rule also requires application providers to notify both their users and DEA of adverse audit reports or certification decisions. Users must be notified within five business days; DEA must be notified within one business day.
Section 1311.302 requires application providers to notify practitioners or pharmacies, as applicable, of any problem that they identify that makes the application noncompliant with part 1311. When providing patches and updates to the application to address these problems, the application provider must inform the users that the application may not be used to issue or process electronic controlled substance prescriptions until the patches or updates have been installed. DEA is requiring that practitioners and pharmacies be notified as quickly as possible, but no later than five business days after the problem is identified.
Section 1311.305 specifies recordkeeping requirements for records required by part 1311.
The following standards are incorporated by reference:
• FIPS Pub 180-3, Secure Hash Standard (SHS), October 2008.
• FIPS Pub 186-3, Digital Signature Standard (DSS), June 2009.
• Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008; Burr, W.
• NIST Special Publication 800-76-1, Biometric Data Specification for Personal Identity Verification, January 2007.
These standards are available from the National Institute of Standards and Technology, Computer Security Division, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899-8930 and are available at
The Office of Management and Budget's E-Authentication Guidance for Federal Agencies (M-04-04) requires agencies to ensure that authentication processes provide the appropriate level of assurance.
M-04-04 states that to determine the appropriate level of assurance in the user's asserted identity, agencies must assess the potential risks and identify measures to minimize their impact. The document states that the risk from an authentication error is a function of two factors: (a) Potential harm or impact and (b) the likelihood of such harm or impact. NIST SP 800-63-1 supplements M-04-04 and defines the steps necessary to reach each assurance level for identity proofing that precedes the issuance of the credential; the use of credential once issued; and the transmission of any document “signed” with the credential. In plain language, an e-authentication risk assessment considers two issues:
• How important is it to know that the person who is issued a credential is, in fact, the person whose identity is associated with the credential.
• How important is it to be certain that the person who uses the credential, once it is issued, is the person to whom it was issued.
This risk assessment addresses the level of assurance needed to allow the use of electronic prescriptions for controlled substances. This section summarizes the assessment that DEA conducted for the interim final rule. The full risk assessment is available in the docket.
As discussed in Section IV J of this preamble, M-04-04 requires that an Agency assess risks as low, moderate, or
Under M-04-04, the overall rating is driven by the highest rating assigned. Therefore, the potential impact of not being able to limit authentication credentials to DEA registrants is rated as high, which means that without mitigating factors, DEA should impose requirements that meet Assurance Level 4 under NIST SP 800-63-1.
DEA included a number of elements in the interim final rule that mitigate the risks of unauthorized access to the electronic prescription application and reduce the potential for diversion. While some of these relate to authentication to the application, others relate to use of the application itself.
This separation of duties ensures that even if someone is able to impersonate a practitioner and obtain a credential from an independent third-party CSP or CA, that impersonator will not be able to gain access to the electronic prescription application to sign controlled substance prescriptions unless the impersonator also has the assistance of two persons (one of whom is a DEA registrant) within a practitioner's office. In this way, it will be significantly more difficult for impersonators to gain access to sign controlled substance prescriptions, reducing the possibility of authentication errors and lessening the potential for diversion.
• The application must have the ability to set logical access controls as discussed above and limit access to indicating that prescriptions are ready for signing and signing prescriptions to DEA registrants or those exempted from registration.
• The application must require the use of the two-factor credential to sign the prescription and digitally sign and archive the record when the two-factor authentication protocol is executed. This step ensures that there is a record of the prescription as signed and allows other people in the practice or facility to add information not required by DEA, (
• The application must not allow a practitioner to sign a prescription if his credential is not linked to the DEA number listed on the prescription.
• The application must undergo a third-party audit to determine whether it complies with the requirements of the interim final rule.
In addition, as part of their approval by the Federal Government, CSPs and CAs issuing credentials undergo third-party audits to ensure compliance with Federal Government standards.
Consistent with M-04-04, DEA believes that it is appropriate for the agency to accept lower level credentials in view of the mitigating factors discussed above. M-04-04 states, in pertinent part (in Section 2.5):
Agencies may also decrease reliance on identity credentials through increased risk-mitigation controls. For example, an agency business process rated for Level 3 identity assertion assurance may lower its profile to accept Level 2 credentials by increasing system controls or `second level authentication' activities.
Following this approach, DEA has concluded that, even though the agency rates overall identity assurance for electronic prescribing of controlled substances at Assurance Level 4, the agency believes that Level 3 credentials are acceptable in view of the system controls that are mandated by this interim final rule. Specifically, DEA believes that the requirements that the interim final rule imposes for identity proofing, logical access controls, the separation of the hard token from the computer being accessed, and the application requirements lower the potential for a nonregistrant to steal an identity or gain access to a registrant's credential and issue illegal prescriptions sufficiently to render acceptable remote identity proofing, consistent with NIST SP 800-63-1 Assurance Level 3 requirements, and the use of FIPS 140-2 Security Level 1 hard tokens that in combination with a second factor provided that the token is not stored on the computer to which the person is gaining access. With these requirements in place, the potential for diversion through misuse of a credential will be limited, which supports the closed system of control DEA is mandated to maintain, protect practitioners from misuse of their identity, and protects the public from the harm of drug abuse. (Note that DEA is not imposing any requirements on the security of the transmission.)
As has been discussed previously, it is important to note that the electronic prescribing of controlled substances is voluntary—practitioners may still dispense controlled substances through the use of written prescriptions, regardless of whether they choose to write controlled substances prescriptions electronically. Also, the compromise of an authentication protocol through loss, credential invalidation, or other cause, does not invalidate the practitioner's authority to write controlled substances prescriptions. Practitioners may continue to write controlled substances prescriptions on paper or generate a prescription electronically to be printed and signed manually even if their authentication credential has been compromised, so long as the practitioner continues to possess a DEA registration.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), DEA must determine whether a regulatory action is “significant” and, therefore, subject to Office of Management and Budget review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal government or communities.
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof.
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A copy of the
DEA conducted an initial economic analysis of the proposed rule and sought comments. DEA received several comments regarding the estimates provided in the NPRM.
DEA's concern is not simply or primarily with the costs of prosecutions, but with the diversion of controlled substances and the societal harm caused by abuse of these drugs. The cost of emergency room treatment alone for people using prescription controlled substances for nonmedical reasons is far higher than the cost of this rule. Without appropriate security measures, electronic prescriptions could facilitate increased drug abuse, with a concomitant increase in deaths, medical treatment, and other societal costs associated with drug dependency.
Although DEA supports electronic prescribing and shares the hope that it will reduce adverse drug events and improve the efficiency of the healthcare system, there is little, if any, evidence that electronic prescribing is achieving this goal. The limited studies that have examined the impacts of electronic prescribing have found that the primary benefit is improved formulary compliance. DEA has not found any studies that quantify the number of adverse drug events associated with illegible prescriptions. The data often cited regarding medication errors are based primarily on inpatient hospital and long-term care facility adverse drug events and include “errors” that are unrelated to legibility (
Although the application providers will have to recover their costs from their customers, the incremental costs for any single customer will be low, particularly when compared to the cost of an electronic health record application. DEA has revised the rule to reduce the costs to application providers by both lengthening the time between audits/certifications and allowing them to substitute certification by an approved organization, where one exists, for a third-party audit. Because the American Recovery and Reinvestment Act requires that an application be certified before a practitioner will be eligible for an incentive payment, it is reasonable to assume that all electronic prescription application providers will be seeking certification and incurring those costs regardless of DEA's rules. On the pharmacy application side, the third-party audit will only need to address compliance with DEA's requirements, most of which existing pharmacy applications already meet.
DEA has removed the requirement for offsite storage. As for the costs for technology, staff resources, and oversight, these apply to acquisition of the application, not to DEA's requirements. DEA is not requiring any registrant to issue or accept electronic prescriptions for controlled substances. Any registrant that purchases an application will incur these costs whether they use the application for controlled substance prescriptions or not.
DEA has not estimated staff time for application providers for audits in part because the interim final rule limits the audit to determining whether the application meets DEA's requirements. An auditor will usually make this determination by testing the application, which will not involve provider staff time. In addition, DEA assumes that once a certification organization is ready to make this determination as part of its certification process, application providers will not need audits. They will obtain the certification for reasons other than compliance with DEA rules.
DEA has determined that this interim final rule is an economically significant regulatory action; therefore, DEA has conducted an analysis of the options. The following sections summarize the economic analysis conducted in support of this rule. DEA is seeking further comments on the assumptions used in this revised economic analysis and is especially interested in any data or information that commenters can provide that would reduce the many uncertainties in the estimates as discussed below and improve the options considered in the analysis of a final rule.
DEA considered three options for the electronic prescribing of controlled substances:
The entities directly affected by this rule are the following:
• DEA individual practitioner registrants who issue controlled substance prescriptions or individual practitioners who are exempt from registration and who are authorized to issue controlled substance prescriptions under an institutional practitioner's registration.
• Hospitals and clinics where practitioners may issue controlled substance prescriptions.
• Pharmacies.
In addition, application providers are indirectly affected because their applications must meet DEA's requirements before a registrant may use them to create or process controlled substance prescriptions. The practitioners who prescribe controlled substances are primarily physicians, dentists, and mid-level practitioners. Hospitals and clinics will be affected if practitioners working for or affiliated with the hospital or clinic use the institutional practitioner's application to issue prescriptions for persons leaving the institution (inpatient medical orders are not subject to these rules). Several thousand institutional practitioner registrants (
The number of application providers is based on the number of providers currently certified by SureScripts/RxHub or CCHIT. For practitioners, that number is about 170, which DEA assumes will increase to 200 by the third year and then begin declining. Pharmacy application providers are estimated to be about 40; the actual number is lower but DEA increased the number to account for pharmacy chains that may have developed their own applications.
The number of controlled substance prescriptions written is relevant to the estimate of cost-savings. DEA estimates the number of prescriptions based on the assumption that the percentage of controlled substance prescriptions in the top 200 brand name and top 200 generic drug prescriptions is the same as it is for the remainder of the prescriptions.
