Background

The U.S. Office of Personnel Management (OPM) occasionally receives subpoenas and requests for OPM employees to provide evidence in litigation in which OPM is not a party. Often these subpoenas and requests are for OPM records that are not available to the public under the Freedom of Information Act. Also, OPM sometimes receives subpoenas and requests for OPM employees to appear as witnesses in litigation in conjunction with a request for nonpublic records. Requesters have sought information, for example, on retirement records, pay issues, and other program matters, under OPM jurisdiction. Responding to such demands and requests can result in a significant disruption to OPM employees' work schedules. The result is that employees may be diverted from performing their official duties in order to respond to requests from parties in litigation. In order to address this problem, many agencies over the years have issued regulations that are similar to this proposed regulation, governing the circumstances and manner in which an employee may respond to demands for testimony or for the production of documents. Such a regulation was sustained by the United States Supreme Court in United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1951).

In Touhy, the Supreme Court held that a U.S. Department of Justice (DOJ) official, acting on order of the Attorney General, could not be held in contempt for declining to produce records in response to a subpoena. The employee's refusal was based upon a DOJ regulation that prohibited disclosure of agency files, documents, records, or information without the express approval of the Attorney General. The Court sustained the validity of the DOJ regulations, reasoning that it was appropriate for the Attorney General to prescribe regulations not inconsistent with law for the custody, use and preservation of records, papers, and property pertaining to the Department of Justice.

On June 23, 2008, OPM published in the Federal Register its own proposed Touhy regulation, for codification in a new part 295 of 5 CFR (See 73 FR 35354) which provided for a 60-day public comment period. OPM received suggestions on the rule as proposed from one commenter, whose comments were directed to the penalties section [295.401] and to OPM's authority to regulate the conduct of former employees. As noted below in the summary of this final rule, we are not adopting changes in this final rule from the rule as proposed based upon those comments because employees and former employees are already on notice of and subject to penalties for violating the precepts established herein. However, in order to clarify the application of this rule, OPM has decided to revise the proposed part heading to make express that it applies to testimony by OPM employees “relating to official information” (as opposed to private matters), as well as to the production of official records in legal proceedings. In addition, OPM has determined to add a reference to 31 U.S.C. 9701 to the new part 295 authority citation. This statute authorizes agencies to issue regulations providing for fair and cost-based fees and charges.

Briefly summarized, this final rule prohibits disclosure of nonpublic official records or testimony by OPM employees unless there is compliance with the rule (295.201 and 295.203). The rule identifies the factors that OPM will consider in making determinations in response to such requests and what information requesters must provide (295.202 and 295.203). On its own initiative, OPM has added “otherwise protected information” to the types of sensitive information enumerated in paragraph (i) of 295.202. The rule also specifies when the request should be submitted (295.203), the time period for review (295.205), potential fees (295.301), and, if a request is granted, any restrictions that may be placed on the disclosure of records or the appearance of an OPM employee as a witness (295.207 and 295.208). OPM is also adopting in this final rule two other changes on its own initiative. First, OPM is adding the phrase “when necessary” to the procedure provided in 295.209 for informing the court or other competent authority and seeking a stay when a decision is not made prior to the time a response is required. This modification from the section as proposed recognizes that at times there can be informal resolution of such matters short of seeking a stay. The second change is that OPM is adding the phrase “unless otherwise advised by the General Counsel” to the procedure provided in 295.210 for personal appearance of an OPM employee when a stay of a demand (or, as now added by OPM, a request) is denied. This change likewise recognizes that such denials can sometimes be resolved instead by written response (see the section's last sentence) or otherwise.

The commenter generally objected to penalizing employees who fail to comply with this rule (295.401), upon the grounds that the language of subsection 401 would appear to penalize an employee, even if OPM did not have an opportunity to appear and be heard by the court in question. Additionally, the commenter questions penalizing employees who are trying to be helpful and provide responses to informal inquiries from outside parties that seek clarification. OPM is not changing the penalty section based upon these comments. First, the penalties section (295.401) does not impose penalties a priori. Rather, as with any potential disciplinary matter, it provides that employees may be subject to discipline for violation of the rule. Moreover, employees and former employees are already subject to the provisions of the statutes cited in the subsection. Additionally, the rule does not apply to mere informal requests for clarification. Instead, as set out in subsections 101 and 102, it applies to demands or requests for official records or information in a legal proceeding in which OPM is not a party, while recognizing that requests may be received informally. Moreover, as set out in subsections 209 and 210, an employee is given guidance as to how to respond if OPM has not had the opportunity to be heard by the court.

The charges for witnesses are the same as those provided by the Federal courts; and the fees related to production of records are the same as those charged under FOIA. The charges for time spent by an employee to prepare for testimony and for certification of records by OPM are authorized under 31 U.S.C. 9701, which permits an agency to charge for services or things of value that are provided by the agency.

This final rule applies to a broad range of matters in any legal proceeding in which OPM is not a named party. It also applies to former and current OPM employees (as well as OPM consultants and advisers). Former OPM employees are prohibited from testifying about specific matters for which they had responsibility during their active employment unless permitted to testify as provided in the rule. They would not be barred from appearing to testify about general matters unconnected with the specific matters for which they had responsibility.

This final regulation will ensure a more efficient use of OPM resources, minimize the possibility of involving OPM in issues unrelated to its responsibilities, promote uniformity in responding to such requests and subpoenas, and maintain the impartiality of OPM in matters that are in dispute between other parties. It will also serve OPM's interest in protecting sensitive, confidential, and privileged information and records that are generated in response to the requirements in the ethics laws and regulations.

This final OPM rule is internal (not branch-wide), and is essentially procedural, not substantive. It does not create a right to obtain official records or the official testimony of an OPM employee and it does not create any additional right or privilege not already available to OPM to deny any demand or request therefor. However, any failure to comply with the procedures in this rule would be a basis for denying a demand or request submitted to OPM.

For purposes of the Regulatory Flexibility Act (5 U.S.C. chapter 6), this final rule will not have a significant economic impact on a substantial number of small entities. The final rule addresses only the procedures to be followed in the production or disclosure of OPM materials and information in litigation where OPM is not a party. Accordingly, OPM has determined that a Regulatory Flexibility Analysis is not required.

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), the final rule would not significantly or uniquely affect small governments and would not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation).

In issuing this final regulation, OPM has adhered to the regulatory philosophy and the applicable principles of regulation as set forth in section 1 of Executive Order 12866, Regulatory Planning and Review. This final rule has not been reviewed by the Office of Management and Budget under that Executive Order since it is not a significant regulatory action with the meaning of the Executive Order.

As Acting Director of OPM, I have reviewed this final regulation in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.

The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this final regulation does not contain information collection requirements that require approval by the Office of Management and Budget. OPM expects the collection of information that is called for by the final regulation would involve fewer than ten persons each year.

Table of Contents I. Background and Purpose II. The Final Rule III. Discussion of Comments A. Objections to the Inadmissibility of HIV-Positive Aliens B. Opposition to Admission of HIV-Positive Aliens C. Asylees and the Required Waiver of Adjustment of Status D. Privacy Rights/Annotation of Visas E. Whether the Rule Is More Stringent Than the Existing Process F. Sufficient Insurance and Medication G. Human Rights Concerns H. Public Health Reasons for the Rule I. Disparate Treatment Applied to Contagious Diseases J. The 30-Day Temporary Admission Limit K. Extension of the Comment Period L. Vagueness in Criteria and Medical Expertise of Consular Officers M. Negative Impact on United States Citizens N. Focus on Illegal Aliens O. Aliens Who Are Unaware of Their HIV Status P. Appeal of Decision Q. Future Bar Due to Noncompliance R. Effect on Naturalization and Aliens From Visa Waiver Countries S. Returning Permanent Residents IV. Statutory and Regulatory Reviews I. Background and Purpose

Section 212 of the Immigration and Nationality Act (INA) makes ineligible for admission into the United States any nonimmigrant alien “who is determined (in accordance with regulations prescribed by the Secretary of Health and Human Services) to have a communicable disease of public health significance.” See INA section 212(a)(1)(A)(i); 8 U.S.C. 1182(a)(1)(A)(i); 42 CFR 34.2. 1 The Secretary of Homeland Security may authorize visa issuance and temporary admission of such nonimmigrants despite existing grounds of inadmissibility, subject to conditions prescribed by the Secretary. See INA section 212(d)(3)(A); 8 U.S.C. 1182(d)(3)(A).

On December 1, 2006, the President directed the Secretaries of State and Homeland Security to initiate a rulemaking action to propose a categorical authorization to allow HIV-positive nonimmigrant aliens to enter the United States through a streamlined process. See White House, Fact Sheet: World AIDS Day 2006 , (December 1, 2006), http://www.whitehouse.gov/news/releases . On November 6, 2007, DHS published a notice of proposed rulemaking proposing a streamlined process for HIV-infected nonimmigrant aliens to more easily enter the United States through a streamlined process. See 72 FR 62593.

This final rule adopts the proposed amendments to the regulations and simplifies the process for authorization of admission with some modifications in light of the public comments received. Under the final rule, DHS will allow aliens who are HIV-positive to enter the United States as visitors (for business or pleasure) for a temporary period not to exceed 30 days, without being required to seek such admission under the current, more complex (individualized, case-by-case) process provided under the current DHS procedures.

The current process requires the Department of State (DOS) to make individual recommendations to DHS, which must make a case-by-case evaluation and decision to authorize the issuance of the visa and the applicant's temporary admission. This process takes significant time. In fiscal year (FY) 2007, the average processing time for DHS to make decisions on such consular nonimmigrant recommendations (for issuance of visas and authorization for temporary admission) was 18 days. This final rule streamlines this process and will make visa authorization and issuance available to many aliens who are HIV-positive on the same day as their interview with the consular officer.

An alien who is HIV-positive is currently inadmissible to the United States under INA section 212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i), as implemented through 42 CFR 34.2. As more fully discussed in the proposed rule, such aliens have been, and are currently, able to apply for admission to the United States pursuant to INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A), and applicable DHS regulations (8 CFR 212.4(a)), which allow the Secretary of Homeland Security to authorize issuance of a visa and temporary admission despite certain grounds for inadmissibility. 72 FR 62593, 62594-5 (Nov. 6, 2007). These existing processes require specific, individualized action by DHS upon submission of eligibility information by the alien (the same kind of information that is required under the proposed regulations) that must be reviewed, evaluated, and ruled upon on a case-by-case basis. In contrast, the process established in this final rule would authorize a consular officer or the Secretary of State to categorically grant a nonimmigrant visa and authorize the applicant to apply for admission into the United States, notwithstanding an applicant's inadmissibility due to HIV infection, if the applicant meets applicable requirements and conditions, without the additional step of seeking review and decision by DHS prior to the granting of the nonimmigrant visa. This categorical authorization provides a more streamlined and rapid process for obtaining temporary admission under INA section 212(d)(3)(A)(i), 8 U.S.C. 1182(d)(3)(A)(i).

Under current criteria for authorizing admission of otherwise inadmissible nonimmigrant aliens generally, DHS must take into consideration the risk of harm to society if the applicant is admitted into the United States, the seriousness of any immigration law or criminal law violations (if any), and the nature of the reason for travel. See Matter of Hranka , 16 I&N Dec. 491 (BIA 1978). These are general criteria applicable to any application for authorization of a visa under INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A).

DHS currently allows otherwise inadmissible aliens to apply for admission on a case-by-case basis by employing a balancing test involving several factors that incorporates the criteria required under Hranka (regardless of whether the authorization is applied for before a consular officer, the Secretary of State, or directly to DHS). As discussed in the proposed rule, DHS applies these criteria to HIV-positive aliens seeking admission to the United States on a temporary basis by considering whether: (1) The danger to the public health from admission of the nonimmigrant alien is minimal; (2) the possibility of the transmission of the infection is minimal; and (3) any cost will be incurred by any level of government agency in the United States (local, State, or Federal) without the prior consent of that agency. Consular officers must find (based on evidence provided by the applicant that satisfies reviewing officials) that the first two factors are no more than minimal and that there will not be a cost to an agency absent prior consent.

This final rule incorporates these criteria, as well as additional factors applied under current policy that were developed in a series of instructions from the former Immigration and Naturalization Service (INS) and the Department of Justice (DOJ). Nonimmigrant aliens who are HIV-positive who do not meet the specific circumstances of these clarifying instructions or who do not wish to consent to the conditions imposed by this rule may still elect a case-by-case determination of their eligibility for issuance of nonimmigrant visas and admission.

This final rule provides an additional avenue for temporary admission of HIV-positive nonimmigrant aliens while minimizing costs to the government and the risk to public health. These goals are accomplished by setting requirements and conditions that govern an alien's admission, affect certain aspects of his or her activities while in the United States (e.g., using proper medication when medically appropriate, avoiding behavior that can transmit the infection), and ensure his or her departure after a short stay. This final rule facilitates the temporary admission to the United States of HIV-positive nonimmigrant aliens.

This final rule is consistent with Congress' humanitarian purpose in enacting the limited waiver of INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A), and complies with the statute regarding aliens inadmissible due to health reasons by prescribing “conditions * * * to control and regulate the admission and return of inadmissible aliens applying for temporary admission.” INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A). Thus, under the final rule, an HIV-positive applicant for a nonimmigrant visitor visa would be required to satisfy criteria designed to ensure that the risk to the public health is minimized to the greatest reasonable extent and that no cost will be imposed on any level of government in the United States (local, State, or Federal). The short duration of admission under the amended regulation, and the various conditions designed to control the alien's temporary stay and ensure his or her return (departure from the United States), minimize the risk of disease transmission in the United States, as well as the risk of increased burden on our public health resources. HIV-positive aliens not meeting the criteria under the amended regulation would still be able to seek individualized (case-by-case) consideration for admission pursuant to INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A), under current DHS policy. See 8 CFR 212.4(a) or (b).

The final rule includes specific requirements (based in large part on the existing criteria) discussed in the proposed rule. 72 FR at 62595-6. After consultation with the HHS' Centers for Disease Control and Prevention, and National Institutes of Health, and careful consideration of the comments received from the public on the proposed rule, DHS has determined not to change the criteria relating to medical etiology, personal understanding, limited potential health danger, continuity of health care, temporary admission, general enforcement, and general duration. DHS has made several modifications in light of the public comments, as discussed more fully below.

Several commenters questioned whether it was appropriate to impose a waiver of adjustment of status pursuant to a grant of asylum under INA section 208, 8 U.S.C. 1158. After further consideration, DHS agrees that asylees have continued eligibility for permanent resident status; therefore, under the final rule, an alien who has been granted asylum after having been admitted pursuant to the proposed categorical authorization will have continued eligibility to apply to adjust status under the asylum statute and regulations. However, nothing within the rule exempts the alien from the requirement that the alien establish his or her eligibility to adjust under INA section 209, 8 U.S.C. 1159. Specifically, nothing within this rule waives any of the requirements for adjustment of status including, but not limited to, the requirements in 8 CFR part 209.

Additionally, the short duration raised a number of questions about extensions. After further consideration, DHS has decided to permit an additional period or periods of satisfactory departure in exigent circumstances under a provision modeled after the Visa Waiver Program. See 8 CFR 212.4(f)(5) of this final rule.

