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###### Department of Health and Human Services

###### National Institutes of Health

          - 42 CFR Part 66
          - RIN 0925-AA16

# AGENCY:

National Institutes of Health, Department of Health and Human Services.

# ACTION:

Final rule.

# SUMMARY:

The National Institutes of Health (NIH) is amending the regulations governing National Research Service Awards (NRSA) in order to incorporate changes necessitated by enactment of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) Reorganization Act of 1992, Public Law 102-321, and the National Institutes of Health Revitalization Act of 1993, Public Law 103-43.

# DATES:

This final rule is effective on July 2, 2001.

# FOR FURTHER INFORMATION CONTACT:

Jerry Moore, NIH Regulations Officer, National Institutes of Health, 6011 Executive Blvd., Room 601, MSC 7669, Rockville, MD 20892, or telephone (301) 496-4607 (not a toll-free number). For further information about the National Research Service Awards program contact the Extramural Outreach and Information Resources Office (EOIRO), Office of Extramural Research, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910, (301) 435-0714 (not a toll-free number). Information may also be obtained by contacting the EOIRO via its e-mail address (asknih@odrockml.od.nih.gov) and by browsing the NIH Home Page site on the World Wide Web (http://www.nih.gov).

# SUPPLEMENTARY INFORMATION:

The ADAMHA Reorganization Act of 1992, Public Law 102-321, was enacted on July 10, 1992. That Act transferred the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) to NIH, effective October 1, 1992, and provided for the administration of treatment and service programs under a newly created Substance Abuse and Mental Health Services Administration (SAMHSA). In order to avoid confusion between the ADAMHA Minority Access to Research Careers (MARC) program and the NIH MARC program, the name of the ADAMHA program was changed to Career Opportunities in Research Education and Training (COR). Currently, the MARC program is administered by the National Institute of General Medical Sciences (NIGMS) and the COR program is administered by the NIMH. NIH is revising paragraph (g) of § 66.102 of the existing regulation to reflect this name change and the current organization locations of the respective programs.

Subsequently, the National Institutes of Health Revitalization Act of 1993, Public Law 103-43, was enacted on June 10, 1993. Provisions of that Act necessitate that NIH make changes in both Subparts A and B of the current regulations governing the NRSA program.

Section 1601 of Public Law 103-43 directs the Secretary of Health and Human Services (HHS) to conduct the NRSA program in a manner that will result in the recruitment of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) into fields of biomedical or behavioral research and the provision of research training to women and those individuals. The United States House of Representatives report accompanying the NIH Revitalization Act of 1993 suggested that NIH consider the possibility of permitting part-time research training for women to keep them from losing training experience while having child care responsibilities. We are revising paragraph (b) of § 66.103 of the current NRSA regulations and adding a new paragraph (c) to permit individuals, in cases of disability or pressing family need, part-time research or training. Additionally, we are amending paragraph (a) of § 66.103 by changing the word “application” to read “the award” to reflect the current policy with regard to eligibility requiring that a recipient must be lawfully admitted to the United States for permanent residence at the time of the award rather than at the time of application.

                    Section 1602 of the NIH Revitalization Act of 1993 substantially modifies the service payback obligation under the NRSA program. Under provisions of the new law, only individuals in the first twelve months of postdoctoral training incur a payback obligation. Additionally, individuals may pay back this obligation by engaging in service for an equal period of health-related research or health-related teaching; or, if individuals receive an NRSA for more than twelve months, each month beyond 12 months will count toward satisfaction of the repayment obligation. We are amending § 66.105 by revising paragraphs (a), (b), and (c); revising § 66.110 in its entirety; amending § 66.111 of subpart A by revising paragraph (a)(1), the introductory language of paragraph (b), and paragraph (b)(4); and amending § 66.205                           ( print page 29499)                        of subpart B by revising paragraphs (a)(1) and (b) to reflect these changes in the payback obligation. Additionally, we are amending paragraph (a)(2) by changing the word “application” to read “the award” in order to reflect the current policy with regard to eligibility requiring that a recipient must be lawfully admitted to the United States for permanent residence at the time of the award rather than at the time of application. We are amending paragraph (b) of § 66.205 by changing the reference to “§ 66.106(d)” to read “§ 66.106(e)” to correct an error in the current text.                

