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Federal Aviation Administration (FAA), DOT.
Direct final rule; confirmation of effective date and correction.
This document confirms the effective date of the direct final rule which revises Class E airspace at Bolivar, MO and corrects the airport reference point coordinates.
Grant Nichols, System Support, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64106; telephone: (816) 329-2522.
The FAA published this direct final rule with a request for comments in the
Federal Aviation Administration (FAA), DOT.
Direct final rule; confirmation of effective date.
This document confirms the effective date of the direct final rule which revises Class E airspace at Hugoton, KS.
Grant Nichols, System Support, DOT Regional Headquarters Building, Federal Aviation Administration, 901 Locust, Kansas City, MO 64106; telephone: (816) 329-2522.
The FAA published this direct final rule with a request for comments in the
Bureau of Industry and Security, Commerce.
Final rule.
This rule sets forth BIS policy concerning voluntary self-disclosures of violations of part 760 (Restrictive Trade Practices or Boycotts) of the Export Administration Regulations (EAR) and violations of part 762 (Recordkeeping) of the EAR that relate to part 760. This rule also sets forth the factors that the Bureau of Industry and Security (BIS) considers when deciding whether to pursue administrative charges or settle allegations of such violations as well as the factors that BIS considers when deciding what level of penalty to seek in administrative antiboycott cases.
This rule is effective August 16, 2007.
Edward O. Weant III, Director, Office of Antiboycott Compliance, Bureau of Industry and Security, United States Department of Commerce, at (202) 482-2381.
Part 760 of the EAR—Restrictive Trade Practices or Boycotts—prohibits U.S. persons from taking or knowingly agreeing to take certain actions with intent to comply with, further, or support an unsanctioned foreign boycott. Part 760 of the EAR also requires U.S. persons who are recipients of requests “* * * to take any action which has the effect of furthering or
This rule does not address disclosure provisions or penalty determination factors in any other matters such as criminal prosecutions for violations of the antiboycott provisions or tax penalties that the Department of Treasury may impose for antiboycott violations that arise pursuant to the Ribicoff Amendment to the Tax Reform Act of 1976, as implemented by Section 999 of the Internal Revenue Code. Voluntary self-disclosure provisions and guidance on charging and penalty determinations in settlement of administrative enforcement cases that are not related to the antiboycott provisions are stated elsewhere in the EAR.
BIS received comments from two organizations regarding the proposed rule. Collectively, the two organizations raised seven issues. Three of the issues were general in nature and four addressed specific provisions of the proposed rule.
One commenter suggested that BIS consult with industry and provide guidance on what a company's reporting structure should be. BIS concludes that this proposal is outside the scope of the issues raised by the proposed rule. BIS recognizes that among the entities that have reporting obligations, one could find myriad organizational structures. BIS believes that any tailoring of the manner of reporting to accommodate both an organization's structure and BIS's need to properly identify the source of reports can best be done through consultations between the organization and BIS rather than through an amendment to the regulations. BIS encourages organizations that have questions about how to submit reports to contact BIS for such consultations.
One commenter suggested that BIS develop a system to allow the public to submit boycott reports electronically. This suggestion is outside the scope of the proposed rule.
One commenter suggested that BIS update and publish its telephone advice guidance and look for other opportunities to provide practical written guidance for companies to use in complying with boycott requests. This comment is outside the scope of the proposed rule.
The comments address four specific issues in connection with the proposed rule. Those four issues are: The burden that would be imposed by new § 764.8 regarding voluntary self-disclosures; whether the provision of new § 764.8(f) regarding requests to take action that would otherwise violate § 764.2(e) is contrary to prior agency practice; whether new § 764.8 should allow verbal voluntary self-disclosures with written follow-up; and whether the rule should provide more concrete incentives to disclose by making a warning letter the maximum sanction for most voluntary self-disclosure cases.
One commenter stated that BIS had underestimated the costs large global companies would incur in complying with the voluntary disclosure provisions. In particular, the commenter noted that a company with decentralized operations would incur costs measured in tens of thousands of dollars if it conducted the five-year review of all its operations recommended by BIS. Upon review, BIS acknowledges that the burden on large companies with decentralized operations would be greater than estimated in the proposed rule. However, BIS believes that such burden will be justified in many instances because of the risks to the firm involved if it performs a less comprehensive review. The risk of conducting a review covering a period shorter than five years or that does not include all business units is that some violations will be made known to OAC through other sources or during the course of an OAC investigation initiated in response to the voluntary self-disclosure. Such undisclosed violations would not receive the “great weight” mitigating factor that BIS would apply in settlement negotiations to voluntarily self-disclosed violations under this rule. The larger penalties imposed for such undisclosed violations might exceed the cost of doing a business-wide five-year search. Hence, BIS believes that it is appropriate to recommend a five-year period for this kind of review. BIS notes that the proposed rule and this final rule recommend but do not require a review extending back for a period of five years prior to the initial notification.
In the proposed rule, BIS stated that it intended to treat the collection of information related to the voluntary self-disclosure procedures in this rule as an extension of the scope of the collection approved under OMB control number 0694-AD58. Based on this comment, BIS re-evaluated the burden hours associated with this information collection and concluded that the burden is large enough to justify a separate collection authorization. Therefore, BIS sought and obtained separate OMB authorization for the collection related to the voluntary self-disclosure procedure in this rule. The collection related to the voluntary self-disclosure procedure in this rule explicitly accounts for the larger burden that would be imposed on large companies with decentralized locations and is authorized under OMB control number 0694-0132 for which the estimated annual burden hours and costs are 1,280 and $51,200, respectively.
One commenter raised an issue concerning the implication of proposed § 764.8(f). Proposed § 764.8(f) would have provided a procedure by which a person making a voluntary self-disclosure of a violation of the antiboycott provision may request authorization to take certain actions with respect to the transaction. The commenter expressed a belief that “the current OAC practice is not to require companies to seek BIS authorization to continue with a transaction after filing a voluntary disclosure.” The commenter went on to state that “[t]he proposed rule, however, would impose such a requirement * * * if a company were to commit a Category B or C violation it seems unreasonable that the company would have to file a voluntary disclosure and then seek BIS authorization to continue with the transaction. A more reasonable approach would be to require BIS
BIS agrees that, in the past, OAC has advised members of the public who contacted OAC via its telephone advice line a violation of part 760 does not preclude exporting in connection with the same commercial transaction. Upon review, BIS has decided to remove paragraph (f) from § 764.8 because it is not consistent with prior agency practice.
BIS received one comment expressing the opinion that the Bureau of Customs and Border Protection self-disclosure procedure set forth in 19 CFR 162.74(a) is better than the procedure in the proposed rule. The procedure in 19 CFR 162.74(a) allows an importer to make a verbal disclosure to a Customs officer of a violation with the requirement that the disclosure be followed up in writing within 10 days. The commenter suggested that this Customs procedure encourages more disclosures by allowing the importer to disclose the violation at the earliest possible moment. The ten day written follow-up deadline encourages accurate and complete disclosures. BIS has reviewed 19 CFR 162.74(a) and the commenter's rationale. BIS notes that 19 CFR 162.74(a) applies to penalties for certain violations related to tariffs on imports into the United States. Compliance with the disclosure requirements in § 162.74 can allow the importer to pay a reduced penalty as compared with violations for which no such disclosure takes place. The penalties are set forth in 19 CFR 162.73 and 19 CFR 162.73a. Generally, the penalties are expressed as a percentage of value of the merchandise that was the subject of the violation. BIS believes that violations of the antiboycott provisions are substantively different from the violations addressed by 19 CFR 162.74(a). As noted in the preamble to the proposed rule, BIS believes that written initial notifications reduce the possibility of confusion as to whether a particular communication was intended to be a voluntary self-disclosure and are likely to produce more complete disclosures than would oral disclosures. In addition, BIS believes that preparing and submitting a written submission of the information required in an initial notification,
One commenter recommended that BIS provide more concrete incentives for making disclosures of violations of the antiboycott provisions. This commenter noted that although new Supplement No. 2 to part 764 provides that voluntary self-disclosures be given “GREAT WEIGHT” as a mitigating factor, other language in the supplement concerning the effect of other factors as well as language in new § 764.8(b) stating that “[t]he weight given to a voluntary self-disclosure is solely within discretion of BIS and the effect of voluntary self-disclosure may be outweighed by aggravating factors” makes the benefits of voluntary self-disclosure almost speculative and could affect decisions to disclose. That commenter stated that BIS's proposal “contrasts sharply with * * * customs law administration. [Where] * * * definite advantages always flow from disclosing violations * * *.” The commenter recommended that BIS at least adopt a position of resolving all voluntary self-disclosure cases with a warning letter unless the “violation involves serious anti-boycott concerns—
BIS notes that as stated in § 764.8, the weight to be given to any factor is solely within the discretion of BIS. Supplement No. 2 to part 764 describes how BIS exercises that discretion. BIS's statement in the supplement that voluntary self-disclosure made in accordance with § 764.8 be given great weight and that factors of great weight ordinarily should be given considerably more weight than other factors reflects the policy that BIS has followed and intends to follow in settling administrative enforcement actions involving the antiboycott provisions. However, given the myriad possible combinations of facts that may be present in any given case, including a range of possible aggravating and mitigating factors, BIS believes that it cannot determine in advance the maximum sanction that would be appropriate for a particular violation or combination of violations. Moreover, attempting to do so could create incentives to violate the antiboycott provisions in cases where the potential economic benefit to the violator is large relative to the maximum monetary penalty. Such incentives could occur, for example, in a situation in which a single violation provides the violator with access to a very large market.
This rule creates a new § 764.8 setting forth the procedures for voluntary self-disclosure of violations of the antiboycott provisions. It also creates a new supplement No. 2 to part 764 that describes how BIS responds to violations of the antiboycott provisions and how BIS makes penalty determinations in the settlement of antiboycott administrative enforcement cases. The rule also makes technical and conforming changes to part 766.
This rule provides specific criteria with respect to what constitutes a voluntary self-disclosure and how voluntary self-disclosures relate to other sources of information that OAC may have concerning violations of the antiboycott provisions. The rule also informs the public of the factors that BIS usually considers to be important when settling antiboycott administrative enforcement cases. BIS believes that publishing this information in the EAR will tend to place all potential respondents on a more equal footing because procedures for making voluntary self-disclosures, information about how BIS responds to violations and how BIS makes penalty determinations in the settlement of antiboycott administrative enforcement cases will all be matters of public record. BIS also believes such publication will make settlement of antiboycott administrative cases more efficient, as respondents and BIS will be able to focus on the important factors in antiboycott administrative enforcement cases and OAC generally expends fewer resources to obtain information received through voluntary self-disclosure than information obtained by other means.
This rule also revises Supp. No. 1 to part 730 of the EAR to display the OMB control number of the newly approved collection of information that relates to § 764.8 of the EAR, which is created by this rule.
The new § 764.8 both defines what constitutes a voluntary self-disclosure and provides the procedures for making such disclosures. Compliance with the provisions of § 764.8 is important because a voluntary self-disclosure “satisfying the requirements of § 764.8” is designated as a mitigating factor of “GREAT WEIGHT” in the settlement of administrative cases as set forth in the new Supplement No. 2 to part 764. Supplement No. 2 provides that such
Section 764.8 requires, among other things, that voluntary self-disclosures be in writing and that they be received by OAC before OAC learns of the same or substantially similar information from “another source” and has commenced an investigation or inquiry in connection with that information. Section 764.8 provides that a person may make an initial written notification followed by submission of a more detailed narrative account and supporting documents. For purposes of determining whether a voluntary self-disclosure was received before OAC learned of the same or substantially similar information from another source, the date of the voluntary self-disclosure will be deemed to be the date that OAC received the initial notification if the person making the disclosure subsequently submits the required narrative account and supporting documentation.
BIS recognizes that two features of its existing regulations and practices may impact the requirement that a voluntary self-disclosure be received before OAC learns of the same or substantially similar information from another source. The first such feature is the set of reporting requirements in § 760.5. The second such feature is OAC's practice of encouraging persons with questions about the EAR to contact OAC by telephone or e-mail for advice.
Section 760.5 of the EAR requires any “U.S. person who receives a request to take any action that would have the effect of furthering or supporting a restrictive trade practice or boycott fostered or imposed by a foreign country against a country friendly to the United States or against any United States person” to report to OAC both receipt of the request and the action that the person took in response to that request. In some instances, taking the requested action would be a violation of § 760.2. BIS recognizes that, in such instances, the reporting requirements of § 760.5 would have the effect of requiring a person to disclose a violation that it had committed. Section 764.8(b)(3)(i) provides that reports filed pursuant to § 760.2 constitute “information received from another source.” Thus, a person who wishes to make a voluntary self-disclosure of a violation that is based on an action that § 760.5 requires that person to report would have to make sure that OAC receives the written initial notification portion of the voluntary self-disclosure before OAC began an investigation or inquiry based on the information received in the required report. The report itself would not serve as the initial notification. However, if OAC received the report and the initial notification simultaneously, it would be deemed to have received the initial notification before it had begun an investigation or inquiry based on the report. That person would then have to comply with the remaining requirements of § 764.8, but once that person complied with those requirements, the voluntary self-disclosure would be treated as having been received at the time that the initial notification was received.
OAC has, for a number of years, provided advice about the antiboycott provisions to persons requesting such advice via telephone or e-mail. In some instances, the persons requesting such advice may disclose that they have committed a violation. OAC's practice has been to encourage such persons to make voluntary self-disclosures. OAC wants to continue to encourage persons with questions about the antiboycott provisions to disclose fully all relevant facts when making telephone or e-mail inquiries for advice concerning the antiboycott provisions. Therefore, § 764.8(b)(3)(ii) provides that violations revealed in telephone or e-mail requests for advice concerning the antiboycott provisions are not information received from another source for purposes of § 764.8. Section 764.8(b)(3)(ii) also states that the information provided over the telephone or via e-mail while seeking advice would not constitute a voluntary self-disclosure or even an initial notification of a voluntary self-disclosure. OAC's practice is to inform persons who reveal violations in the course of seeking such advice of their opportunity to make a voluntary self-disclosure.
Section 764.8 also provides that for a firm to be deemed to have made a voluntary self-disclosure under that section, the individual making the disclosure must do so with the “full knowledge and authorization of the firm's senior management or of an officer or employee who is authorized to make such disclosures on behalf of the firm.” BIS believes that approval of a person with such authority is needed to make clear that a firm may not claim the benefits of a voluntary self-disclosure when a subordinate employee acting on his or her own initiative has disclosed wrongdoing. The proposed rule did not include the phrase “or of an officer or employee who is authorized to make such disclosures on behalf of the firm.” Upon review, BIS does not believe that knowledge and approval of “senior management” are needed so long as someone with authority to make such disclosures on behalf of the firm has approved the disclosure on behalf of the firm.
This rule creates a new supplement to part 766 of the EAR to set forth publicly BIS's practice with respect to violations of the antiboycott provisions. The supplement describes the ways that BIS responds to violations, the types of administrative sanctions that may be imposed for violations, the factors that BIS considers in determining what sanctions are appropriate, the factors that BIS considers in determining the appropriate scope of the denial or exclusion order sanctions, and the factors BIS considers when deciding whether to suspend a sanction.
Paragraph (a) of the supplement contains introductory material that defines the scope and limitations of the supplement as well as sets forth BIS's policy of encouraging any party in settlement negotiations with BIS to provide all information that the party believes is relevant to the application of the guidance in the supplement as well as information that is relevant to determining whether a violation has, in fact, occurred and whether the party has a defense to any potential charges.
Paragraph (b) of the supplement sets forth the three actions that BIS may take in response to a violation, namely, issuing a warning letter, pursuing an administrative case, and referring a case to the Department of Justice for criminal prosecution. This paragraph also lists the factors that often cause BIS to issue a warning letter. Additionally, it notes BIS's ability to issue
Paragraph (c) of the supplement lists the types of administrative sanctions that may be imposed in antiboycott administrative enforcement cases. Those sanctions are: A monetary penalty, a denial of export privileges and an order excluding the party from practice before BIS.
Paragraph (d) provides information about how BIS determines what sanctions are appropriate in settlement of antiboycott administrative enforcement cases. The paragraph describes the general factors that BIS believes are important in cases concerning violations of the antiboycott provisions. The paragraph then describes specific mitigating and aggravating factors. BIS typically looks to the presence or absence of the specific factors, alongside the general factors, in determining what sanctions should apply in a given settlement.
Paragraph (d) begins by listing seven general factors to which BIS looks in determining what administrative sanctions are appropriate in each settlement. Those seven general factors are: Degree of seriousness, category of violation, whether multiple violations arise from related transactions, whether multiple violations arise from unrelated transactions, the timing of a settlement, whether there are related civil or criminal violations, and the party's familiarity with the antiboycott provisions. The supplement provides general guidance on how BIS applies each of these seven general factors.
Paragraph (d) then addresses the role of eight specific mitigating and nine specific aggravating factors whose presence or absence BIS generally considers when determining what sanctions should apply. The listed factors are not exhaustive and BIS may consider other factors as well in a particular case. However, the listed factors are those that BIS's experience indicates are commonly relevant to penalty determinations in cases that are settled. Factors identified by the term “GREAT WEIGHT” will ordinarily be given considerably more weight than other factors.
The eight specific mitigating factors in paragraph (d) are: Voluntary self-disclosure, effective compliance program, limited business with or in boycotted or boycotting countries, history of compliance with the antiboycott provisions, exceptional cooperation with the investigation, (lack of) clarity of request to furnish prohibited information or take prohibited action, violations arising out of a party's “passive” refusal to do business in connection with an agreement, and isolated occurrence. The proposed rule contained a statement in paragraph (d)(2)(i)(B)(
The nine specific aggravating factors in paragraph (d) are: Concealment or obstruction, serious disregard for compliance responsibilities, history of (lack of) compliance with the antiboycott provisions, familiarity with the type of transaction at issue in the violation, prior history of business with or in boycotted countries or boycotting countries, long duration or high frequency of violations, clarity of request to furnish prohibited information or take prohibited action, violation relating to information concerning a specific individual or entity, and violations relating to “active” conduct concerning an agreement to refuse to do business.
The specific mitigating and aggravating factors are set forth in more detail in the supplement. BIS believes that in most cases evaluating these factors provides a fair basis for determining the penalty that is appropriate when settling an antiboycott administrative enforcement case. However, these mitigating and aggravating factors are not exclusive. BIS may consider other factors that are relevant in a particular case and respondents in settlement negotiations may submit other relevant factors for BIS's consideration.
Paragraph (e) sets forth the factors that BIS considers to be particularly relevant when deciding whether to impose a denial or exclusion order in the settlement of antiboycott administrative enforcement cases. Certain factors in paragraph (d)—the four factors that are given great weight, degree of seriousness, and history of prior violations and their seriousness—are included in paragraph (e). In addition, BIS considers the extent to which a firm's senior management participated in or was aware of the conduct that gave rise to the violation, the likelihood of future violations, and whether a monetary penalty could be expected to have a sufficient deterrent effect to be particularly relevant in determining whether a monetary penalty is appropriate.
Paragraph (f) provides examples of factors that BIS may consider in deciding whether to suspend or defer a monetary penalty or suspend an order denying export privileges or an order providing for exclusion from practice. With respect to suspension or deferral of monetary penalties, BIS may consider whether the party has demonstrated a limited ability to pay a penalty that would be appropriate for such violation so that suspended or deferred payment can be expected to have sufficient deterrent value, and whether the impact of the penalty would be consistent with the impact of penalties on other parties who commit similar violations. When deciding whether to suspend denial or exclusion orders, BIS may consider the adverse economic consequences of the order on the party, its employees, and other persons, as well as on the national interest in the competitiveness of U.S. businesses. However, such orders will be suspended for adverse economic consequences only if future violations are unlikely and if there are adequate measures (usually a substantial civil penalty) to achieve the necessary deterrent effect.
1. This rule has been determined to be not significant for purposes of Executive Order 12866.
2. 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 Office of Management and Budget Control Number. This rule contains a new collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501
Send comments about this collection, including suggestions for reducing the burden, to David Rostker, Office of Management and Budget, by e-mail to
3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.
4. The Chief Counsel for Regulation at the Department of Commerce certified
Administrative practice and procedure, Advisory committees, Exports, Reporting and recordkeeping requirements, Strategic and critical materials.
Administrative practice and procedure, Exports, Law enforcement, Penalties.
Administrative practice and procedure, Confidential business information, Exports, Law enforcement, Penalties.
50 U.S.C. app. 2401
50 U.S.C. app. 2401
This section sets forth procedures for disclosing violations of part 760 of the EAR—Restrictive Trade Practices or Boycotts and violations of part 762—Recordkeeping—with respect to records related to part 760. In this section, these provisions are referred to collectively as the “antiboycott provisions.” This section also describes BIS's policy regarding such disclosures.
(a)
(b)
(2) The provisions of this section apply only when information is provided to OAC for its review in determining whether to take administrative action under parts 764 and 766 of the EAR for violations of the antiboycott provisions.
(3)
(i)
(ii)
(4) Although a voluntary self-disclosure is a mitigating factor in determining what administrative sanctions, if any, will be sought by BIS, it is a factor that is considered together with all other factors in a case. The weight given to voluntary self-disclosure is solely within the discretion of BIS, and the mitigating effect of voluntary self-disclosure may be outweighed by aggravating factors. Voluntary self-disclosure does not
(5) A firm will not be deemed to have made a disclosure under this section unless the individual making the disclosure did so with the full knowledge and authorization of the firm's senior management or of a person with authority to make such disclosures on behalf of the firm.
(6) The provisions of this section do not, nor should they be relied on to, create, confer, or grant any rights, benefits, privileges, or protection enforceable at law or in equity by any person, business, or entity in any civil, criminal, administrative, or other matter.
(c)
(2)
(3)
(i) The kind of violation involved, for example, the furnishing of a certificate indicating that the goods supplied did not originate in a boycotted country;
(ii) An explanation of when and how the violations occurred, including a description of activities surrounding the violations (
(iii) The complete identities and addresses of all individuals and organizations, whether foreign or domestic, involved in the activities giving rise to the violations; and
(iv) A description of any mitigating factors.
(4) Supporting documentation.
(i) The narrative account should be accompanied by copies of documents that explain and support it, including:
(A) Copies of boycott certifications and declarations relating to the violation, or copies of documents containing prohibited language or prohibited requests for information;
(B) Other documents relating to the violation, such as letters, facsimiles, telexes and other evidence of written or oral communications, negotiations, internal memoranda, purchase orders, invoices, bid requests, letters of credit and brochures;
(ii) Any relevant documents not attached to the narrative account must be retained by the person making the disclosure until the latest of the following: the documents are supplied to OAC; BIS informs the disclosing party that it will take no action; BIS issues a warning letter for the violation; BIS issues an order that constitutes the final agency action in the matter and all avenues for appeal are exhausted; or the documents are no longer required to be kept under part 762 of the EAR.
(5)
(6)
(7)
(d)
(1) Inform the person making the disclosure that, based on the facts disclosed, it plans to take no action;
(2) Issue a warning letter;
(3) Issue a proposed charging letter and attempt to settle the matter pursuant to § 766.18 of the EAR;
(4) Issue a charging letter pursuant to § 766.3 of the EAR if a settlement is not reached or BIS otherwise deems appropriate; and/or
(5) Refer the matter to the Department of Justice for criminal prosecution.
(e)
50 U.S.C. app. 2401
(a)
(f) Supplements Nos. 1 and 2 to this part describe how BIS typically exercises its discretion regarding the terms under which it is willing to settle particular cases.
(a)
(1)
(2)
(3)
(b)
(1)
(i) BIS may issue warning letters where:
(A) The investigation commenced as a result of a voluntary self-disclosure satisfying the requirements of § 764.8 of the EAR; or
(B) The party has not previously committed violations of the antiboycott provisions.
(ii) BIS may also consider the category of violation as discussed in paragraph (d)(2) of this supplement in determining whether to issue a warning letter or initiate an enforcement proceeding. A violation covered by Category C (failure to report or late reporting of receipt of boycott requests) might warrant a warning letter rather than initiation of an enforcement proceeding.
(iii) BIS will not issue a warning letter if it concludes, based on available information, that a violation did not occur.
(iv) BIS may reopen its investigation of a matter should it receive additional evidence or if it appears that information previously provided to BIS during the course of its investigation was incorrect.
(2)
(i) Charging letters may be issued when there is reason to believe that a violation has occurred. Cases may be settled before or after the issuance of a charging letter.
(ii) Although not required to do so by law, BIS may send a proposed charging letter to a party to inform the party of the violations that BIS has reason to believe occurred and how BIS expects that those violations would be charged. Issuance of the proposed charging letter provides an opportunity for the party and BIS to consider settlement of the case prior to the initiation of formal enforcement proceedings.
(3)
(c)
(1) A monetary penalty may be assessed for each violation as provided in § 764.3(a)(1) of the EAR;
Note to paragraph (c)(1): The maximum penalty is subject to adjustments under the Federal Civil Penalties Adjustment Act of 1990 (28 U.S.C. 2461, note (2000)), which are codified at 15 CFR 6.4. For violations that occurred before March 9, 2006, the maximum monetary penalty per violation is $11,000. For violations occurring on or after March 9, 2006, the maximum monetary penalty per violation is $50,000.
(2) An order denying a party's export privileges under the EAR may be issued, under § 764.3(a)(2) of the EAR; or
(3) Exclusion from practice under § 764.3(a)(3) of the EAR.
(d)
(1)
(i)
(ii)
(A) The Category A violations and the sections of the EAR that set forth their elements are:
(
(
(
(
(
(
(B) The Category B violations and the sections of the EAR that set forth their elements are:
(
(
(C) The Category C violation and the section of the EAR that sets forth its elements is: Failing to report timely receipt of boycott requests—§ 760.5.
(iii)
(A)
(B)
(C)
(iv)
(v)
(vi)
(vii)
(2)
(i)
(A)
(B)
(
(
(C)
(D)
(
(
(
(
(
(
(E)
(F)
(G)
(H)
(ii)
(A)
(B)
(C)
(
(
(
(
(
(
(
(D)
(E)
(F)
(G)
(H)
(I)
(e)
(f)
(1)
(2)
Bureau of Industry and Security, Commerce.
Final rule.
This rule provides clarifying guidance for distinguishing the export and reexport licensing jurisdiction of the U.S. Department of State from that of the U.S. Department of Commerce concerning microelectronic circuits. In this same issue of the
Although this is a final rule, comments are welcome and should be sent to
Brian Baker, Deemed Exports and Electronics Division, Office of National Security and Technology Transfer Controls, by telephone at 202-482-5534 or by e-mail at
Entries for certain Export Control Classification Numbers (ECCNs) contain “Related Controls” paragraphs that alert readers to the possible application of export controls administered by other U.S. government agencies or that of export controls set forth in other similar ECCNs. The “Related Controls” paragraph of ECCN 3A001 currently provides guidance on the licensing jurisdiction of the Directorate of Defense Trade Controls of the U.S. Department of State with respect to certain “space qualified” and certain radiation-hardened commodities.
Concurrent with this final rule, the U.S. Department of State is publishing a final rule amending the ITAR with respect to State's jurisdiction over radiation-hardened microelectronic circuits in Category XV(d) of the USML (22 CFR part 121). Within Category XV(d) of the USML, the U.S. Department of State is changing the measurement for the single event upset rate parameter. As a result, radiation-hardened microelectronic circuits that meet or exceed the four unchanged parameters in Category XV(d) and whose single event upset rate parameter lies between the old and new standard will be moved to the Commerce Control List (CCL) under ECCN 3A001.a.1.
To reflect the new licensing jurisdiction standard in the USML, this rule adds language to the “Related Controls” paragraph of ECCN 3A001 to assist readers in correctly determining whether certain microelectronic circuits are covered by the CCL and subject to the licensing jurisdiction of the Bureau of Industry and Security of the U.S. Department of Commerce, or are on the USML and subject to the licensing jurisdiction of the Directorate of Defense Trade Controls of the U.S. Department of State.
Specifically, the language added to ECCN 3A001 states that the following are subject to the licensing jurisdiction of the Department of State, Directorate of Defense Trade Controls: Radiation-hardened microelectronic circuits controlled by Category XV(d) of the United States Munitions List (USML) and all specifically designed or modified systems or subsystems, components, parts, accessories, attachments, and associated equipment controlled by Category XV(e) of the USML.
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as extended by the Notice of August 3, 2006, 71 FR 44551 (August 7, 2006), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act.
1. This final rule has been determined to be not significant for purposes of E.O. 12866.
2. 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 of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. BIS finds that there is good cause under 5 U.S.C. 553 (b)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment
Exports, Reporting and recordkeeping requirements.
50 U.S.C. app. 2401
Department of State.
Final rule.
The Department of State, in consultation with the Departments of Defense and Commerce, is amending the text of the United States Munitions List (USML), Category XV—Spacecraft Systems and Associated Equipment to clarify the coverage and to alter one of the five performance characteristics that define radiation-hardened microelectronic circuits that are subject to the licensing jurisdiction of the International Traffic in Arms Regulations (ITAR).
Interested parties are invited to submit comments at any time by the following methods:
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Persons with access to the Internet may also view this notice by going to the regulations.gov Web site at:
Mr. Stephen Tomchik, Office of Defense Trade Controls Policy, Department of State, Telephone (202) 663-2799 or Fax (202) 261-8199. ATTN: Regulatory Change, USML Part 121, Category XV.
The specific results of the Department of State-led interagency review are as follows:
1. Category XV. One substantive change is made to the characteristics defining radiation hardened microelectronic circuits in paragraph (d). The exponential measure describing the single event upset rate described in (d)(4) is changed from 1×10
2. Several additional textual clarifications are made to the five characteristics. The word “threshold” is inserted in (d)(2) and (d)(4) for purposes of technical clarity. In (d)(3) the insertion of the expression “1 MeV Equivalent” describes the energetic activity of neutrons. Finally, in (d)(4) an expression is added to clarify the representative environment for performance in space.
3. It is stressed that any microelectronic circuit that is specifically designed, developed, configured, adapted, or modified for a military or space application, to include its incorporation into any defense article described on the United States Munitions List (USML) remains subject to the licensing requirements of the International Traffic in Arms Regulations (ITAR).
4. Manufacturers and exporters are responsible for compliance with the controls of this subchapter. Consequently, the Department of State advises that companies must be able to demonstrate, either through testing, statistical analyses, design analyses, or other means, whether semiconductors meet or fail to meet the parameters established in USML Category XV(d). Records of such testing, analyses, or other means must be retained and made available as appropriate to demonstrate compliance.
This amendment involves a foreign affairs function of the United States and, therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554.
This rule does not require analysis under the Regulatory Flexibility Act.
This rule does not require analysis under the Unfunded Mandates Reform Act.
This amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996. It will not have substantial direct effects on the States, the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.
It is determined that this rule does not have sufficient federalism implications to warrant application of the consultation provisions of Executive Orders 12372 and 13132.
This amendment is exempt from review under Executive Order 12866, but has been reviewed internally by the Department of State to ensure consistency with the purposes thereof.
This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Arms and munitions, Exports.
Sec. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2278, 2797); E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp. p. 79; 22 U.S.C. 2658; Pub. L. 105-261, 112 Stat. 1920.
(d) Radiation-hardened microelectronic circuits that meet or exceed all five of the following characteristics:
(1) A total dose of 5×10
(2) A dose rate upset threshold of 5×10
(3) A neutron dose of 1×10
(4) A single event upset rate of 1×10
(5) Single event latch-up free and having a dose rate latch-up threshold of 5×10
Postal Service.
Final rule.
The Postal Service is revising portions of title 39, Code of Federal Regulations, to clarify the division of investigatory responsibilities between the Office of the Inspector General of the Postal Service and the Postal Inspection Service.
Effective July 17, 2007.
Gladis C. Griffith, Deputy General Counsel, Office of the Inspector General, United States Postal Service, 703-248-4683.
To promote efficient use of resources, and prevent unnecessary duplication of effort, the Postal Service has determined it is appropriate to clarify the division of investigative authority between the Office of the Inspector General and the Postal Inspection Service. Most notably, it has been determined that the Office of the Inspector General should investigate allegations of violations of postal laws or misconduct by postal employees, including mail theft, and the Inspection Service should investigate allegations of violations or postal laws or misconduct by all other persons. This delineation of responsibilities reflects agreement between the Postmaster General and the Chairman of the Board of Governors.
Authority delegations (Government agencies), Freedom of information, Organization and functions (Government agencies), Privacy
Administrative practice and procedure, Banks, banking, Credit, Crime, Infants and children, Law enforcement, Penalties.
False claims and statements, Law enforcement, Penalties, Program fraud.
5 U.S.C. App. 3; 39 U.S.C. 401(2) and 1001.
(d) The Office of Inspector General is responsible for detecting and preventing fraud, waste, and abuse in the programs and operations of the Postal Service, including, investigating all allegations of violations of postal laws or misconduct by postal employees, including mail theft, and for reviewing existing and proposed legislation and regulations relating to the programs and operations of the Postal Service.
39 U.S.C. 101, 102, 202, 204, 401, 402, 403, 404, 406, 410, 411, 1003, 3005(e)(1); 12 U.S.C. 3401-3422; 18 U.S.C. 981, 1956, 1957, 2254, 3061; 21 U.S.C. 881; Omnibus Reconciliation Act of 1996, sec. 662 (Pub. L. 104-208).
(b)
(1) In the enforcement of laws regarding property in the custody of the Postal Service, property of the Postal Service, the use of the mails, and other postal offenses. With the exception of enforcing laws related to the mails:
(i) The Office of Inspector General will investigate all allegations of violations of postal laws or misconduct by postal employees, including mail theft; and
(ii) The Inspection Service will investigate all allegations of violations of postal laws or misconduct by all other persons.
(a)
31 U.S.C. Chapter 38; 39 U.S.C. 401.
(c )
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Final rule.
This action modifies the integrity management regulations for hazardous liquid and natural gas transmission pipelines. The modifications include adding an eight-month window to the period for reassessing hazardous liquid pipelines; modifying notification requirements for operators of hazardous liquid and natural gas pipelines; repealing a requirement for gas operators to notify local authorities; and allowing alternatives in calculating pressure reduction when making an immediate repair on a hazardous liquid pipeline. This action is intended to improve pipeline safety by clarifying the integrity management regulations and providing operators with increased flexibility in implementing their integrity management (IM) programs.
This rule is effective August 16, 2007.
Mike Israni by phone at (202) 366-4571 or by e-mail at
PHMSA is the Federal regulatory agency responsible for promoting the safe, reliable, and environmentally sound operation of over two million miles of natural gas and hazardous liquid pipelines in the United States. PHMSA has broad authority under 49 U.S.C. 60102 to issue regulations establishing standards for pipeline facility design, installation, inspection, emergency planning and response, testing, construction, extension, operation, replacement, and maintenance. By law, PHMSA pipeline safety standards must be both practicable and designed to meet the need for environmental safety and protection, taking account of specified criteria (49 U.S.C. 60102(b)(1-2)). Our rulemaking actions are reviewed by one or both of two statutorily-mandated advisory committees—the Technical Pipeline Safety Standards Committee, and the Technical Hazardous Liquid Pipeline Safety Standards Committee—which provide peer review of all proposed pipeline safety rules to assure technical feasibility, reasonableness, cost-effectiveness, and practicability.
Since 2000, PHMSA has issued IM requirements for pipeline operators. PHMSA's pipeline IM regulations require operators of hazardous liquid and gas transmission pipelines to assess, evaluate, repair, and validate through comprehensive analyses the integrity of pipeline segments in areas where a leak or failure would do the most damage. These areas are referred to as “High Consequence Areas” and include populated, unusually sensitive environmental areas, and other areas defined by the IM regulations.
On December 1, 2000, PHMSA issued IM program regulations at 49 CFR 195.452 for operators with more than 500 miles of hazardous liquid pipeline (65 FR 75378). On January 14, 2002, PHMSA issued IM program repair criteria (67 FR 1650). On January 16, 2002, the IM program regulations were extended to operators with less than 500 miles of hazardous liquid pipeline (67 FR 2136). On December 15, 2003, PHMSA issued IM program regulations for gas transmission pipelines at 49 CFR Part 192, Subpart O (68 FR 69778).
The American Petroleum Institute (API) and the Association of Oil Pipelines (AOPL) represent members who operate more than 85 percent of the U.S hazardous liquid infrastructure. On June 18, 2004, API and AOPL jointly submitted a petition for rulemaking seeking changes to the hazardous liquid pipeline IM regulations.
API and AOPL requested the rule changes to benefit pipeline safety and provide operators additional flexibility in the following three areas: Adding flexibility to reassessment intervals; adding flexibility to scheduling repairs, and providing for notification to PHMSA when an operator is unable to make a repair because of permitting or other problems.
An important concept in IM is that an operator's program is to evolve into a more detailed and comprehensive program as the operator gains information about its pipeline system. An operator is required to continually improve its IM program. Similarly, as
PHMSA published a notice of proposed rulemaking (NPRM) on December 15, 2005 (70 FR 74265), proposing to revise its pipeline IM regulations to address the API and AOPL petition to improve the IM regulations and to get additional information about reasons for repair delays. In the NPRM, PHMSA proposed four revisions. First, we proposed to allow more flexibility in the integrity reassessment intervals for hazardous liquid pipelines by adding an eight-month window to the five-year time frame for operators to complete reassessments. Second, we proposed to require hazardous liquid pipeline and gas transmission pipeline operators to notify us of repair-related reductions in operating pressure. The proposal would require operators to notify us whenever they reduce pipeline pressure to make a repair, to provide reasons for any pressure reduction, and to provide further notice and explanation when a pressure reduction exceeds 365 days. Third, we proposed to repeal as unnecessary an existing regulation requiring gas operators to provide notice of pressure reductions to local authorities. Lastly, PHMSA proposed to amend an existing provision for calculating a pressure reduction when making an immediate repair on a hazardous liquid pipeline. The proposal would allow use of an alternative method to calculate reduced operating pressure when the prescribed formula is not applicable or results in a calculated pressure higher than the operating pressure.
PHMSA received comments from 12 parties: API and AOPL; the American Gas Association; Texas Pipeline Association; Kinder Morgan Energy Partners, L.P.; Southwest Gas Corporation; Paiute Pipeline Company; Orange and Rockland Utilities, Inc.; Duke Energy Gas Transmission Corporation; Magellan Midstream Partners, L.P.; Panhandle Energy; Puget Sound Energy; and Enbridge Energy Company, Inc.—Liquids Transportation Segment.
Current regulations require hazardous liquid pipeline operators to set up intervals not to exceed five years for continually assessing pipeline integrity (§ 195.452(j)(3)). The NPRM proposed adding an eight-month window to the five-year time frame for operators to complete reassessments.
A commenter also requested that PHMSA extend similar flexibility to gas transmission pipeline operators, maintaining that the current reassessment time frames on gas transmission pipelines do not have a technical basis. The commenter offered RSTRENG, a means of predicting the effects of metal loss on the remaining strength of the corroded pipe, and other industry-accepted methods as alternatives that could be useful in setting reassessment time frames on gas transmission pipelines.
PHMSA agrees that reassessment intervals should be adjusted over time based on engineering, technical studies, and integrity management principles. At this point, we do not have sufficient scientific and technical data to support modifying the five-year interval in regulation.
Nevertheless, section § 195.452(j)(4) of the IM regulations allows hazardous liquid operators to seek a variance from the five-year interval for particular pipeline facilities based on engineering data or if needed technology is not available. In these instances, operators notify PHMSA and provide scientific and technical justifications and alternate intervals for variation requests. PHMSA (and States where pipelines are under State jurisdiction) reviews the documentation to ensure sufficient justification has been provided for the proposed interval. This approach has been adequate to cover situations in which longer intervals are needed.
Both PHMSA and the U.S. General Accountability Office have testified that assessment intervals for natural gas transmission pipelines should be established based on technical data, risk factors, and engineering analyses. However, making those changes to the gas IM regulations in this action is outside the scope of the NPRM.
In the NPRM, PHMSA requested submission of data and comments on operators' experience with identification of defect characteristics needing short-term (60 and 180-day) remediation. The NPRM allowed a longer period to submit these analyses, and API and AOPL responded to this request by submitting engineering analysis produced by Kiefner and Associates, Inc. on April 13, 2006. This analysis required detailed technical review.
PHMSA contracted with Oak Ridge National Laboratory to review the API/AOPL analysis. The Oak Ridge review documented which of the proposed changes in the API analysis could lead to improvements in safety and which could lead to reduced safety. It attempted neither to evaluate the significance to safety of each proposed change, nor to describe the composite impact on safety of the group of proposed changes. The Oak Ridge review did identify the technical factors that a comprehensive evaluation of the proposed changes should consider. PHMSA is currently evaluating operator treatment of many of these factors in ongoing IMP inspections.
DOT's Inspector General issued an audit in September 2006 addressing, among other issues, uncertainties in the characterization of defects using in-line inspection (ILI). Although uncertainties,
Both the hazardous liquid (§ 195.452(h)) and gas transmission (§ 192.933) pipeline IM remediation criteria require operators to reduce pressure or to shut down the pipeline until they can remediate all anomalous conditions. The IM regulations do not require notification when an operator reduces pressure unless the operator cannot meet its schedule for evaluating and remediating conditions and cannot provide safety through a temporary decrease in operating pressure. If a pressure reduction exceeds 365 days, a gas transmission pipeline operator must provide technical justification that the continued pressure reduction will not jeopardize the pipeline's integrity, and a hazardous liquid pipeline operator must take further remedial action to ensure the safety of the pipeline.
PHMSA proposed amending its regulations to require an operator of a gas transmission or hazardous liquid pipeline to notify PHMSA when it reduces pressure on an IM program segment (to remediate a defect), and to provide a justification for the pressure reduction. If a repair was not completed within 365 days, the operator would again be required to notify PHMSA and provide an explanation for the delay. PHMSA intended the proposed notification to provide better information on what causes schedule delays (permitting, scheduling, other); and where and under what circumstances PHMSA would be in a position to help streamline the permit process.
For gas transmission pipeline operators, PHMSA proposed repealing the requirement for notification of local pipeline safety authorities. PHMSA is not aware of any instance where an intrastate gas transmission pipeline is regulated by a local, rather than a State or Federal, authority.
Some commenters recommended a demonstration project and suggested PHMSA collect and review the proposed notification data over a two-year period before making a final determination on the need for continued notification. Commenters also suggested collecting the information through annual reporting for any case where operators could not meet the remediation schedule requirements of § 195.452(h).
Other commenters suggested pressure reduction notifications should apply where remediation requirements cannot be met due to circumstances beyond the operator's control, when events impact energy supply, or when the operator cannot meet the remediation time limits and the pressure reduction exceeds 365 days. Notifications in these situations would provide PHMSA with more information on conditions interfering with repair attempts and help PHMSA recognize patterns potentially affecting pipeline safety.
Commenters also requested PHMSA clarify that the notifications requested are for pressure reductions related to IM remediation and not for other situations, such as pressure reductions done as safety precautions.
In addition to the existing requirement, PHMSA has added a requirement for notification when a pressure reduction exceeds 365 days. PHMSA believes that notification of extended delay, with justification for the pressure reduction, will provide important information on conditions interfering with the operator's ability to complete defect remediation without placing an undue burden on the operator. This notification will enable PHMSA to intervene if necessary in order to facilitate needed repairs (e.g., by assisting in resolving permitting delays) and to evaluate the necessity for additional safety measures until remediation can be completed.
PHMSA expects that greater understanding of the causes of repair delays will help identify where extra actions can help. We are particularly interested in whether any delays are due to permitting problems. We also agree that periodic information collection, as part of the annual report, would reduce the paperwork burden without compromising safety. In the future, PHMSA will consider revising requirements for annual reports to include the number of times repairs required by IM regulations are delayed, beyond required repair times, because of permitting issues.
PHMSA has clarified that the notification requirements apply to certain pressure reductions made for purposes of IM remediation requirements. We have also modified the wording in §§ 192.933(c) and 195.452(h)(3) to make it clearer and consistent with wording in the IM notification requirements. There is no change in the requirement. With the revised wording, this section will now require an operator to explain why it cannot meet its schedule for evaluation and remediation of a condition and that the changed schedule will not jeopardize public safety (gas transmission) or public safety or environmental protection (hazardous liquid).
We received favorable comments on the proposal to eliminate the notification provisions for local pipeline safety authorities. Accordingly, we are
Section 195.452(h)(4) requires a hazardous liquid pipeline operator to calculate a temporary reduction in operating pressure using the formula in section 451.7 of ASME/ANSI B 31.4 when making an immediate repair. The requirement is to ensure an extra safety margin. However, this formula only applies to metal loss anomalies, not to all immediate repair conditions, and can result in a calculated pressure higher than the original operating pressure.
PHMSA proposed revising the provision by allowing hazardous liquid pipeline operators to use the ASME/ANSI B 31.4 formula, if applicable. If not applicable to the anomaly, or if the formula results in a calculated pressure higher than the original operating pressure, operators could use an alternative acceptable method to calculate pressure reductions.
The amendments adopted in this final rule have been reviewed and approved by both of our pipeline safety standards advisory committees, the Technical Pipeline Safety Standards Committee, and the Technical Hazardous Liquid Pipeline Safety Standards Committee. On June 28, 2006, PHMSA held a joint meeting of the Committees and two concurrent public workshops in Alexandria, VA. PHMSA presented the proposed changes to the committees for a vote. Following a brief discussion, the committee members unanimously carried a motion to accept the rule changes.
Anyone can search the electronic form of all comments received in response to any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). DOT's complete Privacy Act Statement was published in the
This final rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 (58 FR 51735; Oct. 4, 1993) or the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034; Feb. 26, 1979). A final regulatory evaluation is in the docket for this rulemaking.
The rule's provision concerning scheduling continued integrity assessments will yield benefits in the form of additional flexibility, and will have no cost effects. PHMSA believes the change to the notification requirement for pressure reductions exceeding 365 days will add minimally to the annual average cost to each operator, and to the number of operators affected. PHMSA expects the benefits will offset costs. Together, PHMSA expects these changes to IM regulations for hazardous liquid and gas transmission pipelines to create positive net benefits.
The Regulatory Flexibility Act (5 U.S.C. 601-611) requires agencies to review each new regulation and assess its impact on small businesses and other small entities to determine whether the final rule will have a significant impact on a substantial number of small entities. This rule imposes minimal new costs of compliance on the regulated community. The requirements do not apply to a substantial number of small entities. The revisions to the IM rules will affect hazardous liquid pipeline operators and gas transmission pipeline operators. PHMSA expects notification costs per operator to be significantly less than $3.04 annually, a non-significant burden on any pipeline operator, large or small. The changes to add scheduling flexibility to the integrity reassessments will create positive benefits and impose minimal additional costs. The changed notification requirements for pressure reductions exceeding 365 days will also create benefits, and negligible added costs. Together, PHMSA expects these changes to the IM regulations for hazardous liquid and gas transmission pipelines to create positive net benefits to the affected industry. Based on the cost benefit analysis the regulatory changes will not have a significant impact on a substantial number of small entities.
PHMSA developed this final rule in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that the potential impact of rules on small entities are properly considered. The Small Business Administration's small business definition is either $6 million in revenue (for natural gas pipelines under North American Industry Classification System (NAICS) 486210) or 1,500 employees (for crude oil and refined petroleum product pipelines under NAICS 486110 and 486910). Based on a review of data collected from the hazardous liquid pipeline industry, PHMSA estimates there are 10-20 small entities. PHMSA does not have an estimate of the number of gas transmission pipeline operators that meet the small business definition. Information collection determining pipeline operator staffing or revenue would require separate Office of Management and Budget (OMB) approval. However, as stated above, compliance with this regulation requires a trivial expenditure and imposes a minimal burden on small businesses.
I certify this final rule would not have a significant economic impact on a substantial number of small entities. The costs associated with this final rule will be offset with benefits such as increased flexibility for operators. The changed notification requirements for pressure reductions exceeding 365 days would create benefits and negligible added costs.
PHMSA analyzed this rule under the principles and criteria contained in Executive Order 13132 (Federalism). None of the changes in this final rule: (1) Have a substantial direct effect on States, relationships between the Federal government and the States, or on distribution of power and responsibilities among various levels of government; (2) imposes substantial direct compliance costs on States and local governments; or (3) preempts State law. Therefore, the consultation and funding requirements of Executive
PHMSA analyzed this rule under the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”) (63 FR 27655; November 9, 2000). Because this rule will not significantly or uniquely affect the communities of the Indian tribal governments, the funding and consultation requirements of this Executive Order do not apply.
This rule is not a “significant energy action” under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). It is not likely to have a significant adverse effect on energy supply, distribution, or use. This rule does not change the pressure reduction restrictions in the IM regulations. It only changes the notification requirements associated with those pressure reductions.
This rule does not impose unfunded mandates under the 1995 Unfunded Mandates Reform Act. It does not result in costs of $100 million or more to either State, local, or tribal governments, in aggregate, or to the private sector, and is the least burdensome alternative for achieving the objectives.
PHMSA evaluated the rule, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), and believes the rule will impose no significant paperwork burden on industry or individual operators. Industry commenters to the rule supported the revised notification requirements. As required, PHMSA presented a separate paperwork analysis to OMB for review and will file a copy of the analysis in the docket.
This rule imposes minimal information collection requirements. Based on information currently available to PHMSA, 26 operators filed 74 pressure reduction notifications over the last three years. The revised notification requirements will likely result in minimal additional paperwork burden. The estimated average time to prepare a notification request is 30 minutes. PHMSA does not know how many more notifications will result from the requirement but estimates, on average, less than $3.04 per affected operator per year. Therefore, there should be no significant cost or hourly burden on individual operators or the industry because of the notification requirement in this rule.
PHMSA analyzed this rule under section 102(2)(c) of the National Environmental Policy Act (42 U.S.C. 4332), the Council on Environmental Quality regulations (40 CFR 1500-1508), and DOT Order 5610.1C, and determined this action will not significantly affect the quality of the human environment. PHMSA did not receive comments on the environmental assessment prepared on the proposed rule. The final environmental assessment is in the Docket.
Pipeline safety, Reporting and recordkeeping requirements.
Pipeline safety, Reporting and recordkeeping requirements.
49 U.S.C. 5103, 60102, 60104, 60108, 60109, 60110, 60113, and 60118; and 49 CFR 1.53.
(a)
(1)
(2)
(c)
49 U.S.C. 5103, 60102, 60104, 60108, 60109, 60118; and 49 CFR 1.53.
(h) * * * (1)
(i)
(ii)
(3)
(4)
(3)
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the gypsy moth regulations by making editorial and nonsubstantive changes to several terms and providing necessary updates throughout the regulations. These actions would improve the clarity and consistency of the regulations while continuing to provide protection against the artificial spread of gypsy moth into noninfested areas of the United States.
We will consider all comments that we receive on or before September 17, 2007.
You may submit comments by either of the following methods:
•
•
Mr. Weyman Fussell, Program Manager, Emergency and Domestic Programs, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1236; (301) 734-5705.
The regulations in “Subpart-Gypsy Moth” (7 CFR 301.45 through 301.45-12, referred to below as the regulations) restrict the interstate movement of regulated articles from generally infested areas of States quarantined for gypsy moth in order to prevent the artificial spread of gypsy moth into noninfested areas of the United States.
The gypsy moth,
The first major outbreak of gypsy moth in the United States occurred in Massachusetts in 1889. Since then, the gypsy moth has infested 19 States and the District of Columbia and has defoliated thousands of acres of hardwood forests across the northeastern United States. The infestation continues to move south and west despite ongoing eradication and control efforts.
We are proposing to amend the regulations by making editorial and nonsubstantive changes to several terms and providing necessary updates throughout the regulations. These actions would improve the clarity and consistency of the regulations, while continuing to provide protection against the spread of gypsy moth into noninfested areas of the United States.
Section 301.45-1 defines certain terms used in the regulations. We are proposing to make nonsubstantive changes to several of these definitions to improve the clarity and consistency of the regulations. These proposed change are described below.
The current definition of
The current definition of
The definition of
We are also proposing to revise footnote 1 in the definition of
Similarly, footnote 2 in the definition of
We are also proposing to add a definition for
Section 301.45-4, paragraph (b), specifies that any regulated article moved interstate from a noninfested area through a generally infested area during certain months of the year “must be in an enclosed vehicle, or completely enclosed by a covering adequate to prevent access by gypsy moths, such as canvas, plastic, or closely woven cloth.” We are proposing to revise this paragraph by removing the references to specific types of enclosures and coverings, and put in its place a more general requirement that the regulated articles “must be safeguarded by a covering adequate to prevent access by any gypsy moth life stages.” We believe that moving to a more performance-based standard would offer more flexibility in meeting the requirements for the interstate movement of regulated articles, while continuing to provide protection against the artificial spread of gypsy moth into noninfested areas of the United States.
Section 301.45-12 pertains to the disqualification of qualified certified applicators. In the regulations, a qualified certified applicator may be disqualified if he or she is not certified by a State and/or Federal government to use specific pesticides, fails to comply with the provisions in the regulations, or fails to attend and complete a recertification workshop approved by the Administrator on the identification and treatment of life stages of gypsy moth on outdoor household articles and mobile homes. We are proposing to amend § 301.45-12, paragraph (a)(1), by removing the references to specific pesticides. What would remain would be the simple requirement that a person be certified as a qualified certified applicator under the Federal Insecticide, Fungicide, and Rodenticide Act in a category allowing the use of restricted use pesticides. That basic requirement renders the citing of specific pesticides by name unnecessary. For consistency, we are also proposing to amend paragraph (a)(2) of § 301.45-12 by adding the requirement that qualified certified applicators must also comply “* * * with stipulations agreed on in the compliance agreement between the certified applicator and the Administrator.” We are also proposing to remove paragraph (a)(3) of this section, which states that qualified certified applicators may be disqualified from issuing certificates if they fail to attend and complete a recertification workshop approved by the Administrator on the identification and treatment of life stages of gypsy moth on outdoor household articles and mobile homes. We would remove this paragraph in its entirety because we have not offered, or approved, the referenced recertification workshops for several years.
The regulations in § 301.45-2(a)(1) refer to the Integrated Pest Management (IPM) alternative of the March 1985 Final Environmental Impact Statement (FEIS) on Gypsy Moth Suppression and Eradication Projects. The March 1985 FEIS has been superseded by an updated FEIS that was filed February 15, 1996. In the 1996 FEIS, the IPM alternative was replaced by the Eradication, Suppression, and Slow the Spread alternative. We would update this paragraph so that it refers to the most recent FEIS and alternative.
Section 301.45-7 addresses the assembly and inspection of regulated articles and outdoor household articles prior to interstate movement. The section refers to inspectors and qualified certified applicators examining regulated articles. However, § 301.45-5(e) authorizes an individual to self-certify outdoor household articles for interstate movement if that person has inspected the outdoor household article and has found it to be free of any life stage of gypsy moth. To ensure that § 301.45-7 includes references to all the possible certification options, we would amend the section to included a reference to the self-certification provisions of § 301.45-5(e).
Finally, because the APHIS “officer in charge” position title has been changed to “State Plant Health Director,” we would update § 301.45-8 to reflect the position name change.
This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
We are proposing to amend the gypsy moth regulations by making editorial and nonsubstantive changes to several terms and providing necessary updates throughout the regulations. These actions would improve the clarity and consistency of the regulations, while continuing to provide protection against the artificial spread of gypsy moth into noninfested areas of the United States.
The gypsy moth is a pest of concern for the U.S. forest industry. Defoliation of trees by gypsy moths often results in the death of the trees, which leads to economic loss, changes in ecosystems and wildlife habitat, and disturbed
The Small Business Administration (SBA) has established size standards based on the North American Industry Classification System (NAICS) to determine and to classify which economic entities can be considered small entities. Entities potentially affected by our gypsy moth regulations include sawmills, pulp mills, nursery and tree production farms and nurseries and garden centers that are involved in the interstate movement of Christmas trees, nursery products, household products, and bark and bark products from gypsy moth generally infested areas. The effects on all these entities of the proposed updates to the regulations would be positive.
The SBA classifies nursery and tree production (floriculture, nursery, Christmas trees, etc.) farms (NAICS code 111421) small if their annual receipts are not more than $750,000.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.
Accordingly, we propose to amend 7 CFR part 301 as follows:
1. The authority citation for part 301 would continue to read as follows:
7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421 note).
2. Section 301.45-1 would be amended as follows:
a. By adding a definition of
b. In the definition of
c. In the definition of
d. In the definition of
Qualified certified applicator. * * *
3. In § 301.45-2, paragraph (a)(1) would be revised to read as follows:
(a) * * *
(1) The area is subject to a gypsy moth eradication program conducted by the Federal government or a State government in accordance with the Eradication, Suppression, and Slow the Spread alternative of the Final Environmental Impact Statement (FEIS) on Gypsy Moth Suppression and Eradication Projects that was filed with the United States Environmental Protection Agency on January 16, 1996; and,
4. In § 301.45-4, paragraph (b) would be amended by revising the last sentence to read as follows:
(b) * * * The articles must be safeguarded by a covering adequate to prevent access by any gypsy moth life stages.
5. In § 301.45-7, a new sentence would be added after the last sentence to read as follows:
* * * An owner who wants to move outdoor household articles interstate may self-inspect the articles and issue an OHA document in accordance with § 301.45-5(e).
6. In § 301.45-8, paragraph (c) would be amended by removing the words “officer in charge” and adding the words “State Plant Health Director” in their place.
7. Section 301.45-12 would be amended as follows:
a. By revising paragraph (a)(1) to read as set forth below.
b. In paragraph (a)(2), by removing the word “; or,” from the end of the sentence and adding the words “or with stipulations agreed on in the compliance agreement between the certified applicator and the Administrator.” in its place.
c. By removing paragraph (a)(3).
(a) * * *
(1) Such person is not certified by a State and/or the Federal government as a commercial certified applicator under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136i) in a category allowing the application of restricted use pesticides.
Animal and Plant Health Inspection Service, USDA.
Notice of availability of draft environmental impact statement and request for comments.
We are evaluating our regulatory program to determine whether we should revise our regulations regarding the importation, interstate movement, and environmental release of genetically engineered organisms. We are seeking public comment on the draft environmental impact statement (DEIS) we have prepared relative to the regulatory revisions we are considering. The DEIS evaluates the alternatives we have identified in terms of their potential effects on the human environment compared to the effects of our current regulatory program. We believe our ongoing evaluation of these alternatives would benefit from the submission of additional views and data from the public, and we are especially interested in receiving comments on the subset of DEIS alternatives described in this notice.
We will consider all comments that we receive on or before September 17, 2007.
You may submit comments addressing the draft environmental impact statement by either of the following methods:
•
•
Issues in the DEIS are organized using 10 numbered issue areas developed through the scoping process. When possible, please relate each point in your comment to one of these 10 issue areas.
Dr. Michael Wach, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 734-0485.
Under the Plant Protection Act (PPA) (7 U.S.C. 7701
Under that authority, APHIS administers regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests” (referred to below as the regulations). The regulations govern the introduction (importation, interstate movement, or release into the environment) of any organism or product altered or produced through genetic engineering that is a plant pest or that there is reason to believe may be a plant pest, or any product that contains such an organism that is unclassified and/or whose classification is unknown. The regulations refer to such genetically engineered organisms as “regulated articles.”
Current APHIS regulations for genetically engineered organisms are based on authority in the PPA to regulate the introduction of organisms that are plant pests or for which there is reason to believe may be plant pests. Applicants must submit required information for review by APHIS scientists who evaluate the potential risks posed by the introduction and the procedures that the applicant will use to minimize those risks. Depending on the nature of the genetically engineered organism, an applicant applies for either a permit or a notification. APHIS authorizes introductions after considering the organism, the nature of the genetic engineering, and the ways in which the genetically engineered organism is likely to interact with the environment.
A notification is a more streamlined authorization process that is used only for plants with traits considered to be low risk. To qualify for a notification, the genetically engineered plant must meet strict eligibility requirements to ensure that it poses a minimal plant pest risk. The genetically engineered plant must also be grown under conditions designed to meet performance standards ensuring confinement of the regulated material. The remaining organisms—including plants that are genetically engineered to produce pharmaceutical or industrial compounds—are subject to the permitting process.
The permit process is designed to ensure the safe introduction of any genetically engineered organism over which APHIS has authority. All required information submitted in a permit application is reviewed by APHIS scientists. Permits will prescribe confinement conditions and standard operating procedures tailored on a case-by-case basis to maintain confinement of the genetically engineered organism throughout the course of the introduction. APHIS requires that all plants genetically engineered to produce pharmaceutical or industrial compounds be grown under extremely strict management protocols. These plants are required to be grown in a way that maintains confinement of the plant to the release area, with additional precautions taken to prevent the escape of pollen, seeds, or plant parts from the field test site.
After a genetically engineered organism has been field tested extensively and the developer demonstrates that the organism does not pose a plant pest risk, the developer may request the deregulation of the organism by filing a petition for a “determination of nonregulated status.” After the applicant submits the required data and it has been carefully evaluated, APHIS prepares an environmental assessment or, if warranted, an environmental impact statement (EIS) to analyze the potential impacts the plant may have on the human environment and seeks public comment. APHIS approves a petition only when it reaches the conclusion that the genetically engineered organism does not pose a plant pest risk. Once APHIS has deregulated an organism, it may be freely moved and planted without the requirement of permits or other regulatory oversight by APHIS. Deregulated status may be extended to genetically engineered organisms which APHIS determines are similar to previously deregulated organisms. Conversely, given new information, APHIS may determine that a previously deregulated genetically engineered organism poses a plant pest risk and should, therefore, be brought back under Agency oversight.
APHIS is evaluating its regulatory program to determine if there is a need to revise its regulations in light of our current knowledge and experience and advances in science and technology. It is important that any regulations we may develop effectively carry out the purposes of the PPA, ensure environmental protection, provide regulatory processes that are transparent to stakeholders and the public, efficiently use Agency resources, minimize regulatory burdens, adhere to the principles of E.O. 12866, and are consistent with our international agreements, such as the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures.
We have prepared a draft EIS (DEIS) evaluating all of the regulatory alternatives we are currently considering for a future proposed rule to revise our biotechnology regulations. A copy of the DEIS may be obtained through the Federal eRulemaking Portal as described under
While we invite comments on all alternatives in the DEIS, this notice identifies specific areas where we are particularly interested in further public input and data that will assist us in evaluating and refining these regulatory alternatives. We are requesting data on specific topics for some of the alternatives listed below, and we also welcome comments on how each alternative would affect areas such as the overall effectiveness of our biotechnology program, its operational efficiency, industry compliance, and other issues that would be associated with the development, adoption, and implementation of an alternative.
The DEIS alternatives highlighted in this notice are discussed in depth in the DEIS, and readers should refer to that document in preparing comments in response to this notice. The issues from the DEIS for which we are especially seeking additional public comment are listed below, with some notes on the particular types of data or views we believe would be most helpful.
Given the rapid advances in biotechnology, the present scope of the regulations may not be of sufficient breadth to cover the full range of genetically engineered organisms and
Based on our evaluation of several alternatives in the DEIS, APHIS has made a preliminary determination that regulatory oversight should be enhanced by expanding the scope of regulations to utilize the range of authorities in the PPA, not just the plant pest provision, to include the authority over noxious weeds and biological control organisms. The noxious weed provision would allow oversight of genetically engineered plants by expanding the scope of what is regulated and by allowing a broader consideration of potential risks, including risks to public health. This would allow APHIS to consider what is known about the potential hazards of the introduced proteins and other substances to humans or animals, if inadvertently consumed or released. This information could, in turn, be used to develop appropriate regulatory safeguards in connection with introductions of genetically engineered organisms.
APHIS has also made a preliminary determination that it would be beneficial to regulate nonviable plant material originating from field tests when there is reason to believe, based on scientific review, that such debris might be harmful to the environment if it were allowed to remain. Such an approach would allow the Agency to maintain regulatory control if nonviable material poses a hazard (e.g., potential food contamination).
APHIS is interested in receiving comment on these preliminary determinations and the other alternatives discussed in the DEIS. In particular, APHIS requests comment on whether APHIS should broaden the scope of its regulations to reflect its authority over noxious weeds and biological control organisms. If APHIS does propose to broaden its regulatory scope to include consideration of noxious weed risk, how should oversight and evaluation of genetically engineered plants differ from what is done under the current plant pest risk-oriented regulations? If APHIS does propose to establish regulations regarding genetically engineered biological control organisms, on what risks should the regulations be focused? Should APHIS tailor the scope of such regulations to focus on specific risks? If so, how?
APHIS has always used a risk-based approach in regulating genetically engineered organisms. The Agency has concluded that there is public interest in biotechnology regulation and how APHIS regulates various types of organisms based on to risk and Agency familiarity with a given organism. In addition, there is a trend toward more highly varied organisms and the regulatory process may need greater flexibility and rigor to more appropriately regulate the increasing variety of organisms. Accordingly, the Agency is considering revising the regulations to make the Agency's use of risk-based categories—where genetically engineered organisms are classified according to risk and familiarity so that oversight and confinement vary by category—more refined, more explicit and more transparent to the industry and the public. Redefined risk categories, we believe, can provide added flexibility, improving the Agency's ability to regulate diverse organisms and new types of traits, and provide better clarity to the regulated community and to the public, which may in turn promote greater confidence in the regulatory system.
Accordingly, APHIS' has made a preliminary determination to adopt an expanded tiered permitting system based on potential environmental risk and Agency familiarity with the organism. A detailed example of such a system is described in this DEIS. The goals of such a tiered system would be to increase transparency with respect to how the Agency regulates various types of genetically engineered organisms and to increase regulatory flexibility such that the Agency could move genetically engineered organisms among the tiers as new information becomes available. For well characterized low-risk genetically engineered organisms, APHIS would continue to use a process similar to the current notification process found in 7 CFR 340.3; however, the term notification would no longer be used. Such a process would become the lowest risk “permit.” This change would, we believe, increase transparency and avoid any potential confusion about the status of these organisms as regulated articles.
APHIS is interested in receiving comment on this alternative, and, in particular, requests comment on the criteria that should be used to establish risk-based categories. What characteristics of genetically engineered plants should be considered in establishing such categories? How many categories should there be? Which types or species of plants should be assigned to which categories? What specific regulatory requirements or restrictions would be appropriate for each such category and why would they be appropriate?
Once an article has been deregulated, APHIS does not place any restrictions or requirements on its use. Restrictions have not been deemed necessary because BRS risk assessments have concluded that the genetically engineered plants APHIS has deregulated pose no plant pest risk. APHIS recognizes, however, that future development and commercialization of plants with less familiar traits may pose new challenges for the Agency because even a thorough and comprehensive assessment may not resolve all unknowns regarding an article proposed for deregulation. These unresolved issues may justify continued scrutiny and data collection or use restrictions, but be of such a minor nature and minimal risk or concern that allowing planting of the article without a permit would be appropriate. APHIS is exploring the concept of a system that could give increased flexibility for handling special cases involving less familiar traits by creating provisions that allow for imposition of conditions for unconfined release. This could facilitate commercialization, while requiring appropriate restrictions or monitoring.
APHIS has made a preliminary determination to propose a new feature for its regulatory system whereby the Agency would retain oversight in specific cases as appropriate. We envision, of course, that the vast
We are therefore interested in receiving comments on how to manage genetically engineered organisms that present only minor unresolved risks that can be mitigated effectively, and on what factors should be considered in establishing appropriate mitigations. APHIS is also considering the use of new terminology to describe both deregulation as it currently exists and the more limited deregulation where some oversight would be retained. One possibility is to use the term “approval” to indicate that specific genetically engineered organisms are “unconditionally approved.” This would be synonymous with full deregulation under our current regulations. Other genetically engineered organisms could be “approved with conditions” but would remain subject to continuing regulatory oversight in some respects. Alternatively, APHIS could retain the term “deregulation” and use “deregulation in part” or another term to refer to situations where genetically engineered organisms remain subject to regulatory oversight in some respects. We are interested in receiving comment on this potential change in terminology.
Genetic engineering technology has advanced to the point where organisms can be developed that produce novel proteins and other substances with biological activity or industrial utility. Because the gene products made by such pharmaceutical and industrial compound producing plants may pose hazards not associated with proteins and other substances commonly found in the food supply, it is particularly important to ensure effective confinement measures for these plants. At the same time, however, the confinement measures prescribed for plants producing pharmaceutical and industrial compounds would be based on risk, not on the type of plant alone.
The Agency has considered various alternatives with respect to the regulation of genetically engineered plants producing pharmaceutical compounds, including whether food crops should be used and whether they should be allowable for open air introductions. We have made a preliminary determination that under stringent conditions and with rigorous oversight, including due consideration of substantive food safety issues, food crops can be safely used for production of these compounds.
In connection with this preliminary determination, the Agency seeks input on the need for and development of new or additional regulatory mechanisms to ensure that genetically engineered organisms producing pharmaceutical or industrial compounds are subject to requirements and oversight commensurate with the potential risks. We are also interested in comments regarding the biological characteristics that the Agency should consider in imposing safeguards. What should be done to ensure that such crops are commercialized under appropriate safeguards?
For organisms that might be commercialized but that do not meet the criteria for deregulation, APHIS is considering whether a new type of permitting system would be more appropriate in terms of efficiency and effectiveness than the current system. In addition, there is much public and State interest in these types of plantings and a new mechanism may increase transparency and allow for greater State involvement.
Based on considerations more fully described in the DEIS, APHIS has made a preliminary determination to create a multi-year permit for genetically engineered organisms, with stringent oversight, in cases where developers are not interested or would not qualify for deregulation but plan to produce under permit. This would cover situations where producers are able to commercialize with relatively small plantings (e.g., industrial and pharmaceutical plants). Regulatory rigor would remain high to protect the environment, but efficiency and transparency would increase. The State partnership would be strengthened under this new system. The system would rely on multiyear permits and intensive reviews of standard operating procedures (SOPs), as well as audits and inspections. Though the new system under consideration could be used for pharmaceutical and industrial plants, the Agency might also find it appropriate for other types of genetically engineered plants.
We are seeking comments on such a system and are particularly interested in comments regarding new or additional regulatory mechanisms to ensure that genetically engineered organisms produced under multi-year permits would be subject to effective requirements and oversight commensurate with the potential risks.
As with traditional plant breeding, large scale annual field testing of genetically engineered plants that have not completed all applicable reviews may result in materials from these trials occasionally being detected at low levels in commercial commodities and seeds. Current regulations do not expressly allow for such occurrences, though experience continues to show that such occurrences can occur. In a notice published in the
Based on our evaluation and assessment of alternatives in the DEIS, APHIS has made a preliminary determination to establish in regulations criteria under which the occurrence of regulated articles would be allowable, that is, considered not actionable by APHIS. The occasional detection of regulated material in commercial crops as seeds can occur as a result of field tests conducted under confinement conditions appropriate for notifications. This is due to cross-pollination and also commingling from shared equipment and facilities. In addition, such incidents will inevitably result from the importation of seeds and commodities from countries where such material has been fully approved but has not completed all U.S. reviews. In the majority of cases, this low-level occurrence of regulated articles will be of minimal risk, and this fact should be accounted for in any regulatory scheme since oversight should be commensurate with risk.