For the interim final Economic Impact Analysis, DEA based all labor costs on May 2008 BLS data, inflated to 2009
Practitioners will have to complete an application to apply for identity proofing and a credential. As these applications generally ask for standard information that practitioners will be able to fill in without needing to collect documents that they would not carry with them (
For hospitals and clinics, DEA estimates that practitioners and someone at the credentialing office will spend 2 minutes to verify the identity document presented. Practitioners are assumed to take 30 minutes total for this process because they will need to go to the credentialing office. This review will occur only when the hospital or clinic first implements controlled substance electronic prescribing and will involve only those practitioners that already work at or have privileges at the hospital or clinic. All practitioners that are hired or gain privileges later will have this step done as part of their regular initial credentialing.
Prior to granting access, someone at each office must verify that each practitioner has a valid DEA registration and State authorization to practice and, where applicable, dispense controlled substances. As this requires nothing more than checking the expiration dates of these documents, which are often visibly displayed, DEA estimates that this will take an average of one minute. In small practices, which are the majority of offices, it may take no time because the registrant will be one of the people granting access and the status of every registrant will be known. Checking registrations and State authorizations is done as part of credentialing at hospitals and clinics and is, therefore, not a cost of the rule. Similarly, once the rule is implemented at offices, it should not be a cost because credentials should be checked before a person is hired.
Prior to granting access, those who will be given this responsibility will need to be trained to do so. DEA estimates the time at one hour per person at practices. This estimate may be high, particularly for smaller offices. It may also be the case that in some larger practices, people already perform this task for other reasons and training may be unnecessary. Because it is likely that in larger pharmacies, access controls are already being set, DEA estimates that the training time will be five minutes.
DEA estimates that it will take, on average, five minutes to enter the data to grant access for the first time at a practice or a pharmacy. The approval of the data entry is estimated to take one minute. The actual approval may take only a few seconds, but the approver may take time away from some other work, but would presumably do it when using the computer for other tasks.
DEA has not estimated the cost of setting logical access controls at hospitals because hospital applications should already do this. The CCHIT criteria for in-patient applications include logical access controls; the HL7 standard used by most hospitals includes logical access controls. In addition, an application used by as many different departments as exist at hospitals necessarily will impose limits on who can carry out certain functions. Consequently, DEA's requirements should not entail any actions not already being performed.
Auditable events reported on security incident logs should be rare once the application has been implemented and staff understand their permission levels. Because of the size of hospitals and clinics and the volume of controlled substance prescriptions at pharmacies, DEA estimates that each of them will review security incident logs monthly; DEA estimates that the review will take hospitals ten minutes per month and pharmacies five minutes per month. Because of the smaller size of private practices and the much lower volume of controlled substance prescriptions issued, DEA estimates that a review will be needed only once a quarter. The review time remains at 5 minutes.
DEA estimates that reprogramming for electronic prescription applications will take, on average, 2,000 hours, an estimate based on industry information obtained during the development of DEA's Controlled Substances Ordering System rule.
To estimate the cost of obtaining identity proofing from a credential service provider, DEA used the fee SAFE BioPharma charges for a three-year digital certificate and a hard token using remote identity proofing ($110). This figure may be high because it assumes a medium rather than the basic assurance level that DEA is requiring. Based on standard industry practice for digital certificates, DEA estimates that the credential will need to be renewed every three years, but that a complete reapplication will not be required until the ninth year. These assumptions are based on the standards incorporated in the Federal PKI Policy Authority Common Policy. The cost for the three-year renewal is estimated to be $35.00, which is what SAFE charges for a three-year digital certificate at the basic assurance level. Hospitals and clinics are assumed to use or adapt their existing access cards to store the credential and, therefore, incur no additional costs for the credential.
In the initial years, application providers may have to obtain a third-party audit to determine whether the application meets the requirements of the rule. DEA estimates the cost of this audit at $15,000. This estimated cost is about 50 percent of the application fee for CCHIT testing and certification of a full ambulatory electronic health record application ($29,000). DEA chose to use the CCHIT fees as a basis because the interim final rule narrows the scope of the third-party audit and allows a larger number of auditors to conduct the audit. The higher cost estimates in the NPRM were based on obtaining particular types of audits and having the audits cover functions that will not be subject to auditing for installed applications. In addition, the one commenter that already obtained the third-party audits specified in the NPRM stated that the costs were much lower than DEA had estimated. DEA estimates that within five years, all electronic prescription application providers will obtain certification from an approved certification organization; because the providers already seek these certifications for other reasons, the cost of continuing to obtain certifications will not accrue to the rule after that point.
Table 5 presents the unit costs for both labor-based costs and fees.
To proceed from unit costs to total costs, it is necessary to establish the frequency of occurrence of cost items and the distribution of those occurrences, and thus of costs, over time. DEA assumes that all application providers will reprogram their applications in the first year and that after the fifth year they will be able to substitute certification for the third-party audit. DEA assumes that pharmacies will be able to accept electronic prescriptions in the first year and set initial access controls in that year, but that they will incur ongoing costs for checking security incident logs. Hospitals and clinics are assumed to adopt applications within five years; identity proofing costs occur only in the first year of adoption. Practitioners are assumed to adopt electronic prescribing over seven years; after that point implementation for practitioners basically covers new practitioners and offices as well as ongoing costs. Practitioners incur ongoing costs for renewal of the credential, reviewing security incident logs, and adding new staff to the access list. DEA estimates costs for 15 years. Table 6 presents the implementation rate for practitioners.
Total costs are calculated by multiplying the unit cost for an item or activity by the number of entities that will incur the cost in each year. Tables 7 and 8 present the Option 1 annualized costs by item and regulated entity at both a 7 percent and 3 percent discount rate.
Option 2 is the same as Option 1, except that the two-factor authentication credential requires a biometric identifier and a hard token. Passwords would not be permitted as an authentication factor. The cost items are:
• Biometric readers for practitioners' offices, hospitals, and clinics.
• Software packages for practitioners' offices and clinics.
• Reprogramming of applications for hospitals.
A biometric reader would be needed for every practitioner's computer. DEA estimates that hospitals would need one for every 15 beds, and each clinic would need an average of two readers. Based on American Hospital Association data, DEA estimates the number of community hospital beds to be 802,658. The number of clinics is estimated to be 7,485. There are 20 firms providing applications to hospitals, and their number is not expected to change.
There are no costs for hospitals and clinics after YEAR 5. All reprogramming costs are in YEAR 1. Costs for practitioners' offices and registrants extend over 15 years following the projected start-up of electronic prescriptions for controlled substances in practitioners' offices and number of registrants in practitioners' offices starting electronic prescriptions for controlled substances.
A biometric reader that meets the requirements costs $114.00.
The cost of the biometrics requirement is additive to the interim final rule cost, since no other requirements are eliminated.
Under this option the security requirements of the interim final rule are set aside and sole reliance for security is placed on a requirement that, on receipt of an electronic prescription for a controlled substance, a pharmacy must call the practitioner's office for verification of the prescription. For the sake of simplicity, DEA has not included in this option estimates of the time that will be required to reprogram existing applications to conform to the basic information included on every controlled substance prescription. DEA has no basis for determining how many existing applications do not include or do not transmit all of this information. Similarly, there may be some pharmacy applications that will require reprogramming to incorporate the requirements for annotations. The costs of reprogramming, however, will be relatively small compared with the primary cost of this option.
The cost of this option depends on the number of prescriptions to be verified. There were 461,172,000 controlled substance prescriptions in 2008.
Industry estimates indicate that 30 percent of original prescriptions generate callbacks to deal with formulary issues, requests to change to generic forms of the prescribed drug, illegibility, and other problems. Based on data from a 2004 Medical Group Management Association survey, 34 percent of callbacks on original prescriptions were for formulary issues, 31 percent were about generic drugs, and 35 percent were on other issues.
Electronic prescriptions are widely expected to reduce errors in medication dispensing because they will eliminate illegible written prescriptions and misunderstood oral prescriptions. They are also expected to reduce the number of callbacks from pharmacy to practitioner to address legibility, formulary, and contraindication issues. Electronic prescriptions may also reduce processing time at the pharmacy and wait time for patients. These benefits are likely to be mitigated to some extent. As a Rand study suggested, practitioners may fail to review the prescription and notice errors that occur when the wrong item is selected from one or more drop-down menus; pharmacists may be less likely to question a legible electronic prescription.
DEA has quantified three types of benefits: reduced number of callbacks to clarify prescriptions, the reduction in wait time for patients picking up prescriptions, and the cost-savings pharmacies will realize from eliminating storage of paper records. One of the greatest burdens in the paper system is the need for callbacks to clarify prescriptions. Clarifications and changes may be required for several reasons: the prescription is not legible; required information is not included on the prescription; the prescribed dosage unit does not exist; the particular medication is not approved by the patient's health insurance; and the drug prescribed is contraindicated because it reacts with other medications the patient is taking or because it negatively affects other conditions from which the patient suffers. Each callback involves the pharmacy staff and one or more staff at the practitioner's office, often including the practitioner. Electronic prescriptions will eliminate illegible prescriptions and could eliminate those with missing information or unavailable dosage units or forms. The recent studies cited above indicate that at least some prescription applications do not prevent practitioners from transmitting electronic prescriptions that are incomplete. At present, the field for directions for use in the NCPDP SCRIPT has not been standardized; when it is, the issues cited in the studies related to these directions may be resolved. Whether formulary and contraindication callbacks are eliminated will depend on the functions of the electronic prescription applications and the accuracy of the drug databases that they use.
The public is also affected by the current system. For the majority of controlled substance prescriptions, the patient (or someone acting for the patient) presents a paper prescription to the pharmacy and then waits for the pharmacy to fill it. The time between the point when the prescription is handed to the pharmacist and the point when it is ready for pick-up is a cost to the public.
The percentage of callbacks that will be eliminated by electronic prescribing is unclear. The Centers for Medicare and Medicaid Services, in its November 16, 2007, proposed rule on formulary and generic transactions, estimated a 25 percent reduction in time spent on callbacks.
