Federal Register Vol No Wednesday February by jennyyingdi


									                                                                          Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules                                                   10455

                                                      List of Subjects                                        Health Disparities Research (or Health                Loan Repayment Program Web site,
                                                        Environmental protection, Bird, Lead,                 Disparities Research LRP). This rule                  www.lrp.nih.gov.
                                                      Lead fishing sinkers, Lead fishing                      compliments efforts afforded by EO                    SUPPLEMENTARY INFORMATION: On
                                                      tackle.                                                 13563.                                                November 4, 1988, Congress enacted the
                                                                                                              DATES: Comments must be received on                   Health Omnibus Programs Extension of
                                                        Dated: February 14, 2012.                                                                                   1988, Public Law (Pub. L.) 100–607,
                                                      James Jones,
                                                                                                              or before April 23, 2012 in order to
                                                                                                              ensure that NIH will be able to consider              Title VI of which amended the Public
                                                      Acting Assistant Administrator, Office of                                                                     Health Service (PHS) Act by adding
                                                      Chemical Safety and Pollution Prevention.
                                                                                                              the comments in preparing the final
                                                                                                              rule.                                                 section 487A (42 U.S.C. 288–1) entitled
                                                      [FR Doc. 2012–4087 Filed 2–21–12; 8:45 am]                                                                    Loan Repayment Program for Research
                                                      BILLING CODE 6560–50–P                                  ADDRESSES:   Persons and organizations                with Respect to Acquired Immune
                                                                                                              interested in submitting comments,                    Deficiency Syndrome. Subsequently, in
                                                                                                              identified by RIN 0925–AA43 and                       the NIH Revitalization Act of 1993 (Pub.
                                                      DEPARTMENT OF HEALTH AND                                Docket Number NIH–2008–0003, may                      L. 103–43), Congress enacted the Loan
                                                      HUMAN SERVICES                                          do so by any of the following methods:                Repayment Program for Research with
                                                                                                                Electronic Submissions: You may                     Respect to Contraception and Infertility
                                                      National Institutes of Health                           submit electronic comments in the                     (section 487B; 42 U.S.C. 288–2); the
                                                                                                              following way:                                        Loan Repayment Program for Research
                                                      42 CFR Part 68                                            • Federal eRulemaking Portal: Follow                Generally (section 487C; 42 U.S.C. 288–
                                                                                                              the instructions for submitting                       3); and the Loan Repayment Program for
                                                      [Docket No. NIH–2008–0003]
                                                                                                              comments.                                             Clinical Researchers from
                                                      RIN 0905–AA43                                           To ensure timelier processing of                      Disadvantaged Backgrounds (section
                                                                                                              comments, NIH is no longer accepting                  487E; 42 U.S.C. 288–5). The Children’s
                                                      National Institutes of Health Loan                      comments submitted to the agency by                   Health Act of 2000 (Pub. L. 106–310),
                                                      Repayment Programs                                      email. The NIH encourages you to                      which was enacted on October 17, 2000,
                                                      AGENCY:    National Institutes of Health,               continue to submit electronic comments                added the Pediatric Research Loan
                                                      HHS.                                                    by using the Federal eRulemaking                      Repayment Program (section 487F; 1 42
                                                                                                              Portal: http://www.regulations.gov.                   U.S.C. 288–6). On November 13, 2000,
                                                      ACTION:   Notice of proposed rulemaking.                                                                      the Clinical Research Enhancement Act,
                                                                                                                Written Submissions: You may submit
                                                      SUMMARY:   The National Institutes of                   written comments in the following                     contained in the Public Health
                                                      Health (NIH) proposes to rescind the                    ways:                                                 Improvement Act of 2000 (Pub. L. 106–
                                                      current regulations governing two of its                  • Fax: 301–402–0169.                                505), enacted the Loan Repayment
                                                      eight loan repayment programs and                          • Mail: Attention Jerry Moore, NIH                 Program for Clinical Research (section
                                                      issue in their place a new consolidated                 Regulations Officer, Office of                        487F; 2 42 U.S.C. 288–5a). On November
                                                      set of regulations governing all of the                 Management Assessment, NIH, 6011                      22, 2000, the Minority Health and
                                                      NIH Loan Repayment Programs (LRPs).                     Executive Boulevard, Suite 601, MSC                   Health Disparities Research and
                                                      There are currently eight programs,                     7669, Rockville, MD 20852–7669.                       Education Act of 2000 (Pub. L. 106–525)
                                                      including three for researchers                            • Hand delivery/courier (for paper,                enacted the Loan Repayment Program
                                                      employed by the NIH (Intramural LRPs)                   disk, or CD–ROM submissions):                         for Health Disparities Research (section
                                                                                                              Attention: Jerry Moore, 6011 Executive                485G, redesignated 464z–5; 3 42 U.S.C.
                                                      and five for non-NIH scientists
                                                                                                              Boulevard, Suite 601, Rockville, MD                   285t–2).
                                                      (Extramural LRPs). The Intramural LRPs
                                                                                                              20852–7669.                                             Sections 487A, 487B, 487C, 487E, and
                                                      include the Loan Repayment Program                                                                            487F of the PHS Act authorize the
                                                      for Research with Respect to Acquired                      Docket: For access to the docket to
                                                                                                              read background documents or                          Secretary of Health and Human
                                                      Immune Deficiency Syndrome (or AIDS                                                                           Services, and section 464z–5 authorizes
                                                      Research LRP); Loan Repayment                           comments received, go to the
                                                                                                              eRulemaking Portal and insert the                     the Director, National Institute on
                                                      Program for General Research (or                                                                              Minority Health and Health Disparities
                                                      General Research LRP), which includes                   docket number provided in brackets in
                                                                                                              the heading on page one of this                       (NIMHD), to enter into contracts with
                                                      a program for the Accreditation Council                                                                       qualified health professionals under
                                                      for Graduate Medical Education                          document into the ‘‘Search’’ box and
                                                                                                              follow the prompts.                                   which such professionals agree to
                                                      (ACGME) Fellows; and Loan Repayment                                                                           conduct research in consideration of the
                                                      Program for Clinical Researchers from                   FOR FURTHER INFORMATION CONTACT: Jerry                Federal Government agreeing to repay,
                                                      Disadvantaged Backgrounds (or Clinical                  Moore, NIH Regulations Officer, Office                for each year of such service, not more
                                                      Research LRP for Individuals from                       of Management Assessment, NIH, 6011                   than $35,000 of the principal and
                                                      Disadvantaged Backgrounds). The                         Executive Boulevard, Room 601, MSC
                                                      Extramural LRPs include the Loan                        7669, Rockville, MD 20892; by email                     1 So in law. There are two sections 487F. Section
                                                      Repayment Program for Contraception                     MooreJ@mail.nih.gov; by fax 301–402–                  1002(b) of Public Law 106–310 (114 Stat. 1129),
                                                      and Infertility Research (or                            0169; or mailto:MooreJ@mail.nih.gov.                  inserted section 487F above. Subsequently, section
                                                                                                                                                                    205 of Public Law 106–505 (114 Stat. 2329), which
                                                      Contraception and Infertility Research                  mailto:(jm40z@nih.gov) by telephone                   relates to the Loan Repayment Program for Clinical
                                                      LRP); Loan Repayment Program for                        301–496–4607 (not a toll-free number)                 Researchers, inserted a section 487F after section
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS

