Organizational Integrity of Entities Implementing Leadership Act Programs and Activities, 61096-61100 [E9-28127]

Download as PDF 61096 Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Proposed Rules Column A Column B Column C Approved critical uses Approved critical user and location of use Limiting critical conditions that exist, or that the approved critical user reasonably expects could arise without methyl bromide fumigation: (c) Members of the North American Millers’ Association in the U.S. Moderate to severe beetle infestation. Presence of sensitive electronic equipment subject to corrosion. Time to transition to an alternative. Moderate to severe beetle or moth infestation. Presence of sensitive electronic equipment subject to corrosion. Time to transition to an alternative. Rapid fumigation required to meet a critical market window, such as during the holiday season. Commodities ........................................ Dry Cured Pork Products ..................... (d) Members of the National Pest Management Association treating processed food, cheese, herbs and spices, and spaces and equipment in associated processing and storage facilities. (a) California entities storing walnuts, beans, dried plums, figs, raisins, and dates (in Riverside county only) in California. (a) Members of the National Country Ham Association and the Association of Meat Processors, Nahunta Pork Center (North Carolina), and Gwaltney and Smithfield Inc. [FR Doc. E9–27822 Filed 11–20–09; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 440 and 441 [CMS–2261–WN] RIN 0938–A081 Medicaid Program; Coverage for Rehabilitative Services; Withdrawal jlentini on DSKJ8SOYB1PROD with PROPOSALS AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Withdrawal of proposed rule. SUMMARY: This document withdraws a proposed rule that was published in the Federal Register on August 13, 2007. The proposed rule discussed our proposal to amend the definition of Medicaid ‘‘rehabilitative services.’’ It also clarified the broad general language of the current regulation to ensure that rehabilitative services are provided in a coordinated manner, are limited to rehabilitative purposes, and are furnished by qualified providers. DATES: Effective November 23, 2009, the proposed rule published on August 13, 2007 (72 FR 45201) is withdrawn. FOR FURTHER INFORMATION CONTACT: Melissa Harris, (410) 786–3397. SUPPLEMENTARY INFORMATION: On August 13, 2007, we published a proposed rule in the Federal Register entitled ‘‘Medicaid Program; Coverage for Rehabilitative Services’’ (72 FR 45201). The rule proposed to amend the definition of Medicaid ‘‘rehabilitative services’’ to include a requirement for a VerDate Nov<24>2008 16:08 Nov 20, 2009 Jkt 220001 Red legged ham beetle infestation. Cheese/ham skipper infestation. Dermested beetle infestation. Ham mite infestation. person-centered written rehabilitation plan and maintenance of case records. We received a total of 1,845 public comments in response to the August 13, 2007 proposed rule. In addition, following the publication of the proposed rule, in section 206 of the Medicare, Medicaid, and SCHIP Extension Act of 2007, Public Law 110– 173, the Congress enacted a moratorium on December 29, 2007 that included a prohibition on the Secretary taking any action, including publication of a final rule that was more restrictive with respect to coverage or payment for rehabilitative services than the requirements in place as of July 1, 2007. That moratorium was extended until April 1, 2009 by section 7001(a)(2) of the Supplemental Appropriations Act of 2008, Public Law 110–52. Before the expiration of that congressional moratorium, the American Recovery and Reinvestment Act of 2009, Public Law 111–5, was enacted on February 17, 2009 and, at section 5003(d), stated that it was the ‘‘sense of Congress’’ that the Secretary should not promulgate as a final regulation the August 13, 2007 proposed regulation concerning rehabilitative services. In light of the clear congressional concern indicated by the statutory moratorium and the resolution opposing issuance of a final rule based on the proposed rule, as well as the complexity of the underlying issues and of the public comments received, we have decided to withdraw the August 2007 proposed rule in order to assure agency flexibility in re-examining the issues and exploring options and alternatives with stakeholders. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 Dated: October 28, 2009. Charlene Frizzera, Acting Administrator, Centers for Medicare & Medicaid Services. Approved: November 17, 2009. Kathleen Sebelius, Secretary. [FR Doc. E9–27954 Filed 11–17–09; 4:15 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 89 RIN 0991–AB60 Organizational Integrity of Entities Implementing Leadership Act Programs and Activities AGENCY: U.S. Department of Health and Human Services. ACTION: Notice of proposed rulemaking. SUMMARY: The Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties. This is a proposal to amend the rule governing the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking. The proposed rule relaxes the criteria for recipient—affiliate separation, and simplifies the process for compliance with the statutory requirement that recipients of HHS Leadership Act HIV/ AIDS funds have a policy explicitly opposing prostitution and sex E:\FR\FM\23NOP1.SGM 23NOP1 Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Proposed Rules trafficking. This proposal eliminates the requirement that recipients prepare and file additional documentation specifically to demonstrate adherence to this policy. The documentation will instead consist of a statement in the awarding document to which the prime recipient must agree in order to receive Leadership Act HIV/AIDS funds. DATES: To be assured consideration, submit electronic comments on or before December 23, 2009 via the Internet at http://www.regulations.gov. ADDRESSES: You may submit comments, identified by RIN 0991–AB60, through the Federal eRulemaking Portal: http:// www.regulations.gov. Instructions: For detailed information on submitting comments and additional information on the rulemaking process, visit http://www.regulations.gov. All submissions must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All comments received will be posted to http://www.regulations.gov, including any personal information provided. FOR FURTHER INFORMATION CONTACT: Diana Perez-Rivera or Natarsha Wright, Office of Global Health Affairs, Hubert H. Humphrey Building, Room 639H, 200 Independence Avenue, SW., Washington, DC 20201, Tel: 202–690– 6174, E-mail: ogha.os@hhs.gov. SUPPLEMENTARY INFORMATION: The Preamble to this NPRM is organized as follows: I. Public Participation II. Summary III. Background IV. Discussion of the Proposed Rule V. Impact Analysis I. Public Participation Comments will be available for public inspection at http:// www.regulations.gov. Electronic Access: You can download an electronic version of the NPRM at http://www.regulations.gov. HHS/OGHA has also posted the NPRM and related materials to its Web site at the following Internet address: http:// www.globalhealth.gov/. II. Summary jlentini on DSKJ8SOYB1PROD with PROPOSALS Statutory Authority This proposal would amend the ‘‘Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act,’’ 73 FR 78997 (Dec. 24, 2008), which implements subsection 7631(f) of the United States Leadership Against HIV/ AIDS, Tuberculosis and Malaria Act VerDate Nov<24>2008 16:08 Nov 20, 2009 Jkt 220001 (‘‘Leadership Act’’), Public Law 108–25 (May 27, 2003), as amended, 22 U.S.C. 7631(f). III. Background Congress enacted the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, 22 U.S.C. §§ 7601–7682, (‘‘Leadership Act’’) in May 2003. The Leadership Act contains limitations on the use of funds provided to carry out HIV/AIDS activities under the Act (‘‘Leadership Act HIV/AIDS funds’’). Subsection 7631(f) prohibits the use of Leadership Act HIV/AIDS funds ‘‘to provide assistance to any group or organization that does not have a policy explicitly opposing prostitution and sex trafficking.’’ (Subsection 7631(f) of the Leadership Act was amended in 2004 to exempt certain public international organizations. Consolidated Appropriations Act of 2004 and 2005, Division D—Foreign Operations, Export Financing, and Related Programs Appropriations (‘‘FY 04 and FY 05 Appropriations Act’’), Title II—Bilateral Economic Assistance, United States Agency for International Development, Child Survival Health Programs Fund. Reauthorization of the Leadership Act in 2008 did not amend Subsection 7631(f)). Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110–293 (July 30, 2008). During legislative debate on the Leadership Act, in response to a question from Senator Leahy on the Senate floor regarding subsection 7631(f), Senator Frist stated that ‘‘a statement in the contract or grant agreement between the U.S. Government and such organization that the organization is opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women * * * would satisfy the intent of the provision.’’ 149 Cong. Rec. S6457 (daily ed. May 15, 2003) (statement of Sen. Frist). By December, 2003, HHS had begun including a requirement in all of its grant and cooperative agreement funding announcements that required all recipients under the Leadership Act of HIV/AIDS funds to have a policy explicitly opposing prostitution and sex trafficking. In March, 2004, HHS exempted domestic U.S. recipients from this restriction, but withdrew the exemption in May, 2005. On July 23, 2007, HHS published sub-regulatory ‘‘Organizational Integrity Guidance’’ in the Federal Register to clarify the scope of the policy requirement by stating that PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 61097 Leadership Act HIV/AIDS funding recipients may have affiliates that do not have a policy against prostitution and sex trafficking. HHS followed the issuance of this guidance with a notice of proposed rulemaking (NPRM) on April 17, 2008, 73 FR 29096, which initiated the notice-and-comment rulemaking process. The final rule was published on December 24, 2008, 73 FR 78997, corrected on January 16, 2009, 74 FR 2888 (codified at 45 CFR part 89), and took effect on January 20, 2009. The final rule established the legal, financial, and organizational standards for determining whether a funding recipient had objective integrity and independence from an affiliated organization that engaged in activities inconsistent with a policy opposing prostitution and sex trafficking. The final rule also required all Leadership Act HIV/AIDS funding recipients, including sub-recipients, to certify compliance with the rule. The proposed amendment to the present rule modifies the criteria for evaluating the separation between recipients and affiliated organizations, while complying with the statutory requirement regarding opposition to prostitution and sex trafficking. It is important to implementation of the Leadership Act that recipients of Leadership Act funds to implement HIV/AIDS programs and activities not confuse the U.S. Government’s message opposing prostitution and sex trafficking by undertaking activities or advocating positions that conflict with this policy. However, HHS has determined after further study that the objectives of the Leadership Act can be effectuated through the application of standards that are less burdensome for funding recipients than the standards set out in the present rule. HHS is working in coordination with USAID to ensure consistent administration of these programs for recipients and subrecipients. Nothing in the proposed amendment is intended to lessen or relieve relevant prohibitions on Federal Government funding under other applicable Federal laws. IV. Discussion of the Proposed Rule These sections discuss the proposed amendment to the rule, including changes to the regulatory separation requirements and deletion of the requirement for certification. Section 89.2 Organizational Integrity of Recipients This section of the proposed rule describes the separation that must exist between a recipient of HHS funds to E:\FR\FM\23NOP1.SGM 23NOP1 jlentini on DSKJ8SOYB1PROD with PROPOSALS 61098 Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Proposed Rules implement HIV/AIDS programs and activities under the Leadership Act and an affiliated organization that engages in activities inconsistent with a policy opposing prostitution and sex trafficking. Proposed amendments to the criteria for evaluating separation are discussed in greater detail below. As amended, this section would also provide that recipients will no longer be required to submit separate documentation certifying that they have a policy explicitly opposing prostitution. Rather, the policy requirement will be included in the notices of availability of funds and similar announcements, and acknowledged by recipients in the documents awarding the funds. Paragraph (a) states the policy to which recipients must adhere under subsection 7631(f), and identifies the criteria that will be used to evaluate the organizational integrity and independence of the recipient from affiliated organizations. Under the amendment, the recipient would agree that it is opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men and children. With respect to criteria, the paragraph retains the prohibition against affiliated organizations that do not satisfy subsection (f)’s requirement of opposing prostitution and sex trafficking from receiving Leadership Act HIV/AIDS funds. The paragraph continues to prohibit the use of Leadership Act HIV/ AIDS funds to subsidize activities inconsistent with a policy opposing prostitution and sex trafficking. However, paragraph (a) would no longer mandate that the affiliate must be ‘‘a legally separate entity,’’ but would instead provide that the legal status of the affiliate is one of the factors to be considered in deciding whether there is adequate separation between the recipient and the affiliate. This change recognizes the reported burden on recipients operating overseas in satisfying this criterion in certain cases, and the difficulty inherent in HHS’s analyzing foreign legal requirements. A similar change would be made to the factor suggesting evaluation of ‘‘[t]he existence of separate personnel, management, and governance.’’ The proposal now refers to ‘‘[t]he existence of separate personnel or other allocation of personnel that maintains adequate separation between the recipient and affiliate.’’ Again, this proposed change reflects reported difficulties in meeting a requirement for fully separate personnel in some situations. The proposed rule also deletes the VerDate Nov<24>2008 16:08 Nov 20, 2009 Jkt 220001 requirement for consideration of separate ‘‘management’’ and ‘‘governance’’ and for separate ‘‘accounts’’ because those elements of the relationship are not necessary to maintain sufficient separation between recipients and affiliated organizations to prevent confusion of the Government’s message opposing prostitution and sex trafficking. Other factors have been simplified and relaxed. Moreover, a further and very significant change to paragraph (a) provides that recipients must meet the criteria for separation ‘‘to the extent practicable in the circumstances,’’ which will permit practical factors to be taken into account in a specific case. In sum, these changes to paragraph (a) are intended to allow a recipient to maintain a relationship with an affiliated organization that may engage in restricted activities, without jeopardizing the recipient’s eligibility for HIV/AIDS funding under the Leadership Act. Paragraph (b) requires HHS agencies to include in funding notices and award instruments a statement that recipients of Leadership Act HIV/AIDS funds from HHS agree that they are opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children. By entering into the award agreement and accepting Leadership Act HIV/AIDS funds, recipients acknowledge this opposition, but are relieved from the necessity of preparing and submitting additional documentation. Paragraph (c) recognizes the statutory exemption for the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization, the International AIDS Vaccine Initiative and any United Nations Agency from subsection 7631(f), and is not affected by this amendment. Section 89.3 Certifications This proposed amendment to the rule deletes this section requiring separate documents certifying compliance with the Leadership Act because the materials described in subsection 89.2(b) will provide the necessary assurances. V. Impact Analysis Paperwork Reduction Act To obtain or retain Leadership Act HIV/AIDS funding, under the December 24, 2008 final rule, HHS required recipients to submit certifications attesting to their non-involvement in activities supporting prostitution and human trafficking and policies to that effect. The title of the information PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 collection was ‘‘Certification Regarding the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities.’’ HHS estimated that 555 respondents had to prepare documents to validate that recipients had objective integrity and independence from organizations that engage in activities inconsistent with policies opposing prostitution and sex trafficking. HHS also estimates that the average cost per hour will be $26.44, with a 0.5 hour estimated time burden per response. In total, the estimated burden cost is approximately $7337.10. This proposed rule removes the certification requirements of the December 24, 2008 rule. As a result, the burden estimate of 0.5 hours per applicant for Leadership Act HIV/AIDS funds is removed along with the associated costs. Executive Order 12866—Regulatory Planning and Review HHS has drafted and reviewed this regulation in accordance with Executive Order 12866, section (b), Principles of regulation. HHS has determined this rule is a ‘‘significant regulatory action’’ under Executive Order 12866, section 3(f)(4), because it raises novel legal or policy issues that arise out of legal mandates and the President’s priorities, and accordingly, the Office of Management and Budget has reviewed it. As explained above, this rule modifies a previously issued final rule on the same subject, published on December 24, 2008 in the Federal Register (P. 78997 to 79002). As explained earlier in this notice, the modification does not change policy, but reduces burden in complying with the established policy. Policy under the Leadership Act has been consistent and clear: The U.S government is opposed to prostitution and sex trafficking. Contractors and subcontractors cannot use Leadership Act HIV/AIDS funds to carry out activities that call into question the antitrafficking/anti-prostitution policy. Enforcement of this policy was originally through language inserted in awards at the time they were executed. The December 24, 2008 final rule required further statements and formal documentation from recipients before they could receive Leadership Act HIV/ AIDS funds. The Impact Analysis and the Paperwork Reduction Act in the December 24, 2008 final rule estimated the burden and cost of writing the additional documentation. This rule no longer requires this additional documentation. It reestablishes the earlier requirement contained in the funding agreement prohibiting activities E:\FR\FM\23NOP1.SGM 23NOP1 Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Proposed Rules and policies that support prostitution and sex trafficking in human beings. As a result, applicants for Leadership Act HIV/AIDS funds will no longer have to incur the costs outlined in the December 24, 2008 impact analysis and paperwork burden analysis. The benefits of this rule are the reduction in burden and the possible encouragement of additional applicants because of the burden reduction. The costs of the rule are minimal as there are no changes in policy and we have determined that the methods of achieving compliance prior to December 24, 2008 are fully compatible with the purposes of the Act. 61099 We are republishing the impact table from the December 24, 2008 final rule. The burden estimate was $7337 calculated by assuming an additional half hour of clerical work to prepare documentation on behalf of 555 grantees at an hourly rate of $26.44. Instrument Number of respondents Number of responses per respondent Average burden hours per response Average cost per hour Total burden hours Total burden cost Certifications ............................................ 555 1 0.5 $26.44 277.5 $7,337 Regulatory Flexibility Act Assessment of Federal Regulation and Policies on Families Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal Departments and agencies to determine whether a final policy or regulation could affect family well-being. If the determination is affirmative, then the Department or agency must prepare an impact assessment to address criteria specified in the law. This rule will not have an impact on family well-being, as defined in this legislation. The Secretary certifies under 5 U.S.C. 605(b), as enacted by the Regulatory Flexibility Act (Pub. L. 96–354), that this rule will not result in a significant impact on a substantial number of small entities. Since enactment of the policy requirement in the Leadership Act, HHS has required its contract solicitations and grant announcements for Leadership Act HIV/AIDS funding to include a section regarding ‘‘Prostitution and Related Activities’’ Furthermore, the proposed rule proposes to remove the requirements for certification that were imposed on recipients in the December 24, 2008 final rule. Executive Order 13132—Federalism Executive Order 13132 on Federalism requires Federal Departments and agencies to consult with State and local Government officials in the development of regulatory policies with implications for Federalism. This rule does not have Federalism implications for State or local Governments, as defined in the Executive Order. jlentini on DSKJ8SOYB1PROD with PROPOSALS Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995 requires that a covered Federal Department or agency prepare a cost-benefit analysis before promulgating a rule that includes any Federal mandate that could 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 adjusted for inflation. The current threshold for preparing a cost-benefit analysis is $133 million. HHS has determined that this rule would not impose a mandate that will result in the expenditure by State, local, and Tribal Governments, in the aggregate, or by the private sector, of more than $133 million in any one year. VerDate Nov<24>2008 16:08 Nov 20, 2009 Jkt 220001 List of Subjects in 45 CFR Part 89 Administrative practice and procedure, Federal aid programs, Grant programs, Grants administration. For the reasons stated in the preamble, the Department of Health and Human Services proposes to amend 45 CFR Part 89 as follows: PART 89—ORGANIZATIONAL INTEGRITY OF ENTITIES IMPLEMENTING PROGRAMS AND ACTIVITIES UNDER THE LEADERSHIP ACT. 1. The authority citation for part 89 continues to read as follows: Authority: 22 U.S.C. 7631(f) and 5 U.S.C. 301. 