§ 63.1 To what programs do these regulations apply?

(a) The regulations in this part apply to research traineeships awarded by each Director of a national research institute of NIH, the Director of the National Library of Medicine (NLM), the Director of the National Center for Human Genome Research (NCHGR), the Director of the Office of Alternative Medicine, or designees pursuant to sections 404E(d)(2), 405(b)(1)(C), 472, and 485B of the Public Health Service Act, as amended.

(b) The regulations of this part do not apply to research training which is part of the National Research Service Award Program provided under 42 CFR part 66, the Mental Health Traineeship Program provided under 42 CFR part 64a, or residency training of physicians or other health professionals.

§ 63.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.). Award means an award of funds under sections 404E(d)(2), 405(b)(1)(C), 472, or 485B of the Act, or other sections of the Act which authorize research training or traineeships.

Awardee means an individual awarded a traineeship under sections 404E(d)(2), 405(b)(1)(C), 472, or 485B of the Act, or other sections of the Act which authorize research training or traineeships.

Director means the director of one of the national research institutes of NIH specified in section 401(b)(1) of the Act, the Director of the National Library of Medicine, the Director of the National Center for Human Genome Research, the Director of the Office of Alternative Medicine, or any official of NIH to whom the authority involved has been delegated.

HHS means the Department of Health and Human Services.

NIH means the National Institutes of Health.

PHS means the Public Health Service.

Traineeship means an award of funds under section 404E(d)(2), 405(b)(1)(C), 472, or 485B of the Act, or other sections of the Act authorizing research training or traineeships, and the regulations of this part, to a qualified indi

The purpose of an NIH research traineeship is to provide support for financial subsistence to an individual during a period in which the awardee is acquiring training in:

(a) Basic and/or clinical biomedical or behavioral research relating to human health, including extending healthy life and reducing the burdens of illness, or

(b) Medical library science or related fields pertaining to sciences related to health or the communication of health sciences information.

Traineeships are intended to make available in the United States an increased number of persons having special competence in these research fields through developmental training and practical research experience in the facilities of NIH, with supplemental training at other qualified institutions (see § 63.8(a)).

§ 63.4 What are the minimum qualifications for awards?

Minimum qualifications for any traineeship shall be established by the Director and shall be uniformly applicable to all applicants in each traineeship program. These minimum qualifications may include requirements as to citizenship, medical standards, academic degrees, professional or other training or experience, and other factors as may be necessary to the fulfillment of the purpose of the traineeship. The Director may, as a matter of general policy or, in individual cases, waive compliance with any minimum qualification so established to the extent that the applicant or applicants have substantially equivalent qualifications or have such special training, experience or opportunity for service as to make an award particularly appropriate, and to the extent the Director finds it is consistent with the

fulfillment of the purpose of the traineeship.

§63.5 How will NIH make awards?

Subject to the regulations of this part, the Director may award traineeships to those qualified applicants who are best able in that official's judgment to carry out the purpose of the traineeships. These awards may be made for a period of one (1) year or other period, including extensions or renewals, as may be specified.

§ 63.6 How to apply.

(a) Application for a traineeship shall be made in writing as prescribed by the Director.

(b) In addition to other pertinent information, the Director may require each applicant to submit the following information:

(1) Certification of the applicant's citizenship status;

(2) The applicant's educational background and other qualifications and experience, including previous academic and professional degrees, if any; and

(3) The subject area of the proposed training.

(c) By applying, eligible individuals agree to abide by HHS, PHS, and NIH regulations, and the terms and conditions of the traineeship award which may require compliance with policies and procedures that apply to the proper conduct of research, such as research involving human and animal subjects, patient care, hospital and laboratory procedures, handling of confidential information, and outside employment.

§ 63.7 What are the benefits of awards? (a) Subject to the availability of funds, each individual awarded a traineeship may receive a stipend fixed in an amount determined by the Director.

(b) Additional allowances and benefits may be authorized by and at the discretion of the Director, taking into account the cost of living and other factors such as the requirements of the training program and availability of discretionary funds. Discretionary allowances and benefits may include: health benefits coverage; dependents' allowance; travel to pre-award interviews, to first duty station, and return to the place of origin upon conclusion

of the traineeship; tuition and institution fees; and other specific costs as may be necessary to fulfill the purpose of the training program.

§ 63.8 What are the terms and conditions of awards?

All traineeships shall be subject to the following terms and conditions:

(a) Training must be carried out at a facility of the NIH, but may be supplemented by additional training acquired at another institution which is found by the Director to be directly related to the purpose of the traineeship and necessary to its successful completion.

(b) Payments shall be made to the awardee or to the institution for payment to the awardee in accordance with payment schedules as prescribed by the Director for each traineeship program.