                                                      Clinical Researchers from                               for information about the rulemaking                  487E.
                                                                                                                                                                      2 So in law. There are two sections 487F. Section
                                                      Disadvantaged Backgrounds (or Clinical                  process. For program information
                                                                                                                                                                    205 of Public Law 106–505 (114 Stat. 2329),
                                                      Research LRP for Individuals from                       contact: the NIH Division of Loan                     inserted section 487F after section 487E. Previously,
                                                      Disadvantaged Backgrounds); Loan                        Repayment by email lrp@nih.gov or                     section 1002(b) of Public Law 106–310 (114 Stat.
                                                      Repayment Program for Clinical                          telephone 866–849–4047. Information                   1129), which relates to the Pediatric Research Loan
                                                      Research (or Clinical Research LRP);                    regarding the requirements, application               Repayment Program, inserted section 487F after
                                                                                                                                                                    section 487E.
                                                      Loan Repayment Program for Pediatric                    deadline dates, and an online                           3 Section 485G of the PHS Act, enacted by Public
                                                      Research (or Pediatric Research LRP);                   application for the NIH Loan Repayment                Law 106–525, was redesignated section 464z–5 by
                                                      and Loan Repayment Program for                          Programs may be obtained from the NIH                 P.L. 111–148.

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                                                      10456               Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules

                                                      interest of the qualified educational                   Pediatric Research LRP, and Health                    organizations, in the aggregate, or by the
                                                      loans of such professionals. In return for              Disparities Research LRP.                             private sector, of ‘‘$100,000,000 or more
                                                      these loan repayments, applicants must                    The purpose of this Notice of                       (adjusted annually for inflation with
                                                      agree to participate in qualifying                      Proposed Rulemaking (NPRM) is to                      base year of 1995) in any one year.’’ The
                                                      research for an initial period of not less              invite public comment on the proposed                 current inflation-adjusted threshold is
                                                      than two years (or a minimum of three                   actions. We provide the following as                  approximately $145.5 million. The
                                                      years for the General Research LRP) as                  public information.                                   Secretary certifies that this rule does not
                                                      one of the following:                                   Regulatory Impact Analysis                            mandate any spending by State, local or
                                                         (a) An NIH employee (for Intramural                                                                        tribal government in the aggregate or by
                                                      LRPs), or                                                 We have examined the impacts of this                the private sector. Participation in the
                                                         (b) A health professional engaged in                 rule as required by Executive Order                   NIH loan repayment programs is
                                                      qualifying research supported by a                      12866, Regulatory Planning and Review                 voluntary and not mandated.
                                                      domestic nonprofit foundation,                          (September 30, 1993), Executive Order
                                                                                                              13563, Improving Regulation and                       Executive Order 13132
                                                      nonprofit professional association, or
                                                      other nonprofit institution (e.g.,                      Regulatory Review (January 18, 2011),                    Executive Order 13132, Federalism,
                                                      university), or a U.S. or other                         the Regulatory Flexibility Act (RFA)                  requires that Federal agencies consult
                                                      government agency (Federal, State or                    (September 19, 1980, Pub. L. 96–354),                 with State and local government
                                                      local).                                                 section 202 of the Unfunded Mandates                  officials in the development of
                                                         The purpose of the LRP programs is                   Reform Act of 1995 (Pub. L. 104–4), and               regulatory policies with federalism
                                                      to recruit and retain highly qualified                  Executive Order 13132 on Federalism                   implications. We reviewed the rule as
                                                      health professionals as biomedical and                  (August 4, 1999).                                     required under the Order, and
                                                      behavioral researchers. LRP programs                    Executive Order 12866                                 determined that it does not have
                                                      offer educational loan repayment for                                                                          ‘‘federalism implications’’ because it
                                                                                                                Executive Order 12866, Regulatory                   will not have substantial direct effect on
                                                      participants who agree, by written                      Planning and Review, directs agencies
                                                      contract, to engage in qualifying                                                                             the States, the relationship between the
                                                                                                              to assess all costs and benefits of                   National Government and the States, or
                                                      domestic nonprofit-supported research                   available regulatory alternatives and, if
                                                      at a qualifying non-NIH institution, or as                                                                    on the distribution of power and
                                                                                                              regulation is necessary, to select                    responsibilities among the various
                                                      an NIH employee, for a minimum of two                   regulatory approaches that maximize
                                                      years (or three years for the Intramural                                                                      levels of government. Accordingly,
                                                                                                              net benefits (including potential                     under E.O. 13132, no further Agency
                                                      General Research LRP).                                  economic, environmental, public health
                                                         Currently, the Clinical Research LRP                                                                       action or analysis is required.
                                                                                                              and safety and other advantages,
                                                      for Individuals from Disadvantaged                      distributive impacts, and equity). A                  Paperwork Reduction Act
                                                      Backgrounds and the Contraception and                   regulatory impact analysis (RIA) must
                                                      Infertility Research LRP are governed by                                                                         This proposed rule does not contain
                                                                                                              be prepared for major rules with                      any new information collection
                                                      their own individual regulations while                  economically significant effects ($100
                                                      the other LRPs are without regulations.                                                                       requirements that are subject to Office of
                                                                                                              million or more in any one year). Based               Management and Budget (OMB)
                                                      We propose to consolidate the                           on our analysis, we believe that the
                                                      regulations into a single set of                                                                              approval under the Paperwork
                                                                                                              proposed rulemaking does not                          Reduction Act of 1995 (44 U.S.C.
                                                      regulations governing all the LRPs.                     constitute an economically significant
                                                         More specifically, we propose to                                                                           chapter 35). More specifically, § 68.6 is
                                                                                                              regulatory action.                                    a reporting requirement, but the
                                                      rescind the current regulations codified
                                                      at 42 CFR Part 68a, entitled, National                  The Regulatory Flexibility Act                        specifics of the burden are determined
                                                      Institutes of Health Clinical Research                                                                        in the approved application forms used
                                                                                                                The Regulatory Flexibility Act
                                                      Loan Repayment Program for                                                                                    by the NIH Loan Repayment Programs
                                                                                                              requires agencies to analyze regulatory
                                                      Individuals from Disadvantaged                                                                                and have been approved under OMB
                                                                                                              options that would minimize any
                                                      Backgrounds (CR–LRP), and 42 CFR Part                                                                         No. 0925–0361, Expiration Date: June
                                                                                                              significant impact of the rule on small
                                                      68c, entitled, National Institute of Child                                                                    30, 2014. Additionally, § 68.3(c),
                                                                                                              entities. For the purpose of this analysis,
                                                      Health and Human Development                                                                                  § 68.3(e), § 68.11(c), § 68.14(c),
                                                                                                              small entities include small business
                                                      Contraception and Infertility Research                                                                        § 68.14(d), and § 68.16(a) are reporting
                                                                                                              concerns as defined by the Small
                                                      Loan Repayment Program, and issue a                                                                           requirements and/or recordkeeping
                                                                                                              Business Administration (SBA), usually
                                                      new consolidated set of regulations at                                                                        requirements, but they are also covered
                                                                                                              businesses with fewer than 500
                                                      42 CFR part 68, entitled, National                                                                            under OMB No. 0925–0361.
                                                                                                              employees. Applicants who are eligible
                                                      Institutes of Health Loan Repayment                     to apply for the loan repayment awards                Catalog of Federal Domestic Assistance
                                                      Programs (LRPs), to govern each of the                  are individuals, not small entities. The
                                                      eight individual NIH Loan Repayment                                                                             The Catalog of Federal Domestic
                                                                                                              Secretary certifies that this rule will not           Assistance numbered programs affected
                                                      Programs, the three that are for                        have a significant impact on a
                                                      researchers employed by the NIH                                                                               by the proposed regulations are:
                                                                                                              significant number of small entities.
                                                      (Intramural LRPs) and the five that are                                                                       93.209—Contraception and Infertility
                                                      for non-NIH scientists (Extramural                      Section 202(a) of the Unfunded                            Research Loan Repayment Program
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS

                                                      LRPs). The three Intramural LRPs                        Mandates Reform Act of 1995                           93.220—Clinical Research Loan
                                                      include the AIDS Research LRP, General                    Section 202(a) of the Unfunded                          Repayment Program for Individuals
                                                      Research LRP, and Clinical Research                     Mandates Reform Act of 1995 requires                      from Disadvantaged Backgrounds
                                                      LRP for Individuals from Disadvantaged                  that agencies prepare a written                       93.232—Loan Repayment Program for
                                                      Backgrounds. The five Extramural LRPs                   statement that includes an assessment of                  General Research
                                                      include the Contraception and Infertility               anticipated costs and benefits before                 93.280—NIH Loan Repayment Program
                                                      Research LRP, Clinical Research LRP for                 proposing ‘‘any rule that includes any                    for Clinical Researchers
                                                      Individuals from Disadvantaged                          Federal mandate that may result in the                93.285—NIH Pediatric Research Loan
                                                      Backgrounds, Clinical Research LRP,                     expenditure by State, local, and tribal                   Repayment Program

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                                                                          Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules                                            10457

                                                      93.307—Minority Health and Health                       Public Health Service Act (42 U.S.C.                     Applicant: Means an individual who
                                                          Disparities Research                                288–1, 42 U.S.C. 288–2, 42 U.S.C. 288–                applies to and meets the eligibility
                                                      93.308—Extramural Loan Repayment                        3, 42 U.S.C. 288–5, 42 U.S.C. 288–5a, 42              criteria for the NIH LRPs.
                                                          for Individuals From Disadvantaged                  U.S.C. 288–6, 42 U.S.C. 285t–2). The                     Breach of Contract: Results when a
                                                          Backgrounds Conducting Clinical                     purpose of these programs is to address               participant fails to complete the
                                                          Research                                            the need for biomedical and behavioral                research service or other obligation(s)
                                                      93.936—NIH Acquired                                     researchers by providing an economic                  required under the contract and may be
                                                          Immunodeficiency Syndrome                           incentive to appropriately qualified                  subject to assessment of monetary
                                                          Research Loan Repayment Program                     health professionals who are engaged in               damages and penalties as defined by
                                                                                                              qualifying research supported by                      statute.
                                                      List of Subjects in 42 CFR Part 68                                                                               Clinical Research: Is patient-oriented
                                                                                                              domestic nonprofit funding, or as
                                                        Health professions, Loan repayment                    employees of NIH. The NIH Loan                        clinical research conducted with human
                                                      programs—health, Medical research.                      Repayment Programs include eight                      subjects, or research on the causes and
                                                        For reasons presented in the                          separate programs, three that are                     consequences of disease in human
                                                      preamble, it is proposed to amend title                 Intramural (for NIH researchers) and                  populations involving material of
                                                      42 of the Code of Federal Regulations by                five that are Extramural (for non-NIH                 human origin (such as tissue specimens
                                                      rescinding the current regulations at                   researchers).                                         and cognitive phenomena) for which an
                                                      parts 68a and 68c, and adding Part 68                      (a) The Intramural LRPs include:                   investigator or colleague directly
                                                      that encompasses all NIH Loan                              (1) Loan Repayment Program for                     interacts with human subjects in an
                                                      Repayment Programs, as set forth below.                 Research With Respect to Acquired                     outpatient or inpatient setting to clarify
                                                                                                              Immune Deficiency Syndrome (or AIDS                   a problem in human physiology,
                                                      PART 68—NATIONAL INSTITUTES OF                          Research LRP);                                        pathophysiology or disease, or
                                                      HEALTH (NIH) LOAN REPAYMENT                                (2) Loan Repayment Program for                     epidemiologic or behavioral studies,
                                                      PROGRAMS (LRPs)                                         General Research (or General Research                 outcomes research or health services
                                                      Sec.                                                    LRP), including a program for                         research, or developing new
                                                      68.1  What is the scope and purpose of the              Accreditation Council for Graduate                    technologies, therapeutic interventions,
                                                          NIH LRPs?                                           Medical Education (ACGME) Fellows;                    or clinical trials.
                                                      68.2 Definitions.                                       and                                                      Commercial Loans: Means loans made
                                                      68.3 Who is eligible to apply?                             (3) Loan Repayment Program for                     for educational purposes by banks,
                                                      68.4 Who is eligible to participate?                    Clinical Researchers from                             credit unions, savings and loan
                                                      68.5 Who is ineligible to participate?                  Disadvantaged Backgrounds (or Clinical                associations, not-for-profit
                                                      68.6 How do individuals apply to                        Research LRP for Individuals From                     organizations, insurance companies,
                                                          participate in the NIH LRPs?                        Disadvantaged Backgrounds). [This                     schools, and other financial or credit
                                                      68.7 How are applicants selected to
                                                                                                              program is also included as a separate                institutions that are subject to
                                                          participate in the NIH LRPs?
                                                      68.8 What do the NIH LRPs provide to                    program under the Extramural LRPs.]                   examination and supervision in their
                                                          participants?                                          (b) The Extramural LRPs include:                   capacity as lending institutions by an
                                                      68.9 What loans qualify for repayment?                     (1) Loan Repayment Program for                     agency of the United States or of the
                                                      68.10 What loans are ineligible for                     Contraception and Infertility Research                State in which the lender has its
                                                          repayment?                                          (or Contraception and Infertility                     principal place of business.
                                                      68.11 What does an individual have to do                Research LRP);                                           Contraception Research: Is defined as
                                                          in return for loan repayments received                 (2) Loan Repayment Program for                     research with the ultimate goal of
                                                          under the NIH LRPs?                                 Clinical Researchers From                             providing new or improved methods of
                                                      68.12 How does an individual receive loan               Disadvantaged Backgrounds (or Clinical                preventing pregnancy.
                                                          repayments beyond the initial applicable                                                                     Current Payment Status: Means that a
                                                                                                              Research LRP for Individuals From
                                                          contract period?
                                                      68.13 What will happen if an individual                 Disadvantaged Backgrounds);                           qualified educational loan is not past
                                                          does not comply with the terms and                     (3) Loan Repayment Program for                     due in its payment schedule, as
                                                          conditions of participation in the NIH              Clinical Researchers (or Clinical                     determined by the lending institution.
                                                          LRPs?                                               Research LRP);                                           Debt Threshold: Means the minimum
                                                      68.14 Under what circumstances can the                     (4) Loan Repayment Program for                     amount of qualified educational debt an
                                                          service or payment obligation be                    Pediatric Research (or Pediatric                      individual must have, on their program
                                                          canceled, waived, or suspended?                     Research LRP); and                                    eligibility date, in order to be eligible for
                                                      68.15 When can an NIH LRP payment                          (5) Loan Repayment Program for                     LRP benefits, as established by the
                                                          obligation be discharged in bankruptcy?             Health Disparities Research (or Health                Secretary.
                                                      68.16 Additional conditions.                            Disparities Research LRP).                               Director: Means the Director of the
                                                      68.17 What other regulations and statutes                                                                     National Institute on Minority Health
                                                          apply?                                              § 68.2   Definitions.                                 and Health Disparities (NIMHD) or
                                                         Authority: 42 U.S.C. 254o, 42 U.S.C. 288–              As used in this part:                               designee.
                                                      1, 42 U.S.C. 288–2, 42 U.S.C. 288–3, 42                   Act: Means the Public Health Service                   Educational Expenses: Means the cost
                                                      U.S.C. 288–5, 42 U.S.C. 288–5a, 42 U.S.C.               Act, as amended (42 U.S.C. 201 et seq.).              of the health professional’s
                                                      288–6, 42 U.S.C. 285t–2.                                  AIDS Research: Means research                       undergraduate, graduate, and health
wreier-aviles on DSK5TPTVN1PROD with PROPOSALS