Electronic prescriptions could also reduce the patient's wait time at the pharmacy. The number of original controlled substance prescriptions that could require public wait time is based on the estimated number of original prescriptions (approximately 356 million in 2009), reduced by 19 percent, to account for those prescriptions phoned to the pharmacy
The estimate for public wait time is an upper bound, as such it is not included in the primary estimate for the benefits of this interim final rule. It assumes that the practitioner will transmit the prescription and that the pharmacist will open the record and fill it before the patient arrives at the pharmacy. Recent research on electronic prescriptions found that 28 percent of electronic prescriptions transmitted were never picked up by patients; for painkillers, more than 50 percent were not picked up.
Table 13 presents the annualized gross benefits at a 7.0 percent and 3.0 percent discount rate.
These benefits are gross rather than net benefits, but it is not possible to compare these cost-savings to the costs of the rule or to estimate net benefits. These savings will accrue to any electronic prescription application. The only way to assess net benefits is to compare them with the costs of the full application and its implementation, not the incremental costs of DEA's requirements.
Pharmacies are required to retain all original controlled substance prescriptions, including oral prescriptions that the pharmacist reduces to writing, on paper for two years. As electronic prescriptions replace paper records, pharmacies will be able to eliminate file cabinets, freeing up space for other uses. The annualized cost of a prescription file cabinet is $78.50 ($715 annualized over 15 years at 7%); the cost of the floor space is $55.34 per cabinet (2.77 square feet times $20/square feet rental price for retail space). The annualized cost-savings for pharmacies are $1.38 million at 7 percent and $1.4 million at 3 percent.
DEA has not attempted to quantify or monetize the benefits of the rule that relate to diversion because of a lack of data on the extent of diversion of controlled substances through forged or altered prescriptions and alteration of pharmacy records. Electronic prescriptions for controlled substances will directly affect the following types of diversion:
• Stealing prescription pads or printing them, and writing non-legitimate prescriptions.
• Altering a legitimate prescription to obtain a higher dose or more dosage units (
• Phoning in non-legitimate prescriptions late in the day when it is difficult for a pharmacy to complete a confirmation call to the practitioner's office.
• Altering a prescription record at the pharmacy to hide diversion from pharmacy stock.
These are examples of prescription forgery that contribute significantly to the overall problem of drug diversion. DEA expects this rule to reduce significantly these types of forgeries because only practitioners with secure prescription-writing applications will be able to issue electronic prescriptions for controlled substances and because any alteration of the prescription at the pharmacy will be discernible from the audit log and a comparison of the digitally signed records. DEA expects that over time, as electronic prescribing becomes the norm, practitioners issuing paper prescriptions for controlled substances may find that their prescriptions are examined more closely.
The Substance Abuse and Mental Health Services Administration (SAMHSA) runs the Drug Abuse Warning Network (DAWN), a public health surveillance system that monitors drug-related visits to hospital emergency departments and drug-related deaths investigated by medical examiners and coroners. SAMHSA reported that in 2003, in six States (Maine, Maryland, New Hampshire, New Mexico, Utah, and Vermont) there were 352 deaths from misuse of oxycodone and hydrocodone, both prescription controlled substances. SAMHSA data for 2006 show that 195,000 emergency department visits involved nonmedical use of benzodiazepines (Schedule IV) and 248,000 involved nonmedical use of opioids (Schedule II and III). Of all visits involving nonmedical use of pharmaceuticals, about 224,000 resulted in admission to the hospital; about 65,000 of those individuals were admitted to critical care units; 1,574 of the visits ended with the death of the patient. More than half of the visits involved patients 35 and older. Using a value per life of $5.8 million, the costs of the 2003 deaths from misuse of prescription controlled substances in the six States is more than $2 billion.
These costs also do not represent all of the costs of drug abuse to society. Drug abuse is associated with crime and lost productivity. Crime imposes costs on the victims as well as on government. DEA does not track information on controlled substance prescription drug diversion because enforcement is generally handled by State and local authorities. The cost of enforcement is, however, considerable. In 2007, DEA spent between $2,700 for a small case and $147,000 for a large diversion case just for the primary investigators; adjudication costs and support staff are additional. It is reasonable to assume that State and local law enforcement agencies are spending similar sums per case. Some cases involve multiple jurisdictions, all of which bear costs for collecting data and deposing witnesses. The rule could reduce the number of cases and, therefore, reduce the costs to governments at all levels. A reduction in forgeries will also benefit practitioners who will be less likely to be at risk of being accused of diverting controlled substances and of then having to prove that they were not responsible.
Adverse drug events that result from medication errors are frequently cited as a benefit of electronic prescriptions. Illegible prescriptions and misunderstood oral prescriptions can result in the dispensing of the wrong drug, which may cause medical problems and, at the very least, fail to provide the treatment a practitioner has determined is necessary. Once a practitioner has access to a patient's complete medication list, electronic prescription applications hold the promise of identifying contraindication problems so that a patient is not prescribed drugs that taken together cause health problems or cancel the benefits. Allergy alerts will also warn practitioners of potential medication concerns.
DEA has not attempted to estimate the extent of these benefits for two reasons. First, there are few data that indicate the extent of the problem as it relates to prescriptions. The data most frequently cited on medication errors and adverse drug events (1.5 million preventable adverse drug events) are from two literature reviews conducted by the
Second, the use of electronic prescription applications and transmission systems may introduce errors. Keystroke and data entry errors may replace some of the errors that occur with illegible handwriting. A comment on the proposed rule from a State pharmacy board indicated that, at least at this early stage of implementation, the translation of the electronic data file to the pharmacies has caused data to be placed in the wrong fields and, in some cases, in the wrong patient's file. Similarly, a 2006 survey of chain pharmacy experience with electronic prescribing noted both positive experiences (improved clarity and speed) and negative, prescribing errors, particularly those with wrong drugs or directions.
DEA believes that electronic prescribing will reduce the number of prescription errors, but it has no basis for estimating the scope of the problem or the extent of reduction that will occur and the speed at which it will occur. Some of the problems will not be solved until EHRs are common and linked; others could be addressed more easily by programming applications to require all of the fields to be completed before transmission. Even the best system is unlikely to be able to eliminate human errors.
Uncertainties:
Any economic analysis involves some level of uncertainty about elements of the analysis. This is particularly true for this analysis, which must estimate costs for implementation of a new technology and project voluntary adoption rates. This section discusses the elements that have the greatest level of uncertainty associated with them.
The American Recovery and Reinvestment Act (Pub. L. 111-5) provides incentives for practitioners to adopt electronic health record applications; the incentives are scheduled to end after 2016. The analysis assumes that practitioners will adopt electronic prescribing by that time; after that point all of the implementation occurs with new entrants. Whether adoption is, in fact, that rapid will depend on a number of factors unrelated to this rulemaking. The barriers to adoption continue to be the high cost of the applications, which may be greater than the subsidies; the disruption that implementation creates in a practice; and uncertainty about the applications themselves.
The time for reprogramming existing applications is estimated to be between 1,000 hours and 2,000 hours. DEA based the upper estimate on information provided by the industry for DEA's rulemaking regarding electronic orders for controlled substances. The actual cost to existing application providers is likely to vary widely. Some providers may meet all or virtually all of the requirements and need little reprogramming. Many of the requirements are standard practice for software (
Another uncertainty of application provider costs relates to the third-party audit and the time that will elapse before a certification organization is able to certify compliance with DEA's requirements. If the Certification Commission for Healthcare Information Technology includes DEA's requirements in its criteria, the costs for third-party audits may be eliminated sooner than estimated. The interim final rule provides more options for obtaining a third-party audit, which should reduce its cost. DEA has not assumed
The single largest cost for practitioners is obtaining identity proofing and an authentication credential. DEA used the cost of a three-year digital certificate at a medium assurance level from the SAFE BioPharma Certification Authority for the cost estimate. SAFE meets the criteria set in the rule. Other firms that meet the criteria provide digital certificates and other credentials for more and for less. The actual cost will not be known until the rule is implemented and practitioners and providers decide on the type of credential they will use. Some commenters on the proposed rule stated that remote identity proofing, which is allowable, can be done very quickly, which could lower the cost. The firms providing the service, however, may impose other requirements beyond those of DEA, which could increase the cost.
There will also be costs associated with lost or compromised credentials. DEA has not attempted to estimate those costs because the frequency with which this will occur and the requirements that credential providers will impose is not known. Some practitioners will never incur these costs while others may incur them multiple times. Credential providers may require a practitioner to go through identity proofing or may impose lesser requirements. If one of the two factors is a password, credential providers may deal with password resets as they do now; password resets do not usually involve issuing a new token or a fee.
Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) (RFA), Federal agencies must evaluate the impact of rules on small entities and consider less burdensome alternatives. In its Economic Impact Analysis, DEA has evaluated the cost of the rule on individual practitioners and small pharmacies. The initial costs to the smallest practitioner office will be about $400 ($110 for identity proofing including the authentication credential, and $290 in labor costs to complete the application, receive access control training, and set logical access controls). The main ongoing costs for the rule will be the renewal of the credential ($49 every three years) and checking security logs ($22 per year) plus any incremental cost of the software or application. The initial costs for the basic rule elements represent about 0.3 percent of the annual income of the lowest paid practitioner and 0.1 percent of average revenues. The ongoing costs are considerably lower. For practices with a physician and a mid-level practitioner, the costs would be lower because access control training would not need to involve the physician. (Mid-level practitioners, because they are generally employees, are not small entities under the Regulatory Flexibility Act.)
Determining the incremental cost of the application requirements per practitioner is difficult because it depends on the number of application providers, the number of customers, the number of application requirements that an application provider does not already meet, and how costs are recovered (in the year in which the money is spent or over time). For example, an electronic health record application that had to reprogram to the full extent will have incremental application costs of $199,000 ($15,000 for the third-party audit and $184,000 for reprogramming). If the provider recovered the costs from 1,000 practitioners (charges are usually on a per practitioner, not per practice basis), the incremental cost to those customers will be $199 or about $17 a month. The costs for the application provider in the out years will be much lower ($15,000 every two years) because no further programming is needed. Even if the application provider did not add practitioners and continued to obtain a third-party audit rather than rely on certification, the incremental cost to practitioners will be less than a dollar a month.