2. Revise § 89.2 to read as follows: § 89.2 Organizational integrity of recipients. (a) A recipient must have objective integrity and independence from any affiliated organization that engages in activities inconsistent with the recipient’s opposition to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children (‘‘restricted activities’’). A recipient will be found to have objective integrity and independence from such an organization if: (1) The organization receives no transfer of Leadership Act HIV/AIDS PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 funds, and Leadership Act HIV/AIDS funds do not subsidize restricted activities; and (2) The recipient is, to the extent practicable in the circumstances, legally, physically, and financially separate from the affiliated organization. Mere bookkeeping separation of Leadership Act HIV/AIDS funds from other funds is not sufficient. HHS will determine, on a case-by-case basis and based on the totality of the facts, whether sufficient legal, physical, and financial separation exists. The presence or absence of any one or more factors will not be determinative. Factors relevant to this determination shall include, but will not be limited to, the following: (i) Whether the organization is a legally separate entity; (ii) The existence of separate personnel or other allocation of personnel that maintains adequate separation of the activities of the affiliated organization from the recipient; (iii) The existence of separate accounting and timekeeping records; (iv) The degree of separation of the recipient’s facilities from facilities in which restricted activities occur, and the extent of such restricted activities by the affiliated organization; and (v) The extent to which signs and other forms of identification that distinguish the recipient from the affiliated organization are present. (b) HHS agencies shall include in the public announcement of the availability of the grant, cooperative agreement, contract, or other funding instrument involving Leadership Act HIV/AIDS funds the requirement that recipients agree that they are opposed to the practices of prostitution and sex trafficking because of the psychological and physical risks they pose for women, men, and children. This statement shall also be included in the award documents for any grant, cooperative agreement or other funding instrument E:\FR\FM\23NOP1.SGM 23NOP1 61100 Federal Register / Vol. 74, No. 224 / Monday, November 23, 2009 / Proposed Rules involving Leadership Act HIV/AIDS funds entered into with the recipient. (c) This regulation applies to all recipients, including prime recipients and sub-recipients, unless they are exempted from the policy by statute. § 89.3 [Removed] 3. Remove § 89.3. Dated: October 29, 2009. John Monahan, Interim Director, Office of Global Health Affairs. Dated: October 29, 2009. Kathleen Sebelius, Secretary, Department of Health and Human Services. [FR Doc. E9–28127 Filed 11–19–09; 4:15 pm] BILLING CODE P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [FWS–R6–ES–2009–0080; 92210–1111– 0000–B2] Endangered and Threatened Wildlife and Plants; Notice of Intent to Conduct a Status Review of Gunnison sagegrouse (Centrocercus minimus) jlentini on DSKJ8SOYB1PROD with PROPOSALS AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent to conduct status review. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), under the authority of the Endangered Species Act of 1973, as amended (Act), give notice of our intent to conduct a status review of Gunnison sage-grouse (Centrocercus minimus). We conduct status reviews to determine whether the species should be listed as endangered or threatened under the Act. Through this notice, we encourage all interested parties to provide us information regarding Gunnison sage-grouse. DATES: To allow us adequate time to conduct this review, we request that we receive information on or before December 23, 2009. After this date, you must submit information directly to the Field Office (see FOR FURTHER INFORMATION CONTACT section below). Please note that we may not be able to address or incorporate information that we receive after the above requested date. You may submit information by one of the following methods: ADDRESSES: VerDate Nov<24>2008 16:08 Nov 20, 2009 Jkt 220001 • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • U.S. mail or hand-delivery: Public Comments Processing, Attn: Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, Suite 222; Arlington, VA 22203. We will not accept faxed comments. FOR FURTHER INFORMATION CONTACT: Al Pfister, Western Colorado Field Office; telephone (970) 243–2778, ext. 29. Individuals who are hearing-impaired or speech-impaired may call the Federal Relay Service at 1–800–877–8339. SUPPLEMENTARY INFORMATION: Information Solicited To ensure that the status review is based on the best available scientific and commercial information and to provide an opportunity to any interested parties to provide information for consideration, we are requesting information concerning Gunnison sagegrouse. We request information from the public, other concerned governmental agencies, Native American tribes, the scientific community, industry, and any other interested party. We are seeking: (1) General information concerning the taxonomy, biology, ecology, genetics, and status of the Gunnison sage-grouse; (2) Specific information on the conservation status of Gunnison sagegrouse, including information on distribution, abundance, and population trends; (3) Specific information on threats to Gunnison sage-grouse, including: (i) The present or threatened destruction, modification, or curtailment of its habitat or range; (ii) overutilization for commercial, recreational, scientific, or educational purposes; (iii) disease or predation; (iv) the inadequacy of existing regulatory mechanisms; and (v) other natural or manmade factors affecting its continued existence; and (4) Specific information on conservation actions designed to improve Gunnison sage-grouse habitat or reduce threats to Gunnison sagegrouse and their habitat. If you submit information, we request you support it with documentation such as data, maps, bibliographic references, methods used to gather and analyze the data, or copies of any pertinent publications, reports, or letters by knowledgeable sources. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or threatened species must be made ‘‘solely on the basis of the best scientific and commercial data available.’’ PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 You may submit your information concerning this status review by one of the methods listed in the ADDRESSES section. If you submit information that includes personal identifying information, you may request at the top of your document that we withhold this personal identifying information from public review. However, we cannot guarantee that we will be able to do so. Information and supporting documentation that we received and used in preparing this finding will be available for you to review by appointment during normal business hours at the U.S. Fish and Wildlife Service, Western Colorado Field Office (see FOR FURTHER INFORMATION CONTACT). Background The sage-grouse (Centrocercus spp.) is the largest grouse in North America and was first described by Lewis and Clark in 1805 (Schroeder et al. 1999, p. 1). Sage-grouse are most easily identified by their large size; dark brown color; distinctive black bellies; long, pointed tails; and association with sagebrush habitats. They are dimorphic in size, with females being smaller. Both sexes have yellow-green eye combs, which are less prominent in females. Sage-grouse are known for their elaborate mating ritual where males congregate on strutting grounds called leks and ‘‘dance’’ to attract a mate. During the breeding season males have conspicuous filoplumes (specialized erectile feathers on the neck) and exhibit yellow-green apteria (fleshy bare patches of skin) on their breasts (Schroeder et al. 1999, pp. 2, 18). For many years sage-grouse were considered a single species. Young et al. (2000, pp. 447–451) identified Gunnison sage-grouse (Centrocercus minimus) as a distinct species based on morphological (Hupp and Braun 1991, pp. 257–259; Young et al. 2000, pp. 447–448), genetic (Kahn et al. 1999, pp. 820–821; OylerMcCance et al. 1999, pp. 1460–1462), and behavioral (Barber 1991, pp. 6–9; Young 1994; Young et al. 2000, p. 449– 451) differences and geographical isolation. Gunnison sage-grouse are smaller than greater sage-grouse (C. urophasianus), weighing approximately one-third less (Hupp and Braun 1991, p. 257; Young et al. 2000, p. 447). Their filoplumes are longer and give the appearance of a ‘‘ponytail’’ during the courtship display, unlike the filoplumes on greater sage-grouse. Gunnison sagegrouse retrices (tail feathers) have distinctive barring, unlike the mottled pattern on greater sage-grouse retrices (Young et al. 2000, p. 448). Gunnison sage-grouse mating displays are slower E:\FR\FM\23NOP1.SGM 23NOP1