                                                      § 68.1 What are the scope and purpose of
                                                                                                              activities related to the Acquired                    professional school’s education,
                                                      the NIH LRPs?                                           Immunodeficiency Syndrome that                        including the tuition expenses and other
                                                        The regulations of this part apply to                 qualify for inclusion in the AIDS                     educational expenses such as living
                                                      the award of educational loan payments                  Research LRP.                                         expenses, fees, books, supplies,
                                                      authorized by sections 487A, 487B,                                                                            educational equipment and materials,
                                                                                                              288–6, the Pediatric Research Loan Repayment          and laboratory expenses.
                                                      487C, 487E, 487F,1 and 464z–5 of the                    Program. Subsequently, section 205 of Public Law
                                                                                                              106–505 also added section 487F, 42 U.S.C. 288–
                                                                                                                                                                       Extramural LRPs: Refers to those
                                                        1 There are two sections 487F. Section 1002(b) of     5a, enacting the Loan Repayment Program for           programs for which health
                                                      Public Law 106–310 added section 487F, 42 U.S.C.        Clinical Researchers.                                 professionals, who are not NIH

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                                                      10458               Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules

                                                      employees and have program-specified                       Institutional Base Salary or Salary: Is            commercial educational loans and
                                                      degrees and domestic nonprofit support,                 the annual income or compensation that                interest for (1) undergraduate, graduate,
                                                      are eligible to apply. The Extramural                   the organization pays for the applicant’s             and health professional school tuition
                                                      LRPs include the (1) Contraception and                  appointment, whether the time is spent                expenses; (2) other reasonable
                                                      Infertility Research LRP, (2) Clinical                  on research, teaching, patient care, or               educational expenses required by the
                                                      Research LRP for Individuals from                       other activities.                                     school(s) attended, including fees,
                                                      Disadvantaged Backgrounds, (3) Clinical                    Living Expenses: Means the                         books, supplies, educational equipment
                                                      Research LRP, (4) Pediatric Research                    reasonable cost of room and board,                    and materials, and laboratory expenses;
                                                      LRP, and (5) Health Disparities Research                transportation and commuting costs,                   and (3) reasonable living expenses,
                                                      LRP.                                                    and other reasonable costs incurred                   including the cost of room and board,
                                                         General Research: Pertains to research               during an individual’s attendance at an               transportation and commuting costs,
                                                      that falls within the basic science or                  educational institution and is part of the            and other reasonable living expenses
                                                      clinical research parameters and is not                 educational loan.                                     incurred.
                                                      targeted toward a specific area (e.g.,                     Loan Repayment Programs (LRPs):                       Reasonable Educational and Living
                                                      AIDS) or type of research (e.g., clinical               Refers to the NIH Loan Repayment                      Expenses: Means those educational and
                                                      research). The focus is on biomedical                   Programs including those authorized by                living expenses that are equal to or less
                                                      and behavioral research studies and                     sections 487A, 487B, 487C, 487E, 487F,                than the sum of the school’s estimated
                                                      investigations across a variety of                      and 464z–5 of the Act, as amended.                    standard student budget for educational
                                                      scientific disciplines within the mission                  Loan Repayment Program Contract:                   and living expenses for the degree
                                                      of NIH.                                                 Refers to the agreement signed by an                  program and for the year(s) during
                                                         Government Loans: Means                              applicant and the Secretary or Director               which the participant was enrolled in
                                                      educational loans made by U.S. Federal,                 (for the following extramural LRPs:                   school. If there is no standard budget
                                                      State, county, or city agencies that are                Health Disparities Research LRP and                   available from the school, or if the
                                                      authorized by law to make such loans.                   Clinical Research LRP for Individuals                 participant requests repayment for
                                                         Health Disparities Population: A                     from Disadvantaged Backgrounds only).                 educational and living expenses that
                                                      population is a health disparity                        Under such an agreement, an Intramural                exceed the standard student budget,
                                                      population if, as determined by the                     LRP applicant agrees to conduct                       reasonableness of educational and living
                                                      Director after consultation with the                    qualified research as an NIH employee,                expenses incurred must be substantiated
                                                      Director of the Agency for Healthcare                   and an Extramural LRP applicant agrees                by additional contemporaneous
                                                      Research and Quality, there is a                        to conduct qualified research supported               documentation, as determined by the
                                                      significant disparity in the overall rate               by domestic nonprofit funding, in                     Secretary.
                                                      of disease incidence, prevalence,                       exchange for repayment of the                            Repayable debt: Means the
                                                      morbidity, mortality, or survival rates in              applicant’s qualified educational loan(s)             proportion, as established by the