For pharmacies, the costs will be the incremental cost that their application provider charges to cover the costs of reprogramming and audits ($92,000 plus $15,000) plus the cost of reviewing the security log ($11.43 per year) and initial access control training and initial access control setting ($4.66). In the first year, if the application providers recover the programming costs and initial audit costs in a single year, the average incremental cost to a pharmacy for these two activities will be $65 ($4,284,900 first year cost divided by 65,421 pharmacies). The total first year cost will, therefore, be less than $100. After that, the incremental charge to recover the cost of the third-party audit will be $9 per pharmacy every two years, assuming the cost is evenly distributed across all pharmacies. The pharmacy will have continuing labor costs for reviewing security logs ($11.43). The first year charge represents less than 0.01 percent of an independent pharmacy's annual sales. The annual cost is less than $0.01 per controlled substance prescription. It also represents a far lower cost than the pharmacy will pay its application provider to cover the fee charged by SureScripts/RxHub or another intermediary for processing the prescriptions. According to comments DEA received to its notice of proposed rulemaking, the application provider charges a transaction fee of $0.30 per electronic prescription to cover intermediary charges for routing and, where necessary converting, prescriptions to ensure that the pharmacy system will be able to capture the data electronically. Based on National Association of Chain Drug Stores data on the average price of prescriptions ($71.69) and the average value of prescription sales, an independent pharmacy processes about 36,000 prescriptions a year and will have to pay about $10,800 to cover the transaction fee.
The average annualized cost to hospitals and clinics is about $180, which does not represent a significant economic impact. Most of the hospital tasks are part of their routine business practices related to credentialing.
Application providers are not directly regulated by the rule and, therefore, are not covered by the requirements of the RFA. DEA notes, however, that the costs of the rule are not so high that any of these firms will not be able to recover them from their customers. Reprogramming is a routine practice in the software industry; applications are updated with some frequency to add features and fix problems. The additional requirements of the rule can be incorporated during the update cycle. Many of these firms are already spending more than DEA has estimated to obtain CCHIT certification; in time, DEA expects that this certification (or a similar certification) will replace the third-party audit, further reducing their costs.
Based on the above analysis, DEA has determined that although the rule will impact a substantial number of small entities, it will not impose a significant economic impact on any small entity directly subject to the rule.
It has been determined that this rule is a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule is voluntary and could result in a net reduction in costs. This rule will not result in a major increase in costs or
As part of its NPRM, DEA included a discussion of the hour burdens associated with the proposed rule. DEA did not receive any comments specific to the information collection aspects of the NPRM.
The Department of Justice, Drug Enforcement Administration, has submitted the following information collection request to the Office of Management and Budget for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995.
All suggestions or questions regarding additional information, to include obtaining a copy of the information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152.
Overview of information collection 1117-0049:
(1)
(2)
(3)
Office of Diversion Control, Drug Enforcement Administration, Department of Justice.
(4) Affected public who will be asked or required to respond, as well as a brief abstract:
(5)
DEA estimates in the first three years of implementation 217,740 practitioners, 8,688 hospitals and clinics, and 65,421 pharmacies will adopt electronic prescribing for a total of 291,849 respondents. The average practitioner is expected to spend 0.17 hours, the average hospital or clinic, 2.23 hours, and the average pharmacy 0.36 hours annually or an average across all respondents of 0.27 hours per year. Table 14 presents the burden hours by activity, registrant type, and year.
(6)
The three year burden hours are estimated to be 296,848 or 98,949 hours annually.
If additional information is required contact: Lynn Bryant, Department Clearance Officer, Information Management and Security Staff, Justice
This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.
This rule will not result in the net expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year and will not significantly or uniquely affect small governments. Because this rule will not affect other governments, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. The economic impact on private entities is analyzed in the Economic Impact Analysis of the Electronic Prescription Rule.
Chemicals, Drug traffic control.
Drug traffic control, Reporting and recordkeeping requirements
Drug traffic control, Prescription drugs.
Administrative practice and procedure, Certification authorities, Controlled substances, Digital certificates, Drug traffic control, Electronic signatures, Incorporation by reference, Prescription drugs, Reporting and recordkeeping requirements.
21 U.S.C. 802, 821, 829, 871(b), 951, 958(f).
For the purposes of this chapter, the following terms shall have the meanings specified:
(1) Capturing a biometric sample from an end user.
(2) Extracting and processing the biometric data from that sample.
(3) Storing the extracted information in a database.
(4) Comparing the biometric data with data contained in one or more reference databases.
(5) Determining how well the stored data matches the newly captured data and indicating whether an identification or verification of identity has been achieved.
(1) Identifies the certification authority issuing it;
(2) Names or otherwise identifies the certificate holder;
(3) Contains a public key that corresponds to a private key under the sole control of the certificate holder;
(4) Identifies the operational period; and
(5) Contains a serial number and is digitally signed by the certification authority issuing it.
(1) One key can be used to encrypt a message that can only be decrypted using the other key; and
(2) Even knowing one key, it is computationally infeasible to discover the other key.
21 U.S.C. 821, 827, 831, 871(b), 958(e), 965, unless otherwise noted.
(c) Except as provided in § 1304.06, a registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual.
(h) A person is required to keep the records and file the reports specified in § 1304.06 and part 1311 of this chapter if they are either of the following:
(1) An electronic prescription application provider.
(2) An electronic pharmacy application provider.
(b) All registrants that are authorized to maintain a central recordkeeping system under paragraph (a) of this section shall be subject to the following conditions:
(1) The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location.
(h) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:
(1) Inventories and records of all controlled substances listed in Schedule I and II shall be maintained separately from all other records of the pharmacy.
(2) Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a separate prescription file.
(3) Inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.
(4) Paper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location either in a separate prescription file for Schedules III, IV, and V controlled substances only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter “C” no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs a computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red “C” is waived.
(5) Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of part 1311 of this chapter. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the Administration or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled.
(a) As required by § 1311.120 of this chapter, a practitioner who issues electronic prescriptions for controlled substances must use an electronic prescription application that retains the following information:
(1) The digitally signed record of the information specified in part 1306 of this chapter.
(2) The internal audit trail and any auditable event identified by the internal audit as required by § 1311.150 of this chapter.
(b) An institutional practitioner must retain a record of identity proofing and issuance of the two-factor authentication credential, where applicable, as required by § 1311.110 of this chapter.
(c) As required by § 1311.205 of this chapter, a pharmacy that processes electronic prescriptions for controlled substances must use an application that retains the following:
(1) All of the information required under § 1304.22(c) and part 1306 of this chapter.
(2) The digitally signed record of the prescription as received as required by § 1311.210 of this chapter.
(3) The internal audit trail and any auditable event identified by the internal audit as required by § 1311.215 of this chapter.
(d) A registrant and application service provider must retain a copy of any security incident report filed with the Administration pursuant to §§ 1311.150 and 1311.215 of this chapter.
(e) An electronic prescription or pharmacy application provider must retain third party audit or certification reports as required by § 1311.300 of this chapter.
(f) An application provider must retain a copy of any notification to the
(g) Unless otherwise specified, records and reports must be retained for two years.
21 U.S.C. 821, 829, 831, 871(b), unless otherwise noted.
(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.
(b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for “detoxification treatment” or “maintenance treatment” must include the identification number issued by the Administrator under § 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of § 1301.28(e) of this chapter.
(c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription.
(d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (
(e) Electronic prescriptions shall be created and signed using an application that meets the requirements of part 1311 of this chapter.
(f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.
(g) An individual practitioner exempted from registration under § 1301.22(c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in § 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner.
(h) An official exempted from registration under § 1301.23(a) of this chapter must include on all prescriptions issued by him his branch of service or agency (
(a) An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements:
(1) The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part;
(2) The practitioner must use an application that meets the requirements of part 1311 of this chapter; and
(3) The practitioner must comply with the requirements for practitioners in part 1311 of this chapter.
(b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter.
(c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record.
(d) If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with § 1304.04(h) of this chapter.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.
(d) * * *
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner);
(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 1306.05, the prescription shall have written on its face “Authorization for Emergency Dispensing,” and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period.
(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.
(a) * * *
(1) Write the words “CENTRAL FILL” on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal. For electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in § 1306.05, except for the signature of the practitioner.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule III, IV, or V only pursuant to a paper prescription signed by an individual practitioner, a facsimile of a paper prescription or order for medication transmitted by the practitioner or the practitioner's agent to the institutional practitioner-pharmacist, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in § 1306.05 except for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to § 1306.07.
(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times.
(b) Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable.
(c) The following information must be retrievable by the prescription number:
(1) The name and dosage form of the controlled substance.
(2) The date filled or refilled.
(3) The quantity dispensed.
(4) The initials of the dispensing pharmacist for each refill.
(5) The total number of refills for that prescription.
(d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.
(e) The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:
(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription.
(2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription.
(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.
(4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.
(f) As an alternative to the procedures provided by paragraphs (a) through (e) of this section, a computer application may be used for the storage and retrieval of refill information for original paper prescription orders for controlled substances in Schedule III and IV, subject to the following conditions:
(1) Any such proposed computerized application must provide online retrieval (via computer monitor or hard-copy printout) of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number; date of issuance of
(2) Any such proposed computerized application must also provide online retrieval (via computer monitor or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application. If such an application provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (
(4) Any such computerized application shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (
(5) In the event that a pharmacy which employs such a computerized application experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription orders. This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data are retained for online data entry as soon as the computer system is available for use again.
(g) When filing refill information for original paper, fax, or oral prescription orders for Schedule III or IV controlled substances, a pharmacy may use only one of the two applications described in paragraphs (a) through (e) or (f) of this section.
(h) When filing refill information for electronic prescriptions, a pharmacy must use an application that meets the requirements of part 1311 of this chapter.
(a) The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(b) Transfers are subject to the following requirements:
(1) The transfer must be communicated directly between two licensed pharmacists.
(2) The transferring pharmacist must do the following:
(i) Write the word “VOID” on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record.
(ii) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record.
(iii) Record the date of the transfer and the name of the pharmacist transferring the information.
(3) For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to § 1306.21(a), the pharmacist receiving the transferred prescription information must write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription pursuant to § 1306.05 and include:
(i) Date of issuance of original prescription.
(ii) Original number of refills authorized on original prescription.