Some commenters questioned whether aliens who receive this visa authorization will receive visas that identify them as HIV-positive. The visa will not be annotated in a manner that would allow the public to identify the alien as HIV-positive.

This final rule does not create the provision for temporary admission of HIV-positive aliens; such a provision exists in statute and regulation. This rule merely provides an alternative, quicker process for obtaining admission to the United States under INA section 212(d)(3)(A)(i) 8 U.S.C. 1182(d)(3)(A)(i). 2

The proposed rule solicited public comments over a 30-day comment period. DHS received over 700 comments.

By far the most numerous of all the comments are those objecting to the inadmissibility of HIV-positive aliens. Many of these commenters objected to the proposed rule's process and called for repeal of the governing statute's ban on HIV-positive aliens for various reasons, including the following: It is unnecessary and ineffective to protect the American public; it is discriminatory; it is unconstitutional; it is outdated and does not reflect current medical science. Others among these commenters expressed approval of the proposed process to streamline temporary admission for these aliens as a first step but also stated that the rule does not go far enough to make it easier for these aliens to travel to the United States. These latter commenters called also for the repeal of the statute's HIV admission ban as a next step. One commenter suggested that the United States mirror Australia's approach to admitting HIV-positive aliens (described only as less restrictive). Several commenters stated that international AIDS conferences are not held in the United States as a result of the inadmissibility of HIV-positive aliens.

Some commenters objected to the governing statute's inadmissibility provision that imposes the travel and immigration ban on HIV-positive aliens and to the proposed rule which, they claimed, creates the impression that the alleged discriminatory statute can be mitigated by the proposed process for temporary admission of these aliens. Some comments called upon the Secretary of Homeland Security and the President to withhold publication of a final rule and support repeal of the statute that imposes this inadmissibility.

Repeal of the statutory inadmissibility provision (the admission ban) applicable to HIV-positive aliens is within the province of Congress as a matter of law, and the President recently signed legislation that removes from applicable law the language requiring that HIV must be included in the list of communicable diseases of public health significance. See Public Law 110-293, 122 Stat. 2918 (July 30, 2008). The INA, as amended, makes inadmissible to the United States any alien “who is determined (in accordance with regulations prescribed by the Secretary of Health and Human Services) to have a communicable disease of public health significance * * *” INA section 212(a)(1)(A)(i), 8 U.S.C. 1182(a)(1)(A)(i). Although Public Law 110-293 eliminates the requirement that HIV be included in the list of communicable diseases of public health significance (as defined at 42 CFR 34.2), HIV remains on that list until HHS amends its regulation. See 42 CFR 34.2. HHS has indicated its intention to do so by rulemaking; pending such action, any alien who is HIV-positive is still inadmissible to the United States.

This regulation will permit short-term admission while HHS completes a rulemaking to remove HIV from the list of communicable diseases of public health significance. 42 CFR 34.2.

A few commenters expressed objection to admission of HIV-positive aliens under the discretionary authority provision of the governing statute and urged its repeal.

In the statute that imposed the ban on admission of aliens with communicable diseases of public health significance, Congress also provided for the discretionary exercise of authority to admit these aliens (among others) for a temporary period under certain circumstances. INA section 212(d)(3)(A), 8 U.S.C 1182(d)(3)(A). Congress restricted the availability of this discretionary authority by precluding its application to aliens who are inadmissible due to several of the security and related grounds; Congress imposed no such restriction on aliens inadmissible on other grounds, including health-related reasons. Also, Congress has made available a waiver of inadmissibility for immigrants seeking admission to the United States who are inadmissible due to a communicable disease listed by HHS. INA sections 209(c) and 212(g), 8 U.S.C. 1159(c) and 1182(g).

This rule does not create a new regulatory provision allowing HIV-positive aliens to enter the United States temporarily; the rule merely provides an alternative process in the regulations to streamline issuance of nonimmigrant visas to, and the temporary admission of, HIV-positive aliens under existing statutory authority within the Secretary's discretion. While the existing process provides for case-by-case authorization (by DHS) for issuing visas and authorizing temporary admission, the authorization process provided in this rule is categorical, i.e., authorization is granted through this rulemaking to any alien applicant who meets the requirements and conditions. The Secretary may exercise his discretion by rulemaking rather than on a case-by-case basis and is doing so here. Lopez v. Davis , 531 U.S. 230, 243-44 (2001) ( quoting American Hosp. Ass'n v. NLRB , 499 U.S. 606, 612 (1999)) (emphasis added); Yang v. INS , 79 F.3d 932, 936 (9th Cir.), cert. denied , 519 U.S. 824 (1996).

The final rule contains several requirements to minimize to the greatest reasonable extent public health risks and risk of cost to any agency of any level of government in the United States. The final rule also imposes conditions to control and regulate the admission and return (to their home countries) of beneficiaries of the categorical authorization.

Several commenters objected to the requirement of the proposed rule that an applicant must waive his right to file for an adjustment of status to that of lawful permanent resident if he applied for and was granted asylum in the United States. Some commenters objected also to the requirement that an applicant must waive his right to file, after entering the United States under the proposed categorical authorization, an application for a change of nonimmigrant status or extension of stay.

DHS agrees that asylees obtain a special status under INA section 208, 8 U.S.C. 1158, that, where possible, should be recognized consistently. Therefore, DHS has modified the adjustment of status waiver in the final rule to clarify that applicants for the categorical authorization will not be required to waive the opportunity to apply for adjustment of status should they be granted asylum after entering the United States via the categorical process. The final rule will retain the required waivers relating to change of nonimmigrant status, extension of stay, and adjustment of status other than through the asylum process. Any alien who is unwilling to agree to these waivers may apply for temporary admission under the existing process of 8 CFR 212.4(a) which is not conditioned on the making of these waivers. However, this waiver is for admission as a nonimmigrant. These visas are not available for aliens who intend to stay permanently in the United States as immigrants. Aliens seeking permanent resident status must apply for immigrant visas and fulfill the requirement for immigrants set out in the INA.

Many commenters expressed concern about the privacy of applicants for the proposed categorical authorization. Primarily, the concern relates to whether the alien's visa (included within his or her passport) would be annotated to indicate admission under the rule's categorical authorization process. These commenters emphasized the stigma attached to HIV status and the risk that annotation could subject these aliens to discrimination. Some of these commenters expressed privacy concerns relative to a DHS database for HIV-positive aliens.

Some commenters questioned whether aliens who receive this visa authorization will receive visas that identify them as HIV-positive. The visa will not be annotated in a manner that would allow the public to identify the alien as HIV-positive.

Section 222(f) of the INA, 8 U.S.C. 1202(f), provides that DOS records pertaining to visa issuance or refusal are confidential, and shall be used only for the formulation, amendment, administration, or enforcement of the immigration and other laws of the United States, with exceptions not relevant here. These confidentiality provisions serve to protect disclosures made as part of an application for a nonimmigrant visa by an alien who is HIV-positive. Moreover, under the final rule's categorical authorization process, unlike the existing process, there is no need for DHS to make case-by-case determinations on individual recommendations from the DOS. DHS will necessarily create the same records relative to aliens receiving authorization for visa issuance under the process (e.g., electronic records), as DHS normally creates for all aliens with visas who gain temporary admission as nonimmigrants. DHS will not maintain a separate database of aliens who are admitted under the categorical authorization process.

DOS scrupulously adheres to the statutory requirement regarding the confidentiality of information submitted during the consular interview process. Record information on applicants will be maintained by the DOS in accordance with confidentiality and security requirements, as well as any DOS System of Records Notices and Privacy Impact Assessments relative to any applicable systems covering this data collection.

Many commenters contended that the requirements and conditions of the proposed process make it more stringent than the existing process. These commenters therefore questioned that it is a “streamlined” process. Some recommended simplifying the process. One commenter suggested that DHS not make any change to the regulations, leaving the existing case-by-case process as the sole option.

The characterization of the categorical authorization process under the proposed rule and this final rule as “streamlined” refers to the fact that the process, unlike the existing process, does not require the alien's application for a visa and temporary admission to be submitted to DHS with the consular officer's recommendation. Under the existing process, DHS must make a case-by-case evaluation and decision to authorize the issuance of the visa and the applicant's temporary admission. This step in the process necessarily takes time. In FY 2007, the average DHS processing time for all consular nonimmigrant recommendations (for issuance of visas and authorization for temporary admission) was 18 days. The categorical authorization process under this final rule does not require that step, and, therefore, the rule is less cumbersome and permits consular officers to issue visas on the same day the alien applies for the visa in many cases. The process is, therefore, more streamlined.

DHS is authorizing issuance of visas and temporary admission on a categorical basis only to those aliens who meet the rule's specific requirements and conditions. An alien may choose to apply for temporary admission under the existing case-by-case decision process if he or she wishes.

The existing process also imposes conditions that an applicant must meet to gain temporary admission, many of which are the same or similar to the conditions of this final rule's process. The conditions of the existing process have been developed through adjudication ( see Matter of Hranka , 16 I&N Dec. 491 (BIA 1978)) and several instructions issued by the former INS. With this final rule, DHS is consolidating into one transparent source, the conditions and instructions applicable to HIV-positive aliens who wish to apply for categorical authorization for admission to the United States; the same conditions that have historically governed discretionary temporary admission under INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A). The process implemented under this final rule retains the same evidentiary requirements as the existing process while providing an alternative to the case-by-case review by DHS that is required under the existing regulation. The rule, however, adds restrictions on application for extension of stay, change of nonimmigrant status, and adjustment of status to that of permanent resident (other than through asylum). These restrictions are necessary to control the admission and return of these aliens since DHS is not performing a case-by-case review.

Many commenters objected to the requirement in the proposed rule (8 CFR 212.4(f)(2)(v)), that an alien admitted under the proposed process for categorical authorization have possession of or access to an adequate supply of antiretroviral drugs (if medically appropriate) for the length of anticipated stay, and sufficient assets, such as medical insurance, to cover any medical care that may be necessary while in the United States. Some of these commenters mentioned that an alien may not have insurance or enough money to cover a medical event, some referring particularly to aliens from poor countries. Others questioned how an alien could establish adequate assets, some referring again to aliens from poor or third world countries. Still others asked about unanticipated expenses, and objected to requiring assets for these expenses. Lastly, several commenters suggested that this rule is racist because HIV-positive populations from developing countries are less likely to have access to medication and medical insurance.

The requirement to demonstrate availability of assets, such as through proof of insurance, is a reasonable condition meant to ensure that the applicant's short-term visit will not cause a financial burden to the American public and that there will be no cost to any agency of the United States without that agency's prior consent. An alien who is likely to become a public charge is inadmissible to the United States under INA section 212(a)(4), 8 U.S.C. 1182(a)(4). The totality of circumstances must be considered in determining whether or not a person is likely to become a public charge. The requirement that an alien possess an adequate supply of medication (if medically appropriate), or have access to such a supply in the United States, would reduce this risk. DHS is aware that prescribed medication is not always necessary; the treatment protocol is determined by the patient's medical service provider. As with other medical determinations for visa purposes, the appropriateness of the alien's treatment protocol is subject to review by DOS' panel physicians. The requirement that the applicant not currently be exhibiting symptoms of an active, contagious infection with AIDS is also relevant to this determination.

Another consideration in deciding whether to exercise discretion favorably for an applicant for categorical authorization is whether any cost will be incurred by any agency of the United States (including State and local government) without that agency's prior written consent. Thus, applicants who do not have sufficient assets to cover the cost of their stay will not benefit from this new provision. Any written offer by a United States agency to provide medication and/or funding that is adequate for the applicant's travel will be considered a favorable factor. Any credible offer from any other financially stable source to provide medication and/or funding that is adequate for the applicant's travel will also be considered a favorable factor. In addition, the nature and duration of the applicant's travel plan and his or her present health are factors for consideration.

An applicant may establish that resources are available to cover medical expenses through several means. First, some medical facilities are operated by State or Federal agencies and, as a matter of policy, do not make provisions for collecting fees from patients accepted for treatment. If an applicant establishes, through documentation provided by a medical facility, that the facility has agreed to provide the applicant services without reimbursement, or that its free services are available to the applicant or to similarly situated persons (such as nonimmigrant aliens) without specific mention of the applicant, the applicant is eligible for visa issuance and temporary admission even if the facility is supported by public funds.

An applicant may have sufficient personal assets to cover anticipated treatment. The assets must be available in the United States within the time frame required for payment by the medical facility. Assets can be established by commonly available documentation. Sponsors (individuals or organizations) may offer to cover potential medical expenses. Such sources should be able to provide documentation of intent and capability to provide that coverage. Finally, short-term medical trip insurance may be available to cover medical costs that the applicant may incur during the relatively short (30-day) period of admission. In every instance above, the applicant must, and should be able to, satisfy the consular officer that assets will be available within the United States to cover anticipated expenses. Again, an alien may seek admission under the existing process if he is unwilling or unable to meet the conditions of this final rule's process. The existing process, through the consular officer interview and DHS review, involves many similar requirements relating to the applicant's health and ability to cover expenses.

Regarding unanticipated medical expenses, the likelihood of such expenses is judged by the totality of circumstances in each applicant's case. Offers of support from individuals and organizations, as well as personal assets, will be given consideration.

DHS and DOS will make every effort to ensure that these regulations are applied consistently without regard to inappropriate considerations, such as an applicant's race.

Some commenters pointed out that the United States is one of only a few countries in the world that restricts travel for those who are HIV-positive. These commenters contended that this is a violation of basic human rights (to travel) and that DHS and HHS should remove HIV infection from the list of contagious diseases of public health significance.

As discussed in the proposed rule, historically, Congress clearly expressed its intent that HIV infection be listed as a communicable disease of public health significance in enacting a statute to that effect. Because Public Law 110-293 eliminated a mandatory listing from the INA, HHS has indicated that it is beginning the process of removing HIV from the list of communicable diseases of public health significance by rulemaking. However, while that process is developing, through rulemaking, DHS is providing a streamlined process for these aliens to be granted temporary admission into the United States as an immediate interim option, pending HHS's plan to remove HIV from the list of communicable diseases of public significance.

Several commenters contended that the proposed process, with its requirements and conditions, is not supported by medical science, i.e. , that the need for the limitations in admitting HIV-positive aliens is not based on sound public health reasons.

The final rule's process was developed in consultation with HHS's Centers for Disease Control and Prevention and National Institutes of Health. DHS relied on those knowledgeable agencies to provide input based on current science. HHS continues to list HIV as a communicable disease of public health significance and DHS must continue to apply the statutory provisions regarding inadmissibility and discretionary authority for temporary admission in a manner appropriate to safeguard the public from what is still recognized under the current statute and regulation as a disease of public health significance.

A few commenters contended that the statutes and regulations pertaining to inadmissibility, discretionary authorization, and process that limit admission to the United States treat HIV infection differently than other communicable diseases, including sexually transmitted diseases (STDs). These commenters questioned the rationale for this disparate treatment and contended that the statute discriminated against aliens who are HIV-positive.