                                                      the population as compared to the                       for a prescribed period.                              Secretary, of an individual’s total
                                                      health status of the general population.                   NIH: Refers to the National Institutes             qualified educational debt that can be
                                                         Individual From Disadvantaged                        of Health.                                            paid by an NIH LRP.
                                                                                                                 Nonprofit Funding/Support:
                                                      Background:                                                                                                      Salary: Has the same meaning as
                                                                                                              Applicants must conduct qualifying
                                                         (1) Comes from an environment that                                                                         ‘‘institutional base salary.’’
                                                                                                              research supported by a domestic
                                                      inhibited the individual from obtaining                                                                          School: Means undergraduate,
                                                                                                              nonprofit foundation, nonprofit
                                                      the knowledge, skill and ability required                                                                     graduate, and health professions schools
                                                                                                              professional association, or other
                                                      to enroll in and graduate from a health                                                                       that are accredited by a body or bodies
                                                                                                              nonprofit institution (e.g., university), or
                                                      professions school; or                                                                                        recognized for accreditation purposes by
                                                                                                              a U.S. or other government agency
                                                         (2) Comes from a family with an                                                                            the U.S. Secretary of Education.
                                                                                                              (Federal, State or local). A domestic
                                                      annual income below a level based on                                                                             Secretary: Means the Secretary of
                                                                                                              foundation, professional association, or
                                                      low-income thresholds according to                                                                            Health and Human Services or designee.
                                                                                                              institution is considered to be nonprofit
                                                      family size published by the U.S.                                                                                Service: Means the Public Health
                                                                                                              if exempt from Federal tax under the
                                                      Bureau of the Census, adjusted annually                                                                       Service.
                                                                                                              provisions of Section 501 of the Internal
                                                      for changes in the Consumer Price                                                                                State: Means one of the fifty States,
                                                                                                              Revenue Code (26 U.S.C. 501).
                                                      Index, and adjusted by the Secretary for                   Participant: Means an individual                   the District of Columbia, the
                                                      use in HHS programs. The Secretary                      whose application to any of the NIH                   Commonwealth of Puerto Rico, the
                                                      periodically publishes these income                     LRPs has been approved and whose                      Northern Mariana Islands, the U.S.
                                                      levels in the Federal Register.                         Program contract has been executed by                 Virgin Islands, Guam, American Samoa,
                                                         Infertility Research: Is defined as                  the Secretary or the Director.                        and the Federated States of Micronesia,
                                                      research with the long-range objective of                  Pediatric Research: Is defined as                  the Republic of the Marshall Islands,
                                                      evaluating, treating or ameliorating                    research directly related to diseases,                and the Republic of Palau.
                                                      conditions that result in the failure of                disorders, and other conditions in                       Waiver: Means a waiver of the service
                                                      couples to either conceive or bear                      children, including pediatric                         obligation granted by the Secretary
                                                      young.                                                  pharmacology.                                         when compliance by the participant is
                                                         Institute or Center (IC): Means an                      Program: Refers to the NIH Loan                    impossible or would involve extreme
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                                                      Institute or Center of the National                     Repayment Program, or LRP.                            hardship, or where enforcement with
                                                      Institutes of Health (NIH).                                Program eligibility date: Means the                respect to the individual would be
                                                         Intramural LRPs: Refers to those                     date on which an individual’s LRP                     unconscionable. (See ‘‘Breach of
                                                      programs for which applicants must be                   contract is executed by the Secretary or              Contract.’’)
                                                      employed by NIH. The intramural LRPs                    the Director.                                            Withdrawal: Means a request by a
                                                      include the (1) AIDS Research LRP, (2)                     Qualified Educational Loans and                    participant, prior to the Program making
                                                      General Research LRP, and (3) Clinical                  Interest/Debt: (See Educational                       payments on his or her behalf, for
                                                      Research LRP for Individuals from                       Expenses) as established by the                       withdrawal from Program participation.
                                                      Disadvantaged Backgrounds.                              Secretary, include Government and                     A withdrawal is without penalty to the

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                                                                          Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules                                          10459