(iii) Date of original dispensing.
(iv) Number of valid refills remaining and date(s) and locations of previous refill(s).
(v) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription information was transferred.
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number, and prescription number from which the prescription was originally filled.
(4) For electronic prescriptions being transferred electronically, the
(i) The date of the original dispensing.
(ii) The number of refills remaining and the date(s) and locations of previous refills.
(iii) The transferring pharmacy's name, address, DEA registration number, and prescription number for each dispensing.
(iv) The name of the pharmacist transferring the prescription.
(v) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.
(5) The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist's name and all of the information transferred with the prescription under paragraph (b)(4) of this section.
(c) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.
(d) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal.
(e) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law.
21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.
This part sets forth the rules governing the creation, transmission, and storage of electronic orders and prescriptions.
Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
(a) These incorporations by reference were approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected at the Drug Enforcement Administration, 600 Army Navy Drive, Arlington, VA 22202 or at the National Archives and Records Administration (NARA). For information on the availability of this material at the Drug Enforcement Administration, call (202) 307-1000. For information on the availability of this material at NARA, call (202) 741-6030 or go to:
(b) These standards are available from the National Institute of Standards and Technology, Computer Security Division, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899-8930, (301) 975-6478 or TTY (301) 975-8295,
(1) Federal Information Processing Standard Publication (FIPS PUB) 140-2, Change Notices (12-03-2002), Security Requirements for Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A through D; incorporation by reference approved for §§ 1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).
(i)
(ii)
(iii)
(iv)
(2) Federal Information Processing Standard Publication (FIPS PUB) 180-2, Secure Hash Standard, August 1, 2002, as amended by change notice 1, February 25, 2004 (FIPS 180-2); incorporation by reference approved for §§ 1311.30(b) and 1311.55(b).
(3) Federal Information Processing Standard Publication (FIPS PUB) 180-3, Secure Hash Standard (SHS), October 2008 (FIPS 180-3); incorporation by reference approved for §§ 1311.120(b) and 1311.205(b).
(4) Federal Information Processing Standard Publication (FIPS PUB) 186-2, Digital Signature Standard, January 27, 2000, as amended by Change Notice 1, October 5, 2001 (FIPS 186-2); incorporation by reference approved for §§ 1311.30(b) and 1311.55(b).
(5) Federal Information Processing Standard Publication (FIPS PUB) 186-3, Digital Signature Standard (DSS), June 2009 (FIPS 186-3); incorporation by reference approved for §§ 1311.120(b), 1311.205(b), and 1311.210(c).
(6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al.; incorporation by reference approved for § 1311.105(a).
(7) NIST Special Publication 800-76-1, Biometric Data Specification for Personal Identity Verification, January 2007 (NIST SP 800-76-1); Wilson, C. et al.; incorporation by reference approved for § 1311.116(d).
(a) This subpart addresses the requirements that must be met to issue and process Schedule II, III, IV, and V controlled substance prescriptions electronically.
(b) A practitioner may issue a prescription for a Schedule II, III, IV, or V controlled substance electronically if all of the following conditions are met:
(1) The practitioner is registered as an individual practitioner or exempt from the requirement of registration under part 1301 of this chapter and is authorized under the registration or exemption to dispense the controlled substance;
(2) The practitioner uses an electronic prescription application that meets all of the applicable requirements of this subpart; and
(3) The prescription is otherwise in conformity with the requirements of the Act and this chapter.
(c) An electronic prescription for a Schedule II, III, IV, or V controlled substance created using an electronic prescription application that does not meet the requirements of this subpart is not a valid prescription, as that term is defined in § 1300.03 of this chapter.
(d) A controlled substance prescription created using an electronic prescription application that meets the requirements of this subpart is not a valid prescription if any of the functions required under this subpart were disabled when the prescription was indicated as ready for signature and signed.
(e) A registered pharmacy may process electronic prescriptions for controlled substances only if all of the following conditions are met:
(1) The pharmacy uses a pharmacy application that meets all of the applicable requirements of this subpart; and
(2) The prescription is otherwise in conformity with the requirements of the Act and this chapter.
(f) Nothing in this part alters the responsibilities of the practitioner and pharmacy, specified in part 1306 of this chapter, to ensure the validity of a controlled substance prescription.
(a) The practitioner must retain sole possession of the hard token, where applicable, and must not share the password or other knowledge factor, or biometric information, with any other person. The practitioner must not allow any other person to use the token or enter the knowledge factor or other identification means to sign prescriptions for controlled substances. Failure by the practitioner to secure the hard token, knowledge factor, or biometric information may provide a basis for revocation or suspension of registration pursuant to section 304(a)(4) of the Act (21 U.S.C. 824(a)(4)).
(b) The practitioner must notify the individuals designated under § 1311.125 or § 1311.130 within one business day of discovery that the hard token has been lost, stolen, or compromised or the authentication protocol has been otherwise compromised. A practitioner who fails to comply with this provision may be held responsible for any controlled substance prescriptions written using his two-factor authentication credential.
(c) If the practitioner is notified by an intermediary or pharmacy that an electronic prescription was not successfully delivered, as provided in § 1311.170, he must ensure that any paper or oral prescription (where permitted) issued as a replacement of the original electronic prescription indicates that the prescription was originally transmitted electronically to a particular pharmacy and that the transmission failed.
(d) Before initially using an electronic prescription application to sign and transmit controlled substance prescriptions, the practitioner must determine that the third-party auditor or certification organization has found that the electronic prescription application records, stores, and transmits the following accurately and consistently:
(1) The information required for a prescription under § 1306.05(a) of this chapter.
(2) The indication of signing as required by § 1311.120(b)(17) or the digital signature created by the practitioner's private key.
(3) The number of refills as required by § 1306.22 of this chapter.
(e) If the third-party auditor or certification organization has found that an electronic prescription application does not accurately and consistently record, store, and transmit other information required for prescriptions under this chapter, the practitioner must not create, sign, and transmit electronic prescriptions for controlled substances that are subject to the additional information requirements.
(f) The practitioner must not use the electronic prescription application to sign and transmit electronic controlled substance prescriptions if any of the functions of the application required by this subpart have been disabled or appear to be functioning improperly.
(g) If an electronic prescription application provider notifies an individual practitioner that a third-party audit or certification report indicates that the application or the application provider no longer meets the requirements of this part or notifies him that the application provider has identified an issue that makes the application non-compliant, the practitioner must do the following:
(1) Immediately cease to issue electronic controlled substance prescriptions using the application.
(2) Ensure, for an installed electronic prescription application at an individual practitioner's practice, that the individuals designated under § 1311.125 terminate access for signing controlled substance prescriptions.
(h) If an electronic prescription application provider notifies an institutional practitioner that a third-party audit or certification report indicates that the application or the application provider no longer meets the requirements of this part or notifies it that the application provider has identified an issue that makes the application non-compliant, the institutional practitioner must ensure that the individuals designated under § 1311.130 terminate access for signing controlled substance prescriptions.
(i) An individual practitioner or institutional practitioner that receives a notification that the electronic prescription application is not in compliance with the requirements of this part must not use the application to issue electronic controlled substance prescriptions until it is notified that the application is again compliant and all relevant updates to the application have been installed.
(j) The practitioner must notify both the individuals designated under § 1311.125 or § 1311.130 and the Administration within one business day of discovery that one or more prescriptions that were issued under a DEA registration held by that practitioner were prescriptions the practitioner had not signed or were not consistent with the prescriptions he signed.
(k) The practitioner has the same responsibilities when issuing prescriptions for controlled substances via electronic means as when issuing a paper or oral prescription. Nothing in this subpart relieves a practitioner of his responsibility to dispense controlled substances only for a legitimate medical purpose while acting in the usual course
(a) An individual practitioner must obtain a two-factor authentication credential from one of the following:
(1) A credential service provider that has been approved by the General Services Administration Office of Technology Strategy/Division of Identity Management to conduct identity proofing that meets the requirements of Assurance Level 3 or above as specified in NIST SP 800-63-1 as incorporated by reference in § 1311.08.
(2) For digital certificates, a certification authority that is cross-certified with the Federal Bridge certification authority and that operates at a Federal Bridge Certification Authority basic assurance level or above.
(b) The practitioner must submit identity proofing information to the credential service provider or certification authority as specified by the credential service provider or certification authority.
(c) The credential service provider or certification authority must issue the authentication credential using two channels (
(a) For any registrant or person exempted from the requirement of registration under § 1301.22(c) of this chapter who is eligible to use the institutional practitioner's electronic prescription application to sign prescriptions for controlled substances, the entity within a DEA-registered institutional practitioner that grants that individual practitioner privileges at the institutional practitioner (
(1) Ensure that photographic identification issued by the Federal Government or a State government matches the person presenting the identification.
(2) Ensure that the individual practitioner's State authorization to practice and, where applicable, State authorization to prescribe controlled substances, is current and in good standing.
(3) Either ensure that the individual practitioner's DEA registration is current and in good standing or ensure that the institutional practitioner has granted the individual practitioner exempt from the requirement of registration under § 1301.22 of this chapter privileges to prescribe controlled substances using the institutional practitioner's DEA registration number.
(4) If the individual practitioner is an employee of a health care facility that is operated by the Department of Veterans Affairs, confirm that the individual practitioner has been duly appointed to practice at that facility by the Secretary of the Department of Veterans Affairs pursuant to 38 U.S.C. 7401-7408.
(5) If the individual practitioner is working at a health care facility operated by the Department of Veterans Affairs on a contractual basis pursuant to 38 U.S.C. 8153 and, in the performance of his duties, prescribes controlled substances, confirm that the individual practitioner meets the criteria for eligibility for appointment under 38 U.S.C. 7401-7408 and is prescribing controlled substances under the registration of such facility.
(b) An institutional practitioner that elects to conduct identity proofing must provide authorization to issue the authentication credentials to a separate entity within the institutional practitioner or to an outside credential Service provider or certification authority that meets the requirements of § 1311.105(a).
(c) When an institutional practitioner is conducting identity proofing and submitting information to a credential service provider or certification authority to authorize the issuance of authentication credentials, the institutional practitioner must meet any requirements that the credential service provider or certification authority imposes on entities that serve as trusted agents.