When the statute treated HIV infection (whether or not it is considered a STD) as a communicable disease of public health significance that disqualifies a carrier of the disease from admission to the United States (subject to exception), DHS utilized a lengthy detailed process for determining whether to grant temporary admission. Accordingly, DHS proposed an alternative, streamlined process for HIV-positive aliens to be granted temporary admission into the United States pending completion of HHS rulemaking.

The HHS list does not cover all communicable diseases, but HHS is charged with the responsibility and has the expertise to make distinctions. Some diseases are on the list, including some STDs (HIV, gonorrhea), while others are not. That a given disease is placed on the list while others are not is not, by itself, evidence of discrimination, nor does it show that the disease is wrongfully on the list. Other non-STDs covered include leprosy (infectious) and tuberculosis (active). Other STDs covered include chancroid, granuloma inguinale, lymphogranuloma vereneum, and syphilis (infectious stage). As HIV remains on the HHS list pending further action, publishing a final rule to put into place a streamlined process for temporary admission is appropriate.

A few commenters objected to the 30-day limit imposed by the rule for HIV-positive aliens entering the United States under the rule's categorical authorization process. These commenters contended that this period is needlessly short.

DHS has previously granted blanket authorizations under INA section 212(d)(3)(A), 8 U.S.C. 1182(d)(3)(A), for specific, limited purposes, such as to permit HIV-positive aliens to attend particular events, including the Salt Lake City Olympic games, the United Nations General Assembly Special Session on HIV/AIDS in 2001, various Universal Fellowship of Metropolitan Community Churches events, and the 2006 Gay Games in Chicago. Since 1990, aliens who are HIV-positive have rarely been given blanket authorizations for an admission of greater than 10 days. This new process will allow admissions for up to 30 days, which is in line with 30-day admissions often authorized under the individualized, case-by-case process.

The final rule describes a new (alternative) option for nonimmigrant aliens with HIV who wish to enter the United States in B-1/B-2 status for periods of time that do not exceed 30 days (but a provision for authorization of satisfactory departure in exigent circumstances is included in this final rule). Moreover, the final rule authorizes two applications for admission during the 12-month period of the visa validity. This reasonable condition of visa issuance and admission to the United States applies to the majority of nonimmigrants traveling to the United States (regardless of particular nonimmigrant status). For those who anticipate traveling in other nonimmigrant categories or for longer than 30 days, the processes described in 8 CFR 212.4(a) and (b) remain available.

Moreover, many of the admissions under the existing process for HIV-positive aliens have been more narrowly limited to periods corresponding to a particular event in the United States, such as a seminar or convention. Typically, these admissions have been for less than 30 days. Admission under the existing discretionary authorization process also has been more restrictive for nonimmigrant aliens seeking to enter the United States for general tourism purposes. In these respects, the final rule's process is more advantageous to HIV-positive aliens seeking to enter the United States.

However, DHS recognizes that emergencies do occur and, accordingly, has added to this final rule a provision for authorizing an additional period or periods of stay, as appropriate and as deemed necessary by appropriate DHS officials, where an alien admitted under the final rule's process experiences exigent circumstances that prevent his or her departure from the United States. This provision is modeled after the “satisfactory departure” provision under the Visa Waiver Program regulations. 8 CFR 217.3(a); see 8 CFR 212.4(f)(5) as adopted in this final rule.

A few commenters requested additional time to file comments on the proposed rule.

The comment period was open for 30 days, and over 700 persons submitted comments. The comments submitted come from a wide variety of persons and appear to cover a wide breadth of relevant issues and objections. DHS concludes that there was adequate opportunity for public participation and does not see the need to extend the comment period.

One commenter stated that the criteria of the rule's categorical authorization process that must be met are vague and cannot be administered consistently because consular officers are not able to assess the medical conditions the proposal vaguely puts forward. Similarly, four commenters suggested that consular officers are not trained to handle medical issues.

DHS disagrees. DOS has extensive experience processing applications under the existing HIV authorization process. In order to ensure consistent application of the criteria, DOS has issued specific instructions to consular officers regarding how to evaluate applications for admission to the United States, including medical issues such as those in question. In addition, consular officers may consult with panel physicians to assist with medical issues when necessary.

One commenter stated that the proposal would have a negative effect on United States citizens.

DHS disagrees with this comment. This rule only affects nonimmigrant alien visitors to the United States and has no direct effect on United States citizens.

One commenter suggested that DHS should focus its resources on the illegal alien population in the United States.

DHS is committed to enforcing the laws within its purview, including those laws that relate to illegal immigration and those laws that relate to public health concerns.

One commenter suggested that DHS should focus its resources on those aliens seeking admission to the United States who are not yet aware that they are HIV-positive. Another commenter suggested that DHS focus on education and the prevention of AIDS.

In order to determine whether undiagnosed nonimmigrant aliens are HIV-positive, a medical examination would be required for all nonimmigrant visa applicants. DHS is not proposing to require such an examination as part of this rulemaking. However, the U.S. government is committed to preventing the global spread of AIDS through education and other measures.

One commenter objected because the proposed regulation does not specifically provide for appeal of a consular officer's decision. If an alien is denied a visa and temporary admission under the rule's process, he or she may seek admission under the existing process for a case-by-case determination of eligibility.

One commenter contended that an alien who fails to comply with a condition of admission under the final rule's process should not be barred from seeking authorization under the process in the future.

DHS disagrees and believes that this is a reasonable condition to ensure that nonimmigrant aliens comply with the conditions for admission under this rule's process. In addition, an alien who is ineligible for authorization under these regulations because he or she has previously failed to comply with a condition for admission, or for other reasons, can still seek authorization under the existing case-by-case process. This is similar to the restriction of previous violators of the Visa Waiver Program (VWP) from being able to use the VWP program again for admission. See INA section 217(a)(7), 8 U.S.C. 1187(a)(7). In both of these situations, the violator may still apply for a visa; he or she is only barred from using the streamlined process of this regulation or VWP, respectively.

One commenter expressed concern regarding the effect of the proposed regulations on a permanent resident's ability to become a United States citizen. Several commenters expressed concern regarding the effect of the proposed regulations on travelers from visa waiver countries.

The rule's process does not affect the eligibility of a permanent resident to qualify for naturalization. In addition, these regulations do not change eligibility for aliens seeking admission to the United States under the Visa Waiver Program.

One commenter objected that an HIV-positive alien with permanent resident status could never travel outside the United States because he would not be allowed to return.

An alien with status as a permanent resident of the United States who travels temporarily outside the United States and returns is not considered to be applying for admission for immigration purposes unless one of the six conditions delineated in INA section 101(a)(13)(C), 8 U.S.C. 1101(a)(13)(C), apply. Therefore, absent any of one of the six conditions, a permanent resident alien who travels outside the United States will not be subject to any of the grounds of inadmissibility found at INA section 212(a), 8 U.S.C. 1182(a). If one of the six conditions applies, the permanent resident alien is subject to any applicable ground of inadmissibility.

The Administrative Procedure Act, 5 U.S.C. 553(d), generally requires that a final rule becomes effective no less than 30 days from the date of publication. Rules that grant or recognize an exception or relieve a restriction, however, can be made effective immediately upon publication. This rule does not add new requirements or restrictions; instead it codifies existing criteria for nonimmigrant aliens infected with HIV to obtain a short-term visa authorization. This final rule also removes certain procedural obstacles in the process and provides a more streamlined procedure for HIV-positive aliens to seek admission into the United States. DHS therefore believes that this rule relieves current restrictions on the admissibility to the United States of HIV-positive nonimmigrant aliens. Accordingly, this final rule will become effective immediately upon publication in the Federal Register .

DHS has reviewed the final rule in accordance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), and, by approving it, certifies that this rule will not have a significant economic impact on a substantial number of small entities. The individual non-immigrant aliens to whom this rule applies are not small entities as that term is defined in 5 U.S.C. 601(6). Thus, the RFA does not apply.

The final rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule has been determined to be a significant regulatory action under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, this regulation has been submitted to the Office of Management and Budget for review. There are no new costs to the public associated with this rule. This rule does not create any new or additional requirements.

The final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

The final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

Under the Paperwork Reduction Act of 1995, Public Law 104-13, all Departments are required to submit to OMB, for review and approval, any reporting and recordkeeping requirements inherent in a rule. This rule does not impose any new reporting or recordkeeping requirements under the Paperwork Reduction Act.

The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996, 28 U.S.C. 2461 note (FCPIA Act), requires each Federal agency to adjust each CMP within its jurisdiction by a prescribed cost-of-living adjustment at least once every four years. This cost-of-living adjustment is based on the formula described in section 5(b) of the FCPIA Act. The Board made its last adjustment in October 2004 (see 69 FR 56929).

The required cost-of-living adjustment formula is based on the difference between the Consumer Price Index (CPI) for June of the year preceding the adjustment (in this case, June 2007) and the CPI for June of the year when the CMP was last set or adjusted. To calculate the adjustment, the Board used the Department of Labor, Bureau of Labor Statistics—All Urban Consumers tables, in which the period 1982-84 was equal to 100, to get the CPI values.

The calculations performed for the 2008 adjustment consisted of four categories, depending on the year in which the penalty was last set or adjusted. For penalties that changed in 2004, the relevant CPIs were June 2007 (208.352) and June 2004 (189.7), resulting in a CPI increase of 9.8 percent. For penalties that were last changed in 2000, the relevant CPIs were June 2007 (208.352) and June 2000 (172.4), resulting in a CPI increase of 20.9 percent. For penalties that were last changed in 1996, the relevant CPIs were June 2007 (208.352) and June 1996 (156.7), resulting in a CPI increase of 33.0 percent. One penalty did not exist at the time of the last adjustment and became effective in December 2005. For that penalty, the relevant CPIs were June 2007 (208.352) and June 2005 (194.5), resulting in a CPI increase of 7.1 percent.

Section 5 of the FCPIA Act provides that the adjustment amount must be rounded before adding it to the existing penalty amount. The rounding provision depends on the size of the penalty being adjusted. For example, if the penalty is greater than $100 but less than or equal to $1,000, the increase is rounded to the nearest $100; if it is greater than $1,000 but less than or equal to $10,000, the increase is rounded to the nearest $1,000. Because of this rounding rule, six penalty amounts are not changing at this time. For example, the penalty under 12 U.S.C. 3909(d) prior to the 2008 adjustment was $1,100. As this penalty was last changed in 1996, the 33 percent adjustment would be $363. Rounding that increase to the nearest $1,000 results in an increase of $0. The penalties that are not adjusted at this time because of this rounding formula will be subject to adjustment at the next adjustment cycle to take account of the entire period between the time of their last adjustment (1996, 2000, or 2004) and the next adjustment date. These unadjusted penalties include the inadvertently late or misleading reports under 12 U.S.C. 324; 12 U.S.C. 1832(c); Tier I penalty of 12 U.S.C. 1847(d), 3110(c); 12 U.S.C. 334, 374a, 1884; 12 U.S.C. 3909(d); and 42 U.S.C. 4012(a)(f)(5).

In accordance with section 6 of the FCPIA Act, the increased penalties set forth in this amendment apply only to violations that occur after the date the increase takes effect.

Public Law 104-134, title III, § 31001(s)(2), April 21, 1996, 110 Stat. 1321-272 amended the FCPIA Act and provided that “[t]he first adjustment of a civil monetary penalty * * * may not exceed 10 percent of such penalty.” Although there is one penalty for which an initial adjustment is being made, 12 U.S.C. 1820(k)(6)(A)(ii), due to the effect of the rounding rules, the calculated dollar amount increase in the penalty is the same as a 10 percent increase in this case.

This rule is not subject to the provisions of 5 U.S.C. 553 requiring notice, public participation, and deferred effective date. The FCPIA Act provides Federal agencies with no discretion in the adjustment of CMPs to the rate of inflation, and it also requires that adjustments be made at least every four years. Moreover, this regulation is ministerial and technical. For these reasons, the Board finds good cause to determine that public notice and comment for this new regulation is unnecessary, impractical, and contrary to the public interest, pursuant to the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B). These same reasons also provide the Board with good cause to adopt an effective date for this regulation that is less than 30 days after the date of publication in the Federal Register , pursuant to the APA, 5 U.S.C. 553(d).

The Regulatory Flexibility Act applies only to rules for which an agency publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). See 5 U.S.C. 601(2). Because the Board has determined for good cause that the APA does not require public notice and comment on this final rule, we are not publishing a general notice of proposed rulemaking. Thus, the Regulatory Flexibility Act does not apply to this final rule.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 35; 5 CFR Part 1320 Appendix A.1), the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. No collections of information pursuant to the Paperwork Reduction Act are contained in the final rule.

On July 31, 2008 (73 FR 44630), we published a final rule AD, FR Doc, E8-17423, in the Federal Register . That AD applies to RRD Dart 528, 529, 532, 535, 542, and 552 Series turboprop engines. We need to make the following correction:

This rule amends the EAR to make various revisions as a result of a systematic review of the CCL that was conducted by BIS. This rule is the second phase of the regulatory implementation of the results of that systematic review of the CCL that was conducted by BIS beginning in 2007. The CCL review benefited from input received from BIS's Technical Advisory Committees (TACs) and public comments received in response to a notice of inquiry (July 17, 2007, 72 FR 39052).

On April 18, 2008, BIS published the first phase of the regulatory implementation of the CCL review in a rule titled, “Technical Corrections to the Export Administration Regulations based upon a Systematic Review of the CCL” (73 FR 21035). The first CCL review rule focused on making needed technical corrections and clarifications to the CCL. This rule, the second CCL review rule, makes substantive revisions to the EAR, including the CCL. The revisions to the CCL in this rule are divided into four types of revisions in this background section of the preamble: (I) Clarifications to Existing Controls, (II) Eliminating Redundant or Outdated Controls, (III) Establishing More Focused and Rationalized Controls, and (IV) Adding Additional Controls for Clarity or for Consistency with International Regimes.

As a part of the implementation phase of the CCL review, the agency has also taken other non-regulatory actions to improve the public's understanding of the CCL. These BIS actions have involved publishing certain advisory opinions and creating new web guidance to provide greater clarity to exporters and reexporters regarding existing provisions of the CCL. BIS has also created a new process whereby it has stated its intention to conduct similar types of systematic reviews of the CCL in the future in order to continuously improve the CCL.

This rule makes the following revisions to the Export Administration Regulations (EAR):

1. In Supplement No. 7 to part 742 (Description of Major Weapons Systems), under paragraph (7)(c) (Missiles and Missile Launchers), this rule adds the phrase “except model airplanes” to clarify that the unmanned aerial vehicles (UAVs) subject to this paragraph do not include model airplanes.

2. In § 744.21 (Restrictions on Certain Military End-Uses in the People's Republic of China (PRC)), this rule makes two changes under paragraph (a) (General Prohibition) to clarify the intended scope of the items subject to this end-use control. Under the introductory text of paragraph (a), this rule clarifies that the items that are subject to the general prohibition are any items listed in Supplement No. 2 to part 744 that are subject to the EAR. Adding the phrase “subject to the EAR” will clarify that this prohibition does not extend to items that are not subject to the EAR, such as information that is publicly available. This change is needed because the § 772.1 definition of the term “item” does not distinguish between those items that are subject to the EAR and those that are not. Given this broad definition, in this paragraph the term “item” should be qualified with the phrase “subject to the EAR”.