APHIS is interested in receiving comment on this alternative, but in particular, requests comment on whether APHIS should establish a new
APHIS anticipates an increasing number of requests to import regulated genetically engineered organisms that are not intended for propagation, such as organisms that are intended for direct use as food, feed, or for processing. The current system of permits and notifications was not designed to handle such requests on a case-by-case basis. However, in anticipation of this increase, APHIS' goal is to design an efficient system that protects U.S. agriculture and human health without erecting unnecessary trade barriers. To that end, the Agency has evaluated several different alternatives.
Based on considerations more fully described in the DEIS, APHIS has made a preliminary determination to have a new regulatory mechanism to allow for imports of commodities for nonpropagative use, that is, for food, feed, or processing, in cases where these commodities might not have been deregulated in the United States. With this approach, we could establish criteria to ensure safety and allow for additional environmental review when appropriate. Allowing such imports without prior deregulation would not obviate the need to comply with requirements at other agencies, such as FDA and EPA.
APHIS is interested in receiving comment on this alternative and, more specifically, comments as to the commodity characteristics and other data that APHIS should consider when determining the appropriate safeguards for commodities coming in for processing or to be used directly as food or feed.
Currently, genetically engineered
Are there other genetically engineered organisms that should also be exempt from regulation in the same or similar manner as genetically engineered
As noted above, we are interested in receiving comments on all of the issues presented in the DEIS and particularly on the issues and alternatives outlined above.
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend our Agricultural Quarantine and Inspection Services user fee regulations to update an address that appears in several places. We are also proposing to make several nonsubstantive changes to the Veterinary Services user fees regulations to correct errors and to clarify the services covered by certain existing user fees. These proposed changes, which do not affect any existing fees, are necessary to ensure that the user fee regulations are up-to-date and ensure their clarity.
We will consider all comments that we receive on or before September 17, 2007.
You may submit comments by either of the following methods:
•
•
Mrs. Kris Caraher, User Fees Section Head, Financial Services Branch, Financial Management Division, MRBPS, APHIS, 4700 River Road, Unit 54, Riverdale, MD 20737-1232; (301) 734-5901.
The regulations in 7 CFR, chapter III, and 9 CFR, chapter I, subchapter D, require inspection, laboratory testing, certification, or quarantine of certain plants, plant products, animals, animal products, or other commodities intended for importation into, or exportation from, the United States.
Section 2509(a) of the Food, Agriculture, Conservation, and Trade Act of 1990 (21 U.S.C. 136a), referred to below as the FACT Act, authorizes the Secretary of Agriculture to collect user fees for agricultural quarantine and inspection (AQI) services. The FACT Act was amended on April 4, 1996, and May 13, 2002.
The user fees to reimburse the Animal and Plant Health Inspection Service (APHIS) for the costs of providing inspections for AQI services are contained in 7 CFR part 354. In this document, we propose to amend the AQI international services user fee regulations by correcting and updating the remittance addresses in § 354.3 to reflect the proper addresses for mailings. All current customers have already received notices regarding these changes; however, we need to correct the information that appears in the regulations.
The FACT Act also authorizes the Secretary of Agriculture to, among other things, prescribe and collect fees to reimburse the Secretary for the cost of carrying out the provisions of the Federal animal quarantine laws that relate to the importation, entry, and exportation of animals, articles, or means of conveyance. The Secretary is also authorized to prescribe and collect fees to recover the costs of carrying out certain veterinary diagnostics services.
The user fee regulations in 9 CFR part 130 (referred to below as the regulations) prescribe user fees that APHIS collects for various services that we provide. The regulations currently include fees for: (1) Endorsing export certificates for animals; (2) providing quarantine services within the United States for imported animals; (3) providing certain inspection and supervision services within the United States for animals intended for export; (4) conducting certain veterinary inspections outside the United States; and (5) conducting certain veterinary diagnostics services.
We would make several nonsubstantive changes to the regulations. These proposed changes are explained below.
In § 130.4,
In § 130.7,
In § 130.11,
In § 130.20,
We would also amend § 130.30, paragraph (a)(4), which applies hourly rate fees to services provided for imported birds or ratites that are not subject to quarantine, by specifically mentioning that these hourly rate fees cover services such as monitoring birds, including but not limited to pet birds, between flights. We provide this service frequently and customers regularly need clarification as to which user fees apply. We currently charge the hourly rate to monitor birds between flights, so there will not be any change in fees.
We would also amend § 130.30, paragraph (a), by specifically identifying additional services for which APHIS charges an hourly rate. These services are currently covered under the general catch-all text of paragraph (a)(13)—i.e., under “other import-or export-related services for which there is no flat rate user fee specified elsewhere in this part”—but we provide these services frequently and customers regularly request clarification as to which user fees apply.
The specific services we would add are:
• Import or entry services for feeder animals including, but not limited to, feeder goats and feeder bison not covered by a flat rate user fee in § 130.7;
• Bird banding for identification;
• Inspection and approval of pet food facilities, including laboratories that perform pet food testing;
• Services provided at animal auctions, such as signing export health certificates; and
• Various facility inspections, including, but not limited to, fertilizer plants that utilize poultry waste, rendering plants, and potential embarkation facilities.
Finally, we would clarify that user fees for services under part 130 (specifically, user fees in §§ 130.2 through 130.8) apply whenever APHIS provides the services, be it through APHIS employees, contract veterinarians, or other personnel. We would do this by adding language to the regulations stating that user fees are payable for any service rendered by an APHIS representative, which is defined in § 130.1 as: “An individual, including but not limited to, an animal health technician or veterinarian, authorized by the Administrator to perform services for which the user fees in this part are charged.” This change is necessary to clarify for our customers that when APHIS provides services through an APHIS representative, such as contract veterinarians or other personnel, user fees still apply.
The regulations in 9 CFR part 156 govern the inspection and certification of animal byproducts. Within these regulations, there are provisions regarding cooperative agreements between the Department and some other Federal or State agency, board of trade, chamber of commerce, or other agency, association, organization, person, or corporation as provided for in section 205 of the Agricultural Marketing Act of 1946 (7 U.S.C. 1624) to provide services under part 156.
In this document, we are proposing to remove those references to cooperative agreements because the export product endorsement and inspection services formerly covered by those agreements are now covered by user fees in 9 CFR part 130.
This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
This proposed rule would amend our AQI user fee regulations by updating an address that appears in several places. We would also make several nonsubstantive changes to the Veterinary Services user fees regulations to correct errors and to clarify existing user fee services. The proposed changes to the regulations are administrative in nature and will not result in any new fees being charged or any additional entities becoming subject to user fees.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are in conflict with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Animal diseases, Exports, Government employees, Imports, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Travel and transportation expenses.
Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements, Tests.
Exports, Livestock, Poultry and poultry products, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 7 CFR part 354 and 9 CFR parts 130 and 156 as follows:
1. The authority citation for part 354 continues to read as follows:
7 U.S.C. 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 49 U.S.C. 80503; 7 CFR 2.22, 2.80, and 371.3.
2. In § 354.3, paragraphs (d)(4) introductory text, (d)(5), (d)(6), (e)(3)(i), (e)(3)(ii) introductory text, (e)(4), (f)(5)(i), (f)(5)(ii), (f)(5)(iii) introductory text, (f)(6), and (f)(7), remove the words “Box 952181, St. Louis, MO 63195-2181” and add the words “Box 979044, St. Louis, MO 63197-9000” in their place.
3. The authority citation for part 130 continues to read as follows:
5 U.S.C. 5542; 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, and 371.4.
4. In § 130.2, paragraph (a), the first sentence is amended by adding the words “for any service rendered by an APHIS representative” after the word “fees”.
5. In § 130.3, paragraph (c)(3) is amended by removing the words “for those services” and adding the words “for any service rendered by an APHIS representative” in their place.
6. In § 130.4, the first sentence of the section is amended by adding the words “for any service rendered by an APHIS representative” after the word “fees”, and the sentence “These fees are nonrefundable.” is added after the second sentence.
7. In § 130.5, paragraph (a), the first sentence is amended by adding the words “for any service rendered by an APHIS representative” after the word “fees”.
8. In § 130.6, paragraph (a), the first sentence is amended by adding the words “for any service rendered by an APHIS representative” after the word “fees”.
9. Section 130.7 is amended as follows:
a. In paragraph (a), first sentence, by adding the words “for any service rendered by an APHIS representative” after the word “fees”.
b. By adding paragraph (b) to read as set forth below.
(b) If a service must be conducted on a Sunday or holiday or at any other time outside the normal tour of duty of the employee, then reimbursable overtime, as provided for in part 97 of this chapter, must be paid for each service, in addition to the user fee listed in this section.
10. In § 130.8, paragraph (a), the first sentence is amended by adding the words “for any service rendered by an APHIS representative” after the word “fees”.
11. In § 130.11, paragraph (a) is amended by adding the sentence “These user fees do not apply to inspection activities covered in § 130.30(a)(2).” after the last sentence.
12. In § 130.20, paragraph (b)(1) is amended by adding footnote 1 in the table heading and by revising in the table the entry for “Nonslaughter horses to Canada” to read as follows:
(b)(1) * * *
13. Section 130.30 is amended as follows:
a. In the introductory text of paragraph (a), by removing the words “through (a)(13)” and adding the words “through (a)(18)” in their place.
b. Paragraph (a)(2) is revised.
c. In paragraph (a)(4), by adding the words “, such as monitoring birds-including but not limited to pet birds-between flights” after the word “quarantine”.
d. Paragraph (a)(13) is redesignated as paragraph (a)(18), and new paragraphs (a)(13), (a)(14), (a)(15), (a)(16), and (a)(17) are added to read as set forth below.
(a) * * *
(2) Conducting inspections, including inspections of laboratories and facilities (such as biosecurity level two facilities), required either to obtain import permits for animal products, aquaculture products, or organisms or vectors, or to maintain compliance with import permits. This hourly rate does not apply to inspection activities covered in § 130.11.
(13) Import or entry services for feeder animals including, but not limited to, feeder goats and feeder bison not covered by a flat rate user fee in § 130.7.
(14) Export-related bird banding for identification.
(15) Export-related inspection and approval of pet food facilities, including laboratories that perform pet food testing.
(16) Export-related services provided at animal auctions.
(17) Various export-related facility inspections, including, but not limited to, fertilizer plants that utilize poultry waste, rendering plants, and potential embarkation facilities.
14. The authority citation for part 156 continues to read as follows:
7 U.S.C. 1622 and 1624; 21 U.S.C. 136a; 7 CFR 2.22, 2.80, and 371.4.
15. Section 156.2 is amended as follows:
a. By removing the definition of
b. In the definition of
16. Section 156.4 is amended by removing the words “under a cooperative agreement”.
17. Section 156.5 is amended by removing the words “service is to be furnished under a cooperative agreement;” and adding the words “the requirements of part 130 of this title are met;” in their place.
18. Section 156.7 is revised to read as follows:
User fees under part 130 of this chapter for service (including travel and other expenses incurred in connection with the furnishing of service) under this part shall be paid by the applicant. If required by the Administrator, the user fees under part 130 of this chapter shall be paid in advance. Since the user fees under part 130 of this chapter are for the purpose of reimbursing the Department for all costs incurred in connection with the furnishing of service under this part, the appropriate user fees under part 130 of this chapter to cover any such costs shall be paid even if service is withheld pursuant to § 156.8.
Rural Utilities Service, USDA.
Proposed rule.
The Rural Utilities Service, an agency delivering the United States Department of Agriculture's (USDA) Rural Development Programs, hereinafter referred to as Rural Development and/or Agency, proposes to revise the fiber optic cable specification used by borrowers, their consulting engineers, and cable manufacturers. This revision will bring the specification to meet current industries standards. Additional requirements have been included in the specification to meet the construction requirement of fiber-to-the-home construction.
Comments must be submitted on or by September 17, 2007.
Submit comments by either of the following methods:
Norberto Esteves, Chair, Technical Standards Committee “A” (Telecommunications), Advanced Services Division, USDA Rural Development Telecommunications Program, STOP 1550, Washington, DC 20250-1550, telephone number 202-720-0699, fax number 202-205-2924, e-mail
This rule is exempted from the Office of Management and Budget (OMB) review for purposes of Executive Order 12866 and, therefore, has not been reviewed by OMB.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. USDA Rural Development has determined that this proposed rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this proposed rule will be preempted; no retroactive effect will be given to the rule, and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeals procedures, if any are required, must be exhausted before an action against the Department or its agencies may be initiated.
USDA Rural Development has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601
The information collection and recordkeeping requirements contained in this proposed rule are cleared under control numbers 0572-0059 and 0572-0132 pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Under Executive Order 13132, this proposed rule does not have sufficient federalism implications requiring the preparation the preparation of a Federalism Assessment.
The program described by this proposed rule is listed in the Catalog of Federal Domestic Assistance Program under No. 10.851, Rural Telephone Loans and Loan Guarantees and No. 10.857, Rural Broadband Access Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, the United States Government Printing Office, Washington, DC 20402. Telephone: (202) 512-1800.
This proposed rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. See the final rule related notice titled “Department Programs and Activities Excluded from Executive Order 12372” (50 FR 47034), advising that USDA Rural Development Utilities Programs loans and loan guarantees are excluded from the scope of Executive Order 12372.
This proposed rule contains no Federal Mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. Chapter 25)) for State, local, and tribal governments or the private sector. Thus, this proposed rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.
The Agency has determined that this proposed rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321
This proposed rule revises the current requirements for fiber optic cables of 7 CFR 1755.900 codified in 1995. The proposed rule sets the minimum performance requirements based on current industry standards. This revision was initiated to resolve problems the rural telecom industry is experiencing with cables manufactured under the existing specification and reported by rural carriers and their consulting engineers. It addresses the buffer tube shrinkage caused by storage at low temperatures, which impairs fiber-to-the-home system performance. The proposed specification also sets new requirements for drop cables (cables with 12 or fewer fibers operating up to 100 meters (300 feet)).
Cables manufactured to this revised specification will have lower average bi-directional loss at fusion splices, about 0.1 decibels (dB) instead of the 0.2 dB currently required. For fiber-to-the-home applications the specification requires a maximum mid-span length of 4.9 meters (16 feet) or 3 meters (10 feet), as specified by the buyer, for cables used on mid-span applications with buffer tube storage. From a polarization mode dispersion standpoint, the maximum Statistical Parameter of Polarization Mode Dispersion (PMD
Broadband, Fiber optic cables, Loan programs—communications, Reporting and recordkeeping requirements, Rural areas, Telecommunications, Telephone.
For the reasons set out in the preamble, the Agency proposes to amend part 1755, chapter XVII of title 7 of the Code of Federal Regulations, as follows:
1. The authority citation for part 1755 continues to read as follows:
7 U.S.C. 901
2. The heading of part 1755 is revised to read as set out above.
3. Section 1755.900 is revised, an undesignated center heading is added, appendixes A and B to § 1755.900 are removed, and a new appendix to § 1755.900 is added, to read as follows:
(a)
(1) ASTM American Society for Testing and Materials;
(2) °C Centigrade temperature scale;
(3) dB Decibel;
(4) dB/km Decibels per 1 kilometer;
(5) ECCS Electrolytic chrome coated steel;
(6) EIA Electronic Industries Alliance;
(7) EIA/TIA Electronic Industries Alliance Telecommunications Industry Association;
(8) FTTH Fiber-to-the-Home;
(9) Gbps Gigabit per second or Gbit/s;
(10) GE General Electric;
(11) HDPE High density polyethylene;
(12) ICEA Insulated Cable Engineers Association, Inc.;
(13) Km kilometers(s)
(14) LDPE Low density polyethylene;
(15) m meter(s)
(16) Max. Maximum;
(17) MDPE Medium density polyethylene;
(18) MHz-km Megahertz-kilometer;
(19) Min. Minimum;
(20) MFD Mode-Field Diameter
(21) nm Nanometer(s);
(22) N Newton(s);
(23) NA Numerical aperture;
(24) NESC National Electrical Safety Code;
(25) OC Optical cable;
(26) O.D. Outside Diameter;
(2) OF Optical fiber;
(28) OSHA Occupational Safety and Health Administration;
(29) OTDR Optical Time Domain Reflectometer
(30) % Percent;
(31) ps/(nm·km) Picosecond per nanometer times kilometer;
(32) ps/(nm
(33) SI International System (of Units) (From the French Système international d'unités); and
(34) μm Micrometer.
(b)
(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)
(c)
(1)
(i) The optical waveguides are glass fibers having directly-applied protective coatings, and are called “fibers”, herein. These fibers may be assembled in either loose fiber bundles with a protective core tube, encased in several protective buffer tubes, in tight buffer tubes, or ribbon bundles with a protective core tube.
(ii) Fillers, strength members, core wraps, and bedding tapes may complete the cable core.
(iii) The core or buffer tubes containing the fibers and the interstices between the buffer tubes, fillers, and strength members in the core structure are filled with a suitable material or water swellable elements to exclude water.
(iv) The cable structure is completed by an extruded overall plastic jacket. A shield or armor or combination thereof may be included under the jacket. The jacket may have strength members embedded in it.
(v) Buried installation requires armor under the outer jacket.
(vi) For self-supporting cable, the outer jacket may be extruded over the support messenger and cable core.
(vii) Cables for mid-span applications for network access shall be designed for easy mid-span access to the fibers. The manufacturer may use reversing oscillating stranding (SZ) described in section 6.4 of ITU-T Recommendation L.58 or any other manufacturer's method that is acceptable to the Agency.
(2) The normal temperature ranges for cable under this specification must meet paragraph 1.1.3 of ANSI/ICEA S-87-640.
(3)
(4)
(5)
(6) The cable is fully color coded so that each fiber is distinguishable from every other fiber. A basic color scheme of twelve colors allows individual fiber identification. Colored tubes, binders, threads, strippings, or markings provide fiber group identification.
(7) Cable manufactured to this specification must demonstrate compliance with the qualification testing requirements to ensure satisfactory end-use performance characteristics for the intended applications.
(8) Optical cable designs not specifically addressed by this specification may be allowed if accepted by the Agency. Justification for acceptance of a modified design must be provided to substantiate product utility and long term stability and endurance.
(9) All cables sold to Agency borrowers for projects involving Agency loan funds under this specification must be accepted by the Agency's Technical Standards Committee “A” (Telecommunications.) For cables manufactured to this specification, all design changes to an accepted design must be submitted for acceptance. The Agency will be the sole authority on what constitutes a design change.
(10) The Agency intends that the optical fibers contained in the cables manufactured under this specification have characteristics that will allow signals, having a range of wavelengths, to be carried simultaneously.
(d)
(2)
(3)
(4)
(5)
(6) Buyers will normally specify the MFD for the fibers in the cable. When a buyer does not specify the MFD for fiber compliant with ITU-T Recommendation G.652.B or 652.D, the fibers shall be manufactured to an MFD of 9.2 ± 0.5 μm (362 ± 20 microinch), unless the buyer agrees to accept cable with fibers specified to a different MD. When the buyer does specify an MFD with a MDF tolerance conflicting with the MFD maximum tolerance allowed by paragraph (d)(5) of this section, the requirements of paragraph (d)(5) shall prevail.
(7) Factory splices are not allowed.
(8)
(9) All optical fibers in any single length of cable must be of the same type unless otherwise specified by purchaser.
(10) Optical fiber dimensions and data reporting shall be as required by paragraph 7.13.1.1 of ANSI/ICEA S-87-640.
(e)
(2) The tubes for single mode loose tube cables shall be designed to allow a maximum mid-span buffer tube exposure of 3 meters (10 feet) or 4.9 meters (16 feet). The buyer should be aware that certain housing hardware may require cable designed for 4.9 meter buffer tube storage.
(3) Optical fibers covered in near contact with an extrusion (tight tube) must have an intermediate soft buffer to allow for thermal expansions and minor pressures. The buffer tube dimension shall be established by the manufacturer to meet the requirement of this specification. Tight buffer tubes must be removable without damage to the fiber when following the manufacture's recommended procedures. The tight buffered fiber shall be strippable per paragraph 7.20 of ANSI/ICEA S-87-640.
(4) Both loose tube and tight tube coverings of each color and other fiber package types removed from the finished cable must meet the following shrinkback and cold bend performance requirements. The fibers may be left in the tube.
(i)
(ii)
Channel cores and similar slotted single component core designs need not be tested for cold bend.
(f)
(2) The colors designated for identification of loose buffer tubes, tight tube buffer fibers, individual fibers in multi-fiber tubes, slots, bundles or units of fibers, and the units in cables with more than one unit shall be per TIA-598-C,
(3)
(g)
(2) Ribbon fiber count shall be specified by the purchaser,
(3) Ribbon dimensions shall be as agreed by the purchaser and manufactures per Paragraphs 3.4.4.1 of ANSI/ICEA S-87-640.
(4) Ribbons shall meet each of the following tests. These tests are included in the paragraphs of ANSI/ICEA S-87-640 that are indicated in parentheses below.
(i) Ribbon Dimensions (7.14 through 7.14.2)—Measures ribbon dimension using FOTP-123.
(ii) Ribbon Twist Test (7.15 through 7.15.2)—evaluates the ability of the ribbon to resist splitting or other damage while undergoing dynamic cyclically twisting the ribbon under load.
(iii) Ribbon Residual Twist Test (7.16 through 7.16.2)—evaluates the degree of permanent twist in a cabled optical ribbon.
(iv) Ribbon Separability Test (7.17 through 7.17.2)—evaluates the ability to separate fibers.
(5) Ribbons shall meet paragraph 3.4.4.6 of ANSI/ICEA S-87-640, Ribbon Strippability.
(h)
(2) The strength members may be metallic or nonmetallic.
(3) The combined strength of all the strength members must be sufficient to support the stress of installation and to protect the cable in service.
(4) Strength members may be incorporated into the core as a central support member or filler, as fillers between the fiber packages, as an annular serving over the core, as an annular serving over the intermediate jacket, embedded in the outer jacket or as a combination of any of these methods.
(5) The central support member or filler must contain no more than one splice per kilometer of cable. Individual fillers placed between the fiber packages and placed as annular servings over the core must contain no more than one splice per kilometer of cable. Cable sections having central member or filler splices must meet the same physical requirements as un-spliced cable sections.
(6) In each length of completed cable having a metallic central member, the dielectric strength between the shield or armor, when present, and the metallic center member must withstand at least 15 kilovolts when tested per ASTM D 4566. The voltage shall be applied for 3 seconds minimum; no failures are allowed.
(i)
(2) The standard cylindrical group or core designs commonly consist of 4, 6, 12, 18, or 24 fibers. Cylindrical groups or core designs larger than the sizes shown above must meet all the applicable requirements of this section.
(3) When threads or tapes are used in cables using water blocking elements as core binders, they must be a non-hygroscopic and non-wicking dielectric material or be rendered such by the gel or water blocking material produced by the ingress of water.
(4) When threads or tapes are used as unit binders to define optical fiber units in loose tube, tight tube, slotted, or bundled cored designs, they must be a
(j)
(2) The materials or elements must be homogeneous and uniformly mixed; free from dirt, metallic particles and other foreign matter; easily removed; nontoxic and present no dermal hazards. The filling compound and water blocking elements shall contain a suitable antioxidant or be of such composition as to provide long term stability.
(3) The individual cable manufacturer must satisfy the Agency that the filling compound or water blocking elements selected for use is suitable for its intended application by submitting test data showing compliance with ASTM D 4568. The filling compound and water blocking elements must be compatible with the cable components when tested per ASTM D 4568 at a temperature of 80 °C (176 °F). The jacket shall retain a minimum of 85% of its un-aged tensile and elongation values.
(k)
(2) The flooding compound or water blocking elements must be compatible with the jacket when tested per ASTM D 4568 at a temperature of 80 °C ± 1 °C (176 ± 2 °F). The aged jacket shall retain a minimum of 85% of its unaged tensile strength and elongation values. The flooding compound must exhibit adhesive properties sufficient to prevent jacket slip when tested per paragraph 7.30.1 of ANSI/ICEA S-87-640 and meets paragraph 7.30.2 for minimum sheath adherence of 14 N/mm for armored cables.
(3) The individual cable manufacturer must satisfy the Agency by submitting test data showing compliance with the appropriate cable performance testing requirements of this section that the flooding compound or water blocking elements selected for use is acceptable for the application.
(l)
(2) The core wrap(s) can be used to provide a heat barrier to prevent deformation or adhesion between the fiber tubes or can be used to contain the core.
(m)
(2) For armored and unarmored cable an inner jacket is optional. The inner jacket may absorb stresses in the cable core that may be introduced by armor application or by armored cable installation.
(3) The inner jacket material and test requirements must be as for the outer jacket material of this specification, except that either black or natural polyethylene may be used and the thickness requirements are included in paragraph (m)(4) of this section. In the case of natural polyethylene, the requirements for absorption coefficient and the inclusion of furnace black are waived.
(4) The inner jacket thickness shall be determined by the manufacturer, but shall be no less than a nominal jacket thickness of 0.5mm (0.02 inch) with a minimum jacket thickness of 0.35mm (0.01 inch.)
(n)
(2) The jacket must be free from holes, splits, blisters, or other imperfections and shall be as smooth and concentric as is consistent with the best commercial practice.
(3) The raw material used for the outer jacket must be one of the types listed below. The raw material must contain an antioxidant to provide long term stabilization and the materials must contain a minimum of 2.35 percent concentration of furnace black to provide ultraviolet shielding.
(i) Type L1. Low density, polyethylene (LDPE) must conform to the requirements of ASTM D 1248, Type I, Class C, Category 4 or 5, Grade J3.
(ii) Type L2. Linear low density, polyethylene (LLDPE) must conform to the requirements of ASTM D 1248, Type I, Class C, Category 4 or 5, Grade J3.
(iii) Type M. Medium density polyethylene (MDPE) must conform to the requirements of ASTM D 1248, Type II, Class C, Category 4 or 5, Grade J4.
(iv) Type H. High density polyethylene (HDPE) must conform to the requirements of ASTM D 1248, Type III, Class C, Category 4 or 5, Grade J4.
(4) Particle size of the carbon selected for use must not average greater than 20 nm.
(5) Absorption coefficient must be a minimum of 400 per the procedures of ASTM D 3349.
(6) The outer jacketing material removed from or tested on the cable shall be capable of meeting the performance requirements of Table 5.1 found in ANSI/ICEA S-87-640.
(7)
(i)
(ii)
(iii)
(iv)
(v)
(8)
(9)
(o)
(2) The uncoated steel tape must be electrolytic chrome coated steel (ECCS) and shall meet the requirements of paragraph B.2.4 of ANSI/ICEA S-87-640.
(3) The reduction in thickness of the armoring material due to the corrugating or application process must be kept to a minimum and must not exceed 10 percent at any spot.
(4) The armor of each length of cable must be electrically continuous with no more than one joint or splice allowed in any length of one kilometer of cable. This requirement does not apply to a joint or splice made in the raw material by the raw material manufacturer.
(5) The breaking strength of any section of an armor tape, containing a factory splice joint, must not be less than 80 percent of the breaking strength of an adjacent section of the armor of equal length without a joint.
(6) For cables containing no flooding compound over the armor, the overlap portions of the armor tape must be bonded in cables having a flat, non-corrugated armor to meet the mechanical requirements of paragraphs (t)(1) through (t)(16)(ii) of this section. If the tape is corrugated, the overlap portions of the armor must be sufficiently bonded and the corrugations must be sufficiently in register to meet the requirements of paragraphs (t)(1) through (t)(16)(ii) of this section.
(7) The armor tape must be so applied as to enable the cable to pass the Cable Low (−30 °C (−22 °F)) and High (60 C (140 F)) Temperatures Bend Test, as required by paragraph (t)(3) of this section.
(8) The protective coating on the steel armor must meet the Bonding-to-Metal, Heat Sealability, Lap-Shear and Moisture Resistance requirements of Type I, Class 2 coated metals per ASTM B 736-92a.
(9) The ability of the plastic-clad metal to resist the flooding compound must be determined as required by ASTM D 4568 using a one meter (3.3 feet) length of coated steel which must be aged for 7 days at 68 ± 1 °C (154 ± 2 °F). There must be no delamination of the coating from the steel at the conclusion of the test.
(10) When the jacket is bonded to the plastic coated armor, the bond between the plastic coated armor and the outer jacket must not be less than 525 Newtons per meter (36 pound-force) over at least 90 percent of the cable circumference when tested per ASTM D 4565-90a. For cables with strength members embedded in the jacket, and residing directly over the armor, the area of the armor directly under the strength member is excluded from the 90 percent calculation.
(p)
(i) Any section of a completed strand containing a joint must have minimum tensile strength and elongation of 29,500 Newtons (6,632 pound-force) and 3.5 percent, respectively, when tested per the procedures specified in ASTM A 640.
(ii) The individual wires from a completed strand which contain joints must not fracture when tested according to the “Ductility of Steel” procedures specified in ASTM A 640 except that the mandrel diameter must be equal to 5 times the nominal diameter of the individual wires.
(iii) The support strand must be completely covered with a flooding compound that offers corrosion protection. The flooding compound must be homogeneous and uniformly mixed.
(iv) The flooding compound must be nontoxic and present no dermal hazard.
(v) The flooding compound must be free from dirt, metallic particles, and other foreign matter that may interfere with the performance of the cable.
(2) Other methods of providing self-supporting cable specifically not addressed in this section may be allowed if accepted by the Agency. Justification for acceptance of a modified design must be provided to substantiate product utility and long term stability and endurance.
(3)
(i) The minimum jacket thickness at any point over the support messenger must meet the requirements of paragraph D.3 of ANSI/ICEA S-87-640.
(ii) The web dimension for self-supporting aerial cable must meet the requirements of paragraph D.3 of ANSI/ICEA S-87-640.
(q)
(2) When a sheath slitting cord is used it must be capable of slitting the jacket or jacket and armor, at least a 1 meter (3.3 feet) length without breaking the cord at a temperature of 23 ± 5 °C (73 ± 9 °F).
(3) The sheath slitting cord must meet the sheath slitting cord test depicted in paragraph (t)(1) of this section.
(r)
(2) The color of the initial marking must be white or silver. If the initial marking fails to meet the requirements of the preceding paragraphs, it will be permissible to either remove the defective marking and re-mark with the white or silver color or leave the defective marking on the cable and re-mark with yellow. No further re-marking is permitted. Any re-marking must be on a different portion of the cables circumference than any existing marking when possible and have a numbering sequence differing from any other marking by at least 3,000. Any reel of cable that contains more than one set of sequential markings must be labeled to indicate the color and sequence of marking to be used. The labeling must be applied to the reel and also to the cable.
(3) Each length of cable must be permanently labeled either OPTICAL CABLE, OC, OPTICAL FIBER CABLE, or OF on the outer jacket and identified as to manufacturer and year of manufacture.
(4) Each length of cable intended for direct burial installation shall be marked with a telephone handset in compliance with Rule 350G of the National Electrical Safety Code (NESC).
(5) Each length of cable shall be identified as to the manufacturer and year of manufacturing. The manufacturer and year of manufacturing may also be indicated by other means as indicated in paragraphs 6.1.2 through 6.1.4 of ANSI/ICEA S-87-640.
(6) The number of fibers on the jacket shall be marked on the jacket.
(7) An alternative method of marking may be used if acceptable to the Agency.
(8) The completed cable must have sequentially numbered length markers in METERS or FEET at regular intervals of not more than 2 feet or not more than 1 meter along the outside of the jacket. Continuous sequential numbering must
(9) Agreement between the actual length of the cable and the length marking on the cable jacket must be within the limits of +1 percent and −0 percent.
(10)
(s)
(2)
(3)
(4) Measurement of the attenuation must be conducted at the wavelength specified for application and must be expressed in decibels per kilometer.
(5) Because the accuracy of attenuation measurements for single mode fibers becomes questionable when measured on short cable lengths, attenuation measurements are to be made utilizing characterization cable lengths. Master Cable reels shall be tested and the attenuation values measured will be used for shorter ship lengths of cable.
(6) Because the accuracy of attenuation measurements for multimode fibers becomes questionable when measured on short cable lengths, attenuation measurements are to be made utilizing characterization cable lengths. If the ship length of cable is less than one kilometer, the attenuation values measured on longer lengths of cable (characterization length of cable) before cutting to the ship lengths of cable may be applied to the ship lengths.
(7) Attenuation must be measured per FOTP-78.
(8) The bandwidth of multimode fibers in a finished cable shall be no less than the values specified in ANSI/ICEA S-87-640, Table 8.2 according to paragraph 8.3.1
(t)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(i) The specimen shall be installed in a commercially available pedestal or closure, or in a device that mimics their performance, as follows: A length of cable sheath, equal to the mid-span length, shall be removed from the middle of the test specimen so as to allow access the buffer tubes. All binders, tapes, strength members, etc. shall be removed. The buffer tubes shall be left intact. The cable ends defining the ends of the mid-span length shall be properly secured in the closure, to the
(ii) The expressed buffer tubes shall be loosely constrained during the test.
(iii) The enclosure, with installed cable, shall be placed in an environmental chamber for temperature cycling. It is acceptable for some or all of the two 20 ft. cable segments to extend outside the environmental chamber.
(iv) Lids, pedestal enclosures, or closure covers shall be removed if possible to allow for temperature equilibrium of the buffer tubes. If this is not possible, the manufacture must demonstrate that the buffer tubes are at temperature equilibrium prior to beginning the soak time.
(v) Measure the attenuation of dispersion-unshifted single mode fibers at 1310 ± 10 and 1550 ± 10 nm, dispersion-shifted single mode fibers at 1550 ± 10 nm.
(vi) After measuring the attenuation of the optical fibers, test the cable sample per EIA/TIA-455-3A. The following detailed test conditions shall apply:
(A) Section 4.1—Loose tube single mode optical cable sample shall be tested.
(B) Section 4.2—An Agency accepted 8 to 12 inch diameter optical buried distribution pedestal or equivalent sample shall be tested.
(C) Mid-span opening for installation of loose tube single mode optical cable in pedestal shall be 3 meters (10 feet) or 4.9 meters (16 feet) depending on the cable listing.
(D) Section 5.1—3 hours soak time.
(E) Section 5.2—Test Condition C-2, minimum −40 °C (−40 °F) and maximum 70° Celsius (158 °F).
(F) Section 5.7.2—A statistically representative amount of transmitting fibers in all express buffer tubes passing through the pedestal and stored shall be measured.
(vii) The cable may be allowed to warm to room temperature before visual inspection. The cable mid-span opening must not show visible evidence of fracture of the buffer tubes nor any degradation of all exposed cable assemblies. Fiber cable attenuation measured through the express buffer tubes during the last cycle at −40 °C C (−40 °F) and +70C (158 °F) and after the test shall not exceed 0.1 dB from the initial baseline measurements made per EIA/TIA-455-3A, Section 5.7.1 and Section 5.7.2 specified in paragraph (t)(15)(vi) of this section.
(16)
(i)
(ii)
(u)
(2) All connectors must be accepted by the Agency prior to their use.
(v)
(2)
(i) An original signature certification that the product fully complies with each section of this specification;
(ii) Qualification Test Data, per the Appendix to this section;
(iii) A set of instructions for handling the cable;
(iv) OSHA Material Safety Data Sheets for all components;
(v) Agree to periodic plant inspections;
(vi) A certification stating whether the cable, as sold to the Agency Telecommunications program borrowers, complies with the following two provisions:
(A) Final assembly or manufacture of the product, as the product would be used by an Agency Telecommunications program borrower, is completed in the United States or eligible countries (currently, Mexico, Canada and Israel); and
(B) The cost of United States and eligible countries' components (in any combination) within the product is more than 50 percent of the total cost of all components utilized in the product. The cost of non-domestic components (components not manufactured within the United States or eligible countries) which are included in the finished product must include all duties, taxes, and delivery charges to the point of assembly or manufacture;
(vii) Written user testimonials concerning performance of the product; and
(viii) Other nonproprietary data deemed necessary by the Agency.
(3)
(4) Initial and re-qualification acceptance requests should be addressed to: Chairman, Technical Standards Committee “A” (Telecommunications), STOP 1550, Advanced Services Division, Rural Development Telecommunications Program, Washington, DC 20250-1500.
(5)
(ii) Attenuation for each optical fiber in the cable must be measured.
(iii) Optical discontinuities greater than 0.1dB must be isolated and their location and amplitude recorded.
(6)
(i) Numerical aperture and bandwidth of multimode fibers;
(ii) Cut off wavelength of single mode fibers;
(iii) Dispersion of single mode fibers;
(iv) Shrinkback and cold testing of loose tube and tight tube buffers;
(v) Adhesion properties of the protective fiber coating;
(vi) Dielectric strength between the armor and the metallic central member;
(vii) Performance requirements for the fibers.
(viii) Performance requirements for the inner and outer jacketing materials;
(ix) Performance requirements for the filling and flooding compounds;
(x) Bonding properties of the coated armoring material;
(xi) Sequential marking and lettering;
(xii) Mechanical tests depicted in paragraphs (t)(1) through (t)(16)(ii) of this section.
(w)
(2) Measurements and computed values must be rounded off to the number of places or figures specified for the requirement according to ASTM E 29.
(x)
(2) Minor defects in the inner and outer jacket (defects having a dimension of 3 millimeters or less in any direction) may be repaired by means of heat fusing per good commercial practices utilizing sheath grade compounds.
(y)
(2) A circumferential thermal wrap or other means of protection must be secured between the outer edges of the reel flange to protect the cable against damage during storage and shipment. The thermal wrap must comply with the requirements included in the following test:
(i)
(A)
(B)
(3) Cable manufactured to the requirements of this specification must be sealed at the ends to prevent entrance of moisture.
(4) The end-of-pull (outer end) of the cable must be securely fastened to prevent the cable from coming loose during transit. The start-of-pull (inner end) of the cable must project through a slot in the flange of the reel, around an inner riser, or into a recess on the flange near the drum and fastened in such a way to prevent the cable from becoming loose during installation.
(5) Spikes, staples or other fastening devices must be used in a manner which will not result in penetration of the cable.
(6) The arbor hole must admit a spindle 63.5 millimeters (2.5 inches) in diameter without binding. Steel arbor hole liners may be used but must be accepted by the Agency prior to their use.
(7) Each reel must be plainly marked to indicate the direction in which it should be rolled to prevent loosening of the cable on the reel.
(8) Each reel must be stenciled or lettered with the name of the manufacturer.
(9) The following information must be either stenciled on the reel or on a tag firmly attached to the reel:
4. Section 1755.901 is added to read as follows:
(a) The specifications in the table following paragraph (b) of this section are incorporated by reference by the Telecommunications Program and apply to §§ 1755.900 and 1755.902. This incorporation by reference was approved by the Director of the Federal Register per 5 U.S.C. 552(a) and 1 CFR part 51. Copies of these documents are available for inspection at the National Archives and Records Administration (NARA). For more information on the availability of this material at NARA, call 202-741-6030, or go to:
(b) ANSI/IEEE C-2 can be obtained from IEEE at
5. Section 1755.902 and an undesignated center heading are added to read as follows:
This section covers the requirements for fiber optic service entrance cables intended for aerial installation either by attachment to a support strand or by an integrated self-supporting arrangement, for underground application by placement in a duct, or for buried installations by trenching, direct plowing, directional or pneumatic boring. Cable meeting this specification is recommended for fiber optic service entrances having 12 or fewer fibers with distances less than 100 meters (300 feet.) Service entrance cables shall meet the requirements of § 1755.900, except for any conflicting requirements with this section, in which case the following stipulations supersede requirements of § 1755.900:
(a)
(b)
(c)
(d)
(e)
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for GE CF6-80C2D1F turbofan engines, installed on McDonnell Douglas Corporation MD-11 series airplanes. This proposed AD would require removing previous software versions from the engine electronic control unit (ECU). Engines with new version software will have increased margin to flameout. This proposed AD results from reports of engine flameout events during flight, including reports of events where all engines simultaneously experienced a flameout or other adverse operation. Although the root cause investigation is not yet complete, we believe that exposure to ice crystals during flight is associated with these flameout events. We are proposing this AD to minimize the potential of an all-engine flameout event caused by ice accretion and shedding during flight.
We must receive any comments on this proposed AD by September 17, 2007.
Use one of the following addresses to comment on this proposed AD.
•
•
•
•
•
You can get the service information identified in this proposed AD from General Electric Company via Lockheed Martin Technology Services, 10525 Chester Road, Suite C, Cincinnati, Ohio 45215, telephone (513) 672-8400, fax (513) 672-8422.
John Golinski, 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 us any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under
We will post all comments we receive, without change, to
You may examine the AD docket on the Internet at
GE CF6-80C2 and CF6-80E1 series turbofan engines continue to experience flameout events that are due to ice accretion and shedding into the engine during flight. Although the investigation is not yet complete, we believe that the ice accretion is caused by exposure to ice crystals during flight. Industry reports 35 airplane flameout events, including reports of multi-engine events where all engines on the airplane simultaneously experienced a flameout. Some of these events had high pressure compressor blade damage that may have been caused by impact with shedding ice. In all events, the engines restarted and continued to operate normally for the remainder of the flight.
This proposed AD addresses only the CF6-80C2D1F turbofan engines, installed on McDonnell Douglas Corporation MD-11 series airplanes. We believe this model of CF6-80C2 engine is susceptible to flameouts caused by ice accretion and shedding into the engine during flight. Similar AD actions for other CF-80C2 and CF6-80E1 series engines may be forthcoming.
We view an all-engine flameout event as an unsafe condition particularly for low-altitude events, or other factors that might result in the inability to restart the engines and regain control of the airplane. Since some aspects of this problem are not completely understood, this proposed AD is considered an interim action due to GE's on-going investigation. Future AD action might become necessary based on the results of the investigation and field experience. This condition of insufficient margin to engine flameout due to ice accretion and shedding during flight, if not addressed, could result in an all-engine flameout event during flight.
We have reviewed and approved the technical contents of GE Service Bulletin (SB) No. CF6-80C2 S/B 73-0351, dated April 11, 2007. That SB describes procedures for removing certain software versions from the ECU, and installing a software version that is FAA-approved. The new FAA-approved software version described in the SB modifies the variable bleed valve schedule, which will provide an increased margin to flameout. This increased margin is expected to reduce the rate of flameout occurrences due to ice accretion and shedding during flight.
We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other products of this same type design. We are proposing this AD, which would require removing certain software versions from the engine ECU.
These actions are interim actions due to the on-going investigation. We may take further rulemaking actions in the future, based on the results of the investigation and field experience.
We estimate that this proposed AD would affect 175 CF6-80C2D1F turbofan engines installed on McDonnell Douglas Corporation MD-11 series airplanes of U.S. registry. We estimate it would take about 3 work-hours per ECU to perform the proposed actions if done at ECU shop visit, and 6 work-hours per ECU if done at engine shop visit. We estimate that 50% of the ECUs would be worked at ECU shop visit and the remaining 50% worked at engine shop visit. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost to U.S. operators to be $63,120. Our cost estimate is exclusive of warranty coverage.
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 have 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 that the proposed AD:
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. Would 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. You may get a copy of this summary at the address listed under
Air transportation, Aircraft, Aviation safety, Safety.
Under the authority delegated to me by the Administrator, the Federal Aviation Administration 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 airworthiness directive:
(a) The Federal Aviation Administration (FAA) must receive comments on this airworthiness directive (AD) action by September 17, 2007.
(b) None.
(c) This AD applies to General Electric Company (GE) CF6-80C2D1F turbofan engines, installed on McDonnell Douglas Corporation MD-11 series airplanes.
(d) This AD results from reports of engine flameout events during flight, including reports of events where all engines simultaneously experienced a flameout or other adverse operation. We are issuing this AD to minimize the potential of an all-engine flameout event, due to ice accretion and shedding during flight. Exposure to ice crystals during flight is believed to be associated with these flameout events.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done.
(f) These actions are interim actions due to the on-going investigation, and we may take further rulemaking actions in the future based on the results of the investigation and field experience.
(g) At the next shop visit of the engine or of the ECU, whichever occurs first, and not to exceed 60 months from the effective date of this AD, remove the following software versions from the ECUs:
(h) For a period of 24 months after the effective date of this AD, once an ECU containing a software version not listed in Table 1 of this AD is installed on an engine, that ECU can be replaced with an ECU containing a previous version of software listed in Table 1.
(i) Once the software version listed in Table 1 of this AD has been removed and new FAA-approved software version is installed in an ECU, reverting to those older software versions in that ECU is prohibited.
(j) After 60 months from the effective date of this AD, use of an ECU with a software version listed in Table 1 of this AD is prohibited.
(k) For the purposes of this AD:
(1) Next shop visit of the ECU is when the ECU is removed from the engine for overhaul or maintenance after the effective date of this AD.
(2) Next shop visit of the engine is when the engine is removed from the airplane for maintenance in which a major flange is disassembled after the effective date of this AD. The following engine maintenance actions, either separately or in combination with each other, are not considered a next shop visit of the engine:
(i) Removal of the upper high pressure compressor (HPC) stator case solely for airfoil maintenance.
(ii) Module-level inspection of the HPC rotor stages 3-9 spool.
(iii) Replacement of stage 5 HPC variable stator vane bushings or lever arms.
(iv) Removal of the accessory gearbox.
(v) Replacement of the inlet gearbox polytetrafluoroethylene seal.
(l) The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19.
(m) Special flight permits are not authorized.
(n) Information on removing ECU software and installing new software, which provides increased margin to flameout, can be found in GE Service Bulletin No. CF6-80C2 S/B 73-0351, dated April 11, 2007.
(o) Contact John Golinski, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail:
Occupational Safety and Health Administration (OSHA), Department of Labor.
Proposed rule; close of comment period.
On April 13, 2007, the U.S. Department of Labor published a proposed rule entitled Explosives with a comment period that ended 7/12/2007. On July 9, 2007, the comment period was extended to 9/10/2007. At this time the U.S. Department of Labor is closing the comment period effective July 17, 2007. The Department intends to re-propose the Explosives NPRM at a later date in order to clarify the intent of the rulemaking.
The comment period for the proposed rule published on April 13, 2007 (72 FR 18792) is closed effective July 17, 2007.
For general information and press inquiries, contact Mr. Kevin Ropp, Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-1999. For technical inquiries, contact Donald Pittenger, Directorate of Standards and Guidance, Room N-3609, OSHA, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2255 or fax (202) 693-1663.
United States Agency for International Development.
Privacy Act System of Records Notice.
Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the United States Agency for International Development (USAID) is giving notice that it proposes to establish a new system of records, the Partner Vetting System (PVS). The PVS will support the vetting of individuals, officers, or other officials of non-governmental organizations who apply for USAID contracts, grants, cooperative agreements, or other funding, or who apply for registration with USAID as Private and Voluntary Organizations (PVOs), ensuring that neither USAID funds nor USAID-funded activities inadvertently or otherwise provide support to entities or individuals associated with terrorism.
Written comments must be received on or before August 27, 2007. Unless there is a further notice in the
You may submit comments to:
For general questions, please contact: Coordinator for Counterterrorism, Office of Security, United States Agency for International Development, Ronald Reagan Building, 1300 Pennsylvania Avenue, NW., Washington, DC 20523. For privacy issues please contact: Chief Privacy Officer, United States Agency for International Development, 1300 Pennsylvania Avenue, NW., Office 2.12-003, Washington, DC 20523-2120.
USAID is establishing a new system of records pursuant to the Privacy Act (5 U.S.C. 552a), entitled the Partner Vetting System (PVS). Since September 2001, in accordance with Executive Order 13224 which prohibits any transactions or dealings with entities or individuals designated as terrorists, USAID has taken several steps to ensure USAID funds are not provided to individuals or entities associated with terrorism. These efforts include: (1) Requiring that all solicitations, contracts, Annual Program Statements or Requests for Applications, grants or cooperative agreements, or other comparable documents contain language reminding USAID partners of the laws and Executive Orders prohibiting the provision of resources and support to individuals and organizations associated with terrorism; (2) requiring all non-governmental organization (NGO) applicants for grants and cooperative agreements to submit terrorist financing certifications; and (3) requiring USAID contracting officers and agreement officers to check applicable terrorist listings to ensure that potential contractors, grantees, sub-contractors, and sub-grantees are not on these listings.
In addition to the precautions described above, there is also a statutory requirement for vetting under USAID's West Bank and Gaza (WBG) program. Since Fiscal Year 2003, the annual foreign operations appropriations legislation has required that, “the Secretary of State shall take all appropriate steps to ensure that such assistance is not provided to or through any individual, private or government entity, or education institution that the Secretary knows or has reason to believe advocates, plans, sponsors, engages in, or has engaged in, terrorist activity.” Accordingly, USAID's mission for the WBG developed anti-terrorism procedures for all awards that it administers and has conducted vetting since 2003. A recent review of the WBG program by the Government Accountability Office (GAO) identified processes and procedures that could be improved and streamlined with the use of additional information technology. The PVS is being created, in part, as a result of these recommendations and will assist not only the mission for WBG in better tracking and managing the overall vetting process, but all locations in which USAID has or will have a program.
PVS will facilitate the management and collection of information from individuals, officers, employees, or other officials of NGOs who apply for USAID contracts, grants, cooperative agreements or other USAID funding, or who apply for registration with USAID as PVOs. The information will be used to conduct national security screening of such individuals and NGOs to ensure that USAID funds do not inadvertently or otherwise provide support to entities or individuals associated with terrorism. To thoroughly conduct this screening, it is necessary to collect information on the principal officers and other employees of applicant organizations or on individuals that are applying directly for awards on their own behalf. Principal officers may include directors, program managers, members of governing bodies, or other individuals with operational control of the organization or those individuals that administer funds.
The primary source of information in PVS will be collected directly from the individuals acting in their own capacity or from the appointed official for the NGO applying for USAID funding or registration as a PVO. An exemption will not be claimed for information collected directly from the individuals acting in their own capacity or from the appointed official for the NGO and this information will be treated as unclassified. USAID is currently devising a retention schedule for these records. However, some information may be obtained from other U.S. government agencies or another agency's system of records. Any information that is recompiled from another agency's system of records will follow the retention plan for that agency, will carry the appropriate classification level, and be considered exempt under the originating agency's exemptions.
You may submit comments by sending e-mail to:
This document was received at the Office of the Federal Register on July 5, 2007.
Partner Vetting System (PVS).
Classified and Sensitive but Unclassified.
The United States Agency for International Development (USAID), Office of Security, 1300 Pennsylvania Avenue, Washington, DC 20523, and any relevant location(s) where USAID has a program.
a. Individuals who are directors, officers, or are otherwise employed by either for-profit or non-profit non-governmental organizations who apply for USAID contracts, grants, cooperative agreements or other types of instruments;
b. Individuals who apply for personal services contracts or for other contracts, grants, or cooperative agreements;
c. Individuals or organizations who attempt to obtain other USAID assistance or benefits; and
d. Individuals who are officers or other officials of non-profit, non-governmental organizations who apply for registration with USAID as Private and Voluntary Organizations (PVOs).
Sensitive but Unclassified and non-exempt identifying information in this system includes, but is not limited to:
a. Full name (including any aliases or variations of spelling),
b. Date and place of birth,
c. Government-issued identification information (including, but not limited to, social security number, passport number, or other numbers originated by a government that specifically identifies an individual),
d. Current mailing address,
e. Telephone and fax numbers,
f. Email addresses,
g. Country of origin and/or nationality,
h. Citizenship,
i. Gender, and
j. Profession or other employment data.
a. Results generated from the screening of individuals covered by this notice;
b. Intelligence and law enforcement information related to national security; and
c. National security vetting and terrorism screening information, provided to USAID by other agencies.
18 U.S.C. 2339A, 2339B and 2339C; 22 U.S.C. 2151 et seq.; Section 559 of the FY06 Foreign Operations Appropriations Act; Executive Orders 13224, 13099 and 12947; and HSPD-6.
To support the vetting of directors, officers, or other employees of non-governmental organizations who apply for USAID contracts, grants, cooperative agreements or other funding or who apply for registration with USAID as Private and Voluntary Organizations. The information collected from these individuals is specifically used to conduct screening to ensure that USAID funds and USAID-funded activities are not purposefully or inadvertently used to provide support to entities or individuals deemed to be a risk to national security.
USAID may disclose relevant system records in accordance with any current and future blanket routine uses established for its record systems. See the Statement of General Routine Uses (and amendments), 42 FR 47371 (September 20, 1977); 59 FR 52954 (October 20, 1994); 59 FR 62747 (December 6, 1994). Routine uses are not meant to be mutually exclusive and may overlap in some cases.
None.
Records in this system are stored in both paper and electronic format. Paper records are maintained by the USAID regional offices when the information cannot be collected electronically. Electronic storage is on servers (hard disk media) and magnetic tapes (or other backup media), stored within a secure location within the USAID Washington headquarters.
Records in this system are retrieved by individual name, date of birth, place of birth, social security numbers, passport numbers or other identifying data specified under Categories of Records in the System.
USAID maintains all classified records in an authorized security container with access limited to authorized government personnel and authorized contractors. Physical security protections include guards and locked facilities requiring badges. Only authorized government personnel and authorized contractors can access records within the system. USAID mandates and certifies that physical and technological safeguards appropriate for classified and Sensitive but Unclassified systems are used to protect the records against unauthorized access. All authorized government personnel and authorized contractors with access to the system must hold appropriate security clearance, sign a non-disclosure agreement, and undergo both privacy and security training.
Records in this system will be retained and disposed of in accordance with a records schedule to be approved by the National Archives and Records Administration.
Coordinator for Counterterrorism, Office of Security, United States Agency for International Development, Ronald Reagan Building, 1300 Pennsylvania Avenue, NW., Washington, DC 20523.
To the extent applicable, because this system contains classified information related to the government's national security programs, records in this system may be exempt from notification, access, and amendment as permitted by subsection (j) and (k) of the Privacy Act.
United States citizens or legal permanent residents can request access to a non-exempt record pertaining to him/her by sending a request in writing, signed, to the Chief Privacy Officer at the following address: Chief Privacy Officer, United States Agency for International Development, 1300 Pennsylvania Avenue, NW., Office 2.12-003, Washington, DC 20523-2120.
When requesting access to records covered by this Notice, an individual should provide his/her full name, date of birth, and complete address. An individual requesting access to records in person must provide identity documents, such as a government-issued photo ID, sufficient to satisfy the custodian of the records that the requester is entitled to access.
Requesters should also reasonably specify the record contents being sought. Rules regarding access to Privacy Act records appear in 22 CFR Part 215. If additional information or assistance is required, contact: Chief Privacy Officer, United States Agency for International Development, 1300 Pennsylvania Avenue, NW., Office 2.12-003, Washington, DC 20523-2120.
Requests for correction or amendment must identify the information to be changed and the corrective action sought. Requests must be submitted to the Chief Privacy Officer as provided in the record access procedures above.
Information in this system is obtained from the non-governmental organization's official who is responsible for completing the application package required to compete for USAID funds or who apply for registration with USAID as a Private and Voluntary Organization. In the case of applications by an individual in his/her own capacity, the information will be collected directly from the individual applicant. Information in this system may also be obtained from public sources, agencies conducting national security screening, law enforcement and intelligence agency record systems, and other government databases.
To the extent applicable, records in this system may be exempt from any part of 5 U.S.C. 552a except subsections (b), (c)(1) and (2), (e)(4)(A) through (F), (e)(6), (7), (9), (10), and (11) if the records in the system are subject to the exemption found in 5 U.S.C. 552a(j). To the extent applicable, records in this system may be exempt from subsections (c)(3), (d), (e)(1), (e)(4)(G), (H), (I), and (f) of 5 U.S.C. 552a if the records in the system are subject to the exemption found in 5 U.S.C. 552a(k). Any other exempt records from other systems of records that are recompiled into this system are also considered exempt to the extent they are claimed as such in the original systems. Rules have been promulgated in accordance with the requirements of 5 U.S.C. 553(b), (c), and (e).
Rural Housing Service, USDA.
Notice.
The Rural Housing Service (RHS) announces the availability of agriculture, aquaculture, and seafood processing and/or fishery worker housing grants in the States of Alaska, Mississippi, Utah, and Wisconsin. This Notice was published on April 6, 2004, in the
Public Law 108-199 (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2004) authorized RHS to establish a demonstration program to provide financial assistance (grants) for processing and/or fishery worker housing in the States of Alaska, Mississippi, Utah, and Wisconsin. This RFP requests proposals from qualified private and public nonprofit agencies, non-profit cooperatives, state and local governments, and tribal organizations in Alaska, Mississippi, Utah, and Wisconsin to construct housing for agriculture, aquaculture, and seafood processing and/or fishery workers. Any one project may not receive grant funds of more than $1,370,595 from this program. Applications will only be accepted from applicants who will use the funds awarded in the following states: Alaska, Mississippi, Utah, or Wisconsin. Housing facilities constructed under this RFP are expected to increase the supply of housing for agriculture, aquaculture, and seafood processing and/or fishery workers in markets where adequate housing is not available. The Agency has remaining funds in the amount of $1,370,595 which will be awarded in this Notice.
Under the Paperwork Reduction Act, 44 U.S.C. 3501
The agriculture, aquaculture, and seafood processing and/or fishery worker housing grants authorized by Public Law 108-199 are for the purpose of developing a housing demonstration program for agriculture, aquaculture, and seafood processing and/or fishery worker housing in markets that have a demonstrated need for housing for such workers. Under Public Law 108-199, RHS had the authority to award $4,970,500 in grant funds for a housing demonstration program for agriculture, aquaculture, and seafood processing and/or fishery workers in Alaska, Mississippi, Utah, and Wisconsin. This Notice is awarding the remaining $1,370,595 for the aforementioned purposes.
As part of the application, all applicants must also provide a Dun and Bradstreet Data Universal Numbering System (DUNS) number. As required by the Office of Management and Budget
To comply with the President's Management Agenda, the Department of Agriculture is participating as a partner in the new government-wide site in FY 2007 grants.gov. The Web site can be found at
Users of grants.gov will be able to download a copy of the application package, complete it off line, and then upload and submit the application via the grants.gov site. You may not e-mail an electronic copy of a grant application to RHS; however, the Agency encourages your participation in grants.gov. The following are useful tips and instructions on how to use the Web site:
• When you enter the grants.gov site, you will find information about submitting an application electronically through the site as well as the hours of operation. RHS strongly recommends that you do not wait until the application deadline date to begin the application process through grants.gov. To use grants.gov, applicants must have a DUNS number.
• You may submit all documents electronically through the Web site, including all information typically included on the Application for Rural Housing Preservation Grants, and all necessary assurances and certifications.
• Your application must comply with any page limit requirements described in this NOFA.
• After you electronically submit your application through the Web site, you will receive an automatic acknowledgement from grants.gov that contains a grants.gov tracking number.
• RHS may request that you provide original signatures on forms at a later date.
• You must meet the closing date and local time deadline. If you experience technical difficulties on the closing date and are unable to meet the 5 p.m. (Washington, DC time) deadline, print out your application and submit it to your State Office.
The deadline for receipt of all applications in response to this RFP is 5 p.m., eastern time, on ____ 2007. The application closing deadline is firm as to date and hour. RHS will not consider any application that is received after the closing deadline. Applicants intending to mail applications must provide sufficient time to permit delivery on or before the closing deadline. Acceptance by a post office or private mailer does not constitute delivery. Facsimile (FAX), Cash on Delivery (COD), and postage due applications will not be accepted.
Applications should be submitted to Henry Searcy, Jr., Senior Loan Specialist, USDA Rural Development, Rural Housing Service, Multi-Family Housing Processing Division, STOP 0781, Room 1263, 1400 Independence Ave., SW., Washington, DC 20250-0781. RHS will date and time certify incoming applications to evidence timely receipt and, upon request, will provide the applicant with a written acknowledgement of receipt.
For further information and an application package, including all required forms, contact Henry Searcy, Jr., Senior Loan Specialist, USDA, Rural Housing Service, Multi-Family Housing Processing Division, Stop 0781, Room 1263, 1400 Independence Avenue, SW., Washington, DC 20250-0781, telephone (202) 720-1753. (This is not a toll-free number.)
Public Law 108-199 authorized funds to implement a demonstration grant program for the construction of housing for agriculture, aquaculture, and seafood processing and/or fishery workers in Alaska, Mississippi, Utah, and Wisconsin.
The demonstration program has been designed to increase the supply of rental housing for a growing segment of the population whose needs are not currently being met. The program is expected to provide housing opportunities for processing workers in markets that cannot support other forms of conventional and government housing models. Grantees may not require any occupant of the housing or related facilities, as a condition of occupancy, to work or be employed by any particular processor, fishery, or other place, or work for or be employed by any particular person, firm, or interest.
Developers of housing under this program will receive a grant of up to 80% of the Total Development Cost (TDC) of the project. TDC includes all hard costs, soft costs, initial operating reserves, administrative fees, furnishings and equipment, and related facilities.
Housing constructed under this program may not receive RHS Rental Assistance or Operating Subsidies authorized under 42 U.S.C. 1490a for payment of tenant rents. Project financial models should be structured to work without rental subsidies while keeping rents affordable for the target population.
Projects should be located close to tenants' workplaces and services as much as feasible. Location of the project is not limited to rural areas as defined in 42 U.S.C. 1490.
All applications must meet the minimum threshold requirements contained in this RFP. The threshold criteria are as follows:
Eligibility for residency in facilities constructed under this RFP is limited to individuals and families who earn at least 40% of their income from work as an agriculture, aquaculture, or seafood processing and/or fishery worker and earn less than or equal to 60% of the National Median Income for a family of four as reported by the U.S. Census Bureau. Residents must be United States citizens or be legally admitted for permanent residence.
Eligibility for grants under this notice is limited to qualified private and public non-profit agencies, non-profit cooperatives, state and local governments, and tribal organizations in Alaska, Mississippi, Utah and Wisconsin to construct housing for agriculture, aquaculture, and seafood processing and/or fishery workers. Faith based applicants meeting these requirements are also eligible. Applicants must possess the experience, knowledge, and capacity to develop
A grant under this RFP may fund up to 80% of a project's TDC. TDC includes all hard costs, soft costs, initial operating reserves, administrative fees, furnishings and equipment, and related facilities. Applications will only be accepted from the following states Alaska, Mississippi, Utah, or Wisconsin.
As stated above, a grant may fund up to 80% of the TDC which leaves at least 20% of the TDC to be funded from other sources. The applicant is encouraged to seek funding from sources with favorable rates and terms in order to keep rents within the reach of the target population. For this reason, additional selection points will be given to proposals that have funding with favorable rates and terms. Examples of such funding sources may include the Federal Home Loan Bank, the U.S. Department of Housing and Urban Development, or a State, county, or local government. Conventional loans may also be used; however, the rates and terms may not be in excess of what is common in the housing industry. For this purpose, the interest rate of any such loan may not exceed 200 basis points above the 10-year Treasury bond rate as of the date of grant closing. The term of any loan must be a minimum of 10 years and it must be amortized over a 30 year period. Longer terms are preferred. The objective in setting these limits is to create affordable rents for the tenants. In each case, equity contributions and loans must be contributed and disbursed prior to the disbursement of any grant funds from the Agency.
Eligible costs for grants under this RFP include all project related costs including all hard costs, soft costs, initial operating reserves, administrative fees, furnishings and equipment, and related facilities. Eligible costs also include technical assistance received from a non-identity of interest nonprofit organization with housing and/or community development experience, to assist the applicant in the development and packaging of its grant docket and project. Eligible costs for technical assistance is permitted by 7 CFR 3560.53 and may not exceed 4 percent of the TDC.
The project will remain in use for the intended purpose as required under 7 CFR parts 3015, 3016, or 3019, as applicable. These provisions require the grant recipient to use the real property for the authorized purpose of the project. The type of security instrument will be determined, prior to grant closing, by the Agency's Regional Office of the General Counsel.
The developer must own or demonstrate evidence of site control of the proposed site. At a minimum, site control must extend 180 days past the date of application submission and is preferred to be for one year. Proof of site control should be submitted with the application. This can be in the form of a contract of sale, option agreement, long-term lease agreement, or deed or other documentation of ownership by the applicant. The applicant must exercise care in site selection. Site approval is subject to completion of an environmental assessment by RHS and sites with environmental problems will increase the amount of time necessary to complete this assessment. Proposals which will directly or indirectly impact protected resources, such as floodplains or wetlands, can require consideration of alternative sites, changes in project design, or the implementation of other mitigation measures to lessen adverse effects on the environment.
A zoning designation adequate to develop the type of housing and number of units proposed is required. Evidence of proper zoning must be included with the application. Where there is a clear plan to have a site rezoned, a narrative explaining the situation and detailing the process and timeline for rezoning may be accepted.
Adequate capacity to connect the project to water, sewer, electricity, and telephone services must be demonstrated. Letters from utility providers must be included in the application. If on-site utilities are proposed, engineering reports indicating correct soil types, adequate land capacity, etc. must be included in the application.
As required by 7 CFR 3015.56, if land is being donated as part of the grantee's contribution, the market value must be set by an independent appraiser and certified by a responsible official of the grantee. An appraisal will also be required if project funds are used to purchase land.
Projects funded under this RFP shall be in markets with demonstrated need for agriculture, aquaculture, and seafood processing and/or fishery worker housing. All applications should include documentation of this need in the form of a market analysis, survey, or other documentation of need.
Housing constructed under this demonstration may be of any architectural style as long as it is permitted by local zoning laws, meets all applicable building codes, and fits with the character of the surrounding community. However, the facilities should not be of extravagant design and their size must be commensurate with the needs of the workers who will occupy the housing facility. When planning units for families, lower density building design and layout is normally desirable. Housing should be designed in such a manner that it will be decent, safe, sanitary, and modest in size and cost. Actual plans, specifications, and contract documents must be prepared in accordance with 7 CFR part 1924, subpart A.
Building design is subject to the requirements of section 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act, the Fair Housing Amendments Act of 1988, and any state or local accessibility requirements. For these reasons, buildings must be designed and constructed in accordance with the Uniform Federal Accessibility Standards, the Americans with Disabilities Act Accessibility Guidelines, the Fair Housing Act Accessibility Guidelines, and any state or local standards.
Particular attention should be given to 7 CFR 1924.13 which gives supplemental requirements for complex construction. All construction contracts must be awarded on the basis of competitive bidding unless an exception is granted in accordance with 7 CFR 1924.13. In either case, the Contractor must be reliable and experienced in the construction of projects of similar size, design, scope, and complexity. The construction contracts must contain the nondiscrimination language, in its entirety, that is required by E.O. 11246 (refer to 41 CFR 60-1.4(b) subparagraphs 1-7 for the specific language). The plans and specifications, including the construction contract, must be reviewed and accepted by RHS prior to the start of construction.
Until the plans and specifications have been approved and the grant is closed, construction work should not be started. When there are construction changes that affect design, costs, or time, the change must be documented as a contract change order and must be signed by the borrower, borrower's architect, contractor, and Agency representative before the work involved in the change is started or the costs are included in a payment request. Changes that do not affect design, costs, or time, may be handled as field orders and do not require Agency approval.
RHS will conduct periodic inspections during construction to protect the interest of the Government.
Title VI of the Civil Rights Act of 1964 prohibits recipients of Federal financial assistance from discriminating in their programs and activities on the basis of race, color, or national origin. It also requires recipients (1) to sign a civil rights assurance agreement (i.e., Form RD 400-4), (2) to collect statistical data on race and national origin, (3) submit to the Agency timely, complete, and accurate compliance reports so that the Agency can determine compliance with program regulations and applicable civil rights laws, and (4) to disseminate information to the public stating that the recipient operates a program that is subject to the non-discrimination requirements of Title VI and briefly explain the procedures for filing complaints.
Borrowers and grantees must take reasonable steps to ensure that Limited English Proficiency (LEP) persons receive the language assistance necessary to afford them meaningful access to USDA programs and activities, free of charge. Failure to ensure that LEP persons can effectively participate in or benefit from federally-assisted programs and activities may violate the prohibition under Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d and Title VI regulations against national origin discrimination.
Section 504 of the Rehabilitation Act of 1973 prohibits recipients of Federal financial assistance from discriminating against persons with disabilities and requires recipients to make their programs and activities accessible to, and usable by, persons with disabilities.
The Fair Housing Act (Title VIII of the Civil Rights Act of 1968, as amended by the Fair Housing Amendments Act of 1988) prohibits discrimination because of race, color, religion, sex, handicap, familial status, and national origin in the sale, rental, or advertising of dwellings in providing services or availability of residential real estate transactions.
The Age Discrimination Act of 1975 prohibits recipients of Federal financial assistance from discriminating in their programs and activities on the basis of age. Post award compliance reviews will be conducted in accordance with RD Instruction 1901-E, section 1901.204.
As part of the grant proposal, the applicant must provide (1) a notice of all civil rights law suits filed against it; (2) a description of assistance applications they have pending in other Agencies and of Federal assistance being provided; (3) a description of any civil rights compliance reviews of the applicant during the preceding two years; and (4) a statement as to whether the applicant has been found in noncompliance with any civil rights requirements.
Successful applicants have a duty to affirmatively further fair housing. Proposals will include specific steps that the applicant will take to promote, ensure, and affirmatively further fair housing.
In the event Federal financial assistance will be used to obtain or improve real property, instruments of conveyance shall contain a covenant running with the land assuring non-discrimination for the period the real property is used for the same or similar purpose the Federal financial assistance is extended or for another purpose involving the provisions of similar services or benefits. The covenant shall be as follows:
“The property described herein was obtained or improved with Federal financial assistance and is subject to the provisions of Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, and the regulations issued thereto. This covenant is in effect for as long as the property continues to be used for the same or similar purpose for which the financial assistance was extended, or for as long as the above recipient owns it, whichever is longer.”
Contractors must comply with the Equal Employment Opportunity Executive Order 11246, as amended, and construction contracts must contain the specific non-discrimination language, in its entirety, that is required by the Executive Order.
Before funds are disbursed, a pre-award civil rights compliance review will be conducted by the Agency to determine whether the applicant is, and will be, in compliance with Title VI of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act of 1973, the Fair Housing Act, and the Age Discrimination Act of 1975. In addition, the Agency will conduct a Civil Rights Impact Analysis.
All applications are subject to satisfactory completion of the appropriate level of environmental review by RHS in accordance with 7 CFR part 1940, subpart G. For the purposes of 7 CFR part 1940, subpart G, applications under this RFP will be considered as applications for the financing of multi-family housing. All applications are subject to the requirements of Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-income Populations.”
All applications are subject to the flood insurance requirements of 7 CFR part 1806, subpart B.
All grants funded under this program must meet the requirements of 7 CFR part 3015 and parts 3016 or 3019, as applicable, Rural Development Instruction 1924-A (7 CFR part 1924, subpart A), and 1924-C (7 CFR part 1924, subpart C).
As required by the Office of Management and Budget (OMB), all grant applicants must provide a DUNS number when applying for Federal grants, on or after October 1, 2003. Organizations can receive a DUNS number at no cost by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711. Additional information concerning this requirement is provided in a policy directive issued by OMB and published in the
A. Proposals must include the following:
1. Standard Form (SF)-424, “Application for Federal Assistance.”
2. Applicant's DUNS number.
3. Documentation to evidence the applicant's status as a private or public nonprofit agency, nonprofit cooperative, state or local government, or tribal organization.