(d) An institutional practitioner that elects to conduct identity proofing and authorize the issuance of the authentication credential as provided in paragraphs (a) through (c) of this section must do so in a manner consistent with the institutional practitioner's general obligation to maintain effective controls against diversion. Failure to meet this obligation may result in remedial action consistent with § 1301.36 of this chapter.
(e) An institutional practitioner that elects to conduct identity proofing must retain a record of the identity-proofing. An institutional practitioner that elects to issue the two-factor authentication credential must retain a record of the issuance of the credential.
(a) To sign a controlled substance prescription, the electronic prescription application must require the practitioner to authenticate to the application using an authentication protocol that uses two of the following three factors:
(1) Something only the practitioner knows, such as a password or response to a challenge question.
(2) Something the practitioner is, biometric data such as a fingerprint or iris scan.
(3) Something the practitioner has, a device (hard token) separate from the computer to which the practitioner is gaining access.
(b) If one factor is a hard token, it must be separate from the computer to which it is gaining access and must meet at least the criteria of FIPS 140-2 Security Level 1, as incorporated by reference in § 1311.08, for cryptographic modules or one-time-password devices.
(c) If one factor is a biometric, the biometric subsystem must comply with the requirements of § 1311.116.
(a) If one of the factors used to authenticate to the electronic prescription application is a biometric as described in § 1311.115, it must comply with the following requirements.
(b) The biometric subsystem must operate at a false match rate of 0.001 or lower.
(c) The biometric subsystem must use matching software that has demonstrated performance at the operating point corresponding with the false match rate described in paragraph (b) of this section, or a lower false match rate. Testing to demonstrate performance must be conducted by the National Institute of Standards and Technology or another DEA-approved
(d) The biometric subsystem must conform to Personal Identity Verification authentication biometric acquisition specifications, pursuant to NIST SP 800-76-1 as incorporated by reference in § 1311.08, if they exist for the biometric modality of choice.
(e) The biometric subsystem must either be co-located with a computer or PDA that the practitioner uses to issue electronic prescriptions for controlled substances, where the computer or PDA is located in a known, controlled location, or be built directly into the practitioner's computer or PDA that he uses to issue electronic prescriptions for controlled substances.
(f) The biometric subsystem must store device ID data at enrollment (i.e., biometric registration) with the biometric data and verify the device ID at the time of authentication to the electronic prescription application.
(g) The biometric subsystem must protect the biometric data (raw data or templates), match results, and/or non-match results when authentication is not local. If sent over an open network, biometric data (raw data or templates), match results, and/or non-match results must be:
(1) Cryptographically source authenticated;
(2) Combined with a random challenge, a nonce, or a time stamp to prevent replay;
(3) Cryptographically protected for integrity and confidentiality; and
(4) Sent only to authorized systems.
(h) Testing of the biometric subsystem must have the following characteristics:
(1) The test is conducted by a laboratory that does not have an interest in the outcome (positive or negative) of performance of a submission or biometric.
(2) Test data are sequestered.
(3) Algorithms are provided to the testing laboratory (as opposed to scores or other information).
(4) The operating point(s) corresponding with the false match rate described in paragraph (b) of this section, or a lower false match rate, is tested so that there is at least 95% confidence that the false match and non-match rates are equal to or less than the observed value.
(5) Results of the testing are made publicly available.
(a) A practitioner may only use an electronic prescription application that meets the requirements in paragraph (b) of this section to issue electronic controlled substance prescriptions.
(b) The electronic prescription application must meet the requirements of this subpart including the following:
(1) The electronic prescription application must do the following:
(i) Link each registrant, by name, to at least one DEA registration number.
(ii) Link each practitioner exempt from registration under § 1301.22(c) of this chapter to the institutional practitioner's DEA registration number and the specific internal code number required under § 1301.22(c)(5) of this chapter.
(2) The electronic prescription application must be capable of the setting of logical access controls to limit permissions for the following functions:
(i) Indication that a prescription is ready for signing and signing controlled substance prescriptions.
(ii) Creating, updating, and executing the logical access controls for the functions specified in paragraph (b)(2)(i) of this section.
(3) Logical access controls must be set by individual user name or role. If the application sets logical access control by role, it must not allow an individual to be assigned the role of registrant unless that individual is linked to at least one DEA registration number as provided in paragraph (b)(1) of this section.
(4) The application must require that the setting and changing of logical access controls specified under paragraph (b)(2) of this section involve the actions of two individuals as specified in §§ 1311.125 or 1311.130. Except for institutional practitioners, a practitioner authorized to sign controlled substance prescriptions must approve logical access control entries.
(5) The electronic prescription application must accept two-factor authentication that meets the requirements of § 1311.115 and require its use for signing controlled substance prescriptions and for approving data that set or change logical access controls related to reviewing and signing controlled substance prescriptions.
(6) The electronic prescription application must be capable of recording all of the applicable information required in part 1306 of this chapter for the controlled substance prescription.
(7) If a practitioner has more than one DEA registration number, the electronic prescription application must require the practitioner or his agent to select the DEA registration number to be included on the prescription.
(8) The electronic prescription application must have a time application that is within five minutes of the official National Institute of Standards and Technology time source.
(9) The electronic prescription application must present for the practitioner's review and approval all of the following data for each controlled substance prescription:
(i) The date of issuance.
(ii) The full name of the patient.
(iii) The drug name.
(iv) The dosage strength and form, quantity prescribed, and directions for use.
(v) The number of refills authorized, if applicable, for prescriptions for Schedule III, IV, and V controlled substances.
(vi) For prescriptions written in accordance with the requirements of § 1306.12(b) of this chapter, the earliest date on which a pharmacy may fill each prescription.
(vii) The name, address, and DEA registration number of the prescribing practitioner.
(viii) The statement required under § 1311.140(a)(3).
(10) The electronic prescription application must require the prescribing practitioner to indicate that each controlled substance prescription is ready for signing. The electronic prescription application must not permit alteration of the DEA elements after the practitioner has indicated that a controlled substance prescription is ready to be signed without requiring another review and indication of readiness for signing. Any controlled substance prescription not indicated as ready to be signed shall not be signed or transmitted.
(11) While the information required by paragraph (b)(9) of this section and the statement required by § 1311.140(a)(3) remain displayed, the electronic prescription application must prompt the prescribing practitioner to authenticate to the application, using two-factor authentication, as specified in § 1311.140(a)(4), which will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.
(12) The electronic prescription application must not permit a practitioner other than the prescribing practitioner whose DEA number (or institutional practitioner DEA number and extension data for the individual practitioner) is listed on the prescription as the prescribing practitioner and who has indicated that the prescription is ready to be signed to sign the prescription.
(13) Where a practitioner seeks to prescribe more than one controlled substance at one time for a particular
(14) The electronic prescription application must time and date stamp the prescription when the signing function is used.
(15) When the practitioner uses his two-factor authentication credential as specified in § 1311.140(a)(4), the electronic prescription application must digitally sign at least the information required by part 1306 of this chapter and electronically archive the digitally signed record. If the practitioner signs the prescription with his own private key, as provided in § 1311.145, the electronic prescription application must electronically archive a copy of the digitally signed record, but need not apply the application's digital signature to the record.
(16) The digital signature functionality must meet the following requirements:
(i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140-2 Security Level 1 validated. FIPS 140-2 is incorporated by reference in § 1311.08.
(ii) The digital signature application and hash function must comply with FIPS 186-3 and FIPS 180-3, as incorporated by reference in § 1311.08.
(iii) The electronic prescription application's private key must be stored encrypted on a FIPS 140-2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140-2 is incorporated by reference in § 1311.08.
(iv) For software implementations, when the signing module is deactivated, the application must clear the plain text password from the application memory to prevent the unauthorized access to, or use of, the private key.
(17) Unless the digital signature created by an individual practitioner's private key is being transmitted to the pharmacy with the prescription, the electronic prescription application must include in the data file transmitted an indication that the prescription was signed by the prescribing practitioner.
(18) The electronic prescription application must not transmit a controlled substance prescription unless the signing function described in § 1311.140(a)(4) has been used.
(19) The electronic prescription application must not allow alteration of any of the information required by part 1306 of this chapter after the prescription has been digitally signed. Any alteration of the information required by part 1306 of this chapter after the prescription is digitally signed must cancel the prescription.
(20) The electronic prescription application must not allow transmission of a prescription that has been printed.
(21) The electronic prescription application must allow printing of a prescription after transmission only if the printed prescription is clearly labeled as a copy not for dispensing. The electronic prescription application may allow printing of prescription information if clearly labeled as being for informational purposes. The electronic prescription application may transfer such prescription information to medical records.
(22) If the transmission of an electronic prescription fails, the electronic prescription application may print the prescription. The prescription must indicate that it was originally transmitted electronically to, and provide the name of, a specific pharmacy, the date and time of transmission, and that the electronic transmission failed.
(23) The electronic prescription application must maintain an audit trail of all actions related to the following:
(i) The creation, alteration, indication of readiness for signing, signing, transmission, or deletion of a controlled substance prescription.
(ii) Any setting or changing of logical access control permissions related to the issuance of controlled substance prescriptions.
(iii) Notification of a failed transmission.
(iv) Auditable events as specified in § 1311.150.
(24) The electronic prescription application must record within each audit record the following information:
(i) The date and time of the event.
(ii) The type of event.
(iii) The identity of the person taking the action, where applicable.
(iv) The outcome of the event (success or failure).
(25) The electronic prescription application must conduct internal audits and generate reports on any of the events specified in § 1311.150 in a format that is readable by the practitioner. Such internal audits may be automated and need not require human intervention to be conducted.
(26) The electronic prescription application must protect the stored audit records from unauthorized deletion. The electronic prescription application shall prevent modifications to the audit records.
(27) The electronic prescription application must do the following:
(i) Generate a log of all controlled substance prescriptions issued by a practitioner during the previous calendar month and provide the log to the practitioner no later than seven calendar days after that month.
(ii) Be capable of generating a log of all controlled substance prescriptions issued by a practitioner for a period specified by the practitioner upon request. Prescription information available from which to generate the log must span at least the previous two years.
(iii) Archive all logs generated.