The Commerce Control List (CCL) (Supplement No. 1 to Part 774 of the EAR) is amended by making various substantive revisions to the CCL that are divided below into four types of revisions: (I) Clarifications to Existing Controls, (II) Eliminating Redundant or Outdated Controls, (III) Establishing More Focused and Rationalized Controls, and (IV) Adding Additional Controls for Clarity or for Consistency with International Regimes.

This rule is making revisions to the headings of three (3) CCL entries: 2B351, 4D993 and 6A995, to clarify the items controlled under those CCL entries.

ECCN 2B351 is amended by revising the heading to clarify the items controlled under this CCL entry by adding the phrases “as follows” and “see List of Items Controlled”.

ECCN 4D993 is amended by adding the phrase, “see List of Items Controlled” at the end of the heading of the CCL entry. This rule also makes revisions to the “Items” paragraph of this ECCN by adding the conjunction “or” between “Items” paragraphs (b) and (c) to clarify the scope of the items controlled under this CCL entry.

ECCN 6A995 is amended by revising the heading to remove the phrase “not controlled by 0B001.h.6, 6A005 or 6A205”, and replacing that with the phrase, “see List of Items Controlled” to the heading of this CCL entry. This revision is intended to clarify the scope of the control.

This rule revises the “Related Controls” paragraphs in the List of Items Controlled section in the following twelve (12) CCL entries: 1C351, 1C352, 1C353, 1C354, 1C360, 2B119, 2B350, 4E992, 7D001, 7D002, 7E002, and 7E101 by adding additional related control references or making changes for greater specificity for the related controls references. BIS includes related control references in CCL entries to assist exporters in classifying items on the CCL and in some cases provides cross-references for items that are listed on the CCL, but are under the export control jurisdiction of other U.S. Government agencies. Several of the public comments received by BIS, as a part of the CCL review process, requested that BIS add these types of additional related controls references to better assist the public in classifying their items using the CCL.

The revisions being made to the “Related Controls” paragraphs under these six (6) CCL entries: 1C351, 1C352, 1C353, 1C354, 1C360, and 2B350 also involve revising and moving text from the “Related Controls” paragraph to new License Requirement notes for those CCL entries. These revisions make no change to the scope of the items controlled under those CCL entries. However, it was determined during the CCL review, that those “Related Controls” under those CCL entries could be better characterized as “License Requirement Notes”. Given that determination, BIS decided it would be helpful to move those “Related Controls” references to new “License Requirement Notes” to better assist exporters and reexporters when classifying their items.

ECCN 1C351 is amended by moving subparagraphs (2) through (4) from the “Related Controls” paragraph to the newly created “License Requirement Notes” and redesignating subparagraph (5) of the “Related Controls” paragraph as a subparagraph (2).

ECCN 1C352 is amended by moving subparagraph (1) from the “Related Controls” paragraph to the newly created “License Requirement Note” and redesignating subparagraph (2) of the “Related Controls” paragraph. This rule also makes some minor revisions for clarity in the text of the new “License Requirement Note”.

ECCN 1C353 is amended by moving the first sentence from the “Related Controls” paragraph to the newly created “License Requirement Note”, and leaving the second sentence, which references related controls from the Centers for Disease Control and Prevention (CDC), U.S. Department of Health and Human Services controls and the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, in the “Related Controls” paragraph.

ECCN 1C354 is amended by moving subparagraph (1) from the “Related Controls” paragraph to the newly created “License Requirement Note” and redesignating subparagraph (2) of the “Related Controls” paragraph. This rule also makes some minor revisions for clarity to the text of the new “License Requirement Note”.

ECCN 1C360 is amended by moving subparagraph (1) from the “Related Controls” paragraph to the newly created “License Requirement Note” and redesignating subparagraphs (2) and (3) in the “Related Controls” paragraph as subparagraphs (1) and (2). This rule also makes some minor revisions for clarity for the text in the new “License Requirement Note”.

The revisions made to the “Related Controls” paragraphs under the following six (6) CCL entries: 1D001, 4E992, 2B119, 7D001, 7D002 and 7E002 all involve removing nonexistent ECCNs that were listed as “Related Controls” references under those CCL entries. ECCN 1D001 had an outdated “Related Controls” reference to the nonexistent 1D102. ECCN 2B119 referred to a nonexistent 2B219, and 4E992 referred to a nonexistent 4E994. Under ECCNs 7D001, 7E001 and 7E002 outdated references to the nonexistent 7A007 are all removed with this rule.

This rule makes revisions to the “Items” paragraphs under the following two (2) CCL entries: 1C350 and 2B350 to provide greater clarity regarding the items controlled under those CCL entries. These changes include adding additional text under some of these CCL entries, rearranging text of some of these CCL entries to improve readability, or revising the “Items” paragraphs of these CCL entries to clarify the intended scope of the control. Specifically, these revisions include the following:

ECCN 1C350 is amended by adding a sentence at the end of “Note 2” of the “License Requirement Notes” section to make persons aware that although certain mixtures as described in this note may be classified EAR99, a license may still be required for reasons set forth elsewhere in the EAR. This is stated in other parts of the EAR, but this additional text being added to this CCL entry will help make persons aware that although their commodity may not be controlled under this CCL entry, it still may require a license under other parts of the EAR.

ECCN 2B350 is amended by reordering the “Items” paragraph in the List of Items Controlled Section in order to improve the readability of the “Items” paragraph. This rule makes no changes to the items that are controlled under ECCN 2B350. This reordering of the “Items” paragraph for parallelism helps improve the readability of the “Items” paragraph of that ECCN entry. BIS is making this change to better assist the public in classifying their materials under this ECCN. In addition, this rule redesignates the “Technical Note” at the end of the “Items” paragraph in the List of Items Controlled section, as “Technical Note 1”, and adds a “Technical Note 2” to define the term “alloy”. This new definition of “alloy” clarifies to the public that the metal alloys in 2B350 are those containing a higher percentage by weight of the stated metal than any other element. Lastly, under this CCL entry, this rule moves the text of the “Related Controls” paragraph to a new “License Requirement Note” to clarify the intended scope of the control.

This rule makes clarifications to the “Items” paragraphs in these two (2) CCL entries: 4A101and 4A980 to clarify what items are controlled under those entries and to better conform those entries to the language used in multilateral control lists.

ECCN 4A101 is amended by adding a new note at the end of the “Items” paragraph in the List of Items Controlled section to provide a definition for “radiation hardened”. “Radiation hardened” is used in paragraph (b) of the “Items” paragraph, but no definition was provided, prior to publication of this rule, for this term. This new note clarifies that under this CCL entry, “radiation hardened” means that the component or equipment is designed or rated to withstand radiation levels which meet or exceed a total irradiation dose of 5 × 10  5 rads (Si). This revision will assist the public in understanding the types of analog computers, “digital computers” and differential analyzers that are controlled under this ECCN entry.

ECCN 4A980 is amended by adding a new note at the end of the “Items” paragraph to clarify the existing control. This note clarifies that ECCN 4A980 does not control equipment limited to one finger and designed for user authentication or access control.

Category 1 (Materials, Chemicals, “Microorganisms,” and Toxins) of the CCL, is amended by adding a new note to the beginning of the category to make the public more aware that the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) may control exports of items subject to the EAR and on the CCL. Public comments submitted for the CCL review suggested that BIS add additional cross-references on the CCL to the FDA and DEA regulations. Supplement No. 3 to Part 730 (Other U.S. Government Departments and Agencies with Export Control Responsibilities) and certain ECCN cross-references to other agencies' controls already accomplish the same type of thing. However, in conducting the CCL review, BIS determined it would be helpful to the public to add a new note at the beginning of Category 1 to make the public more aware that these other agencies of the U.S. Government may also apply controls to these items. This note makes no changes to the items subject to the EAR.

1.ECCN 4A994 is amended by making various revisions to the “Items” paragraph of this CCL entry to remove technically outdated controls and to update certain technical control parameters to better reflect current industry standards. Specifically, this rule deletes paragraphs (d), (e), (g), (h), and (k)(1) of the “Items” paragraph in the List of Items Controlled section of this CCL entry. This change is being made because these controls are technically outdated, so these commodities no longer need to be controlled under this CCL entry. Under paragraph (b) of the “Items” paragraph, this rule clarifies the types of digital computers that are controlled under this CCL entry and increases the Weighted TeraFLOPS (WT) control threshold for this paragraph (b) from 0.00001 WT to 0.0128 WT. In addition, under paragraph (c) of the “Items” paragraph, this rule deletes the technically outdated control parameter that was listed under paragraph (c)(2) prior to publication of this rule. This change to paragraph (c) will specify that “electronic assemblies” covered under this paragraph are those that are designed to be capable of aggregation in configurations of 16 or more processors. Finally, under paragraph (k), this rule clarifies the types of “hybrid computers” and “electronic assemblies” and specially designed components that are controlled under this CCL entry.

2.ECCN 5A991 is amended by removing three outdated entries from the “Items” paragraph under paragraphs (b)(8), (c)(2), and (c)(4) of this CCL entry. In the public comments, people asked for clarifications regarding what commodities were controlled under these three “Items” paragraphs under ECCN 5A991. However, in reviewing these three technical parameters, BIS determined that for each of the commodities controlled under this ECCN, the commodities were either covered under another ECCN (meaning these entries were merely empty boxes on the CCL), or the commodities that were controlled under one of these three “Items” paragraphs were outdated and should appropriately be designated EAR99 (meaning the commodities controlled under these three paragraphs, that were not already controlled under another ECCN entry, were no longer commonly used by industry or the general public).

1. ECCN 1E001 is amended by adding Australia and Norway to the list of countries that are eligible to receive technology controlled under this ECCN under the provisions of License Exception TSR (Technology and software restricted) (§ 740.6), as described under paragraphs (a) or (b) of the License Exception TSR paragraph in the License Exceptions section of this ECCN entry. Prior to publication of this rule, there were seventeen countries that were eligible for License Exception TSR under this CCL entry. When this list of seventeen countries eligible for License Exception TSR was added to the CCL entry on January 15, 1998 (63 FR 2482), Australia and Norway were inadvertently not included, which is being corrected with this rule. With the addition of Australia and Norway, nineteen countries are now eligible to receive technology under License Exception TSR. As with any EAR list-based license exception, the provisions of § 740.2 and the specific provisions of the list-based license exception, in this case License Exception TSR, determine whether a list-based license exception can be used to authorize a specific transaction.

2. ECCN 2B018 is amended by removing an advisory note from the “Items” paragraph and converting that note into License Exception GBS eligibility (Shipments to Country Group B Countries) (15 CFR 740.4). The items that were described in that advisory note, prior to publication of this rule, will now be eligible for License Exception GBS, provided the transaction meets the terms and conditions of License Exception GBS and § 740.2. Under ECCN 2B018, the entire entry is controlled for national security reasons under NS column 1 and regional stability reasons under RS column 2, among others reasons for control. To be eligible for License Exception GBS, the ultimate destination must be subject to a license requirement for national security reasons only on the Commerce Country Chart and the destination must be listed in Country Group B in Supplement No. 1 to Part 740 of the EAR. The only countries listed in Country Group B that do not require a license under RS column 2 are Australia, Japan, New Zealand and countries in North Atlantic Treaty Organization (NATO). Therefore, this new License Exception GBS availability under this ECCN entry is limited to these countries in Country Group B.

This rule adds new reasons for control to one (1) existing CCL entry: 1E002. This existing CCL entry was intended to have this control at an earlier time, but this control was inadvertently not added to the entry when changes were made to other parts of the EAR (e.g., a NP or MT item was added to the CCL, but the corresponding change to control the related technology or software was not made at that time). This rule adds a new item to one (1) existing CCL entry: 9E101. The EAR were previously amended to include new commodities controlled for MT reasons. However, the EAR omitted the corresponding control on the “technology” related to those commodities.

ECCN 1E002 is amended by adding a new NP reason for control to this ECCN. This new NP reason for control applies to “technology” for items controlled by 1A002 for NP reasons. This corrects an inadvertent omission from the CCL of this NP reason for control. The intent of the U.S. Government was to have a NP technology control on the NP portion of 1E002.f applicable to the NP portion of 1A002, but in an earlier revision to the CCL this change had not been implemented into the EAR, as intended. This rule corrects that inadvertent omission by adding this NP reason for control to this existing ECCN.

ECCN 9E101 is amended by adding 9C110 to the heading of 9E101 to correct an inadvertent error that occurred when 9C110 was added to the CCL. ECCN 9C110 was added to the CCL on April 2, 2003 (68 FR 16144) to implement a Missile Technology Control Regime (MTCR) Plenary change. However, at the time that change was implemented in the EAR, ECCN 9E101 was not amended to add a Missile Technology (MT) technology control for this new MT commodity controlled under ECCN 9C110. Prior to publication of this rule, ECCN 9E101 controlled “technology” according to the General Technology Note for the “development” or “production” of commodities or software controlled by 9A012, 9A101, 9A104 to 9A111, 9A115 to 9A119, 9D101, 9D103, 9D104 or 9D105. ECCN 9C110 should have been added to the heading in 9E101 when the change implementing the MTCR Plenary change was made to the EAR, but it was inadvertently left off. This technology for ECCN 9C110 is a current control within the MTCR and should be reflected on the CCL under ECCN 9E101. This rule corrects that inadvertent error by adding this new MT control to the CCL.

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 July 23, 2008, 73 FR 43603 (July 25, 2008), 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, unless that collection of information displays a currently valid Office of Management and Budget Control Number. This rule contains a collection of information subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq. ). This collection has been approved by the Office of Management and Budget under control number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 58 minutes for a manual or electronic submission.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Therefore, this regulation is issued in final form.

5. The other changes made under this rule are nonsubstantive changes that do not meet the criteria noted in the preceding paragraph. For these nonsubstantive changes described in this paragraph, the Department 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 because they are unnecessary. The changes made by this rule described under this paragraph are not substantive changes, but rather are clarifications to existing controls. These nonsubstantive changes are described under Part I: Clarifications to Existing Controls in the Background section of this rule. These nonsubstantive changes include: Revisions to the headings of existing CCL entries; removal of outdated “Related Controls” references in CCL entries; nonsubstative revisions to “items” paragraphs in CCL entries to improve things, such as readability; and additions of “items” paragraphs for certain items subject to the licensing requirements of the U.S. Department of State. This rule does not alter any right, obligation or prohibition that applies to any person under the Export Administration Regulations (EAR). Because these revisions are not substantive changes, it is unnecessary to provide notice and opportunity for public comment. In addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) is not applicable because this rule is not a substantive rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

On May 14, the Deputy Secretary of State determined that six countries, Cuba, Eritrea, Iran, North Korea, Syria and Venezuela, are not cooperating fully with anti-terrorism efforts (73 FR 29172). As a result of this determination, Section 40A of the Arms Export Control Act, as amended (22 U.S.C. 2781), prohibits the sale or licensing for export of defense articles and defense services to those countries effective October 1. This rule adds Eritrea to the list of countries identified in 22 CFR 126.1(a).

This amendment involves a foreign affairs function of the United States and, therefore, is not subject to the procedures contained in 5 U.S.C. 553 and 554.

Since this amendment is not subject to the procedures in 5 U.S.C. 553, it does not require analysis under the Regulatory Flexibility Act.