4. Applicant's Financial Statements.
5. Form HUD 935.2, “Affirmative Fair Housing Marketing Plan.”
6. Form RD 3560-30, “Identity of Interest (IOI) Disclosure Certification” and, “Identity of Interest (IOI) Qualification.”
7. Form HUD 2530, “Previous Participation Certification.”
8. Form RD 1924-13, “Estimate and Certificate of Actual Cost.”
9. Form RD 3560-7, “Multiple Family Housing Project Budget” including rent schedule and operating and maintenance budget.
10. Form RD 1940-20, “Request for Environmental Information.”
11. A narrative statement that documents the applicant's experience, knowledge, and capacity to develop multifamily housing.
12. A Sources and Uses Statement showing all sources of funding included in the proposed project. The terms and schedules of all sources included in the project should be included in the Sources and Uses Statement.
13. Applicant organizational documents (articles of incorporation, by laws, etc.).
14. A narrative description of the proposed project, including a description of site, housing, amenities, etc.
15. A location map showing the site and surrounding services.
16. Evidence of site control.
17. Evidence of proper zoning or explanation of how proper zoning will be achieved.
18. Evidence of utilities availability or evidence that the site is suitable for on-site utilities.
19. A description of any related facilities including justification and cost of such facilities.
20. Schematic design drawings including a site plan, building elevations, and floor plans.
21. Outline specifications.
22. A statement agreeing to pay any cost overruns from the applicant's own sources.
23. Documentation of need in the form of a market study, survey, or other sources.
24. A list of all other funding sources and conditional commitments from those funding sources. The conditional commitments must provide the costs of those funds (i.e., rates, terms, fees, etc.).
25. If seeking points under Evaluation Criteria, Paragraph IV.B., a copy of the Tenant Services Plan and letters from the service provider which document that they will provide the service on-site and on a reoccurring basis.
26. Form RD 400-4, Assurance Agreement.
B. The above items are required for the RFP response. If a proposal is accepted for further processing, there will be additional submittals required.
Points will be awarded based on the percent of non-RHS funds specifically identified and designated to supplement RHS funds. Leveraged funds may include donated land. In the case of donated land, the amount of leveraging will be determined by an opinion of value to be prepared by an independent, licensed appraiser. Points will be awarded as follows:
Additional points will be awarded based on the cost of the leveraged funds. A maximum of 30 points will be awarded under this criteria. If a proposal has multiple funding sources, points will be awarded proportionately to the amount that each funding source provides, as a percentage of the applicant's contribution. Points will be awarded as follows:
Points will be awarded based on the presence of and extent to which a tenant services plan exists that clearly outlines services that will be provided to residents of the proposed project.
These services include but are not limited to:
1. Day care or before and after school child care.
2. Computer learning centers.
3. Homeownership and budget counseling.
4. Parenting programs for young parents (such as family support centers), parenting skills sessions for all interested parents, and parent and child activities.
5. Literacy programs (such as book clubs, toddler reading programs, story groups), libraries and book sharing groups or centers.
6. Art activities or art centers for children that include painting, photography, ceramics, etc.
7. Health education and referral or health care outreach centers.
8. Job training and preparation centers.
9. Housing services and/or community coordinators.
10. Mentoring programs where young adults mentor adolescents or more established adults mentor other adults.
11. Community meeting centers.
12. Recreation centers located within housing complexes.
13. Nutritional services.
14. Transportation services.
A Tenant Services Plan must be submitted with the application to receive points under this criteria. In addition, letters from the service provider must be submitted. The letters from the service providers must document that they will provide the services at the project site and on a regular, reoccurring basis. In addition, the proposed design of the housing must include the necessary physical space for the services to be provided on-site. Unless each of the above requirements are met, points will not be awarded. Five points will be awarded for each resident service included in the tenant services plan up to a maximum of 25 points.
In an effort to implement USDA's nationwide initiative to promote renewable energy and energy conservation, Rural Development (RD) has adopted incentives for energy generation and energy conservation. Participation in these nationwide initiatives is voluntary, but is strongly encouraged.
The Applicant will include in the narrative an explanation of how they
All proposals will be evaluated by a RHS grant committee. The grant committee will make recommendations to the RHS Administrator concerning preliminary eligibility determinations and for the selection of proposal for further processing, based on the selection criteria contained in this RFP and the availability of funds. The Administrator will inform applicants of the status of their proposals within 30 days of the closing date of the RFP.
If the proposal is accepted for further processing, the applicant will be expected to submit additional information prior to grant obligation. In addition, RHS must complete the appropriate level of environmental review prior to grant obligation. The applicant is expected to assist RHS, as necessary, in the development of this environmental review. In the event that an application is selected for further processing and the applicant either declines or reduces the size of their grant request, the RHS National Office will, at its discretion, either select the next highest ranked unfunded proposal or not utilize the funds for this demonstration project.
Prior to grant obligation, grant recipients shall enter into the grant agreement provided as Appendix A to this RFP.
The applicant will have one year from the date of the obligation of grant funds to begin construction.
During construction, RHS will take part in periodic progress meetings at the project site and shall inspect completed work. RHS approval of work completed must be given before grant funds can be disbursed for that work.
RHS monitoring shall continue throughout the useful life of the project or until the grant is terminated under provisions established in 7 CFR part 3015 and parts 3016 or 3019, as applicable. Monitoring shall consist of initial and annual tenant certifications, civil rights compliance reviews, triennial physical inspections, annual proposed and actual operating budgets, and annual audits. If other funding sources involved in the project require reporting, those formats may be used in place of RHS methods as long as those formats meet RHS requirements.
Tenants and grantees must execute an Agency-approved tenant certification form establishing the tenant's eligibility prior to occupancy. In addition, tenant households must be recertified and must execute a tenant certification form at least annually.
Grantees will submit to a triennial (once every three years) physical inspection of the project. RHS will inspect for health and safety issues, deferred maintenance, and other physical problems that can endanger the provision of decent, affordable housing to the target population on a long-term basis.
Annual proposed and actual operating and maintenance budgets will be required to insure that all project needs are being met and all RHS guidelines are being followed. The form of operating and maintenance budgets will be designated by RHS.
The grantee must submit annual audits of the project finances to RHS in accordance with the requirements established by OMB, in accordance with in 7 CFR part 3052.
“The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and where applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of an individual's income is derived from any public assistance program. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
To file a complaint of discrimination write to USDA, Director, Office of Civil Rights, 1400 Independence Avenue, SW., Washington, DC. 20250-9410 or call (800) 795-3272 (voice) or (202) 720-6382 (TDD). USDA is an equal opportunity provider, employer, and lender.”
This Grant Agreement (Agreement) dated ____, __, is a contract for receipt of grant funds under the Processing and/or Fishery Worker Housing Grant Demonstration Program authorized in the Consolidated Appropriations Act, 2004 (Pub. L. 108-199). This grant will be administered under the Request for Proposals (RFP): Demonstration Program for Agriculture, Aquaculture, and Seafood Processing and/or Fishery Worker Housing Grants published in the
Between ____________, a private or public nonprofit agency, nonprofit cooperative, state or local government, or tribal organization (Grantee) and the United States of America acting through the Rural Housing Service (RHS), Department of Agriculture, (Grantor)
Witnesseth:
All references herein to “Project” refer to a Processing and/or Fishery Worker Housing facility to serve a rural community generally known as ____. The principal amount of the grant is $____ (Grant Funds) which is ____ percent of Project costs.
Whereas
Grantee has determined to undertake the acquisition, construction, enlargement, capital improvement, or purchase of equipment for a project with a total estimated cost of $____. Grantee is able to finance and has committed $____ of Project costs.
The Grantor has agreed to give the Grantee the Grant Funds, subject to the terms and conditions established by the Grantor. Provided, however, that any Grant Funds actually advanced and not needed for grant purposes shall be returned immediately to the Grantor. The Grantor may terminate the grant in whole, or in part, at any time before the date of completion, whenever it is determined that the Grantee has failed to
As a condition of this Agreement, the Grantee assures and certifies that it is in compliance with and will comply in the course of the Agreement with all applicable laws, regulations, Executive Orders, and other generally applicable requirements, including those contained in 7 CFR 3015.205(b), which are incorporated into this Agreement by reference, and such other statutory provisions as are specifically contained herein.
Now, therefore, in consideration of said grant, and completing and reviewing the collection of information, Grantee agrees that Grantee will:
A. Cause said Project to be constructed within the total sums available to it, including Grant Funds, in accordance with any architectural or engineering reports, and any necessary modifications, prepared by Grantee and approved by Grantor.
B. Provide periodic reports as required by Grantor and permit periodic inspection of the Project by a representative of the Grantor. For grant-only Projects, Form SF-269, “Financial Status Report,” and a project performance report will be required on a quarterly basis (due 15 working days after each calendar quarter). A final project performance report will be required with the last “Financial Status Report.” The final report may serve as the last quarterly report. Grantees shall constantly monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. The project performance reports shall include, but are not limited to, the following:
1. A comparison of actual accomplishments to the objectives established for that period;
2. Reasons why established objectives were not met;
3. Problems, delays, or adverse conditions which will affect attainment of overall project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular project work elements during established time periods. This disclosure shall be accomplished by a statement of the action taken or planned to resolve the situation; and
4. Objectives and timetables established for the next reporting period.
C. Manage, operate, and maintain the facility, including this Project if less than the whole of said facility, continuously in an efficient and economical manner.
D. Not use grant funds to replace any financial support previously provided or assured from any other source. The Grantee agrees that the Grantee's level of expenditure for the Project shall be maintained and not reduced as a result of Grant Funds.
E. Make the public facility or services available to all persons in Grantee's service area without discrimination as to race, color, religion, sex, national origin, age, marital status, sexual orientation or physical or mental disability at reasonable rates, including assessments, taxes, or fees. Grantee may make modifications as long as they are reasonable and nondiscriminatory. The Grantee agrees to comply with Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, Title XI of the Education Act of 1973, the Age Discrimination Act of 1975, Title XI of the Education Act of 1972, Title VIII of the Fair Housing Act of 1968 as amended in 1988, and Executive Order 11246. The Grantee will make the public facility or service available to all persons in the Grantee's service area without regard to discrimination on the grounds of race, color, religion, sex national origin, age, martial status and disability. Grantee will make known to tenants and applicants the reasonable accommodation requirements under the Fair Housing Amendments Act, Section 504 of the Rehabilitation Act of 1973 and Departmental Regulations. Grantee is required to make modification at the complex's expense, unless to so, would cause an undue financial or administrative burden.
F. Execute any agreements required by Grantor which Grantee is legally authorized to execute. If any such agreement has been executed by Grantee as a result of a loan being made to Grantee by Grantor contemporaneously with the making of this grant, that agreement applies equally to the grant and another identical agreement need not be executed in connection with this grant.
G. Repay to Grantor the Grant Funds with any legally permitted interest from the date of any default under its representations or agreements contained in this instrument. The provisions of this Agreement may be enforced by Grantor, at its option and without regard to prior waivers of previous defaults by Grantee, by judicial proceedings to require specific performance of the terms of this Agreement or by such other proceedings in law or equity, in either Federal or State courts, as may be deemed necessary by Grantor to assure compliance with the provisions of this Agreement and the laws and regulations under which this grant is made.
H. Use the real property including land, improvements, structures, and appurtenances thereto, for authorized purposes of the grant as long as needed.
1. Title to real property shall vest in the Grantee subject to the condition that the Grantee shall use the real property for the authorized purpose of the original grant as long as needed.
2. The Grantee shall obtain Grantor's approval to use the real property in other projects when the Grantee determines that the property is no longer needed for the original grant purposes. Use in other projects shall be limited to those under other Federal grant programs or programs that have purposes consistent with those authorized for support by the Grantor.
3. When the real property is no longer needed, as provided in Paragraphs H.1 and H.2 above, the Grantee shall request disposition instructions from the Grantor.
This Grant Agreement covers the following described real property (use continuation sheets as necessary).
I. Abide by the following conditions pertaining to equipment which is furnished by the Grantor or acquired wholly or in part with Grant Funds. Equipment means tangible, non-expendable personal property having a useful life of more than one year.
1. Use of equipment.
(a) The Grantee shall use the equipment in the Project for which it was acquired as long as needed. When no longer needed for the original project, the Grantee shall dispose or use the equipment in accordance with 7 CFR parts 3015, 3016 or 3019 whichever is applicable.
3. The Grantee's property management standards for equipment shall include:
(a) Property records which accurately provide for: A description of the equipment; manufacturer's serial number or other identification number; acquisition date and cost; source of the equipment; percentage (at the end of budget year) of Federal participation in the cost of the Project for which the equipment was acquired; location, use, and condition of the equipment and the date the information was reported; and ultimate disposition data including sales price or the method used to determine current fair market value if the Grantee reimburses the Grantor for its share.
(b) A physical inventory of equipment shall be taken and the results reconciled with the equipment records at least once every two years to verify the existence, current utilization, and continued need for the equipment.
(c) A control system shall be in effect to ensure adequate safeguards to prevent loss, damage, or theft of the equipment. Any loss, damage, or theft of equipment shall be investigated and fully documented.
(d) Adequate maintenance procedures shall be implemented to keep the equipment in good condition.
(e) Proper sales procedures shall be established for unneeded equipment which would provide for competition to the extent practicable and result in the highest possible return.
This Grant Agreement covers the following described equipment (use continuation sheets as necessary).
J. Provide Financial Management Systems which will include:
1. Accurate, current, and complete disclosure of the financial results of each grant. Financial reporting will be on an accrual basis.
2. Records which identify adequately the source and application of funds for grant-supported activities. Those records shall contain information pertaining to grant awards and authorizations, obligations, unobligated balances, assets, liabilities, outlays, and income.
3. Effective control over and accountability for all funds, property, and other assets. Grantees shall adequately safeguard all such assets and shall ensure that they are used solely for authorized purposes.
4. Accounting records supported by source documentation.
K. Retain financial records, supporting documents, statistical records, and all other records pertinent to the grant for a period of at least three years after grant closing except that the records shall be retained beyond the three-year period if audit findings have not
L. Provide either an audit report, annual financial statements, or other documentation prepared in accordance with Grantor regulations to allow the Grantor to determine that funds have been used in compliance with the proposal, any applicable laws and regulations, and this Agreement.
M. Agree to account for and to return to Grantor interest earned on grant funds pending their disbursement for program purposes when the Grantee is a unit of local government. States and agencies or an instrumentality of a State shall not be held accountable for interest earned on Grant Funds pending their disbursement.
N. Not encumber, transfer or dispose of the property or any part thereof, furnished by the Grantor or acquired wholly or in part with Grantor funds without the written consent of the Grantor except as provided in Paragraphs H and I.
O. Not duplicate other Project purposes for which monies have been received, are committed, or are applied to from other sources (public or private).
P. From construction completion throughout the term of the grant, the grantee shall submit on an annual basis, or as needed, the following:
1. Project Operating Budget to be completed on Form RD 1930-7 “Multiple Family Housing Project Budget.” All sections of the budget are to be completed including, but not limited to, proposed and actual income and expense estimates, operating and maintenance expenses, special account statements (reserve, tax and insurance, and security deposit accounts) and capital improvement budgets.
2. Annual Tenant Certification to be completed on Form RD 1944-8, “Tenant Certification.” This document shall be the official means by which tenant eligibility is established. This document must be completed by each tenant and the Grantee at the time of initial move-in, following a fluctuation in tenant income or change in employment sector (processing to non-processing), and on each annual lease anniversary. The Grantee shall verify tenant income and employment sector with pay stubs, employer letters, or other documents which can verify the tenant's employment in agriculture, aquaculture, and seafood processing and/or fishery work and the tenants household income.
3. Other forms and reports as required by Federal, State, or local statute.
Q. Use of Real Property. The facility shall remain in use for its initially designated purpose of providing housing for agriculture, aquaculture, and seafood processing and/or fishery workers. Grantee will not require any occupant of the housing or related facilities, as a condition of occupancy, to work or be employed by any particular processor, fishery, or other place, or work for or be employed by any particular person, firm, or interest. When no longer needed, RHS may approve the use of the property for other uses in accordance with 7 CFR parts 3015, 3016 and 3019, whichever is applicable.
Grantor Agrees That It:
A. Will make available to Grantee for the purpose of this Agreement not to exceed $____ which it will advance to Grantee to meet but not to exceed __ percent of the Project development costs in accordance with the actual needs of Grantee as determined by Grantor.
B. Will assist Grantee, within available appropriations, with such technical assistance as Grantor deems appropriate in planning the Project and coordinating the plan with local official comprehensive plans for essential community facilities and with any State or area plans for the area in which the project is located.
C. At its sole discretion and at any time, may give any consent, deferment, subordination, release, satisfaction, or termination of any or all of Grantee's grant obligations, with or without valuable consideration, upon such terms and conditions as Grantor may determine to be (1) advisable to further the purpose of the grant or to protect Grantor's financial interest therein and (2) consistent with both the statutory purposes of the grant and the limitations of the statutory authority under which it is made.
This Agreement may be terminated for cause in the event of default on the part of the Grantee or for convenience of the Grantor and Grantee prior to the date of completion of the grant purpose. Termination for convenience will occur when both the Grantee and Grantor agree that the continuation of the Project will not produce beneficial results commensurate with the further expenditure of funds.
In witness whereof, Grantee has this day authorized and caused this Agreement to be executed by
Notice is hereby given that the application submitted by the Louisville and Jefferson County Riverport Authority, grantee of FTZ 29, requesting special-purpose subzone status for the forklift truck manufacturing facility of NACCO Materials Handling Group, Inc. (NMHG), located in Berea, Kentucky (71 FR 54611, 9-18-2006) has been amended to include an additional site (1 warehouse/195,000 sq.ft./22 acres) comprised of Building 105 located at 145 Hi Lane Drive in Richmond (Madison County), Kentucky.
Public comment is invited from interested parties. The comment period is hereby reopened until [30 days from date of publication]. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below.
A copy of the application and the amendment is available for public inspection at each of the following locations: U.S. Department of Commerce Export Assistance Center, 1600 World Trade Center, 333 W. Vine Street, Lexington, Kentucky 40507; and, Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW, Washington, District of Columbia 20230-0002. For further information, contact Pierre Duy, examiner, at pierre_duy@ita.doc.gov, or (202) 482-1378.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board
Subzone 86D (108,200 BPD capacity, 350 employees) was approved by the Board in 2001 for the manufacture of fuel products and certain petrochemical feedstocks and refinery by-products (Board Order 1140, 66 FR 6583-6585, 1-22-2001).
The subzone is located on West March Point Road in Anacortes, Washington (Skagit County). The request anticipates expansion of Tesoro's crude unit and modifications and upgrades to existing units within the refinery complex that may increase the overall crude distillation capacity of the refinery up to 150,000 BPD. No additional feedstocks or products have been requested.
Zone procedures would exempt the increased production from customs duty payments on the foreign products used in its exports. On domestic sales of the increased production, the company would be able to choose the finished product duty rate on certain petrochemical feedstocks and refinery by-products (duty-free) by admitting foreign crude oil in non-privileged foreign status. The duty rates on crude oil range from 5.25 cents/barrel to 10.5 cents/barrel. The application indicates that the savings from zone procedures help improve the refinery's international competitiveness.
In accordance with the Board's regulations, a member of the FTZ staff has been designated examiner to investigate the application and report to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is September 17, 2007. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period (to October 1, 2007).
A copy of the application and accompanying exhibits will be available for public inspection at each of the following locations:
U.S. Department of Commerce Export Assistance Center, 2601 Fourth Avenue, Suite 310, Seattle, WA 98121.
Office of the Executive Secretary, Foreign-Trade Zones Board, U.S. Department of Commerce, Room 2111, 1401 Constitution Ave., NW, Washington, DC 20230.
For further information, contact Diane Finver at
Bureau of Industry and Security, Commerce.
Notice of inquiry.
The Bureau of Industry and Security (BIS) is soliciting comments from the public regarding the Commerce Control List (CCL) in the Export Administration Regulations (EAR). BIS has already requested that its Technical Advisory Committees (TACs) review the CCL and recommend potential changes to BIS. BIS believes that it would also be beneficial to allow interested members of the public to submit comments regarding the CCL.
Comments must be received by September 17, 2007.
Written comments on this notice of inquiry may be sent by e-mail to
Timothy Mooney, Regulatory Policy Division, Bureau of Industry and Security, telephone: (202) 482-2440, e-mail:
The Commerce Control List (CCL) is found in Supplement No. 1 to part 774 of the EAR. The CCL is a list of items subject to the Export Administration Regulations (EAR). Items subject to the EAR are under the export control jurisdiction of the Bureau of Industry and Security (BIS), U.S. Department of Commerce. The CCL covers items (i.e., commodities, software, and technology) enumerated in Export Control Classification Numbers (ECCNs). There are 10 general categories (0-9) of ECCNs and each category has five parts (Systems, Equipment and Components; Test, Inspection and Production Equipment; Materials; Software; and Technology). The CCL covers a broad range of commodities, software and technologies and plays an important role in the U.S. system for controlling the export of dual-use items. Items not listed on the CCL, but subject to the EAR, are designated as EAR99.
Changes are made regularly to the CCL to reflect revisions in the control lists of the multilateral export control regimes (Wassenaar Arrangement; Missile Technology Control Regime; Australia Group; Nuclear Suppliers' Group). To conduct a more systematic review of the CCL, BIS has requested that its TACs review the CCL and recommend potential changes to BIS.
In addition to seeking recommendations from its TACs, BIS is also inviting the interested public to submit comments regarding:
(1) The overall structure of the CCL, including suggestions for how the structure of the CCL may be changed to better advance U.S. national security, foreign policy, and economic interests;
(2) Types of items that should be listed on the CCL and the appropriate levels of controls to be placed on those items, taking into account technology levels, markets, and foreign availability;
(3) Any updates to the CCL item descriptions that would enable the descriptions to better reflect the intent of the multinational controls and to eliminate any overly broad descriptions that inadvertently capture non-critical items that are not controlled by other countries; and
(4) Coordination and harmonization of controls on items covered by the multilateral regimes, such as the Wassenaar Arrangement.
Comments should be submitted to BIS as described in the
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) is conducting an administrative review of the antidumping duty order on chlorinated isocyanurates (“chlorinated isos”) from the People's Republic of China (“PRC”) covering the period December 16, 2004, through May 31, 2006. We have preliminarily determined that sales have been made below normal value (“NV”) by Hebei Jiheng Chemical Company Ltd. (“Jiheng Chemical”). If these preliminary results are adopted in our final results of this review, we will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of subject merchandise during the period of review (“POR”).
Interested parties are invited to comment on these preliminary results. We intend to issue the final results no later than 120 days from the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”).
July 17, 2007.
Katharine Huang or Charles Riggle, AD/CVD Operations, Office 8, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-1271 or (202) 482-0650, respectively.
On June 24, 2005, the Department published the antidumping duty order on chlorinated isos from the PRC.
On July 27, 2006, the Department initiated this administrative review with respect to Jiheng Chemical.
On August 16, 2006, the Department requested that the Office of Policy provide a list of surrogate countries for this review.
On August 24, 2006, the Department requested that interested parties submit surrogate value information. On September 12, 2006, the Department requested that interested parties provide surrogate country selection comments. On September 15, 2006, Clearon and OxyChem (“Petitioners”) and BioLab requested an extension of time for all interested parties to submit surrogate value information, provide surrogate country selection comments, and submit factual information. On September 19, 2006, the Department granted the Petitioners' and BioLab's extension requests. On October 25, 2006, BioLab requested a further extension of time to submit surrogate value information and provide surrogate country selection comments. On October 31, 2006, the Department granted the requested extension to all parties.
On November 17, 2006, Petitioners, BioLab and Jiheng Chemical provided comments on publicly available information to value the factors of production (“FOP”) and the selection of a surrogate country. All interested parties recommended India as the surrogate country. On November 27, 2006, Jiheng Chemical submitted rebuttal comments on Petitioners' November 17, 2006 surrogate value submission. On November 27, 2006, Petitioners and BioLab requested an extension of time for all parties to submit rebuttal information concerning surrogate values. On November 28, 2006, the Department granted Petitioners' and BioLab's extension requests. On November 30, 2006, BioLab requested an extension of time for all parties to submit factual information. On December 4, 2006, the Department granted BioLab's extension request. On December 6, 2006, Petitioners and BioLab submitted rebuttal comments on Jiheng Chemical's November 17, 2006 surrogate value submission. On December 15, 2006, Jiheng Chemical submitted rebuttal information on Petitioners' and BioLab's December 6, 2006 submissions.
On December 15, 2006, Petitioners and BioLab submitted factual information on surrogate value selection. On December 26, 2006, Petitioners submitted comments on Jiheng Chemical's December 15, 2006 rebuttal information. On January 5, 2007, Jiheng Chemical submitted rebuttal information on Petitioners' December 26, 2006 comments. On January 16, 2007, Petitioners submitted rebuttal information on Jiheng Chemical's January 5, 2007 comments.
On October 11, 2006, Jiheng Chemical submitted its sections A, C, and D questionnaire responses (“AQR, CQR and DQR”, respectively). On November 6, 2006, the Department issued a section A supplemental questionnaire to Jiheng Chemical. On November 17, 2006, BioLab submitted comments on Jiheng Chemical's AQR, CQR and DQR. Petitioners submitted comments on Jiheng Chemical's AQR, CQR and DQR on November 20, 2006. On November 28, 2006, Jiheng Chemical submitted rebuttal comments on Petitioners' November 20, 2006, and BioLab's November 17, 2006, comments on its AQR, CQR and DQR. On December 5, 2006, Jiheng Chemical submitted its section A supplemental questionnaire response (“1
On March 6, 2007, the Department issued a second supplemental questionnaire to Jiheng Chemical. On April 5, 2007, Jiheng Chemical submitted its second supplemental questionnaire response (“2
On April 30, 2007, Jiheng Chemical submitted its supplemental questionnaire response on desiccant. Jiheng Chemical submitted rebuttal comments on May 1, 2007, addressing Petitioners' April 24, 2007 and BioLab's April 25, 2007 comments on its 2
On March 5, 2007, the Department published a notice in the
The products covered by this order are chlorinated isocyanurates, as described below:
Chlorinated isocyanurates are derivatives of cyanuric acid, described as chlorinated s-triazine triones. There are three primary chemical compositions of chlorinated isocyanurates: (1) trichloroisocyanuric acid (Cl
Chlorinated isocyanurates are currently classifiable under subheadings 2933.69.6015, 2933.69.6021, 2933.69.6050, 3808.40.50, 3808.50.40 and 3808.94.50.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). The tariff classification 2933.69.6015 covers sodium dichloroisocyanurates (anhydrous and dihydrate forms) and trichloroisocyanuric acid. The tariff classifications 2933.69.6021 and 2933.69.6050 represent basket categories that include chlorinated isocyanurates and other compounds including an unfused triazine ring. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive.
Jiheng Chemical did not contest the Department's treatment of the PRC as a non-market economy (“NME”), and the Department has treated the PRC as an NME country in all past antidumping duty investigations and administrative reviews and continues to do so in this case.
Section 773(c)(1) of the Act directs the Department to base NV on the NME producer's FOPs, valued in a surrogate market-economy country or countries considered to be appropriate by the Department. In accordance with section 773(c)(4) of the Act, in valuing the FOPs, the Department shall use, to the extent possible, the prices or costs of the FOPs in one or more market-economy countries that are: (1) at a level of economic development comparable to that of the NME country; and (2) significant producers of comparable merchandise. The sources of the surrogate factor values are discussed under the “Normal Value” section below and in the Surrogate Value Memorandum.
The Department has previously determined that India, Indonesia, Sri Lanka, the Philippines, and Egypt are countries comparable to the PRC in terms of economic development.
The Department used India as the primary surrogate country and accordingly, has calculated NV using Indian prices to value the PRC producers' FOPs, when available and appropriate.
In accordance with 19 CFR 351.301(c)(3)(ii), for the final results in an antidumping administrative review, interested parties may submit publicly available information to value factors of production within 20 days after the date of publication of the preliminary results of review.
In proceedings involving NME countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control, and thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of subject merchandise subject to review in an NME country a single rate unless an exporter can demonstrate that it is sufficiently independent of government control to be entitled to a separate rate.
The Department's separate-rate test to determine whether the exporters are independent from government control does not consider, in general, macroeconomic/border-type controls,
To establish whether an exporter is sufficiently independent of government control to be entitled to a separate rate, the Department analyzes the exporter in light of select criteria, discussed below.
Jiheng Chemical provided company-specific separate-rate information. Jiheng Chemical reported that it is owned by all the people of the PRC.
The Department considers the following
Jiheng Chemical has placed documents on the record to demonstrate the absence of
As stated in previous cases, there is some evidence that certain enactments of the PRC central government have not been implemented uniformly among different sectors and/or jurisdictions in the PRC.
With regard to
Section 351.401(i) of the Department's regulations states that:
in identifying the date of sale of the subject merchandise or foreign like product, the Secretary normally will use the date of invoice, as recorded in the exporter or producer's records kept in the normal course of business. However, the Secretary may use a date other than the date of invoice if the Secretary is satisfied that a different date better reflects the date on which the exporter or producer establishes the material terms of sale.
To determine whether sales of chlorinated isos to the United States by Jiheng Chemical were made at less than NV, we compared export price (“EP”) to NV, as described in the “Export Price,” and “Normal Value” sections of this notice, pursuant to section 771(35) of the Act.
Petitioners and BioLab requested that the Department determine that Jiheng Chemical is affiliated with one of its U.S. customers and, accordingly, base U.S. price on constructed-export-price (“CEP”) rather than EP. Our analysis of Jiheng Chemical's questionnaire responses reveals no information to support a finding that Jiheng Chemical is affiliated with its U.S. customer.
We calculated EP based on the delivered price to unaffiliated purchasers for Jiheng Chemical. From this price, we deducted amounts for foreign inland freight, brokerage and handling and marine insurance, where applicable, pursuant to section 772(c)(2)(A) of the Act.
The Department used two sources to calculate a surrogate value for domestic brokerage expenses. The Department averaged the December 2003-November 2004 data contained in Essar Steel's February 28, 2005 public version response submitted in the antidumping duty administrative review of hot-rolled carbon steel flat products from India.
To value truck freight, we used the freight rates published by Indian Freight Exchange, available at http://www.infreight.com. The truck freight rates are contemporaneous with the POR; therefore, we made no adjustments for inflation.
Jiheng Chemical reported that its U.S. customer(s) provided it with certain raw materials and packing materials free of charge. For Jiheng Chemical's products that contained inputs provided free of charge by its customer,
Section 773(c)(1) of the Act provides that, in the case of an NME, the Department shall determine NV using an FOP methodology if the merchandise is exported from an NME and the information does not permit the calculation of NV using home-market prices, third-country prices, or constructed value under section 773(a) of the Act.
The Department will base NV on FOP because the presence of government controls on various aspects of these economies renders price comparisons and the calculation of production costs invalid under our normal methodologies. Therefore, we calculated NV based on FOP in accordance with sections 773(c)(3) and (4) of the Act and 19 CFR 351.408(c). The FOPs include: (1) hours of labor required; (2) quantities of raw materials employed; (3) amounts of energy and other utilities consumed; and (4) representative capital costs. We used the FOPs reported by respondents for materials, energy, labor, by-products, and packing.
In accordance with 19 CFR 351.408(c)(1), the Department will normally use publicly available information to value the FOPs, but when a producer sources an input from a market-economy country and pays for it in market-economy currency, the Department may value the factor using the actual price paid for the input.
With regard to both the Indian import-based surrogate values and the market-economy input values, we have disregarded prices that we have reason to believe or suspect may be subsidized. We have reason to believe or suspect that prices of inputs from India, Indonesia, South Korea, and Thailand may have been subsidized. We have found in other proceedings that these countries maintain broadly available, non-industry-specific export subsidies and, therefore, it is reasonable to infer that all exports to all markets from these countries may be subsidized.
In accordance with section 773(c) of the Act, we calculated NV based on the FOPs reported by Jiheng Chemical for the POR. To calculate NV, we multiplied the reported per-unit factor quantities by publicly available Indian surrogate values (except as noted below). In selecting the surrogate values, we considered the quality, specificity, and contemporaneity of the data. As appropriate, we adjusted input prices by including freight costs to render them delivered prices. Specifically, we added to Indian import surrogate values a surrogate freight cost using the shorter of the reported distance from the domestic supplier to the factory or the distance from the nearest seaport to the factory. This adjustment is in accordance with the decision of the Federal Circuit in
Except as noted below, we valued raw material inputs using the weighted-average unit import values derived from the Monthly Statistics of the Foreign Trade of India, as published by the Directorate General of Commercial Intelligence and Statistics of the Ministry of Commerce and Industry, Government of India in the World Trade Atlas, available at http://www.gtis.com/wta.htm (“WTA”). Where we could not obtain publicly available information contemporaneous with the POR with which to value FOPs, we adjusted the SVs using, where appropriate, the Indian Wholesale Price Index (“WPI”) as published in the International Financial Statistics of the International Monetary Fund.
We valued hydrochloric acid, barium chloride and sulfuric acid using
Jiheng Chemical reported that its U.S. customer(s) provided certain raw materials and packing materials free of charge. For Jiheng Chemical's products that included raw materials and packing materials provided free of charge by its customer, consistent with the Department's practice, we used the built-up cost (
To value electricity, we used the 2000 electricity price data from International Energy Agency, Energy Prices and Taxes - Quarterly Statistics (First Quarter 2003), adjusted for inflation.
To value water, we used the revised Maharashtra Industrial Development Corporation (“MIDC”) water rates for June 1, 2003 for the Mumbai region, available at http://www.midcindia.com/water-supply, adjusted for inflation.
For direct labor, indirect labor and packing labor, consistent with 19 CFR 351.408(c)(3), we used the PRC regression-based wage rate as reported on Import Administration's web site.
For factory overhead, selling, general, and administrative expenses (“SG&A”), and profit values, we used information from Kanoria Chemicals and Industries Limited, and DCM Sriram Consolidated Ltd. for the year ending March 31, 2006. From this information, we were able to determine factory overhead as a percentage of the total raw materials, labor and energy (“ML&E”) costs; SG&A as a percentage of ML&E plus overhead (
For packing materials, we used the per-kilogram values obtained from the WTA and made adjustments to account for freight costs incurred between the PRC supplier and Jiheng Chemical's plant.
We made currency conversions into U.S. dollars, in accordance with section 773A(a) of the Act, based on the exchange rates in effect on the dates of the U.S. sales, as certified by the Federal Reserve Bank.
We preliminarily determine that the following weighted-average dumping margin exists:
We will disclose the calculations used in our analysis to parties to this proceeding within five days of the publication date of this notice.
Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after the date of publication of the final results of this administrative review. If these preliminary results are adopted in our final results of review, we will direct CBP to assess the resulting per-unit value or
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) for Jiheng Chemical, which has a separate rate, the cash deposit rate will be the company-specific rate established in the final results of review (except, if the rate is zero or
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This determination is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On April 20, 2007, the Department of Commerce (“the Department”) published the preliminary intent to rescind the antidumping duty new shipper review of the antidumping duty order on certain circular welded non-alloy steel pipe from Mexico.
July 17, 2007.
John Drury or Patrick Edwards, 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) 482-0195 or (202) 482-8029, respectively.
On November 2, 1992, the Department published the antidumping duty order on circular welded non-alloy steel pipe from Mexico.
On April 20, 2007, the Department published in the
The merchandise under review is circular welded non-alloy steel pipes and tubes, of circular cross-section, not more than 406.4 millimeters (16 inches) in outside diameter, regardless of wall thickness, surface finish (black, galvanized, or painted), or end finish (plain end, beveled end, threaded, or threaded and coupled). These pipes and tubes are generally known as standard pipes and tubes and are intended for the low-pressure conveyance of water, steam, natural gas, and other liquids and gases in plumbing and heating systems, air conditioning units, automatic sprinkler systems, and other related uses, and generally meet ASTM A-53 specifications. Standard pipe may also be used for light load-bearing applications, such as for fence tubing, and as structural pipe tubing used for framing and support members for reconstruction or load-bearing purposes in the construction, shipbuilding, trucking, farm equipment, and related industries. Unfinished conduit pipe is also included in these orders. All carbon steel pipes and tubes within the physical description outlined above are included within the scope of these orders, except line pipe, oil country tubular goods, boiler tubing, mechanical tubing, pipe and tube hollows for
Imports of the products covered by these orders are currently classifiable under the following Harmonized Tariff Schedule (HTS) subheadings: 7306.30.10.00, 7306.30.50.25, 7306.30.50.32, 7306.30.50.40, 7306.30.50.55, 7306.30.50.85, and 7306.30.50.90. Although the HTS subheadings are provided for convenience and customs purposes, our written description of the scope of these proceedings is dispositive.
The Department may rescind a new shipper review with respect to an exporter or producer if the Department concludes that there were no entries, exports, or sales of the subject merchandise to the United States during the period of review.
The Department will notify U.S. Customs and Border Protection that bonding is no longer permitted to fulfill security requirements for shipments by Conduit of certain circular welded non-alloy steel pipe from Mexico entered, or withdrawn from warehouse, for consumption in the United States on or after the publication of this rescission notice in the
This notice also serves as the only reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR § 351.305(a)(3). Timely written notification of the return/destruction of APO material or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation that is subject to sanctions.
This notice is issued and published in accordance with sections 751(a)(2) and 777(i)(1) of the Tariff Act of 1930, as amended.
Import Administration, International Trade Administration, Department of Commerce.
This new shipper review covers stainless steel bar from Germany manufactured by Schmiedewerke Groditz GmbH (“SWG”). The Department of Commerce (“the Department”) published the preliminary results of this new shipper review on March 19, 2007.
July 17, 2007.
Damian Felton, Audrey R. Twyman, or Brandon Farlander, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington DC 20230; telephone (202) 482-0133, (202) 482-3534, or (202) 482-0182, respectively.
On March 19, 2007, the Department published its
The period of review (“POR”) covers March 1, 2005, through February 28, 2006.
For the purposes of this order, the term “stainless steel bar” includes articles of stainless steel in straight lengths that have been either hot-rolled, forged, turned, cold-drawn, cold-rolled or otherwise cold-finished, or ground, having a uniform solid cross section along their whole length in the shape of circles, segments of circles, ovals, rectangles (including squares), triangles, hexagons, octagons, or other convex polygons. Stainless steel bar (“SSB”) includes cold-finished stainless steel bars that are turned or ground in straight lengths, whether produced from hot-rolled bar or from straightened and cut rod or wire, and reinforcing bars that have indentations, ribs, grooves, or other deformations produced during the rolling process.
Except as specified above, the term does not include stainless steel semi-finished products, cut length flat-rolled products (
The SSB subject to this order is currently classifiable under subheadings 7222.11.00.05, 7222.11.00.50, 7222.19.00.05, 7222.19.00.50, 7222.20.00.05, 7222.20.00.45, 7222.20.00.75, and 7222.30.00.00 of the
All issues raised in the case and rebuttal briefs by parties to this new shipper review are addressed in the
Based on our analysis of comments received, we have made no changes to our
As a result of our review, we determine that the following weighted-average margin exists for SWG for the period of March 1, 2005, through February 28, 2006:
The Department shall determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries. Pursuant to 19 CFR 351.212(b)(1), for the U.S. sale made by the respondent for which it has reported the importer of record and entered value, we have calculated an importer-specific assessment rate based on the ratio of the total amount of antidumping duties calculated for the examined sales to the total entered value of the U.S. sale.
The Department clarified its “automatic assessment” regulation on May 6, 2003 (68 FR 23954). This clarification will apply to entries of subject merchandise during the period of review produced by reviewed companies for which these companies did not know their merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. For a full discussion of this clarification, see
The Department will issue appropriate assessment instructions directly to CBP 15 days after the date of publication of these final results of the new shipper review.
The following cash deposit rate will be effective upon publication of the final results of this new shipper review for shipments of stainless steel bar from Germany entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Tariff Act of 1930, as amended (“the Act”). For subject merchandise produced and exported by SWG, the cash deposit rate will be the rate established in the final results of this review, except if the rate is less than 0.50 percent and, therefore, de minimis, the cash deposit rate will be zero. This cash deposit requirement, when imposed, shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation, which is subject to sanction.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Comment 1: Quantity, Pricing and Terms of Sale Differences
Comment 2: Principal/Agent Relationship
Comment 3: Mill Certificates
Comment 4: Communication with U.S. Customer
Comment 5: Home Market Date of Sale
National Oceanic and Atmospheric Administration, U.S. Department of Commerce, and the U.S. Environmental Protection Agency.
Notice of Intent to Approve the Guam Coastal Nonpoint Program.
Notice is hereby given of the intent to fully approve the Guam Coastal Nonpoint Pollution Control Program (coastal nonpoint program) and of the availability of the draft Approval Decisions on conditions for the Guam coastal nonpoint program. Section 6217 of the Coastal Zone Act Reauthorization Amendments (CZARA), 16 U.S.C. section 1455b, requires States and Territories with coastal zone management programs that have received approval under section 306 of the Coastal Zone Management Act to develop and implement coastal nonpoint programs. Coastal States and Territories were required to submit their coastal nonpoint programs to the National Oceanic and Atmospheric Administration (NOAA) and the U.S. Environmental Protection Agency (EPA) for approval in July 1995. NOAA and EPA conditionally approved the Guan coastal nonpoint program on October 3, 1997. NOAA and EPA have drafted approval decisions describing how Guam has satisfied the conditions placed on its program and therefore has a fully approved coastal nonpoint program.
NOAA and EPA are making the draft decisions for the Guam coastal nonpoint program available for a 30-day public comment period. If comments are received, NOAA and EPA will consider whether such comments are significant enough to affect the decision to fully approve the program.
Copies of the draft Approval Decisions can be found on the NOAA Web site at
Individuals or organizations wishing to submit comments on the draft Approval Decisions should do so by August 16, 2007.
Comments should be made to: John King, Chief, Coastal Programs Division (N/ORM3), Office of Ocean and Coastal Resource Management, NOS, NOAA, 1305 East-West Highway, Silver Spring, Maryland 20910, phone (301) 713-3155, x188, e-mail
Allison Castellan, Coastal Programs Division, (N/ORM3), Office of Ocean and Coastal Resource Management, NOS, NOAA, 1305 East-West Highway, Silver Spring, Maryland 20910, phone (301) 713-3155, x125, e-mail
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council will hold a meeting of its Information and Education Advisory Panel, in North Charleston, SC.
The meeting will take place August 29-30, 2007. See
The meeting will be held at the Hilton Garden Inn Charleston Airport, 5265 International Boulevard, North Charleston, SC; telephone: (843) 308-9331 or toll free (800) 445-8667.
Kim Iverson, Public Information Officer; telephone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email:
Members of the Information and Education Advisory Panel will meet from 1:30 p.m. to 5 p.m. on August 29, 2007, and from 8:30 a.m. to 5 p.m. on August 30, 2007.
Agenda items for the meeting include, but are not limited to: (1) Review and update of current outreach efforts used by the South Atlantic Fishery Management Council, including web site, news releases, quarterly newsletters and other publications; (2) discussion and recommendations for outreach efforts, including partnerships, for deepwater marine protected areas proposed for the South Atlantic region; and (3) review and provide recommendations for NOAA Fisheries' FishWatch Seafood Consumer Education Program.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see
Note: The times and sequence specified in this agenda are subject to change.
National Guard Bureau (NGB), Department of the Army (DA), DoD.
Notice of Availability.
This LEIS has been prepared by NGB (lead agency) and the Department of the Interior's (DOIs) Bureau of Land Management (BLM) (cooperating agency). The LEIS analyzes the proposed withdrawal of 18,644 acres of federal land within the Limestone Hills Training Area (LHTA) from BLM administration. The LEIS proposes that the DOI and Congress transfer administrative responsibility of all federal land within the LHTA to the Army for military training use by the MTARNG. No new facilities are proposed in this LEIS.
The public comment period for the Draft LEIS will end 90 days after publication of an NOA in the
Written comments or questions should be forwarded by mail to Ms. Sundi West, MTARNG, Fort Harrison, P.O. Box 4789, Helena, Montana 59604-4789; via telephone at (406) 324-3088, or via e-mail at
Ms. Mary L. Figarelle, BLM, 106 North Parkmont, Butte, Montana 59701; via telephone at (406) 533-7671; or via e-mail at
The objective of the LEIS is to provide comprehensive analysis of the proposed action and alternatives to the Secretaries of Interior and Army so findings and recommendations can be forwarded to Congress regarding the proposed land withdrawal. The study area for the environmental analysis is resource dependent. It includes Lewis and Clark County and Broadwater County for socioeconomic resources, MTARNG facilities for military mission, and the LHTA for biological and mineral resources.
The LEIS analyzes potential environmental effects of four alternatives:
(1)
(2)
(3)
(4)
Issues in the LEIS include the following: (1) Continued ability of Graymont Western's Indian Creek Limestone Mine to extract and process ore within the LHTA; (2) allocation and management of grazing allotments; (3) public access to the LHTA; (4) noise and dust generated during training exercises and by vehicular traffic; (5) impacts to Broadwater County due to possible termination of FLM payments in lieu of taxes if the withdrawal is granted; (6) potential impacts to wildlife I the Elkhorn Management Area; (7) consistency of land management policies after transfer of administrative responsibilities; (8) potential impacts to range management and cleanup activities; (9) owner access to, and use of, in-holdings; and (10) impacts to the local economy and MTARNG training under the no action alternative.
Potential significant adverse impacts to socioeconomics are expected under Alternatives 1 and 4. There are no potentially significant adverse impacts expected under Alternative 2 or 3 (Preferred Alternative).
The DA, through MTARNG, is continuing its public comment process for this action. Public meetings will be held during the LEIS public review period.
Department of Education.
The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before August 16, 2007.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, Washington, DC 20503. Commenters are encouraged to submit responses electronically by e-mail to:
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and
Requests for copies of the information collection submission for OMB review may be accessed from:
Comments regarding burden and/or the collection activity requirements should be electronically mailed to:
Department of Education.
The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before September 17, 2007.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) title; (3) summary of the collection; (4) description of the need for, and proposed use of, the information; (5) respondents and frequency of collection; and (6) reporting and/or recordkeeping burden. OMB invites public comment.
The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Requests for copies of the proposed information collection request may be accessed from:
Comments regarding burden and/or the collection activity requirements should be electronically mailed to:
National Committee on Foreign Medical Education and Accreditation, Department of Education.
The purpose of this notice is to announce the upcoming meeting of the National Committee on Foreign Medical Education and Accreditation. Parts of this meeting will be open to the public, and the public is invited to attend those portions.
We will hold the public meeting on September 10, 2007 from 8 a.m. until approximately 5 p.m. in the Potomac Three Room at The Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington, DC 20037-6936. You may call the hotel at 202-955-6400 to inquire about room accommodations.
The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format) notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.
Please contact Ms. Carol A. Griffiths, the Designated Federal Official for the National Committee on Foreign Medical Education and Accreditation, if you have questions about the meeting. You may contact her at the U.S. Department of Education, room 7128, MS 7563, 1990 K St., NW., Washington, DC 20006, telephone: (202) 219-7035, fax: (202) 219-7005, e-mail:
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service at 1-800-877-8339.
The National Committee on Foreign Medical Education and Accreditation was established by the Secretary of Education under section 102 of the Higher Education Act of 1965, as amended.
The Committee's responsibilities are to:
• Evaluate the standards of accreditation applied to applicant foreign medical schools; and
• Determine the comparability of those standards to standards for accreditation applied to United States medical schools.
The National Committee on Foreign Medical Education and Accreditation will review the standards of accreditation applied to medical schools by several foreign countries to determine whether those standards are comparable to the standards of accreditation applied to medical schools in the United States. Discussions of the standards of accreditation will be held in sessions open to the public. Discussions that focus on specific determinations of comparability are closed to the public in order that each country may be properly notified of the decision.
The countries tentatively scheduled to be discussed at the meeting include: Australia/New Zealand, Dominican Republic, Hungary, India, Israel, The Netherlands, Pakistan, Philippines, Poland, Saba, Slovakia, and Taiwan. Beginning August 27, you may call the contact person listed above to obtain the final listing of the countries whose standards will be discussed during this meeting. The listing of countries will also be posted on the Department of Education's Web site at the following address:
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
5 U.S.C. Appendix 2.
United States Election Assistance Commission.
Notice of public meeting (amended agenda).
Thursday, July 19, 2007, 1 p.m.-4 p.m.
The Charlotte Convention Center, Room 207D, 501 South College Street, Charlotte, NC 28202, (704) 339-6000.
In addition to considering the adoption of a draft EAC manual on Poll Worker Recruitment, Training and Retention, and a draft EAC manual on Recruiting College Poll Workers, and other administrative matters (notice published in the
This meeting will be open to the public.
Bryan Whitener, Telephone: (202) 566-3100.
United States Election Assistance Commission.
Notice of rescheduled plenary teleconference meeting for the Technical Guidelines Development Committee.
Friday August 17, 2007, 11:30 a.m. to 5:30 p.m. EDT.
National Institute of Standards and Technology, 100 Bureau Drive, Building 101, Gaithersburg, Maryland 20899-8900.
This teleconference meeting will be Web cast to the public. Additional meeting information and URL Web link for the event will be available at:
The Technical Guidelines Development Committee (the “Development Committee”) has rescheduled a plenary teleconference meeting for August 17, 2007. This meeting date serves as a rescheduling of the July 3, 2007 plenary teleconference that was cancelled. The Development Committee was established in 2004 to act in the public interest to assist the Executive Director of the U.S. Election Assistance Commission (EAC) in the development of voluntary voting system guidelines. The Development Committee has held nine previous plenary meetings. The proceedings of these plenary sessions are available at:
The Technical Guidelines Development Committee (the “Development Committee”) has scheduled a plenary teleconference meeting for July 3, 2007. The Committee was established pursuant to 42 U.S.C. 15361, to act in the public interest to assist the Executive Director of the Election Assistance Commission in the development of the voluntary voting system guidelines. The Technical Guidelines Development Committee held their first plenary meeting on July 9, 2004. At this meeting, the Development Committee agreed to a resolution forming three working groups: (1) Human Factors & Privacy; (2) Security & Transparency; and (3) Core Requirements & Testing to gather information and review preliminary reports on issues pertinent to voluntary voting standard recommendations. At subsequent plenary sessions, additional resolutions were debated and adopted by the TGDC. The resolutions define technical work tasks for NIST that assist the TGDC in developing recommendations for voluntary voting system guidelines. The Development Committee approved initial recommendations for voluntary voting system guidelines at the April 20th & 21st, 2005 meeting. The recommendations were formally delivered to the EAC in May 2005 for their review. In September of 2005, the Development Committee began review of preliminary technical reports for the next iteration of voluntary voting system guidelines. The Committee will review, debate and approve a final draft of recommendations for the next iteration of voluntary voting system guidelines at the August 17, 2007 teleconference meeting.
Allan Eustis 301-975-5099. If a member of the public would like to submit comments concerning the Committee's affairs at any time before or after the meeting, written comments should be addressed to the contact person indicated above, c/o NIST, 100 Bureau Drive, Mail Stop 8970, Gaithersburg, MD 20899 or to:
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Tuesday, July 31, 2007, 9 a.m. to 5 p.m., and Wednesday, August 1, 2007, 8:30 a.m. to 12 p.m.
Hilton Washington DC/Rockville Executive Meeting Center 1750 Rockville Pike, Rockville, MD.
Karen Talamini; Office of Basic Energy Sciences; U.S. Department of Energy; Germantown Building, Independence Avenue, Washington, DC 20585; Telephone: (301) 903-4563.
Department of Energy.
Notice of open meeting.
The Hydrogen and Fuel Cell Technical Advisory Committee (HTAC) was established under section 807 of the Energy Policy Act of 2005 (EPACT), Public Law 109-58; 119 Stat. 849. The Federal Advisory Committee Act, Public Law 92-463, 86 Stat. 770, requires that public notice of these meetings be announced in the
Tuesday, July 31, 2007, from 9 a.m.-6 p.m. and Wednesday, August 1, 2007 from 9 a.m.-12 p.m.
Crystal City Marriott, 1999 Jefferson-Davis Highway, Arlington, Virginia 22202.
• Input from HTAC on Suggested Focus Areas for the Interagency Task Force.
• Briefing on the Well-to-Wheels Analysis, Appendix B of Hydrogen Posture Plan.
• Update on Restructuring of HELP.
• Members' Preparation of the Posture Plan Review Report.
• Next Steps.
The following notice of meeting is published pursuant to section 3(a) of the Government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Chairman Kelliher and Commissioners Kelly, Spitzer, Moeller, and Wellinghoff voted to hold a closed meeting on July 19, 2007. The certification of the General Counsel explaining the action closing the meeting is available for public inspection in the Commission's Public Reference Room at 888 First Street, NE., Washington, DC 20426.
The Chairman and the Commissioners, their assistants, the Commission's Secretary, the General Counsel and members of his staff, and a stenographer are expected to attend the meeting. Other staff members from the Commission's program offices who will advise the Commissioners in the matters discussed will also be present.
Environmental Protection Agency (EPA).
Notice of final orders on petitions to object to State operating permits.
This document announces that the EPA Administrator has responded to four petitions asking EPA to object to six Clean Air Act (CAA) operating permits proposed by the Illinois Environmental Protection Agency (IEPA). Specifically, the Administrator denied the petitions submitted by the Illinois Attorney General, the Chicago Legal Clinic and the Environmental Law and Policy Center to object to the proposed operating permits for all six of the Midwest Generation, LCC stations.
Pursuant to section 505(b)(2) of the CAA, a Petitioner may seek judicial review in the United States Court of Appeals for the appropriate circuit of those portions of the petitions which EPA denied. Any petition for review shall be filed within 60 days from the date this notice appears in the
You may review copies of the final orders, the petitions, and other supporting information at the EPA Region 5 Office, 77 West Jackson Boulevard, Chicago, Illinois 60604. If you wish to examine these documents, you should make an appointment at least 24 hours before visiting day. Additionally, the final orders for the Midwest Generation petitions are available electronically at:
Pamela Blakley, Chief, Air Permits Section, Air Programs Branch, Air and Radiation Division, EPA, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone (312) 886-4447.
The Act affords EPA a 45-day period to review, and object to as appropriate, operating permits proposed by state permitting authorities. Section 505(b)(2) of the Act authorizes any person to petition the EPA Administrator within 60 days after the expiration of the EPA review period to object to state operating permits if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period, or the grounds for the issues arose after this period.
On November 28, 2005 and April 5, 2006, the EPA received four petitions from the Illinois Attorney General, the Chicago Legal Clinic and the Environmental Law and Policy Center requesting that EPA object to the proposed Title V operating permits for the Midwest Generation, LCC stations. The petitions raise issues regarding the lack of compliance schedules in the permits. The petitioners alleged that the proposed permits are legally inadequate because: (1) Self-reporting by Midwest Generation based on continuous opacity monitoring provides evidence that all of the Midwest Generation facilities are in violation of their opacity limitations, yet the permits lack the required compliance schedules; and (2) IEPA failed to require compliance schedules to bring Midwest Generation into compliance with New Source Review requirements.
On June 14, 2007 and June 18, 2007, the Administrator issued orders denying the petitions. The orders explain the reasons behind EPA's conclusion to deny the petitions.
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 application 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 August 9, 2007.
Board of Governors of the Federal Reserve System, July 11, 2007.
The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage
Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 10, 2007.
Board of Governors of the Federal Reserve System, July 12, 2007.
Board of Governors of the Federal Reserve System.
11:30 a.m., Monday, July 23, 2007.
Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, NW., Washington, DC 20551.
Closed.
1. Personnel actions (appointments, promotions, assignments, reassignments, and salary actions) involving individual Federal Reserve System employees.
2. Any items carried forward from a previously announced meeting.
Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202-452-2955.
You may call 202-452-3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at
Board of Governors of the Federal Reserve System, July 13, 2007.
Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office of Minority Health.
Notice.
42 U.S.C. 300u-6, Section 1707 of the Public Health Service Act, as amended. The Advisory Committee is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
The Department of Health and Human Service (HHS), Office of Public Health and Science (OPHS), is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (ACMH). In accordance with Public Law 105-392, the Committee provides advice to the Deputy Assistant Secretary for Minority Health, on the development of goals and specific program activities of the Office of Minority Health (OMH) designed to improve the health of racial and ethnic minority groups. Nominations of qualified candidates are being sought to fill vacant positions on the Committee.
Nominations for membership on the Committee must be received no later than 5 p.m. EST on September 17, 2007, at the address listed below.
All nominations should be mailed or delivered to Dr. Garth Graham, Deputy Assistant Secretary for Minority Health, Office of Minority Health, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootton Parkway, Suite 600, Rockville, MD 20852.
Ms. Monica Baltimore, Executive Director, Advisory Committee on Minority Health, Office of Minority Health, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootton Parkway, Suite 600, Rockville, MD 20852; Telephone: (240) 453-2882.
A copy of the Committee charter and list of the current membership can be obtained by contacting Ms. Baltimore or by accessing the Web site managed by OMH at
Pursuant to Public Law 105-392, the Secretary of Health and Human Services established the ACMH. The Committee provides advice to the Deputy Assistant Secretary for Minority Health in carrying out the duties stipulated under Public Law 105-392. This includes providing advice to improve the health of each racial and ethnic minority group and in the development of goals and specific activities of the OMH, which are:
(1) Establish short-range and long-range goals and objectives and coordinate all other activities within the Public Health Service that relate to disease prevention, health promotion, service delivery, and research concerning such individuals;
(2) Enter into interagency agreements with other agencies of the Public Health Service;
(3) Support research, demonstrations, and evaluations to test new and innovative models;
(4) Increase knowledge and understanding of health risk factors;
(5) Develop mechanisms that support better information dissemination, education, prevention, and service delivery to individuals from disadvantaged backgrounds, including individuals who are members of racial or ethnic minority groups;
(6) Ensure that the National Center for Health Statistics collects data on the health status of each minority group;
(7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts with public and nonprofit private providers of primary health services for the purpose of increasing the access of these individuals to such services by developing and carrying out programs to provide bilingual or interpretive services;
(8) Support a national minority health resource center to carry out the following:
(a) Facilitate the exchange of information regarding matters relating to health information and health promotion, preventive health services, and education in appropriate use of health care;
(b) Facilitate access to such information;
(c) Assist in the analysis of issues and problems relating to such matters;
(d) Provide technical assistance with respect to the exchange of such information (including facilitating the development of materials for such technical assistance);
(9) Carry out programs to improve access to health care services for individuals with limited proficiency in speaking the English language. Activities under the preceding sentence shall include developing and evaluating model projects; and
(10) Advising in matters related to the development, implementation, and evaluation of health professions education in decreasing disparities in health care outcomes, including cultural competency as a method of eliminating health disparities.
Management and support services for the ACMH are provided by the OMH, which is a program office within the OPHS.
(1) Expertise in minority health and racial and ethnic health disparities.
(2) Expertise in developing or contributing to the development of health policies and/or programs. This may include experience in the analysis, evaluation, and interpretation of Federal health or regulatory policy.
(3) Involvement in national, regional, tribal, and/or community efforts to improve minority health.
(4) Educational achievement, professional certification(s) in health-related field (behavioral health, public health, nursing, environmental health, nutrition, pharmacy, epidemiology, health administration, etc.), and professional experience that will support ability to give expert advise on issues related to improving minority health and eliminating racial and ethnic health disparities.
(1) Knowledge of national health policies and programs managed by the HHS.
(2) Job-related training, self-development, and outside professional activities which provides evidence of initiative, resourcefulness, and potential for effective performance.
Individuals selected for appointment to the Committee shall be invited to serve four year terms. Committee members who are not officers or employees of the United States Government will receive a stipend for attending Committee meetings and conducting other business in the interest of the Committee, including per diem and reimbursement for travel expenses incurred.
The Department makes every effort to ensure that the membership of HHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that a broad representation of geographic areas, females, ethnic and minority groups, and the disabled are given consideration for membership on HHS Federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. Nominations must state that the nominee is willing to serve as a member of ACMH and appears to have no conflict of interest that would preclude membership. An ethics review is conducted for each selected candidate. Therefore, individuals selected for nomination will be required to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts to permit evaluation of possible sources of conflict of interest.
Coast Guard, DHS.
Notice of intent, notice of public meeting, and request for public comments.
The U.S. Coast Guard (USCG) announces that it intends to prepare a Programmatic Environmental Impact Statement (PEIS) on the Future of the Long Range Aids to Navigation (LORAN) Program. The current system (LORAN-C) is a low frequency hyperbolic radionavigation system approved for use in the U.S. Coastal Confluence Zone (CCZ) and as a supplemental air navigation aid. LORAN-C provides navigation, location, and timing services for both civil and military air, land, and marine users in the CONUS and Alaska. The PEIS will evaluate the environmental effects of alternative futures for the LORAN-C Program, and aid the USCG in its decision on whether to terminate or continue to operate and invest in the LORAN-C system.
Publication of this notice begins a scoping process that will identify and determine the scope of environmental issues to be addressed in the PEIS. This notice requests public participation in the scoping process, establishes a public comment period, and provides information on how to participate.
Public meetings will be held August 15, 21 and 23, 2007, in Washington, DC, Juneau, AK, and Seattle, WA, respectively. Each meeting will consist of an informational open house from 4:30 p.m. to 6 p.m. and a public scoping meeting from 6 p.m. to 8 p.m. The public meetings may end later than the stated time, depending on the number of persons wishing to speak. Comments and related material must reach the docket on or before August 31, 2007.
The Washington, DC meeting will be held at:
Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, NW., Washington, DC 20004, 202-312-1426.
The Seattle meeting will be held at: Seattle Hilton, 1301 Sixth Avenue, Seattle, WA 98101, (206) 695-6060.
The Juneau meeting will be held at: Centennial Hall Convention Center, 101 Egan Drive, Juneau, AK 99801, (907) 586-5283.
All meeting spaces will be wheelchair-accessible. You do not need to attend the meetings in order to comment. You may submit comments, identified by docket number USCG 2007-28460, to the Docket Management Facility at the U.S. Department of Transportation (DOT). To avoid duplication, please use only one of the following methods:
(1) Electronically through the Web site for the Docket Management System, at:
(2) By mail to the Docket Management Facility, U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(3) By fax to the Docket Management Facility at (202) 493-2251.
(4) By delivery to Room W12-140, West Building, Ground Floor, 1200 New Jersey Avenue, SE., Washington, DC, from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays. The telephone number is (202) 366-9329.
(5) By the Federal eRulemaking Portal at:
The Docket Management Facility maintains the public docket for this notice. Comments and material received from the public will become part of this docket and will be available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays. This docket may also be found on the Internet at:
Comments and related material must reach the Docket Management Facility by August 31, 2007.
If you have questions on this notice, please call or e-mail LT Michael Herring, LORAN-C Program Manager, at (202) 372-1561, or
The USCG requests public comments and other relevant information on environmental issues related to the future of the LORAN-C Program. The scheduled public meetings are not the only opportunity you have to comment. In addition to or instead of providing comments at the meeting, you can submit comments to the Docket Management Facility during the public comment period (see
On January 8, 2007, the USCG published a request for comments on the need to continue to operate or invest in the North American LORAN-C radionavigation system (72
All comments received will be posted, without change, to:
The USCG invites you to learn about the PEIS on the Future of the LORAN-C Program at an informational open house, and to identify and comment on environmental issues related to the proposed action and alternatives at a public meeting. Your comments will help the USCG identify and refine the scope of the environmental issues to be addressed in the PEIS.
In order to allow everyone a chance to speak at the public meeting, the USCG may limit speaker time, or extend the meeting hours, or both. When you rise to speak, you must identify yourself, and any organization you represent, by name. Your remarks will be recorded or transcribed for inclusion in the public docket.
You may submit written material at the public meeting, either in place of or in addition to speaking. Written material must include your name and address, and will be included in the public docket. Comments given at a public meeting and written comments submitted to the docket will receive full and equal consideration.
The public meeting locations are wheelchair-accessible. If you plan to attend an open house or public meeting and need special assistance such as sign language interpretation or other reasonable accommodation, please notify the USCG (see
LORAN is a radionavigation system first developed during World War II and operated by the USCG. The current system (LORAN-C) is a low frequency hyperbolic radionavigation system approved for use in the CCZ and as a supplemental air navigation aid. LORAN-C provides navigation, location, and timing services for both civil and military air, land, and marine users in the Contiguous United States (CONUS) and Alaska. The USCG operates 18 CONUS LORAN Stations, 6 Alaska LORAN Stations, and 24 monitor sites. The system is controlled remotely from Alexandria, VA and Petaluma, CA. Nationwide system operation is based on links between “chains” of stations; therefore, decisions made on any one station may potentially impact multiple stations or chains, necessitating an overall LORAN system decision rather than a segmented approach.
The PEIS will evaluate the environmental effects of alternatives regarding the LORAN-C Program to aid the USCG in its decision of whether further investment in modernizing and improving LORAN-C is in the public interest.
The PEIS on the Future of the LORAN-C Program will be a program-level document that will provide USCG with high-level analysis of the potential impacts on the human environment from the alternatives for the future of the LORAN-C Program. The USCG is the lead agency for determining the scope of this review and has determined that a PEIS will best meet its needs. The PEIS will comply with the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality regulations in 40 CFR parts 1500-1508, Department of Homeland Security (DHS) Management Directive 5100.1 (
The PEIS will address the following four alternatives to represent the range of possible management options for the future of the USCG LORAN-C Program:
(1)
(2)
(3)
(4)
The PEIS will serve as a top tier environmental analysis of program-level changes. This notice of intent is required by 40 CFR 1508.22, and briefly describes the proposed action and possible alternatives and our proposed scoping process. The PEIS will provide a general level of analysis of environmental impacts on the 24 LORAN Stations, 24 Monitoring Sites, and the LORAN Support Unit (LSU) since the disposition of each facility is not currently known. The PEIS will also discuss the No Action Alternative as required under NEPA. You can address any questions about the proposed action, the scoping process, or the PEIS to the USCG LORAN-C Program Office (see
Public scoping is an early and open process for identifying and determining the scope of issues to be addressed in the PEIS. Scoping begins with this notice, continues through the public comment period (see DATES), and ends when the USCG has completed the following actions:
• Invites the participation of Federal, State, and local agencies, any affected Indian tribe and other interested persons;
• Determines the actions, alternatives, and impacts described in 40 CFR 1508.25;
• Identifies and eliminates from detailed study those issues that are not significant or that have been covered elsewhere;
• Identifies other relevant environmental review and consultation requirements on the future of the LORAN-C Program;
• Indicates the relationship between timing of the environmental review and other aspects of the proposed action; and
• At its discretion, exercises the options provided in 40 CFR 1501.7(b).
Once the scoping process is complete, the USCG will prepare a draft PEIS, and will publish a
U.S. Fire Administration, Federal Emergency Management Agency, DHS.
Notice of open meeting via conference call.
In accordance with the Federal Advisory Committee Act, the Federal Emergency Management Agency announces the following committee meeting:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, the Federal Emergency Management Agency announces that the committee meeting will be open to the public in the Emmitsburg commuting
Minutes of the meeting will be prepared and will be available for public viewing in the Office of the U.S. Fire Administrator, U.S. Fire Administration, Federal Emergency Management Agency, Emmitsburg, Maryland 21727. Copies of the minutes will be available upon request within 60 days after the meeting.
The National Fire Academy Board of Visitors is administered by the U.S. Fire Administration which is part of the Federal Emergency Management Agency in the Department of Homeland Security.
Fish and Wildlife Service, Interior.
Notice of availability.
The U.S. Fish and Wildlife Service (Service), on behalf of the Department of the Interior (DOI), National Oceanic and Atmospheric Administration (NOAA), and New York State Department of Environmental Conservation (New York), as natural resource trustees, announces the release of the Final Restoration Plan (RP) for the Mattiace Petrochemical Superfund Site (Site). The Final RP presents the selected restoration alternative, consisting of a single restoration project that compensates for impacts to natural resources caused by contaminant releases associated with the Site.
Requests for copies of the RP may be made to: U.S. Fish and Wildlife Service, New York Field Office, 3817 Luker Road, Cortland, NY 13045.
Ken Karwowski, Environmental Contaminants Program, U.S. Fish and Wildlife Service, New York Field Office, 3817 Luker Road, Cortland, NY 13045.
Interested parties may also call Ken Karwowski at 607-753-9334 or e-mail him at
During the period of March 1996 through December 2000, natural resource damage settlements were achieved for the Mattiace Petrochemical Superfund Site. NOAA and the State of New York were settling Trustees with the DOI. A variety of hazardous chemicals were discharged from the Site into Glen Cove Creek, located in the Town of Oyster Bay, Nassau County, New York. Chemical releases and remedial activities at the Site adversely affected natural resources such as anadromous, catadromous, euryhaline, and marine finfish; shellfish; invertebrates; waterfowl; other migratory birds; and reptiles. The funds available from the settlement for restoration activities total approximately $155,000.
The RP is being released in accordance with the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended, commonly known as Superfund (42 U.S.C. 9601
The RP describes a number of habitat restoration and protection alternatives and discusses the environmental consequences of each. The restoration effort with the greatest potential to restore natural resources and services that were injured by contaminants or remedial activities is preferred. Based on an evaluation of the various restoration alternatives, the selected alternative consists of a single restoration project involving tidal marsh/wetland restoration and protection.
Copies of the RP are available from the Service's New York Field Office at 3817 Luker Road, Cortland, NY 13045. Additionally, the RP is available for viewing at the following Web site:
The authority for this action is the CERCLA of 1980, as amended, commonly known as Superfund (42 U.S.C. 9601
Fish and Wildlife Service, Interior.
Notice of meeting.
We, the Fish and Wildlife Service, announce a public meeting of the Sport Fishing and Boating Partnership Council (Council).
We will hold the meeting from 8:30 a.m. to 5 p.m. on Wednesday, August 8, 2007, (Alaska time) and Thursday, August 9, 2007. Members of the public wishing to participate in the meeting must notify Douglas Hobbs by close of business on Thursday, August 2, 2007, per instructions in the
The meeting will be held at the Alaska Islands and Ocean Visitor Center, 95 Sterling Highway, Suite 1, Homer, Alaska 99603; telephone (907) 235-6961.
Douglas Hobbs, Council Coordinator, 4401 North Fairfax Drive, Mailstop 3103-AEA, Arlington, Virginia 22203, (703) 358-2336 (phone), (703) 358-2548 (fax), or
In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we give notice that the Sport Fishing and Boating Partnership Council will hold the meeting from 8:30 a.m. to 5 p.m. on Wednesday, August 8, 2007 (Alaska time) and Thursday, August 9, 2007.