(iv) Ensure that all logs are easily readable or easily rendered into a format that a person can read.
(v) Ensure that all logs are sortable by patient name, drug name, and date of issuance of the prescription.
(28) Where the electronic prescription application is required by this part to archive or otherwise maintain records, it must retain such records electronically for two years from the date of the record's creation and comply with all other requirements of § 1311.305.
(a) At each registered location where one or more individual practitioners wish to use an electronic prescription application meeting the requirements of this subpart to issue controlled substance prescriptions, the registrant(s) must designate at least two individuals to manage access control to the application. At least one of the designated individuals must be a registrant who is authorized to issue controlled substance prescriptions and who has obtained a two-factor authentication credential as provided in § 1311.105.
(b) At least one of the individuals designated under paragraph (a) of this section must verify that the DEA registration and State authorization(s) to practice and, where applicable, State authorization(s) to dispense controlled substances of each registrant being granted permission to sign electronic prescriptions for controlled substances are current and in good standing.
(c) After one individual designated under paragraph (a) of this section
(d) A registrant's permission to indicate that controlled substances prescriptions are ready to be signed and to sign controlled substance prescriptions must be revoked whenever any of the following occurs, on the date the occurrence is discovered:
(1) A hard token or any other authentication factor required by the two-factor authentication protocol is lost, stolen, or compromised. Such access must be terminated immediately upon receiving notification from the individual practitioner.
(2) The individual practitioner's DEA registration expires, unless the registration has been renewed.
(3) The individual practitioner's DEA registration is terminated, revoked, or suspended.
(4) The individual practitioner is no longer authorized to use the electronic prescription application (
(a) The entity within an institutional practitioner that conducts the identity proofing under § 1311.110 must develop a list of individual practitioners who are permitted to use the institutional practitioner's electronic prescription application to indicate that controlled substances prescriptions are ready to be signed and to sign controlled substance prescriptions. The list must be approved by two individuals.
(b) After the list is approved, it must be sent to a separate entity within the institutional practitioner that enters permissions for logical access controls into the application. The institutional practitioner must authorize at least two individuals or a role filled by at least two individuals to enter the logical access control data. One individual in the separate entity must authenticate to the application and enter the data to grant permissions to individual practitioners to indicate that controlled substances prescriptions are ready to be signed and to sign controlled substance prescriptions. A second individual must authenticate to the application to execute the logical access controls.
(c) The institutional practitioner must retain a record of the individuals or roles that are authorized to conduct identity proofing and logical access control data entry and execution.
(d) Permission to indicate that controlled substances prescriptions are ready to be signed and to sign controlled substance prescriptions must be revoked whenever any of the following occurs, on the date the occurrence is discovered:
(1) An individual practitioner's hard token or any other authentication factor required by the practitioner's two-factor authentication protocol is lost, stolen, or compromised. Such access must be terminated immediately upon receiving notification from the individual practitioner.
(2) The institutional practitioner's or, where applicable, individual practitioner's DEA registration expires, unless the registration has been renewed.
(3) The institutional practitioner's or, where applicable, individual practitioner's DEA registration is terminated, revoked, or suspended.
(4) An individual practitioner is no longer authorized to use the institutional practitioner's electronic prescription application (
(a) The electronic prescription application may allow the registrant or his agent to enter data for a controlled substance prescription, provided that only the registrant may sign the prescription in accordance with §§ 1311.120(b)(11) and 1311.140.
(b) If a practitioner holds multiple DEA registrations, the practitioner or his agent must select the appropriate registration number for the prescription being issued in accordance with the requirements of § 1301.12 of this chapter.
(c) If required by State law, a supervisor's name and DEA number may be listed on a prescription, provided the prescription clearly indicates who is the supervisor and who is the prescribing practitioner.
(a) For a practitioner to sign an electronic prescription for a controlled substance the following must occur:
(1) The practitioner must access a list of one or more controlled substance prescriptions for a single patient. The list must display the information required by § 1311.120(b)(9).
(2) The practitioner must indicate the prescriptions that are ready to be signed.
(3) While the prescription information required in § 1311.120(b)(9) is displayed, the following statement or its substantial equivalent is displayed: “By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.”
(4) While the prescription information required in § 1311.120(b)(9) and the statement required by paragraph (a)(3) of this section remain displayed, the practitioner must be prompted to complete the two-factor authentication protocol.
(5) The completion by the practitioner of the two-factor authentication protocol in the manner provided in paragraph (a)(4) of this section will constitute the signing of the prescription by the practitioner for purposes of § 1306.05(a) and (e) of this chapter.
(6) Except as provided under § 1311.145, the practitioner's completion of the two-factor authentication protocol must cause the application to digitally sign and electronically archive the information required under part 1306 of this chapter.
(b) The electronic prescription application must clearly label as the signing function the function that prompts the practitioner to execute the two-factor authentication protocol using his credential.
(c) Any prescription not signed in the manner required by this section shall not be transmitted.
(a) An individual practitioner who has obtained a digital certificate as provided in § 1311.105 may digitally sign a controlled substance prescription using the private key associated with his digital certificate.
(b) The electronic prescription application must require the individual practitioner to complete a two-factor authentication protocol as specified in § 1311.140(a)(4) to use his private key.
(c) The electronic prescription application must digitally sign at least all information required under part 1306 of this chapter.
(d) The electronic prescription application must electronically archive the digitally signed record.
(e) A prescription that is digitally signed with a practitioner's private key
(f) If the electronic prescription is transmitted without the digital signature, the electronic prescription application must check the certificate revocation list of the certification authority that issued the practitioner's digital certificate. If the digital certificate is not valid, the electronic prescription application must not transmit the prescription. The certificate revocation list may be cached until the certification authority issues a new certificate revocation list.
(g) When the individual practitioner digitally signs a controlled substance prescription with the private key associated with his own digital certificate obtained as provided under § 1311.105, the electronic prescription application is not required to digitally sign the prescription using the application's private key.
(a) The application provider must establish and implement a list of auditable events. Auditable events must, at a minimum, include the following:
(1) Attempted unauthorized access to the electronic prescription application, or successful unauthorized access where the determination of such is feasible.
(2) Attempted unauthorized modification or destruction of any information or records required by this part, or successful unauthorized modification or destruction of any information or records required by this part where the determination of such is feasible.
(3) Interference with application operations of the prescription application.
(4) Any setting of or change to logical access controls related to the issuance of controlled substance prescriptions.
(5) Attempted or successful interference with audit trail functions.
(6) For application service providers, attempted or successful creation, modification, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee of the application service provider.
(b) The electronic prescription application must analyze the audit trail at least once every calendar day and generate an incident report that identifies each auditable event.
(c) Any person designated to set logical access controls under §§ 1311.125 or 1311.130 must determine whether any identified auditable event represents a security incident that compromised or could have compromised the integrity of the prescription records. Any such incidents must be reported to the electronic prescription application provider and the Administration within one business day.
(a) The electronic prescription application must transmit the electronic prescription as soon as possible after signature by the practitioner.
(b) The electronic prescription application may print a prescription that has been transmitted only if an intermediary or the designated pharmacy notifies a practitioner that an electronic prescription was not successfully delivered to the designated pharmacy. If this occurs, the electronic prescription application may print the prescription for the practitioner's manual signature. The printed prescription must include information noting that the prescription was originally transmitted electronically to [name of the specific pharmacy] on [date/time] and that transmission failed.
(c) The electronic prescription application may print copies of the transmitted prescription if they are clearly labeled: “Copy only—not valid for dispensing.” Data on the prescription may be electronically transferred to medical records, and a list of prescriptions written may be printed for patients if the list indicates that it is for informational purposes only and not for dispensing.
(d) The electronic prescription application must not allow the transmission of an electronic prescription if an original prescription was printed prior to attempted transmission.
(e) The contents of the prescription required by part 1306 of this chapter must not be altered during transmission between the practitioner and pharmacy. Any change to the content during transmission, including truncation or removal of data, will render the electronic prescription invalid. The electronic prescription data may be converted from one software version to another between the electronic prescription application and the pharmacy application; conversion includes altering the structure of fields or machine language so that the receiving pharmacy application can read the prescription and import the data.
(f) An electronic prescription must be transmitted from the practitioner to the pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (
(a) Before initially using a pharmacy application to process controlled substance prescriptions, the pharmacy must determine that the third-party auditor or certification organization has found that the pharmacy application does the following accurately and consistently:
(1) Import, store, and display the information required for prescriptions under § 1306.05(a) of this chapter.
(2) Import, store, and display the indication of signing as required by § 1311.120(b)(17).
(3) Import, store, and display the number of refills as required by § 1306.22 of this chapter.
(4) Import, store, and verify the practitioner's digital signature, as provided in § 1311.210(c), where applicable.
(b) If the third-party auditor or certification organization has found that a pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions under this chapter, the pharmacy must not process electronic prescriptions for controlled substances that are subject to the additional information requirements.
(c) If a pharmacy application provider notifies a pharmacy that a third-party audit or certification report indicates that the application or the application provider no longer meets the requirements of this part or notifies it that the application provider has identified an issue that makes the application non-compliant, the pharmacy must immediately cease to process controlled substance prescriptions using the application.
(d) A pharmacy that receives a notification that the pharmacy application is not in compliance with the requirements of this part must not use the application to process controlled substance prescriptions until it is notified that the application is again compliant and all relevant updates to the application have been installed.
(e) The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are permitted under this chapter). The pharmacy must ensure that logical access controls in the pharmacy application are set so that only such employees are granted access to perform these functions.
(f) When a pharmacist fills a prescription in a manner that would require, under part 1306 of this chapter, the pharmacist to make a notation on the prescription if the prescription were a paper prescription, the pharmacist must make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record or in linked files. When a prescription is received electronically, the prescription and all required annotations must be retained electronically.
(g) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to the pharmacy, the pharmacist must check its records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
(h) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void.
(i) Nothing in this part relieves a pharmacy and pharmacist of the responsibility to dispense controlled substances only pursuant to a prescription issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
(a) The pharmacy may only use a pharmacy application that meets the requirements in paragraph (b) of this section to process electronic controlled substance prescriptions.