This amendment does not involve a mandate that will result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996.

This amendment will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this amendment.

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.

This action provides for a revised schedule to flag data and submit documentation related to exceptional events that influence ozone data which may affect designations under the recently revised ozone NAAQS. This action creates no additional regulatory requirements. We are publishing this direct final rule because we view this as a noncontroversial action and anticipate no adverse comment.

In the “Proposed Rules” section of this Federal Register , we are publishing a separate document that will serve as the proposed rule for this action to revise the schedule for flagging and documenting ozone exceptional events data if relevant adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document.

If EPA receives an adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in any subsequent final rule based on the proposed rule.

States are responsible for identifying air quality data that they believe warrant special consideration, including data affected by exceptional events. States identify such data by flagging (making a notation in a designated field in the electronic data record) specific values in the Air Quality System (AQS) database. States must flag the data and submit a justification that the data are affected by exceptional events if they wish EPA to consider excluding the data in determining whether or not an area is attaining the revised ozone NAAQS.

All states that include areas that could exceed the ozone NAAQS, and could therefore be designated as nonattainment for the ozone NAAQS, have the potential to be affected by this rulemaking. Therefore, this action applies to all states; to local air quality agencies to which a state has delegated relevant responsibilities for air quality management including air quality monitoring and data analysis; and, to Tribal air quality agencies where appropriate. The Exceptional Events Rule describes in greater detail to whom the Rule applies in 72 FR at 13562-13563 (March 22, 2007).

Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

When submitting comments, remember to:

• Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns, and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• Make sure to submit your comments by the comment period deadline identified.

The official record for this rulemaking, as well as the public version, has been established under Docket ID No. EPA-HQ-OAR-2005-0159 (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The official rulemaking record is located at the address provided in ADDRESSES at the beginning of this document.

The Exceptional Events Rule (Treatment of Data Influenced by Exceptional Events (72 FR 13560, March 22, 2007)) sets a general schedule for states to flag monitored data affected by exceptional events in AQS and for them to submit documentation to demonstrate that the flagged data were impacted by an exceptional event. Under this general schedule, a state must initially notify EPA that data have been affected by an exceptional event by July 1 of the year after the data are collected; this is accomplished by flagging the data in AQS. The state must also include an initial description of the event when flagging the data. In addition, the state is required to submit a full demonstration to justify exclusion of such data within three years after the quarter in which the data were collected, or if a regulatory decision based on the data (such as a designation action) is anticipated, the demonstration must be submitted to EPA no later than one year before the regulatory decision is to be made.

However, the rule also authorizes EPA to revise data flagging and documentation schedules for the initial designation of areas under a new or revised NAAQS. This general schedule, while appropriate for the period after initial designations have been made under a NAAQS, may need adjustment when a new or revised NAAQS is promulgated because until the level and form of the NAAQS have been promulgated a state would not have complete knowledge of the criteria for excluding data. In these cases the general schedule may preclude states from submitting timely flags and associated documentation for otherwise approvable exceptional events. This could, if not modified, result in some areas receiving a nonattainment designation when the NAAQS violations were legitimately due to exceptional events.

For example, EPA finalized new standards for ozone of 0.075 pounds per billion (ppb) on March 12, 2008, with an effective date of May 27, 2008. In accordance with Clean Air Act Section 107(b), state Governors must provide their recommendations to EPA by March 12, 2009, on designating areas as attainment, nonattainment, or unclassifiable with the new standards. States will base their recommendations on the three most recent years of quality-assured ozone data, which could be data collected between calendar years 2006-2008, or 2005-2007. EPA must complete final area designations for these new standards by March 12, 2010. EPA will base its designations decisions on the three most recent years of quality-assured air quality data for each area, which would be ozone data collected during calendar years 2007-2009 where states have submitted quality-assured data for calendar year 2009. However, in some cases the most recent complete data may cover 2006-2008 or 2005-2007. In this example, the general exceptional event flagging schedule for 2005 and 2006 data has already passed and the flagging deadline for exceptional events that occurred in 2007 would be July 1, 2008—approximately 33 days after the effective date of the revised NAAQS. In addition, the general schedule would require states to submit demonstrations for 2009 data influenced by exceptional events no later than March 12, 2009, one year before the final designation decisions. This is clearly not possible for air quality data collected from March 13, 2009 to December 31, 2009.

EPA is, therefore, using the authority provided in the Exceptional Events Rule at 40 CFR 50.14(c)(2)(v), to modify the schedule for data flagging and submission of demonstration for exceptional events data considered for initial designations under the 2008 revised ozone NAAQS.

This direct final rule amends the Exceptional Events Rule by providing a revised exceptional event data flagging and documentation schedule regarding claimed exceptional events affecting ozone monitoring data that will be compared to the 2008 revised ozone NAAQS for the purpose of initial ozone designations. In some cases, EPA is extending the otherwise applicable deadline for states to flag data and submit documentation. In other cases, EPA is shortening (for this purpose only) the otherwise applicable schedule to assure that the exceptional events claims can be fully considered by EPA in the designations decisions.

For air quality data collected in the years 2005 through 2007, this revised schedule extends the general schedule for flagging data (and providing a brief initial description of the event) from July 1 of the year following the year the data are collected, to December 31, 2008. For data collected in 2008, the revised schedule extends the general schedule for flagging data and providing a brief initial description of the event to March 12, 2009, to coincide with the deadline for state Governors to submit designation recommendations to EPA. The deadline for submitting to EPA a detailed demonstration to justify exclusion of data collected in 2005 through 2008 is also being set to March 12, 2009. The deadline for submitting to EPA flagged data with initial descriptions and a detailed demonstration to justify exclusion of data collected in 2009 is being set to January 8, 2010. For data collected in 2008 and 2009 this would give a state less time, but EPA believes still sufficient time, to decide what 2008 and 2009 data to flag, and would allow EPA to have access to the flags and supporting data in time for EPA to develop its own proposed and final plans for designations. (If EPA extends the designations date beyond March 2010 due to insufficient information, a new event flagging deadline and detailed documentation submission deadline will be published.) While the new deadlines for submission of a state's demonstration for data collected in 2009 is less than a year before the designation decisions would be made, EPA believes it is a reasonable approach between giving states a reasonable period to prepare the justifications, and EPA a reasonable period to consider the information submitted by the state. With this direct final action EPA amends § 50.14(c)(2)(v) to add a tabular schedule of data submittal deadlines, by pollutant, for new or revised NAAQS standards. (PM 2.5 data submittal schedules revised in March 2007 and presented in this table are for informational purposes only. EPA is not taking further comment on the PM 2.5 data submittal schedule published in 72 FR 13560, March 22, 2007.) EPA anticipates providing amendments to the following table to add data submission schedules for new or revised NAAQS standards in the future.

Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it is likely to raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., where burden is defined at 5 CFR 1320.3(b). This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any State, local or tribal governments or the private sector. Therefore, it does not impose an information collection burden.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of this rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any State, local or tribal governments or the private sector. Thus, it does not impose any requirements on small entities.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (URMA), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. This action imposes no enforceable duty on any State, local or tribal governments or the private sector. This action modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any State, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 and 205 of the UMRA.

This action is also not subject to the requirements of section 203 of URMA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any small governments.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by state and local officials in the development of regulatory policies that have federalism implications.” Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This direct final does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any state, local or tribal governments or the private sector. Thus, Executive Order 13132 does not apply to this rule.

This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on tribal governments. Thus, Executive Order 13175 does not apply to this rule.

This action is not subject to EO 13045 (62 F.R. 19885, April 23, 1997) because the Agency does not believe the environmental health risks or safety risks addressed by this action present a disproportionate risk to children. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse effects because this action modifies previously established deadlines under the Exceptional Events Rule.

This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has determined that this direct final will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it will not affect the level of protection provided to human health or the environment. This rule modifies previously established deadlines under the Exceptional Events Rule and does not impose any new obligations or enforceable duties on any state, local or tribal governments or the private sector. It will neither increase nor decrease environmental protection.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A Major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective December 22, 2008.

Under CAA section 307(b), judicial review of this final action is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit on or before December 5, 2008. Under CAA section 307(d)(7)(B), only those objections to the final rule that were raised with specificity during the period for public comment may be raised during judicial review. Moreover, under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce these requirements.

The Preamble to this interim rule is organized as follows:

HHS/CDC is promulgating this rule under the authority of 42 U.S.C. 252 and 8 U.S.C. 1182 and 1222.

Under section 212(a)(1) of the Immigration and Nationality Act (INA) (8 U.S.C. 1182(a)(1)), any alien determined to have a specified health-related condition is inadmissible to the United States. Those aliens outside the United States with a specified health-related condition (see below) are ineligible to receive a visa and ineligible to be admitted into the United States. The grounds of inadmissibility for specified health-related conditions also pertain to aliens in the United States who are applying for adjustment of immigration status to that of a lawful permanent resident.

Aliens are currently inadmissible into the United States if they have a communicable disease of public health significance, defined as follows: Active tuberculosis, infectious syphilis, gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, granuloma inguinale, and HIV infection.

Medical examinations, including a physical and mental evaluation, to determine whether an alien may have such a health-related condition, are authorized under section 232 of the INA (8 U.S.C. 1222). Under sections 212(a)(1) and 232 of the INA, and section 325 of the Public Health Service (PHS) Act (42 U.S.C. 252), the Secretary of Health and Human Services promulgates regulations to establish the requirements for the medical examination and to list the health-related conditions that make aliens ineligible for entry into the United States. The regulations, administered by HHS/CDC, are promulgated at 42 FR part 34.

As currently listed in § 34.1, the provisions in this part apply to the medical examination of (1) aliens outside the United States who are applying for an immigrant visa at an embassy or consulate of the United States; (2) aliens arriving in the United States; (3) aliens required by the U.S. Department of Homeland Security (DHS) [formerly required by the Immigration and Naturalization Service (INS)] to have a medical examination in connection with the determination of their admissibility into the United States; and (4) applicants in the United States who apply for adjustment of their immigration status to that of permanent resident.

Panel physicians, designated by consular officers of the U.S. Department of State, perform medical examinations abroad, and civil surgeons, designated by the U.S. Citizenship and Immigration Services, perform medical examinations for aliens who are already present in the United States. Aliens determined to have a communicable disease of public health significance may request a waiver to enter the United States under sections 212(d)(3)(a) and 212(g) of the INA (8 U.S.C. 1182(d)(3)(a) and 1182(g)).

Aliens are inadmissible if they are determined: (1) To have a communicable disease of public health significance; (2) to have a physical or mental disorder and behavior associated with the disorder that may pose, or has posed, a threat to the property, safety, or welfare of the alien or others; (3) to have had a physical or mental disorder and a history of behavior associated with the disorder, which has posed a threat to the property, safety, or welfare of the alien or others and which is likely to recur or lead to other harmful behavior; or (4) to be a drug abuser or addict. In addition, except for certain adopted children 10 years of age or younger, any alien who seeks admission as an immigrant, or seeks adjustment of immigration status to legal permanent resident, is inadmissible if the alien fails to present documentation of having received vaccination against mumps, measles, rubella, polio, tetanus and diphtheria toxoids, pertussis, Haemophilus influenzae type B, hepatitis B and any other vaccination recommended by the Advisory Committee for Immunization Practices.

Annually, the U.S. Government admits more than 1,000,000 immigrants and refugees to reside permanently in this country. The majority arrives from Asia, Africa and Central and South America, regions with recently reported outbreaks of emerging, infectious diseases, including yellow fever, dengue, Ebola and Marburg hemorrhagic fevers and the H5N1 strain of highly pathogenic avian influenza. These regular outbreaks, many of which affect both urban and rural areas, and the movement of large population resettlements from these regions, highlight the serious threat to public health in the United States to which the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS) has to respond on very short notice.

In the recent past, the demographics of U.S.-bound refugees have shifted to populations that are at higher risk for communicable diseases. These newer groups of refugees have lower baseline rates of vaccination, higher rates of parasitic infections and more limited access to basic medical care and preventive health interventions before resettlement. Between 1996 and 2003, at least half of all arriving refugees were European. In 1998, 70 percent were European. Beginning in 2003, however, the numbers of refugees from Europe rapidly declined. In 2008, only three percent of all refugees arriving in the United States were European. At the same time, a larger proportion of refugees have come from countries with poorer economies, weaker health infrastructure, and limited access to basic medical care. As a result, these refugees have a higher incidence of major infectious diseases.

This demographic shift is one of the most important factors that have led to the substantial increase in the number and nature of outbreaks of communicable diseases that have affected refugee resettlements. These new populations bring new diseases but the diseases for which individuals are inadmissible into the United States have remained much the same as at the end of the nineteenth century.

The highest rates of tuberculosis among immigrants and refugees are for those born in sub-Saharan African and Southeast Asian countries, with rates of at least 250 cases per 100,000. By comparison, the rate in the United States is fewer than five cases per 100,000. Overall, approximately one-third of the world's population has the infection, and over 50 percent of TB cases in the United States are in foreign-born residents.

Panel physicians miss up to 67 per cent of tuberculosis (TB) cases based on the current scope of medical examination requirements. Implementation of these revisions to the regulations would ensure the methods for screening and testing TB used during the medical examination of aliens reflect the most current medical practice.

The resettlement of these populations, many of which are coming from high-risk countries, is a strong argument for an immediate implementation of the changes in the list of communicable diseases of public health significance to reduce the potential of emerging disease threats in this higher-risk caseload. Urgent changes to this list are needed to prevent importing communicable diseases into our country. The current regulations do not address emerging and re-emerging diseases in immigrant or refugee populations. HHS is adding diseases to the communicable diseases of public health significance that better reflect the true threats that our Nation faces, including cholera, diphtheria, plague, smallpox, yellow fever, viral hemorrhagic fevers, and severe acute respiratory syndrome (SARS). These diseases currently exist in the list of quarantinable, communicable diseases defined by Presidential Executive Order, but do not appear on the list of communicable diseases of public-health significance. These diseases cause severe illness and death in regions of the world that are home to large numbers of immigrants and refugees bound for the United States.

In addition, the revision to part 34 is consistent with relevant provisions of the revised International Health Regulations (2005), which came into force in July of 2007.

HHS/CDC also issues technical instructions and provides technical consultation and guidance to panel physicians and civil surgeons who conduct the medical examinations of aliens. The HHS/CDC Technical Instructions for Medical Examination of Aliens, including the most current updates, which panel physicians and civil surgeons must follow in accordance with these regulations, are available to the public on the HHS/CDC Web site, located at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm. HHS/CDC will also post and maintain a list of all medical conditions and locations for which additional screening requirements are in effect pursuant to this rule. This list will be available at the same Internet address: http://www.cdc.gov/ncidod/dq/technica.htm, and http://www.globalhealth.gov.

HHS/CDC is amending the definition of a communicable disease of public health significance. Current communicable diseases of public health significance are: active tuberculosis, infectious syphilis, gonorrhea, infectious leprosy, chancroid, lymphogranuloma venereum, granuloma inguinale, and HIV infection.

