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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 fulillment of the purpose of the Eraineeship. The Director may, as a matter of general policy or, in individal cases, waive compliance with any minimum qualification so established co the extent that the applicant or applicants have substantially equivalent qualifications or have such special craining, experience or opportunity for service as to make an award particuarly appropriate, and to the extent the Director finds it is consistent with the ulfillment of the purpose of the raineeship.

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 offiial's judgment to carry out the purpose of the traineeships. These awards may be made for a period of one (1) Fear or other period, including extendons or renewals, as may be specified.

63.6 How to apply.

(a) Application for a traineeship shall ⇒ made in writing as prescribed by the irector.

(b) In addition to other pertinent inrmation, the Director may require ach applicant to submit the following formation:

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

(2) The applicant's educational backound and other qualifications and exerience, including previous academic nd professional degrees, if any; and (3) The subject area of the proposed aining.

(c) By applying, eligible individuals Free to abide by HHS, PHS, and NIH gulations, and the terms and condions of the traineeship award which ay require compliance with policies ad procedures that apply to the prop- conduct of research, such as rearch involving human and animal bjects, patient care, hospital and labatory procedures, handling of con

fidential information, and outside employment.

$63.7 What are the benefits of awards?

(a) Subject to the availability of funds, each individual awarded а 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.

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§64.1 Programs to which these regula tions apply.

(a) The regulations of this part apply to grants under section 472 of the Pub lic Health Service Act (42 U.S.C. 28603) to public and private nonprofit insti tutions to assist in developing, expanding, and improving training programs (excluding training in a biomedical 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 "cooper tive 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).

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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 ther official of HHS to whom the auhority involved is delegated.

Stipend means a payment to an indiidual that is intended to help meet hat individual's subsistence expenses uring training.

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

84.3 Who is eligible for a grant?

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

44 How to apply for a grant. Applications for grants must include Fe following information:

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

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

(3) A description of the facilities, aff, support services, and other orgazational resources available to carry it the project.

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

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

(6) Other pertinent information the cretary may require to evaluate the oposed project.

(b) Required information on costs. (1) A idget for the proposed project and a stification of the amount of grant nds requested.

(2) If institutional expenses are reested, a separate statement of the nounts requested for personal serves, equipment, supplies, or other non ́ersonal 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.

§ 64.6 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 regula tions of this part (see §64.1), and address program priorities.

(b) Project period. (1) The notice of grant award specifies how long the Heo retary 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 con tinuation awards will also be for one year at a time. A grantee must submit a separate application to have the sup port continued for each subsequent year. Decisions regarding continuation awards and the funding level of these awards will be made after consider

ation 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 accord

ance 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 serv ices by individuals receiving training and instruction; or

(b) Payments to any individual who does not meet the minimum qualifications for training and instruction es tablished 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 Depart mental Grant Appeals Board.

45 CFR part 74—Administration of grants. 45 CFR part 75-Informal grant appeals) cedures.

45 CFR part 76-subparts A-F. Governmentwide debarment and suspens (nonprocurement) and requirements drug-free workplace (grants). 45 CFR part 80-Nondiscrimination programs receiving Federal assista through the Department of Health Human Services effectuation of title the Civil Rights Act of 1964.

45 CFR part 81-Practice and procedure hearings under 45 CFR part 80 of this 45 CFR part 84-Nondiscrimination on basis of handicap in programs and act ties receiving or benefiting from Fed financial assistance.

45 CFR part 86-Nondiscrimination on basis of sex in education programs and tivities receiving or benefiting from eral financial assistance.

45 CFR part 91-Nondiscrimination on basis of age in HHS programs or activ receiving Federal financial assistance. 45 CFR part 92-Uniform administrativ quirements for grants and cooper agreements to state and local go ments.

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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.).

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 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

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