                    In § 66.112, subpart A, we are removing the reference to the regulations pertaining to inventions and patents at 45 CFR parts 6 and 8 to reflect the rescinding of parts 6 and 8, effective on October 22, 1996 (61 FR 54743); and we are amending the references to the regulations pertaining to debarment and suspension at 45 CFR part 76 and the guidelines for research involving recombinant DNA molecules to comply with                     **Federal Register**                     format requirements. Additionally, we are amending the title of § 66.112 to reflect that policies, as well as regulations, are referenced in that section.                

                    In § 66.207, we are amending the reference to the regulations pertaining to the administration of grants at 45 CFR part 74, the reference to the regulations pertaining to debarment and suspension from eligibility for financial assistance at 45 CFR part 76, and the reference to the guidelines for research involving recombinant DNA molecules to comply with                     **Federal Register**                     format requirements. Also, we are adding a reference to the regulations to ensure objectivity in PHS-funded research at 42 CFR part 50, subpart F, to reflect their applicability to NRSA research training grants and direct fellowship awards.                

Additionally, we are revising the Authority section and the references to section 472 of the Public Health Service Act and the United States Code [42 U.S.C. 2891-1] in § 66.101, § 66.102(d), § 66.105(b), § 66.106(a)(2), § 66.201, and § 66.206(a)(3) to reflect the correct citations.

Finally, we are amending § 66.104 by adding the word “and” immediately following the word “resources” in paragraph (b)(5) to correct an error in the current text.

                    We announced our intentions to make these changes to the regulations in a notice of proposed rulemaking (NPRM) published in the                     **Federal Register**                     on June 30, 1999 (64 FR 35119). No comments were received. Consequently, the regulations are the same as those proposed in the NPRM.                

We provide the following statements as information for the public.

The Department strongly encourages all grant recipients to provide a smoke-free workplace and to promote the nonuse of all tobacco products and reminds that Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children.

## Executive Order 12866

Executive  Order 12866, Regulatory Planning and Review, requires that all regulatory actions reflect the costs and benefits they generate, and that they meet certain standards, such as avoiding the imposition of unnecessary burdens on the affected public. We reviewed the rule as required under Executive Order 12866 and deemed it within the scope of the definition of the term “significant regulatory action” contained in section 3(f) of the Order. Consequently, we submitted the rule to the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) for the pre-publication review required for all regulatory actions deemed “significant” under the Order.

## Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that we analyze regulatory actions to determine whether they create a significant impact on a substantial number of small entities. The Secretary certifies that the changes in the NRSA program regulations would not have a significant economic impact on a substantial number of small entities and, therefore, a regulatory flexibility analysis, as defined under the Regulatory Flexibility Act, is not required.

## Executive Order 13132

Executive Order 13132, Federalism, requires that we consult with State and local government officials in the development of regulatory policies with federalism implications. We received the rule as required under the Order and determined that it does not have any federalism implications. The Secretary certifies that the changes in the NRSA program regulations will not have an effect on the States or on the distribution of power and responsibilities among the various levels of government.

## Paperwork Reduction Act

The rule does not contain any information collection requirements that are subject to OMB approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).

## Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance (CFDA) numbered program affected by this rule is: 93.186 National Research Service Awards-Health Service Research Training.

# List of Subjects in 42 CFR Part 66

      - Grant programs-Health research training

Dated: November 15, 2000.

Ruth L. Kirschstein,

Principal Deputy Director, NIH.

Tommy G. Thompson,

Secretary.

For the reasons set forth in the preamble, part 66, subparts A and B, of title 42 of the Code of Federal Regulations are revised to read as set forth below.

# PART 66—NATIONAL RESEARCH SERVICE AWARDS

# Subpart A—Direct Awards

1. The authority citation of part 66 is revised to read as follows: 

Authority:42 U.S.C. 216, 288.

