[Title 42 CFR E]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter E - FELLOWSHIPS, INTERNSHIPS, TRAINING]
[From the U.S. Government Printing Office]


42PUBLIC HEALTH12008-10-012008-10-01falseFELLOWSHIPS, INTERNSHIPS, TRAININGESUBCHAPTER EPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
             SUBCHAPTER E_FELLOWSHIPS, INTERNSHIPS, TRAINING



PART 61_FELLOWSHIPS--Table of Contents




                      Subpart A_Regular Fellowships

Sec.
61.1 Definitions.
61.2 Applicability.
61.3 Purpose of regular fellowships.
61.4 Establishment and conditions.
61.5 Qualifications.
61.6 Method of application.
61.7 Review of applications; committees; awards.
61.8 Benefits: Stipends; dependency allowances; travel allowances; 
          vacation.
61.9 Payments: Stipends; dependency allowances; travel allowances.
61.10 Benefits: Tuition and other expenses.
61.11 Payments: Tuition and other expenses.
61.12 Accountability.
61.13 Duration and continuation.
61.14 Separate consideration of information concerning moral character 
          or loyalty.
61.15 Moral character or loyalty; reference to Special Review Committee; 
          review and recommendation.
61.16 Termination of or refusal to continue award on grounds relating to 
          moral character or loyalty; hearing.
61.17 Termination on grounds other than those relating to moral 
          character or loyalty.
61.18 Publications.
61.19 Copyright and reproduction.
61.20 Inventions or discoveries.
61.21 Interest.
61.22 Nondiscrimination.

                      Subpart B_Service Fellowships

61.30 Definitions.
61.31 Applicability.
61.32 Purpose of service fellowships.
61.33 Establishment of service fellowships.
61.34 Qualifications.
61.35 Method of application.
61.36 Selection and appointment of service fellows.
61.37 Stipends, allowances, and benefits.
61.38 Duration of service fellowships.



                      Subpart A_Regular Fellowships

    Authority: Sec. 215, 58 Stat. 690, as amended, sec. 8, 77 Stat. 400; 
42 U.S.C. 216, 1857g; secs. 301, 402, 58 Stat. 691, as amended, 707, 
secs. 412, 422, 62 Stat. 464, 598, sec. 433, 64 Stat. 444, as amended, 
sec. 308, 74 Stat. 364, sec. 444, 76 Stat. 1073, sec. 3, 77 Stat. 394, 
secs. 394, 395, 79 Stat. 1062; 42 U.S.C. 241, 282, 287a, 288a, 289c, 
242f, 289g, 1857b, 280b-4, 280b-5.

    Source: 31 FR 12096, Sept. 16, 1966, unless otherwise noted.



Sec. 61.1  Definitions.

    As used in this part:
    (a) Continuation award is an award made by the Surgeon General, 
within the period of support recommended by a fellowship committee, 
without necessity for further action by the committee.
    (b) Noncitizen national means any person who, though not a citizen 
of the United States, owes permanent allegiance to the United States.
    (c) Regular fellowship means an award to support activity not 
requiring performance of services for the Public Health Service.
    (d) Surgeon General means the Surgeon General of the U.S. Public 
Health Service or his delegate.
    (e) Continental United States does not include Hawaii or Alaska.



Sec. 61.2  Applicability.

    The regulations in this subpart apply to the establishment, award, 
and operation of all regular fellowships awarded under the Public Health 
Service Act and the Clean Air Act.



Sec. 61.3  Purpose of regular fellowships.

    Regular fellowships are provided to encourage and promote:
    (a) Research and training for research relating to (1) the physical 
and mental diseases and impairments of man, (2) the organization, 
provision, and financing of health services, (3) the causes, prevention, 
and control of air pollution, and (4) medical library and related health 
sciences and communication of information.
    (b) Special scientific projects for the compilation of existing, or 
writing of original, contributions relating to scientific, social, or 
cultural advancements in sciences related to health.



Sec. 61.4  Establishment and conditions.

    All regular fellowships in the Public Health Service shall be 
established by the Surgeon General. In establishing a fellowship or 
series of fellowships, the Surgeon General shall prescribe in

[[Page 351]]

writing the conditions (in addition to those provided in the regulations 
in this part) under which the fellowships are to be awarded and held.



Sec. 61.5  Qualifications.

    In order to qualify for a regular fellowship, an applicant must:
    (a) Meet the Public Health Service requirements of general 
suitability, including professional and personal fitness.
    (b) Have been accepted by a public or other nonprofit institution 
for the purpose of the activity for which the fellowship is sought.
    (c) Be free from any disease or disability that would interfere with 
the accomplishment of the fellowship purpose.
    (d) If a citizen or noncitizen national of the United States, sign 
and file with the Surgeon General the following statement:

    I do solemnly swear (or affirm) that I bear true faith and 
allegiance to the United States of America and will support and defend 
the Constitution and laws of the United States against all its enemies, 
foreign and domestic.