Agencies

[Federal Register Volume 74, Number 224 (Monday, November 23, 2009)]
[Proposed Rules]
[Pages 61096-61100]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 89

RIN 0991-AB60


Organizational Integrity of Entities Implementing Leadership Act 
Programs and Activities

AGENCY: U.S. Department of Health and Human Services.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) is issuing 
this Notice of Proposed Rulemaking (NPRM) to obtain input from 
stakeholders and other interested parties. This is a proposal to amend 
the rule governing the separation that must exist between a recipient 
of HHS funds to implement HIV/AIDS programs and activities under the 
United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act 
of 2003 and an affiliate organization that engages in activities that 
are not consistent with a policy opposing prostitution and sex 
trafficking. The proposed rule relaxes the criteria for recipient--
affiliate separation, and simplifies the process for compliance with 
the statutory requirement that recipients of HHS Leadership Act HIV/
AIDS funds have a policy explicitly opposing prostitution and sex

[[Page 61097]]

trafficking. This proposal eliminates the requirement that recipients 
prepare and file additional documentation specifically to demonstrate 
adherence to this policy. The documentation will instead consist of a 
statement in the awarding document to which the prime recipient must 
agree in order to receive Leadership Act HIV/AIDS funds.

DATES: To be assured consideration, submit electronic comments on or 
before December 23, 2009 via the Internet at http://www.regulations.gov.

ADDRESSES: You may submit comments, identified by RIN 0991-AB60, 
through the Federal eRulemaking Portal: http://www.regulations.gov.
    Instructions: For detailed information on submitting comments and 
additional information on the rulemaking process, visit http://www.regulations.gov. All submissions must include the agency name and 
docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted to http://www.regulations.gov, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Diana Perez-Rivera or Natarsha Wright, 
Office of Global Health Affairs, Hubert H. Humphrey Building, Room 
639H, 200 Independence Avenue, SW., Washington, DC 20201, Tel: 202-690-
6174, E-mail: ogha.os@hhs.gov.