The Council was formed in January 1993 by the Secretary of the Interior (Secretary) to advise the Secretary,
The Council will convene to discuss: (1) The Council's continuing role in providing input to the Fish and Wildlife Service on the Service's strategic plan for its Fisheries Program; (2) The Council's role in providing input into the Fish and Wildlife Service's Sport Fish Restoration Program; (3) The Council's work in addressing the issue of boating and fishing access; (4) The Council's work to assess the Clean Vessel Act Grant Program; (5) The Council's role in communicating with partners and stakeholders about the Sport Fish Restoration and Boating Trust Fund; (6) The Council's role in the continued implementation of the National Fish Habitat Action Plan; (7) Future strategic issues that the Council will address through its activities; and (8) The Council's role in providing the Secretary with information about the implementation of the Strategic Plan for the National Outreach and Communications Program, authorized by the 1998 Sportfishing and Boating Safety Act, that is now being implemented by the Recreational Boating and Fishing Foundation, a private, nonprofit organization. The final agenda will be posted on the Internet at
We are reserving time at 1:30 p.m. (Alaska time) on Thursday, August 9, 2007, for oral public comments, and will assign speaking times on a first-come, first-served basis. Questions from the public will not be considered during this comment period, which is intended to allow interested members of the public to submit relevant written or oral information for the Council to consider in the course of its business. We are limiting each individual or group's oral presentation during the oral public comment period to 3 minutes per speaker, with no more than a total of one-half hour for all speakers. Speakers wishing to submit a full statement should do so at the meeting. We invite those speakers unable to be placed on the agenda, or to attend in person, to submit written statements.
To be placed on our public speaker list for this meeting, contact Douglas Hobbs, Council Coordinator, in writing (preferably via e-mail), by July 30, 2007, at the contact information under
To ensure that ample seating is available, we recommend that anyone wishing to attend this meeting register by close of business August 2, 2007. Please submit your name, time of arrival, e-mail address, and phone number to Douglas Hobbs, and he will provide you with instructions for admittance. Mr. Hobbs' e-mail address is
Summary minutes of the conference will be maintained by the Council Coordinator at 4401 N. Fairfax Drive, MS-3101-AEA, Arlington, VA 22203, and will be available for public inspection during regular business hours. You may purchase personal copies for the cost of duplication.
Safford Field Office, Bureau of Land Management (BLM), Interior.
Call for nominations for the Gila Box Riparian National Conservation Area (NCA) Advisory Committee.
The BLM is publishing this Notice under Section 9(a)(2) of the Federal Advisory Committee Act to solicit public nominations for four members on the Gila Box Riparian NCA Advisory Committee. The Advisory Committee was created through Title 2, Section 201, of the Arizona Desert Wilderness Act of 1990 to provide informed advice to the Safford Field Manager on management of public lands in the Gila Box Riparian NCA in southeastern Arizona.
Any individual or organization may nominate one or more persons to serve on the Advisory Committee. Persons wishing to nominate themselves or other individuals should submit an application form, which is available from the BLM Safford Field Office or online at
Nominations and reference letters should be mailed to the BLM address on the application form, and must be received no later than August 30, 2007.
For more information contact: Jeff Wilbanks, BLM Safford Field Office, 711 14th Avenue, Safford, AZ 85546; call (928) 348-4573; or e-mail
To ensure membership of the Advisory Committee is balanced in terms of categories of interest represented, nominees must be qualified to provide informed advice in specific areas related to the primary purposes for which the NCA was created. These include wildlife conservation, riparian ecology, hydrology, outdoor recreation, watershed management, environmental education, cultural resources, or other related disciplines.
Committee members are selected by the Secretary of the Interior to serve a three-year term, with terms beginning on the date of appointment. The Advisory Committee will meet 1-2
Terms of two committee members will begin serving immediately upon their appointment. Terms of the other two committee members will begin with the expiration of two current memberships that will expire on March 31, 2008. All four current members may apply to serve another term on the Committee.
Bureau of Land Management, Interior.
Notice of reestablishment of the National Historic Oregon Trail Interpretive Center Advisory Board.
This notice is published in accordance with Section 9(a)(2) of the Federal Advisory Committee Act of 1972, Public Law 92-463. Notice is hereby given that the Secretary of the Interior has reestablished the Bureau of Land Management's National Historic Oregon Trail Interpretive Center Advisory Board. The purpose of the Advisory Board will be to advise the Bureau of Land Management's Vale District Manager regarding policies, programs, and long-range planning for the management use, and further development of the Interpretive Center; establish a framework for enhanced partnership and participation between the Bureau and the Oregon Trail Preservation Trust; ensure a financially secure, world-class historical and educational facility, operated through a partnership between the Federal Government and the community. This cooperative relationship enriches and maximizes visitor experiences in the region, and improves the coordination of advice and recommendations from the publics served.
Douglas Herrema, National Landscape Conservation System (100), Bureau of Land Management, 1620 L Street, NW., Mail Stop 301, Washington, DC 20036, telephone (202) 452-7787.
I hereby certify that the reestablishment of the National Historic Oregon Trail Interpretive Center Advisory Board is necessary and in the public interest in connection with the Secretary of the Interior's responsibilities to manage the lands, resources, and facilities administered by the Bureau of Land Management.
Minerals Management Service (MMS), Interior.
Notice of extension of an information collection (1010-0150).
To comply with the Paperwork Reduction Act of 1995 (PRA), MMS is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements in form MMS-144, Rig Movement Notification Report.
Submit written comments by September 17, 2007.
You may submit comments by any of the following methods listed below. Please use the Information Collection Number 1010-0150 as an identifier in your message.
• E-mail MMS at
• Fax: 703-787-1093. Identify with Information Collection Number 1010-0150.
• Mail or hand-carry comments to the Department of the Interior; Minerals Management Service; Attention: Cheryl Blundon; 381 Elden Street, MS-4024; Herndon, Virginia 20170-4817. Please reference “Information Collection 1010-0150” in your comments.
Cheryl Blundon, Regulations and Standards Branch at (703) 787-1607. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the form that requires the subject collection of information.
This ICR concerns the regulations in 30 CFR 250 Subparts D, E, and F, specifically §§ 403(c), 502, and 602, on the movement of drilling, completion, and workover rigs and related equipment on and off an offshore platform or from well to well on the same offshore platform. The requirement for operators to notify MMS of rig movements is only specifically stated in § 250.403(c). Since MMS is mandated to perform timely inspections on rigs and platforms, we must have accurate information with regard to their location on the OCS. We use this information in scheduling inspections with regard to priority and cost effectiveness.
However, because of the increased volume of activity in the Gulf of Mexico Region (GOMR), it is now standard MMS procedure to require this notification as a condition of approval for well workover, recompletion, or abandonment operations. Because of this we have included the rig movement notification with the other general information collection requirements of these regulations under OMB Control Numbers 1010-0141, 1010-0067, and 1010-0043 (30 CFR 250, Subparts D, E, and F, respectively). The MMS District
We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2) and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” No items of a sensitive nature are collected. Responses are mandatory.
Agencies must also estimate the “non-hour costs” burdens to respondents or recordkeepers resulting form the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased: (1) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Government; or (iv) as part of customary and usual business or private practices.
We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB.
National Park Service, Department of the Interior.
Notice of Availability of the Draft Environmental Impact Statement (EIS) for the Resource Protection Study (RPS), Curecanti National Recreation Area.
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of a Draft Environmental Impact Statement for the Resource Protection Study for Curecanti National Recreation Area, Colorado.
Under Alternative 1, the No Action Alternative, NPS would continue to manage the natural, cultural, and recreational resources of Curecanti National Recreation Area (NRA), and associated facilities, pursuant to Reclamation law, NPS law, the 1965 Memorandum of Agreement between NPS and Reclamation (1965 MOA), and other applicable laws and regulations. Reclamation would continue to mange the three dams and reservoirs, power plants, access roads, and other related facilities, to meet the purposes of the Colorado River Storage Project Act (CRSP); and the East Portal area to meet the purposes of the Uncompahgre Project; pursuant to Reclamation law, the 1965 MOA, and other applicable laws and regulations. There would be no significant change in the NRA boundary. However, a permanent NPS presence would not be assured under this alternative.
Under Alternative 2, the Proposed Action, NPS would manage the same natural, cultural, and recreational resources and facilities as Alternative 1, pursuant to Reclamation law, NPS law, including new legislation establishing the NRA with 10,040 acres of additional agreed-upon neighboring agency lands, a revised MOA with Reclamation, and other applicable laws and regulations. Reclamation would manage their same facilities as Alternative 1, pursuant to Reclamation law, the revised MOA, and other applicable laws and regulations. NPS would be authorized to work in partnership with private landowners within a Conservation Opportunity Area of 24,300 acres outside the NRA boundary, to implement a variety of tools, including acquiring interests in land from willing landowners, which would promote the long-term conservation of resources. A permanent NPS presence would be assured under this alternative, which is also the environmentally preferred alternative.
The National Park Service will accept comments on the Draft Environmental Impact Statement from the public. Comments will be accepted for 90 days from the date the
The entire Draft RPS/EIS, and a Summary Document will be available for public review and comment on the project's Web site, described below; and at the following locations in Colorado: (A) Curecanti NRA, 102 Elk Creek, Gunnison, CO 81230, telephone: (970) 641-2337; (B) Montrose Public Lands Center, 2505 South Townsend Avenue, Montrose, CO 81401, telephone (970) 240-5300; (C) Gunnison Public Library; (D) Montrose Public Library; (E) Hotchkiss Public Library; (F) Delta Public Library; and (G) Grand Junction Public Library.
(A) Dave Roberts, Management Assistant, telephone: (970) 240-5432 (Montrose, CO); (B) Connie Rudd, Superintendent, telephone: (970) 641-2337 x. 220 (Gunnison, CO); or (C) Jeff Heywood, Project Leader, telephone: (303) 969-2835 (Lakewood, CO).
If you wish to comment, you may do so via the Internet at:
Judicial Conference of the United States, Advisory Committee on Rules of Civil Procedure.
Notice of open meeting.
The Advisory Committee on Rule of Civil Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
November 8-9, 2007.
Thurgood Marshall Federal Judiciary Building, 4th Floor Agency Conference Room, One Columbus Circle, NE., Washington, DC 20544.
John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Judicial Conference of the United States, Advisory Committee on Rules of Appellate Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Appellate Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
November 1-2, 2007.
Four Seasons Hotel, 75 14th Street, Atlanta, Georgia 30309.
John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Judicial Conference of the United States, Advisory Committee on Rules of Criminal Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Criminal Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
October 1-2, 2007.
Time: 8:30 a.m. to 5 p.m.
Hotel Park City, 2001 Park Avenue, Park City, Utah 84068.
John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Judicial Conference of the United States, Advisory Committee on Rules of Evidence Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Evidence Procedure will hold a one-day meeting. The meeting will be open to public observation but not participation.
November 16, 2007.
Time: 8:30 a.m. to 5 p.m.
Thurgood Marshall Federal Judiciary Building, Mecham Conference Center, One Columbus Circle, NE., Washington, DC 20544.
John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Judicial Conference of the United States, Advisory Committee on Rules of Bankruptcy Procedure.
Notice of open meeting.
The Advisory Committee on Rules of Bankruptcy Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
September 6-7, 2007.
Teton Mountain Lodge & Spa, 3385 West Village Drive, Teton Village, Wyoming 83025.
John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on June 28, 2007 in response to a petition filed by a company official on behalf of a worker of Agilent Technologies, Electronic Measurements Group, Loveland, Colorado, in support of Agilent Technologies, Global Infrastructure Organization, Santa Clara, California.
The worker on whose behalf the petition is filed is covered by an active certification, (TA-W-60,320, as amended) which expires on November 21, 2008. Consequently, further investigation in this case would serve no purpose, and the investigation has been terminated.
In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification Regarding Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on November 21, 2006, applicable to workers of Agilent Technologies, Global Infrastructure Organization, Santa Clara, California. The notice was published in the
At the request of company officials, the Department reviewed the certification for workers of the subject firm. New information shows that a worker separation occurred involving an employee in support of the Santa Clara, California facility of Agilent Technologies, Global Infrastructure Organization located in Loveland, Colorado.
Mr. David Herder provided management function services of the Global Infrastructure Organization's programs and suppliers for the Santa Clara, California location of the subject firm.
Based on these findings, the Department is amending this certification to include an employee in support of the Santa Clara, California facility of Agilent Technologies, Global Infrastructure Organization, located in Loveland, Colorado.
The intent of the Department's certification is to include all workers of Agilent Technologies, Global Infrastructure Organization, Santa Clara, California who were adversely affected by increased company imports.
The amended notice applicable to TA-W-60,320 is hereby issued as follows:
”All workers of Agilent Technologies, Global Infrastructure Organization, Santa Clara, California (TA-W-60,320), and including an employee in support of Agilent Technologies, Global Infrastructure Organization, Santa Clara, California, located in Loveland, Colorado (TA-W-60,320A), who became totally or partially separated from employment on or after October 24, 2005, through November 21, 2008, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974 and are also eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.”
Pursuant to Section 221 of the Trade Act of 1974, an investigation was initiated on June 26, 2007 in response to a worker petition filed by a company official on behalf of workers at The Apparel Group, Foxcroft Sportswear Division, Fall River, Massachusetts.
The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated.
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Baker Furniture, Grand Rapids, Michigan. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued.
By application dated June 22, 2007, the United Automobile, Aerospace & Agricultural Implement Workers of America requested administrative reconsideration of the Department of Labor's Notice of Negative Determination Regarding Eligibility to Apply for Worker Adjustment Assistance, applicable to workers and former workers of the subject firm. The determination was signed on May 7, 2007 and published in the
The initial investigation resulted in a negative determination based on the finding that imports of vehicles like or directly competitive with the Lincoln Towncar did not contribute importantly to worker separations at the subject firm and no shift of production to a foreign source occurred.
The Department reviewed the request for reconsideration and has determined that the petitioner has provided additional information. Therefore, the Department will conduct further investigation to determine if the workers meet the eligibility requirements of the Trade Act of 1974.
After careful review of the application, I conclude that the claim is of sufficient weight to justify reconsideration of the Department of Labor's prior decision. The application is, therefore, granted.
On June 27, 2007, the Department issued an Affirmative Determination Regarding Application on Reconsideration applicable to workers and former workers of the subject firm. The notice will soon be published in the
The previous investigation initiated on April 11, 2007, resulted in a negative determination issued on May 9, 2007, was based on the finding that imports of machine parts, such as shafts and sheaves for CVT transmissions did not contribute importantly to worker separations at the subject firm and no shift of production to a foreign source occurred. The denial notice was published in the
In the request for reconsideration, the petitioner provided additional information regarding the subject firm's declining customers.
The Department requested additional list of customers from the subject firm and conducted a survey of a major declining customer regarding its purchases of like or directly competitive products with machine parts, such as shafts and sheaves for CVT transmission. It was revealed that the major declining customer increased its reliance on imports of machine parts, such as shafts and sheaves for CVT transmission while decreasing their purchases from the subject firm during the relevant period. The increases in imports accounted for a meaningful portion of the subject plant's lost sales.
In accordance with Section 246 the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor herein presents the results of its investigation regarding certification of eligibility to apply for alternative trade adjustment assistance (ATAA) for older workers.
In order for the Department to issue a certification of eligibility to apply for ATAA, the group eligibility requirements of Section 246 of the Trade Act must be met. The Department has determined in this case that the requirements of Section 246 have been met.
A significant number of workers at the firm are age 50 or over and possess skills that are not easily transferable. Competitive conditions within the industry are adverse.
After careful review of the additional facts obtained on reconsideration, I conclude that increased imports of articles like or directly competitive with those produced at Form Tech Industries, LLC, Canal Fulton, Ohio, contributed importantly to the declines in sales or production and to the total or partial separation of workers at the subject firm. In accordance with the provisions of the Act, I make the following certification:
”All workers of Form Tech Industries, LLC, Canal Fulton, Ohio, who became totally or partially separated from employment on or after April 3, 2006, through two years from the date of this certification, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are eligible to apply for alternative trade adjustment assistance under Section 246 of the Trade Act of 1974.”
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Hewlett-Packard Company, Technology Solutions Group—Global Mission Critical Solution Center—Nonstop Tech/Proactive, Austin, Texas. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued.
Petitions have been filed with the Secretary of Labor under Section 221 (a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221 (a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than July 27, 2007.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than July 27, 2007.
The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room C-5311, 200 Constitution Avenue, NW., Washington, DC 20210.
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at TMP Directional Marketing, LLC, Graphics Division, Fort Wayne, Indiana. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued.
Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Welex, Inc., Blue Bell, Pennsylvania. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued.
This notice is published in accordance with the provisions of section 9(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) and advises of the renewal of the National Archives and Records Administration's (NARA) Advisory Committee on Preservation for a two-year period. In accordance with Office of Management and Budget (OMB) Circular A-135, OMB approved the inclusion of the Advisory Committee on Preservation in NARA's ceiling of discretionary advisory committees.
The Archivist of the United States has determined that the renewal of the Advisory Committee on Preservation is in the public interest due to the expertise and valuable advice the committee members provide on technical preservation issues affecting all types of media. NARA uses the Committee's recommendations in its implementation of strategies for preserving the permanently valuable records of the Federal Government.
Quarterly Meeting.
Crowne Plaza Hotel Metro, 733 West Madison, Chicago, Illinois.
Public Comment Sessions; Livable Communities/Mental Health Best Practices Panel Presentation; Emergency Preparedness Panel Presentation; Reports from the Chairperson, Council Members, and the Executive Director; Strategic Planning; Budget Planning; ADA Reports Release News Conference; Unfinished Business; New Business; Announcements; Adjournment.
Mark S. Quigley, Director of Communications, NCD, 1331 F Street, NW., Suite 850, Washington, DC 20004; 202-272-2004 (voice), 202-272-2074 (TTY), 202-272-2022 (fax).
NCD is an independent Federal agency and is composed of 15 members appointed by the President, by and with the advice and consent of the Senate. NCD provides advice to the President, Congress, and executive branch agencies promoting policies, programs, practices, and procedures that (A) guarantee equal opportunity for all individuals with disabilities, regardless of the nature or severity of the disability; and (B) empower individuals with disabilities to achieve economic self-sufficiency, independent living, and inclusion and integration into all aspects of society.
Those needing reasonable accommodations should notify NCD immediately.
In accordance with E.O. 13166, Improving Access to Services for Persons with Limited English Proficiency, those people with disabilities who are limited English proficient and seek translation services for these meetings should notify NCD immediately.
9:30 a.m., Thursday, July 26, 2007.
NTSB Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314-6100.
Individuals requesting specific accommodations should contact Chris Bisett (202) 314-6305 by Friday, July 20, 2007.
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Vicky D'Onofrio, (202) 314-6410.
Weeks of July 16, 23, 30, August 6, 13, 20, 2007.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address,
This meeting will be webcast live at the Web address,
This meeting will be webcast live at the Web address,
There are no meetings scheduled for the Week of August 6, 2007.
There are no meetings scheduled for the Week of August 13, 2007.
This meeting will be webcast live at the Web address,
This meeting will be webcast live at the Web address,
* The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings call (recording)—(301) 415-1292. Contact person for more information: Michelle Schroll, (301) 415-1662.
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g. braille, large print), please notify the NRC's Disability Program Coordinator, Rohn Brown, at 301-492-2279, TDD: 301-415-2100, or by e-mail at
This notice is distributed by mail to several hundred subscribers; if you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969). In addition, distribution of this meeting notice over the Internet system is available. If you are interested in receiving this Commission meeting schedule electronically, please send an electronic message to
Pursuant to section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC staff) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from June 21, 2007 to July 3, 2007. The last biweekly notice was published on July 3, 2007 (72 FR 36520).
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Written comments may be submitted by mail to the Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and should cite the publication date and page number of this
Within 60 days after the date of publication of this notice, the licensee may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR Part 2. Interested persons should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner/requestor intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner/requestor intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner/requestor to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff; (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission,
Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer of the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(a)(1)(i)-(viii).
For further details with respect to this action, see the application for amendment which is available for public inspection at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site,
The NRC staff issued a notice of opportunity for comment in the
The proposed change allows relocating main steam and main feedwater valve isolation times to the Licensee Controlled Document that is referenced in the Bases. The proposed change is described in Technical Specification Task Force (TSTF) Standard TS Change Traveler TSTF-491 related to relocating the main steam and main feedwater valves isolation times to the Licensee Controlled Document that is referenced in the Bases and replacing the isolation time with the phrase, within limits.
The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). The proposed changes relocate the main steam and main feedwater isolation valve times to the Licensee Controlled Document that is referenced in the Bases. The requirements to perform the testing of these isolation valves are retained in the TS. Future changes to the Bases or licensee-controlled document will be evaluated pursuant to the requirements of 10 CFR 50.59, Changes, test and experiments, to ensure that such changes do not result in more than minimal increase in the probability or consequences of an accident previously evaluated.
The proposed changes do not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, and configuration of the facility or the manner in which the plant is operated and maintained. The proposed changes do not adversely affect the ability of structures, systems and components (SSCs) to perform their intended safety function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed changes do not affect the source term, containment isolation, or radiological consequences of any accident previously evaluated. Further, the proposed changes do not increase the types and the amounts of radioactive effluent that may be released, nor significantly increase individual or cumulative occupation/public radiation exposures.
Therefore, the changes do not involve a significant increase in the probability or consequences of any accident previously evaluated.
The proposed changes relocate the main steam and main feedwater valve isolation times to the Licensee Controlled Document that is referenced in the Bases. In addition, the valve isolation times are replaced in the TS with the phrase “within limits.” The changes do not involve a physical altering of the plant (i.e., no new or different type of equipment will be installed) or a change in methods governing normal plant operation. The requirements in the TS continue to require testing of the main steam and main feedwater isolation valves to ensure the proper functioning of these isolation valves.
Therefore, the changes do not create the possibility of a new or different kind of accident from any previously evaluated.
The proposed changes relocate the main steam and main feedwater valve isolation times to the Licensee Controlled Document that is referenced in the Bases. In addition, the valve isolation times are replaced in the TS with the phrase “within limits.” Instituting the proposed changes will continue to ensure the testing of main steam and main feedwater isolation valves. Changes to the Bases or license controlled document are performed in accordance with 10 CFR 50.59. This approach provides an effective level of regulatory control and ensures that main steam and feedwater isolation valve testing is conducted such that there is no significant reduction in the margin of safety.
The margin of safety provided by the isolation valves is unaffected by the proposed changes since there continue to be TS requirements to ensure the testing of main steam and main feedwater isolation valves. The proposed changes maintain sufficient controls to preserve the current margins of safety.
The NRC staff has reviewed the licensees analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment requests involve no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change to Technical Specifications Administrative Controls Section 5.3.1 involves the use of a more generic designation for the unit staff position responsible for Health Physics without reducing the level of authority required for that position. The proposed change also allows the flexibility to use an accredited program for qualifying personnel to fill unit staff positions, which represents an acceptable alternative to the qualification requirements for these positions as currently specified in the Technical Specifications. Since the proposed changes are administrative in nature, they do not involve any physical changes to any structures, systems, or components, nor will their performance requirements be altered. The proposed changes also do not affect the operation, maintenance, or testing of the plant. Therefore, the response of the plant to previously analyzed accidents will not be affected. Consequently, the proposed changes do not involve a significant increase or any increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any previously evaluated?
The proposed changes to the Technical Specifications will have no adverse impact on the overall qualification of the unit staff. The use of a more generic designation for the unit staff position responsible for Health Physics and the alternative use of an accredited program that has been endorsed by the NRC will ensure the educational requirements and power plant experience for each unit staff position are properly satisfied and will continue to fulfill applicable regulatory requirements. Also, since no change is being made to the design, operation, maintenance, or testing of the plant, no new methods of operation or failure modes are introduced by the proposed changes. Therefore, the possibility of a new or different kind of accident from any previously evaluated is not created.
3. Does the proposed change involve a significant decrease in the margin of safety?
The proposed changes to the Technical Specifications will have no adverse impact on the onsite organizational features necessary to assure safe operation of the plant. Lines of authority for plant operation are unaffected by the proposed changes. Also, the adoption of the more generic designation of the individual responsible for Health Physics will reduce the regulatory burden of having to devote limited resources to process a license amendment whenever a title change for this position is implemented. Accordingly, this reduction in regulatory burden and the option to use an accredited program endorsed by NRC to qualify the unit staff will improve plant efficiency without compromising plant safety. Therefore, the proposed changes do not involve a significant decrease in the margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The NRC staff issued a notice of availability of a model safety evaluation and model no significant hazards consideration (NSHC) determination for referencing in license amendment applications in the
1. Does the change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change extends the frequency for testing control rod scram time testing from every 120 days of cumulative Mode 1 operation to 200 days of cumulative Mode 1 operation. The frequency of surveillance testing is not an initiator of any accident previously evaluated. The frequency of surveillance testing does not affect the ability to mitigate any accident previously evaluated, as the tested component is still required to be operable. Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change extends the frequency for testing control rod scram time testing from every 120 days of cumulative Mode 1 operation to 200 days of cumulative Mode 1 operation. The proposed change does not result in any new or different modes of plant operation. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change extends the frequency for testing control rod scram time testing from every 120 days of cumulative Mode 1 operation to 200 days of cumulative Mode 1 operation. The proposed change continues to test the control rod scram time to ensure the assumptions in the safety analysis are protected. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Operating with increased maximum service water temperature limits does not affect the frequency of accident initiating events. Therefore, the probability of an accident previously analyzed is not increased. Plant systems supported by SW have been evaluated for operation with a service water temperature limit of 100 °F, and it determined that there is no operational impact when operating at the higher SW temperature.
Although the service water temperature limit is being increased, the containment will continue to meet its design basis acceptance criteria following a large-break loss of coolant accident as identified in the UFSAR [Updated Final Safety Analysis Report]. Therefore, there is no increase in the consequences of any accident previously evaluated resulting from operation of Surry Units 1 and 2 with an increased service water temperature limit.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
There are no new failure modes or mechanisms associated with operating Surry Units 1 and 2 with an increased service water temperature limit of 100 °F. As noted above, the increased service water temperature limit does not affect plant operation, since plant systems supported by SW have been evaluated for operation with a SW temperature limit of 100 °F and no operational impact was identified. Therefore, there are no new or different kinds of accidents created by operation of Surry Units 1 and 2 with increased service water temperature limits.
3. Does the proposed change involve a significant reduction in the margin of safety?
The containment analysis acceptance criteria continue to be met when operating with the proposed increased maximum service water temperature limit. Containment integrity will not be challenged and will continue to meet its design basis acceptance criteria following a large break loss of coolant accident. Therefore, the existing margin of safety is not significantly reduced by operation of Surry Units 1 and 2 with increased service water temperature limits.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
Notice of Consideration of Issuance of Amendment to Facility Operating License, Proposed No Significant Hazards Consideration Determination, and Opportunity for A Hearing in connection with these actions was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) The applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the internet at the NRC Web site,
The supplements dated February 26, May 22, and June 5, 2007 provided additional information that clarified the application, did not expand the scope of the application as originally noticed and did not change the NRC staff's original proposed no significant hazards determination. The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2007.
The Commission's related evaluation of the amendment is contained in a safety evaluation dated June 15, 2007.
The supplement dated April 4, 2007, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 25, 2007.
The supplement dated April 4, 2007, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 25, 2007.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 21, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 2, 2007.
No significant hazards consideration comments received: No.
The August 18, 2006, October 5, 2006, and January 11, 2007, supplements contained clarifying information and did not change the NRC staff's initial proposed finding of no significant hazards consideration.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 21, 2007.
No significant hazards consideration comments received: No.
The April 6, 2007 supplement, contained clarifying information and did not change the NRC staff's initial proposed finding of no significant hazards consideration.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 29, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 22, 2007.
No significant hazards consideration comments received: No.
The supplemental information provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the Nuclear Regulatory Commission's staff's original proposed no significant hazards consideration determination.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 28, 2007.
No significant hazards consideration comments received: No.
The supplemental letters contained clarifying information and did not change the initial no significant hazards consideration determination, and did not expand the scope of the original
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 25, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 25, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 26, 2007.
No significant hazards consideration comments received: No.
The supplement dated April 11, 2007, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 7, 2007.
No significant hazards consideration comments received: No.
The supplement dated April 11, 2007, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 12, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 13, 2007.
No significant hazards consideration comments received: No.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 29, 2007.
No significant hazards consideration comments received: No.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Notice of availability.
Notice is hereby given that the staff of the Nuclear Regulatory Commission (NRC) has prepared a model license amendment request (LAR), model safety evaluation (SE), and model proposed no significant hazards consideration (NSHC) determination related to changes to Actions in the Standard Technical Specifications (STS) relating to One Steam Supply to Turbine Driven Auxiliary Feedwater/Emergency Feedwater (AFW/EFW) Pump Inoperable. This change establishes a Completion Time in the Standard Technical Specifications for the Condition where one steam supply to the turbine driven AFW/EFW pump is inoperable concurrent with an inoperable motor driven AFW/EFW train.
The purpose of these models is to permit the NRC to efficiently process amendments that propose to adopt the associated changes into plant-specific technical specifications (TS). Licensees of nuclear power reactors to which the models apply can request amendments confirming the applicability of the SE and NSHC determination to their reactors.
The NRC staff issued a
Trent L. Wertz, Technical Specifications Branch, Division of Inspection and Regional Support, Office of Nuclear Reactor Regulation, Mail Stop O-12H2, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-1568.
Regulatory Issue Summary 2000-06, “Consolidated Line Item Improvement Process for Adopting Standard Technical Specification Changes for Power Reactors,” was issued on March 20, 2000. The consolidated line item improvement process (CLIIP) is intended to improve the efficiency and transparency of NRC licensing processes. This is accomplished by processing proposed changes to the Standard Technical Specifications (STS) (NUREGs 1430—1434) in a manner that supports subsequent license amendment applications. The CLIIP includes an opportunity for the public to comment on proposed changes to the STS following a preliminary assessment by the NRC staff and finding that the change will likely be offered for adoption by licensees. The CLIIP directs the NRC staff to evaluate any comments received for a proposed change to the STS and to either reconsider the change or proceed with announcing the availability of the change to licensees. Those licensees opting to apply for the subject change to TS are responsible for reviewing the NRC staff's evaluation, referencing the applicable technical justifications, and providing any necessary plant specific information. Each amendment application submitted in response to the notice of availability would be processed and noticed in accordance with applicable rules and NRC procedures.
This notice involves establishing a Completion Time in the Limiting Condition for Operation (LCO) 3.7.5 of the STS for the Condition where one steam supply to the turbine driven AFW/EFW pump is inoperable concurrent with an inoperable motor driven AFW/EFW train. This notice also involves two additional changes to the STS that establish specific Conditions and Action requirements: (1) For when two motor driven AFW/EFW trains are inoperable at the same time and; (2) for when the turbine driven AFW/EFW train is inoperable either (a) due solely to one inoperable steam supply, or (b) due to reasons other than one inoperable steam supply. The changes were proposed by the Technical Specification Task Force (TSTF) in TSTF Traveler TSTF-412, Revision 3, which is accessible electronically from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site
This change is applicable to all pressurized water reactors (PWRs) designed by Babcock and Wilcox (B&W), Westinghouse, and Combustion Engineering (CE). To efficiently process the incoming license amendment applications, the NRC staff requests that each licensee applying for the changes use the CLIIP to submit a License Amendment Request (LAR) that conforms to the enclosed Model Application (Enclosure 1). Any deviations from the Model Application should be explained in the licensee's submittal. Significant deviations from the approach, or inclusion of additional changes to the license, will result in staff rejection of the submittal. Instead, licensees desiring significant variations and/or additional changes should submit a LAR that does not claim to adopt TSTF-412. Variations from the approach recommended in this notice may require additional review by the NRC staff and may increase the time and resources needed for the review.
The staff issued a
In response to the notice soliciting comments from the interested members of the public about NRC's pending action to establish a Completion Time in the Standard Technical Specifications for the Condition where one steam supply to the turbine driven AFW/EFW pump is inoperable concurrent with an inoperable motor driven AFW/EFW train, the staff received one comment (from a licensee). The comment on the model SE is summarized and discussed below:
1. COMMENT: The first sentence in the third paragraph under “STS 3.7.5, Condition C (as Proposed),” in Section 3.0 of the Proposed Model Safety Evaluation states the following:
“The STS typically allows a 72 hour Completion Time for Conditions where the remaining operable equipment is able to mitigate postulated accidents without assuming a concurrent single active failure.” Since there are several TSs in the STS that allow a longer Completion time than 72 hours for conditions where the remaining operable equipment is able to mitigate postulated accidents without assuming a concurrent single active failure (such as seven days in TS 3.5.2, 3.6.6, and 3.7.10 in NUREG-1432), it is recommended that the sentence be changed to the following: “The STS typically allows a 72 hour or longer Completion Time for Conditions where the remaining operable equipment is able to mitigate postulated accidents without assuming a concurrent single active failure.”
For the Nuclear Regulatory Commission.
The following example of a license amendment request (LAR) was prepared by the NRC staff to facilitate the adoption of Technical Specifications Task Force (TSTF) Traveler TSTF-412, Revision 3 “Provide Actions for One Steam Supply to Turbine Driven AFW/EFW Pump Inoperable.” The model provides the expected level of detail and content for a LAR to adopt TSTF-412, Revision 3. Licensees remain responsible for ensuring that their plant-specific LAR fulfills their administrative requirements as well as NRC regulations.
Gentlemen: In accordance with the provisions of 10 CFR 50.90 of Title 10 of the
The proposed amendment establishes Conditions, Required Actions, and Completion Times in the Standard Technical Specifications (STS) for the Condition where one steam supply to the turbine driven Auxiliary Feedwater/Emergency Feedwater (AFW/EFW) pump is inoperable concurrent with an inoperable motor driven AFW/EFW train. In addition, this amendment establishes changes to the STS that establish specific Actions: (1) For when two motor driven AFW/EFW trains are inoperable at the same time and; (2) for when the turbine driven AFW/EFW train is inoperable either (a) due solely to one inoperable steam supply, or (b) due to reasons other than one inoperable steam supply. The change is consistent with NRC-approved Technical Specification Task Force (TSTF) Traveler, TSTF-412, Revision 3, “Provide Actions for One Steam Supply to Turbine Driven AFW/EFW Pump Inoperable.” The availability of this technical specification improvement was announced in the
Enclosure 1 provides a description of the proposed change and confirmation of applicability. Enclosure 2 provides the existing TS pages marked-up to show the proposed change. Enclosure 3 provides the existing TS Bases pages marked-up to reflect the proposed change. There are no new regulatory commitments associated with this proposed change.
[LICENSEE] requests approval of the proposed license amendment by [DATE], with the amendment being implemented [BY DATE OR WITHIN X DAYS].
In accordance with 10 CFR 50.91, a copy of this application, with enclosures, is being provided to the designated [STATE] Official.
I declare under penalty of perjury under the laws of the United States of America that I am authorized by [LICENSEE] to make this request and that the foregoing is true and correct. [Note that request may be notarized in lieu of using this oath or affirmation statement].
If you should have any questions regarding this submittal, please contact [ ].
Enclosures: 1. Description and Assessment
The proposed License amendment establish a new Completion Time in Standard Technical Specifications Section [3.7.5] where one steam supply to the turbine driven AFW/EFW pump is inoperable concurrent with an inoperable motor driven AFW/EFW train. This amendment also establishes specific Conditions and Action requirements: (1) For when two motor driven AFW/EFW trains are inoperable at the same time and; (2) for when the turbine driven AFW/EFW train is inoperable either (a) due solely to one inoperable steam supply, or (b) due to reasons other than one inoperable steam supply.
The changes are consistent with NRC approved Industry/Technical Specification Task Force (TSTF) Standard Technical Specification Change Traveler, TSTF-412, Revision 3, “Provide Actions for One Steam Supply to Turbine Driven AFW/EFW Pump Inoperable.” The availability of this
[LICENSEE] has reviewed the safety evaluation published on [DATE ] ([xx FR xxxxx]) as part of the CLIIP. This verification included a review of the NRC staff's evaluation as well as the supporting information provided to support TSTF-412, Revision 3. [LICENSEE] has concluded that the justifications presented in the TSTF proposal and the safety evaluation prepared by the NRC staff are applicable to [PLANT, UNIT NOS.] and justify this amendment for the incorporation of the changes to the [PLANT] Technical Specifications.
[LICENSEE] is not proposing any variations or deviations from the technical specification changes described in TSTF-412, Revision 3, or the NRC staff's model safety evaluation published in the
A description of the proposed change and its relationship to applicable regulatory requirements and guidance was provided in the Notice of Availability published on [DATE] ([xx FR xxxxx]).
[LICENSEE] has reviewed the proposed no significant hazards consideration determination published on [DATE] as part of the CLIIP. [LICENSEE] has concluded that the proposed determination presented in the notice is applicable to [PLANT] and the determination is hereby incorporated by reference to satisfy the requirements of 10 CFR 50.91(a).
There are no new regulatory commitments associated with this proposed change.
[LICENSEE] has reviewed the environmental evaluation included in the model safety evaluation published in the
Technical Specification Task Force Traveler TSTF-412, Revision 3, Provide Actions for One Steam Supply to the Turbine Driven AFW/EFW Pump Inoperable
By application dated [DATE], [LICENSEE NAME] (the licensee), submitted a request for changes to the [PLANT NAME], Technical Specifications (TS) (Agencywide Documents Access and Management System (ADAMS) Accession No. [MLxxxxxxxxx]). The requested changes adopt TSTF-412, Revision 3, “Provide Actions for One Steam Supply to the Turbine Driven AFW/EFW Pump Inoperable.” NRC approval of these changes was announced in the
These changes were described in a Notice of Availability published in the
In 10 CFR 50.36, the Commission established its regulatory requirements related to the content of Technical Specifications (TS). Pursuant to 10 CFR 50.36(c), TS are required to include items in the following categories: (1) Safety limits, limiting safety system settings, and limiting control settings; (2) limiting conditions for operation (LCOs); (3) surveillance requirements (SRs); (4) design features; and (5) administrative controls. The rule does not specify the particular requirements to be included in a plant's TS.
Also, in 10 CFR 50 Appendix A the Commission established regulatory requirements related to Auxiliary Feedwater Systems. General Design Criteria 34 and 44 state that the AFW system is required to assure (1) the capability to transfer heat loads from the reactor system to a heat sink under both normal operating and accident conditions; (2) the redundancy of components for performance of the safety function under accident conditions, assuming a single active component failure; and (3) the capability to isolate components, subsystems, or piping if required to maintain system safety function.
The AFW/EFW System is designed to automatically supply sufficient water to the steam generator(s) to remove decay heat upon the loss of normal feedwater supply with steam generator pressure at the set point of the Main Steam Safety Valves (MSSVs). Subsequently, the AFW/EFW System supplies sufficient water to cool the unit to Residual Heat Removal (RHR) System entry conditions, with steam being released through the Atmospheric Dump Valves (ADVs).
AFW/EFW Systems typically consist of two motor driven AFW/EFW pumps and one steam turbine driven pump configured into three trains. The capacity of the motor driven and steam driven AFW/EFW pumps can vary by plant. Motor driven pumps typically provide 50% or 100% of the required AFW/EFW flow capacity as assumed in the accident analysis. Motor driven AFW/EFW pumps are typically powered from an independent Class 1E power supply and each pump train typically feeds half of the steam generators, although each pump has the capability to be realigned from the control room to feed other steam generators. The steam turbine driven AFW/EFW pump provides either 100% or 200% of the required capacity to all steam generators. The steam turbine driven pump receives steam from two main steam lines upstream of the main
Condition A is modified to refer to the inoperability of a turbine driven AFW/EFW train due to an inoperable steam supply, instead of referring to the inoperability of a turbine driven AFW/EFW pump. This change is being proposed in order to make Condition A train oriented instead of component oriented, consistent with the other Conditions that are included in STS 3.7.5. The train oriented approach is consistent with the preferred approach that is generally reflected in the STS, and therefore the proposed change is considered to be acceptable.
A new Condition C with two possible Required Actions (C.1 OR C.2) is proposed for the turbine driven AFW/EFW train being inoperable due to one inoperable steam supply and one motor driven AFW/EFW train being inoperable at the same time. Required Action C.1 requires restoration of the affected steam supply to operable status within either 24 or 48 hours, depending on the capability of the motor driven AFW/EFW train that remains operable. Alternatively, Required Action C.2 requires restoration of the inoperable motor driven AFW/EFW train within either 24 or 48 hours, again depending on the capability of the motor driven AFW/EFW train that remains operable. New Condition C provides two proposed Completion Times that are dependent upon the capacity of the remaining operable motor driven AFW/EFW train to provide AFW/EFW to the steam generators.
A proposed 24 hour Completion Time is applicable to plants that may provide insufficient flow to the steam generators (SGs) in accordance with accident analyses assumptions if a main steam line break (MSLB) or feedwater line break (FLB) were to occur that renders the remaining steam supply to the turbine driven AFW/EFW pump inoperable (a concurrent single failure is not assumed). Insufficient feedwater flow could result, for example, if a single motor driven AFW/EFW train does not have sufficient capacity to satisfy accident analyses assumptions, or if the operable pump is feeding the faulted SG (i.e. the SG that is aligned to the operable steam supply for the turbine driven AFW/EFW pump). [This would typically apply to plants with each AFW/EFW motor driven pump having less than 100% of the required flow.] A proposed 48 hour Completion Time is applicable when the remaining operable motor driven AFW/EFW train is capable of providing sufficient feedwater flow in accordance with accident analyses assumptions. [This would typically apply to plants with each AFW/EFW motor driven pump having greater than or equal to 100% of the required flow.]
The STS typically allows a 72 hour or longer Completion Time for Conditions where the remaining operable equipment is able to mitigate postulated accidents without assuming a concurrent single active failure. In this particular case, a 24 hour Completion Time is proposed for the situation where the AFW/EFW system would be able to perform its function for most postulated events, and would only be challenged by a MSLB or FLB that renders the remaining operable steam supply to the turbine driven AFW/EFW pump inoperable. Additionally, depending on the capacity of the operable motor driven AFW/EFW pump, it may be able to mitigate MSLB and FLB accidents during those instances when it is not aligned to the faulted SG. The selection of 24 hours for the Completion Time is based on the remaining operable steam supply to the turbine driven AFW/EFW pump and the continued functionality of the turbine driven AFW/EFW train, the remaining operable motor driven AFW/EFW train, and the low likelihood of an event occurring during this 24 hour period that would challenge the capability of the AFW/EFW system to provide feedwater to the SGs. The proposed Completion Time for this particular situation is consistent with what was approved for Waterford 3 by License Amendment 173 for a similar Condition (ADAMS Accession No. ML012840538), and it is consistent with the STS in that the proposed Completion Time is much less than the 72 hours that is allowed for the situation where accident mitigation capability is maintained. Therefore, the NRC staff agrees that the proposed 24 hour Completion Time is acceptable for this particular situation.
A 48 hour Completion Time is proposed for the situation where the remaining operable motor driven AFW/EFW train is able to mitigate postulated accidents in accordance with accident analyses assumptions without assuming a concurrent single active failure. The selection of 48 hours is based on the continued capability of the AFW/EFW system to perform its function, while at the same time recognizing that this Condition represents a higher level of degradation than one inoperable AFW/EFW train which is currently allowed for up to 72 hours by STS 3.7.5. The proposed 48 hour Completion Time represents an appropriate balance between the more severe 24 hour situation discussed in the previous paragraph and the less severe Condition that is afforded a 72 hour Completion Time by the current STS. Therefore, the NRC staff agrees that the proposed 48 hour Completion Time is acceptable for this particular situation.
The current Condition C is renamed as Condition D. This Condition has been modified to incorporate changes brought on by the addition of new Condition C. The first of the two listed Conditions under Condition D has been modified and now applies to the situation where the Required Action and associated Completion Time of Condition A, B, or C are not met. This section of Condition D is modified to also apply to the new Condition C when the Completion Time that is specified for new Condition C is not met. The NRC staff considers this to be appropriate and consistent with existing STS 3.7.5 requirements to place the plant in a mode where the Condition does not apply when the Required Actions are not met.
The second listed Condition under Condition D (following the first “OR”) is modified from “Two AFW/EFW trains inoperable in MODE 1, 2, or 3” to “Two AFW/EFW trains inoperable in MODE 1, 2, or 3 for reasons other than Condition C.” This change is necessary to recognize the situation specified by Condition C (as proposed) where one motor driven AFW/EFW train is allowed to be inoperable at the same time that the turbine driven AFW/EFW train is inoperable due to an inoperable steam supply to the pump turbine. Therefore, the NRC staff considers the proposed change to be acceptable.
The Required Actions associated with this Condition were renamed from C.1 AND C.2 to D.1 AND D.2 but not otherwise changed. Required Action D.1 requires the plant to be in Mode 3 in 6 hours, and Required Action D.2 requires the plant to be in Mode 4 in 18 hours. This change is purely editorial as no other changes are involved. Therefore, this proposed change is acceptable.
Because current Condition C is renamed as Condition D, current Condition D is renamed as Condition E. This change is purely editorial as no other changes are involved. Therefore, the proposed change is acceptable.
Because current Condition D is renamed as Condition E, current Condition E is renamed as Condition F. This change is purely editorial as no other changes are involved. Therefore, the proposed change is acceptable.
In accordance with the Commission's regulations, the [STATE] State official was notified of the proposed issuance of the amendments. The State official had [(1) no comments or (2) the following comments—with subsequent disposition by the NRC staff].
The amendment changes a requirement with respect to the installation or use of a facility component located within the restricted area as defined in 10 CFR Part 20 and changes surveillance requirements. The NRC staff has determined that the amendment involves no significant increase in the amounts and no significant change in the types of any effluents that may be released offsite, and that there is no significant increase in individual or cumulative occupational radiation exposure. The Commission has previously issued a proposed finding that the amendment involves no significant hazards consideration, and there has been [(1) no public comment on such finding (2) the following comments with subsequent disposition by the NRC staff ([xx FR xxxxx, DATE]). Accordingly, the amendment meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Pursuant to 10 CFR 51.22(b) no environmental impact statement or environmental assessment need be prepared in connection with the issuance of the amendment.
The Commission has concluded, based on the considerations discussed above, that (1) there is reasonable assurance that the health and safety of the public will not be endangered by operation in the proposed manner, (2) such activities will be conducted in compliance with the Commission's regulations, and (3) the issuance of the amendments will not be inimical to the common defense and security or to the health and safety of the public.
The proposed changes are consistent with NRC practices and policies as generally reflected in the STS and as reflected by applicable precedents that have been approved. Therefore, the NRC staff has determined that the proposed changes to STS 3.7.5 should be approved.
Description of amendment request: The requested change, applicable to all pressurized water reactors (PWRs) designed by Babcock and Wilcox (B&W), Westinghouse, and Combustion Engineering (CE), would provide changes to the Actions in the Standard Technical Specifications (STS) relating to One Steam Supply to Turbine Driven Auxiliary Feedwater / Emergency Feedwater (AFW/EFW) Pump Inoperable. The proposed change is described in Technical Specification Task Force (TSTF) Standard TS Change Traveler TSTF-412, Revision 3, and was described in the Notice of Availability published in the
Basis for proposed no significant hazards consideration determination: As required by 10 CFR 50.91(a), an analysis of the issue of no significant hazards consideration is presented below:
1. Does the proposed change involve a significant increase in the probability or consequences of any accident previously evaluated?
The Auxiliary/Emergency Feedwater (AFW/EFW) System is not an initiator of any design basis accident or event, and therefore the proposed changes do not increase the probability of any accident previously evaluated. The proposed changes to address the condition of one or two motor driven AFW/EFW trains inoperable and the turbine driven AFW/EFW train inoperable due to one steam supply inoperable do not change the response of the plant to any accidents.
The proposed changes do not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, and configuration of the facility or the manner in which the plant is operated and maintained. The proposed changes do not adversely affect the ability of structures, systems, and components (SSCs) to perform their intended safety function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed changes do not affect the source term, containment isolation, or radiological release assumptions used in evaluating the radiological consequences of any accident previously evaluated. Further, the proposed changes do not increase the types and amounts of radioactive effluent that may be released offsite, nor significantly increase individual or cumulative occupational/public radiation exposures.
Therefore, the changes do not involve a significant increase in the probability or consequences of any accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes do not result in a change in the manner in which the AFW/EFW System provides plant protection. The AFW/EFW System will continue to supply water to the steam generators to remove decay heat and other residual heat by delivering at least the minimum required flow rate to the steam generators. There are no design changes associated with the proposed changes. The changes to the Conditions and Required Actions do not change any existing accident scenarios, nor create any new or different accident scenarios.
The changes do not involve a physical alteration of the plant (
Therefore, the changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
The proposed changes do not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The safety analysis acceptance criteria are not impacted by these changes. The proposed changes will not result in plant operation in a configuration outside the design basis.
Therefore, it is concluded that the proposed change does not involve a significant reduction in a margin of safety.
Based on the above, the proposed change involves no significant hazards consideration under the standards set forth in 10 CFR 50.92(c), and accordingly, a finding of no significant hazards consideration is justified.
Dated at Rockville, Maryland, this th day of , 2007.
For the Nuclear Regulatory Commission.
Office of Personnel Management.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management (OPM) intends to submit to the Office of Management and Budget (OMB) a request for review of a revised information collection. The Federal Employees Health Benefits (FEHB) Open Season Express Interactive Voice Response (IVR) System and the Open Season Web site, Open Season Online, are used by retirees and survivors. They collect information for changing FEHB enrollments, collecting dependent and other insurance information for self and family enrollments, requesting plan brochures, requesting a change of address, requesting cancellation or suspension of FEHB benefits, asking to make payment to the Office of Personnel Management when the FEHB payment is greater than the monthly annuity amount, or for requesting FEHB plan accreditation and Customer Satisfaction Survey information.
Comments are particularly invited on: Whether this information is necessary for the proper performance of functions of the Office of Personnel Management and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
We receive approximately 215,000 responses per year to the IVR system and the online Web. Each response takes approximately 10 minutes to complete. The annual burden is 35,833 hours.
For copies of this proposal, contact Mary Beth Smith-Toomey on (202) 606-8358, FAX (202) 418-3251 or via e-mail to:
Comments on this proposal should be received within 60 calendar days from the date of this publication.
Send or deliver comments to—
Ed Foelster, Chief, Methods and Procedures Branch, Operations Support Group, Center for Retirement and Insurance Services, U.S. Office of Personnel Management, 1900 E Street, NW., Room 3349, Washington, DC 20415-3540.
For Information Regarding Administrative Coordination—
Contact: Cyrus S. Benson, Team Leader, Publications Team, RIS Support Services/Support Group, (202) 606-0623.
Office of Personnel Management.
Notice.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management (OPM) intends to submit to the Office of Management and Budget (OMB) a request for extension of a currently approved information collection. OPM Form 1530, Report of Medical Examination of Person Electing Survivor Benefit Under the Civil Service Retirement System, is used to collect information regarding an annuitant's health so that OPM can determine whether the insurable interest survivor benefit election can be allowed.
Comments are particularly invited on: Whether this information is necessary for the proper performance of functions of the Office of Personnel Management, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Approximately 500 OPM Form 1530 will be completed annually. We estimate it takes approximately 90 minutes to complete the form. The annual burden is 750 hours.
For copies of this proposal, contact Mary Beth Smith-Toomey on (202) 606-8358, FAX (202) 418-3251 or via e-mail to:
Comments on this proposal should be received within 60 calendar days from the date of this publication.
Send or deliver comments to—
Pamela S. Israel, Chief, Operations Support Group, Center for Retirement and Insurance Services, U.S. Office of Personnel Management, 1900 E Street, NW., Room 3349, Washington, DC 20415-3540.
For Information Regarding Administrative Coordination—
Contact: Cyrus S. Benson, Team Leader, Publications Team, RIS Support Services/Support Group, (202) 606-0623.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• Rule 19h-1 (17 CFR 240.19h-1): SRO notification of admission and/or continuance despite statutory disqualification.
Rule 19h-1 (“Rule”) under the Securities Exchange Act of 1934 (15
The Commission uses the information provided in the submissions filed pursuant to Rule 19h-1 to review decisions by SROs to permit the entry into or continuance in the securities business of persons who have committed serious misconduct. The filings submitted pursuant to the Rule also permit inclusion of an application to the Commission for consent to associate with a member of an SRO notwithstanding a Commission order barring such association.
The Commission reviews filings made pursuant to the Rule to ascertain whether it is in the public interest to permit the employment in the securities business of persons subject to statutory disqualification. The filings contain information that is essential to the staff's review and ultimate determination on whether an association or employment is in the public interest and consistent with investor protection.
It is estimated that approximately 5 respondents will make submissions pursuant to this rule annually and that they each will make 5 responses, for a total burden of 200 hours, based upon past submissions (25 × 8 = 200). The staff estimates that the average number of hours necessary to complete a submission pursuant to Rule 19h-1 is 8 hours. The average cost per hour for completion of a submission is approximately $101. Therefore, the total cost of compliance for the respondents is $20,200. (25 responses × 8 hours per response × $101 per hour).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
General comments regarding the estimated burden hours should be directed to the following persons: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503 or send an e-mail to:
Rule 6a-4; SEC File No. 270-496; OMB Control No. 3235-0554.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995,
Section 6 of the Securities Exchange Act of 1934 (“Act”)
The respondents to the collection of information are futures markets.
The Commission estimates that the total annual burden for all respondents to provide the amendments and periodic updates under Rule 6a-4 would be 105 hours (15 hours/respondent per year x seven respondents) and $10,066 ($1438/response × seven responses/year). The Commission estimates that the total annual burden for the filing of the supplemental information and the monthly reports required under Rule 6a-4 would be 87.5 hours (25 filings/respondent × seven respondents x 0.5 hours/response). The SEC estimates that the total annual cost for all supplemental filings would be $3675 (25 filings/respondent per year × 7 respondents × $21/response).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Comments should be directed to (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503 or by sending an e-mail to:
Securities symbols are a key element in the operation of a national market system and essential to the dissemination of trade information in a common format. Historically, securities symbols have been assigned under an informal understanding among the listing markets. It has been the practice of the New York Stock Exchange LLC (“NYSE”) to list securities of companies using one-, two-, or three-character symbols. Other exchanges, including the American Stock Exchange LLC (“Amex”) and regional exchanges, have also listed securities of companies using two- and three-character symbols. Until recently, The Nasdaq Stock Market, Inc. (“Nasdaq”) has always listed securities of companies using four- or five-character symbols.
In 1975, Congress directed the Securities and Exchange Commission (“Commission”), through its enactment of section 11A of the Securities Exchange Act of 1934 (“Act”),
On March 23, 2007, pursuant to Rule 608 of Regulation NMS under the Act
Although the two plans are identical in many respects, they also differ on several significant matters. The primary difference between the two plans is their scope. The Three-Characters Plan would only cover one-, two-, and three-character symbols; the Five-Characters Plan would cover one-, two-, three-, four-, and five-character symbols. In addition, the plans differ with regard to the number of, and the length of time that, symbols may be reserved, the portability of symbols for issuers that move their listing from one market to another, the allocation of costs relating to the plan, and the process of withdrawing from the plan. Pursuant to Rule 608, the Commission is publishing this notice of, and soliciting comments on, both the Three-Characters Plan and the Five-Characters Plan.
Section 11A of the Act grants the Commission broad authority to authorize or require SROs, either by rule or order, to act jointly with respect to planning, developing, operating, or regulating a national market system.
The Commission requests comment on whether all SROs that list securities should be required to join any symbol reservation national market system plan approved by the Commission. If commenters believe that SROs that list securities should not be required to join such an approved national market system plan, the Commission requests commenters to address how to preclude duplicative symbols from being selected and reserved, how to resolve disputes about symbols, or how otherwise to address concerns the plans are designed to address.
Pursuant to Rule 601 of Regulation NMS under the Act,
The term “ticker symbol” originates from the ticker tape.
As the securities markets have grown over the years, one-, two-, and three-character symbols, traditionally used by the exchanges, have become scarce. There are 26 combinations for one-character symbols, 676 combinations for two-character symbols, and 17,576 combinations for three-character symbols, for a total of 18,278 one-, two-, and three-character symbols. Several factors have also been increasing the demand for one-, two-, and three-character symbols. In recent years, exchanges have begun listing new and innovative products, such as exchange-traded funds, that are also now competing with listed companies for symbols. In addition, Nasdaq has expressed its intention to start using one-, two-, and three-character symbols.
Concerns about constraints on symbol supply heighten the need to revisit the existing informal symbol reservation system. Currently, the process of designating securities symbols is not done pursuant to a formal national market system plan or agreement, but is conducted informally among the SROs. Each SRO keeps its own records of reserved symbols. If an SRO wishes to reserve a particular symbol, the SRO will first consult its own list of reserved symbols to confirm that the desired symbol has not been reserved by another SRO. Once the listing SRO has verified that a particular symbol is not already reserved according to its own records of reserved symbols, the listing SRO will notify the other SROs that it wishes to reserve such symbol. If no other SRO objects, then the listing SRO has successfully reserved that symbol and each SRO would update its own records of reserved symbols accordingly.
While the existing informal reservation system has performed the function of allocating symbols among the listing markets in the past, the weakness in the current system could potentially have significant market consequences as exchanges compete more aggressively for listings and the supply of available symbols becomes more restricted over time. The absence of universal reservation records, for example, could cause confusion about the availability of certain symbols and could lead to disputes between listing markets about the availability of a symbol. Such disputes raise the potential for investor confusion and symbol duplication. Under the existing system, listing markets may reserve an excess amount of symbols indefinitely, which may exacerbate the strain on symbol supply. The fear of symbol supply constraints could even drive listing markets to reserve an excess amount of symbols, either to protect their interests in the event of needing such symbols in the future or to give themselves advantages over their competitors in securing future listings. Moreover, the existing system does not limit the potential for symbol reservations to be used for anti-competitive purposes. For example, a listing market could use the existing symbol reservation system to withhold unused symbols from their competitors, trade reserved symbols only with certain, allied exchanges, or use their power to withhold desired symbols to compel other listing markets not to trade symbols with their direct competitors. Also, the existing system does not universally permit issuers transferring their listings to a new exchange to keep their ticker symbols. For example, the exchange where an issuer listed originally could dispute the new listing exchange's right to use the issuer's ticker symbol, which could disrupt the process of transferring the listing. In addition, issuers with one-, two-, or three-character symbols currently may not transfer their listings to Nasdaq,
The two proposed plans are identical in numerous respects. A brief summary of the most significant aspects of the plans, highlighting their distinctions, is provided below. The full text of the separate plans submitted by the SROs is available on the Commission's Web site at:
The preambles to the plans are nearly identical.
Each of the proposed plans would cover only root symbols, without any suffix or special conditional identifier.
• The Three-Characters Plan would be the exclusive means of allocating and using symbols of one-, two-, or three-characters in length and would not govern the use of four- or five-character symbols.
• The Five-Characters Plan would be the means of allocating and using symbols of one-, two-, three-, four-, or five-characters in length.
The Commission requests comment on whether it would be advisable for it to approve one plan or two plans. For example, commenters views are requested on whether the Commission could approve a plan covering only one-, two-, and three-character symbols and a plan covering one-, two-, three-, four-, and five-character ticker symbols. Would there be any potential inefficiencies and inconsistencies arising from having two plans that would render that situation unworkable or undesirable? Would there be any special benefit derived from having two plans that might justify the additional burden of administering two plans? The Commission also requests comment on whether it is advisable to have a single plan covering one-, two-, three-, four-, and five-character symbols. Would there be any difficulties with having a single plan for the allocation of all symbols? What are the benefits of having only one plan? In addition, the Commission requests comment on how having either a single plan or two plans would assure fair competition among all parties and, in particular, new listing markets.
The proposed plans' provisions regarding qualifications to be a party to the plan are described below:
• The Three-Characters Plan would allow an SRO to join the plan if it maintains a market for the listing and trading of securities that are identified by one-, two-, or three-character symbols and that are identified as “eligible” securities for “Network A” or “Network B” as those terms are defined in the CTA Plan.
• The Five-Characters Plan would allow an SRO to join the plan if it maintains a market for the listing of securities that are identified by one-, two-, three-, four-, or five-character symbols.
The Commission requests comment on the proposed plans' requirements for SROs to join each plan. In particular, the Commission requests comment on whether it is appropriate to limit, as the Three-Character Plan proposes, participation in the plan to SROs that maintain a market for the listing and trading of eligible securities for Network A and Network B. Would such a requirement impede fair competition? More generally, would the proposed plans' provisions on eligibility assure fair competition among all parties and, in particular, new listing markets?
Section II of each of the plans sets forth the administration of the ISRA. A Policy Committee would administer the ISRA and, unless expressly provided otherwise in the plan, the Policy Committee would make all policy decisions on behalf of the ISRA in furtherance of the functions and objectives of the ISRA under the Act and the plan. Specifically, the Policy Committee would: (1) Oversee the operation of the Symbol Reservation System;
Both of the proposed plans provide that one voting member and one alternate voting member representing each party would compose the Policy Committee.
Both plans also provide that a meeting of the Policy Committee would be held
The Commission requests comment on the proposed plans' provisions relating to the administration of the ISRA by the Policy Committee. In particular, the Commission requests comment on the powers of the Policy Committee, as well as whether the committee's decision-making process by majority vote is appropriate. In addition, the Commission requests comment on the appeal procedures for an aggrieved party. Should the plans specify what is meant by the phrase “other appropriate forum”? Do the proposed plans provide enough clarity as to how an aggrieved party could pursue relief under the plans?
Section III of each of the proposed plans establishes that the ISRA would delegate the operation of the Symbol Reservation System to an independent third party (the “Processor”) and would enter into contracts with the Processor relating to the operation of the Symbol Reservation System. The Processor would receive reservation requests from the parties and reserve and allocate symbols among the parties in accordance with the terms of the plan. To this end, the Processor would create and maintain a symbol reservation database.
The Commission requests comment on the proposed plans' provisions related to the delegation of the operation of the Symbol Reservation System to a Processor.
Section IV of each of the proposed plans sets forth the operating details of the Symbol Reservation System. Here, the plans diverge in key ways.
Each plan would provide that, within a specified time period after the plan's approval, a participant in the plan may submit to the Processor requests for the initial reservation of symbols.
Each of the proposed plans would permit a party to reserve a limited number of symbols in perpetuity (“perpetual reservations”).
• The Three-Characters Plan provides that NYSE and Amex each could reserve up to 200 symbols as perpetual reservations; other parties to the plan each could reserve up to 40 symbols as perpetual reservations.
• The Five-Characters Plan provides that there would be two perpetual reservation lists—one list for one-, two-, and three-character symbols and one list for four- and five-character symbols. Each party to the plan could reserve up to 20 one-, two-, or three-character symbols as perpetual reservations, and up to 20 four- or five-character symbols as perpetual reservations.
Both proposed plans provide that a party could not add symbols to its perpetual reservation list after the initial reservation process, except when reserving a symbol for re-use.
The Commission requests comment on the plans' proposals to include perpetual reservations lists. Should SROs be permitted to reserve symbols in perpetuity? Commenters are requested to explain why SROs should or should not be permitted to reserve symbols into perpetuity. Would there be any public benefit derived from having perpetual reservations? What impact would allowing perpetual reservations have on competition, particularly for new markets? The Commission also requests commenters' views on the number of symbols an SRO should be permitted to reserve under any such list. Specifically, the Commission requests comment on whether all SROs should be given the same number of perpetual reservations, as proposed under the Five-Characters Plan, or whether it is reasonable to provide certain SROs a greater number of such reservations, as proposed under the Three-Characters Plan. In particular, the Commission requests comment on what basis would be appropriate for certain SROs to receive more perpetual reservations than other SROs. For example, should the primary listing markets receive a greater number of perpetual reservations?
Finally, the Commission requests commenters' views on how the proposed provisions on perpetual reservations would affect new listing markets. How would an SRO that joins the plan after the initial reservation process be able to reserve symbols? Would the existence of perpetual reservations present a significant barrier to entry by new listing markets? Would it prevent or reduce competition from new listing markets? Would conducting another initial reservation process for all plan participants upon a new market joining the plan provide a more level playing field for a new entrant? How else could the provisions on perpetual reservations be adjusted to account for new listing markets?
Under both plans, symbols could also be reserved for 24 months (“limited-time reservations”).
• The Three-Characters Plan provides that Amex and NYSE each could reserve up to 1,500 symbols as limited-time reservations and NYSE Arca could reserve up to 500 symbols as limited-time reservations. The Three-Characters Plan does not specify the number of limited-time reservations for other parties. Instead, this plan would need to be amended when an additional party joins the plan to specify how many limited-time reservations such party is entitled.
• The Five-Characters Plan would provide two limited-time reservation lists—one list for one-, two-, and three-character symbols and one list for four- and five-character symbols. Each party could reserve up to 1,500 symbols under the one-, two-, or three-character limited-time reservations list and up to 1,500 symbols under the four-or five-character limited-time reservations list. Moreover, under the Five-Characters Plan, a party may not make any limited-time reservations with respect to a particular symbol unless the party has a reasonable basis to utilize the symbol within the next 24 months.
As with perpetual reservation requests, under both plans, a party that requests limited-time reservations for more symbols than permitted would be required to place its symbols requests in priority ranking.
The Commission requests comment on the plans' proposals to include limited-time reservations. Should SROs be permitted to make limited-time reservations? Commenters are requested to explain why SROs should or should not be permitted to reserve symbols for a limited-time. Would there be any public benefit derived from having limited-time reservations? What impact would allowing limited-time reservations have on competition, particularly for new markets? The Commission also requests comment on the requirement for a “reasonable basis” for reserving a symbol, as articulated in the Five-Characters Plan. Specifically, should the plan be more specific as to what would be a “reasonable basis” or who would make such a determination and how?
The Commission requests comment on the number of symbols an SRO should be permitted to reserve as limited-time reservations. The Commission also requests comment on the length of time symbols may be reserved as limited-time reservations. Is 24 months an appropriate length of time—should it be shorter or longer? In addition, the Commission requests comment on whether all SROs should receive the same number of limited-time reservations, as provided under the Five-Characters Plan, or whether it is appropriate for certain SROs to receive a greater number of such reservations, as proposed under the Three-Characters Plan. In particular, the Commission requests comment on what basis would be appropriate for certain SROs to receive more limited-time reservations than other SROs. For example, should the primary listing markets receive a greater number of limited-time reservations? Finally, the Commission requests commenters' views on how the proposed provisions on limited-time reservations would affect new listing markets. How would an SRO join the plan after the initial reservation process reserve symbols? Would limited-time reservations prevent or reduce competition from new listing markets and present a significant barrier to entry by new listing markets? Would conducting a new initial reservation process for all plan participants upon a new market joining the plan provide a more level playing field for a new entrant? How else could the provisions on limited-time reservations be adjusted to account for new listing markets?
Both plans would permit a party to have priority over other parties in reserving a symbol that it claims was properly reserved under the current informal system (“legacy reservation”), prior to the effective date of the plan.
• Under the Three-Characters Plan, if there is only one party that claims such prior reservation of a symbol, such party would have priority over other SROs to retain its reservation of that symbol.
• Under the Five-Characters Plan, if there is only one party that claims such prior reservation of a symbol, such party would have priority over other SROs to retain reservation of that symbol only if the party represents that it has a reasonable basis to believe that it would utilize such symbol within the next six months.
Both plans would provide the same process for resolving claims by more than one party to a legacy reservation.
The Commission requests comment on the proposed plans' processes for recognizing legacy reservations. Should parties have the right to reserve, under the plans, symbols for which they claim to have a legacy reservation? Should a party only be able to retain a legacy reservation if it is able to represent that it has a reasonable basis to believe that it would utilize such symbol within the next six months, as provided under the Five-Characters Plan? If so, the Commission requests comment on the requirement to have “a reasonable basis” for retaining legacy reservations. Specifically, should the plan be more specific as to what would be a “reasonable basis” or who would make such a determination and how?
The Commission also requests comment on the proposed process for resolving claims to legacy reservations. Could the requirement of a majority vote for resolving such claims affect fair competition among the parties? How could this process be adjusted to address any competitive concerns? The Commission also requests comment on how decisions to grant extensions of legacy reservations, as proposed under the Five-Characters Plan, would be made. Should the plan be more specific as to who would make a determination that a reasonable basis for an extension exists and how?
Both plans would provide the same process for initial reservations of symbols that have not been properly reserved prior to the effective date of the plan.
The Commission requests comment on the proposed plans' processes for initial reservation requests. In particular, the Commission requests comment on how the proposed processes would affect new listing markets. Would the proposed processes
Both plans contain substantially identical provisions on reserving symbols after the initial reservation process.
The Commission requests comment on the proposed plans' provisions for the subsequent reservations of symbols. In particular, the Commission requests comment on whether the proposed provisions assure fair competition among all parties and, in particular, new listing markets.
Both plans provide that the Processor would release any limited-time reservation symbols not used within the 24-month time period.
The Commission requests comment on the proposed plans' provisions for the non-use or release of symbols. How should the random order of priority for the waiting list be designed? For example, should the order be selected anew for every symbol? Would another assignment methodology be more appropriate or fair? Would the proposed plans' processes for the non-use or release of symbols affect competition?
Both plans would provide the same method for a party to request the release by another party of a reserved symbol.
The Commission requests comment on the proposed plans' processes for releasing symbols. The Commission requests commenters' views on whether a requesting party that is at the maximum number of limited-time reservations should be allowed to either surrender or re-designate another symbol in order to reserve the requested symbol. The Commission notes that the Five-Characters Plan does not define or describe the process of “re-designating” a symbol. The Commission requests comment on whether it is necessary for the plan to describe the process of “re-designation.” The Commission also requests comment on how a symbol could be “re-designated” if a requesting party is at its maximum number of limited-time reservations. Finally, the Commission requests comment on whether the proposed provisions on releasing symbols assure fair competition among all parties and, in particular, new listing markets.
Both plans would provide substantially identical waiting list processes.
When a symbol becomes available, the Processor would notify the party with priority on the waiting list. Such party would then have two business days to reserve that symbol; otherwise, the Processor would repeat the process as necessary with all parties on the waiting list, in order of priority. The maximum number of symbols for which a party may be on the waiting list at any time would be 100 symbols.
The Commission requests comment on the proposed plans' waiting list provisions. In particular, the Commission requests comment on whether 100 symbols is an appropriate number of symbols for the waiting list. With respect to a party's request to use a symbol already in use either within 30 days of the effective date of the plan or within two business days of notice of a symbol's availability, the Commission requests comment on whether such time periods are appropriate. In addition, the Commission requests comment on whether the proposed provisions for waiting lists assure fair competition among all parties and, in particular, new listing markets. Finally, how should the random order of priority for the waiting list be designed? For example, should the order be selected anew for every symbol? Would another assignment
The plans propose different approaches to the reuse and portability of symbols.
• The Three-Characters Plan would provide that if a party ceases to use a symbol,
This plan would provide that the SRO from which the issuer delisted its security would have the rights to the symbol for that security, unless it consents to the transfer of the symbol to the new SRO. If the SRO to which the issuer transferred its listing believes there is a compelling business reason why it should have the rights to the symbol (if it is a two-or three-character symbol, but not a one-character symbol), the new SRO may submit to the Processor the determination of which SRO shall have the rights in that symbol.
• The Five-Characters Plan would also provide that if a party ceases to use a symbol, such party automatically reserves that symbol, notwithstanding any other limits on the number of reserved symbols under the plan. However, this plan would provide an exception to this automatic reservation right when an issuer transfers its listing from one SRO to another. In this case, the SRO to which a listing is transferred would have the rights to that issuer's symbol.
