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

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

42 CFR part 50, subpart A-Responsibility of PHS awardee and applicant institutions for dealing with and reporting possible misconduct in science

42 CFR part 50, subpart D-Public Health Service grant appeals procedure

45 CFR part 16-Procedures of the Departmental Grant Appeals Board

45 CFR part 46-Protection of human subjects

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 75-Informal grant appeals procedures

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 45 CFR part 92-Uniform administrative requirements for grants and cooperative agreements to State and local governments

45 CFR part 93-New restrictions on lobbying 59 FR 14508 (March 28, 1994)-NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. [Note: this policy is subject to change, and interested persons should contact the Office of Research on Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD 20892-0161 (301-402-1770; not a toll-free number) to obtain references to the current version and any amendments.]

59 FR 34496 (July 5, 1994)-NIH Guidelines for Research Involving Recombinant DNA Molecules. [Note: this policy is subject to change, and interested persons should con

tact the Office of Recombinant DNA Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, Bethesda, MD 208927010 (301-496-9838; not a toll-free number) to obtain references to the current version and any amendments.]

"PHS Grants Policy Statement," DHHS Publication No. (OASH) 94-50,000 (Revised April 1, 1994), as amended by the Addendum, dated January 24, 1995. [Note: this policy is subject to change, and interested persons should 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) to obtain references to the current version and any amendments. Information may also be obtained by contacting the EOIRO via its e-mail address (ask nih@odrockml.od.nih.gov) and by browsing the NIH Home Page site on the World Wide Web (http://www.nih.gov).] "Public Health Service Policy on Humane Care and Use of Laboratory Animals," Office for Protection from Research Risks, NIH (Revised September 1986).

[NOTE: This policy is subject to change, and interested persons should contact the Office for Protection from Research Risks, NIH, Suite 3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-4967005; not a toll-free number) to obtain references to the current version and any amendments.]

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specialty and residency training) in library science and the field of communications of information pertaining to sciences relating to health.

(b) The regulations of this part also apply to cooperative agreements awarded for these purposes. References to "grant(s)" shall include "cooperative agreement(s)."

(c) The regulations of this part do not apply to research training support under the National Research Service Awards Program (see part 66 of this chapter).

§ 64.2 Definitions.

As used in this part:

HHS means the Department of Health and Human Services.

Nonprofit private entity means an agency, organization, institution, or other entity which may not lawfully hold or use any part of its net earnings to the benefit of any private shareholder or individual which does not hold or use its net earnings for that purpose.

Other trainee costs means those costs other than stipends, such as tuition, fees, and trainee travel, which are directly associated with and necessary for the training of individuals receiving stipends and which are incurred within the period of training.

Project 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 project.

Project period. See § 64.6(b).

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 that is intended to help meet that individual's subsistence expenses during training.

Training grant means an award of funds to an eligible entity for a project authorized under § 64.1(a).

§ 64.3 Who is eligible for a grant?

Except as otherwise prohibited by law, any public or private nonprofit entity is eligible for a training grant.

§64.4 How to apply for a grant.

Applications for grants must include the following information:

(a) Required information on the proposed project. (1) The nature, duration, and purpose of the training for which the application is filed.

(2) The name and qualifications of the project director and any key personnel responsible for the proposed project.

(3) A description of the facilities, staff, support services, and other organizational resources available to carry out the project.

(4) The intended number of trainees and the minimum qualifications and criteria for their selection.

(5) A description of the plan for evaluating the proposed project.

(6) Other pertinent information the Secretary may require to evaluate the proposed project.

(b) Required information on costs. (1) A budget for the proposed project and a justification of the amount of grant funds requested.

(2) If institutional expenses are requested, a separate statement of the amounts requested for personal services, equipment, supplies, or other nonpersonal services.

(3) If stipend costs are requested, a statement for each grant year of the estimated number of individuals to whom stipends will be provided and the length of time for which the stipend support will be provided. If other trainee costs are requested, they must be separately stated and justified.

(Approved by the Office of Management and Budget under control number 0925-0276)

§ 64.5 How are grant applications evaluated?

The Secretary shall evaluate applications through the officers and employees, experts, consultants, or groups engaged by the Secretary for that purpose. The Secretary's evaluation will be for technical merit and shall take into account, among other pertinent factors, the significance of the project, the qualifications and competency of the project director and proposed staff, the adequacy of selection criteria for trainees for the project, the adequacy of the applicant's resources available

for the project, and the amount of grant funds necessary for completion of its objectives.

864.6 Awards.

(a) Criteria. Within the limits of available funds, the Secretary may award training grants to carry out those projects which:

(1) Are determined by the Secretary to be technically meritorious; and

(2) In the judgment of the Secretary best promote the purpose of the grant program as authorized by section 472 of the Act (42 U.S.C. 286b-3), the regulations of this part (see §64.1), and address program priorities.

(b) Project period. (1) The notice of grant award specifies how long the Secretary intends to support the project without requiring the project to recompete for funds. This period, called the project period, will usually be for one to five years.

(2) Generally, the grant will initially be for one year and subsequent continuation awards will also be for one year at a time. A grantee must submit a separate application 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 a determination by the Secretary that continued funding is in the best interest of the Federal Government.

(3) 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.

(4) 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 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.

§ 64.7 What other conditions apply?