2. Section 66.101 is revised to read as follows: 

§ 66.101

The regulations in this subpart apply to National Research Service Awards made by the Secretary to individuals for research and training to undertake research, under section 487 of the Public Health Service Act, as amended (42 U.S.C. 288).

3. Section 66.102 is amended by revising paragraphs (d) and (g) to read as follows: 

§ 66.102

* * * * *

                            (d)                             *Award*                             means a National Research Service Award under section 487 of the Act (42 U.S.C. 288).                        

* * * * *

                            (g)                             *Predoctoral training*                             means training at the post-baccalaureate level in a program leading to the award of a doctor of philosophy of science, or equivalent degree. For purposes of Awards under the Minority Access to Research Careers programs of the National Institute of General Medical Sciences and the Career Opportunities in Research Education and Training programs of the National Institute of Mental Health,                             *predoctoral training*                             also means training in a program leading to                                   ( print page 29500)                                the award of a baccalaureate in science or equivalent degree.                        

* * * * *

4. Section 66.103 is amended by revising paragraphs (a) and (b) and adding a new paragraph (c) to read as follows: 

* * * * *

§ 66.103

* * * * *

(a) Be a citizen, noncitizen national of the United States, or lawfully admitted to the United States for permanent residence at the time of the award.

(b) Propose to engage in such research, or training to undertake research, in a program specified in section 487(a)(1)(A) of the Act; and

(c) Propose to engage in such research or training to undertake research on a full-time basis except in cases of disability or pressing family need.

5. Section 66.104 is amended by adding the word “and” immediately following the word “resources” in paragraph (b)(5). As revised, paragraph (b)(5) reads as follows: 

§ 66.104

* * * * *

(b) * * *

(5) The availability of necessary resources and facilities at the institution where the research or training would be conducted.

6. Section 66.105 is amended by revising paragraphs (a), (b) introductory text, and (c) to read as follows: 

§ 66.105

* * * * *

(a) For any Award made for an individual's initial twelve months of NRSA postdoctoral research or training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110.

(b) If the proposed research or training would take place at an institution other than the National Institutes of Health, the institution has assured the Secretary, in the form and manner the Secretary may prescribe, that:

* * * * *

(c) The individual has assured the Secretary, in the form and manner the Secretary may prescribe, that the Award to the individual will not be used to support a residency.

7. Section 66.106 is amended by revising paragraph (a)(2) introductory text to read as follows: 

§ 66.106

(a)  * * * 

(2) Whose proposed research or training would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(A) of the Act, taking into consideration among other pertinent factors:

* * * * *

8. Section 66.110 as revised in its entirety to read as follows: 

§ 66.110

(a) Each individual who receives an Award for postdoctoral research or training shall engage in a month of research training, research, or teaching that is health-related (or any combination thereof) for each month of support received, up to a maximum of twelve months. Such period shall be served in accordance with the usual patterns of such employment or training.

(b) In any case in which an individual receives an Award for more than twelve months, the thirteenth month and each subsequent month of performing activities under the Award shall be considered to be activities toward satisfaction of the requirement established in paragraph (a) of this section.

(c) Except as provided in § 66.111, an individual subject to the requirements for service in paragraph (a) of this section must begin to undertake the service on a continuous basis within two years after the expiration or termination for his or her Award.

(d) If the individual fails to undertake or perform the service in accordance with the requirements of this section, the United States shall be entitled to recover from the individual an amount determined in accordance with the formula:

In which

*A*                                 is the amount the United States is entitled to recover;                            

*0*                                 is the sum of the total amount paid to the individual for the months of postdoctoral support up to a maximum of twelve months;                            

*t*                                 is total number of months in the individual's service obligation;                            

                                and                                 *s*                                 is the number of months of the obligation served by him or her in accordance with paragraph (a) or (b) of this section.                            

(e) Except as provided in § 66.111, the individual shall pay to the United States any  amount which it is entitled to recover under paragraph (d) of this section within a three-year period beginning on the date the United States becomes entitled to recovery that amount. Interest shall accrue to the United States until any amount due it under paragraph (d) of the section is paid. The rate of interest will be fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to recovery.