    (e) Comply with such other requirements as may be prescribed by the 
Surgeon General.



Sec. 61.6  Method of application.

    Application for a regular fellowship shall be made on forms 
prescribed by the Surgeon General. In addition to the information 
supplied by the applicant in his application, such further information 
may be required as is necessary to determine his qualifications and 
fitness.



Sec. 61.7  Review of applications; committees; awards.

    The Surgeon General shall appoint one or more fellowship committees 
to examine the qualifications of applicants for fellowships and the 
merits of their proposals for research, training, or special scientific 
projects. A fellowship committee shall submit to the Surgeon General its 
recommendations concerning appointments. Awards of regular fellowships 
shall be made in writing by the Surgeon General.



Sec. 61.8  Benefits: Stipends; dependency allowances; travel allowances; 

vacation.

    Individuals awarded regular fellowships shall be entitled to such of 
the following benefits as are authorized for the particular series of 
fellowship:
    (a) Stipend.
    (b) Dependency allowances.
    (c) When authorized in advance, separate allowances for travel. Such 
allowances may not exceed amounts prescribed by the Surgeon General for
    (1) Travel to the place where the fellow is to be located during the 
fellowship term, and
    (2) Travel to return the fellow at the end of the fellowship term to 
his home or other place he left to carry out the fellowship, provided 
that (unless otherwise prescribed by the Surgeon General) such return 
travel is to or from a place outside the continental United States.

No allowances will be granted for shipping personal effects or household 
goods and no allowances will be granted for transporting dependents, 
except as authorized by the Surgeon General for travel undertaken by 
dependents (spouse and/or dependent children only) to or from a place 
outside the continental United States where the fellow is to be located 
during the fellowship term and for return from such place or except as 
otherwise prescribed by the Surgeon General for a particular series of 
fellowships.
    (d) Vacation. Stipends and allowances will not be increased, or be 
paid beyond the term of a fellowship, on account of vacation an 
individual might have been entitled to but did not take.



Sec. 61.9  Payments: Stipends; dependency allowances; travel allowances.

    Payments for stipends, dependency allowances, and the travel 
allowances specified in Sec. 61.8 may be made directly to the fellow or 
to the sponsoring institution for payment to the fellow.



Sec. 61.10  Benefits: Tuition and other expenses.

    The Surgeon General may authorize allowances for payment of 
expenses, in whole or in part, of tuition, fees, equipment, supplies, 
attendance at meetings required to carry out the purposes of

[[Page 352]]

the fellowship, or other expenses of the activities of the fellow.



Sec. 61.11  Payments: Tuition and other expenses.

    (a) Tuition and fees. Allowances for tuition and fees may be made to 
the fellow or sponsoring institution.
    (b) Other expenses; standard or maximum allowances. Any allowances 
for equipment, supplies, attendance at meetings, and other expenses 
shall, except as may otherwise be prescribed herein or by the Surgeon 
General, be paid to the sponsoring institution. The Surgeon General may 
establish a standard allowance or a maximum allowance for payment to the 
sponsoring institution for such expenses.
    (c) Attendance at meetings--fellows sponsored by Federal agencies. 
Allowances for expenses of attendance at meetings by fellows who are 
sponsored by Federal agencies may be paid directly to such fellows.
    (d) Installments. Payments to sponsoring institutions and to fellows 
under this section or under Sec. 61.9 may be made in advance or by way 
of reimbursement and, except as may otherwise be prescribed by the 
Surgeon General, in monthly installments.



Sec. 61.12  Accountability.

    Payments shall be subject to such requirements relating to 
accountability as may be specified by the Surgeon General.



Sec. 61.13  Duration and continuation.

    An award period may be any period not in excess of 2 years. The 
Surgeon General may make one or more continuation awards for an 
additional period upon a finding of satisfactory progress toward 
accomplishment of the purposes of the initial fellowship award. 
Additional support may be provided on appropriate justification after 
expiration of the period of support involved in the previous award.



Sec. 61.14  Separate consideration of information concerning moral character 

or loyalty.

    No information in the records or possession of the Public Health 
Service concerning the moral character or loyalty of a fellow will be 
made available to any fellowship committee involved in recommending 
appointments of fellows.



Sec. 61.15  Moral character or loyalty; reference to Special Review Committee; 

review and recommendation.