SUPPLEMENTARY INFORMATION: The Preamble to this NPRM is organized as 
follows:

I. Public Participation
II. Summary
III. Background
IV. Discussion of the Proposed Rule
V. Impact Analysis

I. Public Participation

    Comments will be available for public inspection at http://www.regulations.gov.
    Electronic Access: You can download an electronic version of the 
NPRM at http://www.regulations.gov. HHS/OGHA has also posted the NPRM 
and related materials to its Web site at the following Internet 
address: http://www.globalhealth.gov/.

II. Summary

Statutory Authority

    This proposal would amend the ``Regulation on the Organizational 
Integrity of Entities That Are Implementing Programs and Activities 
Under the Leadership Act,'' 73 FR 78997 (Dec. 24, 2008), which 
implements subsection 7631(f) of the United States Leadership Against 
HIV/AIDS, Tuberculosis and Malaria Act (``Leadership Act''), Public Law 
108-25 (May 27, 2003), as amended, 22 U.S.C. 7631(f).

III. Background

    Congress enacted the United States Leadership Against HIV/AIDS, 
Tuberculosis and Malaria Act of 2003, 22 U.S.C. Sec. Sec.  7601-7682, 
(``Leadership Act'') in May 2003. The Leadership Act contains 
limitations on the use of funds provided to carry out HIV/AIDS 
activities under the Act (``Leadership Act HIV/AIDS funds''). 
Subsection 7631(f) prohibits the use of Leadership Act HIV/AIDS funds 
``to provide assistance to any group or organization that does not have 
a policy explicitly opposing prostitution and sex trafficking.'' 
(Subsection 7631(f) of the Leadership Act was amended in 2004 to exempt 
certain public international organizations. Consolidated Appropriations 
Act of 2004 and 2005, Division D--Foreign Operations, Export Financing, 
and Related Programs Appropriations (``FY 04 and FY 05 Appropriations 
Act''), Title II--Bilateral Economic Assistance, United States Agency 
for International Development, Child Survival Health Programs Fund. 
Reauthorization of the Leadership Act in 2008 did not amend Subsection 
7631(f)). Tom Lantos and Henry J. Hyde United States Global Leadership 
Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 
2008, Public Law 110-293 (July 30, 2008).
    During legislative debate on the Leadership Act, in response to a 
question from Senator Leahy on the Senate floor regarding subsection 
7631(f), Senator Frist stated that ``a statement in the contract or 
grant agreement between the U.S. Government and such organization that 
the organization is opposed to the practices of prostitution and sex 
trafficking because of the psychological and physical risks they pose 
for women * * * would satisfy the intent of the provision.'' 149 Cong. 
Rec. S6457 (daily ed. May 15, 2003) (statement of Sen. Frist).
    By December, 2003, HHS had begun including a requirement in all of 
its grant and cooperative agreement funding announcements that required 
all recipients under the Leadership Act of HIV/AIDS funds to have a 
policy explicitly opposing prostitution and sex trafficking. In March, 
2004, HHS exempted domestic U.S. recipients from this restriction, but 
withdrew the exemption in May, 2005. On July 23, 2007, HHS published 
sub-regulatory ``Organizational Integrity Guidance'' in the Federal 
Register to clarify the scope of the policy requirement by stating that 
Leadership Act HIV/AIDS funding recipients may have affiliates that do 
not have a policy against prostitution and sex trafficking. HHS 
followed the issuance of this guidance with a notice of proposed 
rulemaking (NPRM) on April 17, 2008, 73 FR 29096, which initiated the 
notice-and-comment rulemaking process. The final rule was published on 
December 24, 2008, 73 FR 78997, corrected on January 16, 2009, 74 FR 
2888 (codified at 45 CFR part 89), and took effect on January 20, 2009. 
The final rule established the legal, financial, and organizational 
standards for determining whether a funding recipient had objective 
integrity and independence from an affiliated organization that engaged 
in activities inconsistent with a policy opposing prostitution and sex 
trafficking. The final rule also required all Leadership Act HIV/AIDS 
funding recipients, including sub-recipients, to certify compliance 
with the rule.
    The proposed amendment to the present rule modifies the criteria 
for evaluating the separation between recipients and affiliated 
organizations, while complying with the statutory requirement regarding 
opposition to prostitution and sex trafficking. It is important to 
implementation of the Leadership Act that recipients of Leadership Act 
funds to implement HIV/AIDS programs and activities not confuse the 
U.S. Government's message opposing prostitution and sex trafficking by 
undertaking activities or advocating positions that conflict with this 
policy. However, HHS has determined after further study that the 
objectives of the Leadership Act can be effectuated through the 
application of standards that are less burdensome for funding 
recipients than the standards set out in the present rule.
    HHS is working in coordination with USAID to ensure consistent 
administration of these programs for recipients and subrecipients.
    Nothing in the proposed amendment is intended to lessen or relieve 
relevant prohibitions on Federal Government funding under other 
applicable Federal laws.

IV. Discussion of the Proposed Rule

    These sections discuss the proposed amendment to the rule, 
including changes to the regulatory separation requirements and 
deletion of the requirement for certification.