The definition of a communicable disease of public health significance in this rule remains as those diseases currently listed in § 34.2(b), plus the addition of (1) quarantinable diseases designated by Presidential Executive Order, and (2) those diseases that meet the criteria of a public health emergency of international concern which require notification to the World Health Organization (WHO) under the revised International Health Regulations of 2005. A delay in implementing these updates to Part 34 poses a risk of further severe illness for refugees and immigrants as they move into receiving U.S. communities and presents American taxpayers with elevated medical costs. Updating the list of communicable diseases of public health significance will diminish complex and costly measures such as vaccination, chemoprophylaxis and isolation, and lessen illness and death among the affected migrating populations.

The following is a section-by-section analysis of proposed changes:

The revision updates the definition provided in § 34.2(b) for a communicable disease of public health significance to include two new categories of disease. The first category, added as § 34.2(b)(2), is the quarantinable, communicable diseases specified by the President in Executive Order, as provided under Section 361(b) of the Public Health Service Act. The second category, added as § 34.2(b)(3), is any communicable disease that requires notification to the World Health Organization as an event that may constitute a public health emergency of international concern, pursuant to the revised International Health Regulations of 2005.

HHS/CDC is publishing section 34.3 in its entirety for clarity, including republication of some provisions that are unchanged. HHS/CDC has revised section 34.3 to include screening and testing for the updated list of communicable diseases of public health significance, as defined in § 34.2(b). HHS/CDC has also revised section 34.3 to require additional medical screening and testing using a more flexible risk-based approach for those medical examinations performed outside of the United States. HHS/CDC has also revised the specific requirements concerning the required evaluation for tuberculosis.

The U.S. Department of Homeland Security (DHS) currently is the entity responsible for administering the immigration authority and functions previously administered by the Immigration and Naturalization Service (INS), which was within the U.S. Department of Justice. The revised rule text changes the reference to INS in existing § 34.3(b)(2)(i) to U.S. Department of Homeland Security in new § 34.3(e)(3)(i).

The title of § 34.3(b) has changed to Scope of all medical examinations , and provides that all medical examinations will include a general physical examination and medical history, evaluation for tuberculosis, serologic testing for syphilis and HIV, and also a physical examination and medical history for diseases specified in §§ 34.2(b)(1) and 34.2(b)(4) through 34.2(b)(10). The unindented paragraph currently at the end of § 34.3(a) has been moved to § 34.3(b)(2).

The title of § 34.3(c) has been changed to Additional medical screening and testing for examinations performed outside of the United States and provides that HHS/CDC may require additional screening and testing for medical examinations performed outside the United States for diseases specified in §§ 34.2(b)(2) and 34.2(b)(3) by applying the risk-based medical and epidemiologic factors listed in § 34.3(d)(2). It provides that such examinations shall be conducted in a defined population, in a geographic region or area outside the United States, for a period of time as determined by HHS/CDC. Additional medical screening and testing shall include a medical interview, physical examination, laboratory testing, radiologic exam, or other diagnostic testing as determined by HHS/CDC. Section 34.3(c)(4) and (5) indicate that additional medical screening and testing will continue until HHS/CDC determines such activity is not necessary, based on medical and epidemiologic factors, and that HHS/CDC will provide medical examiners with information pertaining to all additional screening and testing requirements, and will also post the information on the HHS/CDC Web site.

Section 34.3(d) is entitled Risk-based approach , and provides the medical and epidemiological factors that HHS/CDC will use to determine whether a disease as specified in § 34.2(b)(3)(ii) is a communicable disease of public health significance , which diseases in §§ 34.2(b)(2) and (b)(3) merit additional screening and testing, and the geographic area in which HHS/CDC will require this screening. These factors include the seriousness of the disease's public health impact; whether the emergence of the disease was unusual or unexpected; the risk of the spread of the disease to the United States; the transmissibility and virulence of the disease; the impact of the disease at the geographic location of medical screening; and other specific pathogenic factors that would bear on a disease's ability to threaten the health security of the United States.

HHS/CDC has revised § 34.3 to require testing for tuberculosis of children under the age of 15 years old when they have symptoms of tuberculosis, a history of tuberculosis, or possible exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period. With regard to additional testing requirements for an applicant that has a radiograph that indicates an abnormality suggestive of tuberculosis disease, HHS/CDC has revised § 34.3 to require additional testing for tuberculosis. Specific changes regarding the required evaluation for tuberculosis appear below.

Section 34.3(b), entitled Persons subject to requirement for chest x-ray examination and serologic testing is now § 34.3(e). The revision adds § 34.3(e)(2)(ii) to include a chest x-ray examination for applicants under 15 years of age if they have symptoms of tuberculosis, a history of tuberculosis, or evidence of possible exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period. The paragraph describing requirements for tuberculin skin test (TST) examination is now § 34.3(e)(3), and has been renamed Immune response to Mycobacterium tuberculosis antigens to reflect updated, current equivalent tests that are increasingly used in clinical settings and may eventually be used as an alternative to the tuberculin skin test for refugee and immigrant screening. The Quantiferon-TB Gold (QFT-G) test is one recommended method for screening for tuberculosis in clinical practice in most circumstances instead of the TST. The incorporation of Immune Globulin Release Assays (IGRAs), which include QFT-G, is under consideration by CDC for screening for tuberculosis in aliens. This change will insure that current, updated medical technology will be used, as appropriate, by panel physicians and civil surgeons conducting the medical examinations. This section also includes the addition of § 34.3(e)(3)(iii) which requires a tuberculin skin test, or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, for applicants outside of the United States who are required to have a medical examination and, if indicated, a chest x-ray examination, if the applicant is of sufficient age to be considered contagious.

Section 34.3(e)(3)(iv) requires both a tuberculin skin test, or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, and a chest x-ray examination for any applicant outside of the United States, regardless of age, if the applicant has symptoms of tuberculosis, a history of tuberculosis, or possible exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period.

Section 34.3(e)(4), entitled Additional testing requirements , indicates that all applicants subject to the chest x-ray examination and for whom the radiograph shows an abnormality suggestive of tuberculosis disease must undergo additional testing for tuberculosis. This change allows for the use of the most current testing procedures for tuberculosis disease.

References to the Attorney General in existing §§ 34.3(b)(4) and (e) are changed to the Secretary of Homeland Security in new §§ 34.3(e)(5) and (h) to reflect the creation of DHS in 2003 and its assumption of applicable authorities and responsibilities. Reference to INS in existing § 34.3(b)(2)(i) is changed to U.S. Department of Homeland Security in new § 34.3(e)(3)(i). These ministerial corrections are the only amendments to these sections which are otherwise republished unchanged.

As stated in Section 212(a)(1) of the INA, aliens are inadmissible into the United States if they are determined to have a specified health condition, which includes a communicable disease of public health significance . Currently, medical examinations require the screening of all aliens subject to these requirements for all listed communicable diseases of public health significance. Regulations have historically defined the term communicable disease of public health significance by listing specific diseases. The current definition in 42 CFR 34.2(b) includes chancroid, gonorrhea, granuloma inguinale , human immunodeficiency virus (HIV) infection, infectious leprosy, lymphogranuloma venereum , infectious-stage syphilis, and active tuberculosis.

Recent experience has demonstrated that a fixed list of diseases does not allow HHS/CDC the flexibility it needs to rapidly respond to unanticipated emerging or re-emerging outbreaks of disease. Rather, HHS/CDC requires an approach based on potential risks and consequences instead of a static list that does not reflect the potential for future outbreaks of novel diseases. National and international health agencies have recently developed guidelines for defining diseases of public health significance that threaten global health security and require an urgent response. This guidance provides the framework to update the list of communicable diseases of public health significance for the United States to screen and test aliens during disease outbreaks in real time.

HHS/CDC is adding the following two disease categories to the current list of communicable diseases of public health significance:

(1) Quarantinable, communicable diseases specified by Presidential Executive Order, as provided under Section 361(b) of the Public Health Service Act; and

(2) Any communicable disease that requires notification to the World Health Organization as an event that may constitute a public health emergency of international concern, pursuant to the revised International Health Regulations of 2005.

Section 361 of the Public Health Service Act authorizes the Secretary of HHS to enact rules and regulations for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the United States, and from one State or possession into another. Executive Order 13295 of April 4, 2003, as amended by Executive Order 13375 of April 1, 2005, contains the most recent list of quarantinable, communicable diseases, and includes the following: Cholera, yellow fever, plague, viral hemorrhagic fevers, diphtheria, infectious tuberculosis, smallpox, severe acute respiratory syndrome (SARS), and influenza caused by novel or re-emergent influenza viruses that are causing, or have the potential to cause, a pandemic (pandemic influenza). HHS/CDC is adding diseases listed by Presidential Executive Order to the definition of communicable diseases of public health significance , subject to screening and testing requirements outlined in the section on the scope of examinations.

In May 2005, the World Health Assembly adopted the revised International Health Regulations (IHR (2005)). These regulations entered into force for most of the Member States of the WHO in June 2007 and for the U.S. in July 2007. The purpose and scope of the IHR (2005) are to prevent, protect against, control and provide a public health response to the international spread of disease, while minimizing interference with world travel and trade. Annex 2 of the IHR (2005) contains an algorithm for identifying a public health emergency of international concern , and can be located at the following Internet address: http://www.who.int/gb/ghs/pdf/IHR_IGWG2_ID4-en.pdf .

The IHR (2005) define a public health emergency of international concern as an extraordinary event which is determined: (i) To constitute a public health risk to other [Member] States through the international spread of disease and (ii) to potentially require a coordinated international response. Under the IHR (2005), Member States must notify the World Health Organization of any disease event that fulfills the criteria presented in the three categories of the algorithm in Annex 2. The definition in the revised part 34 rule text is intended to capture those diseases that require notification by any country to the WHO under the IHR (2005) and determined to be an event that may constitute a public health emergency of international concern. The revised part 34 rule text references IHR (2005) category (1), below, in § 34.2(b)(3)(i), and categories (2) and (3), below, together in § 34.2(b)(3)(ii).

Annex 2 of the IHR (2005) specifies that smallpox, poliomyelitis from wild-type poliovirus, pandemic influenza and severe acute respiratory syndrome (SARS) are diseases with serious public health impact, and that a single case, irrespective of context, requires immediate notification to the WHO. HHS/CDC is adding diseases listed in this category to the definition of a communicable disease of public health significance , subject to screening and testing requirements outlined in the section on the scope of examinations.

The impact of the SARS outbreak demonstrates the importance of using the IHR (2005) algorithm to quickly detect and identify emerging and re-emerging pathogens in this category. SARS coronavirus is a droplet-spread illness that rapidly emerged as a global threat in 2003, caused more than 8,000 cases and 800 deaths, and required isolation and quarantine control measures. Although now contained, the disease (or one similar to it) could re-emerge at any time. The use of the IHR (2005) process for disease notification to the WHO will ensure the earliest possible protection of citizens in the United States through medical screening of a pathogen like SARS when the next outbreak occurs. Smallpox, which causes high mortality and morbidity, is another disease in this category. Because smallpox is now successfully eradicated, it poses an ongoing threat as a bioterrorism agent.

In addition to the single-case notification diseases, Annex 2 indicates that an event that involves the following diseases shall always lead to the use of the IHR (2005) algorithm to determine whether the disease occurrence amounts to a public health emergency of international concern, because these diseases have demonstrated the ability to cause serious public health impact and to spread rapidly internationally:

HHS/CDC is adding diseases listed in this category to the definition of a communicable disease of public health significance , subject to screening and testing requirements and risk-based factors outlined in the section on the scope of examinations.

Ongoing threats in this category include Ebola hemorrhagic fever, a severe, often fatal disease, easily spread through close personal contact. An outbreak of Ebola in the Democratic Republic of the Congo, confirmed in September 2007, resulted in 26 laboratory-confirmed cases of illness as of October 2007. There have been a total of 264 suspected cases, and Ebola is believed to have killed up to 187 people over eight months. A subsequent outbreak of Ebola in the Republic of Uganda produced 149 suspect cases and killed 37 people. Cholera, which can cause severe diarrhea and death, also continues to be active. From August 2007 through November 2007, an outbreak spread throughout Iraq and caused over 4500 cases of illness and 23 deaths.

Annex 2 also refers to any event of potential international health concern, including those of unknown causes or sources, and those that involve events or diseases, other than the IHR (2005) single-case notifiable and other specified notifiable diseases (listed in (1) and (2) above), that lead to use of the IHR (2005) algorithm. HHS/CDC is adding diseases listed in this category to the definition of a communicable disease of public health significance , subject to screening and testing requirements and risk-based factors outlined in the section on scope of examinations. Addition of this last category to the definition of diseases of public health significance allows HHS/CDC to respond rapidly to emerging disease threats in a way that adding specific diseases to a fixed list does not.

Once HHS/CDC acknowledges an event from the IHR (2005) algorithm as a disease of public health significance, HHS/CDC will immediately advise the physicians who conduct medical examinations of the additional medical screening or testing required for the identified disease(s) via electronic notification, coordination with embassies, consulates and the International Organization for Migration, by publication on the HHS/CDC Web site, and publication of a notice in the Federal Register . HHS/CDC will also provide any required disease notifications to appropriate DOS bureaus. HHS/CDC will also maintain a current list of diseases and locations subject to additional medical screening and will update addenda to the Technical Instructions for Medical Examination of Aliens regarding these diseases, available to the public on the HHS/CDC Division of Global Migration and Quarantine Web site, located at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm , and also at http://www.globalhealth.gov .

The HHS/CDC Division of Global Migration and Quarantine is the current name of the former Division of Quarantine used in existing § 34.3(f), and section 34.3(i) of the revised rule text uses the correct name. The section is otherwise republished unchanged.

HHS/CDC is amending the scope of the medical examination in 42 CFR 34.3 to allow greater agility to respond to significant outbreaks of communicable diseases of public health significance for applicants examined in geographic locations where these diseases exist, and for which importation into the United States would pose a threat. HHS/CDC believes a risk-based approach that uses medical and epidemiologic factors to detect additional diseases of public health significance provides a flexible, fair and practical means to address infectious disease threats among at-risk aliens without placing an undue burden on other applicants.

Beginning on the effective date of this rule, HHS/CDC will also make a distinction between the medical examinations performed for aliens outside the United States, and those performed for aliens already in the United States who are applying for adjustment of status to that of permanent resident, in that the risk-based approach to detect additional diseases of public health significance will apply only to medical examinations outside the United States and only in those geographic areas where the risk is high. Applicants already within the United States who apply for adjustment of immigration status will not be subject to additional screening or testing using the risk-based approach. Disease outbreaks in aliens who are within the United States primarily fall under the jurisdiction of state and local public health authorities. For both groups of aliens, those applying for status adjustment from within the United States and those applying for admission from outside the United States, the medical screening examination will continue to consist of a general physical examination and medical history, evaluation for tuberculosis, and serologic testing for syphilis and HIV. In addition, under the new risk-based approach, HHS/CDC may require aliens outside the United States applying for U.S. immigration to undergo additional screening and testing for specific communicable diseases of public health significance.

Medical screening for these diseases will be achieved through physical examination and medical history. Accomplish HHS/CDC may require additional screening or testing for these diseases for aliens receiving medical examinations at the specific location or area where outbreaks of the disease or diseases may be occurring. This additional screening and testing will involve applying the defined risk-based approach by using medical and epidemiologic factors (shown below in this section.)