Both plans provide that a symbol being reused pursuant to such provisions could be reserved as a perpetual reservation if the party has not yet reserved the full number of perpetual reservations available to it.
The Commission requests comment on the proposed plans' provisions relating to the reuse of symbols. In particular, the Commission requests comment on the proposed plans' provisions regarding the portability of a securities symbol to a new listing market when an issuer transfers its listing. When an issuer moves its listing to a new listing market, should either the former listing market or the new listing market retain the right to use the issuer's symbol? How would awarding the rights to the symbol to the former listing market affect competition? How would awarding such rights to the new listing market affect competition? Should there be a process for resolving symbol disputes between the former listing market and the new listing market or should the plans categorically award the rights to the symbol to one market or the other? If the former, the Commission requests comment on the Three-Characters Plan's proposed process for resolving such disputes.
Under the Three-Characters Plan, the new listing market may request the transferred symbol if it believes that there is a compelling business reason for the transferred symbol. The Commission requests comment on whether the plan should be more specific as to what would be a “compelling business reason” and how the Processor should assess the various business needs of the two listing markets to make the decision as to who should have the rights to the symbol. Should the business reasons of the two listing markets be the only factor in the Processor's determination? Or should other factors also be considered? If so, what other factors should be considered? Is the Three-Characters Plan's provision that the Processor's decision is final and not subject to appeal fair and reasonable? Or would it be more appropriate to provide the parties with an alternative venue for pursuing relief? Finally, the Commission requests comment on whether single-character symbols should be subject to the same portability provisions as two- and three-character symbols.
Both plans would provide that the Processor would create and maintain a symbol reservation database.
Sections I and V of the plans set forth the manner in which the parties would share the initial development costs, as well as continuing costs. The proposed plans differ significantly in their method of cost allocation.
• Under the Three-Characters Plan, the parties would share the initial development costs equally. The Three-Characters Plan would also provide that the continuing costs and expenses of ISRA would be shared equally among the parties at the end of each calendar year. The continuing costs would only be prorated for a party that had not been a party for the entire calendar year. Section I of the Three-Characters Plan would provide that any new party that joins the plan would pay to the existing parties a proportionate share of the aggregate development costs previously paid by such existing parties, with the result that each party's share of all development costs is approximately the same.
• Under the Five-Characters Plan, the parties would share the initial development costs pro-rata based on the number of symbols initially reserved by each party. Section V of the Five-Characters Plan would provide that any new party that joins the plan would also be responsible for a pro-rata portion of the initial development costs based upon the number of symbols initially reserved by such new party during the
The Commission requests comment on the proposed plans' provisions relating to financial matters. In particular, should the initial development and continuing costs be allocated by the number of parties, or by the number of reserved symbols of a party? Are there other cost allocation methodologies the Commission should consider? In addition, the Commission requests comment on the proposed plans' effects on new listing markets. Do the proposed plans' provisions on allocation of costs assure fair competition among all parties and, in particular, new listing markets? Would new listing markets be adversely affected by either formula for allocating initial development costs? The Commission also requests comment on whether the proposed plans should address the scenario of a former party who later wishes to rejoin the plan. Specifically, should such an entity be viewed as a new party who would be required to pay a share of the initial development costs according to the prescribed formula for new parties?
Section VI of both plans would provide that the Processor would maintain all information received from the parties in strictest confidence and that the only information that the Processor would make available to the parties is the symbol reservation database. The Three-Characters Plan would also specifically provide that the Processor would make available to the parties any notices or other information specifically called for by the plan. Both plans would provide that the Processor would not make the symbol reservation database available to any person except the Commission or the parties, unless otherwise required by applicable law.
The Commission requests comment on the proposed plans' provisions with respect to the Processor's responsibility to keep information confidential.
Section VII of both plans would establish the method for a party to withdraw from the plan. Specifically, to withdraw from the plan, a party would be required to provide at least six months prior written notice to the other parties. The withdrawing party would remain liable for its proportionate share of costs and expenses during the time it was a party to the plan, but would have no further obligations after the withdrawal. The Three-Characters Plan specifically states that withdrawal by a party would not result in any rebate or adjustment in the initial development costs paid, or payable, at the time of termination.
The Commission requests comment on the proposed plans' provisions related to withdrawal. If a party withdraws from the plan, to what extent should that party be responsible for costs paid or payable at the time of its termination from the plan? Should a party that lists securities be permitted to withdraw from the plan? The Commission requests comment on whether it should require all listing markets to join any approved national market system plan for the selection and reservation of securities symbols.
In addition, under both plans, an SRO would cease to be a party to the plan when it ceases to maintain a facility for the quoting and trade reporting of securities transactions or ceases to use symbols subject to the plan.
The Commission requests comment on whether a vote is appropriate to allow an SRO that no longer maintains a facility for quoting or trade reporting of securities transactions or ceases to use symbols subject to the plan to remain a party to the plan. If so, the Commission requests comment on whether a unanimous or majority vote is appropriate. In particular, the Commission requests comment on how the requirement of either a majority vote, as proposed by the Five-Characters Plan, or unanimous vote, as proposed by the Three-Characters Plan, would affect competition among the listing markets.
Finally, both plans would provide that the right of a party to participate in the Symbol Reservation System under the plan is not transferable without the consent of the other parties.
The Commission requests comment on the proposed plans' provisions for the transfer of a party's rights under the plans. The Three-Characters Plan would subject the transferability provision to section I(d) of the plan. Section I(d) of the Three-Characters Plan states that an SRO that is a party to the plan would cease to be a party at such time as it ceases to maintain a facility for the quoting and trade reporting of securities or ceases to use symbols subject to the plan, unless such SRO asks to continue as a party and the other parties to the plan, by a unanimous vote, approve such SRO to continue as a party. Would the proposed plans' provisions for the transfer of a party's rights affect competition?
The Commission requests comment on this cross-reference to Section I(d), and notes that such cross-reference is not proposed in the Five-Characters Plan.
Section VIII of both plans would provide that the plan may be amended from time to time when authorized by the affirmative vote of all the parties, subject to any required approval of the Commission. The Commission notes that SROs proposing an amendment to a national market system plan must file such amendment with the Commission under Rule 608 of Regulation NMS.
Both plans anticipate that the plan would be implemented upon the Commission's approval.
Parties to the Three-Characters Plan contemplate that the development and implementation phase would take place according to a timetable agreed to by the parties and the Processor. Parties to the Five-Characters Plan would determine
The Commission requests comment on whether the plans should specify the timetable for implementation. If so, what would be an appropriate timetable? In addition, the Commission requests comment on whether the plans should address the interim period when the symbol reservation system is not yet implemented and the parties are operating under the existing informal reservation system.
Parties to both plans do not believe that their plan would impose any burden on competition. Parties to the Five-Characters Plan believe that the plan would promote competition among exchanges by: (1) Providing all exchanges equal ability to use all symbols, (2) preserving full portability of symbols, and (3) allowing all exchanges equal ability to reserve symbols subject to equal application of reasonable time limits.
In addition to the questions above, the Commission requests comment on whether the proposed plans have adequately addressed the impact that they might have on competition. If not, what issues have not been adequately addressed?
Parties to both plans state that they do not have any written understanding or agreement relating to the interpretation of, or participation in, their plan.
Parties to both plans state that they do not intend to operate a “facility” as that term is defined under the Act.
Section I of each of the plans contains a provision for the admission of new participants, under which any SRO that meets the eligibility standards of the plan may become a party thereto by signing a current copy of the plan and paying to the other parties a share of the aggregate development costs previously paid by such parties to the Processor.
The Commission requests comment on the proposed plans' provision with respect to new participants. In particular, the Commission requests commenters' view on whether the provisions set forth fair terms for access for all parties and, in particular, new listing markets.
Parties to the Three-Characters Plan contemplate that they would evaluate the Processor on a periodic basis, with a formal evaluation timetable, after they have selected the Processor. Parties to the Five-Characters Plan would determine the method and frequency of the evaluation of the Processor at a later time.
Generally, parties to the Three-Characters Plan would seek to resolve disputes by means of negotiation and discussion among their ISRA Policy Committee representatives; parties to the Five-Characters Plan would seek to resolve disputes by communication among parties. Except in the specific instances noted below, both plans do not provide for a specific mechanism for the resolution of disputes arising under the plan but acknowledge that all parties retain the right to present their views on issues relating to the plan and their rights in the appropriate forum.
There are two instances in which the proposed plans provide mechanisms for dispute resolution. Under Section IV(b)(2)(B) of each of the plans, the Policy Committee would resolve disputes related to the initial reservation requests. Under Section IV(f) of the Three-Characters Plan, the Processor would resolve disputes with respect to which SRO would retain the rights to the symbol when an issuer moves its listing to a new SRO.
The Commission requests comment on the proposed plans' provisions on dispute resolution. Specifically, the Commission requests commenters' view whether the proposed plans should prescribe the appropriate forums that aggrieved parties may seek to present their views.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed plans are consistent with the Act. The Commission invites comments on whether the foregoing assures fair competition among all parties, including new listing markets. 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
By the Commission.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold the following meeting during the week of July 16, 2007:
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), (8), (9)(B), and (10) and 17 CFR 200.402(a)(3), (5), (7), (8), 9(ii) and (10), permit consideration of the scheduled matters at the Closed Meeting.
Commissioner Casey, as duty officer, voted to consider the items listed for the closed meeting in closed session, and determined that no earlier notice thereof was possible.
The subject matter of the Closed Meeting scheduled for Tuesday, July 17, 2007 will be:
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact: The Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is proposing to extend its Short Term Option Series pilot program (“Pilot Program”) for an additional year, through July 12, 2008. The text of the proposed rule change is available on the Exchange's Web site (
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 July 12, 2006, the Commission approved a one-year extension of the Pilot Program, which was initially approved on July 12, 2005.
The Exchange believes that Short Term Option Series provide investors with a flexible and valuable tool to manage risk exposure, minimize capital outlays, and be more responsive to the timing of events affecting the securities that underlie option contracts. At the same time, the Exchange is cognizant of the need to be cautious in introducing a product that can increase the number of outstanding strike prices. In order to respond to potential customer demand and to remain competitive, the Exchange proposes to extend the Pilot Program for another year.
In its original proposal to establish the Pilot Program, the Exchange stated that if it were to propose an extension of the program, the Exchange would submit a Pilot Program report (“Report”) that would provide analysis of the Pilot Program covering the entire period during which the Pilot Program was in effect. Since the Exchange did not list any Short Term Option Series during this past year of the Pilot Program, there is no data available to prepare the Report at this time, and the Exchange has not submitted a Report with this proposal to extend the Pilot Program.
The Exchange notes that it possesses the adequate systems capacity to trade any Short Term Option Series, should any be listed in the future.
The Exchange believes that the proposed rule change is consistent with Section 6 of the Act
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 designated the proposed rule change as one that: (1) Does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) does not become operative for 30 days from the date of filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest. Therefore, the foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the benefits of the Pilot Program to continue without interruption.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate the 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is proposing to amend its rules to extend the Short Term Option Series Pilot Program (“Pilot Program”) for an additional year. The text of the proposed rule change is
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 July 12, 2005, the Commission approved the Pilot Program, which allows ISE to list and trade Short Term Option Series.
The Pilot Program is currently set to expire on July 12, 2007.
In the original proposal to establish the Pilot Program, the Exchange stated that if it were to propose an extension or an expansion of the Pilot Program, the Exchange would submit, along with any filing proposing such amendments to the Pilot Program, a report (“Pilot Program Report”) that would provide an analysis of the Pilot Program covering the entire period during which the Pilot Program was in effect. Since the Exchange did not list any Short Term Option Series during the preceding year of the Pilot Program, there is no data available to compile such a report at this time. Therefore, the Exchange is not submitting a Pilot Program Report with this proposal.
Finally, the Exchange represents that it has the necessary systems capacity to support the listing of Short Term Option Series, should it determine to do so in the future.
The Exchange believes that Short Term Option Series increase the variety of listed options available to investors and provide investors with a valuable tool to manage risk exposure, minimize capital outlays, and be more responsive to the timing of events affecting the securities that underlie options contracts. For these reasons, the Exchange believes the proposed rule change is consistent with section 6(b) of the Act.
The Exchange believes that the proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The Exchange has designated the proposed rule change as one that: (1) Does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) does not become operative for 30 days from the date of filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest. Therefore, the foregoing rule change has become effective pursuant to section 19(b)(3)(A) of the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the benefits of the Pilot Program to continue without interruption.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate the 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-ISE-2007-54. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commissions Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Nasdaq proposes to modify Nasdaq IM-4300 to provide additional transparency to how Nasdaq applies its public interest authority. Nasdaq will implement the proposed rule upon approval. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
In order to further issuers' understanding of Rule 4300, Nasdaq is adopting this Interpretive Material as a non-exclusive description of the circumstances in which the Rule is generally invoked.
Nasdaq may use its authority under Rule 4300 to deny initial or continued listing to an issuer when an individual with a history of regulatory misconduct is associated with the issuer. Such individuals are typically an officer, director, substantial security holder (as defined in Rule 4350(i)(5)), or consultant to the issuer. In making this determination, Nasdaq [shall]
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○ the individual's current or proposed position;
○ o the individual's current or proposed scope of authority;
○ the extent to which the individual has responsibility for financial accounting or reporting; and
○ the individual's equity interest.
Based on this review, Nasdaq may determine that the regulatory history rises to the level of a public interest concern, but may also consider whether remedial measures proposed by the issuer, if taken, would allay that concern. Examples of such remedial measures could include any or all of the following, as appropriate:
• The individual's resignation from officer and director positions, and/or other employment with the company;
• divestiture of stock holdings;
• terminations of contractual arrangements between the issuer and the individual; or
• the establishment of a voting trust surrounding the individual's shares.
Nasdaq staff is willing to discuss with issuers, on a case-by-case basis, what remedial measures may be appropriate to address public interest concerns, and for how long such remedial measures would be required. Alternatively, Nasdaq may conclude that a public interest concern is so serious that no remedial measure would be sufficient to alleviate it. In the event that Nasdaq staff [makes such a determination] denies initial or continued listing based on such public interest considerations, the issuer may seek review of that determination through the procedures set forth in the Rule 4800 Series. On consideration of such appeal, a listing qualifications panel comprised of persons independent of Nasdaq may accept, reject or modify the staff's recommendations by imposing conditions.
Nasdaq may also use its discretionary authority, for example, when an issuer files for protection under any provision of the federal bankruptcy laws or comparable foreign laws, when an issuer's independent accountants issue a disclaimer opinion on financial statements required to be audited, or when financial statements do not contain a required certification.
In addition, pursuant to its discretionary authority, Nasdaq [shall]
Although Nasdaq has broad discretion under Rule 4300 to impose additional or more stringent criteria, the Rule does not provide a basis for Nasdaq to grant exemptions or exceptions from the enumerated criteria for initial or continued listing, which may be granted solely pursuant to rules explicitly providing such authority.
In its filing with the Commission, Nasdaq 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. Nasdaq has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq proposes to modify Nasdaq IM-4300 to provide additional transparency to how Nasdaq applies its public interest authority. Specifically, Nasdaq proposes to clarify certain of the factors contained in this interpretive material to better guide companies. Nasdaq also proposes to change the formatting of portions of the text to enhance their readability and to add new language highlighting Nasdaq staff's willingness to discuss these concerns, and possible remedial measures, with companies. Nasdaq does not consider these changes to be substantive in nature.
Nasdaq believes that the proposed rule change is consistent with the provisions of section 6 of the Act,
Nasdaq 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.
Written comments were neither solicited nor received.
Within 35 days of the date of publication of this notice in the
A. By order approve such 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-NASDAQ-2007-024 and should be submitted on or before August 7, 2007.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
NASD Dispute Resolution proposes to amend the Code of Arbitration Procedure for Customer Disputes (“Customer Code”), and the Code of Arbitration Procedure for Industry Disputes (“Industry Code”) to amend the definition of public arbitrator to add an annual revenue limitation. The text of the proposed rule change is available at NASD,
In its filing with the Commission, NASD included statements concerning the purpose of and basis for the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. NASD has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
NASD has taken numerous steps in recent years to ensure the integrity and neutrality of its arbitrator roster by addressing classification of arbitrators. For example, in August 2003, NASD proposed changes to Rules 10308 and 10312 of the Code of Arbitration Procedure (“Code”) to modify the definitions of public and non-public arbitrators to further prevent individuals with significant ties to the securities industry from serving as public arbitrators.
• Increased from three years to five years the period for transitioning from a non-public to public arbitrator after leaving the securities industry.
• Clarified that the term “retired” from the industry includes anyone who spent a substantial part of his or her career in the industry.
• Prohibited anyone who has been associated with the industry for at least 20 years from ever becoming a public arbitrator, regardless of how long ago the association ended.
• Excluded from the public arbitrator roster attorneys, accountants, or other professionals whose firms have derived 10 percent or more of their annual revenue in the previous two years from clients involved in securities-related activities.
On July 22, 2005, NASD proposed a further amendment to Rule 10308 of the Code relating to arbitrator classification to prevent individuals with certain indirect ties to the securities industry from serving as public arbitrators. Specifically, NASD proposed to amend the definition of public arbitrator to exclude individuals who work for, or are officers or directors of, an entity that controls, is controlled by, or is under common control with, a broker/dealer, or who have a spouse or immediate family member who works for, or is an officer or director of, an entity that is in such a control relationship with a broker/dealer. NASD also proposed to amend Rule 10308 to clarify that individuals registered through broker-dealers may not be public arbitrators, even if they are employed by a non-broker-dealer (such as a bank). This rule filing was approved by the SEC on October 16, 2006, and became effective on January 15, 2007.
Finally, during the time that the above changes were being made, NASD also had pending at the Commission a 2003 proposal to amend the Code to reorganize the rules into the Customer Code, the Industry Code, and a separate code for mediation. The final provisions of this proposal were approved by the Commission on January 24, 2007, and became effective on April 16, 2007.
Despite these many initiatives amending the arbitrator classification rules, some users of the forum continue to voice concerns about individuals serving as public arbitrators when they have business relationships with entities that derive income from broker-dealers. The concern is that, for example, an arbitrator classified as public might work for a very large law firm that derived less than 10% of its annual revenue from broker-dealer clients, but still receives a large dollar amount of such revenue. The concern focused primarily on the law firm's defense of action (in arbitration or litigation) by customers of broker-dealers, and not on representing broker-dealers in underwriting or other activities. Therefore, those concerned with the amount of annual revenue recommended that there be an annual dollar limitation of $50,000 on revenue from broker-dealers relating to customer disputes with a brokerage firm or associated person concerning an investment account.
NASD supports these recommendations and is, therefore, proposing to amend the definition of public arbitrator in Rule 12100(u) of the Customer Code and Rule 13100(u) of the Industry Code to add a provision that would prevent an attorney, accountant, or other professional from being classified as a public arbitrator, if the person's firm derived $50,000 or more in annual revenue in the past two years from professional services rendered to any persons or entities listed in Rule 12100(p)(1) of the Customer Code or Rule 13100(p)(1) of the Industry Code relating to any customer disputes concerning an investment account or transaction, including but not limited to, law firm fees, accounting firm fees, and consulting fees.
NASD believes the proposed amendment, in conjunction with the existing 10 percent revenue limitation,
NASD believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act, which requires, among other things, that the Association's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest. NASD believes that the proposed rule change will enhance investor confidence in the fairness and neutrality of NASD's arbitration forum, by providing further assurance to parties that persons who have a relationship with those who receive a significant amount of compensation from the securities industry are not able to serve as public arbitrators in NASD arbitrations.
NASD 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.
Within 35 days of the date of publication of this notice in the
A. By order approve such 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is proposing to extend the Quarterly Options Series pilot program (“Pilot Program”) for an additional two-week period, through July 24, 2007, and to amend Rule 5.19(a) regarding the restriction on the number of strike prices for Quarterly Options Series based on an underlying index. The text of the proposed rule change is available on the Exchange's Web site (
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 July 12, 2006, the Exchange filed with the Commission a proposed rule change that allowed it to establish the Pilot Program, pursuant to which the Exchange lists and trades Quarterly Options Series.
In the Pilot Program Release, the Exchange stated that it would submit, in connection with any proposed extension of the Pilot Program, a Pilot Program Report (“Report”) that would provide an analysis of the Pilot Program covering the entire period which the program was in effect. The Report will include: (1) Data and written analysis on the open interest and trading volume in the classes for which Quarterly Options Series were opened; (2) an assessment of the appropriateness of the option classes selected for the Pilot Program; (3) an assessment of the impact of the Pilot Program on the capacity on the Exchange, OPRA, and market data vendors (to the extent data from market data vendors is available); (4) any capacity problems or other problems that arose during the operation of the Pilot Program and how the Exchange addressed such problems; (5) any complaints that the Exchange received during the operation of the Pilot Program and how the Exchange addressed them; and (6) any additional information that would assist the Commission in assessing the operation of the Pilot Program. The Exchange plans to submit the Report in connection with a proposal that will extend the Pilot Program until July 10, 2008. This proposal and Report will be filed with the Commission at the conclusion of the proposed two-week extension.
The Exchange also proposes at this time to add a provision to Rule 5.19(a) regarding the limitations on the number of strikes the Exchange may list for Quarterly Options Series based on an underlying index. These changes mirror provisions previously submitted by the Chicago Board Options Exchange (“CBOE”) and approved by the Commission.
Finally, NYSE Arca represents that the Exchange has the necessary system capacity to support any additional series listed as part of the Pilot Program.
The Exchange believes that the continuation of the Quarterly Options Series Pilot Program will stimulate customer interest in options by creating greater trading opportunities and flexibility in investment choices. The Exchange further believes that continuation of the Pilot Program will provide the ability to more closely tailor investment strategies and provide a valuable hedging tool for investors. For these reasons, the Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder and, in particular, the requirements of section 6(b) of the Act.
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 designated the proposed rule change as one that: (1) Does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) does not become operative for 30 days from the date of filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest. Therefore, the foregoing rule change has become effective pursuant to section 19(b)(3)(A) of the Act
The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest because it will allow the benefits of the Pilot Program to continue without interruption.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate the 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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade shares (“Shares”) of the iShares ®
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 III below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Pursuant to NYSE Arca Equities Rule 8.201, which permits the trading of Commodity-Based Trust Shares
The Shares represent beneficial ownership interests in the net assets of the Trust, which holds gold bullion. The objective of the Trust is for the value of the Shares to reflect, at any given time, the price of gold owned by the Trust at that time, less the Trust's expenses and liabilities. The Trust is not actively managed and does not engage in any activities designed to obtain a profit from, or to ameliorate losses caused by, changes in the price of gold. The Trust is neither an investment company registered under the Investment Company Act of 1940 nor a commodity pool for purposes of the Commodity Exchange Act.
A detailed discussion of the gold market, including the over-the-counter gold market and the gold futures exchanges, gold market regulation, COMEX gold futures contracts, the process for creations and redemptions of the Shares, certificates evidencing the Shares, and Trust distributions, among others, can be found in the Amex Notice and in the Trust Prospectus.
The Web site for the Trust at
The Exchange would make available, through the facilities of the Consolidated Tape Association (“CTA”), quotation information including the last sale price for the Shares, the daily trading volume, closing prices, and the NAV for the Shares from the previous day. In addition, the Exchange or a major market data vendor would disseminate each day through the facilities of the CTA the number of Shares outstanding and the Indicative Trust Value (“ITV”) on a per-Share basis at least every 15 seconds
Shortly after 4 p.m. ET each business day, the Trustee,
The Exchange states that information on gold prices and gold markets is available on public Internet Web sites and through professional and subscription services. In most instances, real-time information is available only for a fee, and information available free-of-charge is subject to delay (typically 20 minutes). The Exchange also states that investors may obtain on a 24-hour basis gold pricing information based on the spot price for a troy ounce of gold from various financial information service providers, such as Reuters and Bloomberg. Reuters and Bloomberg provide at no charge on their Web sites delayed information regarding the spot price of gold and last sale prices of gold futures, as well as information about news and developments in the gold market. Reuters and Bloomberg also offer a professional service to subscribers for a fee that provides information on gold prices directly from market participants. In addition, an organization named EBS provides an electronic trading platform to institutions such as bullion banks and dealers for the trading of spot gold, as well as a feed of live streaming prices to Reuters and Moneyline Telerate subscribers.
The Exchange further represents that complete real-time data for gold futures and options prices traded on COMEX is available by subscription from Reuters and Bloomberg. The closing price and settlement prices of the COMEX gold futures contracts are publicly available from NYMEX at
The Exchange states that the Shares are subject to the criteria for initial and continued listing of Commodity-Based Trust Shares under NYSE Arca Equities Rule 8.201. As indicated above, the Shares are currently trading on the Exchange pursuant to UTP. A minimum of 100,000 Shares would be required to be outstanding when the Shares are listed. This minimum number of Shares required to be outstanding is comparable to requirements that have been applied to previously listed series of exchange-traded funds. The Exchange believes that the proposed minimum number of Shares outstanding at the start of trading is sufficient to provide market liquidity. In addition, the Exchange represents that the Trust is required to comply with Rule 10A-3 under the Act
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. The trading hours for the Shares on the Exchange are the same as those set forth in NYSE Arca Equities Rule 7.34 (Opening, Core, and Late Trading Sessions, 4 a.m. ET to 8 p.m. ET).
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares. Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These reasons may include (1) the extent to which trading is not occurring in the underlying COMEX gold futures contract, or (2) whether other unusual conditions or circumstances detrimental
The Exchange intends to utilize its existing surveillance procedures applicable to derivative products to monitor trading in the Shares. The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules. The Exchange may also obtain information via the Intermarket Surveillance Group (“ISG”) from other exchanges that are members or affiliate members of ISG. In addition, the Exchange has an information sharing agreement in place with NYMEX for the purpose of providing information in connection with trading in or related to gold futures contracts traded on COMEX. Furthermore, the Exchange states that the Shares are subject to NYSE Arca Equities Rule 8.201(g)-(i), which set forth certain restrictions on ETP Holders
Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin (“Bulletin”) of the special characteristics and risks associated with trading the Shares. Specifically, the Bulletin will discuss the following: (a) Description of the Shares; (b) the risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated ITV will not be calculated or publicly disseminated;
The proposal is consistent with Section 6(b) 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 purpose of the Act.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission further believes that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
Furthermore, the Commission believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately. The Commission notes that the Exchange will obtain a representation from the Trust, prior to listing, that the NAV per Share would be calculated daily and made available to all market participants at the same time.
The Commission also believes that the Exchange's trading halt rules are reasonably designed to prevent trading in the Shares when transparency is impaired. NYSE Arca Equities Rule 8.201(e)(2) provides that, when the Exchange is the listing market, if the value of the underlying commodity or ITV is no longer calculated or available on at least a 15-second delayed basis, the Exchange would consider suspending trading in the Shares. The Exchange further represents that if the interruption to the calculation or wide dissemination of the value of the underlying gold or ITV persists past the trading day in which it occurred, the Exchange would halt trading no later than the beginning of the trading day following the interruption. NYSE Arca Equities Rule 8.201(e)(2) also provides that the Exchange may seek to delist the Shares in the event the value of the underlying gold or ITV is no longer calculated or available as required.
The Commission further believes that the trading rules and procedures to which the Shares will be subject pursuant to this proposal are consistent with the Act. The Exchange has represented that any securities listed pursuant to this proposal will be deemed equity securities, and subject to existing Exchange rules governing the trading of equity securities.
In support of this proposal, the Exchange has made the following representations:
(1) The Exchange's surveillance procedures are adequate to address any concerns associated with the trading of the Shares.
(2) The Exchange would inform its members in an Information Bulletin of the special characteristics and risks associated with trading the Shares, including risks inherent with trading the Shares during the Opening and Late Trading Sessions when the updated ITV is not calculated and disseminated and suitability recommendation requirements.
(3) The Exchange would require its members to deliver a prospectus or product description to investors purchasing Shares prior to or concurrently with a transaction in such Shares and will note this prospectus delivery requirement in the Information Bulletin.
The Commission finds good cause for approving this proposal before the thirtieth day after the publication of notice thereof in the
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange, through NYSE Arca Equities, proposes to trade partnership units (“Units”) of the United States Natural Gas Fund, LP (“USNG” or “Partnership”) pursuant to unlisted trading privileges (“UTP”). 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 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 III below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Under NYSE Arca Equities Rule 8.300, which permits the trading of Partnership Units either by listing or pursuant to UTP,
The net assets of USNG consist of investments in futures contracts based on natural gas, crude oil, heating oil, gasoline, and other petroleum-based fuels traded on the New York Mercantile Exchange (“NYMEX”), Intercontinental Exchange (“ICE Futures”), or other U.S. and foreign exchanges (such futures contracts collectively referred to herein as “Futures Contracts”). USNG may also invest in other natural-gas-related investments such as cash-settled options on Futures Contracts; forward contracts for natural gas; over-the-counter instruments that are based on the price of natural gas, oil, and other petroleum-based fuels; Futures Contracts; and indices based on the foregoing (collectively referred to herein as “Other Natural Gas Related Investments,” and together with Futures Contracts, “Natural Gas Interests”). A detailed discussion of the natural gas, crude oil, heating oil, and gasoline markets; futures regulation and the regulation of USNG; investment strategy; creations and redemptions of baskets of Units; and calculation methodology of the net asset value (“NAV”) for the Units, among others, can be found in the Amex Notice.
The Web site for Amex at
The NAV for USNG is calculated and disseminated daily.
To provide updated information relating to USNG for use by investors, professionals, and persons wishing to create or redeem the Units, Amex disseminates through the facilities of the Consolidated Tape Association an updated Indicative Partnership Value (“Indicative Partnership Value”). The Indicative Partnership Value is disseminated on a per-Unit basis at least every 15 seconds during the regular trading hours of 9:30 a.m. to 4:15 p.m. Eastern Time (“ET”). The Indicative Partnership Value is calculated based on the Cash
The Indicative Partnership Value does not reflect price changes to the price of the Benchmark Futures Contract between the close of open-outcry trading of such contract on NYMEX at 2:30 p.m. ET and the open of trading on the NYMEX ACCESS market at 3:15 p.m. ET.
While NYMEX is open for trading, the Indicative Partnership Value can be expected to closely approximate the value per Unit of the Basket Amount. However, during trading hours when the Futures Contracts have ceased trading, spreads and resulting premiums or discounts may widen, and therefore, increase the difference between the price of the Units and the NAV of the Units. The Indicative Partnership Value on a per-Unit basis disseminated from 9:30 a.m. to 4:15 p.m. ET should not be viewed as a real-time update of the NAV, which is calculated only once a day.
The Exchange represents that it will cease trading the Units of USNG if: (1) The original listing market stops trading the Units; or (b) the original listing market delists the Units. Additionally, the Exchange may cease trading the Units if such other event shall occur or condition exists which, in the opinion of the Exchange, makes further dealings on the Exchange inadvisable.
The Exchange deems the Units to be equity securities, thus rendering trading in the Units subject to the Exchange's existing rules governing the trading of equity securities. Units will trade on the NYSE Arca Marketplace from 4 a.m. ET until 8 p.m. ET in accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late Trading Sessions). The Exchange states that it has appropriate rules to facilitate transactions in the Units during all trading sessions.
The Exchange intends to utilize its existing surveillance procedures applicable to derivative products to monitor trading in the Units. The Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Units in all trading sessions and to deter and detect violations of Exchange rules. The Exchange may also obtain information via the Intermarket Surveillance Group (“ISG”) from other exchanges who are members or affiliate members of ISG. In addition, the Exchange has information sharing agreements in place with NYMEX and ICE Futures for the purpose of providing information in connection with trading in or related to futures contracts traded on NYMEX and ICE Futures, respectively. To the extent that USNG invests in Natural Gas Interests traded on other exchanges, the Exchange will seek to enter into information sharing agreements with those particular exchanges. In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its ETP Holders
The proposal is consistent with Section 6(b) 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 purpose of the Act.
The Exchange has neither solicited nor received written comments on the proposed rule change.
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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
In addition, the Commission finds that the proposal is consistent with Section 12(f) of the Act,
The Commission further believes that the proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
The Commission also believes that the Exchange's trading halt rules are reasonably designed to prevent trading in the Shares when transparency is impaired. Existing NYSE Arca Equities Rule 7.34(a)(4), which will apply to the trading of the Units, provides that, if the Benchmark Futures Contract or Indicative Partnership Value is no longer calculated or disseminated as required (a) during the Opening Session (4 a.m. to 9:30 a.m. ET), the Exchange may continue to trade the Units for the remainder of the Opening Session; (b) during the Core Trading Session (9:30 a.m. to 4 p.m. ET), the Exchange must halt trading in the Units; and (c) during the Late Trading Session (4 p.m. to 8 p.m. ET), the Exchange may continue trading in the Units only if the original listing market traded such Units until the close of its regular trading session without halt.
The Commission notes that, if the Units should be delisted by the listing exchange, the Exchange would no longer have authority to trade the Units pursuant to this order.
In support of this proposal, the Exchange has made the following representations:
(1) The Exchange's surveillance procedures are adequate to address any concerns associated with the trading of the Units on a UTP basis.
(2) The Exchange would inform its members in an Information Bulletin of the special characteristics and risks associated with trading the Units, including risks inherent with trading the Units during the Opening and Late Trading Sessions when the updated Indicative Partnership Value is not calculated and disseminated and suitability recommendation requirements.
(3) The Exchange would require its members to deliver a prospectus or product description to investors purchasing Units prior to or concurrently with a transaction in such Units and will note this prospectus delivery requirement in the Information Bulletin.
The Commission finds good cause for approving this proposal before the thirtieth day after the publication of notice thereof in the
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Phlx proposes to revise its listing standards, adopted pursuant to Rule 19b-4(e),
The text of the proposed rule change is available at Phlx, from the Commission's Public Reference Room, and on Phlx's Web site (
In its filing with the Commission, Phlx 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 III below. Phlx 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 provide for the more efficient and timely listing and trading of ETFs. This proposal would enable the Exchange to list and trade ETFs pursuant to Rule 19b-4(e) under the Act
Currently, Phlx Rule 803(i) provides standards for listing Trust Shares on Phlx. A Trust Share is a security based on a unit investment trust registered under the Investment Company Act of 1940 (“1940 Act”),
Pursuant to Phlx Rule 803(i), Trust Shares that are eligible for listing on the Exchange must be issued in a specified aggregate minimum number in return for a deposit of specified securities and/or a cash amount. When aggregated in the same specified minimum number, the Trust Shares must be redeemable from the Trust for the securities and/or cash. Pursuant to Phlx Rule 803(
To meet the investment objective of providing investment returns that correspond to the price and the dividend and yield performance of the underlying index, an ETF may use a “replication” strategy or a “representative sampling” strategy with respect to the ETF portfolio.
In addition, an ETF portfolio may be adjusted in accordance with changes in the composition of the underlying index or to maintain compliance with requirements applicable to a regulated investment company under the Internal Revenue Code (“IRC”).
The Commission has previously approved generic listing standards for ETFs based on indexes that consist of stocks listed on U.S. exchanges.
In addition, the Commission has previously approved generic listing standards of exchanges governing the listing and trading of ETFs based on indexes composed of non-U.S. Component Stocks as well as indexes based on both non-U.S. Component Stocks and U.S. Component Stocks.
The Exchange believes that adopting generic listing standards and applying Rule 19b-4(e) should fulfill the intended objective of that rule by allowing those ETFs that satisfy the
ETFs that are listed pursuant to the proposed generic listing standards or that are traded pursuant to UTP would be traded, in all other respects, under the Exchange's existing trading rules and procedures that apply to ETFs and would be covered under Exchange's surveillance program for ETFs.
To list a Trust Share or IFS pursuant to the proposed generic listing standards for international and global indexes, the index underlying the Trust Share or IFS must satisfy all the conditions contained in proposed Phlx Rules 803(i)(11)(b) or (
As proposed, Phlx Rule 803(i)(1)(iii) and (iv) and Phlx Rule 803(
The Exchange proposes that, to list a Trust Share or an IFS based on an international or global index or portfolio pursuant to the generic listing standards, such index or portfolio must meet the following criteria:
• Component stocks that in the aggregate account for at least 90% of the weight of the index or portfolio each must have a minimum market value of at least $100 million (Phlx Rules 803(i)(11)(b)(i) and (
• Component stocks representing at least 90% of the weight of the index or portfolio each must have a minimum worldwide monthly trading volume during each of the last six months of at least 250,000 shares (Phlx Rules 803(i)(11)(b)(ii) and (
• The most heavily weighted component stock may not exceed 25% of the weight of the index or portfolio and the five most heavily weighted component stocks may not exceed 60% of the weight of the index or portfolio (Phlx Rules 803(i)(11)(b)(iii) and (
• The index or portfolio shall include a minimum of 20 component stocks (Phlx Rules 803(i)(11)(b)(iv) and (
• Each U.S. Component Stock must be listed on a national securities exchange and be an NMS stock as defined in Rule 600 of Regulation NMS under the Act, and each Non-U.S. Component Stock must be listed on an exchange that has last-sale reporting (Phlx Rules 803(i)(11)(b)(v) and (
The Exchange believes that these proposed standards are reasonable for international and global indexes, and, when applied in conjunction with the other listing requirements, would result in the listing and trading on the Exchange of ETFs that are sufficiently broad-based in scope and not readily susceptible to manipulation. The Exchange also believes that the proposed standards would result in ETFs that are adequately diversified in weighting for any single security or small group of securities to significantly reduce concerns that trading in an ETF based on an international or global index could become a surrogate for the trading of securities not registered in the United States.
The Exchange further notes that, while these standards are similar to those for indexes that include only U.S. Component Stocks, they differ in certain important respects and are generally more restrictive, reflecting greater concerns over portfolio diversification with respect to ETFs investing in components that are not individually registered with the Commission. First, in the proposed standards, component stocks that in the aggregate account for at least 90% of the weight of the index or portfolio each shall have a minimum market value of at least $100 million, compared to a minimum market value of at least $75 million for indexes with only U.S. Component Stocks. (Market value is calculated by multiplying the total shares outstanding by the price per share of the component stock.) Second, in the proposed standards, the most heavily weighted component stock cannot exceed 25% of the weight of the index or portfolio, in contrast to a 30% standard for an index or portfolio comprised of only U.S. Component Stocks. Third, in the proposed standards, the five most heavily weighted component stocks shall not exceed 60% of the weight of the index or portfolio, compared to a 65% standard for indexes comprised of only U.S. Component Stocks. Fourth, the minimum number of stocks in the proposed standards is 20, in contrast to a minimum of 13 in the standards for an index or portfolio with only U.S. Component Stocks. Finally, the proposed standards require that each Non-U.S. Component Stock included in the index or portfolio be listed and traded on an exchange that has last-sale reporting.
The Exchange also proposes new Phlx Rules 803(i)(11)(e) and (
In addition, proposed Phlx Rules 803(i)(11)(e) and (
As set forth in proposed Phlx Rules 803(i)(11)(l) and (
The Exchange is also proposing to add provisions, proposed Phlx Rules 803(i)(11)(k) and (
The Commission has approved generic listing standards providing for the listing, pursuant to Rule 19b-4(e), of derivative securities products based on indexes described in rules previously approved by the Commission under Section 19(b)(2) of the Act.
The Exchange also proposes to include additional continued listing standards relating to ETFs. The Exchange proposes to adopt Phlx Rules 803(i)(5)(D) and (
Phlx's proposed amendments to Phlx Rule 136 would expand the application of the trading halt provisions of Rule 136(c) and (d) from index-linked securities to a broader range of derivative securities products listed or traded on Phlx on a UTP basis. Current Phlx Rule 136, among other things, sets out the trading halt rules for a Derivative Securities Product
The Exchange proposes to amend Phlx Rule 803 to stipulate that, as provided by Commission Rule 12f-5,
The Exchange is proposing other minor and clarifying changes to Phlx Rules 803(i) and (
The Exchange represents that its surveillance procedures are adequate to properly monitor the trading of Trust Shares and IFSs that would be listed pursuant to the proposed listing standards or traded on a UTP basis. Specifically, Phlx will rely on its existing surveillance procedures governing equities, options, and ETFs. The Exchange states that it will closely monitor activity in ETFs to identify and deter any potential improper trading activity in ETFs. In addition, the Exchange has a general policy prohibiting the dissemination of material, non-public information by its employees.
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 would result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments were neither solicited nor received.
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 Nancy M. Morris, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
After careful review, the Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
Currently, the Exchange must file a proposed rule change with the Commission pursuant to Section 19(b)(1) of the Act
The Commission previously has approved generic listing standards for other exchanges that are substantially similar to those proposed here by the Exchange.
Proposed Phlx Rules 803(i)(11)(b) and (
The proposed generic listing standards will permit the Exchange to list and trade an ETF if the Commission has previously approved an SRO rule change that contemplates listing and trading a derivative product based on the same underlying index. Phlx would be able to rely on that earlier approval order, provided that: (1) The securities comprising the underlying index consist of U.S. Component Stocks or Non-U.S. Component Stocks; and (2) Phlx complies with the commitments undertaken by the other SRO set forth in the prior order, including any surveillance-sharing arrangements with a foreign market.
The Commission believes that Phlx's proposal is consistent with Section 11A(a)(1)(C)(iii) of the Act,
In addition, an IIV, which represents an estimate of the value of a share of each ETF, must be updated and disseminated at least once every 15 seconds during Phlx XLE's Core Session. If the underlying components are trading during the same hours as the XLE's Pre Market Session, Phlx may not trade the ETF unless an updated IIV is being calculated and disseminated. The IIV must reflect changes in the exchange rate between the U.S. dollar and the currency in which any index or portfolio component stock is denominated. When there is no overlap with the trading hours of the primary market or markets trading the underlying components of an ETF, Phlx may trade such ETF during the Pre Market Session, as long as the last official calculated IIV remains available.
The Commission believes the proposal is reasonably designed to preclude trading of ETFs when transparency is impaired. Existing Phlx Rule 136 sets out the trading halt rules for Derivative Securities Products in the event that there is a temporary interruption in the calculation and dissemination of the index value or the IIV. In the proposed rule change, Phlx would amend its definition of a “Derivative Securities Product” and thereby extend Rule 136 to a broader range of derivative securities products that currently trade on the Exchange, including Trust Shares and IFSs. This proposed rule change is designed to ensure that similar derivative securities products are treated consistently and that the same trading halt rules apply when there is a temporary disruption in the dissemination of the IIV and index value.
In addition, in the proposed rule change, Phlx would clarify that the trading halt rules apply when values that are comparable to the IIV, such as the Indicative Optimized Portfolio Value, are not disseminated as required. The Commission believes that it is reasonable and consistent with the Act for Phlx to apply consistent trading halt rules to similar derivative securities products.
The Commission believes that the proposed rules are reasonably designed to promote fair disclosure of information that may be necessary to price an ETF appropriately. These generic listing standards provide that the issuer of an ETF must represent that it will calculate the NAV and make it available daily to all market participants at the same time.
In approving this proposal, the Commission relied on Phlx's representation that its surveillance procedures are adequate to properly monitor the trading of the Trust Shares and IFSs listed pursuant to the proposed new listing standards or traded on a UTP basis. This approval is conditioned on the continuing accuracy of that representation.
The Commission finds good cause for approving the proposed rule change, as amended, prior to the 30th day after the date of publication of the notice of filing thereof in the
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-1709-DR), dated 06/29/2007.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for the State of Texas, dated 06/29/2007 is hereby amended to re-establish the incident period for this disaster as beginning 06/16/2007 and continuing.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-1709-DR), dated 06/29/2007.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Texas, dated 06/29/2007 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
This notice amends and supplements Department of State Public Notice 4819, 69 FR 59980-81 (October 6, 2004).
Section 459A of the Social Security Act (42 U.S.C. 659A) authorizes the Secretary of State with the concurrence of the Secretary of Health and Human Services to declare foreign countries or their political subdivisions to be reciprocating countries for the purpose of the enforcement of family support
Once such a declaration is made, support agencies in jurisdictions of the United States participating in the program established by Title IV-D of the Social Security Act (the IV-D program) must provide enforcement services under that program to such reciprocating countries as if the request for service came from a U.S. State.
The declaration authorized by the statute may be made “in the form of an international agreement, in connection with an international agreement or corresponding foreign declaration, or on a unilateral basis.” The Secretary of State has authorized either the Legal Adviser or the Assistant Secretary for Consular Affairs to make such a declaration after consultation with the other.
As of this date, the following countries (or Canadian provinces or territories) have been designated foreign reciprocating countries:
Each of these countries (or Canadian provinces or territories) has designated a Central Authority to facilitate enforcement and ensure compliance with the standards of the statute. Information relating to the designated Central Authorities, and the procedures for processing requests may be obtained by contacting the United States Central Authority for International Child Support, Department of Health and Human Services, Office of Child Support Enforcement (OCSE), 370 L'Enfant Promenade, SW., 4-East, Washington, DC 20447; phone (202) 401-5566, fax (202) 401-5539, e-mail:
As of this date, reciprocity agreements have been signed, but are not yet in effect, with Costa Rica and Finland.
Questions regarding this notice, the status of negotiations, declarations and agreements may be obtained by contacting Mary Helen Carlson at the Office of the Assistant Legal Adviser for Private International Law, Suite 203 South Building, 2430 E Street, NW., Washington, DC 20037-2851; phone (202) 776-8420, fax (202) 776-8482, e-mail:
The law also permits individual states of the United States to establish or continue existing reciprocating arrangements with foreign countries when there has been no Federal declaration. Many states have such arrangements with additional countries not yet the subject of a Federal declaration. Information as to these arrangements may be obtained from the individual State IV-D Agency.
Federal Aviation Administration, DOT.
Notice of intent of waiver with respect to land.
The Federal Aviation Administration (FAA) is considering a proposal to change a portion of the airport from aeronautical use to non-aeronautical use and to authorize the lease of the airport property. The area is a 224-acre parcel of vacant land located west of the airport. The land is presently subject to a farm lease. The land was acquired via quitclaim deed dated February 13, 1948, recorded February 27, 1948, in Jennings County, Deed Record No. 78, Page No. 634-636. There are no impacts to the airport by allowing the airport to lease the property. The land is not needed for aeronautical use, and will be sub-let to various future developers as an industrial airpark. Approval does not constitute a commitment by the FAA to financially assist in the disposal of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA. The disposition of the proceeds from the lease of the airport property will be in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the
In accordance with Section 47107(h) of Title 49, United States Code, this notice is required to be published in the
Comments must be received on or before August 16, 2007.
Documents reflecting this FAA action may be reviewed at 2300 East Devon Avenue, Des Plaines, IL, 60018, or at North Vernon Municipal Airport, North Vernon, Indiana.
Bobb Beauchamp, Environmental Program Manager, 2300 East Devon Avenue, Des Plaines, IL, 60018. Telephone Number 847-294-7364/FAX Number 847-294-7046.
Following is a legal description of the property: A parcel of land situated in Sections 15 and 22, Township 7 North, Range 8 East, Center Township, Jennings County, Indiana, being more particularly described as follows: Beginning at the point of the intersection of the east right-of-way line of the C.C.C. and St. L. Railroad and east and west centerline of said Section 15 also being the point of beginning of the Quitclaim Deed in the Jennings County Deed Record 78 page 634 to 636; thence North 89 degrees, 26 minutes, 06 seconds East, 2134.3 feet to a point on the centerline of Jennings County Road 20 West to a point on the south line of said Quitclaim Deed; thence westerly on and along said south line of said Quitclaim Deed to the west line of said
Together containing 224 acres more or less, subject to all liens, encumbrances, easements, limitations, and restrictions of record.
Federal Highway Administration (FHWA), DOT.
Letter of Project Initiation; Notice of Intent to prepare an Environmental Impact Statement (EIS); and initiation of public and agency scoping for the addition of traffic lanes, interchange configuration improvements, structure widening, structure replacements and pavement reconstruction to Interstate 84 (I-84) from the Karcher Interchange in Canyon County to the Five Mile Road overpass in Ada County, Idaho.
The FHWA hereby gives notice that it intends to prepare an EIS for the proposed addition of lanes and other reconstruction improvements to approximately 16 miles of I-84 between the Karcher Interchange in Canyon County and Five Mile Road in Ada County, Idaho. The environmental study will evaluate the potential impacts of design alternatives for future construction of the additional lanes and several associated staged improvement projects of this highway segment. This EIS is being prepared and considered in accordance with the National Environmental Policy Act (NEPA) of 1969, regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and FWHA regulations, guidance and policy.
Anticipated Federal approvals/actions needed for this project to be constructed include permits for Sections 401 and 404 of the Clean Water Act (U.S. Army Corps of Engineers) and compliance with Section 106 of the National Historic Preservation Act.
Public comments and questions are welcome anytime during the NEPA process and should be directed to the addresses listed below. Additional formal opportunities for public participation after the Public Scoping are tentatively scheduled as follows:
Notices of availability for the Draft EIS, Final EIS and Record of Decision will be provided through direct mail, the
Edwin Johnson, Field Operations Engineer; Federal Highway Administration, 3050 Lake Harbor Lane, Suite 126, Boise, Idaho 83703, Telephone: (208) 334-9180; or Gwen Smith, GARVEE Public Involvement Coordinator, Idaho Transportation Department, P.O. Box 7129, Boise, Idaho 83707-1129, Telephone: (208) 334-4444.
An electronic copy of this document may be downloaded using a modem and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's home page at
The FHWA in cooperation with the Idaho Transportation Department (ITD) will prepare an EIS for the proposed addition of lanes and other staged associated reconstruction improvement projects to approximately 16 miles of I-84 between the Karcher Interchange in Canyon County (Mile Post 33) and Five Mile Road (Mile Post 49) in Ada County, Idaho. These associated projects could include reconstructing existing lanes, reconstructing interchanges at Meridian Road and Garrity Boulevard; replacing seven overpass structures at Five Mile Road, Cloverdale Road, Ten Mile Road, 11th Avenue, Franklin Boulevard, Northwest Boulevard and Karcher Boulevard; ramp modifications at the
• The reconstruction and widening of the existing Garrity overpass to accommodate additional lanes on I-84.
• The reconstruction and widening of I-84 mainline from Franklin Boulevard to the Garrity Road Interchange.
• The reconstruction and widening of the Garrity Interchange to Meridian Interchange.
Another associated project that is anticipated to be added to the 2008 STIP is:
• The reconstruction of the east half of the Franklin Boulevard Interchange.
Additional associated projects have been identified through previous studies, the Community Planning Association of Southwest Idaho (COMPASS) MPO plan and other long range planning documents. These projects have been presented to the public through public meetings, workshops, and publicly distributed documents. These projects are not in the current STIP or may not be programmed for funding at this time, but have been identified as a needed improvement through these studies. These projects are:
• The rehabilitation of the bridge on the eastbound lane of the Karcher Boulevard Interchange.
• The rehabilitation of the I-84, UPRR overpass, westbound lanes.
• Widening I-84 mainline from Eagle Road to the Five Mile Overcrossing at Mile Post 49.
• Widening I-84 mainline from Ten Mile Road to Eagle Road.
• Widening I-84 mainline from Garrity Boulevard to Ten Mile Road.
• The Meridian Road Interchange improvement project.
• Reconstruction of the Garrity Boulevard Interchange.
Notice is hereby given that the public scoping process has been initiated to prepare an EIS that will address the impacts of and alternatives to the proposal. The purpose of the scoping process is to solicit public comment regarding the full spectrum of issues and concerns, including a suitable range of alternatives, and the nature and extent of potential environmental impacts and appropriate mitigation measures that should be addressed in the EIS process. The EIS will examine the short and long-term impacts of a reasonable range of alternatives, including the no action alternative, on the natural, physical, and human environments. The impacts assessment will include, but not be limited to, impacts on wetlands, wildlife; social environment; changes in land use; noise, aesthetics; changes in traffic; and economic impacts. Environmental Justice (as outlined in Executive Order 12898) will also be addressed as part of the impact assessment. The EIS will also examine measures to mitigate adverse impacts resulting from the proposed action.
Comments are being solicited from Federal, State, and local agencies and from private organizations and citizens who have interest in this proposal. Public information meetings, including scoping meetings, will be held in the project area to discuss the potential alignments and alternatives. The draft EIS will be available for public and agency review, and a public hearing will be held to receive comments. Public notice will be given of the time and place of all meetings and hearings.
Comments and/or suggestions from all interested parties are requested, to ensure that the purpose and need for the project, the full range of all issues, and significant environmental issues in particular, are identified and reviewed. Comments or questions concerning this proposed action and/or its EIS should be directed to the FHWA, or ITD at the addresses listed previously.
23 U.S.C. 315; 23 CFR 771.123; 49 CFR 1.48.
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), notice is hereby given that the Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain requirements of its safety standards. The individual petition is described below, including the party seeking relief, the regulatory provisions involved, the nature of the relief being requested, and the petitioner's arguments in favor of relief.
The Union Pacific Railroad Company (UP) seeks a waiver of compliance from certain provisions of 49 CFR Part 232,
UP states that they are performing repairs and wheel change-outs to cars in-train on selected trains in their yards across their system, in order to reduce the number of impact wheels and satisfy the demands of their customers to move commodities. UP claims that the in-train repairs also greatly reduce the number of switching events that would otherwise be required to effect the repairs, further reducing the risk of injury and derailment. UP believes that reducing the number of impact wheels has helped reduce the number of derailments due to broken rails, joint bars, wheels and bearings. The majority of these trains are in coal service and the cars are privately owned. UP contends that these cars receive regular periodic maintenance, so they seldom approach the 5-year limit in which a single car air brake test would normally be required. In addition, UP states that their system automatically flags cars in the yard when they are listed on the Association of American Railroad's MA-63, which is a list that identifies cars within 90 days of the 5-year limit. UP states that they will continue to perform a single car air brake test in compliance with § 232.305 (b)(4-5), (c), (d), and (e). UP believes that this request will not have an adverse effect on safety.
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA in writing before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number (
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and 49 U.S.C. 20502(a), the following railroad has petitioned the Federal Railroad Administration (FRA) seeking approval for the discontinuance or modification of the signal system or relief from the requirements of 49 CFR Part 236, as detailed below.
The Union Pacific Railroad Company (UP) seeks approval of the proposed discontinuance and removal of the automatic block signal system (ABS) on the UP Albert Lea Subdivision between Milepost 193.1 and Milepost 194.2 in or near Mason City, Iowa. Train movements on the affected portion of track will be governed by Rule 6.13 of the General Code of Operating Rules,
The reason given for the proposed changes is that the ABS system is no longer needed for safe train operation.
Any interested party desiring to protest the granting of an application shall set forth specifically the grounds upon which the protest is made, and include a concise statement of the interest of the party in the proceeding. Additionally, one copy of the protest shall be furnished to the applicant at the address listed above.
FRA expects to be able to determine these matters without an oral hearing. However, if a specific request for an oral hearing is accompanied by a showing that the party is unable to adequately present his or her position by written statements, an application may be set for public hearing.
All communications concerning this proceeding should be identified by Docket Number FRA-2007-28424 and may be submitted by one of the following methods:
Communications received within 45 days of the date of this notice will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable. All written communications concerning these proceedings are available for examination during regular business hours (9 a.m.-5 p.m.) at the above facility. All documents in the public docket are also available for inspection and copying on the Internet at the docket facility's Web site at
FRA wishes to inform all potential commenters that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Federal Transit Administration, U.S. Department of Transportation, and the Detroit Department of Transportation.
Early Scoping Notice for the Detroit Transit Options for Growth Study.
The Federal Transit Administration (FTA) and the Detroit Department of Transportation (DDOT) are issuing this early scoping notice to advise agencies and the public that they intend to explore, in the context of the Council on Environmental Quality's early scoping process, alternative means of implementing rapid transit improvements in the Detroit area in Wayne County, Michigan. Three alignments, described below, will be examined, largely to explore their potential for implementation of a major transit capital investment (New Start). Public scoping meetings have been planned and are announced below. This process may result in selection of a locally preferred alternative (proposed action). If preparation of an environmental impact statement is warranted, this early scoping process is intended to satisfy standard National Environmental Policy Act scoping requirements, except that comments on the purpose and need for the proposed action, the range of alternatives to be considered, and potentially significant impacts, as described in a forthcoming notice of intent, will be invited and considered.
One interagency scoping meeting and four public scoping meetings will be conducted on the following dates and times at the locations indicated:
Friday, July 27, 2007, 1 p.m. to 3 p.m., Detroit Department of Transportation, 1301 East Warren, Detroit, Michigan 48207.
Wednesday, July 25, 2007, 11 a.m. to 2 p.m., The Guardian Building, Mezzanine Lobby, 500 Griswold, Detroit, Michigan 48226.
Wednesday, July 25, 2007, 5 p.m. to 8 p.m., Wayne State University, Welcome Center, 42 West Warren Avenue, Detroit, Michigan 48202.
Thursday, July 26, 2007, 5 p.m. to 8 p.m., Wayne County Community College, Cooper Community Center, 5901 Conner, Detroit, MI 48213.
Saturday, July 28, 2007, 10 a.m. to 1 p.m., Ford Community and Performing Arts Center, Studio A, 15801 Michigan Avenue, Dearborn, MI 48126.
The public scoping meetings will begin with an hour-long open house allowing the public to discuss the scoping process and study options with project staff. Handouts describing alignments, study options, and other aspects of contemplated rapid transit improvements will be available at the meetings. The meetings will be facilitated and a court reporter will be present to record oral comments which are welcomed. The scoping information will also be available on the project Web site at
Written comments on this notice should be submitted by August 29, 2007 to: Mr. Tim Roseboom, Project Manager, Detroit Department of Transportation, 1301 East Warren, Detroit, Michigan 48207, Telephone: (313) 833-7973, Fax: (313) 833-5493, E-mail:
Mr. Bill Wheeler, Community Planner, Federal Transit Administration (FTA), Region V, 200 West Adams Street, Suite 320, Chicago, Illinois 60606-5232, Telephone: (312) 353-2789.
Early scoping is a National Environmental Policy Act (NEPA) process that is particularly useful in situations where, as here, a proposed action (the locally preferred alternative) has not been identified and multiple broad alternatives are under consideration in several corridors. While scoping normally follows issuance of a notice of intent, which must describe the proposed action, it “may be initiated earlier, as long as there is appropriate public notice and enough information available on the proposal so that the public and relevant agencies can participate effectively.” Council on Environmental Quality, “Forty Most Asked Questions Concerning CEQ's National Environmental Policy Act Regulations,” 46 FR 18026, 18030 (1981) (Answer to Question 13). Available information is more than adequate to permit the public and relevant agencies to participate effectively in early scoping.
The Detroit Transit Options for Growth (DTOG) Study identifies 14 corridors in the study area that includes the cities of Dearborn, Detroit, Hamtramck, and Highland Park and encompasses approximately 160 square miles. The study-area population is over 1 million and estimated employment stands at nearly 500,000 jobs. Transit service in the study area is provided by buses, which have strong ridership and serve many people who depend on transit for their trips. The Detroit People Mover, a 2.9 mile elevated rail circulator in downtown Detroit, also provides transit service, but no rapid transit service is available within the study area. The DTOG Study represents a major step to promote regional and local rapid transit improvements in Southeast Michigan for the purposes of addressing existing, as well as projected congestion, and improving air quality, or at least not degrading it any further.
In the summer of 2006, DDOT initiated State and local planning required for anticipated New Starts transit projects to be eligible for Federal funding assistance under 49 U.S.C. 5309. The objective of beginning early planning efforts was to advance the realization of regional and local rapid transit improvements to serve current and future population and employment centers and destinations by narrowing options developed in the DTOG Study. Following a multi-phase screening process that included public participation, it was determined that three priority corridors (of the 14 identified in the DTOG Study) would be advanced for further study. The three alignments include: (1) The Woodward Avenue Corridor from downtown Detroit to Eight Mile Road; (2) a combined Woodward and Michigan Avenues Corridor from downtown Detroit to Grand Boulevard near the New Center area and on Michigan Avenue from downtown Detroit to the City of Dearborn near Fairlane Mall and University of Michigan Dearborn; and (3) a combined Woodward and Gratiot Avenues Corridor from downtown Detroit to Grand Boulevard near the New Center area and the Gratiot Avenue Corridor from downtown Detroit to Eight Mile Road. It was further determined that potential rapid transit modes that would meet the objectives of the DTOG Study included Bus Rapid Transit (BRT), Light Rail Transit (LRT), and modern streetcar. A public participation program has been developed and initiated with a Web site, newsletter, and public meetings and stakeholder meetings. A technical committee has been established and meets monthly.
Public planning for an anticipated New Starts transit project in the Detroit area continues. The public planning process resembles in some respects alternatives analysis required by the NEPA process, except that the former evaluates alternatives broadly by examining several modal and alignment options for addressing defined mobility needs in a particular corridor. Essentially, State and local planning produces a clearly defined project problem statement for use in New Starts in alternative analysis whereas consideration of project alternatives under NEPA calls for a concise statement of purpose and need. Nevertheless, to the extent that State and local planning efforts can lead toward a well-defined purpose and need statement and satisfy requirements of the NEPA process, including scoping, it should not have to be duplicated subsequently in that process. See 40 CFR 1506.2(b) (“Agencies shall cooperate with State and local agencies to the fullest extent possible to reduce duplication between NEPA and State and local requirements.”). Early scoping provides a means through which duplication, waste, and delay that could otherwise be experienced in situations such as this may be avoided.
Future New Starts planning alternatives analysis will examine alignments, technologies, station locations, costs, funding, ridership, economic development, land use, engineering feasibility, and environmental factors in a selected corridor. During alternatives analysis, DDOT will also evaluate options for transportation improvements in the study area that do not involve significant capital investment (e.g., enhanced bus service). At the conclusion of this early scoping and alternatives analysis process, a locally preferred alternative—the “proposed action”—will be determined, as well as the appropriate NEPA process—environmental assessment or environmental impact statement—to be undertaken for the proposed action. If preparation of an environmental impact statement is warranted, a notice of
In conjunction with issuance of this notice, and consistent with provisions of 23 U.S.C. 139, invitations will be extended to other Federal and non-Federal agencies that may have an interest in this matter to be participating agencies. A plan for coordinating public and agency participation in and comment on the environmental review process for issues and alternatives under consideration here and at subsequent phases of the process will be prepared.
Notice of intention to request extension of OMB approval and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Maritime Administration's (MARAD's) intention to request extension of approval (with modifications) for three years of a currently approved information collection.
Comments should be submitted on or before September 17, 2007.
Mitch Hudson, Maritime Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone: 202-366-9373; or E-Mail:
Expiration Date of Approval: Three years from date of approval by the Office of Management and Budget.
49 CFR 1.66.
By Order of the Maritime Administrator,
Maritime Administration, Department of Transportation.
Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel MANAWALE'A.
As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-28702 at
Submit comments on or before August 16, 2007.
Comments should refer to docket number MARAD-2007-28702. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979.
As described by the applicant the intended service of the vessel MANAWALE'A is:
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel REDWINGS.
As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-28703 at
Submit comments on or before August 16, 2007.
Comments should refer to docket number MARAD-2007-28703. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Joann Spittle, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue, SE., Room W21-203, Washington, DC 20590. Telephone 202-366-5979.
As described by the applicant the intended service of the vessel REDWINGS is:
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By order of the Maritime Administrator.
Pipeline and Hazardous Materials Safety Administration (PHMSA), U.S. Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that PHMSA forwarded an Information Collection Request to the Office of Management and Budget (OMB) for a change to an existing information collection for pipeline integrity management (IM). The purpose of this notice is to allow the public an additional 30 days to submit comments.
Submit comments on or before August 16, 2007.
Send comments directly to the Office Management and Budget, Office of Regulatory Affairs, Attn: Desk Officer for the Department of Transportation, 726 Jackson Place, NW., Washington, DC 20503.
Mike Israni by phone at (202) 366-4571 or by e-mail at:
PHMSA's IM regulations require operators of hazardous liquid and gas transmission pipelines to assess, evaluate, repair, and validate through comprehensive analyses the integrity of pipeline segments in high consequence areas where a leak or failure would do the most damage to populated, unusually sensitive environmental areas, and other populated areas. These regulations also require operators who cannot meet their evaluation schedules to notify PHMSA when temporarily reducing operating pressure or shutting down their pipelines. This change adds a requirement for operators to also notify PHMSA if pressure reductions exceed 365 days.
PHMSA published a notice of proposed rulemaking (NPRM) on December 15, 2005 (70 FR 74265) requesting comments on a change to these existing information collections.
PHMSA received comments from 12 parties: American Petroleum Institute and Association of Oil Pipe Lines; the American Gas Association; Texas Pipeline Association; Kinder Morgan Energy Partners, L.P.; Southwest Gas Corporation; Paiute Pipeline Company; Orange and Rockland Utilities, Inc.; Duke Energy Gas Transmission Corporation; Magellan Midstream Partners, L.P.; Panhandle Energy; Puget Sound Energy; and Enbridge Energy Company, Inc.—Liquids Transportation Segment.
Pursuant to 44 U.S.C. 3506(c)(2)(A) of the PRA, PHMSA will include the comments in the request for OMB's clearance of this information collection. PHMSA is now forwarding the collection of information request to OMB and providing an additional 30 days for comments. PHMSA is inviting comments on whether the proposed information collection is necessary for the proper performance of the functions of DOT. The term “information collection” includes all work related to preparing and disseminating information in accordance with recordkeeping requirements. The comments should address (1) whether the information will have practical utility; (2) the accuracy of the Department's estimate of the burden of the proposed information collection; (3) ways to enhance the quality, utility, and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, including the use of automated collection techniques or other forms of information technology.
Pipeline and Hazardous Materials Safety Administration (PHMSA), U.S. Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that PHMSA forwarded an Information Collection Request to the Office of Management and Budget (OMB) for an extension of the currently approved collection of information “Incorporation by Reference of Industry Standard on Leak Detection” (2137-0598). The purpose of this notice is to invite the public to submit comments on the request to OMB.
Submit comments on or before August 16, 2007.
Send comments directly to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attn: Desk Office for the Department of Transportation, 725 17th Street, NW., Washington, DC 20503.
L.E. Herrick at (202) 366-5523, or by e-mail at:
The hazardous liquid pipeline safety regulations require operators that elect to use software-based Computer Monitoring System (CPM) leak detection systems to comply with the American Petroleum Institute's (API) 1130 standard (49 CFR 195.134). API 1130 provides guidance for operating, maintaining, and testing software-based CPM systems. Hazardous liquid operators, with software-based CPM systems, must maintain records documenting the operation, maintenance, and testing of those systems. PHMSA, through the incorporation of this industry standard, will be able to continue to ensure that appropriate technology is used to
Pursuant to 44 U.S.C. 3506(c)(2)(A) of the PRA, PHMSA is required to obtain OMB approval for all information collections. The term “information collection” includes all work related to the preparing and disseminating of information in accordance with the recordkeeping requirements. PHMSA published a notice providing a 60 day period for comments on these information collection renewals in the
BNSF Railway Company (BNSF) has filed a notice of exemption under 49 CFR Part 1152 Subpart F—
BNSF has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) overhead traffic handled on the line will be rerouted; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the Surface Transportation Board or with any U.S. District Court or has been decided in favor of complainant within the 2-year period; and (4) the requirements of 49 CFR 1105.7 (environmental report), 49 CFR 1105.8 (historic report), 49 CFR 1105.11 (transmittal letter), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to governmental agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial assistance (OFA) has been received, this exemption will be effective on August 11, 2007, unless stayed pending reconsideration. Petitions to stay that do not involve environmental issues,
A copy of any petition filed with the Board should be sent to BNSF's representative: Sidney L. Strickland, Jr., Sidney Strickland and Associates, PLLC, 3050 K Street, NW., Suite 101, Washington, DC 20007.
If the verified notice contains false or misleading information, the exemption is void
BNSF has filed environmental and historic reports which address the effects, if any, of the abandonment on the environment and historic resources. SEA will issue an environmental assessment (EA) by July 17, 2007. Interested persons may obtain a copy of the EA by writing to SEA (Room 1100, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at (202) 245-0305. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.] Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), BNSF shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by BNSF's filing of a notice of consummation by July 12, 2008, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of the Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the
Written comments should be received on or before August 16, 2007 to be assured of consideration.
In notice document E7-12446 beginning on page 35230 in the issue of Wednesday, June 27, 2007, make the following correction:
On page 35232, the table appearing under the heading “
In notice document 07-3270 beginning on page 37054 in the issue of Friday, July 6, 2007, make the following correction:
On page 37054, in the third column, in the first paragraph of the document, in the third line “2001” should read “2007”.
In rule document E7-11148 beginning on page 32794 in the issue of Thursday, June 14, 2007, make the following correction:
On page 32807, in the third column, in the four lines above amendatory instruction
In proposed rule document E7-10529 beginning on page 30501 in the issue of Friday, June 1, 2007, make the following corrections:
1. On page 30503, in the second column, in amendatory instruction
2. On the same page, in the same column, in the same paragraph, in the third line, “§ 54.4980g-4” should read “§ 54.4980G-4”.
3. On the same page, in the third column, in § 54.4980G-0, in the first line, “§ 54.4980g-0” should read “§ 54.4980G-0”.
4. On the same page, in the same column, in the same section, in the third line, “§ 54.4980g-4” should read “§ 54.4980G-4”.
5. On the same page, in the same column, in § 54.4880G-4, in amendatory instruction
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period will implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid Program. The DRA requires the Secretary of HHS to promulgate a final regulation no later than July 1, 2007. In addition, we are adding to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule will bring together existing and new regulatory requirements in one, cohesive subpart.
Finally, this final rule with comment period allows for further public comment on the Average Manufacturer Price and Federal upper limit (FUL) outlier section of the rule.
In commenting, please refer to file code CMS-2238-FC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates, please):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Kimberly Howell, (410) 786-6762 (for issues related to the determination of average manufacturer price (AMP)).
Joseph Fine, (410) 786-2128 (for issues related to the determination of best price).
Yolanda Reese, (410) 786-9898 (for issues related to authorized generics).
Madlyn Kruh, (410) 786-3239 (for issues related to nominal prices).
Marge Watchorn, (410) 786-4361 (for issues related to manufacturer reporting requirements).
Gail Sexton, (410) 786-4583 (for issues related to FULs).
Christina Lyon, (410) 786-3332 (for issues related to physician-administered drugs).
Bernadette Leeds, (410) 786-9463 (for issues related to the regulatory impact analysis (RIA)).
Comments received timely will be also available for public inspection as they are received, generally beginning approximately three weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Under the Medicaid Program, States may provide coverage of outpatient drugs as an optional service under section 1905(a)(12) of the Social Security Act (the Act). Section 1903(a) of the Act provides for Federal financial participation (FFP) in State expenditures for these drugs. In order for payment to be made available under section 1903 for certain drugs, manufacturers must enter into the national rebate agreement as set forth in section 1927(a) of the Act. Section 1927 of the Act provides specific requirements for rebate agreements, drug pricing submission and confidentiality requirements, the formula for calculating rebate payments, and requirements for States with respect to covered outpatient drugs.