(c) The awardee shall reimburse NIH for any overpayment of stipends or other allowances because of early termination of the traineeship or any other reason, unless waived for good cause shown by the awardee.

(d) The Director may establish procedures and requirements applicable to traineeship awards, consistent with the regulations in this part, regarding: (1) The proper conduct of research investigations, including research involving human and animal subjects; (2) patient care; (3) hospital and laboratory procedures; (4) handling of confidential information; (5) outside employment; and (6) additional conditions the Director finds necessary to fulfill the purpose of the traineeship.

(e) The awardee shall sign an agreement to comply with the terms and conditions of the traineeship.

§ 63.9 How may NIH terminate awards?

The Director may terminate a traineeship at any time:

(a) Upon written request of the awardee; or

(b) If it is determined that the awardee is ineligible, has materially failed to comply with the terms and conditions of the award, or to carry out the purpose for which it was made.

§ 63.10 Other HHS regulations and policies that apply.

Several other policies and regulations apply to awards under this part. These include, but are not necessarily limited to:

45 CFR part 46-Protection of human subjects.

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

45 CFR part 80-Nondiscrimination under programs receiving Federal assistance through the Department of Health and Human Services-effectuation of title VI of the Civil Rights Act of 1964.

45 CFR part 81-Practice and procedure for hearings under part 80 of this title. 45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving Federal financial assistance. 45 CFR part 86-Nondiscrimination on the basis of sex in education programs and activities receiving or benefiting from Federal financial assistance.

45 CFR part 91-Nondiscrimination on the basis of age in HHS programs or activities receiving Federal financial assistance. 51 FR 16958 (May 7, 1986)-NIH Guidelines for Research Involving Recombinant DNA Molecules.

"Public Health Service Policy on Humane Care and Use of Laboratory Animals," Office for Protection from Research Risks, NIH (Revised September 1986).

59 FR 14508 (March 28, 1994)-NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

PART 63a-NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS

Sec.

63a.1 To what programs do these regulations apply?

63a.2 Definitions.

63a.3 What is the purpose of training grants?

63a.4 Who is eligible for a training grant? 63a.5 How to apply for a training grant. 63a.6 How are training grant applications evaluated?

63a.7 Awards.

63a.8 How long does grant support last? 63a.9 What are the terms and conditions of awards?

63a.10 How may training grant funds be spent?

63a.11 Other HHS regulations and policies that apply.

AUTHORITY: 42 U.S.C. 216, 2427(b)(3), 284(b)(1)(C), 287c(b), 300cc-15(a)(1), 300cc41(a)(3)(C), 7403(h)(2).

SOURCE: 61 FR 55111, Oct. 24, 1996, unless otherwise noted.

§ 63a.1 To what programs do these regulations apply?

(a) The regulations of this part apply to:

(1) Grants awarded by the John E. Fogarty International Center for Advanced Study in the Health Sciences, NIH, for training in international cooperative biomedical research endeavors, as authorized under section 307(b)(3) of the Act;

(2) Grants awarded by NIH for research training with respect to the human diseases, disorders, or other aspects of human health or biomedical research, for which the institute or other awarding component was established, for which fellowship support is not provided under section 487 of the Act and which is not residency training of physicians or other health professionals, as authorized by sections 405(b)(1)(C), 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and,

(3) Grants awarded by the National Institute of Environmental Health Sciences, NIH, for the education and environtraining of physicians in mental health, as authorized under section 103(h)(2) of the Clean Air Act, as amended.

(b) The regulations of this part also apply to cooperative agreements awarded to support the training specified in paragraph (a) of this section. References to "grant(s)” shall include "cooperative agreement(s).”

(c) The regulations of this part do not apply to:

(1) Research training support under the National Research Service Awards Program (see part 66 of this chapter);

(2) Research training support under the NIH Center Grants programs (see part 52a of this chapter);

(3) Research training support under traineeship programs (see part 63 of this chapter);

(4) Research training support under the NIH AIDS Research Loan Repayment Program (see section 487A of the Act); or

(5) Research training support under the National Library of Medicine training grant programs (see part 64 of this chapter).

§ 63a.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201 et seq.). HHS means the Department of Health and Human Services.

NIH means the National Institutes of Health and its organizational components that award training grants.

Nonprofit as applied to any agency or institution, means an agency or institution which is a corporation or association, no part of the net earnings of which inures or may lawfully inure to the benefit of any private shareholder or individual.

Program director means the single individual named by the grantee in the grant application and approved by the Secretary, who is responsible for the management and conduct of the training program.

Project period See § 63a.8(a).

Secretary means the Secretary of Health and Human Services and any other official of HHS to whom the authority involved is delegated.