This change addresses diseases in immigrant and refugee populations (and, in extreme cases, non-immigrant aliens) outside the United States, and ensures the lists of quarantinable diseases and inadmissible conditions remain consistent. Whenever this Executive Order is amended in the future to add additional diseases, HHS/CDC will be able to immediately begin testing and screening for these diseases.

HHS/CDC will consider all the diseases in this category, including diseases included by WHO in the future, as communicable diseases of public health significance and subject to medical screening through physical examination and medical history. HHS/CDC will also consider imposing additional screening and testing, as determined by the specific circumstances of the event, for diseases in this category that meet requirements of the risk-based approach composed of medical and epidemiologic factors (shown below in this section) and for which HHS/CDC determines a threat exists for importation into the United States, and that may potentially affect the health of the American public.

HHS/CDC will consider the diseases in this category as communicable diseases of public health significance and subject to medical screening through physical examination and medical history if they meet one or more of the risk-based criteria of medical and epidemiologic factors (shown below in this section), and HHS/CDC determines (1) a threat exists for importation into the United States, and (2) such diseases may potentially affect the health of the American public. HHS/CDC will also consider imposing additional screening and testing for diseases in this category, as determined by the specific circumstances of the event.

HHS/CDC will determine which diseases merit additional screening and testing, and the geographic area in which HHS/CDC will require this screening, by applying a risk-based approach that takes into account the following medical and epidemiologic factors: (a) The seriousness of the disease's public health impact; (b) whether the emergence of the disease was unusual or unexpected; (c) the risk of the spread of the disease to the United States; (d) the transmissibility and virulence of the disease; (e) the impact of the disease at the geographic location of medical screening; and (f) other, specific pathogenic factors that would bear on a disease's ability to threaten the health security of the United States. HHS/CDC will consider diseases identified through the International Health Regulations algorithm (other than diseases for which a single case requires notification) as communicable diseases of public health significance when they meet one or more of the criteria listed above, and for which HHS/CDC determines (A) a threat exists for importation into the United States, and (B) such diseases may potentially affect the health of the American public.

This risk-based approach will facilitate a meaningful public health response to existing and emerging threats, without overwhelming the entire health system with needless testing. The changes to the scope of the examination will allow HHS/CDC to tailor testing requirements to those areas where the severity of communicable diseases of public health concern are actually affecting populations at the time of the medical examination.

When HHS/CDC requires screening for additional communicable diseases of public health significance for applicants from specific geographic areas, HHS/CDC may require additional screening, including additional medical interviews, a physical examination, laboratory testing, radiologic exams, or other diagnostic procedures.

Screening and testing for newly identified diseases as a part of the list of communicable diseases of public health significance will continue until HHS/CDC determines the particular situation does not warrant this designation, based on factors such as the results of disease investigations; response efforts; the effectiveness of containment and control measures; and the current determination or termination of the public health emergency of international concern by the Director General of the WHO.

HHS/CDC will provide physicians the technical instructions regarding the required additional medical screening and testing to perform for a disease as part of the examination. In most instances, additional medical screening and testing may only consist of epidemiologic questions and further physical examination relating to the disease. HHS/CDC will also update the Technical Instructions for Medical Examination of Aliens , as needed, regarding the additional medical screening and testing protocol for a disease, and this information will also be immediately available to the public on the HHS/CDC Division of Global Migration and Quarantine Web site, located at the following Internet address: http://www.cdc.gov/ncidod/dq/technica.htm ; and at http://www.globalhealth.gov . A listing of current documents regarding the additional medical screening and testing protocol for specific diseases will also be available on the HHS/CDC Web site.

HHS/CDC is amending the medical examination rule for aliens by updating the screening requirements for tuberculosis, to be consistent with current medical knowledge and practice. HHS/CDC is amending 42 CFR 34.3(b) by revising the requirement for a chest X-ray examination to include applicants under the age of fifteen years old, when there is reason to suspect tuberculosis infection. The practical effect of this change is to expand this testing protocol to alien applicant children under the age of 15, when medically appropriate. This change will allow HHS/CDC the flexibility to ensure the tuberculosis screening and testing methods used for medical examination of aliens are current and effective.

HHS/CDC is amending § 34.3(b)(1)(v) by adding the expanded tuberculin skin test requirement, or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, to the exceptions that may be authorized for good cause upon application approved by the Director of CDC.

HHS/CDC is amending § 34.3(b)(2) to indicate that any alien applicant outside the United States shall have a tuberculin skin test or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens and, if indicated, a chest X-ray examination if the applicant is of sufficient age to be considered contagious. Additionally, any alien applicant outside the United States, regardless of age, shall have both a tuberculin skin test or an equivalent test for showing an immune response to Mycobacterium tuberculosis antigens, and a chest X-ray examination if the applicant has symptoms of tuberculosis disease, has a history of tuberculosis, or has exposure to a transmissible tuberculosis case in a household or other enclosed environment for a prolonged period. HHS/CDC is amending this section to make it consistent with current medical knowledge and practice.

HHS/CDC is amending § 34.3 by adding a new provision, entitled Additional Testing Requirements , with the following rule text: All applicants subject to the chest X-ray examination requirement and for whom the radiograph shows an abnormality suggestive of tuberculosis disease shall be required to undergo additional testing for tuberculosis disease.

The current, outdated rule requires sputum smears for anyone with signs, or x-ray findings, suggestive of tuberculosis. Current medical guidelines require mycobacterial culture, which is three times as sensitive as a sputum smear for detecting active tuberculosis.

HHS/CDC is also updating language in 34.3(e) and (f) to replace x-ray film with x-ray image. This change is needed to reflect updated radiology technology such as CD-R and laser-printed x-ray formats. Language concerning chest x-rays being attached to the alien's visa in such a manner to be readily detached at the U.S. port of entry has also been deleted since x-rays are not required to be presented at the port of entry.

The U.S. Department of State proposed 80,000 refugee admissions for Fiscal Year 2008 under the requirements of Section 207(e)(1)-(7) of the Immigration and Nationality Act. This is greater than a ten percent increase from FY 2007 projections. As of June 2008, approximately 35,000 refugees have been resettled, and around 27,000 still expected by the end of September 2008. Major diseases of concern in these incoming refugee populations include multi-drug-resistant tuberculosis (MDR TB), measles, highly pathogenic avian influenza, and cholera. The potential for transmitting viral hemorrhagic fevers, such as Ebola and Marburg, also exists among some of the African populations being resettled. In addition, several vector-borne (animal-transmitted) diseases including chikungunya, dengue and, possibly, Rift Valley fever, are circulating in refugee camps with populations bound for the United States. Vectors (i.e. mosquitoes) prevalent in the United States are capable of widely spreading these diseases.

Allowing serious diseases to enter into the United States can result in significant harm to both the American public and American business. The existing definition of communicable diseases of public health significance and the evaluation criteria for tuberculosis in the current regulation are outdated and no longer in keeping with current medical knowledge. Therefore, immediate changes are needed to improve the ability of the United States to prevent the introduction and spread of infectious diseases that are currently causing severe illness and death abroad. The scope of examination for medical screening is also outdated, and needs immediate changes to allow for medical screening by using a risk-based approach that considers medical and epidemiologic factors. The current regulations do not have a process for allowing HHS/CDC to adapt rapidly to new health threats, and they reference outdated public health practices that do not take advantage of the latest biomedical knowledge and epidemiologic data. Changes are needed now to reduce the potential for significant harm from emerging diseases and outbreaks of infectious diseases that currently threaten U.S. health security.

Newly emerging communicable disease threats are arising with increased frequency because of multiple factors, such as increases in global travel and mobility, migration patterns, human susceptibility to novel infections, and microbial adaptation and mutation, as cited in the latest report of the U.S. Institute of Medicine on emergence of infectious diseases, Microbial Threats to Health: Emergence, Detection and Response , National Academies Press, 2003. Infectious disease outbreaks (e.g., SARS in 2003) or potential threats like pandemic influenza are evidence that virulent diseases with short incubation periods can be carried over a border before signs of illness can be observed. Additionally, when disease outbreaks occur in refugees or immigrants coming to the United States, public health control actions such as vaccination, treatment, chemoprophylaxis and isolation must be implemented immediately to prevent the importation of disease into the United States.

Annually, approximately 1,000,000 immigrants and refugees enter the United States to reside here permanently. The majority arrive from Asia, Africa and Central and South America, regions with recently reported outbreaks of emerging infectious diseases, including yellow fever, dengue and the H5N1 strain of avian influenza. The 50,000-80,000 refugees who resettle in the United States each year are the most vulnerable populations, as they often come from difficult environmental conditions with limited water, sanitation and health care. Living conditions for many refugees include poor to nonexistent health and public health infrastructure; thus, it is difficult to have adequate knowledge of their current and potential medical problems. In refugee camps, disease surveillance and laboratory resources are often limited, which increases the difficulty of maintaining good health and preventing outbreaks of infectious diseases. Historically, outbreaks of communicable diseases have occurred frequently in refugee camps. These regular outbreaks, and the inherent nature of large population resettlements, highlight the health threats to which HHS/CDC has to respond on very short notice.

The shift in the demographics of refugee and immigrant populations bound for the United States and consequent changes in their health risks mandate a change in the definition of a communicable disease of public health significance , because of the current uncertainty of global disease trends. This demographic shift is the single most important cause of the substantial increase in the number and nature of outbreaks of communicable diseases among immigrants who are resettling into the United States.

HHS/CDC is unable to forecast constantly changing migration patterns, and thus must have the flexibility to respond swiftly as unpredictable, problematic health and humanitarian crises arise. The current definition of a communicable disease of public health significance does not adequately accommodate the demographic shifts that have dramatically altered the pattern of diseases among new arrivals in the United States.

HHS/CDC has found that the origins of U.S.-bound populations are increasingly unpredictable, and these populations increasingly originate in areas with challenging and unpredictable communicable diseases of public health significance. Immigration statistics ( http://www.dhs.gov/ximgtn/statistics ) show more U.S.-bound refugees and immigrants now come from regions with a higher risk for communicable diseases. In recent years, the disease burden to the United States has increased as the proportion of refugees resettling from Africa and Asia has increased ( http://www.state.gov/g/prm/refadm/rls/85970.htm ). As an example, the proportion of refugees resettled to the United States from Africa have increased in the recent past. African refugee arrivals have averaged 16,000 per year since FY 2005. These newer groups of refugees have lower baseline rates of vaccination, higher rates of malaria and other parasitic infections (unfamiliar to most American clinicians), and very limited access to basic medical care and preventive health interventions before resettlement. Failure to address these conditions adequately because of the outdated definition of communicable diseases of public health significance has meant that HHS/CDC has had to respond to at least 25 outbreaks of disease among U.S.-bound refugees since 2004.

Major outbreaks of dangerous, communicable diseases around the world in 2007 included Ebola in the Democratic Republic of the Congo in September, and in Uganda in December; cholera in Iraq in August; yellow fever in Togo in February, and in Brazil and Paraguay in December; and 85 animal-to-human cases of the highly pathogenic H5N1 strain of avian influenza throughout the year. These outbreaks have been of diseases that do not naturally occur in the United States, or occur rarely, which could result in disability and death in U.S.-bound immigrants and refugees and secondary spread in the communities in the United States that receive immigrants.

The WHO classifies yellow fever as a disease that has demonstrated the ability to cause serious public health impact, and is a good example of a threat to the health security of the United States. The Ministry of Health in Togo reported an outbreak of yellow fever to the WHO that lasted from December 2006 through February 2007. Moreover, Sudan, Senegal, Mali, Côte d'Ivoire, Burkina Faso, Guinea, Brazil, Peru, Paraguay, Bolivia and Argentina have also reported ongoing outbreaks of yellow fever to the WHO. In total, the WHO considers 46 countries, including 33 African countries and 11 countries in Central and South America, to be currently at risk of yellow fever. Substantial numbers of U.S.-bound immigrants and refugees originate from areas in which yellow fever is endemic, and therefore pose a risk of the importation of this disease. Since mosquitoes that spread yellow fever exist in the United States, and areas of our country experienced outbreaks of the disease throughout the nineteenth century, importation could potentially result in sustained transmission in this country. Yellow fever is not currently included in the specific disease list in the regulation, but HHS/CDC would be classify it as a communicable disease of public health significance under the newly proposed definition, because it is a quarantinable disease by Presidential Executive Order and a disease that requires notification to WHO as an event that may constitute a public health emergency of international concern under the IHR (2005).

The examples below enumerate some of the most recent (and largely unpredictable) disease outbreaks encountered as refugees resettle into the United States:

Vector-borne diseases involve a pathogen transmitted from an infected individual or animal, usually by an insect or other arthropod such as a mosquito or tick. There are several vector-borne diseases that are circulating in areas with U.S.-bound immigrants and refugees, all of which could spread into the U.S. population. These include exotic illnesses like chikungunya, dengue, and possibly Rift Valley fever.

The changes in the medical screening rules will also provide HHS/CDC officials with the authority to screen applicants that are coming into the United States from areas affected by a possible pandemic influenza. The World Health Report 2007—A safer future: global public health security in the 21st century , issued by the WHO, emphasizes the danger of an influenza pandemic. A pandemic strain of influenza would be far more contagious than SARS, since it spreads by coughing and sneezing, and is transmitted with a short incubation period that reduces the time for tracing the spread of disease and isolating patients. An influenza pandemic could extend the enormous health consequences seen with SARS in Asia and Canada to every corner of the world within a matter of months.

Although HHS/CDC cannot predict the timing and exact strain, science and history suggest the world will suffer at least one influenza pandemic this century, which has the potential to have a rapid and immense impact on all segments of the U.S. population and our economy. In the 20th century, the greatest influenza pandemic occurred in 1918-1919, which caused an estimated 40-50 million deaths worldwide. A severe pandemic, as happened in 1918, could now have a much greater impact. When pandemic strains emerge, they sweep through nations with frightening velocity. The three pandemics of the 20th century each encircled the world within months of their emergence into humans. Based on the current speed and volume of international movement of people and animals, there is no reason to think the next pandemic would spread any slower.

Although health care has improved in the past decades, the WHO is predicting that today an influenza pandemic could result in 2-7.4 million deaths globally.  1 The WHO estimates that if a pandemic virus emerged now, the spread of the disease would be rapid. Based on experiences with past pandemics, some experts have predicted an illness that could affect around 25 percent of the world's population—more than 1.5 billion people. Should these forecasts prove accurate, the impact an influenza pandemic would have on national and international public health, and on economic and political security, would be enormous. Even if the virus caused relatively mild symptoms, the economic and social disruption that would arise from sudden surges of illness in so many people—occurring almost simultaneously throughout the world—would be incalculable. 2

Interpandemic (seasonal) influenza results in more than 200,000 hospitalizations every year and causes an average of 36,000 deaths annually in the United States. Modeling studies suggest that, in the absence of effective control measures, a medium-level pandemic (in which 15 to 35 percent of the population of the United States develops influenza) could result in 89,000 to 207,000 deaths, between 314,000 and 734,000 hospitalizations, 18 to 42 million outpatient visits, and 20 to 47 million sick people. The associated economic impact in the United States alone could range between $71.3 and $166.5 billion.