Section 89.2 Organizational Integrity of Recipients

    This section of the proposed rule describes the separation that 
must exist between a recipient of HHS funds to

[[Page 61098]]

implement HIV/AIDS programs and activities under the Leadership Act and 
an affiliated organization that engages in activities inconsistent with 
a policy opposing prostitution and sex trafficking. Proposed amendments 
to the criteria for evaluating separation are discussed in greater 
detail below. As amended, this section would also provide that 
recipients will no longer be required to submit separate documentation 
certifying that they have a policy explicitly opposing prostitution. 
Rather, the policy requirement will be included in the notices of 
availability of funds and similar announcements, and acknowledged by 
recipients in the documents awarding the funds.
    Paragraph (a) states the policy to which recipients must adhere 
under subsection 7631(f), and identifies the criteria that will be used 
to evaluate the organizational integrity and independence of the 
recipient from affiliated organizations. Under the amendment, the 
recipient would agree that it is opposed to the practices of 
prostitution and sex trafficking because of the psychological and 
physical risks they pose for women, men and children. With respect to 
criteria, the paragraph retains the prohibition against affiliated 
organizations that do not satisfy subsection (f)'s requirement of 
opposing prostitution and sex trafficking from receiving Leadership Act 
HIV/AIDS funds. The paragraph continues to prohibit the use of 
Leadership Act HIV/AIDS funds to subsidize activities inconsistent with 
a policy opposing prostitution and sex trafficking. However, paragraph 
(a) would no longer mandate that the affiliate must be ``a legally 
separate entity,'' but would instead provide that the legal status of 
the affiliate is one of the factors to be considered in deciding 
whether there is adequate separation between the recipient and the 
affiliate. This change recognizes the reported burden on recipients 
operating overseas in satisfying this criterion in certain cases, and 
the difficulty inherent in HHS's analyzing foreign legal requirements. 
A similar change would be made to the factor suggesting evaluation of 
``[t]he existence of separate personnel, management, and governance.'' 
The proposal now refers to ``[t]he existence of separate personnel or 
other allocation of personnel that maintains adequate separation 
between the recipient and affiliate.'' Again, this proposed change 
reflects reported difficulties in meeting a requirement for fully 
separate personnel in some situations. The proposed rule also deletes 
the requirement for consideration of separate ``management'' and 
``governance'' and for separate ``accounts'' because those elements of 
the relationship are not necessary to maintain sufficient separation 
between recipients and affiliated organizations to prevent confusion of 
the Government's message opposing prostitution and sex trafficking. 
Other factors have been simplified and relaxed. Moreover, a further and 
very significant change to paragraph (a) provides that recipients must 
meet the criteria for separation ``to the extent practicable in the 
circumstances,'' which will permit practical factors to be taken into 
account in a specific case. In sum, these changes to paragraph (a) are 
intended to allow a recipient to maintain a relationship with an 
affiliated organization that may engage in restricted activities, 
without jeopardizing the recipient's eligibility for HIV/AIDS funding 
under the Leadership Act.
    Paragraph (b) requires HHS agencies to include in funding notices 
and award instruments a statement that recipients of Leadership Act 
HIV/AIDS funds from HHS agree that they are opposed to the practices of 
prostitution and sex trafficking because of the psychological and 
physical risks they pose for women, men, and children. By entering into 
the award agreement and accepting Leadership Act HIV/AIDS funds, 
recipients acknowledge this opposition, but are relieved from the 
necessity of preparing and submitting additional documentation.
    Paragraph (c) recognizes the statutory exemption for the Global 
Fund to Fight AIDS, Tuberculosis and Malaria, the World Health 
Organization, the International AIDS Vaccine Initiative and any United 
Nations Agency from subsection 7631(f), and is not affected by this 
amendment.

Section 89.3 Certifications

    This proposed amendment to the rule deletes this section requiring 
separate documents certifying compliance with the Leadership Act 
because the materials described in subsection 89.2(b) will provide the 
necessary assurances.

V. Impact Analysis

Paperwork Reduction Act

    To obtain or retain Leadership Act HIV/AIDS funding, under the 
December 24, 2008 final rule, HHS required recipients to submit 
certifications attesting to their non-involvement in activities 
supporting prostitution and human trafficking and policies to that 
effect. The title of the information collection was ``Certification 
Regarding the Organizational Integrity of Entities Implementing 
Leadership Act Programs and Activities.''
    HHS estimated that 555 respondents had to prepare documents to 
validate that recipients had objective integrity and independence from 
organizations that engage in activities inconsistent with policies 
opposing prostitution and sex trafficking. HHS also estimates that the 
average cost per hour will be $26.44, with a 0.5 hour estimated time 
burden per response. In total, the estimated burden cost is 
approximately $7337.10.
    This proposed rule removes the certification requirements of the 
December 24, 2008 rule. As a result, the burden estimate of 0.5 hours 
per applicant for Leadership Act HIV/AIDS funds is removed along with 
the associated costs.

Executive Order 12866--Regulatory Planning and Review

    HHS has drafted and reviewed this regulation in accordance with 
Executive Order 12866, section (b), Principles of regulation. HHS has 
determined this rule is a ``significant regulatory action'' under 
Executive Order 12866, section 3(f)(4), because it raises novel legal 
or policy issues that arise out of legal mandates and the President's 
priorities, and accordingly, the Office of Management and Budget has 
reviewed it.
    As explained above, this rule modifies a previously issued final 
rule on the same subject, published on December 24, 2008 in the Federal 
Register (P. 78997 to 79002). As explained earlier in this notice, the 
modification does not change policy, but reduces burden in complying 
with the established policy. Policy under the Leadership Act has been 
consistent and clear: The U.S government is opposed to prostitution and 
sex trafficking. Contractors and subcontractors cannot use Leadership 
Act HIV/AIDS funds to carry out activities that call into question the 
anti-trafficking/anti-prostitution policy. Enforcement of this policy 
was originally through language inserted in awards at the time they 
were executed. The December 24, 2008 final rule required further 
statements and formal documentation from recipients before they could 
receive Leadership Act HIV/AIDS funds. The Impact Analysis and the 
Paperwork Reduction Act in the December 24, 2008 final rule estimated 
the burden and cost of writing the additional documentation. This rule 
no longer requires this additional documentation. It reestablishes the 
earlier requirement contained in the funding agreement prohibiting 
activities