(b) The pharmacy application must meet the following requirements:
(1) The pharmacy application must be capable of setting logical access controls to limit access for the following functions:
(i) Annotation, alteration, or deletion of prescription information.
(ii) Setting and changing the logical access controls.
(2) Logical access controls must be set by individual user name or role.
(3) The pharmacy application must digitally sign and archive a prescription on receipt or be capable of receiving and archiving a digitally signed record.
(4) For pharmacy applications that digitally sign prescription records upon receipt, the digital signature functionality must meet the following requirements:
(i) The cryptographic module used to digitally sign the data elements required by part 1306 of this chapter must be at least FIPS 140-2 Security Level 1 validated. FIPS 140-2 is incorporated by reference in § 1311.08.
(ii) The digital signature application and hash function must comply with FIPS 186-3 and FIPS 180-3, as incorporated by reference in § 1311.08.
(iii) The pharmacy application's private key must be stored encrypted on a FIPS 140-2 Security Level 1 or higher validated cryptographic module using a FIPS-approved encryption algorithm. FIPS 140-2 is incorporated by reference in § 1311.08.
(iv) For software implementations, when the signing module is deactivated, the pharmacy application must clear the plain text password from the application memory to prevent the unauthorized access to, or use of, the private key.
(v) The pharmacy application must have a time application that is within five minutes of the official National Institute of Standards and Technology time source.
(5) The pharmacy application must verify a practitioner's digital signature (if the pharmacy application accepts prescriptions that were digitally signed with an individual practitioner's private key and transmitted with the digital signature).
(6) If the prescription received by the pharmacy application has not been digitally signed by the practitioner and transmitted with the digital signature, the pharmacy application must either:
(i) Verify that the practitioner signed the prescription by checking the data field that indicates the prescription was signed; or
(ii) Display the field for the pharmacist's verification.
(7) The pharmacy application must read and retain the full DEA number including the specific internal code number assigned to individual practitioners authorized to prescribe controlled substances by the hospital or other institution as provided in § 1301.22(c) of this chapter.
(8) The pharmacy application must read and store, and be capable of displaying, all information required by part 1306 of this chapter.
(9) The pharmacy application must read and store in full the information required under § 1306.05(a) of this chapter. The pharmacy application must either verify that such information is present or must display the information for the pharmacist's verification.
(10) The pharmacy application must provide for the following information to be added or linked to each electronic controlled substance prescription record for each dispensing:
(i) Number of units or volume of drug dispensed.
(ii) Date dispensed.
(iii) Name or initials of the person who dispensed the prescription.
(11) The pharmacy application must be capable of retrieving controlled substance prescriptions by practitioner name, patient name, drug name, and date dispensed.
(12) The pharmacy application must allow downloading of prescription data into a database or spreadsheet that is readable and sortable.
(13) The pharmacy application must maintain an audit trail of all actions related to the following:
(i) The receipt, annotation, alteration, or deletion of a controlled substance prescription.
(ii) Any setting or changing of logical access control permissions related to the dispensing of controlled substance prescriptions.
(iii) Auditable events as specified in § 1311.215.
(14) The pharmacy application must record within each audit record the following information:
(i) The date and time of the event.
(ii) The type of event.
(iii) The identity of the person taking the action, where applicable.
(iv) The outcome of the event (success or failure).
(15) The pharmacy application must conduct internal audits and generate reports on any of the events specified in § 1311.215 in a format that is readable by the pharmacist. Such an internal audit may be automated and need not require human intervention to be conducted.
(16) The pharmacy application must protect the stored audit records from unauthorized deletion. The pharmacy application shall prevent modifications to the audit records.
(17) The pharmacy application must back up the controlled substance prescription records daily.
(18) The pharmacy application must retain all archived records electronically for at least two years from the date of their receipt or creation and comply
(a) Except as provided in paragraph (c) of this section, a copy of each electronic controlled substance prescription record that a pharmacy receives must be digitally signed by one of the following:
(1) The last intermediary transmitting the record to the pharmacy must digitally sign the prescription immediately prior to transmission to the pharmacy.
(2) The first pharmacy application that receives the electronic prescription must digitally sign the prescription immediately on receipt.
(b) If the last intermediary digitally signs the record, it must forward the digitally signed copy to the pharmacy.
(c) If a pharmacy receives a digitally signed prescription that includes the individual practitioner's digital signature, the pharmacy application must do the following:
(1) Verify the digital signature as provided in FIPS 186-3, as incorporated by reference in § 1311.08.
(2) Check the validity of the certificate holder's digital certificate by checking the certificate revocation list. The pharmacy may cache the CRL until it expires.
(3) Archive the digitally signed record. The pharmacy record must retain an indication that the prescription was verified upon receipt. No additional digital signature is required.
(a) The pharmacy application provider must establish and implement a list of auditable events. The auditable events must, at a minimum, include the following:
(1) Attempted unauthorized access to the pharmacy application, or successful unauthorized access to the pharmacy application where the determination of such is feasible.
(2) Attempted or successful unauthorized modification or destruction of any information or records required by this part, or successful unauthorized modification or destruction of any information or records required by this part where the determination of such is feasible.
(3) Interference with application operations of the pharmacy application.
(4) Any setting of or change to logical access controls related to the dispensing of controlled substance prescriptions.
(5) Attempted or successful interference with audit trail functions.
(6) For application service providers, attempted or successful annotation, alteration, or destruction of controlled substance prescriptions or logical access controls related to controlled substance prescriptions by any agent or employee of the application service provider.
(b) The pharmacy application must analyze the audit trail at least once every calendar day and generate an incident report that identifies each auditable event.
(c) The pharmacy must determine whether any identified auditable event represents a security incident that compromised or could have compromised the integrity of the prescription records. Any such incidents must be reported to the pharmacy application service provider, if applicable, and the Administration within one business day.
(a) Except as provided in paragraph (e) of this section, the application provider of an electronic prescription application or a pharmacy application must have a third-party audit of the application that determines that the application meets the requirements of this part at each of the following times:
(1) Before the application may be used to create, sign, transmit, or process controlled substance prescriptions.
(2) Whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
(b) The third-party audit must be conducted by one of the following:
(1) A person qualified to conduct a SysTrust, WebTrust, or SAS 70 audit.
(2) A Certified Information System Auditor who performs compliance audits as a regular ongoing business activity.
(c) An audit for installed applications must address processing integrity and determine that the application meets the requirements of this part.
(d) An audit for application service providers must address processing integrity and physical security and determine that the application meets the requirements of this part.
(e) If a certifying organization whose certification process has been approved by DEA verifies and certifies that an electronic prescription or pharmacy application meets the requirements of this part, certification by that organization may be used as an alternative to the audit requirements of paragraphs (b) through (d) of this section, provided that the certification that determines that the application meets the requirements of this part occurs at each of the following times:
(1) Before the application may be used to create, sign, transmit, or process controlled substance prescriptions.
(2) Whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
(f) The application provider must make the audit or certification report available to any practitioner or pharmacy that uses the application or is considering use of the application. The electronic prescription or pharmacy application provider must retain the most recent audit or certification results and retain the results of any other audits or certifications of the application completed within the previous two years.
(g) Except as provided in paragraphs (h) and (i) of this section, if the third-party auditor or certification organization finds that the application does not meet one or more of the requirements of this part, the application must not be used to create, sign, transmit, or process electronic controlled substance prescriptions. The application provider must notify registrants within five business days of the issuance of the audit or certification report that they should not use the application for controlled substance prescriptions. The application provider must also notify the Administration of the adverse audit or certification report and provide the report to the Administration within one business day of issuance.
(h) For electronic prescription applications, the third-party auditor or certification organization must make the following determinations:
(1) If the information required in § 1306.05(a) of this chapter, the indication that the prescription was signed as required by § 1311.120(b)(17) or the digital signature created by the practitioner's private key, if transmitted, and the number of refills as required by § 1306.22 of this chapter, cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.
(2) If other information required under this chapter cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application has failed to meet the requirements for the specific information and should not be used to create, sign, and transmit prescriptions that require the additional information.
(i) For pharmacy applications, the third-party auditor or certification
(1) If the information required in § 1306.05(a) of this chapter, the indication that the prescription was signed as required by § 1311.205(b)(6), and the number of refills as required by § 1306.22 of this chapter, cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.
(2) If the pharmacy application accepts prescriptions with the practitioner's digital signature, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part if the application does not consistently and accurately import, store, and verify the digital signature.
(3) If other information required under this chapter cannot be consistently and accurately imported, stored, and displayed, the third-party auditor or certification organization must indicate that the application has failed to meet the requirements for the specific information and should not be used to process electronic prescriptions that require the additional information.
(a) If an application provider identifies or is made aware of any issue with its application that make the application non-compliant with the requirements of this part, the application provider must notify practitioners or pharmacies that use the application as soon as feasible, but no later than five business days after discovery, that the application should not be used to issue or process electronic controlled substance prescriptions.
(b) When providing practitioners or pharmacies with updates to any issue that makes the application non-compliant with the requirements of this part, the application provider must indicate that the updates must be installed before the practitioner or pharmacy may use the application to issue or process electronic controlled substance prescriptions.
(a) If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.
(b) Records required by this subpart must be maintained electronically for two years from the date of their creation or receipt. This record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regulation, applicable to practitioners, pharmacists, or pharmacies.
(c) Records regarding controlled substances prescriptions must be readily retrievable from all other records. Electronic records must be easily readable or easily rendered into a format that a person can read.
(d) Records required by this part must be made available to the Administration upon request.
(e) If an application service provider ceases to provide an electronic prescription application or an electronic pharmacy application or if a registrant ceases to use an application service provider, the application service provider must transfer any records subject to this part to the registrant in a format that the registrant's applications are capable of retrieving, displaying, and printing in a readable format.
(f) If a registrant changes application providers, the registrant must ensure that any records subject to this part are migrated to the new application or are stored in a format that can be retrieved, displayed, and printed in a readable format.
(g) If a registrant transfers its electronic prescription files to another registrant, both registrants must ensure that the records are migrated to the new application or are stored in a format that can be retrieved, displayed, and printed in a readable format.
(h) Digitally signed prescription records must be transferred or migrated with the digital signature.