9. Section 66.111 is amended by revising paragraphs (a) introductory text, (b) introductory text, and (c)(4) to read as follows: 

§ 66.111

(a) The Secretary may extend the period for undertaking service described in § 66.110(c), permit breaks in the continuous service required under § 66.110(c), or extend the period of repayment under § 66.110(e) if the Secretary determines that: 

* * * * *

(b) The Secretary may waive, in whole or in part, the obligation of the individual to repay pursuant to § 66.110(d) if the Secretary determines that: 

* * * * *

(c) * * *

(4) The extent to which the individual has been engaged in activities encompassed by § 66.110(a) and (b); 

* * * * *

10. Section 66.112 is amended by revising the heading; removing the entry “ 45 CFR parts 6 and 8”, revising the entry “45 CFR part 76”, removing the entry “48 FR 24556”, and adding the entry “51 FR 16958 (May 7, 1986)” to read as follows: 

§ 66.112

* * * * *

45 CFR part 76—Governmentwide debarment and suspension (nonprocurement) and governmentwide requirements for drug-free workplace (grants)

51 FR 16958 (May 7, 1986)—NIH Guidelines for Research Involving Recombinant DNA Molecules.

# Note:

This policy is subject to change, and interested persons should contact the Office of Science Policy, Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.

# Subpart B—Institutional Grants

11. Section 66.201 is revised to read as follows: 

§ 66.201 

                            The regulations in this subpart apply to grants under section 487 of the Public                                   ( print page 29501)                                Health Service Act, as amended (42 U.S.C. 288), to public institutions and to nonprofit private institutions to enable those institutions to make National Research Service Awards to individuals for research and training to undertake research, in programs specified in section 487 of the Act.                        

12. Section 66.205 is amended by revising paragraphs (a)(1) and (a)(2), and (b) to read as follows: 

§ 66.205 

(a) * * *

(1) For any award made for an individual's initial twelve months of NRSA postdoctoral research training, the individual has assured the Secretary, in the form and manner the Secretary may prescribe, that he or she will satisfy the requirements of § 66.110 of subpart A of this part;

(2) The individual is a citizen or noncitizen national of the United States or has been lawfully admitted to the United States for permanent residence at the time of the award;

* * * * *

(b) No Award shall be made to an individual under such grant which would provide that individual with aggregate support in excess of five years for predoctoral training and three years for postdoctoral training, unless the Secretary for good cause shown as provided in § 66.106(e) of subpart A of this part, waives the application of the limitation with respect to that individual;

* * * * *

13. Section 66.206 is amended by revising paragraph (a)(3) introductory text to read as follows: 

§ 66.206 

(a) * * *

(3) Whose proposed programs would, in the judgment of the Secretary, best promote the purposes of section 487(a)(1)(B) of the Act, taking into consideration among other pertinent factors:

* * * * *

14. Section 66.207 is amended by revising the references to 45 CFR part 74, 45 CFR part 76, and 48 FR 24556; and adding an entry for 42 CFR part 50, subpart F, immediately following the entry “42 CFR part 50, subpart D” and an entry for 51 FR 16958 (May 7, 1986) to read as follows:

§ 66.207 

* * * * *

42 CFR part 50, subpart F—Responsibility of applicants for promoting objectivity in research for which PHS funding is sought.

* * * * *

45 CFR part 74—Uniform administrative requirements for awards and subawards to institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations; and certain grants and agreements with states, local governments and Indian tribal governments.

* * * * *

45 CFR part 76—Governmentwide debarment and suspension (non procurement) and governmentwide requirements for drug-free workplace (grants)

* * * * *

51 FR 16958 (May 7, 1986)—NIH Guidelines for Research Involving Recombinant DNA Molecules.

# Note:

This policy is subject to change, and interested persons should contact the Office of Biotechnology Activities, NIH, Suite 302, 6000 Executive Boulevard, MSC 7052, Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to obtain references to the current version and any amendments.

[FR Doc. 01-13692  Filed 5-30-01; 8:45 am]

BILLING CODE 4140-01-M