The H5N1 virus that is currently circulating in Asia, Africa and Europe provides an example of the immense potential impact of an emerging influenza virus. As of March 19, 2008, the H5N1 strain of influenza virus has killed over 63 percent of the 373 humans affected, and authorities fear the disease could mutate into a form that could pass quickly and efficiently from human to human, which could spark a global pandemic. The 14 countries that have reported laboratory-confirmed human cases of H5N1 infection as of March 19, 2008, are Azerbaijan, The People's Republic of China, Djibouti, Thailand, Egypt, Vietnam, Cambodia, Indonesia, Laos, Nigeria, Pakistan, Burma, Turkey, and Iraq. Before the next pandemic virus becomes well-adapted to humans, there is an urgent need for the United States to be prepared to detect human cases, and to prevent a novel influenza virus from being imported to the United States. One of the most effective ways to protect the American population is the preventive medical screening of aliens which would thereby help avert the entry and importation of a pandemic strain, or at least delay its arrival.

HHS/CDC is implementing these new provisions immediately because the United States needs to respond effectively to any potential emerging communicable disease. HHS/CDC is taking this immediate action because the existing definition of communicable diseases of public health significance and the scope of medical screening do not adequately reflect current threats or protect against the significant harm to the American public currently ongoing and future outbreaks represent. Changing our approach to identifying, screening and testing for communicable diseases of public health significance will greatly improve our ability to detect, treat, and mitigate the potential introduction into—and spread throughout our country—of newly emerging and re-emerging diseases.

Under the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(3)(B) and (d)(3), HHS/CDC finds that good cause exists to waive prior notice and comment and a 30 day delay in effective date on this rule is impracticable and contrary to the public interest. It is critical, for the reasons stated above, that HHS/CDC act quickly to ensure appropriate response, now and in the immediate future, to urgent disease threats that could have significant consequences in the United States. As noted, CDC is eager to consider public comment and will revise the rule as appropriate after receiving and analyzing any comments submitted.

HHS/CDC has examined the impact of the Interim Final Rule under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act (UMRA) of 1995.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits.

HHS/CDC commissioned an analysis of the rule, which is included in the docket. The analysis examined the increased costs to immigrants, refugees and other entities, and the benefits of additional screening in preventing the spread of disease in the U.S. population.

Based on recent history of disease outbreaks worldwide, the analysis estimates an additional cost of $4 million per year to immigrants and refugees. Immigrants will bear the additional medical testing costs for themselves, and the U.S. government will bear the additional medical testing costs for refugees. The benefit to the U.S. population associated with reduced incidence of secondary infections is estimated to be $30 million.

These estimates only reflect the costs and benefits based on recent history. The study examined the benefits and costs associated with a new or re-emerging disease separately, but did not include them in the annualized values because of the inherent inability to estimate the frequency of an unknowable event.

Based on the analysis, HHS/CDC has determined that the rule is not economically significant, as defined under Executive Order 12866.

HHS/CDC considered the proposed regulation's effects on small entities, as required by the Regulatory Flexibility Act, and certifies that the final rule will not have a significant economic impact on small entities.

HHS/CDC evaluated the rule requirements for compliance with the UMRA of 1995. This rule does not contain Federal mandates under the regulatory provisions of Title II of the UMRA for State, local or tribal governments, nor for the private sector. Finally, the rule's provisions will not affect small governments.

HHS has determined that provisions that amend 42 CFR part 34 will not have a significant impact on the human environment.

In accordance with Executive Order 13132, HHS/CDC determines that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

HHS/CDC has reviewed this rule under Executive Order 12988, on Civil Justice Reform. This rule (1) preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court to challenge this rule.

The Paperwork Reduction Act applies to the data collection requirements found in 42 CFR part 34. The U.S. Department of State (DoS) is responsible for providing forms to panel physicians to document the medical examination and screening information for aliens. The Office of Management and Budget (OMB) last approved this data collection under OMB Control No. 1405-0113, on September 30, 2007. DoS will update its information collection request to reflect the changes made to the forms by this Interim Final Rule.

The following references are available at the following Internet address: http://www.who.int.

The reef fish fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. Those regulations set the commercial quota for deepwater grouper in the Gulf of Mexico at 1.02 million lb (463,636 kg) and for tilefish in the Gulf of Mexico at 440,000 lb (200,000 kg) for the current fishing year, January 1 through December 31, 2008.

Under 50 CFR 622.43(a), NMFS is required to close the commercial fishery for a species or species group when the quota for that species or species group is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register . NMFS projected the fisheries for deepwater grouper and tilefishes would reach their respective quotas on May 10, 2008, and closed the fisheries on that date (73 FR 24883, May 6, 2008). Based on current statistics, NMFS has determined that only 89 percent of the available commercial quotas for deepwater grouper and tilefishes were landed. Based on 2008 daily landings rates and the pounds remaining on each quota (approximately 100,000 lb (45,359 kg) for deepwater grouper and 46,000 lb (20,865 kg) for tilefishes), NMFS has determined these fisheries can reopen for 10 days. Accordingly, NMFS is reopening the commercial deepwater grouper and tilefish fisheries in the Gulf of Mexico EEZ from 12:01 a.m., local time, on November 1, 2008, until 12:01 a.m., local time, on November 11, 2008. The fisheries will then be closed until 12:01 a.m., local time, on January 1, 2009. November 1 was chosen as the opening day based on feedback from the fishing industry and weather concerns. Many fishers indicated that this was the most productive time for the reopening. NMFS also chose to wait until after the peak of hurricane season to promote safety at sea, consistent with National Standard 10 of the Magnuson-Stevens Act.

The operator of a vessel with a valid commercial vessel permit for Gulf reef fish may not fish for or possess deepwater grouper or tilefishes prior to 12:01 a.m., local time, November 1, 2008, and must have landed and bartered, traded, or sold such deepwater grouper or tilefishes prior to 12:01 a.m., local time, November 11, 2008.

During the closure, the bag and possession limits specified in 50 CFR 622.39(b) apply to all harvest or possession of deepwater grouper and tilefishes in or from the Gulf of Mexico EEZ, and the sale or purchase of deepwater grouper and tilefishes taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to sale or purchase of deepwater grouper or tilefishes that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, November 11, 2008, and were held in cold storage by a dealer or processor. Vessels with commercial quantities of Gulf reef fish on board are prohibited from retaining a recreational bag limit of Gulf reef fish. Thus, such a vessel may only have a commercial quantity of reef fish other than deepwater grouper or tilefishes or a recreational bag limit of Gulf reef fish.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such prior notice and opportunity for public comment is unnecessary. Prior notice and opportunity for public comment on the reopening is unnecessary because the rule establishing the annual quota has already been subject to notice and comment, and all that remains is the annual administrative act of notifying the public of where harvest stands in relation to the quota, and in this case that additional time is needed to harvest the established quota. The rule contains a routine determination relative to harvest levels for the fishing year that are relatively insignificant in nature and impact to the industry and to the public as a whole.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.

The Atlantic red drum fishery off the South Atlantic and Mid-Atlantic coastal states is currently managed under two separate FMPs. Atlantic red drum located in the EEZ are managed under the Atlantic Coast Red Drum FMP prepared by the South Atlantic Council, in cooperation with the Mid-Atlantic Council (Council FMP), and implemented under the authority of the Magnuson-Stevens Act by regulations at 50 CFR part 622. The Council FMP prohibits harvest or possession of red drum in the South Atlantic and Mid-Atlantic EEZ. Atlantic red drum located in state waters are managed under the Interstate Fishery Management Plan (ISFMP) for Red Drum by the Atlantic coast states (New Jersey through Florida) and the Commission. This final rule repeals the Council FMP and implementing regulations issued under the Magnuson-Stevens Act and simultaneously replaces them with substantially identical regulations under the Atlantic Coastal Act. The Atlantic Coastal Act allows the Federal government to better coordinate its management practices with the states via the Commission process. The repeal of the Council FMP would occur at the same time as this rule is implemented.

On April 3, 2008, NMFS published a proposed rule for the transfer of management authority of Atlantic red drum and requested public comment (73 FR 18253). The rationale for this action, including the statute giving authority to the Commission to manage Atlantic red drum in the EEZ, the purpose and need for transfer of management authority, and the benefits of this transfer are included in the preamble to the proposed rule and are not repeated here.

The following is a summary of the comments NMFS received on the proposed rule and NMFS' responses. Three comments were received on this action. One comment was in favor of the transfer of management authority, one comment was opposed to the transfer of authority, and one comment was in favor of the transfer of authority but did not agree that regulations under the Atlantic Coastal Act are comparable to the current Magnuson-Stevens Act regulations.

Comment 1 : The first commenter stated the transfer of authority will result in more efficient and effective management for Atlantic red drum.

Response : The purpose of this action is to manage Atlantic red drum under one FMP rather than two, thus minimizing management costs and eliminating unnecessary duplication of management efforts. This transfer of management authority furthers Magnuson-Stevens Act national standard 7, which states “Conservation and management measures shall, where practicable, minimize costs and avoid unnecessary duplication.”

Comment 2 : The second commenter stated the changes being proposed are anti-environmental in nature, and NMFS in particular is biased toward “fish profiteers.”

Response : This rule will not change existing restrictions prohibiting the harvest or possession of red drum in the EEZ. NMFS and the U.S. Coast Guard will continue to enforce those prohibitions. Repealing the Council FMP under the Magnuson-Stevens Act and simultaneously implementing comparable regulations under the Commission FMP under the Atlantic Coastal Act, will provide for a more efficient and timely rebuilding of the Atlantic red drum resource.

Comment 3 : One commenter stated the regulations under the Atlantic Coastal Act intended to replace those under the Magnuson-Stevens Act are not comparable, and the EA does not acknowledge some of the essential fish habitat (EFH) designated for red drum will be eliminated, nor does it mention the loss of habitat areas of particular concern (HAPC).

Response : NMFS does not believe that adoption of this rule will result in an appreciable loss of habitat protection for red drum.

As a preliminary matter, red drum EFH, including habitat areas of particular concern, substantially overlaps the EFH of other species. Accordingly, even if red drum EFH designations are necessarily withdrawn in the transfer, NMFS would still likely recommend the same protective measures through its EFH consultations on other species. In other words, although red drum habitat protections would be incidental to EFH consultations on other species, red drum habitat would nevertheless still be protected. For example, the South Atlantic Coastal Migratory Pelagics FMP (CMP FMP) includes EFH areas that overlap areas previously designated as EFH for red drum, namely, barrier island ocean-side waters from the surf to the shelf break zone, all coastal inlets, and all state-designated nursery habitats of particular importance to coastal migratory pelagics. Under the CMP FMP the surf zone is not referred to as a “high-salinity” surf zone as it is in the red drum EFH description; however, the same meaning for each is inferred. Additionally, the South Atlantic Shrimp FMP (Shrimp FMP) does use the term “tidal freshwater” in its designation of EFH for penaeid shrimp. The Shrimp FMP includes inshore nursery areas in its designation of EFH for penaeid shrimp and defines this habitat as tidal freshwater, estuarine, and marine emergent wetlands (e.g., intertidal marshes); tidal palustrine forested areas; mangroves, tidal freshwater, estuarine, and submerged aquatic vegetation (SAV) (e.g., seagrass); and subtidal and intertidal non-vegetated flats. This designation of EFH for penaeid shrimp applies from North Carolina through the Florida Keys.

Further, to the extent that protection is lost under the Magnuson-Stevens Act in the transfer, NMFS believes that such loss is mitigated by comparable protections that would remain under other statutes. Specifically, the Fish and Wildlife Coordination Act, similar to the Magnuson-Stevens Act, requires Federal agencies to first consult with NMFS before taking an action that might impact NMFS trust resources. The Fish and Wildlife Coordination Act requires that the Federal agency “...shall consult with...the head of the agency exercising administration over the wildlife resources...with a view to the conservation of wildlife resources by preventing loss of and damage to such resources...” Further, the Fish and Wildlife Coordination Act allows the Secretary to make recommendations to the Federal agency on alternative “...means and measures that should be adopted to prevent the loss of or damage to such wildlife resources...” (16 U.S.C. 661-667e). Accordingly, although EFH is a technical term unique to the Magnuson-Stevens Act and EFH consultation is a process reserved to species managed under the Magnuson-Stevens Act, it does not necessarily follow that comparable habitat protection would be altogether lost if red drum were managed under an alternative statute. Federal agencies would still be required to consult with NMFS on the potential impacts of their actions to red drum habitat, but simply under a different statute.

Comment 4 : One of the above commenters also stated that the EA does not discuss Executive Order (E.O.) 13449, (72 FR 60531, October 24, 2007), regarding the protection of striped bass and red drum, and the rule would not establish consistent EFH consultation requirements between red drum stocks of the Gulf of Mexico and Atlantic.

Response : The commenter is concerned this rule will establish inconsistent regulations between the red drum stocks of the Gulf of Mexico and the Atlantic. Gulf of Mexico red drum stocks are already managed independently of the Atlantic red drum stocks. The ability of the NMFS to consult and provide consistent recommendations for the conservation and preservation of habitats utilized by red drum under the Fish and Wildlife Coordination Act will not change. Additionally, because NMFS will continue to consult and provide conservation recommendations for EFH of all other Council-managed species, the ability to consistently protect and conserve fishery habitats, including all habitats utilized by red drum, will not be significantly changed.

NMFS understands this rule to be consistent with the spirit and intent of E.O. 13449, because comparable EFH protections for Atlantic red drum will be maintained under previously noted FMPs for Council-managed species, and comparable fishery management regulations under the Atlantic Coastal Act will take the place of current regulations under the Magnuson-Stevens Act, and because comparable habitat consultation will occur under the Fish and Wildlife Coordination Act. Furthermore, the Atlantic Coastal Act clearly includes habitat conservation among its intended goals with regards to state-federal cooperation by stating: “The Secretary in cooperation with the Secretary of the Interior shall develop and implement a program to support the interstate fishery management efforts of the Commission. The program shall include activities to support and enhance State cooperation in collection, management, and analysis of fishery data; law enforcement, habitat conservation; fishery research, including biological and socioeconomic research; and fishery management planning” (16 U.S.C. 5103).

The Administrator, Southeast Region, NMFS, determined that the transfer of management authority is necessary for the conservation and management of the Atlantic red drum fishery and that it is consistent with the Magnuson-Stevens Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required, and none was prepared.

Fisheries, Fishing, Puerto Rico, Reporting and recordkeeping requirements, Virgin Islands.

Fisheries, Fishing.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2008 TAC of Pacific cod allocated to vessels catching Pacific cod for processing by the inshore component of the Central Regulatory Area of the GOA is 25,583 metric tons (mt) as established by the 2008 and 2009 harvest specifications for groundfish of the GOA (73 FR 10562, February 27, 2008).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2008 TAC of Pacific cod allocated to vessels catching Pacific cod for processing by the inshore component of the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 24,583 mt, and is setting aside the remaining 1,000 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels catching Pacific cod for processing by the inshore component in the Central Regulatory Area of the GOA.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by vessels catching Pacific cod for processing by the inshore component of the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 29, 2008.

The AA also finds good cause to waive the 30 -day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.