                                                      participant and without obligation to                   § 68.5   Who is ineligible to participate?            administration, in such form and
                                                      the Program.                                               The following individuals are                      manner as the Secretary prescribes.
                                                                                                              ineligible for NIH LRP participation:
                                                      § 68.3   Who is eligible to apply?                                                                            § 68.7 How are applicants selected to
                                                                                                                 (a) Persons who do not meet the
                                                                                                                                                                    participate in the NIH LRPs?
                                                         To be eligible for consideration for the             eligibility requirements as specified
                                                      NIH LRPs, applicants must meet the                      under § 68.3;                                            The NIH LRP awards are competitive.
                                                      following criteria:                                        (b) Any individual who has or had a                To be selected for participation in an
                                                         (a) Be citizens, nationals, or                       Federal judgment lien against his/her                 NIH LRP, applicants must satisfy the
                                                      permanent residents of the United                       property arising from Federal debt;                   following requirements:
                                                      States;                                                    (c) Persons who owe an obligation of                  (a) Applicants must meet the
                                                                                                              health professional service to the                    eligibility requirements specified in
                                                         (b) Have the necessary degree from an
                                                                                                              Federal Government, a State, or other                 § 68.3 and § 68.4.
                                                      accredited institution as determined by
                                                                                                              entity, unless deferrals or extensions are               (b) Applicants must not be ineligible
                                                      the NIH to be consistent with the needs
                                                                                                              granted for the length of the service of              for participation as specified in § 68.5.
                                                      of the LRP;                                                                                                      (c) Upon receipt, applications for any
                                                         (c)(1) For Intramural LRPs only:                     their LRP contract. The following are
                                                                                                              examples of programs that have a                      of the NIH LRPs will be reviewed for
                                                      Applicants must be employed by the                                                                            eligibility and completeness by the NIH
                                                      NIH and engage in qualified full-time                   service obligation:
                                                                                                                 (1) Armed Forces (Army, Navy, or Air               Division of Loan Repayment.
                                                      research as specified by the LRP and be                                                                       Incomplete or ineligible applications
                                                      recommended by the employing IC or                      Force) Professions Scholarship Program,
                                                                                                                 (2) Exceptional Financial Need (EFN)               will not be processed or reviewed
                                                      have a firm commitment of employment                                                                          further.
                                                      from an authorized official of the NIH;                 Scholarship Program,
                                                                                                                 (3) Financial Assistance for                          (d)(1) Applications for the Intramural
                                                         (2) For Extramural LRPs only:                                                                              LRPs that are deemed eligible and
                                                                                                              Disadvantaged Health Professions
                                                      Applicants must be conducting                                                                                 complete are submitted to the Loan
                                                                                                              Students (FADHPS),
                                                      qualified research for an average of at                                                                       Repayment Committee (LRC), which
                                                                                                                 (4) Indian Health Service (IHS)
                                                      least 20 hours per week that is                                                                               reviews, ranks, and approves/
                                                                                                              Scholarship Program,
                                                      supported by a domestic nonprofit                                                                             disapproves LRP awards. The LRC is
                                                                                                                 (5) National Health Service Corps
                                                      foundation, nonprofit professional                                                                            composed of senior intramural
                                                                                                              (NHSC) Scholarship Program,
                                                      association, or other nonprofit                                                                               scientists, including basic (bench) and
                                                                                                                 (6) National Research Service Award
                                                      institution (e.g., university), or a U.S. or                                                                  clinical researchers and science policy
                                                                                                              (NRSA) Program,
                                                      other government agency (Federal, State                    (7) NIH Undergraduate Scholarship                  administrators. Since LRP participation
                                                      or local);                                              Program (UGSP),                                       in the Intramural programs is contingent
                                                         (d) Have total qualifying educational                   (8) Physicians Shortage Area                       upon NIH employment, applicants must
                                                      loan debt as determined on the program                  Scholarship Program,                                  be recommended by the employing IC of
                                                      eligibility date;                                          (9) Primary Care Loan (PCL) Program,               the NIH to be considered by the LRC.
                                                         (e) The NIH or the employing                         and                                                      (2) Applications for the Extramural
                                                      institution must provide an assurance                      (10) Public Health Service                         LRPs that are deemed eligible and
                                                      that the applicant will be employed/                    Scholarship (PHS) Program;                            complete will be referred by the NIH
                                                      appointed and provided research                            (d) For extramural LRPs only:                      Center for Scientific Review (CSR) to an
                                                      support for the applicable term of the                  Individuals who receive any research                  appropriate NIH IC for peer review. In
                                                      LRP contract; and                                       funding support or salary from a for-                 evaluating the application, reviewers are
                                                         (f) Recipients of LRP awards must                    profit institution or organization, or                directed to consider the following
                                                      conduct their research in accordance                    Federal Government employees working                  components and how they relate to the
                                                      with applicable Federal, State, and local               more than 20 hours per week;                          likelihood that the applicant will
                                                      law (e.g., applicable human subject                        (e) Current recipients of NIH                      continue in a research career:
                                                      protection regulations).                                intramural training awards, e.g., NIH                    (i) Applicant’s potential to pursue a
                                                         (g) For Clinical Research for                        Intramural Research Training Awards                   career in research as defined by the
                                                      Individuals from Disadvantaged                          (IRTA) or Cancer Research Training                    appropriate LRP:
                                                      Background only: Individual must be                     Awards (CRTA);                                           (A) Appropriateness of the applicant’s
                                                      from a disadvantaged background. (See                      (f) Individuals conducting research for            previous training and experience to
                                                      § 68.2, Definitions, Individual from                    which funding is precluded by Federal                 prepare for a research career.
                                                      Disadvantaged Background.)                              law, regulation, or HHS/NIH policy or                    (B) Appropriateness of the proposed
                                                                                                              that does not comply with applicable                  research activities during the LRP
                                                      § 68.4   Who is eligible to participate?                Federal, State, and local law regarding               contract to foster a career in research.
                                                        To be eligible to participate in the                  the conduct of the research (e.g.,                       (C) Commitment to a research career,
                                                      NIH LRPs, individuals must:                             applicable human subject protection                   as reflected by the personal statement of
                                                                                                              regulations);                                         long-term career goals and plan to
                                                        (a) Meet the eligibility requirements
                                                                                                                 (g) Individuals with only ineligible               achieve those goals.
                                                      specified in § 68.3;
                                                                                                              loans or loans that are not educational;                 (D) Strength of the letters of
                                                        (b) Not be ineligible for participation                                                                     recommendations attesting to the
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                                                      as specified in § 68.5;                                                                                       applicant’s potential for a successful
                                                                                                                 (h) Individuals who do not have
                                                        (c) Engage in qualified research for the                                                                    career in research.
                                                                                                              sufficient qualifying educational debt to
                                                      contractual period;                                                                                              (ii) Quality of the overall environment
                                                                                                              meet the debt threshold.
                                                        (d) Engage in such research for the                                                                         to prepare the applicant for a research
                                                      percentage of time specified for the                    § 68.6 How do individuals apply to                    career:
                                                      particular LRP; and                                     participate in the NIH LRPs?                             (A) Quality and availability of
                                                        (e) Comply with all other terms and                     An application for participation in an              appropriate scientific mentors and
                                                      conditions of the applicable Loan                       NIH LRP shall be submitted to the NIH,                colleagues to help achieve or enhance
                                                      Repayment Program.                                      which is responsible for the Program’s                the applicant’s research independence,

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                                                      10460               Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules

                                                      including the mentors’ record in                        transportation and commuting costs,                     (h) Loan amounts that participants
                                                      mentoring researchers, funding history,                 and other living expenses, as                         were due to have been paid prior to the
                                                      and research productivity.                              determined by the NIH.                                LRP contract start date;
                                                        (B) Quality and appropriateness of                                                                            (i) Parents PLUS loans (except the
                                                                                                              § 68.10 What loans are ineligible for                 Graduate PLUS loans for students);
                                                      institutional resources and facilities.
                                                        (iii) For the Health Disparities                                                                              (j) Loans for which promissory notes
                                                      Research LRP, at least 50 percent of the                   The following loans are ineligible for             have been signed after the LRP contract
                                                      contracts are required by statute to be                 repayment under the NIH LRPs:                         start date (with the exception of
                                                                                                                 (a) Loans not obtained from a bank,                qualifying student loan consolidations);
                                                      for appropriately qualified health
                                                                                                              credit union, savings and loan                        and
                                                      professionals who are members of a
                                                                                                              association, not-for-profit organization,               (k) Home equity loans or other
                                                      health disparity population.
                                                                                                              insurance company, school, and other                  noneducational loans.
                                                      § 68.8 What do the NIH LRPs provide to                  financial or credit institution that is
                                                      participants?                                           subject to examination and supervision                § 68.11 What does an individual have to do
                                                        (a) Loan Repayments: For each year of                 in its capacity as a lending institution              in return for loan repayments received
                                                                                                              by an agency of the United States or of               under the NIH LRPs?
                                                      the applicable service period the
                                                      individual agrees to serve, the NIH may                 the State in which the lender has its                    Individuals must agree to:
                                                      pay up to $35,000 per year of a                         principal place of business;                             (a) Engage in qualified research for the
                                                      participant’s repayable debt.                              (b) Loans for which supporting                     applicable contract service period;
                                                        (b) Payments are made directly to a                   documentation is not available;                          (b)(1) For Intramural LRPs: Engage in
                                                      participant’s lender(s). If there is more                  (c) Loans that have been consolidated              such research full-time as employees of
                                                      than one outstanding qualified                          with loans of other individuals, such as              NIH, or; (2) For Extramural LRPs:
                                                      educational loan, the NIH will repay the                spouses or children;                                  Engage in such research for an average
                                                      loans in the following order, unless the                   (d) Loans or portions of loans                     of 20 hours per week supported by a
                                                      NIH determines significant savings                      obtained for educational or living                    domestic nonprofit foundation,
                                                      would result from paying loans in a                     expenses that exceed the standard of                  nonprofit professional association, or
                                                      different order of priority:                            reasonableness as determined by the                   other nonprofit institution (e.g.,
                                                        (1) Loans guaranteed by the U.S.                      participant’s standard school budget for              university), or a U.S. or other
                                                      Department of Health and Human                          the year in which the loan was made                   government agency (Federal, State or
                                                      Services;                                               and are not determined by the NIH to                  local);
                                                        (2) Loans guaranteed by the U.S.                      be reasonable based on additional                        (c) Keep all loan accounts in good
                                                      Department of Education;                                documentation provided by the                         standing, provide timely documentation
                                                        (3) Loans made or guaranteed by a                     individual;                                           as needed, including payment
                                                      State;                                                     (e) Loans, financial debts, or service             verification, service verification, change
                                                        (4) Loans made by a school; and                       obligations incurred under the following              of research, change of institution, etc.
                                                        (5) Loans made by other entities.                     programs, or similar programs, which                  Failure to provide such documentation
                                                        (c) Tax Liability Payments: In                        provide loans, scholarships, loan                     may result in early termination, and the
                                                      addition to the loan repayments, the                    repayments, or other awards in                        individual may be subject to statutory
                                                      NIH shall make tax payments in an                       exchange for a future service obligation:             financial penalties; and
                                                      amount equal to 39 percent of the total                    (1) Armed Forces (Army, Navy, or Air                  (d) Satisfy all of the other terms and
                                                      annual loan repayment to the Internal                   Force) Professions Scholarship Program,               conditions of the LRP and the LRP
                                                                                                                 (2) Exceptional Financial Need (EFN)               Contract (e.g., Obligations of the
                                                      Revenue Service on the participant’s
                                                                                                              Scholarship Program,                                  Participant). Failure to adhere to the
                                                      behalf. The NIH may make additional                        (3) Financial Assistance for
                                                      payments to those participants who                                                                            terms and conditions of the LRP
                                                                                                              Disadvantaged Health Professions                      contract may result in early termination,
                                                      show increased Federal, State, and/or                   Students (FADHPS),
                                                      local taxes as a result of loan                                                                               and the individual may be subject to
                                                                                                                 (4) Indian Health Service Scholarship              statutory financial penalties.
                                                      repayments.                                             Program,
                                                        (d) Under § 68.8(a), (b), and (c), the                   (5) National Health Service Corps                  § 68.12 How does an individual receive
                                                      NIH will make loan and tax liability                    Scholarship Program,                                  loan repayments beyond the initial
                                                      payments to the extent appropriated                        (6) National Institutes of Health                  applicable contract period?
                                                      funds are available for these purposes.                 Undergraduate Scholarship Program                        An individual may apply for a
                                                      § 68.9   What loans qualify for repayment?
                                                                                                              (UGSP),                                               competitive extension contract for at
                                                                                                                 (7) National Research Service Award                least a one-year period if the individual
                                                         The NIH LRPs will repay participants’                (NRSA) Program,                                       is engaged in qualifying research and
                                                      lenders the principal, interest, and                       (8) Physicians Shortage Area                       satisfies the eligibility requirements
                                                      related expenses of qualified U.S.                      Scholarship Program,                                  specified under § 68.3 and § 68.4 for the
                                                      Government and commercial                                  (9) Primary Care Loans (PCL), and                  extension period and has remaining
                                                      educational loans obtained by                              (10) Public Health Service                         repayable debt as established by the
                                                      participants for the following:                         Scholarship Program;                                  Secretary.
                                                         (a) Undergraduate, graduate, and                        (f) Any loan in default, delinquent, or
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                                                      health professional school tuition                      not in a current payment status;                      § 68.13 What will happen if an individual
                                                      expenses;                                                  (g) Any Federal educational loan                   does not comply with the terms and
                                                         (b) Other reasonable educational                     debt—including debt arising from the                  conditions of participation in the NIH LRPs?
                                                      expenses required by the school(s)                      conversion of a service obligation to a                 Program participants who breach their
                                                      attended, including fees, books,                        loan—that has been in default or written              Loan Repayment Program Contracts will
                                                      supplies, educational equipment and                     off as uncollectible is ineligible for                be subject to the applicable monetary
                                                      materials, and laboratory expenses; and                 repayment under the Program, even if                  payment provisions set forth at section
                                                         (c) Reasonable living expenses,                      currently considered to be in good                    338E of the Act (42 U.S.C. 254o).
                                                      including the cost of room and board,                   standing;                                             Payment of any amount owed under

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                                                                          Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules                                                10461