(a) Grants awarded under this part are subject to the following conditions: (1) The grantee may not materially change the quality, nature, or duration of the project unless the written approval of the Secretary is obtained prior to the change.

(2) The grantee must submit to the Secretary, in the manner prescribed by the Secretary, the name and other pertinent information regarding each individual who is awarded a stipend under a grant.

(b) The Secretary may impose additional conditions prior to the award of any grant under this part if it is determined by the Secretary that the conditions are necessary to carry out the purpose of the grant.

(Approved by the Office of Management and Budget under control number 0925-0276)

§ 64.8 How may funds be used?

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 subpart Q of 45 CFR part 74. The funds may not be expended for:

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

(b) 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.

$64.9 Other HHS regulations that apply.

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

42 CFR part 50, subpart D-Public Health Service grant appeals procedure.

45 CFR part 16-Procedures of the Departmental Grant Appeals Board.

45 CFR part 74-Administration of grants. 45 CFR part 75-Informal grant appeals procedures.

45 CFR part 76-subparts A-F. Governmentwide debarment and suspension (nonprocurement) and 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 45 CFR part 80 of this title. 45 CFR part 84-Nondiscrimination on the basis of handicap in programs and activities receiving or benefiting from 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.

45 CFR part 92-Uniform administrative requirements for grants and cooperative agreements to state and local governments.

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§64a.102 To whom do these regulations apply?

This part applies to any institution which receives a training grant under section 303 of the Public Health Service Act and to any individual who receives a stipend or other trainee allowances under such a grant for any period beginning on or after July 1, 1981, for clincial training in the field of psychology, psychiatry, nursing, or social work, except for training that is of a limited duration or experimental nature.

§64a.103 Definitions.

As used in this part:

Act means the Public Health Service Act as amended by Pub. L. 96-398.

Clinical traineeship means a stipend or other trainee allowances provided to an individual for clinical training in psychology, psychiatry, nursing, or social work, except for training that is of a limited duration or experimental nature, under a training grant authorized by section 303 of the Act.

Community Mental Health Centers Act means the Community Mental Health Centers Act (42 U.S.C. 2689 et seq.) other than Part D thereof.

Experimental nature refers to the training of undergraduates; the training of individuals in disciplines other than psychology, psychiatry, nursing, or social work; and any other training which the Secretary specifically designates as experimental in the notice of award for a training grant under section 303 of the Act.

Limited duration means a period that is equal to or less than 180 days, computed cumulatively over a two year period which begins on the first day of the clinical traineeship.

Mental Health Systems Act means the Mental Health Systems Act (42 U.S.C. 9401 et seq.).

or

Nonprofit private entity means an agency, organization, institution other entity which may not lawfully hold or use any part of its net earnings to the benefit of any private shareholder or individual and which does not hold or use its net earnings for that purpose.

Other trainee allowances means financial assistance for those costs not covered by stipends, such as tuition, fees,

and trainee travel, which are directly associated with and necessary to the training of individuals receiving stipends and are incurred within the period of training.

Secretary means the Secretary of Health and Human Services or other official of the Department to whom the authority involved has been delegated.

Stipend means financial assistance to an individual that is intended to help meet that individual's subsistence expenses during training.

§ 64a.104 What requirements are imposed upon grantees?

Recipients of training grants under section 303 of the Act that provide a clinical traineeship to any individual must:

(a) Give each such individual written notice of the service payback and recovery requirements of this part at the time the individual becomes a candidate for the traineeship;

(b) Before awarding a clinical traineeship, conduct an entrance interview with the individual in order to explain and emphasize the service obligation the individual is incurring, obtain the individual's written assurance that he or she will satisfy the requirements of §64a.105, and document, in accordance with paragraph (d) of this section, the entrance interview on the form containing the individual's written assurance.

(c) At the time of termination of the clinical traineeship,

(1) Notify the Secretary in writing of the date on which the individual's traineeship is terminated;

(2) Conduct an exit interview with the individual to remind the trainee of the service obligation, to fully explain the consequences that will incur should the trainee fail to satisfy the obligation, and, to tell the individual that the Secretary has been notified of the date of termination of the traineeship; and

(3) Document, in accordance with paragraph (d) of this section, the exit interview on the form notifying the Secretary of the termination of the traineeship.

(d) Document the entrance and exit interviews with at least the following information: The date of the interview,

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§64a.105 What are the conditions of obligated service?

In order to receive a clinical traineeship an individual must comply with the following conditions:

(a) Written assurance. Prior to the award of a clinical traineeship, the individual must sign a written assurance (in such form and manner as the Secretary prescribes) that he or she will satisfy the requirements of this section.

(b) Commencement and crediting of service. (1) An individual must start the obligated service within twenty-four months after termination of the clinical traineeship and carry out the service on a continuous basis unless, as specified in paragraph (e) of this section, the individual has requested and had approved, respectively, an extension of the time for beginning the service, or a break in service.

(2) Following termination of the traineeship, the individual must annually provide (in such form and manner as the Secretary prescribes) a written report describing those previous years' activities which are related to service that fulfills the payback obligation. The Secretary will review this report and credit all service performed in those categories specified in paragraph (d) of this section toward the individual's payback obligation, except any service which is performed:

(i) Before termination of the individual's clinical traineeship; and

(ii) As part of any activity, such as course work, preparation of a dissertation or thesis, or practicum, which is needed to complete the training for which the individual received the traineeship.

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