Stipend means a payment to an individual to help meet that individual's subsistence expenses during the training period.

Training grant means an award of funds to an eligible agency or institution for a training program authorized under §63a.1 to carry out one or more of the purposes set forth in §63a.3.

§ 63a.3 What is the purpose of training grants?

The purpose of a training grant is to provide financial assistance to an eligible agency or institution to enable it to provide research training to individuals in the diagnosis, prevention, treatment, or control of human diseases or disorders, or other aspects of human health or biomedical research, or in environmental health, in order to increase the number of facilities which provide qualified training and the number of persons having special competence in these fields.

§ 63a.4 Who is eligible for a training grant?

(a) General. Except as otherwise provided in this section or as prohibited by law, any public or private for-profit

or nonprofit agency, institution, or entity is eligible for a training grant.

(b) International training grants for AIDS research. Any international organization concerned with public health is eligible for a training grant to support individuals for research training relating to acquired immunodeficiency syndrome (AIDS), as authorized under section 2315(a)(1) of the Act. In awarding these grants, preference shall be given to:

or

(1) Training activities conducted by, in cooperation with, the World Health Organization and

(2) With respect to training activities in the Western Hemisphere, activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization.

§ 63a.5 How to apply for a training grant.

Any agency, institution, or entity interested in applying for a grant under this part must submit an application at the time and in the form and manner that the Secretary may require.

§ 63a.6 How are training grant applications evaluated?

The Secretary shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Secretary for that purpose, including review or consultation with the appropriate advisory council or other body as may be required by law. The Secretary's evaluation will be for merit and shall take into account, among other pertinent factors, the significance of the program, the qualifications and competency of the program director and proposed staff, the adequacy of the selection criteria for trainees under the program, the adequacy of the applicant's resources available for the program, and the amount of grant funds necessary for completion of its objectives.

§63a.7 Awards.

Criteria. Within the limits of available funds, the Secretary may award training grants for training programs which:

(a) Are determined to be meritorious,

and

(b) Best carry out the purposes of the particular statutory program described in §63a.1 and the regulations of this part.

§ 63a.8 How long does grant support last?

(a) The notice of the grant award specifies how long the Secretary intends to support the project without requiring the grantee to recompete for funds. This period, called the "project period," will usually be for one to five years.

(b) Generally, the grant will be initially for one year and subsequent continuation awards will be for one year at a time. A grantee must submit a separate application at the time and in the form and manner that the Secretary may require to have the support continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consideration of such factors as the grantee's progress and management practices, and the availability of funds. In all cases, continuation awards require determination by the Secretary that continued funding is in the best interest of the Federal Government.

(c) Neither the approval of any application nor the award of any grant commits or obligates the Federal Government in any way to make any additional, supplemental, continuation, or other award with respect to any approved application or portion of an approved application.

(d) Any balance of federally obligated grant funds remaining unobligated by the grantee at the end of a budget period may be carried forward to the next budget period, for use as prescribed by the Secretary, provided that a continuation award is made. If at any time during a budget period it becomes apparent to the Secretary that the amount of Federal funds awarded and available to the grantee for that period, including any unobligated balance carried forward from prior periods, exceeds the grantee's needs for that period, the Secretary may adjust the amounts awarded by withdrawing the

excess.

§ 63a.9 What are the terms and conditions of awards?

In addition to the requirements imposed by law, grants awarded under this part are subject to any terms and conditions imposed by the Secretary to carry out the purpose of the grant or assure or protect advancement of the approved program, the interests of the public health, or the conservation of grant funds.

§ 63a.10 How may training grant funds be spent?

(a) Authorized expenditures; general. A grantee shall expend funds it receives under this part solely in accordance with the approved application and budget, the regulations of this part, the terms and conditions of the grant award, and the applicable cost principles in 45 CFR 74.27.

(b) Authorized categories of expenditures. Subject to any limitations imposed in the approved application and budget or as a condition of the award, grant funds may be expended for the following costs:

(1) Expenses of the grantee in providing training and instruction under the particular program, including salaries of faculty and support personnel, and the costs of equipment and supplies;

(2) Stipends and allowances to individuals during the period of their training and instruction; and,

(3) If separately justified and authorized under the particular program, tuition, fees, and trainee travel expenses which are necessary to carry out the purpose of the training grant.

(c) Expenditures not authorized. Grant funds may not be expended for:

(1) Compensation for employment or for the performance of personal services by individuals receiving training and instruction; or

(2) Payments to any individual who does not meet the minimum qualifications for training and instruction established by the grantee and approved by the Secretary or who has failed to demonstrate satisfactory participation in the training in accordance with the usual standards and procedures of the grantee.