                                                      section 338E of the Act shall be made                   permanent physical or mental disability                 Dated: September 28, 2011.
                                                      within one year of the date the                         resulting in the inability of the                     Francis S. Collins,
                                                      participant breached his or her Loan                    participant to perform the service or                 Director, NIH, National Institutes of Health.
                                                      Repayment Program Contract, unless the                  other activities that would be necessary                Approved: February 7, 2012.
                                                      NIH specifically authorizes a longer                    to comply with the obligation.                        Kathleen Sebelius,
                                                      period. Terminations will not be                           (d) In determining whether to waive                Secretary.
                                                      considered a breach of contract in cases                or suspend any or all of the service or               [FR Doc. 2012–3900 Filed 2–21–12; 8:45 am]
                                                      where such terminations are beyond the                  payment obligations of a participant as               BILLING CODE 4140–01–P
                                                      control of the participant as follows:                  imposing an undue hardship and being
                                                        (a) Terminations for convenience of
                                                                                                              against good conscience, the NIH, on the
                                                      the Government will not be considered
                                                                                                              basis of such information and                         DEPARTMENT OF DEFENSE
                                                      a breach of contract and monetary
                                                                                                              documentation as may be required, will
                                                      damages will not be assessed.
                                                                                                              consider: (1) The participant’s present               GENERAL SERVICES
                                                        (b) Occasionally, a participant’s
                                                      research assignment or funding may                      financial resources and obligations; (2)              ADMINISTRATION
                                                      evolve and change to the extent that the                the participant’s estimated future
                                                      individual is no longer engaged in                      financial resources and obligations; and              NATIONAL AERONAUTICS AND
                                                      approved research. Similarly, the                       (3) the extent to which the participant               SPACE ADMINISTRATION
                                                      research needs and priorities of the IC                 has problems of a personal nature, such
                                                      and/or the NIH may change to the extent                 as a physical or mental disability or                 48 CFR Parts 31 and 52
                                                      that a determination is made that a                     terminal illness in the immediate
                                                                                                                                                                    [FAR Case 2011–011; Docket 2011–0011;
                                                      health professional’s skills may be better              family, which so intrude on the
                                                                                                                                                                    Sequence 1]
                                                      utilized in a nonresearch assignment.                   participant’s present and future ability
                                                      Normally, job changes of this nature                    to perform as to raise a presumption that             RIN 9000–AM13
                                                      will not be considered a breach of                      the individual will be unable to perform
                                                                                                              the obligation incurred.                              Federal Acquisition Regulation;
                                                      contract on the part of either the NIH or                                                                     Unallowability of Costs Associated
                                                      the participant. Under these                            § 68.15 When can an NIH LRP payment                   With Foreign Contractor Excise Tax
                                                      circumstances, the following will apply:                obligation be discharged in bankruptcy?
                                                        (1) Program participation will cease as                                                                     AGENCIES: Department of Defense (DoD),
                                                      of the date an individual is no longer                    Any payment obligation incurred                     General Services Administration (GSA),
                                                      engaged in approved research;                           under § 68.13 may be discharged in                    and National Aeronautics and Space
                                                        (2) Based on the approval of the NIH,                 bankruptcy under Title 11 of the United               Administration (NASA).
                                                      the participant will be released from the               States Code only if such discharge is
                                                                                                                                                                    ACTION: Proposed rule.
                                                      remainder of his or her service                         granted after the expiration of the seven-
                                                      obligation without assessment of                        year period beginning on the first date               SUMMARY:    DoD, GSA, and NASA are
                                                      damages or monetary penalties. The                      that payment is required and only if the              proposing to amend the Federal
                                                      participant in this case will be                        bankruptcy court finds that a                         Acquisition Regulation (FAR) to
                                                      permitted to retain all Program benefits                nondischarge of the obligation would be               implement the requirements of the
                                                      made or owed by the NIH on his/her                      unconscionable.                                       James Zadroga 9/11 Health and
                                                      behalf up to the date the individual is                                                                       Compensation Act of 2010 regarding the
                                                                                                              § 68.16   Additional conditions.
                                                      no longer engaged in research, less the                                                                       imposition of a 2 percent tax on certain
                                                      pro rata portion of any benefits                          (a) When a shortage of funds exists,                foreign procurements.
                                                      advanced beyond the period of                           participants may be funded only                       DATES: Interested parties should submit
                                                      completed service.                                      partially, as determined by the NIH.                  written comments to the Regulatory
                                                                                                              However, once an NIH LRP contract has                 Secretariat at one of the addressees
                                                      § 68.14 Under what circumstances can the
                                                      service or payment obligation be canceled,
                                                                                                              been signed by both parties, the NIH                  shown below on or before April 23,
                                                      waived, or suspended?                                   will obligate such funds as necessary to              2012 to be considered in the formation
                                                                                                              ensure that sufficient funds will be                  of the final rule.
                                                         (a) Any obligation of a participant for
                                                                                                              available to pay benefits for the duration            ADDRESSES: Submit comments in
                                                      service or payment will be canceled
                                                                                                              of the period of obligated service unless,            response to FAR case 2011–011 by any
                                                      upon the death of the participant.
                                                         (b) The NIH may waive or suspend                     by mutual written agreement, the parties              of the following methods:
                                                      any service or payment obligation                       specify otherwise.                                       • Regulations.gov: http://
                                                      incurred by the participant upon request                  (b) Additional conditions may be                    www.regulations.gov. Submit comments
                                                      whenever compliance by the                              imposed as deemed necessary.                          via the Federal eRulemaking portal by
                                                      participant: (1) Is impossible, (2) would                                                                     inputting ‘‘FAR Case 2011–011’’ under
                                                                                                              § 68.17 What other regulations and                    the heading ‘‘Enter Keyword or ID’’ and
                                                      involve extreme hardship to the
                                                                                                              statutes apply?
                                                      participant, or (3) if enforcement of the                                                                     selecting ‘‘Search.’’ Select the link
                                                      service or payment obligation would be                    Several other regulations and statutes              ‘‘Submit a Comment’’ that corresponds
                                                      unconscionable. The NIH may approve                     apply to this part. These include, but are            with ‘‘FAR Case 2011–011.’’ Follow the
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                                                      a request for a suspension of the service               not necessarily limited to:                           instructions provided at the ‘‘Submit a
                                                      or payment obligations for a period of                    Debt Collection Act of 1982 (31 U.S.C.              Comment’’ screen. Please include your
                                                      up to one (1) year.                                     3701 note);                                           name, company name (if any), and
                                                         (c) Compliance by a participant with                                                                       ‘‘FAR Case 2011–011’’ on your attached
                                                      a service or payment obligation will be                   Fair Credit Reporting Act (15 U.S.C.                document.
                                                      considered impossible if the NIH                        1681 et seq.);                                           • Fax: (202) 501–4067.
                                                      determines, on the basis of information                   Federal Debt Collection Procedures                     • Mail: General Services
                                                      and documentation as may be required,                   Act of 1990 (28 U.S.C. 176); and Privacy              Administration, Regulatory Secretariat
                                                      that the participant suffers from a                     Act of 1974 (5 U.S.C. 552a).                          (MVCB), Attn: Hada Flowers, 1275 First

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