This final rule implements sections 6001(a)-(d), 6002, and 6003 of the DRA, Pub. L. 109-171 (Feb. 8, 2006). It also codifies those parts of section 1927 of
The Medicaid Drug Rebate Program was established by section 4401 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90), Pub. L. 101-508 (Nov. 5, 1990) and subsequently modified by the Veterans Health Care Act of 1992 (VHCA), Pub. L. 102-585 (Nov. 4, 1992) and the Omnibus Budget Reconciliation Act of 1993, Pub. L. 103-66 (Aug. 10, 1993). These provisions were implemented primarily through the national rebate agreement (56 Fed. Reg. 7049 (Feb. 21, 1991)) and other informal program releases, which provide standards for manufacturer reporting and rebate calculations. The statutory changes that affect the provisions of this final rule are described below.
Section 6001(a) of the DRA amends section 1927(e) of the Act to revise the formula CMS uses to set FULs for multiple source drugs. Effective January 1, 2007, the upper limit for multiple source drugs shall be established at 250 percent of the AMP (as computed without regard to customary prompt pay discounts extended to wholesalers) for the least costly therapeutic equivalent.
Section 6001(b) of the DRA amends section 1927(b)(3) of the Act to create a requirement that manufacturers report certain prices to the Secretary monthly. It also requires the Secretary to provide AMP to States on a monthly basis beginning July 1, 2006 and post AMP on a Web site at least quarterly. We are aware of concerns that the AMPs released to the States beginning July 1, 2006, will not reflect changes to the definition of AMP made by the DRA and finalized in this rule. While we made the AMPs available to the States beginning July 1, 2006, States should keep these data confidential in accordance with section 1927(b)(3)(D) of the Act. Section 6001(b) of the DRA revises these confidentiality provisions, effective January 1, 2007, to permit States to use AMP to calculate payment rates.
Section 6001(c) of the DRA modifies the definition of AMP to remove customary prompt pay discounts extended to wholesalers from the AMP calculation and requires manufacturers to report these customary prompt pay discounts to the Secretary. It requires the Inspector General of the Department of Health and Human Services (IG) to review the requirements for, and the manner in which, AMP is determined and submit to the Secretary and Congress any recommendations for changes no later than June 1, 2006. Finally, it requires the Secretary to promulgate a regulation that clarifies the requirements for, and the manner in which, AMP is determined no later than July 1, 2007, taking into consideration any IG recommendations.
Section 6001(d) of the DRA requires manufacturers to report information on sales at nominal price to the Secretary for calendar quarters beginning on or after January 1, 2007. It also specifies the entities to which nominal price applies. It limits the merely nominal exclusion to sales at nominal prices to the following: a covered entity described in section 340B(a)(4) of the Public Health Service Act (PHSA), an intermediate care facility for the mentally retarded (ICF/MR), a State-owned or operated nursing facility, and any other facility or entity that the Secretary determines is a safety net provider to which sales of such drugs at a nominal price would be appropriate, based on certain factors such as type of facility or entity, services provided by the facility or entity, and patient population.
Section 6001(e) of the DRA amends section 1927 of the Act to provide for a survey of retail prices and State performance rankings. These provisions were not addressed in the proposed rule.
Section 6001(f) of the DRA makes minor amendments to section 1927(g) of the Act which are self-implementing.
Section 6001(g) of the DRA provides that the amendments in section 6001 are effective on January 1, 2007, unless otherwise noted.
Section 6002 of the DRA amends section 1903(i)(10) of the Act by prohibiting Medicaid FFP for physician-administered drugs unless States submit the utilization data described in section 1927(a) of the Act. It also amends section 1927 of the Act to require the submission of utilization data for physician-administered drugs.
Section 6003(a) of the DRA amends section 1927(b)(3)(A) of the Act to require manufacturers to include within AMP and best price all of its drugs that are sold under a new drug application (NDA) approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FFDCA) when they report AMP and best price to the Secretary.
Section 6003(b) of the DRA amends section 1927(c)(1)(C) of the Act to clarify that manufacturers must include the lowest price available to any entity for a drug sold under an NDA approved under section 505(c) of the FFDCA when determining best price. Section 6003(b) also amends section 1927(k) of the Act to require that in the case of a manufacturer that approves, allows, or otherwise permits any of its drugs to be sold under an NDA approved under section 505(c) of the FFDCA, the AMP shall be calculated to include the average price paid for such drugs by wholesalers for drugs distributed to the retail pharmacy class of trade. Section 6003(c) of the DRA provides that the amendments made by section 6003 are effective January 1, 2007.
On September 19, 1995, CMS (then the Health Care Financing Administration) published a proposed rule in the
We proposed that this subpart would implement specified provisions of sections 1927, 1903(i)(10), and 1902(a)(54) of the Act related to implementation of the DRA. It would include requirements related to State plans, FFP for drugs, and the payment for covered outpatient drugs under Medicaid. In the proposed rule, we also proposed to move the existing Medicaid drug provisions in the Federal regulations from subpart F to subpart I of 42 CFR part 447.
We proposed that the rule include definitions of key terms used in 42 CFR part 447, subpart I. We proposed to use definitions from several sources, including the Act, Federal regulations, program guidance, and the national rebate agreement. We invited the public to provide comments on the terms we chose to define as well as the definitions described below.
We proposed to define “bona fide service fee” as a fee paid by a manufacturer to an entity, that represents fair market value for a bona fide, itemized service actually performed on behalf of the manufacturer that a manufacturer would otherwise perform (or contract for) in the absence of the service arrangement, and that is not passed in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug.
We proposed to define “brand name drug” as a single source or innovator multiple source drug.
We proposed to define “bundled sale” as an arrangement regardless of physical packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or drugs of different types (that is, at the nine-digit National Drug Code (NDC) level) or some other performance requirement (for example, the achievement of market share, inclusion or tier placement on a formulary), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs been purchased separately or outside the bundled arrangement. For bundled sales, the discounts are allocated proportionately to the dollar value of the units of each drug sold under the bundled arrangement. For bundled sales where multiple drugs are discounted, the aggregate value of all the discounts should be proportionately allocated across all the drugs in the bundle.
We proposed to define “Consumer Price Index—Urban (CPI-U)” as the same as it is defined in the national rebate agreement, except we would replace “U.S. Department of Commerce” with “U.S. Department of Labor” to reflect that the Department of Labor is now responsible for updating the CPI-U. Therefore, the term CPI-U would mean the index of consumer prices developed and updated by the U.S. Department of Labor. For purposes of this subpart, it would be the CPI for all urban consumers (U.S. average) for the month before the beginning of the calendar quarter for which the rebate is paid.
We proposed to define “dispensing fee” similarly to how it is defined for the Medicare Part D program in 42 CFR 423.100 in light of some of the parallels of Part D to Medicaid. We proposed to define this term in order to assist States in their evaluation of factors in establishing a reasonable dispensing fee to pharmacy providers. We note that while we proposed to define this term, we do not intend to mandate a specific formula or methodology which the States must use to determine the dispensing fee. The formula is consistent with our regulation that defines estimated acquisition costs which give States flexibility to determine EAC. However, consistent with a recommendation made by the Office of Inspector General (OIG) in its report, “Determining Average Manufacturer Prices for Prescription Drugs under the Deficit Reduction Act of 2005,” (A-06-06-00063) May 2006, we encouraged States to analyze the relationship between AMP and pharmacy acquisition costs to ensure that the Medicaid Program appropriately reimburses pharmacies for estimated acquisition costs.
We proposed to define “dispensing fee” as the fee which—
(1) is incurred at the point of sale and pays for costs other than the ingredient cost of a covered outpatient drug each time a covered outpatient drug is dispensed;
(2) includes only pharmacy costs associated with ensuring that possession of the appropriate covered outpatient drug is transferred to a Medicaid beneficiary. Pharmacy costs include, but are not limited to, any reasonable costs associated with a pharmacist's time in checking the computer for information about an individual's coverage, performing drug utilization review and preferred drug list review activities, measurement or mixing of the covered outpatient drug, filling the container, beneficiary counseling, physically providing the completed prescription to the Medicaid beneficiary, delivery, special packaging, and overhead associated with maintaining the facility and equipment necessary to operate the pharmacy; and
(3) does not include administrative costs incurred by the State in the operation of the covered outpatient drug benefit including systems costs for interfacing with pharmacies.
We proposed to define “innovator multiple source drug” based on the definition in section 1927(k)(7)(A)(ii) of the Act. We also proposed using the definition from the national rebate agreement. Innovator multiple source drug would mean a multiple source drug that was originally marketed under an original NDA approved by the Food and Drug Administration (FDA). It would include a drug product marketed by any cross-licensed producers or distributors operating under the NDA and a covered outpatient drug approved under an NDA, Product License Approval (PLA), Establishment License Approval (ELA) or Antibiotic Drug Approval (ADA). We believe this definition is consistent with our understanding of the drug rebate statute and section 6003 of the DRA which includes within the definition those drugs which often receive a certain amount of patent protection and/or market exclusivity.
We proposed to define “manufacturer” based on the definition in section 1927(k)(5) of the Act and the national rebate agreement. It would also mirror the current definition of manufacturer used by Medicare in the regulations regarding manufacturer's average sales price (ASP) data. For purposes of the Medicaid Program, we proposed that manufacturer would be defined as any entity that possesses legal title to the NDC for a covered drug or biological product and—
(a) is engaged in the production, preparation, propagation, compounding, conversion, or processing of covered outpatient drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or
(b) Is engaged in the packaging, repackaging, labeling, relabeling, or distribution of covered outpatient drug products and is not a wholesaler of drugs or a retail pharmacy licensed under State law.
(c) With respect to authorized generic products, the term “manufacturer” will
(d) With respect to drugs subject to private labeling arrangements, the term “manufacturer” will also include those entities that do not possess legal title to the NDC.
“Multiple source drug” is currently defined in Federal regulations at section 42 CFR 447.301. We proposed to remove the definition from that section and revise the definition to reflect the DRA amendments to section 1927 of the Act. We proposed to define the term multiple source drug to mean, with respect to a rebate period, a covered outpatient drug for which there is at least one other drug product which—
(1) Is rated as therapeutically equivalent. For the list of drug products rated as therapeutically equivalent, see the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” which is available at
(2) Is pharmaceutically equivalent and bioequivalent, as determined by the FDA; and
(3) Is sold or marketed in the United States during the rebate period.
We proposed to define “national drug code (NDC)” as it is used by the FDA and based on the definition used in the national rebate agreement. For purposes of this subpart, it would mean the 11-digit numerical code maintained by the FDA that indicates the labeler, product, and package size, unless otherwise specified in the regulation as being without respect to package size (9-digit numerical code).
“National rebate agreement” is described in section 1927 of the Act. Section 1927(b) of the Act outlines the terms of the national rebate agreement, including reporting timeframes, manufacturer responsibilities, penalties, and confidentiality of pricing data. We proposed that the national rebate agreement would continue to be defined as the rebate agreement developed by CMS and entered into by CMS on behalf of the Secretary or his designee and a manufacturer to implement section 1927 of the Act.
We proposed to define “nominal price” as it is in the national rebate agreement. We proposed incorporating this definition in this rule because it is the standard presently used in the Medicaid Program and the Medicare Part B program, and is similar to that used by the Department of Veterans Affairs (DVA) in administering the Federal Supply Schedule (FSS). We proposed that nominal price would mean a price that is less than 10 percent of AMP in the same quarter for which the AMP is computed.
“Rebate period” is defined in section 1927(k)(8) of the Act as a calendar quarter or other period specified by the Secretary with respect to the payment of rebates under the national rebate agreement. The Medicaid Drug Rebate Program currently operates using a calendar quarter for the rebate period. While AMPs would be reported monthly for purposes of calculating FULs and for release to States, we can find no evidence in the legislative history of the DRA that Congress intended to change the definition of rebate period. Therefore, we proposed to define rebate period as a calendar quarter.
“Single source drug” is defined in section 1927(k)(7)(A)(iv) of the Act as a covered outpatient drug which is produced or distributed under an original NDA approved by the FDA, including a drug product marketed by any cross-licensed producers or distributors operating under the NDA. It is further defined in the national rebate agreement as a covered outpatient drug approved under a PLA, ELA, or ADA.
We proposed to define the term single source drug as it is defined in the statute and the national rebate agreement.
Prior to the DRA, section 1927(k)(1) of the Act specified that the AMP with respect to a covered outpatient drug of a manufacturer for a rebate period is the average unit price paid to the manufacturer for the drug in the United States by wholesalers for drugs distributed to the retail pharmacy class of trade after deducting customary prompt pay discounts.
The national rebate agreement (56 FR 7049 (Feb. 21, 1991)) further specifies that:
• Direct sales to hospitals, health maintenance organizations (HMOs) and wholesalers, where the drug is relabeled under that distributor's NDC number, and FSS prices are not included in the calculation of AMP;
• AMP includes cash discounts and all other price reductions (other than rebates under section 1927 of the Act), which reduce the actual price paid;
• AMP is calculated as net sales divided by the number of units sold, excluding free goods (that is, drugs or any other items given away, but not contingent on any purchase requirements), and
• Net sales means quarterly gross sales revenue less cash discounts allowed and all other price reductions (other than rebates under section 1927 of the Act) which reduce the actual price paid.
Consistent with these provisions, it has been our policy that in order to provide a reflection of market transactions, the AMP for a quarter should be adjusted by the manufacturer if cumulative discounts or other arrangements subsequently adjust the prices actually realized.
AMP should be adjusted for bundled sales (as defined above) by determining the total value of all the discounts on all drugs in the bundle and allocating those discounts proportionately to the respective AMP calculations. The aggregate discount is allocated proportionately to the dollar value of the units of each drug sold under the bundled arrangement. Where discounts are offered on multiple products in a bundle, the aggregate value of all the discounts should be proportionately allocated across all the drugs in the bundle. The average unit price means a manufacturer's quarterly sales included in AMP less all required adjustments divided by the total units sold and included in AMP by the manufacturer in a quarter.
Section 6001(c)(1) of the DRA amended section 1927(k)(1) of the Act to revise the definition of AMP to exclude customary prompt pay discounts to wholesalers, effective January 1, 2007. Section 6001(c)(3) of the DRA requires the OIG to review the requirements for and manner in which AMPs are determined and recommend changes to the Secretary by June 1, 2006. Section 6001(c)(3) of the DRA requires the Secretary to clarify the requirements for and the manner in which AMPs are determined by promulgating a regulation no later than July 1, 2007, taking into consideration the OIG's recommendations.
In accordance with 6001(c)(3) of the DRA, the OIG issued its report, “Determining Average Manufacturer Prices for Prescription Drugs under the Deficit Reduction Act of 2005,” (A-06-06-00063), in May 2006. In this report, the OIG recommended that CMS:
• Clarify the requirements in regard to the definition of retail pharmacy class of trade and treatment of pharmacy benefit manager (PBM) rebates and Medicaid sales and
• Consider addressing issues raised by industry groups, such as:
○ Administrative and service fees,
○ Lagged price concessions and returned goods,
○ The frequency of AMP reporting,
○ AMP restatements, and
○ Base date AMP.
The OIG also recommended that the Secretary direct CMS to:
• Issue guidance in the near future that specifically addresses the implementation of the AMP-related reimbursement provisions of the DRA and
• Encourage States to analyze the relationship between AMP and pharmacy acquisition cost to ensure that the Medicaid Program appropriately reimburses pharmacies for estimated acquisition costs.
We addressed these recommendations as we discussed provisions of the proposed rule in the section below.
We recognize that there have been concerns expressed regarding AMP because of inconsistencies in the way manufacturers determine AMP, changes in the drug marketplace, and the introduction of newer business practices such as payment of services fees. We also realize that in light of the DRA amendments, AMP will serve two distinct purposes: For drug rebate liability and for payments. For the purpose of determining drug rebate liability, drug manufacturers would generally benefit from a broad definition of retail pharmacy class of trade which would include entities that purchase drugs at lower prices and which would lower rebate liability. Including these lower prices would decrease the AMP, decreasing manufacturers' rebate liability. The retail pharmacy industry might benefit from a narrow definition of retail pharmacy prices that would be limited to certain higher priced sales given that, in light of the DRA amendments, States might use AMP to calculate pharmacy payment rates. Excluding low-priced sales would increase AMP, increasing, in all likelihood, manufacturers' rebate payments. The pharmacy industry believes that mail order pharmacies and nursing home pharmacies (long-term care pharmacies) pay less for drugs than retail pharmacies (for example, independents and chain pharmacies), and thus the inclusion of such prices would lower AMP below the price paid by such retail pharmacies.
The statute mandates that, effective January 1, 2007, the Secretary use AMP when computing FULs. For this purpose, we proposed excluding certain outlier payments (see our discussion in the FULs section for a more complete description of outlier exclusions). The statute also requires that AMP be provided to States monthly and be posted on a public Web site. While there is no requirement that States use AMPs to set payment amounts, we believe the Congress intended that States have drug pricing data based on actual prices, in contrast to previously available data that did not necessarily reflect actual manufacturer prices of sales to the retail pharmacy class of trade. We considered several options to define what prices should be included in AMP. We considered including only prices of sales to retail pharmacies that dispense drugs to the general public (for example, independent and chain pharmacies) in retail pharmacy class of trade and removing prices to mail order pharmacies, nursing home pharmacies (long-term care pharmacies), and PBMs. We proposed that this definition would address the retail pharmacy industry's contentions that an AMP used for reimbursement to retail pharmacies should only reflect prices of sales to those pharmacies which dispense drugs to the general public.
The exclusion of prices to mail order pharmacies, nursing home facilities (long-term care facilities), and PBMs would substantially reduce the number of transactions included in AMP. Removal of these prices would simplify AMP calculations for manufacturers because it is our understanding that certain data (for example, PBM pricing data) are difficult for manufacturers to capture. In addition, removal of these prices would address differing interpretations of CMS policy identified by the OIG and the Government Accountability Office (GAO) due to the lack of a clear definition of AMP or specific guidance regarding which retail prices should be included in AMP. However, such a removal would not be consistent with past policy, as specified in Manufacturer Releases 28 and 29 (
We also considered not revising the entities included in the retail pharmacy class of trade. However, this would not address the issues identified by the OIG in its report, “Medicaid Drug Rebates: The Health Care Financing Administration Needs to Provide Additional Guidance to Drug Manufacturers to Better Implement the Program,” (A-06-91-00092), November 1992 and GAO in its report “Medicaid Drug Rebate Program—Inadequate Oversight Raises Concerns about Rebates Paid to States,” (GAO-05-102), February 2005.
We believe, based in part on the OIG and GAO reports, that retail pharmacy class of trade means that sector of the drug marketplace, similar to the marketplace for other goods and services, which dispenses drugs to the general public and which includes all price concessions related to such goods and services. As such, we proposed excluding from AMP the prices of sales to nursing home pharmacies (long-term care pharmacies) because nursing home pharmacies do not dispense to the general public. We proposed including in AMP the prices of sales and discounts to mail order pharmacies. We considered limiting mail order pharmacy prices to only those prices that are offered to all pharmacies under similar terms and conditions. However, given our belief that such prices are simply another form of how drugs enter into the retail pharmacy class of trade, we proposed maintaining these prices in the definition. We noted that even were we to incorporate this change, retail pharmacies may not be able to meet the terms and conditions placed on mail order pharmacies to be eligible for some manufacturer price concessions. CMS sought public comment on the inclusion of all mail order pharmacy prices in our definition of retail pharmacy class of trade for purposes of inclusion in the determination of AMP.
We recognized that a major factor contributing to the determination of AMP is the treatment of PBMs. These entities have assumed a significant role in drug distribution since the enactment of the Medicaid Drug Rebate Program in 1990. We considered how PBM rebates, discounts, or other price concessions should be recognized for purposes of AMP calculations.
A GAO report, “Medicaid Drug Rebate Program—Inadequate Oversight Raises Concerns about Rebates Paid to States,” (GAO-05-102), in February 2005, indicated that the Medicaid Drug Rebate Program does not clearly address certain financial concessions negotiated by PBMs. The GAO recommended that we issue clear guidance on manufacturer price determination methods and the definitions of AMP and best price, and update such guidance as additional issues arise.
The issue regarding PBMs was also addressed in the OIG report, “Determining Average Manufacturer Prices for Prescription Drugs under the Deficit Reduction Act of 2005,” (A-06-06-00063), in May 2006. In this report, the OIG recommended that we clarify the treatment of PBM rebates. This
In developing the proposed rule, we considered including all rebates, discounts and other price concessions from PBMs in the determination of AMP. We also considered excluding rebates, discounts and other price concessions from PBMs in the determination of AMP.
One of the most difficult issues with PBM discounts, rebates, or other price concessions is that manufacturers contend that they do not know what part of these discounts, rebates, or other price concessions is kept by the PBM for the cost of its activities and profit, what part is passed on to the health insurer or other insurer or other entity with which the PBM contracts, and what part, if any, that entity passes on to pharmacies. Despite the difficulties of including certain PBM rebates, discounts or other price concessions in AMP, excluding all of these price concessions could result in an artificial inflation of AMP. For this reason, we proposed to include PBM rebates, discounts, or other price concessions for drugs provided to the retail pharmacy class of trade for the purpose of determining AMP; however, we invited comments on whether this proposal is operationally feasible.
As discussed more fully below, we proposed that PBM rebates and price concessions that adjust the amount received by the manufacturer for drugs distributed to the retail pharmacy class of trade should be included in the calculation of AMP. We acknowledged that manufacturers have a variety of arrangements with PBMs and thus invited comments on all aspects of our proposal as explained below.
The national rebate agreement defines AMP to include cash discounts and all other price reductions (other than rebates under section 1927 of the Act), which reduce the actual price paid to the manufacturer for drugs distributed to the retail pharmacy class of trade. As noted in Manufacturer Release 28 and reiterated in Manufacturer Release 29, manufacturers have developed a myriad of arrangements whereby specific discounts, chargebacks, or rebates are provided to PBMs which, in turn, are passed on to the purchaser. Those releases recognize that certain prices provided by manufacturers to PBMs should be included within AMP calculations. In accordance with those releases, our position has been that PBMs have no effect on the AMP calculations unless the PBM is acting as a wholesaler as defined in the national rebate agreement. We are concerned, however, that this position may unduly exclude from AMP certain PBM prices and discounts which have an impact on prices paid to the manufacturer.
We believe that AMP should be calculated to reflect the net drug price recognized by the manufacturer, inclusive of any price adjustments or discounts provided directly or indirectly by the manufacturer. We were interested in comments on this proposal, including the comments on the operational difficulties of including such PBM arrangements within AMP calculations.
We recognize that the statute defines AMP as the average price paid to the manufacturer by wholesalers for drugs distributed to the retail pharmacy class of trade; however, in light of our understanding of congressional intent, we believe that the definition is meant to capture discounts and other price adjustments, regardless of whether such discounts or adjustments are provided directly or indirectly by the manufacturer. We invited comments on this definition and whether AMP should be calculated to include all adjustments that affect net drug prices.
We acknowledged that there are many PBM/manufacturer arrangements. To the extent manufacturers are offering rebates, discounts, or other price concessions to the PBM that are not bona fide service fees, we proposed that these lower prices should be included in the AMP calculations. We requested comments on the operational difficulties of tracking these rebates, discounts, or chargebacks provided to a PBM for purposes of calculating AMP and on the inclusion of all such price concessions in AMP. Specifically, we solicited comments on the extent to which CMS should or should not define in regulation which rebates, discounts, or price concessions provided to PBMs should be included in AMP and how best to measure these. Also, we solicited public comment on how these PBM price concessions should be reported to CMS to assure that appropriate price adjustments are captured and included in the determination of AMP.
Finally, we requested comments on any other issues that we should take into account in making our final decisions. These included, but were not limited to, possible Federal and State budgetary impacts (our savings estimates assumed no budgetary impacts as generic drugs are rarely, if ever, subject to PBM price adjustments in this context); possible future evolution in industry pricing and management practices (for example, growth of “preferred” generic drugs); and possible impacts on reimbursement for brand name drugs under Medicaid. We were generally interested in comments on how and to what extent PBMs act as “wholesalers.” We proposed to incorporate the explicitly listed exclusions in section 1927 of the Act, and in the national rebate agreement, which are direct sales to hospitals, HMOs/managed care organizations (MCOs), wholesalers where the drug is relabeled under that distributor's NDC and FSS prices.
The specific terms we proposed to clarify and the proposed clarifications follow.
In the proposed rule, we proposed clarifying that the units associated with Medicaid sales should be included as part of the total units in the AMP calculation. We proposed that AMP be calculated to include all sales and associated discounts and other price concessions provided by the manufacturer for drugs distributed to the retail pharmacy class of trade unless the sale, discount, or other price concession is specifically excluded by the statute or regulation or is provided to an entity excluded by statute or regulation. Therefore, we proposed clarifying that rebates paid to States under the Medicaid Drug Rebate Program should be excluded from AMP calculations but that price concessions associated with the sales of drugs in the retail pharmacy class of trade which are provided to Medicaid patients should be included.
We also proposed to clarify how the prices of sales to SCHIP Title XXI non-Medicaid expansion programs should be treated. Like the Medicaid Program, SCHIP non-Medicaid expansion programs do not directly purchase drugs. Because such programs are not part of the Medicaid Program, they are not covered under the provisions of section 1927 of the Act. As with Medicaid sales, these sales are included in AMP to the extent they concern sales at the retail pharmacy class of trade. Therefore, these sales should not be backed out of the AMP calculation to the extent that such sales are included within sales provided to the retail pharmacy class of trade. Rebates and units associated with those sales should also be included in the calculation of AMP.
To implement the provisions set forth in sections 6001 and 6003 of the DRA related to AMP, we proposed a new §447.504. In §447.504(a), we proposed a revised definition of AMP and clarified that AMP is determined without regard to customary prompt pay discounts extended to wholesalers. In §447.504(b), we proposed to define average unit price. In §447.504(c), we proposed to define customary prompt pay discount. In §447.504(d), we proposed to define net sales. In §447.504(e), we proposed to define retail pharmacy class of trade. In §447.504(f), we proposed to define wholesaler. In §447.504(g), we described in detail the sales, rebates, discounts, or other price concessions that must be included in AMP. In §447.504(h), we described the sales, rebates, discounts, or other price concessions that must be excluded from AMP. In §447.504(i), we provided further clarification about how manufacturers should account for price reductions and other pricing arrangements which should be included in the calculation of AMP.
Prior to the DRA, section 1927(c)(1)(C) of the Act provided that manufacturers must include in their best price calculation, for a single source or innovator multiple source drug, the lowest price available from the manufacturers during the rebate period to any wholesaler, retailer, provider, HMO, non-profit entity, or governmental entity within the United States except for those entities specifically excluded by statute. Excluded from best price are prices charged on or after October 1, 1992, to the IHS, the DVA, a State home receiving funds under section 1741 of title 38, United States Code, the DoD, the PHS, or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA); any prices charged under the FSS of the GSA; any prices used under an SPAP; any depot prices (including TRICARE) and single award contract prices, as defined by the Secretary, of any agency of the Federal Government; and prices to a Medicare Part D PDP, an MA-PD, or a qualified retiree prescription drug plan for covered Part D drugs provided on behalf of Part D eligible individuals.
The statute further specifies that best price:
• Includes cash discounts, free goods that are contingent on any purchase requirement, volume discounts and rebates (other than rebates under section 1927 of the Act), which reduce the price paid;
• Must be determined on a unit basis without regard to special packaging, labeling or identifiers on the dosage form or product or package;
• Must not take into account prices that are merely nominal in amount.
Consistent with these provisions and the national rebate agreement, it has been our policy that in order to reflect market transactions, the best price for a rebate period should be adjusted by the manufacturer if cumulative discounts or other arrangements subsequently adjust the prices actually realized.
Best price should be adjusted for any bundled sale. The drugs in a “bundle” do not have to be physically packaged together to constitute a “bundle,” just part of the same bundled transaction.
Section 1927(c)(1)(C)(ii)(I) of the Act specifies that best price must include free goods that are contingent on any purchase requirement. Thus, only those free goods that are not contingent on any purchase requirements may be excluded from best price.
Section 103(e) of the Medicare Modernization Act of 2003 (MMA) modified the definition of best price by excluding prices which are negotiated by a PDP under part D of title XVIII of the Act, by any MA-PD plan under part C of such title with respect to covered part D drugs, or by a qualified retiree prescription drug plan (as defined in section 1860D-22(a)(2) of the Act) with respect to such drugs on behalf of individuals entitled to benefits under part A or enrolled under part B of such title. Section 1002(a) of the MMA modified section 1927(c)(1)(C)(i)(I) of the Act by clarifying that inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA are exempt from best price.
Section 6003 of the DRA amended section 1927(c)(1)(C) of the Act by revising the definition of best price to clarify that the best price includes the lowest price available to any entity for any such drug of a manufacturer that is sold under an NDA approved under section 505(c) of the FFDCA.
In the proposed rule we proposed to define best price with respect to a single source drug or innovator multiple source drug of a manufacturer, including any drug sold under an NDA approved under section 505(c) of the FFDCA, as the lowest price available from the manufacturer during the rebate period to any entity in the United States in any pricing structure (including capitated payments) in the same quarter for which the AMP is computed. It
As with the determination of AMP, the DRA does not establish a mechanism to clarify how best price is to be determined should new entities be formed after this regulation takes effect. We believe that we need to have the ability to clarify best price in an expedited manner in order to address the evolving marketplace for the sale of drugs. We proposed to address future clarifications to best price through the issuance of program releases and by posting the clarifications on the CMS Web site as needed. Even though the DRA did not require CMS to clarify the requirements for best price, we determined that it was reasonable to propose these provisions in the proposed rule, consistent with long-standing Medicaid Drug Rebate Program policy and the MMA with respect to best price as revised by the DRA.
We proposed to incorporate the explicitly listed exclusions in section 1927 of the Act, which are prices charged on or after October 1, 1992, to the IHS, the DVA, a State home receiving funds under section 1741 of title 38, United States Code, the DoD, the PHS, or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA); any prices charged under the FSS of the GSA; any prices paid under an SPAP; any depot prices (including TRICARE) and single award contract prices, as defined by the Secretary, of any agency of the Federal Government; and payments made by a Medicare Part D PDP, an MA-PD, or a qualified retiree prescription drug plan for covered Part D drugs provided on behalf of Part D eligible individuals. We proposed to codify this policy and require that manufacturers exclude the prices to these entities from best price. Because best price represents the lowest price available from the manufacturer to any entity with respect to a single source drug or innovator multiple source drug of a manufacturer, including an authorized generic, any price concession associated with that sale should be netted out of the price received by the manufacturer in calculating best price and best price should be adjusted by the manufacturer if other arrangements subsequently adjust the prices actually realized. We proposed to consider any price adjustment which ultimately affects those prices which are actually realized by the manufacturer as “other arrangements” and that such adjustment should be included in the calculation of best price, except to the extent that such adjustments qualify as bona fide service fees.
We proposed that best price be calculated to include all sales, discounts, and other price concessions provided by the manufacturer for covered outpatient drugs to any entity unless the manufacturer can demonstrate that the sale, discount, or other price concession is specifically excluded by statute or is provided to an entity not included in the rebate calculation. To the extent that an entity is not included in the best price calculation, both sales and associated discounts or other price concessions provided to such an entity should be excluded from the calculation. The specific terms we propose to clarify and the proposed clarification follow.
The national rebate agreement defines best price, in part, as the lowest price at which the manufacturer sells the covered outpatient drug to any purchaser in the United States. We proposed to codify this policy in the proposed rule.
As noted in Manufacturer Release 28 and reiterated in Manufacturer Release 29, manufacturers have developed a myriad of arrangements whereby specific discounts, chargebacks, or rebates are provided to PBMs which in turn are passed on to the purchaser. In such situations where discounts, chargebacks, or rebates are used to adjust drug prices at the wholesaler or retail level, such adjustments are included in the best price calculation.
A GAO report, “Medicaid Drug Rebate Program—Inadequate Oversight Raises Concerns about Rebates Paid to States,” (GAO-05-102), in February 2005, indicated that the Medicaid Drug Rebate Program does not clearly address certain financial concessions negotiated by PBMs. The GAO recommended that we issue clear guidance on manufacturer price determination methods and the definitions of AMP and best price, and update such guidance as additional issues arise.
The issue regarding PBMs was also addressed in the recently issued OIG report, “Determining Average Manufacturer Prices for Prescription Drugs under the Deficit Reduction Act of 2005,” (A-06-06-00063), in May 2006. In this report, the OIG recommended that we clarify the treatment of PBM rebates.
One of the most difficult issues with PBM discounts, price concessions, or rebates is that manufacturers contend that they do not know what part of these discounts, price concessions, or rebates are kept by the PBM for the cost of their activities and profit, what part is passed on to the health insurer or other insurer or other entity with which the PBM contracts, and what part that entity passes on to pharmacies.
Despite the difficulties of including certain PBM rebates, discounts or other price concessions in best price, excluding these price concessions could result in an artificial inflation of best price. We proposed to include PBM rebates, discounts, or other price concessions for the purpose of determining best price.
To the extent manufacturers are offering PBMs rebates, discounts, or other price concessions, these lower prices should be included in the best price calculations. Therefore, where the use of the PBM by manufacturers affects the price available from the manufacturer, we proposed that these lower prices should be reflected in best price calculations. We acknowledged that there are many PBM/manufacturer arrangements.
We believe that PBMs often obtain rebates, discounts, or other price concessions which adjust prices, either directly or indirectly. Unless the fees/discounts qualify as bona fide service fees (which are excluded), we proposed that the PBM rebates, discounts, or chargebacks should be included in best price. We proposed to consider these rebates, discounts, or chargebacks in best price calculations. CMS invited public comment on the inclusion of certain PBM price concessions in the determination of best price. Also, we solicited public comment on how these PBM price concessions should be reported to CMS to assure that appropriate price concessions are captured and included in the determination of best price.
We proposed to incorporate the explicitly listed exclusions in section 1927 of the Act and in the national rebate agreement. Because best price represents the prices available from the manufacturer for prescription drugs, best price should be adjusted by the manufacturer if other arrangements subsequently adjust the prices actually realized. We proposed to consider that any price adjustment which ultimately affects those prices which are actually realized by the manufacturer as “other arrangements” and that such an adjustment should be included in the calculation of best price. The specific terms we proposed to clarify and the proposed clarifications follow.
In the proposed rule, we stated that drug manufacturers participating in the Medicaid Drug Rebate Program are required to report the AMP for each covered outpatient drug offered under the Medicaid Program and the best price for each single source or innovator multiple source drug available to any wholesaler, retailer, provider, HMO, non-profit entity, or governmental entity with certain exceptions.
For purposes of the Medicaid Drug Rebate Program, an authorized generic is any drug product marketed under the innovator multiple source drug or brand manufacturer's original NDA, but labeled with a different NDC than the innovator multiple source drug or brand product. According to our reading of the statute, authorized generics are single source or innovator multiple source drugs for the purpose of computing the drug rebate and are classified based on whether the drug is being sold or marketed pursuant to an NDA. Responsibility for the rebate rests with the manufacturer selling or marketing the drug to the retail pharmacy class of trade.
We proposed to implement section 6003 of the DRA by proposing to adopt the term “authorized generic” and define this term with respect to the Medicaid Drug Rebate Program, as any drug sold, licensed or marketed under an NDA approved by the FDA under section 505(c) of the FFDCA that is marketed, sold or distributed directly or indirectly under a different product code, labeler code, trade name, trademark, or packaging (other than repackaging the listed drug for use in institutions) than the listed drug.
Section 6003 of the DRA amended section 1927(b)(3)(A) of the Act to include drugs approved under section 505(c) of the FFDCA in the reporting requirements for the primary manufacturer (NDA holder) for AMP and best price. We proposed to interpret the language of section 6003 of the DRA to include in the best price and AMP calculations of the branded drugs, the authorized generic drugs that have been marketed by another manufacturer or subsidiary of the brand manufacturer (or NDA holder). We believe that to limit the applicability of this regulation to the sellers of authorized generic drugs would allow manufacturers to circumvent the intent of the provision by licensing rather than selling the rights to such drugs. This is why we proposed a broad definition of authorized generic drugs rather than a more narrow definition of such drugs. We proposed to require the NDA holder to include sales of the authorized generic product marketed by the secondary manufacturer or the brand manufacturer's subsidiary in its calculation of AMP and best price. We welcomed comments on this issue.
The secondary manufacturer or subsidiary of the brand manufacturer would continue to pay the single source drug or innovator multiple source drug rebate for the authorized generic drug products based on utilization under its own NDC number, as required under current law. We welcomed comments on these issues.
In § 447.506(a), we proposed defining the term authorized generic drug for the purposes of the Medicaid Drug Rebate Program.
In § 447.506(b), we proposed requiring the sales of authorized generic drugs that have been sold or licensed to another manufacturer to be included by the primary manufacturer as part of its calculation of AMP for the single source or innovator multiple source drug (including all such drugs that are sold under an NDA approved under section 505(c) of the FFDCA).
In § 447.506(c), we proposed requiring that sales of authorized generic drugs by the secondary manufacturer that buys or licenses the right to sell the drugs be included by the primary manufacturer in sales used to determine the best price for the single source or innovator multiple source drug approved under section 505(c) of the FFDCA during the rebate period to any manufacturer, wholesaler, retailer, provider, HMO, non-profit entity, or governmental entity within the United States. The primary manufacturer must include in its calculation of best price all sales of the authorized generic drug which have been sold or marketed by a secondary manufacturer or by a subsidiary of the brand manufacturer.
Pursuant to the terms of the national rebate agreement, manufacturers excluded from their best price calculations outpatient drug prices below ten percent of the AMP. The national rebate agreement did not specify whether this nominal price exception applied to all purchasers or to a subset of purchasers. Medicaid has used this definition since the start of the Medicaid Drug Rebate Program and Medicare Part B also adopted it in its April 6, 2004 interim final rule with comment period (69 FR 17935) that implemented the ASP provisions enacted in the MMA. It is also similar to the definition of nominal price in the VHCA.
We proposed to continue to define nominal prices as prices at less than 10 percent of the AMP in that same quarter; however, in accordance with the DRA, we further proposed to specify that the nominal price exception applies only when certain entities are the purchasers.
Section 6001(d)(2) of the DRA modified section 1927(c)(1) of the Act to limit the nominal price exclusion from best price to exclude only sales to certain entities and safety net providers. Specifically, it excluded from best price those nominal price sales to 340B covered entities as described in section 340B(a)(4) of the PHSA, ICFs/MR, and State-owned or operated nursing facilities. In addition, the Secretary has authority to identify as safety net providers other facilities or entities to which sales at a nominal price will be excluded from best price if he deems them eligible safety net providers based on four factors: the type of facility or entity, the services provided by the facility or entity, the patient population served by the facility or entity and the number of other facilities or entities eligible to purchase at nominal prices in the same service area.
Section 340B(a)(4) of the PHSA defines entities covered under that provision. Covered entities include: a federally qualified health center as defined in section 1905(l)(2)(B) of the Act; an entity receiving a grant under section 340A of the PHSA; a family planning project receiving a grant or contract under Section 1001 of the PHSA (42 U.S.C. § 300); an entity receiving a grant under subpart II of part C of title XXVI of the PHSA (relating to categorical grants for outpatient early intervention services for HIV disease); a State-operated AIDS drug purchasing assistance program receiving financial assistance under title XXVI of the PHSA; a black lung clinic receiving funds under section 427(a) of the Black Lung Benefits Act; a comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the Act; a Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988; an urban Indian organization receiving funds under the title V of the Indian Health Care Improvement Act, any entity receiving assistance under title XXVI of the PHSA (other than a State or unit of local government or an entity receiving a grant under subpart II of part C of title XXVI of the PHSA), but only if the entity is certified by the Secretary pursuant to section 340B(a)(7) of the PHSA; an entity receiving funds under section 318 of the PHSA (relating to treatment of sexually transmitted diseases) or section 317(j)(2) of the PHSA (relating to treatment of tuberculosis) through a State or unit of local government, but only if the entity is certified by the Secretary pursuant to section 340B(a)(7) of the PHSA; a subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Act) that (i) is owned or operated by a unit of State or local government, is a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government, or is a private non-profit hospital which has a contract with a State or local government to provide health care services to low income individuals who are not entitled to benefits under title XVIII of the Act or eligible for assistance under the State plan under this title, (ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Act) greater than 11.75 percent or was described in section 1886(d)(5)(F)(i)(II) of the Act, and (iii) does not obtain covered outpatient drugs through a group purchasing organization (GPO) or other group purchasing arrangement. We did not believe it necessary to elaborate further on these entities. We proposed to define ICF/MR, for purposes of the nominal price exclusion from best price, to mean an institution for the mentally retarded or persons with related conditions that provides services as set forth in 42 CFR 440.150. Additionally, we proposed to define nursing facility as a facility that provides those services set forth in 42 CFR 440.155.
The statute allows the Secretary to determine other facilities or entities to be safety net providers to whom sales of drugs at a nominal price would be excluded from best price. The Secretary's determination would be based on the four factors noted above established by the DRA. We considered using this authority to expand this exclusion to other safety-net providers. We considered proposing that we use the broader definition of safety net provider used by the Institute of Medicine (IOM). In its report, “America's Health Care Safety Net, Intact but Endangered,” the IOM defines safety-net providers as “providers that by mandate or mission organize and deliver a significant level of healthcare and other health-related services to the uninsured, Medicaid and other vulnerable patients.” We also considered proposing how the Secretary might use the four factors to allow the nominal price exclusion to best price to apply to other safety net providers. However, we believe that the entities specified in the statute are sufficiently inclusive and capture the appropriate safety net providers. Therefore, we chose not to propose to expand the
CMS has concerns that despite the fact that the DRA limits the nominal price exclusion to specific entities, the nominal price exclusion will continue to be used as a marketing tool. Historically, patients frequently remain on the same drug regimen following discharge from a hospital. Physicians may be hesitant to switch a patient to a different brand and risk destabilizing the patient once discharged from the hospital. We believe that using nominal price for marketing is not within the spirit and letter of the law. We considered crafting further guidance to address this issue. CMS invited comments from the public to assist us in ensuring that all aspects of this issue are fully considered.
In accordance with the provisions of the DRA, we proposed that the restriction on nominal price sales shall not apply to sales by a manufacturer of covered outpatient drugs that are sold under a DVA master agreement under section 8126 of title 38, United States Code.
We proposed a new § 447.508 in which we specified those entities to which a manufacturer of covered outpatient drugs may sell at nominal price and provided for the exclusion of such sales from best price.
On August 29, 2003, CMS finalized two of the provisions in the 1995 proposed rule through a final rule with comment period (68 FR 51912). We required manufacturers to retain records for data used to calculate AMP and best price for three years from when AMP and best price are reported to CMS. We also required manufacturers to report revisions to AMP and best price for a period not to exceed 12 quarters from the quarter in which the data are due. On January 6, 2004, we published an interim final rule with comment period replacing the three-year recordkeeping requirement with a ten-year requirement on a temporary basis (69 FR 508 (Jan. 6, 2004)). We also required that manufacturers retain records beyond the ten-year period if the records were subject to certain audits or government investigations. On November 26, 2004, we published final regulations (69 FR 68815) that require that a manufacturer retain pricing data for ten years from the date the manufacturer reports that period's data to CMS. We proposed to move the recordkeeping requirements at § 447.534(h) to § 447.510(f) and revise them by adding the requirement that manufacturers must also retain records used in calculating the customary prompt pay discounts and nominal prices reported to CMS.
Existing regulations at § 447.534(i) require manufacturers to report revisions to AMP and best price for a period not to exceed 12 quarters from the quarter in which the data were due. We proposed to move this provision to § 447.510(b) and revise it to require manufacturers to also report revisions to customary prompt pay discounts and nominal prices for the same period.
In order to reflect the changes to AMP as set forth in the DRA, we proposed allowing manufacturers to recalculate base date AMP in accordance with the definition of AMP in § 447.504(e) of this subpart. Base date AMP is used in the calculation of the additional rebate described in section 1927(c)(2) of the Act. This additional rebate is defined as the difference between the quarterly AMP reported to CMS and the base date AMP trended forward using the CPI-U. We proposed this amendment so that the additional rebate would not increase due to changes in the definition of AMP. We proposed giving manufacturers an opportunity to submit a revised base date AMP with their data submission for the first full calendar quarter following the publication of the final rule. We proposed to allow manufacturers the option to decide whether they will recalculate and submit to CMS a base date AMP based on the new definition of AMP or submit their existing base date AMP. We were giving manufacturers this option because we were aware that some manufacturers may not have the data needed to recalculate base date AMP or may find the administrative burden to be more costly than the savings gained.
Under section 1927(b)(3)(A) of the Act and the terms of the national rebate agreement, manufacturers that sign the national rebate agreement must supply CMS with a list of all product data (for example, date entered market, drug category of single source, innovator multiple source, or noninnovator multiple source) and pricing information for their covered outpatient drugs. In accordance with the statute, we proposed requiring manufacturers to report AMP and best price to CMS not later than 30 days after the end of the rebate period.
Section 6001(b)(1) of the DRA amended section 1927(b)(3)(A)(i) of the Act by adding “month of a” before “rebate period.” Section 6003(a) of the DRA restructured section 1927(b)(3)(A)(i) of the Act. The statute, as amended by these provisions, can be read in different ways. One interpretation is that the revisions made by section 6003(a) of the DRA supersede the revisions made by section 6001(b)(1) of the DRA, effectively eliminating the requirement that manufacturers report data to CMS on a monthly basis. However, we did not believe that this reading is the better reading of the statute. It is unreasonable to presume that Congress would simultaneously establish and render meaningless a new provision of law and we do not propose to adopt this interpretation. Another interpretation is that the revisions made by section 6001(b)(1) of the DRA, when read with the amendments made by section 6003 of the DRA, create a new requirement that AMP, best price, and customary prompt pay discounts be reported on a monthly basis. However, there is no compelling evidence in the legislative history which indicates that Congress intended to change the rebate period from quarterly to monthly. Best price is reported to CMS quarterly for purposes of our calculation of the unit rebate amount (URA) for single source and innovator multiple source drugs. While the DRA requires AMPs to be reported and disclosed to States on a monthly basis, it did not establish any similar monthly use for best price or customary prompt pay discounts. For these reasons, we proposed to interpret section 6001(b) of the DRA to require that manufacturers report only AMP to CMS on a monthly basis beginning January 1, 2007. To implement this provision, we proposed requiring in § 447.510(d) that manufacturers must submit monthly AMP to CMS not later than 30 days after each month. We also proposed requiring manufacturers to report quarterly AMP, best price, and customary prompt pay discounts on a quarterly basis.
We proposed that the monthly AMP will be calculated the same as the quarterly AMP, with the following exceptions. The time frame represented by the monthly AMP would be one calendar month instead of a calendar quarter and once reported, would not be subject to revision later than 30 days after each month. Because we recognized that industry pricing practices sometimes result in rebates or other price concessions being given by manufacturers to purchasers at the end
Section 6001(b)(2)(C) of the DRA amended the confidentiality requirements at section 1927(b)(3)(D) of the Act by adding an exception for AMP disclosure through a Web site accessible to the public. The statute does not specify that this exception only applies to monthly AMP; therefore, we also proposed to make the quarterly AMP publicly available. We noted that the quarterly AMP would not necessarily be identical to the monthly AMP due to the potential differences in AMP from one timeframe to the next.
Section 6001(d)(1) of the DRA modified section 1927(b)(3)(A)(iii) of the Act by adding a requirement that manufacturers report nominal prices for calendar quarters beginning on or after January 1, 2007 to the Secretary. To implement this provision, we proposed to require that manufacturers report nominal price exception data to CMS on a quarterly basis. We further proposed that nominal price exception data shall be reported as an aggregate dollar amount which includes all nominal price sales to the entities listed in § 447.508(a) of this subpart for the rebate period.
Section 1927(b)(3)(C) of the Act describes penalties for manufacturers that provide false information or fail to provide timely information to CMS. In light of these requirements, we proposed to require that manufacturers certify the pricing reports they submit to CMS in accordance with § 447.510. We proposed to adopt the certification requirements established by the Medicare Part B Program for ASP in the interim final rule with comment period published on April 6, 2004. Each manufacturer's pricing reports would be certified by the manufacturer's chief executive officer (CEO), chief financial officer (CFO), or an individual who has delegated authority to sign for, and who reports directly to, the manufacturer's CEO or CFO.
We proposed that all product and pricing data, whether submitted on a quarterly or monthly basis, be submitted to CMS in an electronic format. When the Medicaid Drug Rebate Program was first implemented in 1991, electronic data transfer was one of three data submission options as the use of such electronic media was not yet as commonplace as it is today. Due to the new monthly data reporting requirements and additional quarterly data reporting requirements, we proposed to require manufacturers to use one uniform data transmission format to transmit and collect these data. We stated that CMS will issue operational instructions to provide additional guidance regarding the new electronic data submission requirements.
We proposed that the existing § 447.331 be revised and redesignated as a new § 447.512. We proposed to revise subsection (a) to clarify that the upper limit for multiple source drugs applies in the aggregate. We also proposed to update several cross-references to provisions in subpart I.
We proposed that the existing § 447.332 be revised in a new § 447.514.
Existing regulations at 42 CFR 447.331, 447.332 and 447.334 address upper limits for payment of drugs covered under the Medicaid Program. We proposed to redesignate existing regulations at §§ 447.331, 447.332, and 447.334 as new regulations at §§ 447.512, 447.514, and 447.516, respectively.
Existing regulations at § 447.332(a)(1)(i) state that an upper limit for a multiple source drug may be established if all of the formulations of the drug approved by the FDA have been evaluated as therapeutically equivalent in the current edition of the FDA's publication, “Approved Drug Products with Therapeutic Equivalence Evaluations.”
Section 1927(e)(4) of the Act, as amended by OBRA 90, expanded the criteria for multiple source drugs subject to FUL reimbursement. Specifically, the statute required CMS to establish an upper payment limit for each multiple source drug when there are at least three therapeutically and pharmaceutically equivalent multiple source drugs, regardless of whether all additional formulations are rated as such. Effective January 1, 2007, the DRA changed the requirement such that a FUL must be established for each multiple source drug for which the FDA has rated two or more products as therapeutically equivalent.
Currently, if all formulations of a multiple source drug are identified as A-rated in the FDA's publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” at least two formulations must be listed in that publication for CMS to establish a FUL for that drug. If all formulations of a multiple source drug are not A-rated, there must be at least three A-rated versions of the drug listed in “Approved Drug Products with Therapeutic Equivalence Evaluations” for CMS to establish a FUL for the drug. If a product meets the FDA criteria described above, we confirm that at least three suppliers (that is, manufacturers, wholesalers, re-packagers, re-labelers or any other entity from which a drug can be purchased) list the drug in published compendia of cost information for drugs available for sale nationally (for example, Red Book, First DataBank, or Medi-Span). Then, using these pricing compendia, we select the lowest price (for example, the average wholesale price (AWP), wholesale acquisition cost (WAC), or direct price) from among the A-rated formulations of a particular drug and apply the formula described in existing § 447.332 to determine the FUL for that drug. FUL lists and changes to those lists based on the methodology set forth in the statute and regulations are issued periodically through Medicaid Program issuances and are posted on the CMS Web site.
By the term, “therapeutically equivalent,” we mean drugs that are identified as A-rated in the current edition of the FDA's publication,
We proposed revising the methodology we use to establish FULs for multiple source drugs based on the modifications made by the DRA. Specifically, sections 6001(a)(3) and (4) of the DRA changed the definition of multiple source drug established in section 1927(k)(7)(A)(i) of the Act to mean, with respect to a rebate period, a covered outpatient drug for which there is at least one other drug product which is rated as therapeutically equivalent (under the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”). Also, section 6001(a)(1) of the DRA changed the requirement for a FUL to be established for each multiple source drug for which the FDA has rated three or more products therapeutically and pharmaceutically equivalent to a requirement for a FUL when the FDA has established such a rating for two or more products. Therefore, we proposed in § 447.514(a)(1)(ii) that a FUL will be set when at least two suppliers (for example, manufacturers, wholesalers, re-packagers, or re-labelers) list the drug in a nationally available pricing compendia (for example, Red Book, First DataBank, or Medi-Span).
Existing regulations at § 447.332(b) specify that the agency's payments for multiple source drugs identified and listed must not exceed, in the aggregate, payment levels determined by applying, for each drug entity, a reasonable dispensing fee established by the agency, plus an amount that is equal to 150 percent of the published price for the least costly therapeutic equivalent (using all available national pricing compendia) that can be purchased by pharmacies in quantities of 100 tablets or capsules (or, if the drug is not commonly available in quantities of 100, the package size commonly listed) or, in the case of liquids, the commonly listed size.
Section 6001(a)(2) of the DRA added section 1927(e)(5) to the Act that changed the formula used to establish the FUL for multiple source drugs. Effective January 1, 2007, the upper limit for multiple source drugs shall be established at 250 percent of the AMP (as computed without regard to customary prompt pay discounts extended to wholesalers) for the least costly therapeutic equivalent. The currently reported AMP is based on the nine-digit NDC and is specific only to the product code, combining all package sizes of the drug into the same computation of AMP. We proposed to continue to use the AMP calculated at the nine-digit NDC for the FUL calculation. In accordance with the DRA amendments, we will no longer take the individual 11-digit NDC, and thereby the most commonly used package size into consideration when computing the FUL because the currently reported AMP does not differentiate among package sizes.
We considered using the 11-digit NDC to calculate the AMP, which would require manufacturers to report the AMP at the 11-digit NDC for each package size and that doing so would offer other advantages to the program for FULs and other purposes. An AMP at the 11-digit NDC would allow us to compute a FUL based on the most common package size as specified in current regulations. We did not believe computing an AMP at the 11-digit NDC would be significantly more difficult than computing the AMP at the 9-digit NDC as the data from each of the 11-digit NDCs is combined into the current AMP. The AMP at the 11-digit NDC would also align with State Medicaid drug payments that are based on the package size. It would also allow us to more closely examine manufacturer price calculations and allow the States and the public to know the AMP for the drug for each package size. It would also allow 340B covered entities, which are entitled to buy drugs at a discount that is in part based on calculations related to AMP, to know what the pricing is for each package size, as 340B ceiling prices are established per package size. Calculating the AMP at the 11-digit NDC level permits greater transparency, and may increase accuracy and reduce errors for the 340B covered entities where prices are established for a package-size product rather than a per unit cost using the product's weighted average AMP.
However, the legislation did not change the level at which manufacturers are to report AMP, and we find no evidence in the legislative history that the Congress intended that AMP should be restructured to collect it by 11-digit NDCs. We proposed to use the currently reported 9-digit AMP for calculating the FUL. Changing the current method of calculating the AMP would require manufacturers to make significant changes to their reporting systems and have an unknown effect on the calculation of rebates in the existing Medicaid Drug Rebate Program. In State Medicaid payment systems that consider a number of different factors in deriving payment rates, we also believed it would offer minimal advantages. Furthermore, we expected that because the AMP is marked up 250 percent, the resultant reimbursement should be sufficient to reimburse the pharmacy for the drug regardless of the package size the pharmacy purchased and that to the extent it does have an impact, it would encourage pharmacies to buy the most economical package size.
We specifically asked for comments on the alternative approach of using the 11-digit NDC to calculate the AMP. We invited comments on the merits of using both approaches in calculating the AMP for the FUL.
In computing the FUL, we proposed that the monthly AMP submitted by the manufacturer will be used. Using the monthly AMP will provide for the timeliest pricing data and allow revisions to the FUL list on a monthly basis. It will also permit us to update the FULs on a timely basis in accordance with the provisions of section 1927(f)(1)(B) of the Act, wherein the Secretary, after receiving notification that a therapeutically equivalent drug product is generally available, shall determine within seven days if that drug product should have a FUL.
Section 6001(c)(1) of the DRA redefines AMP to exclude customary prompt pay discounts extended to wholesalers. Due to this change in the computation, and the requirement that monthly AMP first be reported as of January 1, 2007, we proposed that a FUL update of drugs, using the new methodology first be published when the revised AMPs are available and processed.
We proposed to adopt additional criteria to ensure that the FUL will be set at an adequate price to ensure that a drug is available for sale nationally as presently provided in our regulations. When establishing a FUL, we proposed to disregard the AMP of an NDC which has been terminated. The AMP of a terminated NDC will not be used to set the FUL beginning with the first day of the month after the actual termination
We proposed an exception to the 30 percent carve-out policy when the FUL group only includes the innovator single source drug and the first new generic in the market, including an authorized generic. In this event, we would not apply the 30-percent rule as we believe the DRA intends that a FUL be set when new generic drugs become generally available so as to encourage greater utilization of a generic drug when the price is set less than its brand name counterpart.
We invited comments from the public on all issues set forth in this subpart. We invited suggestions on how best to accomplish the goal of ensuring that the use of AMP in calculating the FUL will ensure that a drug is available nationally at the FUL price. We asked commenters to please submit data supporting their proposals when available. Upper Limits for Drugs Furnished as Part of Services (§ 447.516)
We proposed that the existing § 447.334 be redesignated as a new § 447.516.
We proposed that the existing § 447.333 be redesignated as a new § 447.518.
Prior to the DRA, many States did not collect rebates on physician-administered drugs when they were not identified by NDC number because the NDC number is necessary for States to bill manufacturers for rebates. In its report, “Medicaid Rebates for Physician Administered Drugs,” (April 2004, OEI-03-02-00660), the OIG reported that, by 2003, 24 States either required providers to bill using NDC numbers or identified NDC numbers using a Healthcare Common Procedure Coding System (HCPCS)-to-NDC crosswalk for physician-administered drugs in order to collect rebates. Four of the 24 States were able to collect rebates for all physician-administered drugs, both single source and multiple source drugs (one State only collected these rebates from targeted providers). Section 6002 of the DRA added sections 1927(a)(7) and 1903(i)(10)(C) to the Act to require that States collect rebates on certain physician-administered drugs in order for FFP to be available for these drugs.
Section 1927(a)(7)(A) of the Act requires that, effective January 1, 2006, in order for FFP to be available, States must require the submission of utilization data for single source physician-administered drugs using HCPCS codes or NDC numbers. (HCPCS codes are numeric and alpha-numeric codes assigned by CMS to every medical or surgical supply, service, orthotic, prosthetic and generic or brand name drug for the purpose of reporting healthcare transactions for claims billing. Physician-administered drugs are assigned alpha-numeric HCPCS codes, and are commonly referred to as J-codes. However, physician-administered drugs are also coded using other letters of the alphabet. For this reason, we referred to the coding system, HCPCS, as opposed to one set of alpha-numeric codes in our discussion of section 6002 requirements.) If States collect HCPCS codes for single source drugs, they can crosswalk these codes to NDC numbers because most HCPCS codes for single source drugs include only one NDC in order to collect rebates.
Section 1927(a)(7)(C) of the Act requires that, beginning January 1, 2007, States must provide for the submission of claims data with respect to physician-administered drugs (both single source and multiple source drugs) using NDC numbers, unless the Secretary specifies that an alternative coding system can be used. The Secretary did not propose to specify an alternative coding system because we believe that NDC numbers are well established in the medical community and provide States the most useful information to collect rebates.
Section 1927(a)(7)(B) of the Act requires the Secretary, by January 1, 2007, to publish a list of the 20 multiple source physician-administered drugs with the highest dollar volume dispensed under the Medicaid Program. We proposed that the list be developed by the Secretary using data from the Medicaid Statistical Information System and published on the CMS Web site.
Section 1927(a)(7)(B)(ii) of the Act (when read with other DRA amendments) requires that, effective January 1, 2008, in order for FFP to be available, States must provide for the submission of claims for physician-administered multiple source drugs using NDC numbers for those drugs with the highest dollar volume listed by the Secretary.
We proposed, for the purpose of this section, that the term “physician-administered drugs” be defined as covered outpatient drugs under section 1927(k)(2) of the Act (many are also covered by Medicare Part B) that are typically furnished incident to a physician's service. These drugs are usually injectable or intravenous drugs administered by a medical professional in a physician's office or other outpatient clinical setting. Examples include injectables: lupron acetate for depot suspension (primarily used to treat prostate cancer), epoetin alpha (injectable drug primarily used to treat cancer), anti-emetic drugs (injectable drug primarily used to treat nausea resulting from chemotherapy) intravenous drugs primarily used to treat cancer (paclitaxel and docetaxel), infliximab primarily used to treat rheumatoid arthritis, and rituximab primarily used to treat non-Hodgkin's lymphoma. We believed that some oral self-administered drugs (administered in an outpatient clinical setting), such as oral anti-cancer drugs, oral anti-emetic drugs should also be included in the designation of physician-administered
Section 1927(a)(7)(D) of the Act allows the Secretary to grant States extensions if they need additional time to implement or modify reporting systems to comply with this section. We did not propose any criteria for reviewing these extension requests as we expected that most, if not all States would be able to meet the statutory deadlines for collection of NDC numbers on claims. Most States are already collecting rebates for single source drugs that are provided in a physician's office. For multiple source drugs, the States have nearly two years following enactment of the DRA before FFP would be denied for the 20 multiple source drugs specified by the Secretary as having the highest dollar volume.
We expected that States would require physicians to submit all claims using NDC numbers, as using multiple billing systems would be burdensome for physicians and States. This would also advantage States because rebates would be collectible on all physician-administered drugs.
For States not currently billing manufacturers for rebates on single source drugs, we believed that the Medicare Part B crosswalk may be helpful to crosswalk HCPCS codes to NDC numbers. This crosswalk may be found on the CMS Web site at
To implement the provisions set forth in section 6002, we propose a new § 447.520. In § 447.520(a), we proposed to require States to require that claims for physician-administered drugs be submitted using codes that identify the drugs sufficiently to bill a manufacturer for rebates in order for the State to receive FFP. In § 447.520(b), we proposed requiring States to require providers to submit claims using NDC numbers. In § 447.520(c), we proposed allowing States that require additional time to comply with the requirements of this section to apply to the Secretary for an extension.
We received over 1,600 timely items of correspondence that addressed the issues in the proposed rule. We received comments from pharmacists and other health care providers, drug manufacturers, membership organizations, law firms, PBMs, consultants, State agencies, members of Congress, and individuals. A summary of the major issues and our responses follow.
We received many comments expressing general support for the provisions of the proposed rule. One commenter specifically indicated support for Federal efforts that are designed to positively affect the affordability of and access to prescription drugs and healthcare professionals. Other commenters indicated support for CMS' efforts to clarify the definitions of significant terms as well as the treatment of various types of sales and prices in manufacturer calculations.
Other commenters suggested a delay of four quarters for the entire rule. One commenter suggested we delay finalizing the rule until more detailed information regarding AMP and the established FUL is made available to the pharmacy industry; another commenter suggested a delay of 90 days after the release of the new FUL source file. Another commenter suggested a 180-day compliance period followed by a 90-day testing period, during which time the AMP may only be used for research and verification purposes only.
A few commenters specifically asked that we delay the implementation of the requirement that manufacturers submit a base date AMP. Another commenter noted that the practical implication of treating inpatient and outpatient hospital sales differently for AMP purposes would mean that hospital contracts for the purchase of prescription drugs would need to be renegotiated, which could necessitate a delay in the implementation of the AMP rule for six months to a year.
One commenter urged CMS to issue an interim final rule with comment period instead of this final rule. The commenter expressed confusion regarding the correct interpretation of a number of provisions in the proposed rule. The commenter believes that an interim final rule with comment period would foster even greater dialog between the pharmaceutical industry and CMS.
Products A and B are sold under a bundled arrangement and have a combined bundled discount equal to $200,000 on total undiscounted sales of $1 million. If Product A has undiscounted sales of $600,000 and product B has undiscounted sales of $400,000, the manufacturer would allocate 60 percent of the combined bundled discount to Product A when calculating AMP. Forty percent of the combined bundled discount would be allocated to Drug B. The effective unit price of each product would be calculated by subtracting the discount allocated to each drug product ($600,000 − $120,000 = $480,000 for Product A; $400,000 − $80,000 = $320,000 for Product B) and dividing the result by the number of units for each drug product in the bundled sale.
In response to the comments regarding drugs that entered the market prior to 1962, we believe these drugs are not classified as innovator multiple source drugs unless they are marketed under an NDA. Further, we recognize the need to classify drugs that entered the market prior to 1962 that are not marketed under an NDA. Therefore, we are further defining noninnovator multiple source drugs as drugs that entered the market prior to 1962 that were not originally marketed under an original NDA.
In response to comments regarding drugs approved under a BLA, we believe the statutory definition of covered outpatient drug in section 1927 of the Act is sufficient to address these concerns without further revision to the definition of innovator multiple source drug.
Another commenter indicated support for maintaining a quarterly rebate period. The commenter noted that in addition to the lack of legislative intent to change the rebate period, establishing a different or more frequent time period would place unnecessary burdens on changing drug manufacturers’ government reporting systems without additional public benefit.
Another commenter noted that our definition does not address the situation where, at the end of the life cycle of a particular drug product, the only covered outpatient drug remaining on the market in the U.S. happens to be a version of the product that was originally approved by the FDA under an ANDA. The commenter also noted that we did not address products that came to market before 1962 and remain commercially available today. The commenter suggested CMS revise the definition of single source drugs to address these situations.
Commenter: One commenter asked that CMS allow manufacturers discretion in selecting methodologies for determining fair market value and in identifying the types of services that can qualify as bona fide services.
1. The manufacturer coupon is not contingent upon any purchase requirement to individuals.
2. The manufacturer establishes a benefit amount of the coupon to be given to individual patients, without any negotiation between the manufacturer and any other third party (such as an insurer or PBM) as to that amount.
3. The entire amount of the free product or coupon amount is made available to the individual patient, without any opportunity for the retail pharmacy or any third party (such as an insurer or PBM), to reduce the benefit amount, or take a portion of it, for its own purposes.
4. The pharmacy collects no additional payment, other than the benefit amount and a bona fide service fee, from the coupon.
1. The program is focused on extending free products not contingent
2. Each manufacturer establishes an amount of the subsidy to be given to individual patients, without any negotiation between the manufacturer and any other third party (such as an insurer or PBM) as to that amount.
3. The entire amount of the free product or subsidy is made available to the individual patient, without any opportunity for the retail pharmacy or any third party (such as an insurer or PBM), to reduce that subsidy, or take a portion of it, for its own purposes.
4. The pharmacy collects no additional payment, other than the benefit amount and a bona fide service fee, from the patient assistance program.
Other commenters stated that excluding PBM pharmacies from the definition of retail pharmacy class of trade offers numerous benefits, including reduced recordkeeping requirements, reduced risk of price fluctuations, and limiting the need for additional regulatory burdens. In addition, commenters argued that PBMs do not dispense to the public, and that patients have to belong to a specific health plan in order to access drugs through a particular PBM. Consequently, commenters stated that PBM rebates, discounts, or other price concessions are not typically available to the public. Commenters argued that for PBMs to purchase prescription drugs from a manufacturer or wholesaler, or to dispense drugs to the public, PBMs generally need to be licensed as pharmacies under the applicable State's law. Commenters stated that they were not aware of any State that licenses PBMs as pharmacies to purchase, receive, or dispense drugs to the public.
Furthermore, we understand that PBMs do not generally take possession of pharmaceutical products. Only in their role as mail order pharmacies do PBMs participate directly in the purchase or delivery of prescription drugs. Accordingly, except with respect to such mail order activities, we have decided that PBM sales and associated rebates, discounts, or other price concessions fall outside of our definition of AMP.
We received numerous comments regarding the option for State Medicaid Agencies to use AMP as a benchmark to calculate pharmacy payment rates, as discussed below:
1. The program is focused on extending financial assistance to low-income individuals and families, as determined by CMS, who are not otherwise eligible for Medicare and do not have public or private prescription drug coverage.
2. Each manufacturer establishes an amount of the subsidy to be given to individual patients, without any negotiation between the manufacturer and any other third party (such as an insurer or PBM) as to that amount.
3. The entire amount of the subsidy is made available to the individual patient, without any opportunity for the retail pharmacy or any third party (such as an insurer or PBM), to reduce that subsidy, or take a portion of it, for its own purposes.
4. The pharmacy collects no additional payment, other than the benefit amount, from the patient assistance program.
The DRA requires drug manufacturers to include drugs sold under an NDA approved under section 505(c) of the FFDCA in their AMPs and best prices.
In the proposed rule, we would require the manufacturer holding title to the NDA of the authorized generic drug to include the direct and indirect sales of this drug in its AMP and to include in the computation of best price the price of the innovator multiple source drug as well as the single source drug.
We received numerous and detailed comments concerning these proposed requirements that led us to agree with commenters that these requirements would be unduly burdensome on manufacturers, call into question the veracity of manufacturer pricing information reported to CMS, and potentially violate anti-trust statutes because they would require manufacturers to share pricing information and engage in anti-competitive practices.
In the final rule, we limit the application of the requirement to the sale of an authorized generic product from the primary manufacturer; that is, the manufacturer that holds the NDA, to the secondary manufacturer; that is, the manufacturer that markets and sells the authorized generic drug. This eliminates the need for manufacturers to share
At this time, we do not require that subsequent sales of an authorized generic product by the secondary manufacturer be included in the AMP calculation of the primary manufacturer. We note that this is consistent with our reading of the DRA in that, unlike the best price amendment, the DRA did not amend the definition of AMP, which continues to require that AMP be calculated with respect to the covered outpatient drug of a manufacturer based on the price paid to the manufacturer “by wholesalers for drugs distributed to the retail pharmacy class of trade.” The DRA did not amend the AMP definition to include prices paid to the manufacturer by other manufacturers. Furthermore, in light of the comments we have received with respect to the proposed rule, we believe that to require the primary manufacturer to include sales of the secondary manufacturer within its calculation would be problematic from an administrative accounting and anti-trust perspective. We also note that to include the sales of the authorized generic drug in the AMP of the primary manufacturer's drug could lower the AMP and rebate liability, and present additional concerns with respect to the FUL calculation, contrary to our reading of the provision.
In light of the comments received and our concerns given the statutory amendment, at this time we have decided not to include authorized generic products marketed by the secondary manufacturer in the AMP calculation. We will continue to review this issue, but we believe this interpretation best implements the DRA amendments.
In light of the comments, we have decided to reconsider our proposal that primary manufacturers include the authorized generic product pricing data of a secondary manufacturer in their best price and AMP calculations. At this time, we have revised the authorized generics provision to require the primary manufacturer to include in best price the authorized generic sales from the primary manufacturer to a secondary manufacturer or subsidiary of the brand company.
At this time, based on concerns raised by the commenters, primary manufacturers would not be required to incorporate the sales of the authorized generic in the AMP of the brand drug. The primary manufacturer and the secondary manufacturer would be responsible for separately calculating their own AMP. The method for determining the AMP, as described elsewhere in this final rule, is the same for all covered outpatient drugs, including authorized generics.
At this time, we believe this revision will avoid any anti-trust concerns that could potentially arise as a result of pricing data being exchanged between manufacturers. In light of the DRA amendments, we are not eliminating or delaying the implementation of this provision but we will continue to consider this issue as we receive AMP and best price data.