[[Page 61099]]

and policies that support prostitution and sex trafficking in human 
beings. As a result, applicants for Leadership Act HIV/AIDS funds will 
no longer have to incur the costs outlined in the December 24, 2008 
impact analysis and paperwork burden analysis.
    The benefits of this rule are the reduction in burden and the 
possible encouragement of additional applicants because of the burden 
reduction.
    The costs of the rule are minimal as there are no changes in policy 
and we have determined that the methods of achieving compliance prior 
to December 24, 2008 are fully compatible with the purposes of the Act.
    We are republishing the impact table from the December 24, 2008 
final rule. The burden estimate was $7337 calculated by assuming an 
additional half hour of clerical work to prepare documentation on 
behalf of 555 grantees at an hourly rate of $26.44.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of      Average burden
                    Instrument                         Number of      responses per      hours per       Average cost     Total burden     Total burden
                                                      respondents       respondent        response         per hour          hours             cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Certifications....................................             555                1              0.5           $26.44            277.5           $7,337
--------------------------------------------------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Act

    The Secretary certifies under 5 U.S.C. 605(b), as enacted by the 
Regulatory Flexibility Act (Pub. L. 96-354), that this rule will not 
result in a significant impact on a substantial number of small 
entities. Since enactment of the policy requirement in the Leadership 
Act, HHS has required its contract solicitations and grant 
announcements for Leadership Act HIV/AIDS funding to include a section 
regarding ``Prostitution and Related Activities'' Furthermore, the 
proposed rule proposes to remove the requirements for certification 
that were imposed on recipients in the December 24, 2008 final rule.

Executive Order 13132--Federalism

    Executive Order 13132 on Federalism requires Federal Departments 
and agencies to consult with State and local Government officials in 
the development of regulatory policies with implications for 
Federalism. This rule does not have Federalism implications for State 
or local Governments, as defined in the Executive Order.

Unfunded Mandates Reform Act of 1995

    Section 202 of the Unfunded Mandates Reform Act of 1995 requires 
that a covered Federal Department or agency prepare a cost-benefit 
analysis before promulgating a rule that includes any Federal mandate 
that could 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 adjusted for inflation. The current 
threshold for preparing a cost-benefit analysis is $133 million. HHS 
has determined that this rule would not impose a mandate that will 
result in the expenditure by State, local, and Tribal Governments, in 
the aggregate, or by the private sector, of more than $133 million in 
any one year.

Assessment of Federal Regulation and Policies on Families

    Section 654 of the Treasury and General Government Appropriations 
Act of 1999 requires Federal Departments and agencies to determine 
whether a final policy or regulation could affect family well-being. If 
the determination is affirmative, then the Department or agency must 
prepare an impact assessment to address criteria specified in the law. 
This rule will not have an impact on family well-being, as defined in 
this legislation.

List of Subjects in 45 CFR Part 89

    Administrative practice and procedure, Federal aid programs, Grant 
programs, Grants administration.

    For the reasons stated in the preamble, the Department of Health 
and Human Services proposes to amend 45 CFR Part 89 as follows:

PART 89--ORGANIZATIONAL INTEGRITY OF ENTITIES IMPLEMENTING PROGRAMS 
AND ACTIVITIES UNDER THE LEADERSHIP ACT.

    1. The authority citation for part 89 continues to read as follows:

    Authority:  22 U.S.C. 7631(f) and 5 U.S.C. 301.

    2. Revise Sec.  89.2 to read as follows:


Sec.  89.2  Organizational integrity of recipients.

    (a) A recipient must have objective integrity and independence from 
any affiliated organization that engages in activities inconsistent 
with the recipient's opposition to the practices of prostitution and 
sex trafficking because of the psychological and physical risks they 
pose for women, men, and children (``restricted activities''). A 
recipient will be found to have objective integrity and independence 
from such an organization if:
    (1) The organization receives no transfer of Leadership Act HIV/
AIDS funds, and Leadership Act HIV/AIDS funds do not subsidize 
restricted activities; and
    (2) The recipient is, to the extent practicable in the 
circumstances, legally, physically, and financially separate from the 
affiliated organization. Mere bookkeeping separation of Leadership Act 
HIV/AIDS funds from other funds is not sufficient. HHS will determine, 
on a case-by-case basis and based on the totality of the facts, whether 
sufficient legal, physical, and financial separation exists. The 
presence or absence of any one or more factors will not be 
determinative. Factors relevant to this determination shall include, 
but will not be limited to, the following:
    (i) Whether the organization is a legally separate entity;
    (ii) The existence of separate personnel or other allocation of 
personnel that maintains adequate separation of the activities of the 
affiliated organization from the recipient;
    (iii) The existence of separate accounting and timekeeping records;
    (iv) The degree of separation of the recipient's facilities from 
facilities in which restricted activities occur, and the extent of such 
restricted activities by the affiliated organization; and
    (v) The extent to which signs and other forms of identification 
that distinguish the recipient from the affiliated organization are 
present.
    (b) HHS agencies shall include in the public announcement of the 
availability of the grant, cooperative agreement, contract, or other 
funding instrument involving Leadership Act HIV/AIDS funds the 
requirement that recipients agree that they are opposed to the 
practices of prostitution and sex trafficking because of the 
psychological and physical risks they pose for women, men, and 
children. This statement shall also be included in the award documents 
for any grant, cooperative agreement or other funding instrument

[[Page 61100]]

involving Leadership Act HIV/AIDS funds entered into with the 
recipient.
    (c) This regulation applies to all recipients, including prime 
recipients and sub-recipients, unless they are exempted from the policy 
by statute.


Sec.  89.3  [Removed]

    3. Remove Sec.  89.3.

    Dated: October 29, 2009.
John Monahan,
Interim Director, Office of Global Health Affairs.
    Dated: October 29, 2009.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. E9-28127 Filed 11-19-09; 4:15 pm]
BILLING CODE P