Manufacturers did not differentiate between for-profit and non-profit entities when offering nominal pricing, and manufacturers' agreements frequently included market share requirements. Additionally, the surveys found that the use of the nominal price exception has declined since 2003.
Other commenters noted that it is difficult for a manufacturer to quantify the discounts taken by a purchaser, or deducted from payments made during the rebate period, as doing so requires the manufacturer to reconcile the deductions relating to customary prompt pay discounts and deductions taken for other reasons, such as shortages in the amount of product shipped. Even if the manufacturer could quantify such deductions, that amount would relate to the invoices paid rather than the sales made in the rebate period. In contrast, the commenters believed that manufacturers can readily quantify the customary prompt pay discounts offered during a rebate period, and ask that CMS clarify the reporting requirement accordingly.
In addition, we are revising the regulation text at § 447.510(d)(2) to clarify that monthly AMP should be calculated as the weighted average of prices for all the manufacturer's package sizes for each covered outpatient drug sold by the manufacturer during a month. It is calculated as net sales divided by number of units sold, excluding goods or any other items given away unless contingent on any purchase requirements.
However, we note that States may need to revise payments to the extent they base their reimbursement methodologies on AMPs that are subsequently revised by manufacturers.
In regard to the issue of State payment rates, we will continue to review SPAs to ensure that payment complies with section 1902(a)(30) of the Act.
One commenter suggested that CMS compare the NDCs reported by manufacturers with the NDCs listed on databases maintained by First DataBank and Medispan in order to help assure that all NDCs and their AMPs are reported to CMS.
Other commenters expressed concern with allowing manufacturers to revise their monthly AMPs for up to 30 days after each month. The commenters urged CMS to enforce the prohibition against adjusting monthly AMP beyond the 30-day period.
We also recognize that because we are using monthly AMP in the calculation of the FULs, it would be impractical and burdensome for States and pharmacies if we revised the FULs based on revised monthly AMPs for up to three years. Furthermore, we note in § 447.510(d)(2) that manufacturers are required to submit monthly AMPs based on the best data available and to certify the accuracy of those submissions. As a result, we do not expect that we will need to revise the FULs. We will consider revisiting this issue if monthly AMP submissions become problematic.
In the proposed rule, we proposed allowing manufacturers to rely on estimates regarding the impact of their end-of-quarter rebates or other price concessions for purposes of calculating monthly AMP. We suggested a 12-month rolling average of all lagged price concessions for purposes of calculating monthly and quarterly AMPs and requested comments on the appropriate methodology for calculating monthly AMP.
Commenters suggested a modification of the 12-month rolling percentage methodology. They suggested requiring manufacturers to look to the four full calendar quarters before the reporting period to calculate the rolling 12-month percentage, which could then be applied to all three monthly AMPs and the quarterly AMP. As an alternative, chargebacks and rebates could be singled out for lagged treatment on a routine basis. In addition, the commenters urged CMS to provide examples showing how the methodology should be applied in both the monthly and the quarterly context, taking into account the proper treatment of the various types of bundled sales.
Other commenters recommended that manufacturers be permitted to use a four-quarter rolling average of rebates to sales, and apply that percentage to monthly sales. The commenters believe that using a four-quarter rolling average for smoothing is more operationally feasible than a 12-month rolling average because rebates and other price concessions are typically invoiced by customers and paid by the manufacturer on a quarterly basis. The commenters also asked that CMS allow manufacturers to estimate excluded sales for the month using a four-quarter rolling average based on gross sales units divided by excludable AMP units.
One commenter noted that end-of-year rebates or chargebacks should be excluded from the AMP calculation in order to avoid significant 12 to 18-month revisions to AMP data. Such revisions would render AMP data unusable for reimbursement purposes.
The provision requiring manufacturers to restate their quarterly AMPs for a period not to exceed twelve quarters from when the data were due became effective on October 1, 2003. Prior to that time, the national rebate agreement did not provide a specific period for recalculations. As noted in the final rule with comment period published on August 29, 2003 (68 FR 51912) we believe this provision helps streamline the administration of the Medicaid Drug Rebate Program.
In light of the fact that we are requiring manufacturers to submit data to CMS in an electronic format, we will provide that the certification be made electronically. In addition, the
We disagree with the suggestion that the timeframe for restatements be shortened from twelve quarters to four quarters. Quarterly data can be revised for up to twelve quarters after the quarter in which the data were due. Similarly, monthly AMP can be revised for up to 36 months after the month in which the data were due.
Several commenters agreed with CMS' proposal to set the FUL based on the lowest AMP that is not less than 30 percent of the next highest AMP. One commenter stated that CMS should use a statistical calculation of a standard deviation for each group of therapeutically equivalent drugs. Any manufacturer's AMP falling below one standard deviation would be removed as an outlier. The AMP would then be based upon the lowest value within one standard deviation. Another commenter suggested that AMPs falling at or below the 25th percentile of drug prices within the ingredient group should be excluded from establishing the FUL. Several commenters stated that the FUL should be calculated using the AMP of the lowest priced drug that is not less than 50 percent of the next highest AMP. In other words, look at the lowest AMP, and then the next lowest AMP, and so on, rejecting AMPs until an AMP is at least 50 percent of the next highest AMP.
Other commenters suggested that manufacturers should report AMPs at the 11-digit NDC level with their respective unit volume. These commenters state that the final rule should include a FUL outlier methodology that examines AMPs on a cumulative market share basis, starting with the lowest AMP, then the next lowest and so on, rejecting AMPs until a cumulative market share of 50 percent has been reached.
We received many comments regarding the requirement that State Medicaid Agencies provide for the submission of NDCs on claims for
We received several comments on issues that were not addressed in the proposed rule. A summary of those comments and our responses follow.
One commenter concurred with the OIG's findings in its May 2006 report that future errors or inconsistencies in manufacturers' AMP calculations could lead to inaccurate or inappropriate reimbursement amounts as well as rebate errors.
One commenter raised concerns that the public disclosure of manufacturer-specific AMPs negates the confidentiality provisions of section 1927 of the Act. The commenter expressed the opinion that such disclosure must be implemented through notice-and-comment rulemaking, and that failure to do so would violate the Administrative Procedures Act. Another commenter asked that we not make AMPs publicly available. The commenter noted concern that public release of AMP would stifle competition among manufacturers, ultimately driving up the price of generic drugs.
One commenter also expressed that CMS should post a disclaimer stating that limited instructions were provided to guide manufacturers' January AMP calculations. Posted data should be viewed as preliminary and may not accurately reflect prices available in the market to community retail pharmacies. The commenter stated that similar disclaimers should be sent to the States with their download tapes or new electronically transmitted price report files. These disclaimers should also be reiterated in a State Medicaid Director letter.
Another commenter also expressed concern with publishing both monthly and quarterly AMPs on the CMS Web site. The commenter noted that having two different AMP values could lead to confusion. The commenter urged CMS to only publish the last month's AMP data for the quarter. Another commenter urged CMS to publish AMP quarterly, not monthly.
Other commenters expressed support for HRSA's position and asked CMS to clarify that the AMP described in this final rule is not applicable in calculating 340B ceiling prices. One commenter urged CMS to support HRSA's interpretation and for CMS to provide the data required for the calculation of two AMPs. The commenter also suggested that this final rule should specify that HRSA will receive the specific data needed to calculate the 340B ceiling prices from drug manufacturers and/or from CMS.
For the most part, this final rule incorporates the provisions of the proposed rule. Those provisions of this final rule that differ from the proposed rule are as follows:
In § 447.300, we updated a statutory reference.
In § 447.502, we added definitions of three terms: lagged price concession, noninnovator multiple source drug, and States. We also moved the definition of bona fide service fee to § 447.504 and clarified that bona fide service fees mean payment for an expense that would have been paid by the manufacturer at the same rate had these services been performed by the manufacturer or other entity. We also clarified that bona fide service fees are paid by a manufacturer to an entity.
In § 447.502, in the definition of dispensing fee, we inserted “or service” after, “is incurred at the point of sale.”
In § 447.502, we clarified that an innovator multiple source drug includes an authorized generic drug. We also clarified that term to include any labelers operating under the NDA.
In § 447.502, we clarified that a single source drug includes a covered outpatient drug approved under a BLA.
In § 447.504(c), we revised the definition of customary prompt pay discount by inserting “frame and consistent with industry standards and normal business practices for payment” after “a specified time.”
In § 447.504(d), we revised the definition of net sales by inserting “except customary prompt pay discounts extended to wholesalers,” after “cash discounts allowed.”
In § 447.504(e), we removed PBMs from the definition of retail pharmacy class of trade. We also removed entities that arrange for the purchase of drugs from this definition.
In § 447.504(f), we removed “a pharmacy, chain of pharmacies, or PBM” and “arranges for the sale of” from the definition of wholesaler. We also inserted “those entities in the retail pharmacy class of trade” after “including.”
In § 447.504(g)(3) and (h)(4), we clarified that direct and indirect sales to hospitals that cannot be identified with adequate documentation as being used in the outpatient pharmacy for outpatient use are not included in AMP.
In §§ 447.504(g)(6), 447.504(h)(22), and 447.504(i)(1), we clarified that discounts, rebates, or other price concessions to PBMs are excluded from the determination of AMP, except for purchases through the PBMs' mail order pharmacies.
In § 447.504(g)(8), we clarified that sales to outpatient facilities (for example, clinics, surgical centers, ambulatory care centers, dialysis centers, and mental health centers) are included in AMP.
In §§ 447.504(g)(9) through (13), we added sales to home infusion providers, specialty pharmacies, home health care providers, and physicians to the list of sales included in AMP.
In § 447.504(g)(15), we removed manufacturer coupons redeemed by any entity other than the consumer from the list of entities included in AMP. In § 447.504(h)(15), we clarified that manufacturer coupons redeemed by an agent, pharmacy, or other entity acting on behalf of the manufacturer are excluded from AMP. We further clarified that such coupons are excluded as long as the full value of the coupon is passed on to the consumer, pharmacy, agent, or other entity does not receive any price concession.
In § 447.504(g)(15), we clarified that sales of drugs reimbursed by third party payers are included in AMP, provided such drugs are provided to the retail pharmacy class of trade. We further clarified that third party payers include a qualified retiree prescription drug plan under section 1860D-22(a)(2) of the Act, HMOs and MCOs that do not purchase or take possession of drugs, and TRRx. In § 447.504(h)(23) we added associated rebates, discounts, or other price concessions to third party payers including the Medicare Part D Program, an MA-PD, a qualified retiree prescription drug plan under section 1860D-22(a)(2) of the Act, SCHIP, SPAPs, TRRx, and Medicaid programs to the list of prices excluded from AMP.
In § 447.504(h)(5), we clarified that sales to HMO or MCO-operated pharmacies that purchase or take possession of drugs are excluded from AMP.
In § 447.504(h)(6), we clarified that sales to nursing facility pharmacies, contract pharmacies for the nursing facility where these sales can be identified with adequate documentation, and other entities where the drugs are dispensed through a nursing facility pharmacy, such as assisted living facilities, are excluded from AMP.
In §§ 447.504(h)(7) through (12), we added sales to hospices (inpatient and outpatient), veterinarians and prisons, sales outside the 50 States and the District of Columbia, sales to State, county, and municipal entities, and sales to patient assistance programs to the list of sales excluded from AMP.
In § 447.504(h)(16) and (17), we added that manufacturer vouchers and manufacturer-sponsored drug discount card programs are excluded from AMP.
In § 447.504(h)(19), we clarified that bona fide service fees to any entities included in the retail pharmacy class of trade are excluded from the determination of AMP.
In § 447.504(h)(21), we clarified that returned or replaced goods, when accepted or replaced in good faith, are excluded from AMP.
In § 447.504(h)(24), we added Medicaid rebates under the national rebate agreement or a CMS-authorized State supplemental rebate agreement are excluded from AMP.
In § 447.504(i)(1), we clarified that AMP includes cash discounts except
In § 447.504(i)(2), we revised the methodology for calculating quarterly AMP to be the weighted average of monthly AMPs in the quarter.
In § 447.505(c)(2), we deleted PBMs from the list of entities included in best price. We also added “PBM rebates, discounts, or other price concessions except mail order purchases” to the list of prices excluded from best price in § 447.505(d)(13).
In § 447.505(c)(12), we removed “manufacturer coupons redeemed by any entity other than the consumer” from the prices included in best price. We also added manufacturer coupons redeemed by an agent, pharmacy or other entity acting on behalf of a manufacturer, as long as the full value of the coupon is passed on to the consumer and the pharmacy, agent or other entity does not receive any price concession, to the list of prices excluded from best price in § 447.505(d)(8).
In § 447.505(d)(3), we limited the SPAP best price exemption to any prices or price concessions provided to designated SPAPs.
In § 447.505(d)(4), we deleted TRICARE from the list of prices excluded from best price.
In § 447.505(e)(2), we clarified the reference to the nominal price provisions in § 447.508.
In § 447.506(a), we removed the phrase “directly or indirectly” from the definition of authorized generic drug.
In § 447.506(b), we revised the initial provision requiring the manufacturer holding title to the original NDA to include the authorized generic sales of the secondary manufacturer in the AMP of the brand drug by specifying that the manufacturer holding title to the original NDA of an authorized generic must include the sales of authorized generics in the AMP of the manufacturer holding title to the original NDA only when the products are sold directly to a wholesaler.
In § 447.506(c), we removed the initial provision that requires the manufacturer holding title to the original NDA to include the sales of the secondary manufacturer in the best price of the brand drug. We added language that would require sales from the manufacturer holding title to the original NDA to the secondary manufacturer to be included in the best price of the manufacturer holding title to the original NDA. We also added language to state that the best price is the lowest price at which the authorized generic drug is sold.
In § 447.510(a)(3), we clarified that customary prompt pay discounts shall be reported for each covered outpatient drug at the 9-digit NDC level. We also clarified that this term includes discounts provided to all wholesalers in the rebate period.
In § 447.510(a)(4), we clarified that nominal prices include all sales of single source and innovator multiple source drugs to the entities listed in § 447.508(a) of this subpart.
We added § 447.510(b)(2) to specify that manufacturers should not revise AMP when the revision would solely be as a result of data pertaining to lagged price concessions.
In § 447.510(c)(1), we changed the timeframe in which a manufacturer must report base date AMP to CMS from the first full calendar quarter following publication of this final rule to the first four full calendar quarters following publication of this final rule.
In § 447.510(c)(2)(i), we clarified that a manufacturer's recalculation of base date AMP must only reflect the revisions to AMP as provided for in § 447.504 of this subpart, as opposed to § 447.504(e) of the same.
In § 447.510(c)(2)(ii), we added a provision to allow a manufacturer to choose to recalculate base date AMP on a product-by-product basis.
In § 447.510(c)(2)(iii), we added a provision to require manufacturers to use actual and verifiable pricing records in the calculation of base date AMP.
In § 447.510(d)(2), we revised the reg text by removing the reference to § 447.504 and replacing it with the requirement that monthly AMP should be calculated as the weighted average for all the manufacturer's package sizes of each covered outpatient drug sold by the manufacturer during a month. We also added a requirement that a manufacturer must estimate the impacts of its lagged price concessions using a 12-month rolling average to estimate the value of those discounts.
In § 447.510(d)(3), we removed the prohibition against reporting revised monthly AMP and replaced it with a requirement that a manufacturer report revisions to monthly AMP to CMS for a period not to exceed 36 months from the month in which the data were due.
We added § 447.510(d)(4) to prohibit manufacturers from reporting revisions to monthly AMP if the revisions would be solely as a result of data pertaining to lagged price concessions.
We added § 447.510(d)(5) to address monthly AMP reporting requirements for terminated products.
In § 447.510(e)(3), we added a provision to allow pricing reports to be certified by an individual other than a CEO or CFO who has authority equivalent to a CEO or a CFO.
In § 447.510(e)(4), we allowed pricing reports to be certified by an individual who has the directly delegated authority to perform the certification on behalf of a CEO, a CFO, or an individual with authority equivalent to a CEO or a CFO.
In § 447.512(c)(1), we added language that would allow a physician to indicate that a specific brand is necessary when prescribing by an electronic means.
In § 447.514(a)(1)(ii) we deleted “list the drug which has met” and “based on all listings contained in current editions (or updates) of published compendia of cost information for drugs available for sale nationally.
In § 447.514(c)(2), we changed “30 percent” to “40 percent” per the outlier policy which will be implemented during the period of the final rule with comment period.
In § 447.514(c)(3), we clarified the regulation text by replacing “innovator single source” with “brand name.”
Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements:
Section 447.510 states that a manufacturer must report, electronically, product and pricing information for covered outpatient drugs to CMS not later than 30 days after the end of the rebate period. In addition, customary prompt pay discounts and nominal prices must be reported quarterly. Detailed information
The burden associated with these new requirements is the time and effort it would take for a drug manufacturer to gather product and pricing information and submit it to CMS in an electronic format. We estimate that these requirements would affect the approximately 550 drug manufacturers that currently participate in the Medicaid Drug Rebate Program. Our current reporting and recordkeeping hour burden for each manufacturer in the Medicaid Drug Rebate Program is 71 hours per quarter or 284 hours annually. We believe the new reporting requirements will require less than half of this time. Specifically, we believe it would take each manufacturer 31 hours per quarter or 124 hours annually to report additional new information to CMS. The total estimated burden on all drug manufacturers associated with the new requirements under § 447.510 is 68,200 annual hours. These new reporting requirements for drug manufacturers participating in the Medicaid Drug Rebate Program associated with the Medicaid Drug Program Monthly and Quarterly Reporting Form (CMS-367) are approved under OMB# 0938-0578. CMS will revise this collection to include changes in burden based upon this regulation.
Section 447.510(f) requires a manufacturer to retain records (written or electronic) for ten years from the date the manufacturer reports data to CMS for that rebate period. The ten-year time frame applies to a manufacturer's quarterly and monthly submissions of pricing data, as well as any revised quarterly pricing data subsequently submitted to CMS. As stated under § 447.510(f)(2), there are certain instances when records must be maintained beyond the ten-year period.
While this requirement is subject to the PRA, the retention of quarterly data is not a new requirement and is currently approved under OMB# 0938-0578. While this requirement will now also apply to monthly AMP data, we believe a similar set of data is now retained to support the quarterly retention requirement. It may require some additional record-keeping to retain the monthly, as well as the quarterly data, in the AMP system for manufacturers that do not retain this information there now. However, we believe that most manufacturers already have such monthly sales data (for example, data of sale information) in their system and transferring this to the system for calculating monthly AMP would not be a significant burden.
Section 447.520 requires providers, effective January 1, 2007, to submit claims to the State for physician-administered single source drugs and the 20 multiple source drugs identified by the Secretary using NDC numbers.
Assuming all States impose this requirement, the burden associated with this requirement is the time and effort it would take for a physician's office, hospital outpatient department or other entity (for example, non-profit facilities) to include the NDC on claims submitted to the State. We estimate this requirement would affect an excess of 20,000 physicians, hospitals with outpatient departments and other entities that would submit approximately 3,910,000 claims annually. We believe this would take approximately 15 seconds per claim. We estimated the cost based on the average annual wage and benefits paid for office and administrative support services in 2006 of $21.14 per hour (
Many hospital outpatient departments will also need to modify their billing systems to capture the NDC on Medicaid claims (hospitals that receive discounted drugs and bill Medicaid at the actual acquisition cost of the drug and hospitals that use a drug formulary system and bill at the hospital's purchasing cost are exempted). The American Hospital Association (AHA) in 2002 estimated that it would cost $200,000 per hospital for changes needed to use NDC codes for billing. Inflating this figure by the Consumer Price Index (CPI) would make the current cost approximately $230,000 for each of the 5,655 hospitals that participate in Medicaid for the total cost to be $1.3 billion.
We are not adopting this estimate as we believe it to be high. This estimate was developed in 2002 to implement a stand alone NDC system from scratch. Since its development, FDA in 2004 issued a final rule requiring drug manufacturers to include Uniform Product Codes (bar codes) with NDC numbers on drug packages. In their final rule, FDA estimated a significant percent of hospitals would voluntarily start to implement bar-coding systems, in order to lower the number of medication errors and to realize other efficiency gains. Consistent with FDA's findings, some commenters noted that hospitals are planning to use bar codes on drugs in the future. When use of these codes is adopted, hospitals will be able to take the NDC from the bar code when billing Medicaid, minimizing the cost of implementing this provision.
Section 447.520(c) allows States requiring additional time to comply with the requirements of this section to apply for an extension. The burden associated with this requirement is the time and effort it would take for each State to apply for a one-time extension. We estimate that it would take five hours for each State to apply for the extension; however, we believe that only a few States will apply. Therefore, we believe this requirement to be exempt as specified at 5 CFR 1320.3(c)(4). We believe the total estimated annual burden for this rule is 84,492 hours.
We have submitted a copy of this final rule to the OMB for its review of the information collection requirements described above. These requirements are not effective until they have been approved by the OMB.
If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attn: Melissa Musotto, [CMS-2238-FC] Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office
We do not accept that the cost would be this high. We note, as did some commenters, that the Food and Drug Administration is planning on requiring drug manufacturers to place Uniform
Because of the large number of public comments we normally receive on
We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132, and the Congressional Review Act (CRA, 5 U.S.C. 804(2)).
Executive Order 12866 (as amended by Executive Order 13258, which reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). An RIA must be prepared for major rules with “economically significant” effects ($100 million or more in any 1 year). We believe this rule will have an economically significant effect. We believe the rule will save $8.4 billion over the next 5 years ($4.93 billion Federal savings and $3.52 billion State savings as shown in the table below). This figure represents a 5.6 percent reduction in total Medicaid drug expenditures in Federal fiscal years 2007-2011. We consider this final rule with comment to be a major rule for purposes of the CRA.
All savings estimates were developed by the Office of the Actuary (OACT) in CMS. We note that the CBO, in its estimates of the budgetary effects of these provisions of the DRA, reached an almost identical estimate for these years, about $4.8 billion in Federal outlay reduction compared to the CMS estimate of $4.9 billion.
Savings estimates for section 6001 of the DRA—FULs and other provisions—were derived from simulations of the new FULs performed using price and utilization data from the Medicaid Drug Rebate Program combined with generic group codes from First DataBank. Percent savings from these simulations developed by CMS' OACT were applied to project Medicaid prescription drug spending developed for the President's fiscal year 2007 budget. Savings were phased in over 3 years to allow for implementation lags. On the previous chart, the estimate for FFY 2007 through FFY 2010 includes $5 million for the RPS.
The savings estimates for section 6002 of the DRA—rebates on physician-administered drugs—are based on the 2004 OIG report, “Medicaid Rebates for Physician-Administered Drugs.” A key finding of the report is the amount of additional rebates that could have been collected in 2001 if all States had collected rebates on physician-administered drugs. This amount was then projected forward using historical data (2001-2005) and projections consistent with the 2007 President's Budget forecast for Medicaid spending to develop the total estimated impact.
The savings estimates for section 6003 of the DRA—Reporting of authorized generics for Medicaid rebates—were developed by CMS' OACT and are based on the consensus of Medicaid experts and the review of available and relevant data. After estimating the impact of the proposal in the first year of implementation, the total impact was projected using assumptions consistent with the 2007 President's Budget forecast for Medicaid spending as well as adjustments given that the proposal is limited to a subset of the prescription drug market.
None of the estimates include Federal or State administrative costs. We believe these costs will be small as they involve changes in work processes rather than new activities. The resulting program savings will be many times these costs.
The RFA requires agencies to prepare a regulatory flexibility analysis and to analyze options for regulatory relief of small businesses and other small entities if a proposed or final rule would have a “significant impact on a substantial number of small entities.” For purposes of the RFA, small entities include small businesses, non-profit organizations, and small governmental jurisdictions. Individuals and States are not included in the definition of a small entity. For purposes of the RFA, three types of small business entities are potentially affected by this regulation. They are small pharmaceutical manufacturers participating in the Medicaid Drug Rebate Program, small retail pharmacies, and physicians and other practitioners (including small hospitals or other entities such as non-profit providers) that bill Medicaid for physician-administered drugs. We will discuss each type of business in turn.
According to the SBA'S size standards, drug manufacturers are small businesses if they have fewer than 500 employees (
In addition, the rule will affect the level of rebates due from manufacturers. The DRA provides that customary prompt pay discounts be excluded from AMP. This will result in higher AMPs and, consequently, higher rebate payments. We have been told informally by manufacturers that customary prompt pay discounts are generally about two percent. We have found no independent source to confirm this percentage. We also do not know what percent of sales qualify for customary prompt pay discounts. Based on this limited information, we believe that the removal of customary prompt pay discounts will cost manufacturers up to $160 million (two percent of $8 billion in rebate payments annually). In this rule, we also will remove sales to PBMs and nursing home pharmacies from AMP as well as provide manufacturers the option to exclude hospital outpatient sales if information is insufficient to accurately identify sales of drugs to hospitals used in the outpatient department. We have been told by industry representatives that nursing home pharmacies and hospitals receive larger discounts than other sectors, thus potentially resulting in an increase in AMP from these changes. Likewise, some commenters believe that the exclusion of PBM sales will increase AMP. However, because we have no independent data on the cost of drugs to these entities, we cannot quantify the
According to the SBA's size standards, a retail pharmacy is a small business if it has revenues of $6.5 million or less in 1 year (
According to the SBA's size standards, physician practices are small businesses if they have revenues of $9 million or less in 1 year (
According to the SBA's size standards, hospitals are small businesses if they have yearly revenue of $31.5 million or less (
Section 1102(b) of the Act requires us to prepare an RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Core-Based Statistical Area and has fewer than 100 beds. There are approximately 700 small rural hospitals that meet this definition. We do not know how many of these hospitals have outpatient departments. However, we believe that this rule will impact small rural hospitals to the extent that billing systems will need to be changed to capture NDCs on claims for drugs administered by physicians in the outpatient department. We acknowledge the AHA estimate of $200,000 per hospital for these changes ($230,000 in 2007 adjusted by the CPI), but we have no documentation to analyze or verify this estimate. We also believe that hospitals can minimize the cost to the extent that they use bar codes on the drugs they dispense, as this will identify the NDC of the drug needed to bill Medicaid.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates on States and private entities require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $125 million. This rule will mandate that drug manufacturers provide information on drug prices, and that these data be used in calculating FULs. However, our estimate of costs to manufacturers (see next section: Effects on Drug Manufacturers) falls far below the threshold and we anticipate this rule will save States $3.5 billion over the five-year period from October 1, 2006 through September 30, 2011.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this rule will impose only minimal new administrative burden on States and yield substantial savings to States, we believe that these costs can be
As previously indicated, approximately 550 drug manufacturers participate in the Medicaid Drug Rebate Program. The rule will require all drug manufacturers participating in the Medicaid Drug Rebate Program to submit pricing information (AMP) on each of their drug products on a monthly basis. Currently drug manufacturers are required to submit similar information quarterly. In addition, drug manufacturers will be required to submit two additional pricing data elements—customary prompt pay discounts and nominal prices—on each of their drugs on a quarterly basis. We believe that drug manufacturers currently have these data; therefore, the new requirement will not require new data collection. Rather it simply requires that existing information be reported to CMS. For this reason, we believe the burden to be minimal. The estimated startup burden to the manufacturers is $27.5 million for a one-time systems upgrade, or $50,000 for each of the 550 manufacturers that participate in the Medicaid Drug Rebate Program. To estimate the ongoing burden, we expect that the manufacturers will each spend 208 hours annually (114,400 total hours annually) in complying with these requirements. The estimated annual operational expenses are $5.7 million, which is 114,400 total annual hours multiplied by $37.50 per labor hour in wages and benefits, or $4.3 million in labor burden, plus $1.4 million in technical support.
In addition, the proposed regulation would affect the level of rebates due from manufacturers. The DRA provides that customary prompt pay discounts be excluded from AMP. This will result in higher AMPs and, consequently, higher rebate payments. We have been told informally by manufacturers that customary prompt pay discounts are generally about two percent. We have found no independent source to confirm this percentage. We also do not know what percent of sales qualify for customary prompt pay discounts. Based on this limited information, we believe that the removal of customary prompt pay discounts will cost manufacturers up to $160 million (two percent of $8 billion in rebate payments annually). In this rule, we also will remove sales to PBMs and nursing home pharmacies from AMP and allow drug manufactures to exclude sales to outpatient departments of hospitals when data is not available to separate out drugs administered in the outpatient department from the hospital as a whole. We have been told by industry representatives that PBMs, nursing homes and hospital pharmacies receive larger discounts than other sectors. If this information is accurate, removing these prices will increase AMP. However, because we have no independent data on the cost of drugs to these entities, we cannot quantify the effect of this provision other than to say that we believe it will increase rebates owed by drug manufacturers.
States share in the savings from this rule. As noted in the table above, we estimate 5-year State savings of over $3.5 billion. State administrative costs associated with this regulation are minor as States currently pay at or below the FUL for drugs subject to that limit, determine their drug reimbursement rates, and collect claims information on physician-administered drugs.
Retail pharmacies would be affected by this regulation, as the law will result in lower FULs for most drugs subject to the limits, thus reducing Medicaid payments to pharmacies for drugs. The revision to the FULs would generally reduce those limits and, thereby, reduce Medicaid payment for drugs subject to the limits. The savings for section 6001 of the DRA reflect this statutory change. The other provisions concerning payment for drugs would provide States two new data points to use to set payment rates. Beginning in 2007, States may use AMP and retail survey prices in their payment methodologies. The savings for section 6001 of the DRA do not reflect decreases to State payments for drugs not on the FUL list that may result if States change their payment methodologies.
The savings to the Medicaid Program will largely be realized through lower payments to pharmacies. As shown earlier in this analysis, the annual effect of lower FULs and related changes will likely reduce pharmacy revenues by about $800 million in 2007, increasing to a $2 billion reduction annually by 2011. These reductions, while large in absolute terms, represent only a small fraction of overall pharmacy revenues. According to recent data summarized by the National Association of Chain Drug Stores, total retail prescription sales in the United States, including chain drug stores, independent drug stores, and supermarkets totaled about $200 billion in 2006 (
Although it is clear that the effects will be small on the great majority of pharmacies, whether chain or independent, we are unable to estimate quantitatively effects on “small” pharmacies, particularly those in low-income areas where there are high concentrations of Medicaid beneficiaries. We received general comments that these pharmacies will be greatly impacted by the provisions of this rule; however, we did not receive documented estimates of these effects. Because of the lack of evidence as to the true effect, we have retained our prior conclusion that this proposed rule is likely to have a “significant impact” on some pharmacies.
This regulation will affect physician practices that provide and bill Medicaid for physician-administered drugs. This includes about 20,000 physicians as well as hospitals with outpatient departments. The effect on physicians is the same as discussed in section A—Overall Impact above for small businesses because all or nearly all physician offices are small businesses.
This regulation will affect hospitals with outpatient departments that provide and bill Medicaid for physician-administered covered outpatient drugs. As discussed above, hospitals with outpatient departments would need to include the NDC on claims for such
As previously discussed, for purposes of the RFA, three types of small business entities are potentially affected by this regulation. This regulation would affect small pharmaceutical manufacturers participating in the Medicaid Drug Rebate Program, small retail pharmacies, and physicians and other practitioners (including small hospitals or other entities such as non-profit providers).
According to the SBA's size standards, we believe that most of the 550 pharmaceutical manufacturers in the Medicaid Drug Rebate Program are small businesses. We previously indicated that this rule impacts drug manufacturers by requiring them to submit pricing information (AMP) on each of their drug products on a monthly basis with an estimated impact that is minimal. The rule could also increase the amount of drug rebates that manufacturers will pay as a result of removing customary prompt pay discounts and nursing home sales from AMP, which is used in the rebate calculation. To the extent that PBMs are also excluded from best price, the amount of rebates could decrease. The exclusion of customary prompt pay discounts will cost manufacturers up to $160 million (two percent of $8 billion in rebate payments annually). Additional detail regarding the effects of this proposed rule for the determination of drug prices and calculation of drug rebate liability for drug manufacturers is described in the preamble under “Definition of Retail Pharmacy Class of Trade and Determination of AMP.”
We estimate that 18,000 small retail pharmacies will be affected by this regulation. However, we are unable to specifically estimate quantitative effects on small retail pharmacies, particularly those in low-income areas where there are high concentrations of Medicaid beneficiaries. The preamble under “Definition of Retail Pharmacy Class of Trade and Determination of AMP” provides additional information regarding the entities included in the retail pharmacy class of trade and the discounts or other price concessions for drugs provided to the retail pharmacy class of trade. As shown earlier, the annual effect of lower FULs and related changes will likely reduce overall pharmacy revenues by about $800 million in 2007, increasing to a $2 billion reduction annually by 2011.
Nearly all of the approximately 20,000 physician practices that specialize in oncology, rheumatology and urology are considered small businesses. The rule could impose some administrative burden on these practices due to new requirements that claims include the NDC for physician-administered drugs. As shown earlier, we believe that the annual cost per claim would be under 9 cents and the annual cost per physician practice would be under $20. Accordingly, we believe that there is no significant impact on these physician practices.
We also previously indicated that this rule may have a significant impact on the operations of small rural hospitals. There are approximately 700 small rural hospitals that meet the small business standard. As previously discussed, small rural hospitals would need to include the NDC on claims for physician-administered covered outpatient drugs through outpatient departments. We do not have data to quantify how many of the overall claims for physician-administered drugs are submitted by these 700 small rural hospitals. In any case, the cost to manually include the NDC on the claim will be under nine cents per claim.
The following chart depicts the number of small entities and the estimated economic impact for each category of small entity affected by this rule.
We considered a number of different policies and approaches during the development of the final rule.
With regard to the definition of AMP, we considered one definition for quarterly AMP and a different definition for monthly AMP. However, we believe the better reading of statute is for AMP to be defined the same way for quarterly and monthly reporting.
We also considered redefining the entities included in “retail pharmacy class of trade” for purposes of the
We considered retaining the current base date AMP rather than allowing manufacturers to recalculate their base date AMP to reflect the revised definition of AMP. However, we decided that retaining the current base date AMP is not required and it would create a financial burden on manufacturers that was not intended by section 6001 of the DRA.
We considered whether and how to provide for manufacturers to “smooth” the AMP data to account for lagged discounts and other changes to monthly sales. We proposed to allow manufacturers to rely on estimates regarding the impact of their lagged price concessions when calculating monthly AMP. We also requested comments on the possible use of a 12-month rolling average. Many commenters asked for a 12-month rolling average as is used for Medicare Part B. Other commenters suggested that we allow manufacturers to use a four quarter rolling average. We have incorporated the 12-month rolling average in the final rule.
We considered adding other entities to those that may receive drugs at nominal prices and have those sales excluded from best price. However, we were concerned that expanding the list of entities eligible for nominal pricing would drive up best price, which would effectively lower the amount of rebates manufacturers pay for Medicaid drugs.
We considered using a non-weighted AMP, which is specific to a package size, to establish the FUL. However, we decided to continue to base AMP on all package sizes for each drug. We did not find any indication that the Congress intended to change how package size is used for AMP. Such a change would be burdensome on manufacturers and would not have a significant impact on how States pay for drugs.
We considered various methods for determining outlier prices in order to avoid the use of such prices in the FUL calculation and to ensure sufficient national supply. We proposed to set the FUL on the lowest AMP that is not less than 30 percent of the next highest AMP for the drug. Based on comments, we considered substituting a greater percentage difference, expanding outliers to include drugs with AMPs above the lowest but below the next highest AMP by a set percentage, and using market share in determining outliers. We decided to change the outlier policy to set the FUL on the AMP that is not lower than 40 percent of the next highest AMP.
The RFA lists five general requirements for a FRFA and four categories of burden-reducing alternatives. We know of no relevant Federal rules that duplicate, overlap, or conflict with the final rule. The preceding analysis, together with the rest of this preamble, addresses all these general requirements.
We have not, however, adopted any of the various categories of burden reduction listed in the RFA as appropriate for IRFAs. These alternatives, such as an exemption from coverage for small entities, establishment of less onerous requirements for small entities, or use of performance rather than design standards, simply do not appear to apply in a situation where uniform payment standards are being established. However, we welcome comments with suggestions for improvements we can make, consistent with the statute, to minimize any unnecessary burdens on pharmacies or other affected entities.
As required by OMB's Circular A-4 (available at
We estimate savings from this regulation of $8.4 billion over 5 years, $4.9 billion to the Federal Government and $3.5 billion to the States. Most of these savings result from a change in how the FULs on multiple source drugs are calculated and from a change in how authorized generic drugs are treated for AMP and best price. The majority of the savings would come from lower reimbursement to retail pharmacies. The provision on physician-administered drugs does not change the legal liability of drug manufacturers for paying rebates but would make it easier for States to collect these rebates.
While the effects of this regulation are substantial, they are a result of changes to the law.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the OMB.
We have retained most of the original estimates of burden; however, we have updated our impact analysis from what was presented in our December 22, 2006 proposed rule. Our update reflects responses to public comments and improvements to the analysis based on additional information.
See discussion under “V. Collection of Information Requirements for Effects on Physicians.”
See discussion under “V. Collection of Information Requirements for Effects on Hospitals”.
Accounting, Administrative practice and procedure, Drugs, Grant programs—health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
In this subpart, § 447.302 through § 447.325 and § 447.361 implement section 1902(a)(30) of the Act, which requires that payments be consistent with efficiency, economy and quality of care. Section 447.371 implements section 1902(a)(15) of the Act, which requires that the State plan provide for payment for rural health clinic services in accordance with regulations prescribed by the Secretary.
(a)
(1) Interprets those provisions of section 1927 of the Act that set forth
(2) Implements section 1903(i)(10) of the Act with regard to the denial of Federal financial participation (FFP) in expenditures for certain physician-administered drugs.
(3) Implements section 1902(a)(54) of the Act with regard to a State plan that provides covered outpatient drugs.
(b)
(1) Is incurred at the point of sale or service and pays for costs in excess of the ingredient cost of a covered outpatient drug each time a covered outpatient drug is dispensed;
(2) Includes only pharmacy costs associated with ensuring that possession of the appropriate covered outpatient drug is transferred to a Medicaid recipient. Pharmacy costs include, but are not limited to, reasonable costs associated with a pharmacist's time in checking the computer for information about an individual's coverage, performing drug utilization review and preferred drug list review activities, measurement or mixing of the covered outpatient drug, filling the container, beneficiary counseling, physically providing the completed prescription to the Medicaid beneficiary, delivery, special packaging, and overhead associated with maintaining the facility and equipment necessary to operate the pharmacy; and
(3) Does not include administrative costs incurred by the State in the operation of the covered outpatient drug benefit including systems costs for interfacing with pharmacies.
(1) Is engaged in the production, preparation, propagation, compounding, conversion, or processing of covered outpatient drug products, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or
(2) Is engaged in the packaging, repackaging, labeling, relabeling, or distribution of covered outpatient drug products and is not a wholesale distributor of drugs or a retail pharmacy licensed under State law.
(3) With respect to authorized generic products, the term “manufacturer” will also include the original holder of the NDA.
(4) With respect to drugs subject to private labeling arrangements, the term “manufacturer” will also include the entity that does not possess legal title to the NDC.
(1) Is rated as therapeutically equivalent. For the list of drug products rated as therapeutically equivalent, see the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations” which is available at
(2) Is pharmaceutically equivalent and bioequivalent, as determined by the FDA; and
(3) Is sold or marketed in the United States during the rebate period.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(1) Sales to wholesalers, except for those sales that can be identified with adequate documentation as being subsequently sold to any of the excluded entities as specified in paragraph (h) of this section;
(2) Sales to other manufacturers who act as wholesalers and do not repackage/relabel under the purchaser's NDC, including private labeling agreements;
(3) Direct and indirect sales to hospitals, where the drug is used in the outpatient pharmacy, except those sales that cannot be identified with adequate documentation as being used in the outpatient pharmacy for outpatient use (for example hospital outpatient department, clinic, or affiliated entity);
(4) Sales at nominal prices to any entity except a covered entity described in section 340B(a)(4) of the Public Health Service Act (PHSA), an intermediate care facility for the mentally retarded (ICF/MR) providing services as set forth in § 440.150 of this chapter, or a State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter;
(5) Sales to retail pharmacies including discounts or other price concessions that adjust prices either directly or indirectly on sales of drugs to the retail pharmacy class of trade;
(6) Sales including discounts, rebates, or other price concessions provided to pharmacy benefit managers (PBMs) for their mail order pharmacy purchases;
(7) Sales directly to patients;
(8) Sales to outpatient facilities (for example, clinics, surgical centers, ambulatory care centers, dialysis centers, and mental health centers);
(9) Sales to mail order pharmacies;
(10) Sales to home infusion providers;
(11) Sales to specialty pharmacies;
(12) Sales to home health care providers;
(13) Sales to physicians;
(14) Rebates, discounts, or other price concessions (other than rebates under section 1927 of the Act or as otherwise specified in the statute or regulations) associated with sales of drugs provided to the retail pharmacy class of trade; and
(15) Sales of drugs reimbursed by third party payers including the Medicare Part D Program, a Medicare Advantage prescription drug plan (MA-PD), a Qualified Retiree Prescription Drug Plan under section 1860D-22(a)(2) of the Act, State Children's Health Insurance Program (SCHIP), State pharmaceutical assistance programs (SPAPs), health maintenance organizations (HMOs) (including managed care organizations (MCOs)) that do not purchase or take possession of drugs, TRICARE Retail Pharmacy Program (TRRx), and Medicaid Programs that are associated with sales of drugs provided to the retail pharmacy class of trade (except for rebates under section 1927 of the Act or as otherwise specified in the statute or regulations).
(h)
(1) Any prices on or after October 1, 1992, to the Indian Health Service (IHS), the Department of Veterans Affairs (DVA), a State home receiving funds under 38 U.S.C. 1741, the Department of Defense (DoD), the Public Health Service (PHS), or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA);
(2) Any prices charged under the Federal Supply Schedule (FSS) of the General Services Administration (GSA);
(3) Any depot prices (including TRICARE) and single award contract prices, as defined by the Secretary, of any agency of the Federal Government;
(4) Direct and indirect sales to hospitals, where the drug is used in the inpatient setting or in the outpatient pharmacy for outpatient use where the sales cannot be identified with adequate documentation;
(5) Sales to HMOs (including MCOs, and HMO/MCO-operated pharmacies) that purchase or take possession of drugs;
(6) Sales to long-term care facilities, including nursing facility pharmacies, contract pharmacies for the nursing facility where these sales can be identified with adequate documentation, and other entities where the drugs are dispensed through a nursing facility pharmacy, such as assisted living facilities;
(7) Sales to hospices (inpatient and outpatient);
(8) Sales to veterinarians;
(9) Sales to prisons;
(10) Sales outside the 50 States and the District of Columbia;
(11) Sales to State, county, and municipal entities;
(12) Sales to patient assistance programs;
(13) Sales to wholesalers where the drug is distributed to the non-retail pharmacy class of trade;
(14) Sales to wholesalers or distributors where the drug is relabeled under the wholesalers' or distributors' NDC number;
(15) Manufacturer coupons redeemed by a consumer, agent, pharmacy or another entity acting on behalf of the manufacturer, but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other entity does not receive any price concession;
(16) Manufacturer vouchers;
(17) Manufacturer-sponsored drug discount card programs;
(18) Free goods, not contingent upon any purchase requirement;
(19) Bona fide service fees;
(20) Customary prompt pay discounts extended to wholesalers;
(21) Returned or replaced goods when accepted or replaced in good faith;
(22) Discounts, rebates, or other price concessions to PBMs, except for their mail order pharmacy's purchases.
(23) Associated rebates, discounts, or other price concessions to third party payers including the Medicare Part D Program, an MA-PD, Qualified Retiree Prescription Drug Plan under section 1860D-22(a)(2) of the Act, SCHIP, SPAPs, HMOs (including MCOs that do not take possession of drugs) the TRICARE Retail Pharmacy Program, and Medicaid Programs; and
(24) Rebates under the national rebate agreement or a CMS-authorized State supplemental rebate agreement paid to State Medicaid Agencies under section 1927 of the Act.
(i)
(2) Quarterly AMP is calculated as a weighted average of monthly AMPs in the quarter.
(3) The manufacturer must adjust the AMP for a rebate period if cumulative discounts, rebates, or other arrangements subsequently adjust the prices actually realized.
(a)
(b) For purposes of this section,
(c)
(1) Prices to wholesalers;
(2) Prices to any retailer, including rebates, discounts or other price concessions that adjust prices either directly or indirectly on sales of drugs;
(3) Prices to providers (for example, hospitals, HMOs/MCOs, physicians, nursing facilities, and home health agencies);
(4) Prices available to non-profit entities;
(5) Prices available to governmental entities within the United States;
(6) Prices of authorized generic drugs, sold by the primary manufacturer in accordance with § 447.506(d) of this subpart;
(7) Prices of sales directly to patients;
(8) Prices available to mail order pharmacies;
(9) Prices available to outpatient clinics;
(10) Prices to other manufacturers who act as wholesalers and do not repackage/relabel under the purchaser's NDC, including private labeling agreements; and
(11) Prices to entities that repackage/relabel under the purchaser's NDC, including private labeling agreements, if that entity also is an HMO or other non-excluded entity.
(d)
(1) Any prices on or after October 1, 1992, charged to the IHS, the DVA, a State home receiving funds under 38 U.S.C. 1741, the DoD, the PHS, or a covered entity described in section 1927(a)(5)(B) of the Act (including inpatient prices charged to hospitals described in section 340B(a)(4)(L) of the PHSA);
(2) Any prices charged under the FSS of the GSA;
(3) Any prices provided to a designated SPAP;
(4) Any depot prices and single award contract prices, as defined by the Secretary, of any agency of the Federal Government;
(5) Any prices charged which are negotiated by a prescription drug plan under Part D of title XVIII, by any MA-PD plan under Part C of such title with respect to covered Part D drugs, or by a Qualified Retiree Prescription Drug Plan (as defined in section 1860D-22(a)(2) of the Act) with respect to such drugs on behalf of individuals entitled to benefits under Part A or enrolled under Part B of Medicare;
(6) Rebates under the national rebate agreement or a CMS-authorized supplemental rebate agreement paid to State Medicaid Agencies under section 1927 of the Act;
(7) Prices negotiated under a manufacturer-sponsored drug discount card program;
(8) Manufacturer coupons redeemed by a consumer, agent, pharmacy or another entity acting on behalf of the manufacturer; but only to the extent that the full value of the coupon is passed on to the consumer and the pharmacy, agent, or other entity does not receive any price concession;
(9) Goods provided free of charge under a manufacturer's patient assistance programs;
(10) Free goods, not contingent upon any purchase requirement;
(11) Nominal prices to certain entities as set forth in § 447.508 of this subpart;
(12) Bona fide service fees; and
(13) PBM rebates, discounts, or other price concessions except their mail order pharmacy's purchases or where such rebates, discounts, or other price concessions are designed to adjust prices at the retail or provider level.
(e)
(2) Best price must be determined on a unit basis without regard to package size, special packaging, labeling or identifiers on the dosage form or product or package, and must not take into account prices that are nominal in amount as described in § 447.508 of this subpart.
(3) The manufacturer must adjust the best price for a rebate period if cumulative discounts, rebates, or other arrangements subsequently adjust the prices available from the manufacturer.
(a)
(b)
(c)
(a)
(1) A covered entity described in section 340B(a)(4) of the PHSA;
(2) An ICF/MR providing services as set forth in § 440.150 of this chapter; or
(3) A State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter.
(b)
(a)
(1) AMP, calculated in accordance with § 447.504 of this subpart;
(2) Best price, calculated in accordance with § 447.505 of this subpart;
(3) Customary prompt pay discounts, which shall be reported as an aggregate dollar amount for each covered outpatient drug at the nine-digit NDC level, provided to all wholesalers in the rebate period; and
(4) Prices that fall within the nominal price exclusion, which shall be reported as an aggregate dollar amount and shall include all sales of single source and innovator multiple source drugs to the entities listed in § 447.508(a) of this subpart for the rebate period.
(b)
(2) A manufacturer must report revisions to AMP, except when the revision would be solely as a result of data pertaining to lagged price concessions.
(c)
(2)
(ii) A manufacturer may choose to recalculate base date AMP on a product-by-product basis.
(iii) A manufacturer must use actual and verifiable pricing records in recalculating base date AMP.
(d)
(2)
(3)
(4)
(5)
(e)
(1) The manufacturer's chief executive officer (CEO);
(2) The manufacturer's chief financial officer (CFO);
(3) An individual other than a CEO or CFO, who has authority equivalent to a CEO or a CFO; or
(4) An individual with the directly delegated authority to perform the certification on behalf of an individual described in subsections (1) through (3).
(f)
(2) A manufacturer must retain records beyond the ten-year period if both of the following circumstances exist:
(i) The records are the subject of an audit or of a government investigation related to pricing data that are used in AMP, best price, customary prompt pay discounts, or nominal prices of which the manufacturer is aware.
(ii) The audit findings or investigation related to the AMP, best price, customary prompt pay discounts, or nominal price have not been resolved.
(g)
(a)
(b)
(1) EAC plus reasonable dispensing fees established by the agency; or
(2) Providers' usual and customary charges to the general public.
(c)
(2) The agency must decide what certification form and procedure are used.
(3) A checkoff box on a form is not acceptable but a notation like “brand necessary” is allowable.
(4) The agency may allow providers to keep the certification forms if the forms will be available for inspection by the agency or HHS.
(a)
(i) The FDA has rated two or more drug products as therapeutically and pharmaceutically equivalent in its most current edition of “Approved Drug Products with Therapeutic Equivalence Evaluations” (including supplements or in successor publications), regardless of whether all such formulations are rated as such and only such formulations shall be used when determining any such upper limit.
(ii) At least two suppliers meet the criteria in paragraph (a)(1)(i) of this section.
(2) CMS publishes the list of multiple source drugs for which upper limits have been established and any revisions to the list in Medicaid Program issuances.
(b)
(c)
(1) The AMP of a terminated NDC will not be used to set the Federal upper limit (FUL) beginning with the first day of the month after the actual termination date reported by the manufacturer to CMS.
(2) Except as set forth in paragraph (c)(3) of this section, the AMP of the lowest priced therapeutically and pharmaceutically equivalent drug that is not less than 40 percent of the next highest AMP will be used to establish the FUL.
(3) When the FUL group includes only the brand name drug and the first new generic or authorized generic drug which has entered the market, the criteria in paragraph (c)(2) of this section will not apply.
The upper limits for payment for prescribed drugs in this subpart also apply to payment for drugs provided as part of skilled nursing facility services and intermediate care facility services and under prepaid capitation arrangements.
(a)
(b)
(1)
(i) In the aggregate, its Medicaid expenditures for multiple source drugs, identified and listed in accordance with § 447.514(a) of this subpart, are in accordance with the upper limits specified in § 447.514(b) of this subpart; and
(ii) In the aggregate, its Medicaid expenditures for all other drugs are in accordance with § 447.512 of this subpart.
(2)
(c)
(a) No FFP is available for physician-administered drugs for which a State has not required the submission of claims using codes that identify the drugs sufficiently for the State to bill a manufacturer for rebates.
(1) As of January 1, 2006, a State must require providers to submit claims for single source, physician-administered drugs using Healthcare Common Procedure Coding System codes or NDC numbers in order to secure rebates.
(2) As of January 1, 2008, a State must require providers to submit claims for the 20 multiple source physician-administered drugs identified by the
(b) As of January 1, 2007, a State must require providers to submit claims for physician-administered single source drugs and the 20 multiple source drugs identified by the Secretary using NDC numbers.
(c) A State that requires additional time to comply with the requirements of this section may apply to the Secretary for an extension.
Fish and Wildlife Service, Interior.
Final rule.
We, the U.S. Fish and Wildlife Service (Service), are designating critical habitat for the Peck's cave amphipod (
This rule becomes effective on August 16, 2007.
Adam Zerrenner, Field Supervisor, Austin Ecological Services Office, 10711 Burnet Road, Suite 200, Austin, TX 78758 (telephone 512-490-0057; facsimile 512-490-0974).
It is our intent to discuss only those topics directly relevant to the designation of critical habitat in this rule. For more information on these species, refer to the final rule listing the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle that was published in the
All three of the listed species included in this final rule for critical habitat designation are freshwater invertebrates. The Peck's cave amphipod is an eyeless, subterranean (below ground) arthropod that has been found in Comal Springs and Hueco Springs (also spelled Waco Springs). Both spring systems are located in Comal County, Texas. The Comal Springs dryopid beetle is a subterranean insect with vestigial (poorly developed, non-functional) eyes. The species has been found in two spring systems, Comal Springs and Fern Bank Springs, that are located in Comal and Hays Counties, respectively. The Comal Springs riffle beetle is an aquatic insect that is found in and primarily restricted to surface water associated with Comal Springs in Comal County and with San Marcos Springs in Hays County.
The four spring systems (Comal, Fern Bank, Hueco, and San Marcos) designated as critical habitat units are produced by discharge of aquifer spring water along the Balcones fault zone at the edge of the Edwards Plateau in central Texas. The source of water flows for Comal Springs and San Marcos Springs is the San Antonio segment of the Edwards Aquifer. This aquifer is characterized by highly varied, below ground spaces that have been hollowed out within limestone bedrock through dissolution by rainwater. Groundwater is held and conveyed within these hollowed-out spaces, which range in size from honeycomb-like pores to large caverns. The San Antonio segment of the aquifer occurs in a crescent-shaped section over a distance of 176 miles (mi) (283 kilometers (km)), from the town of Brackettville in Kinney County on the segment's west side over to the town of Kyle in Hays County at the segment's northeast side. Groundwater generally moves from recharge areas in the southwest part of the San Antonio segment and travels toward discharge areas in the northeast part of the segment, which includes Comal Springs and San Marcos Springs. The area that recharges groundwater coming to Comal Springs may occur as much as 62 mi (100 km) away from the springs (Brune 1981, p. 130). Hueco Springs is recharged locally from the local watershed basin and possibly by the San Antonio segment of the Edwards Aquifer (Guyton and Associates 1979, p. 2). The source of water for Fern Bank Springs has not been determined. Fern Bank Springs discharges water from the upper member of the Glen Rose Formation, and its flow could originate primarily from that unit; however, water discharged from the springs could also be (1) Drainage from the nearby Edwards Aquifer recharge zone, (2) water lost from the Blanco River, or (3) a combination of all three sources (Veni 2006, p.1).
Comal Springs and San Marcos Springs are the two largest spring systems in Texas with respective mean annual flows of 284 and 170 cubic feet per second (8 and 5 cubic meters per second) (Fahlquist and Slattery 1997, p. 1; Slattery and Fahlquist 1997, p. 1). Both spring systems emerge as a series of spring outlets along the Balcones fault that follows the edge of the Edwards Plateau in Texas. Fern Bank Springs and Hueco Springs have considerably smaller flows and consist of one main spring with several satellite springs or seep areas.
The four spring systems designated for critical habitat are characterized by high water quality and relatively constant water flows, with temperatures that range from 68 to 75 °F (Fahrenheit) (20 to 24 °C (Celsius)). Due to the underlying limestone aquifer, discharged water from these springs has a carbonate chemistry (Ogden
Each of the four spring systems and related subterranean aquifers typically provide adequate resources to sustain life cycle functions for resident populations of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. However, a primary threat to the three invertebrate species is the potential failure of spring flow due to drought or excessive groundwater pumping, which could result in loss of aquatic habitat for the species. Although these invertebrate species persisted at Comal Springs in the 1950s despite drought conditions (Bowles
Bowles
Barr (1993, p. 55) found Comal Springs dryopid beetles in spring flows with low volume discharge as well as high volume discharge and suggested that presence of the species did not necessarily depend on a high spring flow. However, Barr (1993, p. 61) noted that effects on both subterranean species (dryopid beetle and amphipod) from extended loss of spring flow and low aquifer levels could not be predicted due to limited knowledge about their life cycles.
Information about previous Federal actions for Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle can be found in our proposal to designate critical habitat for these species published in the
We requested written comments from the public on the proposed designation of critical habitat for Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle in the proposed rule published on July 17, 2006 (71 FR 40588) and in our March 16, 2007,
During the comment period that opened on July 17, 2006, and closed on September 15, 2006, we received eight responses directly addressing the proposed critical habitat designation: four from peer reviewers, one from a State agency, and three from organizations or individuals. The response we received from the State agency, the Texas Department of Transportation, indicated that the proposed critical habitat designations for these species were “prudently identified” by the Service. However, that agency did not offer any other comments. After completing the draft economic analysis, we reopened the comment period between March 16, 2007, and April 16, 2007 (72 FR 12585). During the second comment period, we received one comment from a peer reviewer and four from organizations; two of which included comments on the economic analysis. Responses to all comments were grouped by those from peer reviewers, followed by public comments. These comments are addressed in the following summary and incorporated into the final rule as appropriate. We did not receive any requests for a public hearing and thus no public hearing was held.
In accordance with our policy published on July 1, 1994 (59 FR 34270), we solicited expert opinions from nine knowledgeable individuals with scientific expertise that included familiarity with the species, the geographic region in which the species occur, and conservation biology principles. We received responses from four of the peer reviewers. Although none of the peer reviewers disagreed with our methods in designating critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle, three of the responses indicated that the critical habitat designation failed to address the broader issue of maintaining spring flows, ecosystem functioning, and groundwater levels within the Edwards Aquifer. Also, two of the peer reviewers disagreed with the reasoning we presented in our determination of Primary Constituent Element (PCE) 4. Three of the peer reviewers' responses provided additional information, clarifications, and suggestions to improve the final critical habitat rule. We address peer reviewer comments in the following summary and have incorporated them into the final rule as appropriate.
We reviewed all comments received from the peer reviewers and the public for substantive issues and new information regarding critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle, and address them in the following summary.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
The designation of critical habitat requires Federal agencies to consult with us when activities they fund, authorize, or carry out may affect the critical habitat of a listed species. Consultation is required where projects may (indirectly or directly) adversely affect critical habitat, even if those projects occur outside designated critical habitat (e.g., the contributing and recharge zones of the aquifer).
16.
17.
Where data are available, the economic analysis does discuss and attempt to measure the net economic impacts of this rulemaking. For example, Chapter 2 discusses the reduction in net economic benefit to municipal and industrial water users that may occur with pumping restrictions. The analysis also discusses the fact that higher springflow levels are anticipated to contribute to river flows downstream of the aquifer, which will make more water available to municipalities, industries, and farmers who use river water. Whether the users will use the water to an economic benefit depends on a myriad of factors that are beyond the scope of the economic analysis; however, the analysis notes that increased springflows are likely to generate potentially significant ecological and/or recreational benefits.
18.
19.
20.
Based upon our review of the peer review and public comments, economic analysis, and any new relevant information that may have become available since the publication of the proposal, we reevaluated our proposed critical habitat designation for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. We made no changes to the critical habitat designation as described in the proposed rule. Other than minor clarifications and incorporation of additional information on the species' biology, status, and threats, this final rule differs from the proposal by the following:
(1) We modified the primary constituent elements for clarity and to reflect additional information received during the public comment period. Specifically we added, “other compounds containing surfactants” and “pharmaceuticals and veterinary medicines,” under the list of potential pollutants under PCE 1. Under PCE 3, we added the phrase, “that allows for adequate spring flows” to clarify the intent of the hydrologic regime. For PCE 4, we added, “living plant material, algae, fungi, bacteria and other
(2) We made technical corrections to some of the information found in the Primary Constituent Elements, Background, and Criteria Used to Identify Critical Habitat sections of this rule.
Critical habitat is defined in section 3 of the Act as—(i) The specific areas within the geographical area occupied by a 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) that may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. Conservation, as defined under section 3 of the Act means to use and the use of all methods and procedures that are necessary to bring any endangered species or threatened species to the point at which the measures provided under the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.
Critical habitat receives protection under section 7 of the Act through the prohibition against destruction or adverse modification of critical habitat with regard to actions carried out, funded, or authorized by a Federal agency. Section 7 of the Act requires consultation on Federal actions that are likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow government or public access to private lands. Section 7 of the Act is a purely protective measure and does not require implementation of restoration, recovery, or enhancement measures.
To be included in a critical habitat designation, the habitat within the area occupied by the species must first have features that are essential to the conservation of the species. Critical habitat designations identify, to the extent known using the best scientific data available, habitat areas that provide essential life cycle needs of the species (
Occupied habitat may be included in critical habitat only if the essential features thereon may require special management or protection. Furthermore, when the best available scientific data do not demonstrate that the conservation needs of the species require additional areas, we cannot designate critical habitat in areas outside the geographical area occupied by the species at the time of listing. However, an area currently occupied by the species but not occupied at the time of listing, will likely be essential to the conservation of the species and, therefore, may be included in the critical habitat designation.
The Service's Policy on Information Standards Under the Endangered Species Act, published in the
Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific and commercial data available. Habitat is often dynamic, and species may move from one area to another over time. Furthermore, we recognize that designation of critical habitat may not include all of the habitat areas that may eventually be determined to be necessary for the recovery of the species. For these reasons, critical habitat designations do not signal that habitat outside the designation is unimportant or may not be required for recovery.
Areas that support populations, but are outside the critical habitat designation, will continue to be subject to conservation actions implemented under section 7(a)(1) of the Act and to the regulatory protections afforded by the section 7(a)(2) jeopardy standard, as determined on the basis of the best available information at the time of the action. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans, or other species conservation planning efforts if new information available to these planning efforts calls for a different outcome.
In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12, in determining which areas to designate as critical habitat, we consider those physical and biological features (known as primary constituent elements) that are essential to the conservation of the species, and within areas occupied by the species at the time of listing, that may require special management considerations or protection. These include, but are not limited to: (1) Space for individual and population growth, and for normal behavior; (2) food, water, air, light, minerals, or other nutritional or physiological requirements; (3) cover or shelter; (4) sites for breeding, reproduction, and rearing (or development) of offspring; and (5) habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of a species.
The specific primary constituent elements required for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle are derived from the biological needs of these species as described in the Background section of this final rule and in the December 18, 1997, final rule listing these species (62 FR 66295).
Pursuant to the Act and its implementing regulations, we are required to identify the known physical
Based on our current knowledge of the life history, biology, and ecology of these species, and the habitat requirements for sustaining the essential life history functions of these species, we have determined that the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle require the PCEs described below. The PCEs apply to all three species unless otherwise noted.
PCE 1. High-quality water with no or minimal levels of pollutants, such as soaps and detergents (Brown 1987, p. 261) and other compounds containing surfactants, heavy metals, pesticides, fertilizer nutrients, petroleum hydrocarbons, pharmaceuticals and veterinary medicines, and semi-volatile compounds, such as industrial cleaning agents, and including:
(a) Low salinity with total dissolved solids that generally range from about 307 to 368 milligrams per liter (mg/L); and
(b) Low turbidity that generally is less than 5 nephelometric (measurement of turbidity in a water sample by passing light through the sample and measuring the amount of the light that is deflected) turbidity units (NTUs).
These spring-adapted aquatic species live in high-quality unpolluted groundwater and spring outflows that have low levels of salinity and turbidity. High-quality discharge water from springs and adjacent subterranean areas also help sustain habitat components, such as riparian vegetation, that are essential to the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. The two beetle species are thought to require water with adequate levels of dissolved oxygen for respiration (Brown 1987, p. 260; Arsuffi 1993, p. 18). Amphipods generally require relatively high concentrations of oxygen and may serve as an indicator of good water quality (Arsuffi 1993, p. 15). While definitive studies on the limits of tolerance and preference for these aquatic invertebrates have not been completed, the aquatic invertebrates are exclusively found in aquatic habitats with constant temperature, low salinity, low turbidity, and extremely low levels of pollutants. In particular, respiration in the riffle beetle may be inhibited by pollutants such as soaps and detergents that can affect its respiratory mechanism (Brown 1987, p. 261). The dryopid beetle may also be affected by these particular pollutants, since this species shares a similar respiratory structure (Arsuffi 1993, p. 18). However, biological tolerances for this species are not understood due to its existence within a subterranean habitat.
Based on available literature, we believe that the PCE for high water quality in the critical habitat for these species should have an approximate range of salinity of about 307 to 368 mg/L and a turbidity of less than 5 NTUs. Fahlquist and Slattery (1997, p. 3) reported a low salinity (as measured by total dissolved solids) as low as 307 mg/L at Comal Springs, and Slattery and Fahlquist (1997, p. 4) found that San Marcos Springs had a low salinity of 328 mg/L. The two springs also have a low turbidity of less than 5 NTUs (Fahlquist and Slattery 1997, p. 3; Slattery and Fahlquist 1997, p. 4). Brune (1975, p. 94) reported a salinity for Hueco Springs of 322 mg/L. The highest salinity (as determined by analysis of total dissolved solids) that we have found associated with any of these invertebrates was 368 mg/L, which was reported from Fern Bank Springs on April 28, 2005 (Texas Water Development Board 2006, p. 1).
PCE 2. Aquifer water temperatures that range from approximately 68 to 75 °F (20 to 24 °C).
The three listed invertebrate species complete their life cycle functions within a relatively narrow temperature range; water temperatures outside of this range could be harmful to these invertebrates. The temperature of spring water emerging from the Edwards Aquifer at Comal Springs and San Marcos Springs ordinarily occurs within a narrow range of approximately 72 to 75 °F (22 to 24 °C) (Fahlquist and Slattery 1997, pp. 3-4; Groeger
PCE 3. A hydrologic regime that allows for adequate spring flows that provide levels of dissolved oxygen in the approximate range of 4.0 to 10.0 mg/L for respiration of the Comal Springs riffle beetle and Comal Springs dryopid beetle.
Respiration in most beetle species belonging to the family Elmidae (which includes the Comal Springs riffle beetle) typically requires flowing waters highly saturated with dissolved oxygen (Brown 1987, p. 260). As a consequence, riffle beetles are most commonly associated with flowing water that has shallow riffles (small waves) or rapids (Brown 1987, p. 253). Although there are not available data to support a correlation between minimum spring flows and survival or other sublethal, adverse effects of low or no spring flows on these species, there is information to indicate that availability and access to water at the spring sites are important factors in their respiration. For example, riffle beetles are known to be restricted to waters with high dissolved oxygen due to their reliance on a plastron (a thin sheet of air) that is held next to the underside of the body surface by a mass of minute, hydrophobic (tending to repel and not absorb water) hairs. The plastron functions as a gill by allowing oxygen to diffuse passively from water into the plastron and replace oxygen absorbed during respiration (Brown 1987, p. 260). Beetle species in the Elmidae family are generally limited to well-aerated water environments since gaseous exchange with a plastron can actually be reversed in oxygen-depleted waters (Brown 1987, p. 260; Ward 1992, p. 130). The Comal Springs dryopid beetle also relies on a plastron for respiration, and this beetle species may also be affected by changes in oxygen levels caused by habitat modification (Arsuffi 1993, pp. 17-18).
PCE 4. Food supply that includes detritus (decomposed materials), leaf litter, living plant material, algae, fungi, bacteria and other microorganisms, and decaying roots.
Feeding ecology in the Elmidae family varies among species, but most riffle beetles, as larvae and adults, feed on algae and detritus scraped from the substrates within their habitat (Brown 1987, p. 262). Specific food requirements for each of the three invertebrate species are unknown. However, the Peck's cave amphipod and dryopid beetle are most commonly found in areas where plant roots are inundated or otherwise influenced by aquifer water. Potential food sources for all three species in these areas include detritus (decomposed materials), leaf litter, and decaying roots; however, it is possible that these species feed on bacteria and fungi associated with decaying plant material. Both beetle species may be detritivores (detritus-feeding animals) that consume detrital materials in spring-influenced riparian zones (Brown 1987, p. 262; Randy
Trees and shrubs in riparian areas adjacent to the spring system may provide plant growth necessary to maintain food sources such as decaying material for these invertebrates. Roots from trees and shrubs in proximity to spring outlets are most likely to penetrate underground down to the water pools, where these roots can serve as habitat for the amphipod and dryopid beetle. We believe relatively intact riparian areas with trees and shrubs may provide an important function within areas designated for critical habitat of the two subterranean species. According to patterns of plant canopies as determined from aerial photographs, trees and shrubs (and their root systems) are generally within 50 ft (15.2 m) of the edge of water in these spring systems.
PCE 5. Bottom substrate in surface water habitat of the Comal Springs riffle beetle that is free of sand and silt, and is composed of gravel and cobble ranging in size between 0.3 to 5.0 inches (in) (8-128 millimeters (mm)).
Although Comal Springs riffle beetles occur in conjunction with a variety of bottom substrates in surface water habitat, Bowles
This designation is designed for the conservation of PCEs necessary to support the life history functions that were the basis for the proposal and the areas containing those PCEs. Because not all life history functions require all of the PCEs, not all of the designated critical habitat may contain all the PCEs.
Units are designated based on sufficient PCEs being present to support at least one of each of the species' life history functions. Some units contain all PCEs and support multiple life processes, while some units contain only a portion of the PCEs necessary to support the species' particular use of that habitat. Where a subset of the PCEs is present at the time of designation, this rule protects those PCEs and thus the conservation function of the habitat.
When designating critical habitat, we assess whether the areas determined to be occupied at the time of listing contain the features essential to the conservation that may require special management considerations or protections. Primary threats to the spring systems designated as critical habitat for the three invertebrate species that may require special management are summarized in Table 2. The threats for individual springs vary according to the degree of urbanization and availability of aquifer source water, but possible threats generally include prolonged cessation of spring flows (in 1956, Comal Springs at New Braunfels did not flow from mid-June to November (U.S. Army Corps of Engineers 1965)) as a result of the loss of hydrological connectivity within the aquifer (
As required by section 4(b)(1)(A) of the Act, we use the best scientific and commercial data available in determining areas that contain the features that are essential to the conservation of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle.
We reviewed available information that pertains to the presence and habitat requirements of these three invertebrate species, such as research published in peer-reviewed articles, data in reports submitted during section 7 consultations, contracted surveys, agency reports and databases, and aerial photographs. Information that has been reviewed includes, but is not limited to: Holsinger (1967), Bosse
We are designating critical habitat for the Peck's cave amphipod in aquatic habitat associated with both Comal Springs and Hueco Springs. To include amphipod food sources in root/water interfaces around spring outlets, we also are designating an area consisting of a 50-ft (15.2-m) distance from spring outlets of both Comal Springs and Hueco Springs (including several satellite springs that are located between the main outlet of Hueco Springs and the Guadalupe River). We believe that this 50-ft distance defines the lateral extent of critical habitat that contains PCEs necessary to provide for life functions of the Peck's cave amphipod with respect to roots that can penetrate into the aquifer. Based on the 50-ft distance, the areas designated for the amphipod critical habitat are about 38.1 ac (15.4 ha) at Comal Springs and 0.4 ac (0.2 ha) at Hueco Springs. The acreages were calculated with a computer-based Geographical Information System (GIS). Designated critical habitat does not
For critical habitat of the Comal Springs dryopid beetle, we are designating aquatic habitat and a 50-ft (15.2-m) distance from spring outlets of Comal Springs and Fern Bank Springs. The 50-ft (15.2-m) distance is based on evaluations of aerial photographs showing tree and shrub canopies occurring in proximity to spring outlets at both spring systems. These plant canopies reflect approximate distances where plant root systems interface with water flows of the two spring systems. Based on the 50-ft (15.2-m) distance, the area designated for dryopid beetle critical habitat at Comal Springs is about 38.1 ac (15.4 ha), and 1.4 ac (0.6 ha) at Fern Bank Springs. These acreages include occupied areas that contain PCEs necessary for life history functions of the Comal Springs dryopid beetle. The acreages were calculated with GIS. Designated critical habitat does not include areas where PCEs do not occur for this species, such as lawns, buildings, roads, parking lots, and sidewalks. Where lakes are designated, critical habitat is only designated in a radius of 50 ft (15.2 m) around springs and does not include other areas of the lake bottom where springs do not occur.
For critical habitat of the Comal Springs riffle beetle, we are designating an area that encompasses all of the spring outlets that are found within the same lake (excluding a slough (slack water) portion that lacks spring outlets). Apart from the slough portion, the approximate linear distance of Spring Lake at its greatest length is 0.2 mi (0.3 km). We are designating about 19.8 ac (8.0 ha) of aquatic habitat in Landa Lake and about 10.5 ac (4.3 ha) of aquatic habitat in Spring Lake as critical habitat. These areas contain PCEs necessary for life-history functions of the Comal Springs riffle beetle. We did not include the 50-ft (15.2-m) lateral extent around springs because, unlike the other two species, the riffle beetle is believed to occur on the surface and not subterranean. The acreages were estimated by calculating the cross-hatched polygon area in two map figures of these lakes using GIS. Designated critical habitat does not include areas where PCEs do not occur for this species, such as lawns, buildings, roads, parking lots, and sidewalks.
When determining critical habitat boundaries, we made every effort to avoid including within those boundaries of the maps contained within this final rule developed areas such as buildings, paved areas, and other structures that lack PCEs for the Peck's cave amphipod, Comal Springs dryopid beetle, or Comal Springs riffle beetle. These efforts included overlaying critical habitat boundaries onto aerial photos to determine the percentage of buildings, lawns, and paved areas that were located within the critical habitat designations. In the few instances that this occurred, these areas were excluded in the text of the critical habitat unit descriptions in the Critical Habitat Designation section of this final rule. The estimated acreages for these areas were so small (i.e., approximately 2 percent or less of the critical habitat units involved), it was not practical to exclude them from the GIS coordinates provided for the designated critical habitat units in this final rule. We believe that eliminating buildings, lawns, and paved areas in the text of the critical habitat descriptions was the most feasible means of excluding these areas from the designations and provided a clearer indication of the exclusions for the public. The scale of the maps prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed areas. Any such structures and the surface under them inadvertently left inside critical habitat boundaries shown on the maps of this final rule have been excluded by text in the final rule and are not designated as critical habitat. Therefore, Federal actions limited to these areas would not trigger section 7 consultation, unless they may affect the species or PCEs in adjacent critical habitat.
We are designating critical habitat in areas that we have determined were occupied at the time of listing and contain sufficient PCEs to support life-history functions essential for the conservation of the species. Units of Comal Springs, Fern Bank Springs, Hueco Springs, and San Marcos Springs were designated based on sufficient PCEs being present to support at least one life process for the Peck's cave amphipod, Comal Springs dryopid beetle, and/or Comal Springs riffle beetle. A brief discussion of each area designated as critical habitat is provided in the unit descriptions below.
We are designating four units as critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. The critical habitat areas described below constitute our best assessment of areas determined to be occupied at the time of listing, that contain the PCEs essential for the conservation of these species and may require special management, and those additional areas that were not known to be occupied at the time of listing but were found to be essential to the conservation of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. The four spring systems designated as critical habitat are: (1) The Comal Springs Unit, (2) the Fern Bank Springs Unit, (3) the Hueco Springs Unit, and (4) the San Marcos Springs Unit. Table 1 shows the occupied units,
Table 2 summarizes land ownership and threats for the four spring systems designated for critical habitat. Land ownership for these spring systems involves only the State of Texas, municipalities, and private landowners, and does not involve Federal or Tribal holdings. Comal Springs and San Marcos Springs are surrounded, respectively, by the cities of New Braunfels and San Marcos. Both Comal Springs and San Marcos Springs have been impounded with dams to form Landa Lake and Spring Lake, respectively. Possible threats to these urban spring systems include, but are not limited to, water withdrawals, pesticide use, and stormwater runoff of pollutants that have accumulated on impervious cover (paved driveways, parking lots, sidewalks, etc.) in urban areas. A thorough threats discussion is found in the December 18, 1997, final rule listing these species (62 FR 66295).
We present brief descriptions of all units and reasons why they meet the definition of critical habitat for Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle below. Maps of the designated critical habitat units are provided in the Regulation Promulgation section of this rule.
The Comal Springs system provides habitat for all three listed invertebrate species, along with a federally listed fish, the endangered fountain darter (
Critical habitat for the three listed invertebrate species in the Comal Springs Unit is as follows:
(1) Landa Lake (Comal Springs riffle beetle only)—aquatic habitat within the lake and outlying spring runs that occur from the confluence of Blieders Creek at the upstream end of Landa Lake down to the lake's lowermost point of confluence with Spring Run No. 1. The part of Landa Lake that lies below the confluence with Spring Run No. 1 down to the impounding dams at the downstream end of the lake is not included.
(2) Aquatic habitat and shoreline areas of Landa Lake (Peck's cave amphipod and Comal Springs dryopid beetle only)—aquatic habitat within the lake and outlying spring runs that occur from the confluence of Blieders Creek at the upstream end of Landa Lake down to the lake's lowermost point of confluence with Spring Run No. 1. The part of Landa Lake that lies below the confluence with Spring Run No. 1 down to the impounding dams at the downstream end of the lake is not included. Land areas along the shoreline of Landa Lake and on small islands inside the lake that are within a 50-ft (15.2-m) distance from habitat spring outlets are included in the critical habitat. These shoreline areas in proximity to spring outlets provide trees and shrubs with roots that penetrate underground to serve as habitat for the Peck's cave amphipod and Comal Springs dryopid beetle. The critical habitat designated for the Peck's cave amphipod and Comal Springs dryopid beetle includes only aquatic and shoreline areas where PCEs exist for these two species and does not include areas where these features do not occur, such as lawns, buildings, roads, parking lots, and sidewalks. Where lakes are included, critical habitat is only designated for areas within a radius of 50 ft (15.2 m) around springs and does not include other areas of the lake bottom in areas where springs are absent.
The Fern Bank Springs system provides habitat for only the Comal Springs dryopid beetle. No other critical habitat has been designated at this spring system. Fern Bank Springs provides all of the PCEs necessary for conservation of this species. The spring system is located approximately 0.2 mi (0.4 km) east of the junction of Sycamore Creek with the Blanco River in Hays County. This spring system occurs in a rural area and is relatively unaffected by current urban activities in the vicinity of the springs. It consists of a main outlet and a number of seep springs that occur at the base of a high bluff overlooking the Blanco River. This spring system is located entirely on land that is privately owned. Approximate acreages of land ownership encompassed within the designated critical habitat unit and threats to the unit are shown in Table 2.
Critical habitat for the Comal Springs dryopid beetle in the Fern Bank Springs Unit as follows: Fern Bank Springs—aquatic habitat and land areas that are within a 50-ft (15.2-m) distance from spring outlets, including the main outlet of Fern Bank Springs and its associated seep springs. These land areas in proximity to spring outlets provide trees and shrubs with roots that penetrate underground to serve as habitat for the Comal Springs dryopid beetle. The critical habitat designated for the Comal Springs dryopid beetle includes only areas where PCEs exist for this species and does not include areas where these features do not occur, such as buildings, lawns, or paved areas.
The Hueco Springs system provides habitat for only the Peck's cave amphipod. No other critical habitat has been designated at this spring system. Hueco Springs provides all of the PCEs necessary for conservation of this species. This spring system occurs in a rural area and is relatively unaffected by current urban activities in the vicinity of the springs. It has a main outlet that is located approximately 0.1 mi (0.2 km) south of the junction of Elm Creek with the Guadalupe River in Comal County. The main outlet itself lies approximately 500 ft (152 m) from the west bank of the Guadalupe River. Several satellite springs lie further south between the main outlet and the river. This spring system is located entirely on private land. The main outlet of Hueco Springs is located on undeveloped land, but the satellite springs occur within undeveloped areas of a privately owned campground. Approximate acreages of land ownership encompassed within the designated critical habitat unit and threats to the unit are indicated in Table 2.
We designate critical habitat for the Peck's cave amphipod within the Hueco Springs Unit as follows:
(1) Hueco Springs—aquatic habitat and land areas that are within 50 ft (15.2 m) from habitat spring outlets, including the main outlet of Hueco Springs and its associated satellite springs. These land areas in proximity to spring outlets provide trees and shrubs with roots that penetrate underground to serve as habitat for the Peck's cave amphipod. The critical habitat designated for the Peck's cave amphipod includes only aquatic habitat and land areas where PCEs exist for this species. Areas consisting of buildings, roads, sidewalks, campgrounds, and lawns are excluded from this designation.
The San Marcos Springs system provides habitat only for the Comal Springs riffle beetle. However, the San Marcos Springs system provides habitat for five other federally listed species: (1) The endangered fountain darter, (2) the endangered San Marcos gambusia (
We designate critical habitat for the Comal Springs riffle beetle in the San Marcos Springs unit as: Spring Lake—aquatic habitat areas within the lake upstream of Spring Lake dam, with the exception of the slough portion of the lake upstream of its confluence with the main body.
Section 7 of the Act requires Federal agencies, including the Service, to ensure that actions they fund, authorize, or carry out are not likely to destroy or adversely modify critical habitat. In our regulations at 50 CFR 402.02, we define destruction or adverse modification as “a direct or indirect alteration that appreciably diminishes the value of critical habitat for both the survival and recovery of a listed species. Such alterations include, but are not limited to, alterations adversely modifying any of those physical or biological features that were the basis for determining the habitat to be critical.” However, recent decisions by the 5th and 9th Circuit Courts of Appeal have invalidated this definition. Pursuant to current national policy and the statutory provisions of the Act, destruction or adverse modification is determined on the basis of whether, with implementation of the proposed Federal action, the affected critical habitat would remain functional (or retain the current ability for the PCEs to be functionally established) to serve the intended conservation role for the species.
Section 7(a) of the Act requires Federal agencies, including the Service, to evaluate their actions with respect to any species that is proposed or listed as endangered or threatened and with respect to its critical habitat, if any is proposed or designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402.
If a species is listed or critical habitat is designated, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of such a species or to destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. As a result of this consultation, compliance with the requirements of section 7(a)(2) will be documented through the Service's issuance of: (1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or (2) a biological opinion for Federal actions that may affect, but are likely to adversely affect, listed species or critical habitat.
When we issue a biological opinion concluding that a project is likely to result in jeopardy to a listed species or the destruction or adverse modification of critical habitat, we also provide reasonable and prudent alternatives to the project, if any are identifiable. “Reasonable and prudent alternatives” are defined at 50 CFR 402.02 as alternative actions identified during consultation that can be implemented in a manner consistent with the intended purpose of the action, that are consistent with the scope of the Federal agency's legal authority and jurisdiction, that are economically and technologically feasible, and that the Director believes would avoid jeopardy to the listed species or destruction or adverse modification of critical habitat. Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.
Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where a new species is listed or critical habitat is subsequently designated that may be affected and the Federal agency has retained discretionary involvement or control over the action or such discretionary involvement or control is authorized by law. Consequently, some Federal agencies may request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions may affect subsequently listed species or designated critical habitat or adversely modify or destroy proposed critical habitat.
Federal activities that may affect the Peck's cave amphipod, Comal Springs dryopid beetle, or Comal Springs riffle beetle or their designated critical habitat will require section 7 consultation under the Act. Activities on State, Tribal, local, or private lands requiring a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act or a permit under section 10(a)(1)(B) of the Act from the Service) or involving some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation Administration, or Federal Emergency Management Agency) will also be subject to the section 7 consultation process. Federal actions requiring section 7 consultation also include pumping of Edwards Aquifer water by Federal agencies, such as the Department of Defense or Service. Federal actions not affecting listed species or critical habitat, and actions on State, Tribal, local, or private lands that are not federally funded, authorized, or permitted, do not require section 7 consultations.
The Service has applied an analytical framework for jeopardy analyses of Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle that relies heavily on the importance of habitat conditions to the survival and recovery of these species. The section 7(a)(2) analysis is focused on the habitat conditions necessary to support them.
The jeopardy analysis usually expresses the survival and recovery needs of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle in a qualitative fashion without making distinctions between what is necessary for survival and what is necessary for recovery. Generally, if a proposed Federal action is incompatible with the viability of the affected species, inclusive of associated habitat conditions, a jeopardy finding is warranted because of the relationship of each core area population to the survival and recovery of the species as a whole.
For the reasons described in the Director's December 9, 2004, memorandum, the key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical habitat would remain functional (or retain the current ability for the PCEs to be functionally established) to serve the intended conservation role for the species. Generally, the conservation role of critical habitat units for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle is to have each unit support viable populations.
Section 4(b)(8) of the Act requires us to briefly evaluate and describe in any proposed or final regulation that designates critical habitat those activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation. Activities that may destroy or adversely modify critical habitat may also jeopardize the continued existence of the species.
Activities that may destroy or adversely modify critical habitat are
(1) Actions that can negatively affect the PCEs of the Peck's cave amphipod, Comal Springs dryopid beetle, or Comal Springs riffle beetle;
(2) Activities that would significantly and detrimentally alter the water quality in any of the spring systems listed above and would thereby destroy or adversely modify the critical habitat for any of theses species. These activities include, but are not limited to, sedimentation from construction or release of chemical or biological pollutants into the surface water or connected groundwater at a point source or by dispersed release (non-point source); such activities could also alter water conditions to a point that negatively affects these invertebrate species;
(3) Actions that change the existing and historic flow regimes and would thereby significantly and detrimentally alter the PCEs necessary for conservation of these species. Such activities could include, but are not limited to, water withdrawal, impoundment, and water diversions. These activities could eliminate or reduce the habitat necessary for the growth, reproduction, or survival of these invertebrate species; and
(4) Actions that remove hydraulic connectivity of the aquifer and the spring areas where it exists and would thereby negatively affect the PCEs of the designated critical habitat of these species and the population dynamics of the species. Alteration of subsurface water flows through destruction of geologic features (for example, excavation) or creation of impediments to flow (for example, concrete filling), especially in proximity to spring outlets, could negatively alter the hydraulic connectivity necessary to sustain these species. It is necessary for subsurface habitat to remain intact with sufficient hydraulic connectivity of flow paths and conduits to ensure that PCEs (water quality, water quantity, and food supply) for the designated critical habitat remain adequate for all three listed invertebrates.
Due in large part to the nature of the aquifer and spring systems, ongoing human activities that occur outside the designated critical habitat may threaten the physical and biological features of the designated critical habitat. While we are only designating critical habitat in occupied areas where PCEs exist and are in need of special management (
We consider all of the units designated as critical habitat to contain features essential to the conservation of the Peck's cave amphipod, Comal Springs dryopid beetle, or Comal Springs riffle beetle. All units are within the geographic range of the species, all were occupied by the species at the time of listing (based on observations made within the last 9 years), and are likely to be used by these listed invertebrates. Federal agencies already consult with us on activities in areas currently occupied by these listed invertebrates, or if the species may be affected by the action, to ensure that their actions do not jeopardize the continued existence of the Peck's cave amphipod, Comal Springs dryopid beetle, or Comal Springs riffle beetle.
The Sikes Act Improvement Act of 1997 (Sikes Act) (16 U.S.C. 670a) required each military installation that includes land and water suitable for the conservation and management of natural resources to complete, by November 17, 2001, an Integrated Natural Resource Management Plan (INRMP). An INRMP integrates implementation of the military mission of the installation with stewardship of the natural resources found on the base.
The National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136) amended the Act to limit areas eligible for designation as critical habitat. Specifically, section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) now provides: The Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.
There are no Department of Defense lands within the designated critical habitat that have completed an INRMP.
Section 4(b)(2) of the Act states that critical habitat shall be designated, and revised, on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact, of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if he determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless he determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making that determination, the Secretary is afforded broad discretion, and the Congressional record is clear that, in making a determination under the section, the Secretary has discretion as to which factors and how much weight will be given to any factor.
Under section 4(b)(2), in considering whether to exclude a particular area from the designation, we must identify the benefits of including the area in the designation, identify the benefits of excluding the area from the designation, determine whether the benefits of exclusion outweigh the benefits of inclusion. If an exclusion is contemplated, then we must determine whether excluding the area would result in the extinction of the species. In the following sections, we address a number of general issues that are relevant to the exclusions we considered.
Pursuant to section 4(b)(2) of the Act, we must consider relevant impacts in addition to economic ones. We determined that the lands within the designation of critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle are not owned or managed by the Department of Defense; there are currently no habitat conservation plans for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle; and the designation does not include any Tribal lands or trust resources.
We have considered a number of programs that exist at the State and local levels (
Other programs that provide some aquifer protection are Edwards Aquifer Rules and Phase I optional water quality measures of the Texas Commission on Environmental Quality (TCEQ). The Edwards Aquifer Rules provide protection for drinking water, and the Phase I measures provide protection for fountain darter, Texas wild-rice, San Marcos salamander, and San Marcos gambusia. The Edwards Aquifer Rules protect water quality by reducing pollutant loading through the implementation of best management practices that can help prevent degradation of groundwater. The Phase I optional water quality measures include enhanced best management practices that protect sensitive karst features. These measures also contain other protective actions that can be applied to many types of new projects. The Edwards Aquifer Rules and Phase I optional measures provide some benefits for the three Comal Springs invertebrates. However, the Phase I optional measures are not mandated for every project. Therefore we have considered excluding but have not excluded any lands from this designation based on the potential benefits from these planned or existing aquifer and water quality management initiatives.
We anticipate no impact to national security, Tribal lands, partnerships, or habitat conservation plans from this critical habitat designation. Based on the best available information, including the prepared economic analysis, we believe that all of these units contain the features that are essential for the conservation of the species. Our economic analysis does not indicate any areas within the critical habitat designation will bear a disproportionate cost of the designation. Therefore, we have found no areas for which the benefits of exclusion outweigh the benefits of inclusion, and so have not excluded any areas from this designation of critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle based on economic impacts. As such, we have considered but not excluded any lands from this designation based on the potential impacts to economic factors.
Section 4(b)(2) of the Act requires us to designate critical habitat on the basis of the best scientific information available and to consider the economic and other relevant impacts of designating a particular area as critical habitat. We may exclude areas from critical habitat upon a determination that the benefits of such exclusions outweigh the benefits of specifying such areas as critical habitat. We cannot exclude such areas from critical habitat when such exclusion will result in the extinction of the species concerned.
Following the publication of the proposed critical habitat designation, we conducted an economic analysis to estimate the potential economic effect of the designation. The draft analysis was made available for public review on March 16, 2007 (72 FR 12585). We accepted comments on the draft analysis until April 16, 2007.
The primary purpose of the economic analysis is to estimate the potential economic impacts associated with the conservation of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. This economic analysis considers the economic efficiency effects that may result from the designation, including habitat protections that may be co-extensive with the listing of the species. It also addresses distribution of impacts, including an assessment of the potential effects on small entities and the energy industry. This information can be used by the Secretary to assess whether the effects of the designation might unduly burden a particular group or economic sector.
This analysis focuses on the direct and indirect costs of the rule. However, economic impacts to land use activities can exist in the absence of critical habitat. These impacts may result from, for example, section 7 consultations under the jeopardy standard, local zoning laws, State and natural resource laws, and enforceable management plans and best management practices applied by other State and Federal agencies.
Under scenarios 1 and 2 in the draft economic analysis, impacts associated with water use changes comprised the vast majority, or between 91 and 99 percent, of the total quantified impacts in the areas we proposed for designation. Economic impacts were based on the total permitted withdrawals from the Edwards Aquifer that are planned to be reduced in part to provide spring flows that were identified in a 1993 lawsuit concerning five endangered species in the Edwards Aquifer that share habitat with the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. The analysis considered that as soon as 2008, total permitted water withdrawals in the Edwards Aquifer may be further limited from the present 549,000 acre-feet per year to 400,000 acre-feet per year (scenario 1). It is also possible that, in dry years, additional restrictions may be imposed that will further limit aquifer withdrawals to 340,000 acre-feet (scenario 2). The draft economic analysis examined social welfare and regional economic impacts that could result from these limits to water withdrawals in the aquifer. It should be noted that the majority of economic impacts quantified in the draft economic analysis are jointly caused by eight endangered species, including the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. Because all of these species reside in the same habitat, separating future impacts of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle from those of the other listed species in the aquifer was not attempted.
We estimated costs related to conservation activities for the area proposed for designation of critical habitat for the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle under sections 4, 7, and 10 of the Act to be approximately $24.5 million over the next 20 years under scenario 1, or $154.3 million under scenario 2 in undiscounted dollars (annualized dollars are estimated to be $1.2 million under scenario 1 and $7.7 million under scenario 2). Future economic impacts associated with conservation activities in areas designated as critical habitat at a 3 percent discount rate are estimated to be $18 million over the next 20 years
A copy of the final economic analysis with supporting documents may be obtained by contacting U.S. Fish and Wildlife Service, Branch of Endangered Species (see
In accordance with Executive Order (E.O.) 12866, this document is a significant rule in that it may raise novel legal and policy issues, but will not have an annual effect on the economy of $100 million or more or affect the economy in a material way. Due to the tight timeline for publication in the
Under the Regulatory Flexibility Act (RFA) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a statement of factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA also amended the RFA to require a certification statement.
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; as well as small businesses. 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 consider the types of activities that might trigger regulatory impacts under this rule, as well as the 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 rule could significantly affect a substantial number of small entities, we consider the number of small entities affected within particular types of economic activities (such as housing development, grazing, oil and gas production, timber harvesting). We apply the “substantial number” test individually to each industry to determine if certification is appropriate. However, the SBREFA does not explicitly define “substantial number” or “significant economic impact.” Consequently, to assess whether a “substantial number” of small entities is affected by this designation, this analysis considers the relative number of small entities likely to be impacted in an area. In some circumstances, especially with critical habitat designations of limited extent, we may aggregate across all industries and consider whether the total number of small entities affected is substantial. In estimating the number of small entities potentially affected, we also consider whether their activities have any Federal involvement.
Designation of critical habitat only affects activities conducted, funded, or permitted by Federal agencies. Some kinds of activities are unlikely to have any Federal involvement and so will not be affected by critical habitat designation. In areas where the species is present, Federal agencies already are required to consult with us under section 7 of the Act on activities they fund, permit, or implement that may affect the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. Federal agencies also must consult with us if their activities may affect critical habitat. Designation of critical habitat, therefore, could result in an additional economic impact on small entities due to the requirement to reinitiate consultation for ongoing Federal activities.
The draft economic analysis examined the potential for Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle conservation efforts to affect small entities. This analysis was based on the estimated impacts associated with the proposed critical habitat designation and evaluated the potential for economic impacts related to water use for agricultural activities, construction or development, and aquatic restoration. Aquatic restoration activities were not anticipated to affect small entities, as these activities will be carried out by a Federal agency (U.S. Army Corps of Engineers). Accordingly, the small business analysis focused on economic impacts resulting from potential water use changes for agricultural activities and construction or development activities. Future restrictions on groundwater pumping are expected to cause irrigated crop acreage to shift to dryland production. Under Scenario 1, where future groundwater pumping is restricted to 400,000 acre-feet per year, approximately 33,000 acres of irrigated cropland are expected to shift to dryland production, and 507 farms are likely to experience a reduction in output valued between $8,000 and $44,000. Under Scenario 2, where future groundwater pumping is restricted to 340,000 acre-feet per year, approximately 35,000 acres of irrigated cropland are expected to shift to dryland production, and 532 farms are likely to experience a reduction in
In general, two different mechanisms in section 7 consultations could lead to additional regulatory requirements for the approximately four small businesses, on average, that may be required to consult with us each year regarding their project's impact on the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle and its habitat. First, if we conclude, in a biological opinion, that a proposed action is likely to jeopardize the continued existence of a species or adversely modify its critical habitat, we can offer “reasonable and prudent alternatives.” Reasonable and prudent alternatives are alternative actions that can be implemented in a manner consistent with the scope of the Federal agency's legal authority and jurisdiction, that are economically and technologically feasible, and that would avoid jeopardizing the continued existence of listed species or result in adverse modification of critical habitat. A Federal agency and an applicant may elect to implement a reasonable and prudent alternative associated with a biological opinion that has found jeopardy or adverse modification of critical habitat. An agency or applicant could alternatively choose to seek an exemption from the requirements of the Act or proceed without implementing the reasonable and prudent alternative. However, unless an exemption were obtained, the Federal agency or applicant would be at risk of violating section 7(a)(2) of the Act if it chose to proceed without implementing the reasonable and prudent alternatives.
Second, if we find that a proposed action is not likely to jeopardize the continued existence of a listed animal or plant species, we may identify reasonable and prudent measures designed to minimize the amount or extent of take and require the Federal agency or applicant to implement such measures through non-discretionary terms and conditions. We may also identify discretionary conservation recommendations designed to minimize or avoid the adverse effects of a proposed action on listed species or critical habitat, help implement recovery plans, or to develop information that could contribute to the recovery of the species.
Based on our experience with consultations pursuant to section 7 of the Act for all listed species, virtually all projects—including those that, in their initial proposed form, would result in jeopardy or adverse modification determinations in section 7 consultations—can be implemented successfully with, at most, the adoption of reasonable and prudent alternatives. These measures, by definition, must be economically feasible and within the scope of authority of the Federal agency involved in the consultation. We can only describe the general kinds of actions that may be identified in future reasonable and prudent alternatives. These are based on our understanding of the needs of the species and the threats it faces, as described in the final listing rule and this critical habitat designation. Within the final critical habitat units, the types of Federal actions or authorized activities that we have identified as potential concerns are:
(1) Regulation of activities affecting waters of the United States by the U.S. Army Corps of Engineers under section 404 of the Clean Water Act;
(2) Regulation of water flows, damming, diversion, and channelization implemented or licensed by Federal agencies;
(3) Activities that may lead to storm water runoff that are regulated under the National Pollution Discharge Elimination System of the Clean Water Act by the Environmental Protection Agency;
(4) Activities authorized, carried out, or funded by any Federal agency that may result in point source storm water pollutant discharges, including excavation, site development, construction, and other surface disturbing activities;
(5) Activities authorized, carried out, or funded by the Federal Highway Administration that could lead to the introduction of pollutants into receiving waters from highway runoff; and
(6) Activities authorized, carried out, or funded by any Federal agency that could result in a reduction of groundwater supplies that support the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle.
It is likely that a developer or other project proponent could modify a project or take measures to protect the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle. The kinds of actions that may be included if future reasonable and prudent alternatives become necessary include conservation set-asides, management of competing nonnative species, restoration of degraded habitat, and regular monitoring. These are based on our understanding of the needs of the species and the threats it faces, as described in the final listing rule and proposed critical habitat designation. These measures are not likely to result in a significant economic impact to project proponents.
In summary, we have considered whether this would result in a significant economic effect on a substantial number of small entities. We have determined, for the above reasons and based on currently available information, that it is not likely to affect a substantial number of small entities. Federal involvement, and thus section 7 consultations, would be limited to a subset of the area designated. The most likely Federal involvement could include actions needing a section 404 permit under the Clean Water Act, actions receiving Federal Highway Administration funding, and actions needing a section 10(a)(1)(B) permit under the Endangered Species Act of 1973, as amended. A regulatory flexibility analysis is not required.
Under SBREFA, this rule is not a major rule. Our detailed assessment of the economic effects of this designation is described in the economic analysis. Based on the effects identified in the economic analysis, we believe that this rule will not have an annual effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. Refer to the final economic analysis for a discussion of the effects of this determination.
On May 18, 2001, the President issued Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) 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. This final rule to designated critical habitat for the
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501
(a) This rule will 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. (At the time of enactment, these entitlement programs were: Medicaid; AFDC work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement.) “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. While non-Federal entities who receive Federal funding, assistance, permits or otherwise require approval or authorization from a Federal agency for an action may be indirectly impacted by the designation of critical habitat, 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) We do not believe that this rule will significantly or uniquely affect small governments because it will 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 designation of critical habitat imposes no obligations on State or local governments. As such, a Small Government Agency Plan is not required.
In accordance with Executive Order 12630 (“Government Actions and Interference with Constitutionally Protected Private Property Rights”), we have analyzed the potential takings implications of designating 38.5 ac (15.6 ha) of lands in Comal County, Texas, as critical habitat for the Peck's cave amphipod, 39.5 ac (16.0 ha) of lands in Comal and Hays Counties, Texas, as critical habitat for the Comal Springs dryopid beetle, and 30.3 ac (12.3 ha) of lands in Comal and Hays counties, Texas, as critical habitat for the Comal Springs riffle beetle in a takings implication assessment. The takings implications assessment concludes that this final designation of critical habitat does not pose significant takings implications for lands within or affected by the designation.
In accordance with Executive Order 13132 (Federalism), the rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with the Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of, this final critical habitat designation with appropriate State resource agencies in Texas. The designation may have some benefit to these governments in that the areas that contain the features essential to the conservation of the species are more clearly defined, and the primary constituent elements of the habitat necessary to the conservation of the species are specifically identified. While making this definition and identification does not alter where and what federally sponsored activities may occur, it may assist these local governments in long-range planning (rather than waiting for case-by-case section 7 consultations to occur).
In accordance with Executive Order 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order. We are designating critical habitat in accordance with the provisions of the Endangered Species Act. This final rule uses standard property descriptions and identifies the primary constituent elements within the designated areas to assist the public in understanding the habitat needs of the Peck's cave amphipod, Comal Springs dryopid beetle, and Comal Springs riffle beetle.
This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act. This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
It is our position that, outside the jurisdiction of the Tenth Federal Circuit, we do not need to prepare environmental analyses as defined by NEPA in connection with designating critical habitat under the Endangered Species Act of 1973, as amended. We published a notice outlining our reasons for this determination in the
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive
A complete list of all references cited in this rulemaking is available upon request from the Field Supervisor, Austin Ecological Services Office (see
The primary authors of this final rule are staff of the Ecological Services Office in Austin, Texas (see
Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.
16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500; unless otherwise noted.
(h) * * *
(h)
Peck's cave amphipod (
(1) Critical habitat units are depicted for Comal County, Texas, on the maps below.
(2) The primary constituent elements of critical habitat for Peck's cave amphipod are:
(i) High-quality water with no or minimal levels of pollutants, such as soaps and detergents (Brown 1987, p. 261) and other compounds containing surfactants, heavy metals, pesticides, fertilizer nutrients, petroleum hydrocarbons, pharmaceuticals and veterinary medicines, and semi-volatile compounds, such as industrial cleaning agents, and including:
(A) Low salinity with total dissolved solids that generally range from 307 to 368 mg/L; and
(B) Low turbidity that generally is less than 5 nephelometric turbity units;
(ii) Aquifer water temperatures that range from approximately 68 to 75 °F (20 to 24 °C); and
(iii) Food supply that includes detritus (decomposed materials), leaf litter, living plant material, algae, fungi,
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the effective date of this rule. Where lakes are designated, critical habitat is only designated for areas where springs occur and does not include areas of the lake bottom beyond a radius of 50 ft (15.2 m) from the spring outlet.
(4)
(5) Note: Index map (Map 1) follows:
(6) Comal Springs Unit, Comal County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 583387, 3287251; 583392, 3287264; 583405, 3287280; 583404, 3287290; 583407, 3287301; 583414, 3287307; 583425, 3287308; 583425, 3287320; 583433, 3287328; 583444, 3287330; 583454, 3287325; 583463, 3287301; 583482, 3287272; 583486, 3287286; 583501, 3287296; 583520, 3287314; 583547, 3287326; 583557, 3287333; 583572, 3287335; 583586, 3287342; 583567, 3287387; 583560, 3287408; 583559, 3287423; 583534, 3287403; 583499, 3287359; 583491, 3287347; 583484, 3287340; 583471, 3287334; 583461, 3287334; 583452, 3287340; 583450, 3287350; 583454, 3287364; 583465, 3287374; 583494, 3287415; 583521, 3287443; 583526, 3287453; 583563, 3287477; 583589, 3287503; 583613, 3287519; 583643, 3287547; 583662, 3287561; 583719, 3287617; 583759, 3287669; 583780, 3287701; 583811, 3287743; 583833, 3287764; 583848, 3287784; 583892, 3287826; 583911, 3287850; 583970, 3287907; 584008, 3287938; 584047, 3287963; 584055, 3287964; 584065, 3287960; 584073, 3287948; 584074, 3287941; 584081, 3287952; 584131, 3288011; 584164, 3288044; 584183, 3288062; 584197, 3288071; 584216, 3288093; 584236, 3288110; 584258, 3288138; 584284, 3288161; 584325, 3288209; 584343, 3288223; 584364, 3288233; 584375, 3288243; 584386, 3288244; 584401, 3288234; 584403, 3288218; 584433, 3288201; 584437, 3288193; 584436, 3288184; 584416, 3288167; 584405, 3288167; 584375, 3288184; 584365, 3288180; 584344, 3288156; 584329, 3288131; 584320, 3288125; 584298, 3288103; 584273, 3288067; 584204, 3287997; 584187, 3287985; 584176, 3287973; 584152, 3287943; 584147, 3287933; 584105, 3287880; 584080, 3287862; 584049, 3287844; 584026, 3287815; 584021, 3287805; 584013, 3287798; 584009, 3287787; 583999, 3287775; 583971, 3287751; 583947, 3287735; 583927, 3287725; 583920, 3287718; 583890, 3287704; 583850, 3287673; 583845, 3287665; 583851, 3287662; 583860, 3287650; 583865, 3287640; 583865, 3287629; 583863, 3287622; 583854, 3287609; 583840, 3287600; 583836, 3287584; 583829, 3287576; 583838, 3287552; 583841, 3287535; 583841, 3287520; 583835, 3287501; 583804, 3287452; 583790, 3287435; 583766, 3287416; 583727, 3287406; 583706, 3287406; 583695, 3287398; 583686, 3287370; 583699, 3287298; 583698, 3287288; 583694, 3287282; 583617, 3287257; 583610, 3287258; 583605, 3287262; 583597, 3287280; 583584, 3287277; 583565, 3287270; 583541, 3287255; 583534, 3287244; 583518, 3287233; 583510, 3287211; 583496, 3287192; 583480, 3287183; 583459, 3287177; 583436, 3287178; 583419, 3287184; 583400, 3287198; 583396, 3287205; 583387, 3287251.
(ii) Note: Comal Springs Unit (Map 2) follows:
(7) Hueco Springs Unit, Comal County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 583113, 3292498; 583114, 3292498; 583115, 3292498; 583116, 3292498; 583117, 3292498; 583118, 3292497; 583119, 3292497; 583120, 3292497; 583120, 3292496; 583121, 3292496; 583122, 3292495; 583123, 3292495; 583124, 3292494; 583124, 3292493; 583125, 3292493;
(ii) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 583132, 3292420; 583133, 3292421; 583133, 3292421; 583133, 3292422; 583134, 3292423; 583134, 3292424; 583134, 3292425; 583135, 3292426; 583136, 3292426; 583136, 3292427; 583137, 3292428; 583138, 3292428; 583138, 3292429; 583139, 3292430; 583140, 3292430; 583141, 3292430; 583142, 3292431; 583143, 3292431; 583143, 3292431; 583144, 3292432; 583145, 3292432; 583146, 3292432; 583147, 3292432; 583148, 3292432; 583149, 3292432; 583150, 3292432; 583151, 3292432; 583152, 3292431; 583153, 3292431; 583154, 3292431; 583155, 3292430; 583155, 3292430; 583156, 3292429; 583157, 3292429; 583158, 3292428; 583158, 3292427; 583159, 3292427; 583160, 3292426; 583160, 3292425; 583161, 3292424; 583161, 3292423; 583162, 3292422; 583162, 3292422; 583162, 3292421; 583162, 3292420; 583163, 3292419; 583163, 3292418; 583163, 3292417; 583163, 3292416; 583163, 3292415; 583162, 3292414; 583162, 3292413; 583162, 3292412; 583162, 3292411; 583161, 3292410; 583161, 3292409; 583160, 3292409; 583160, 3292408; 583159, 3292407; 583159, 3292406; 583158, 3292406; 583157, 3292405; 583156, 3292404; 583156, 3292404; 583156, 3292403; 583155, 3292402; 583155, 3292402; 583155, 3292401; 583154, 3292400; 583154, 3292399; 583153, 3292398; 583152, 3292398; 583152, 3292397; 583151, 3292396; 583150, 3292396; 583149, 3292395; 583149, 3292395; 583148, 3292394; 583147, 3292394; 583146, 3292393; 583145, 3292393; 583144, 3292393; 583143, 3292393; 583142, 3292393; 583141, 3292393; 583140, 3292393; 583139, 3292393; 583138, 3292393; 583137, 3292393; 583137, 3292393; 583136, 3292394; 583135, 3292394; 583134, 3292395; 583133, 3292395; 583132, 3292396; 583132, 3292396; 583131, 3292397; 583130, 3292397; 583129, 3292398; 583129, 3292399; 583128, 3292400; 583128, 3292400; 583127, 3292401; 583127, 3292402; 583127, 3292403; 583126, 3292404; 583126, 3292405; 583126, 3292406; 583126, 3292407; 583126, 3292408; 583126, 3292409; 583126, 3292410; 583126, 3292411; 583126, 3292412; 583127, 3292413; 583127, 3292413; 583127, 3292414; 583128, 3292415; 583128, 3292416; 583129, 3292417; 583129, 3292418; 583130, 3292418; 583131, 3292419; 583131, 3292420; 583132, 3292420.
(iii) Note: Hueco Springs Unit (Map 3) follows:
(i)
Comal Springs dryopid beetle (
(1) Critical habitat units are depicted for Comal and Hays Counties, Texas, on the maps below.
(2) The primary constituent elements of critical habitat for the Comal Springs dryopid beetle are:
(i) High-quality water with no or minimal levels of pollutants, such as soaps and detergents (Brown 1987, p. 261) and other compounds containing surfactants, heavy metals, pesticides, fertilizer nutrients, petroleum hydrocarbons, pharmaceuticals and veterinary medicines, and semi-volatile compounds, such as industrial cleaning agents, and including:
(A) Low salinity with total dissolved solids that generally range from 307 to 368 mg/L; and
(B) Low turbidity that generally is less than 5 nephelometric turbidity units;
(ii) Aquifer water temperatures that range from approximately 68 to 75 °F (20 to 24 °C);
(iii) A hydrologic regime that allows for adequate spring flows that provide levels of dissolved oxygen in the approximate range of 4.0 to 10.0 mg/L for respiration of the Comal Springs dryopid beetle; and
(iv) Food supply that includes detritus (decomposed materials), leaf litter, living plant material, algae, fungi, bacteria and other microorganisms, and decaying roots.
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, roads, and other paved areas) and the land on which they are located existing with the legal boundaries on the effective date of this rule. Where lakes are designated, critical habitat is only designated for areas where springs occur and does not include areas of the lake bottom beyond a radius of 50 ft (15.2 m) from the spring outlet.
(4)
(5) Note: Index map of the critical habitat units for Comal Springs dryopid beetle (Map 1) follows:
(6) Comal Springs Unit, Comal County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 583387, 3287251; 583392, 3287264; 583405, 3287280; 583404, 3287290; 583407, 3287301; 583414, 3287307; 583425, 3287308; 583425, 3287320; 583433, 3287328; 583444, 3287330; 583454, 3287325; 583463, 3287301; 583482, 3287272; 583486, 3287286; 583501, 3287296; 583520, 3287314; 583547, 3287326; 583557, 3287333; 583572, 3287335; 583586, 3287342; 583567, 3287387; 583560, 3287408; 583559, 3287423; 583534, 3287403; 583499, 3287359; 583491, 3287347; 583484, 3287340; 583471, 3287334; 583461, 3287334; 583452, 3287340; 583450, 3287350; 583454, 3287364; 583465, 3287374; 583494, 3287415; 583521, 3287443; 583526, 3287453; 583563, 3287477; 583589, 3287503; 583613, 3287519; 583643, 3287547; 583662, 3287561; 583719, 3287617; 583759, 3287669; 583780, 3287701; 583811, 3287743; 583833, 3287764; 583848, 3287784; 583892, 3287826; 583911, 3287850; 583970, 3287907; 584008, 3287938; 584047, 3287963; 584055, 3287964; 584065, 3287960; 584073, 3287948; 584074, 3287941; 584081, 3287952;
(ii) Note: Comal Springs Unit (Map 2) follows:
(7) Fern Bank Springs Unit, Hays County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 595131, 3317374; 595131, 3317375; 595132, 3317376; 595132, 3317377; 595132, 3317378; 595132, 3317379; 595133, 3317380; 595133, 3317381; 595133, 3317382; 595134, 3317383; 595135, 3317383; 595135, 3317384; 595136, 3317385; 595137, 3317386; 595137, 3317386;
(ii) Note: Fern Bank Springs Unit (Map 3) follows:
Comal Springs riffle beetle (
(1) Critical habitat units are depicted for Comal and Hays Counties, Texas, on the maps below.
(2) The primary constituent elements of critical habitat for Comal Springs riffle beetle are:
(i) High-quality water with no or minimal levels of pollutants, such as soaps and detergents (Brown 1987, p. 261) and other compounds containing surfactants, heavy metals, pesticides, fertilizer nutrients, petroleum hydrocarbons, pharmaceuticals and veterinary medicines, and semi-volatile compounds, such as industrial cleaning agents, and including:
(A) Low salinity with total dissolved solids that generally range from 307 to 368 mg/L; and
(B) Low turbidity that generally is less than 5 nephelometric turbidity units;
(ii) Aquifer water temperatures that range from approximately 68 to 75 °F (20 to 24 °C);
(iii) A hydrologic regime that allows for adequate spring flows that provide levels of dissolved oxygen in the approximate range of 4.0 to 10.0 mg/L for respiration of the Comal Springs riffle beetle;
(iv) Food supply that includes detritus (decomposed materials), leaf litter, living plant material, algae, fungi, bacteria and other microorganisms, and decaying roots; and
(v) Bottom substrate in surface water habitat of the Comal Springs riffle beetle that is free of sand and silt, and is composed of gravel and cobble ranging in size from 0.3 to 5.0 inches (8 to 128 millimeters).
(3) Critical habitat does not include manmade structures (such as buildings, aqueducts, roads, and other paved areas) and the land on which they are located existing within the legal boundaries on the effective date of this rule.
(4)
(5) Note: Index map of the critical habitat units for Comal Springs riffle beetle (Map 1) follows:
(6) Comal Springs Unit, Comal County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 583420, 3287293; 583423, 3287293; 583426, 3287293; 583428, 3287290; 583429, 3287285; 583428, 3287280; 583426, 3287273; 583422, 3287268; 583416, 3287259; 583415, 3287255; 583415, 3287249; 583417, 3287238; 583418, 3287233; 583419, 3287228; 583418, 3287222; 583421, 3287221; 583427, 3287216; 583429, 3287207; 583435, 3287204; 583442, 3287203; 583455, 3287203; 583464, 3287203; 583468, 3287205; 583475, 3287209; 583479, 3287213; 583479, 3287217; 583483, 3287224; 583486, 3287232; 583490, 3287246; 583491, 3287248; 583485, 3287247; 583481, 3287245; 583476, 3287243; 583471, 3287241; 583461, 3287239; 583460, 3287242; 583460, 3287248; 583459, 3287255; 583459, 3287261; 583458, 3287266; 583455, 3287272; 583455, 3287277; 583452, 3287282; 583449, 3287284; 583446, 3287288; 583445, 3287295; 583441, 3287307; 583439, 3287314; 583443, 3287315; 583444, 3287309; 583446, 3287303; 583449, 3287293; 583450, 3287291; 583453, 3287288; 583457, 3287284; 583461, 3287278; 583466, 3287271; 583468, 3287263; 583469, 3287255; 583470, 3287251; 583480, 3287257; 583484, 3287256; 583488, 3287254;
(ii) Note: Comal Springs Unit (Map 2) follows:
(7) San Marcos Springs Unit, Hays County, Texas.
(i) Aquatic habitat areas bounded by the UTM Zone 14 NAD 83 coordinates (meters E, meters N): 602869, 3307092; 602870, 3307100; 602877, 3307131; 602892, 3307172; 602926, 3307215; 602936, 3307229; 602942, 3307237; 602945, 3307243; 602957, 3307286; 603007, 3307329; 603072, 3307386; 603154, 3307462; 603158, 3307463; 603166, 3307466; 603175, 3307465;
(ii) Note: San Marcos Springs Unit (Map 3) follows:
Office of the Chief Procurement Officer, HUD.
Proposed rule.
This rule proposes to amend HUD's Acquisition Regulation (HUDAR) to codify the suspension and debarment procedures applicable to HUD's procurement contracts. Such an amendment would affirm that the suspension and debarment procedures in 24 CFR part 24 apply to procurement as well as nonprocurement contracts. The contracting community is familiar with the suspension and debarment procedures in part 24 and this rule is limited to amending the HUDAR regulations to reflect the applicability of these requirements to procurement contracts.
Interested persons are invited to submit comments regarding this rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Interested persons also may submit comments electronically through the Federal eRulemaking Portal at
Frederick Graves, Office of Policy and Systems, Office of the Chief Procurement Officer (Seattle Outstation), Department of Housing and Urban Development, Seattle Federal Office Building, 909 First Avenue, Seattle, WA 98104-1000; telephone (206) 220-5259, FAX (206) 220-5247 (these are not toll-free numbers). Persons with hearing or speech impairments may access the telephone number via TTY by calling the toll-free Federal Information Relay Service at (800) 877-8339.
The uniform regulation for the procurement of supplies and services by Federal departments and agencies, the Federal Acquisition Regulation (FAR), was promulgated on September 19, 1983 (48 FR 42102). The FAR is codified in title 48, chapter 1, of the Code of Federal Regulations (CFR). HUD promulgated its regulation to implement the FAR on March 1, 1984 (49 FR 7696). The HUDAR (title 48, chapter 24 of the CFR) is prescribed under section 7(d) of the Department of HUD Act (42 U.S.C. 3535(d)); section 205(c) of the Federal Property and Administrative Services Act of 1949 (40 U.S.C. 486(c)); and the general authorization in FAR 1.301.
This proposed rule makes one change to 48 CFR 2409.7001 to clarify that HUD's suspension and debarment procedures, found at 24 CFR part 24, apply to procurement contracts. (On March 23, 2007, HUD published a proposed rule (72 FR 14015) that would redesignate 24 CFR part 24 to 2 CFR part 2424. The proposed rule published in today's
On November 26, 2003, HUD adopted, with minor revisions, the governmentwide nonprocurement debarment and suspension common rule (68 FR 66534). The governmentwide rule sets forth the common policies and procedures that federal executive branch agencies must use in taking suspension or debarment actions. The amendments made by the November 26, 2003, rule limited covered transactions to nonprocurement contracts. For many years prior to the promulgation in 2003 of the governmentwide debarment and suspension common rule, HUD applied, to procurement contracts, the same suspension and debarment procedures that it uses for nonprocurement contracts. HUD is unable to amend the governmentwide debarment and suspension procedures. Therefore, to reflect the applicability of debarment and suspension requirements to procurement contracts, HUD is proposing to revise the HUDAR to affirm that the suspension and debarment rules in 24 CFR part 24 apply to procurement contracts. This regulatory clarification does not impose any additional requirements because the suspension and debarment procedures in part 24 are well established and the contracting community is already familiar with the requirements.
The information collection requirements contained in this proposed rule are currently approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and assigned OMB control number 2535-0091. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538) establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. This rule does not impose any federal mandate on any state, local, or tribal government or the private sector within the meaning of UMRA.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Notwithstanding HUD's determination that this rule will not have a significant economic impact on a substantial number of small entities, HUD specifically invites comments regarding less burdensome alternatives to this rule that will meet HUD's objectives as described in this preamble.
This proposed rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise, or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this proposed rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule would not have federalism implications and would not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.
Government procurement.
For the reasons discussed in the preamble, HUD proposes to amend 48 CFR part 2409 to read as follows:
1. The authority citation for part 2409 continues to read as follows:
40 U.S.C. 486(c); 42 U.S.C. 3535(d).
2. Revise 2409.7001 to read as follows:
HUD's policies and procedures concerning debarment and suspension are contained in 24 CFR part 24 and, notwithstanding 24 CFR 24.220(a)(1), apply to procurement contracts.
Securities and Exchange Commission.
Final rule.
We are adopting rule amendments to extend the current interactive data voluntary reporting program to enable mutual funds voluntarily to submit supplemental tagged information contained in the risk/return summary section of their prospectuses. A mutual fund choosing to tag its risk/return summary information also would continue to file this information in HTML or ASCII format, as currently required. This extension of the voluntary program is intended to help us evaluate the usefulness to investors, third-party analysts, registrants, the Commission, and the marketplace of data tagging and, in particular, of tagging mutual fund information.
Alberto H. Zapata, Senior Counsel, or Brent J. Fields, Assistant Director, Office of Disclosure Regulation, Division of Investment Management, at (202) 551-6784, Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549-5720. If you have questions about the EDGAR system, contact Richard Heroux, EDGAR Program Manager, at (202) 551-8800, in the Office of Information Technology.
The Securities and Exchange Commission (“Commission”) is adopting amendments to rules 401
Text of Rule and Form Amendments
For the past several years, the Commission has been evaluating the use of interactive data tagging as a tool to improve the timeliness and accessibility of the information contained in filings with the Commission under the federal securities laws.
Interactive data has enormous potential to enable investors and other market participants to analyze and compare data from different sources more efficiently and effectively and to exchange information across various platforms automatically. Through interactive data, static text-based information can be transformed into dynamic databases that can readily be searched and analyzed, facilitating the comparison of information across companies, reporting periods, and industries. Interactive data also provides a significant opportunity to automate information processing throughout the business and reporting cycle, with the potential to increase accuracy and reduce costs. By ensuring that information is classified properly at each step of the cycle, and minimizing the need for human intervention and, therefore, human error, interactive data may improve the quality of information at decreased cost.
Tags are defined in taxonomies, which are essentially data dictionaries that describe individual items of information and mathematical and definitional relationships among the items. As tagging has continued to gain prominence in recent years, there has been substantial progress in developing data tagging taxonomies related to a language for the electronic communication of business and financial data known as eXtensible Business Reporting Language (“XBRL”). XBRL was developed as an open source specification that describes a standard format for tagging financial and other information to facilitate the preparation, publication, and analysis of that information by software applications.
As part of our evaluation of the potential of interactive data tagging technology, the Commission adopted rules in 2005 instituting a program that permits filers, on a voluntary basis, to submit financial information tagged in XBRL format as an exhibit to certain filings on the Commission's Electronic Data Gathering, Analysis and Retrieval System (“EDGAR”).
The current voluntary program extends to financial information for investment companies, including open end management investment companies (“mutual funds”).
In a letter to the Commission staff, dated May 18, 2007, the ICI advised that the risk/return summary taxonomy is ready for use and described its response to comments received regarding the taxonomy development.
The risk/return summary section of the mutual fund prospectus contains important information about investment objectives and strategies, risks, and costs,
The Commission received eight comment letters on the proposed rule amendments, including comments from software vendors, an accounting firm, a trade association, and several individuals.
As part of our ongoing effort to evaluate the usefulness of data tagging, we are adopting amendments to extend the voluntary program to enable mutual funds to submit exhibits containing tagged risk/return summary information attached to EDGAR filings.
Currently, the XBRL data furnished under the voluntary program must consist of at least one item from a list of enumerated mandatory content (“Mandatory Content”), including financial statements, earnings information, and, for registered management investment companies, financial highlights or condensed financial information.
Our proposal, like the current voluntary program, would have required that Mandatory Content “consist of a complete set of information for all periods presented in the corresponding official EDGAR filing.”
Three commenters stated that if a mutual fund's official filing contains information for more than one series or class, the fund should be permitted to submit tagged risk/return summary information for one or more, but fewer than all, series or classes.
We disagree, however, with commenters' recommendations
As with all tagged exhibits under the voluntary program, submissions of tagged exhibits containing risk/return summary information will be supplemental and will not replace the required HTML or ASCII version of the information called for in Form N-1A. Volunteers will be required to file their complete official registration statements to ensure that all investors have access to information upon which to base their investment decisions.
We are adopting, as proposed, the requirement that mutual funds submitting tagged risk/return summary information must include this information as an exhibit to an amendment to a previous filing on Form N-1A.
The voluntary program requires all volunteers to use the appropriate version of a standard taxonomy, supplemented with extension taxonomies as specified by the EDGAR Filer Manual. Filers submitting tagged risk/return summary information should not include the risk/return summary taxonomy in their submissions as this taxonomy will be stored as a part of the EDGAR system. Section 5.2.4 of the EDGARLink Filer Manual (Volume II): “EDGAR Filing” will provide instructions and guidance on the preparation, submission, and validation of EDGAR-acceptable electronic filings with attached tagged risk/return summary information.
Similar to the current voluntary program, volunteers will be free to submit tagged risk/return summary information regularly or from time to time, and volunteers may stop and start as they choose. Participating in the voluntary program will not create a continuing obligation for a volunteer to submit tagged risk/return summary information as an exhibit to a subsequent post-effective amendment. A volunteer will, however, be required to amend any tagged risk/return summary exhibits that do not comply with the content and format requirements of rule 401,
One commenter, while agreeing that participation in the voluntary program should not create a continuing obligation to submit tagged risk/return summary information as an exhibit to a subsequent post-effective amendment, noted that rendering tools may not be able to detect that tagged data is no longer current.
The amendments we are adopting will, as proposed, provide mutual funds with the option to submit tagged financial highlights or condensed financial information as a tagged exhibit to an amendment to the Form N 1A filing to which the information relates.
The Commission is adopting, as proposed, a requirement that the exhibit index of any Form N-1A filing that includes a tagged exhibit disclose that the purpose of submitting the tagged exhibit is to test the related format and technology and, as a result, investors should not rely on the exhibit in making investment decisions.
We believe that the inclusion of the cautionary disclosure within tagged risk/return summary exhibits may help to alert investors and other users that the exhibits should not be relied on in making investment decisions. We are modifying the proposed rule to require that the disclosure be included within the exhibits as a tagged data element.
The adopted rules, like the proposed rules and consistent with one commenter's recommendation,
The two commenters who addressed liability issues supported the proposal to extend to tagged risk/return summary information limited protection from liability that is similar to the protection provided under the current voluntary program,
Under the current voluntary program, tagged exhibits are not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (“Exchange Act”)
The amendments we are adopting, as proposed, extend the liability protection
The taxonomy for tagging the risk/return summary information was developed by the ICI. Mutual funds will be permitted to submit documents containing risk/return summary information that is tagged using the ICI's taxonomy commencing on the effective date of the rules that we are adopting. In January 2007, the ICI released a draft risk/return summary taxonomy for public review and comment.
We have concluded that the ICI's taxonomy is sufficiently developed to permit its use in the voluntary program. Three commenters involved in the taxonomy development process stated that the risk/return summary taxonomy is sufficiently developed for use in the voluntary program, noting that the taxonomy was developed through the use of a broad working group that was given the opportunity to review and comment on the taxonomy as it was developed and that the taxonomy was subjected to a public review and comment period.
As in the current voluntary program, filers will be permitted to use extensions to the risk/return summary taxonomy, which are additional tags created by a particular user that further refine the tags contained in a standard taxonomy. Some commenters supported permitting the use of at least some extensions with the risk/return summary taxonomy,
One commenter recommended that the Commission impose validity testing on tagged risk/return summary exhibits
The Commission's Web site currently provides access to a prototype XBRL Web application that converts tagged financial information submitted in the voluntary program into a rendered, or human readable, format.
We will continue to analyze rendering and other capabilities specifically developed for the risk/return summary taxonomy, and we may add these features to our Web site in the future. The Commission also encourages funds and third parties to develop these tools. Users of EDGAR data on the Commission's Web site will be able to download the tagged risk/return summary information to perform their own analysis if they have appropriate software. Users will continue to be able to view the official filing in ASCII or HTML format, as they can today.
The effective date of these amendments is August 20, 2007, in order to provide sufficient time to implement EDGAR system changes necessary to provide for risk/return summary functionality.
The rule and form amendments contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
The title for the collection of information is “Voluntary XBRL-Related Documents” (OMB Control No. 3235-0611). The rule and form amendments expand the current interactive data voluntary reporting program to enable mutual funds voluntarily to submit tagged information contained in the risk/return summary section of their prospectuses on EDGAR as exhibits to Form N-1A filings. We published notice soliciting comments on the collection of information requirements in the release proposing the amendments and submitted the proposed collection of information to OMB for review in accordance with 44 U.S.C. 3507(d) and 5 CFR 1320.11.
The amendments, which will expand the current interactive data voluntary reporting program to enable mutual funds voluntarily to submit tagged information contained in the risk/return summary section of their prospectuses on EDGAR as exhibits to Form N-1A filings, will increase the burden associated with the existing collection of information for Voluntary XBRL-Related Documents. The expansion of the voluntary program will be open to any mutual fund choosing to participate. We estimate that 10% of the approximately 545 fund complexes that have mutual funds, or 55 fund complexes, will each submit documents containing tagged risk/return summary information for one mutual fund.
One commenter suggested that the Commission offer incentives to encourage volunteers to participate in the expanded voluntary program.
Submission of tagged risk/return summary information will not directly affect the burden of preparing the mutual funds' registration statements or the registrants' official EDGAR filings. In order to provide tagged risk/return summary information, a participating mutual fund will have to tag the risk/return summary section of its prospectus using the risk/return summary taxonomy and potentially develop taxonomy extensions and will submit an exhibit to its filing. Based on our previous estimates and our experience with registrants who have submitted tagged financial information in the current voluntary program, we estimate that the initial creation of tagged documents containing risk/return summary information will require, on average, approximately 110 burden hours per mutual fund,
Based on the estimates of 55 participants submitting tagged documents containing risk/return summary information for one mutual fund per year and incurring 43 hours per submission, we estimate that, in the aggregate, the industry will incur an additional 2,365 burden hours associated with the amendments.
We also estimate that 25% of the burden, or approximately 591 hours, will be outsourced to external professionals and consultants retained by the mutual fund complex at an average cost of $256.00 per hour for a total annual increase of approximately $151,296.
Our cost estimates are intended to reflect both initial and ongoing costs over a three-year period. In calculating these costs, we have tried to take into account, among other things, the current state of reporting process automation, automation that likely will be introduced in connection with the initial cost incurred, and the efficiencies that likely will be realized over the course of three years.
Regulation S-T (OMB Control No. 3235-0424) specifies the requirements that govern the electronic submission of documents. The amendments will revise rules under Regulation S-T, but the associated increase in burden is reflected in the “Voluntary XBRL-Related Documents” collection of information as described above.
The Commission is sensitive to the costs and benefits imposed by its rules. The goal of the voluntary program is to increase EDGAR's efficiency and utility and to enhance the usefulness to investors of the information collected through EDGAR. In order to evaluate data tagging further, we are adopting amendments to extend the current interactive data voluntary reporting program to enable mutual funds voluntarily to submit tagged information contained in the risk/return summary section of their prospectuses on EDGAR as exhibits to Form N-1A filings.
We believe that tagged information may allow more efficient and effective retrieval, research, and analysis of company information through automated means. The expansion of the voluntary program will assist us in assessing whether using interactive data tags enhances users' ability to analyze and compare mutual fund risk/return summary information included in mutual funds' filings with the Commission. The expansion of the voluntary program to include narrative, non-financial information, such as that contained in the risk/return summary, also will facilitate our ability to assess further the technical requirements of processing tagged documents using EDGAR.
Currently, a number of companies use computers and data entry staff to mine risk/return summary information provided by mutual funds on EDGAR in order to populate databases that are used to package information for sale to analysts, funds, investors, and others. Permitting funds to tag risk/return summary information in Commission filings will aid this data-mining process in that it will identify points of data at the source, which could reduce the cost to populate databases and improve the
In the future, the availability of potentially more accurate tagged information about mutual funds could also reduce the cost of research and analysis and create new opportunities for companies that compile, provide, and analyze data to produce more value added services. Enhanced access to tagged information also has the potential to allow retail investors (or financial advisers assisting such investors) to perform more personalized and sophisticated analyses and comparisons of mutual funds, which could result in investors making better informed investment decisions, and therefore in a more efficient distribution of assets by investors among different funds. This may, in turn, also contribute to increased competition among mutual funds and result in a more efficient allocation of resources among competing investment products. Although it is not possible to quantify precisely the beneficial effects of more efficient allocation of investors' assets and increased competition, they may be significant, given the size of the mutual fund industry.
In the Proposing Release, we sought comments on our cost-benefit analysis,
The expansion of the voluntary program will lead to some additional costs for funds choosing to submit tagged documents containing risk/return summary information as exhibits to their Form N-1A filings. For purposes of the PRA, we estimated that the increase in annual internal burden hours to the industry will be 1,774 hours, which will amount to approximately $393,828 and that the increase in annual external costs will amount to approximately $169,611 for a total estimated increase of $563,439 on an annual basis.
We based these cost estimates upon, among other things, experience with filers who have submitted tagged financial information in the current voluntary program.
In the future, there may be additional costs to current users of EDGAR data. For example, companies that currently provide tagging and dissemination of EDGAR data may experience decreased demand for their services. These entities have developed certain products and services based on data in EDGAR; many entities disseminate, repackage, analyze, and sell the information. Allowing mutual funds to submit tagged risk/return summary information, even voluntarily, may have an impact on entities providing EDGAR-based services and products. Because the Commission does not regulate all these entities, it is currently not feasible to accurately estimate the number or size of these potentially affected entities. The limited, voluntary nature of the program will help the Commission assess the effect, if any, on these entities. In addition, the availability of mutual fund tagged data on EDGAR may provide these companies with alternative business opportunities.
Section 2(c) of the Investment Company Act
The amendments will extend the interactive data voluntary reporting program to enable mutual funds voluntarily to submit tagged information contained in the risk/return summary section of their prospectuses on EDGAR as exhibits to Form N-1A filings. The expansion of the voluntary program is intended to help us evaluate the usefulness to investors, third-party analysts, mutual funds, the Commission, and the marketplace of data tagging and, in particular, of tagging mutual fund information. Because compliance with the amendments will be voluntary, the Commission estimates that the impact of the amendments will be limited. However, because the tagging of risk/return summary information has the potential to facilitate analysis of that information, we believe that the amendments could promote efficiency by allowing us and others to gain experience with tagged mutual fund information in Commission filings.
Further, tagging of the risk/return summary information has the potential to help streamline the delivery of mutual fund information, and provide investors and others with improved tools to compare funds based upon, among other things, costs, investment objectives, strategies, and risks. We believe that the potential to streamline the delivery of mutual fund information and to provide investors and others with improved mutual fund comparison tools could promote efficiency and competition through more efficient allocation of investments by investors and more efficient allocation of assets among competing funds. In the future,
We requested comment on whether the proposed amendments would promote efficiency, competition, and capital formation. We received no comment on this issue.
This Final Regulatory Flexibility Analysis was prepared in accordance with 5 U.S.C. 604 and relates to the amendments we are adopting that will expand the current interactive data voluntary reporting program to enable mutual funds voluntarily to submit tagged information contained in the risk/return summary section of their prospectuses on EDGAR as exhibits to Form N-1A filings. An Initial Regulatory Flexibility Analysis (“IRFA”), which was prepared in accordance with the 5 U.S.C. 603, was published in the release proposing the amendments.
The purpose of the amendments is to help us evaluate the usefulness to investors, third-party analysts, mutual funds, the Commission, and the marketplace of data tagging and, in particular, of tagging mutual fund information. We believe that the expanded voluntary program will enable us to study further the extent to which interactive data tags enhance the comparability of that data, the usefulness of data tags for dissemination, and our staff's ability to review and assess the accuracy and adequacy of that data. The expanded voluntary program will also help us assess the effect of interactive data tags on the quality and transparency of risk/return summary information, as well as the compatibility of data tagging with the Commission's disclosure requirements.
More specifically, we believe that the expanded voluntary program will better enable us to study the extent to which interactive data enhances the:
• Search capability of the EDGAR database to allow more efficient and effective extraction and analysis of specific data,
• Capability to perform comparisons among mutual funds, and
• Ability to perform analyses of mutual fund data and whether it would reduce the resources needed for data analysis.
In addition, we believe that the expanded voluntary program will enhance our ability to evaluate the:
• Impact on the staff's ability to review filings on a more timely and efficient basis,
• Use of tagged data for risk assessment and surveillance procedures, and
• Compatibility of interactive data with reporting quality, transparency, and other Commission reporting requirements.
In the IRFA for the proposed amendments, we requested comment on the number of small entities that would be affected by the proposed amendments, the existence or nature of the potential effect of the proposals on small entities, how to quantify the effect of the proposals, how different procedures could be provided for small entities, and we asked commenters to provide any empirical data supporting the extent of the impact. We received no comment letters specifically addressing the IRFA in the Proposing Release; however, one commenter suggested that the Commission could lower the barrier for participation for small funds by providing a “literal” or structured form using some commonly used software applications.
The expansion of the voluntary program may have an effect on mutual fund participants in the voluntary program. Under Rule 0-10 under the Investment Company Act, an investment company is a small entity if it, together with other investment companies in the same group of related investment companies, has net assets of $50 million or less as of the end of its most recent fiscal year.
The voluntary program is designed to assist us in assessing the feasibility of using interactive data on a broader basis. Experience with the current voluntary program indicates that the cost of participating in the expanded program, the associated burden on the EDGAR system, and the possible effect of the expanded voluntary program on those entities that use the EDGAR data will be minimal. Nevertheless, the impact of the amendments remains somewhat speculative at this point.
No registrant will be required to submit tagged documents under the expansion of the voluntary program. The submission of tagged risk/return summary information will require a participating mutual fund to tag the risk/return summary section of its prospectus using the risk/return summary taxonomy and potentially develop extensions and to submit exhibits to its filing. Volunteers may also need to purchase software or retain a consultant to assist in tagging data. For purposes of the PRA, we estimated that each volunteer, including small entities, would incur approximately 43 burden hours and $333 in software costs annually.
The Regulatory Flexibility Act directs us to consider significant alternatives that would accomplish the stated objective, while minimizing any significant adverse impact on small entities. The purpose of the amendments is to help us evaluate the usefulness to investors, third-party analysts, mutual funds, the Commission, and the marketplace of data tagging and, in particular, of tagging mutual fund information. Submitting documents containing tagged risk/return summary information is entirely voluntary. We have considered different or simpler procedures for small entities, including:
• The establishment of different compliance or reporting requirements or timetables;
• The clarification, consolidation, or simplification of the proposed requirements;
• The use of performance rather than design standards; and
• Exemption from coverage.
For tagged data to provide benefits such as ready comparability, however, the data tagging system cannot have alternative procedures. Similarly, in order to achieve the benefits of interactive data tagging, use of a single data tagging technology is necessary. Additionally, providing structured input forms, as suggested by one commenter,
The Commission is adopting the rule amendments outlined above under Sections 5, 6, 7, 10, 19(a), and 28 of the Securities Act [15 U.S.C. 77e, 77f, 77g, 77j, 77s(a), and 77z-3] and Sections 6(c), 8, 24(a), 30, and 38 of the Investment Company Act [15 U.S.C. 80a-6(c), 80a-8, 80a 24(a), 80a-29, and 80a-37].
Reporting and recordkeeping requirements, Securities.
Investment Companies, Reporting and recordkeeping requirements, Securities.
15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z-3, 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c), 80a-8, 80a-29, 80a-30, 80a-37, and 7201 et seq.; and 18 U.S.C. 1350.
The addition and revisions read as follows:
(a) An electronic filer that participates in the voluntary XBRL (eXtensible Business Reporting Language) program may submit XBRL-Related Documents (§ 232.11) in electronic format as an exhibit to: The filing (other than a Form N-1A (§ 239.15A and § 274.11A of this chapter) filing) to which the XBRL Related Documents relate; an amendment to such filing, but, in the case of a Form N 1A filing, an amendment made only after the effective date of the Form N-1A filing to which the XBRL-Related Documents relate; or if the electronic filer is eligible to file a Form 8-K (§ 249.308 of this chapter) or a Form 6-K (§ 249.306 of this chapter), a Form 8-K or a Form 6-K, as applicable, that references the filing to which the XBRL-Related Documents relate if such Form 8-K or Form 6-K is submitted no earlier than the date of that filing. * * *
(b) * * *
(1) * * *
(iv) The risk/return summary information set forth in Items 2 and 3 of Form N 1A provided that, in the case of a Form N 1A filing that includes more than one series (as that term is used in rule 18f-2(a) under the Investment Company Act (§ 270.18f 2(a) of this chapter), a filer may include in mandatory content complete risk/return summary information for any one or more of those series.
(d) * * *
(1) * * *
(i) That the financial information contained in the XBRL-Related Documents is “unaudited” or “unreviewed,” as applicable (but only if the mandatory content contained in the XBRL-Related Documents contains information other than risk/return summary information submitted under paragraph (b)(1)(iv) of this section);
(2) * * *
(i) The exhibit index of a Form 10-K (§ 249.310 of this chapter), 10-Q (§ 249.308a of this chapter), 10 (§ 249.210 of this chapter), 10-SB (§ 249.210b of this chapter), 10-KSB (§ 249.310b of this chapter), 10-QSB (§ 249.308b of this chapter), 20-F or N-1A and, in the case of risk/return summary information submitted under paragraph (b)(1)(iv) of this section, within the XBRL-Related Documents as a tagged data element;
3. Revise § 232.402(a)(1) to read as set forth below and amend § 232.402(b) by removing each reference to “Item 401” and adding in its place “Rule 401”.
(a) * * *
(1) Are not deemed filed for purposes of section 11 of the Securities Act (15 U.S.C. 77k), section 18 of the Exchange Act (15 U.S.C. 78r), or section 34(b) of the Investment Company Act (15 U.S.C. 80a-33(b)), or otherwise subject to the liabilities of these sections, and are not part of any registration statement to which they relate;
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77sss, 78c, 78l, 78m, 78n, 78o(d), 78u-5, 78w(a), 78ll, 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26, 80a-29, 80a-30, and 80a-37, unless otherwise noted.
15 U.S.C. 80a-1
A registrant that participates in the voluntary XBRL (eXtensible Business Reporting Language) program may submit, in electronic format as an exhibit to a filing on Form N-1A (§§ 239.15A and 274.11A of this chapter), Form N-CSR (§§ 249.331 and 274.128 of this chapter), or Form N-Q (§§ 249.332 and 274.130 of this chapter) to which they relate, XBRL Related Documents (§ 232.11 of this chapter). A registrant that submits XBRL Related Documents as an exhibit to a form must name each XBRL Related Document
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m, 78n, 78o(d), 80a-8, 80a-24, 80a-26, and 80a-29, unless otherwise noted.
The text of Form N-1A will not appear in the Code of Federal Regulations.
By the Commission.