    (a) Moral character or loyalty; reference to Special Review 
Committee. Whenever the Surgeon General has substantial evidence with 
respect to any fellow (1) that the statement filed pursuant to Sec. 
61.5(d) was not made in good faith; or (2) that a fellow has (i) been 
convicted of a crime involving moral turpitude or (ii) engaged in 
conduct involving moral turpitude (unless in the case of either 
paragraph (a)(2) (i) or (ii) of this section, it is established that the 
fellow is, nevertheless, then a person of good moral character), the 
Surgeon General shall refer the pertinent records to a Special Review 
Committee established as prescribed in paragraph (b) of this section.
    (b) Special Review Committee; composition. The Special Review 
Committee shall be composed of a representative of the Office of the 
Surgeon General designated by the Surgeon General as chairman but 
nonvoting member, the appropriate Associate Director or comparable 
official of the bureau involved, the Chief of the Division of Research 
Grants, the Director of the Institute or the Chief of the Division which 
awarded the fellowship in question, or their delegates, and two 
additional members appointed by the Surgeon General.
    (c) Information; supplementation. The Committee may supplement the 
information referred to it by such correspondence, personal interviews, 
or other informal methods as necessary in order to make its 
recommendation as provided in paragraph (d) of this section.
    (d) Review and recommendation. The Committee shall review the 
pertinent records, determine whether there is substantial reason to 
believe that the award should be terminated or not continued either on 
grounds relating to moral character or on the ground that the statement 
filed pursuant to Sec. 61.5(d) was not made in good faith, and make its 
recommendation to the Surgeon

[[Page 353]]

General in writing, with reasons therefor, accordingly.



Sec. 61.16  Termination of or refusal to continue award on grounds relating to 

moral character or loyalty; hearing.

    If, after review of the recommendation of the Special Review 
Committee, the Surgeon General believes that the award should be 
terminated or should not be continued, he shall notify the fellow and 
sponsoring institution in writing that unless a request for a hearing is 
made by the fellow within 20 days after the fellow's receipt of such 
notice, his fellowship will be terminated or his application for 
continuation of the award denied. A copy of the regulations under this 
subpart and a copy of part 10 of title 45, Code of Federal Regulations, 
shall be enclosed with the notice. The notice shall set forth, as 
specifically as security permits, the grounds for the questions 
pertaining to moral character or loyalty. Any such request for a hearing 
shall be promptly submitted by the Surgeon General to the Chairman of 
the Departmental Fellowship Review Panel for handling in accordance with 
such part 10.



Sec. 61.17  Termination on grounds other than those relating to moral 

character or loyalty.

    The Surgeon General may terminate a fellowship upon receipt from the 
fellow of a written request for termination. The Surgeon General shall 
terminate any fellowship prior to the date it would otherwise expire if 
he determines that the fellow's performance is unsatisfactory or that 
the fellow or the sponsoring institution is unfit or unable to carry out 
the purpose of the fellowship. The fellow and the sponsoring institution 
shall be notified in writing of such termination.



Sec. 61.18  Publications.

    Publication, distribution, and disposition of all manuscripts and 
other materials resulting from a fellowship awarded hereunder shall be 
subject to the conditions that all such materials shall bear appropriate 
acknowledgment of Public Health Service support, that fellows shall 
furnish copies of such publications or other materials as may be 
requested by the Surgeon General, and to such other conditions as the 
Surgeon General may prescribe.



Sec. 61.19  Copyright and reproduction.

    Where the work accomplished under a fellowship award results in a 
book or other copyrightable material, the author is free to copyright 
the work, but the Public Health Service reserves a royalty-free, 
nonexclusive, and irrevocable license to reproduce, publish, or 
otherwise use, and to authorize others to use, all copyrightable or 
copyrighted material resulting from the fellowship award.



Sec. 61.20  Inventions or discoveries.

    Any fellowship award made hereunder is subject to the regulations of 
the Department of Health and Human Services set forth in title 45 CFR 
parts 6 and 8, as amended. Such regulations shall apply to any activity 
for which fellowship funds are in fact used, whether within the scope of 
the fellowship as approved or otherwise. Appropriate measures shall be 
taken by the fellow, the sponsoring institution, and the Surgeon General 
to assure that no contracts, assignments, or other arrangements 
inconsistent with the fellowship obligation are entered into or 
continued and that all personnel involved in the supported activity are 
aware of and comply with such obligation. Laboratory notes, related 
technical data and information pertaining to inventions or discoveries 
shall be maintained for such periods, and filed with or otherwise made 
available to the Surgeon General or those whom he may designate at such 
times and in such manner as he may determine necessary to comply with 
such Department regulations.



Sec. 61.21  Interest.

    Any interest earned through deposit or investment by the sponsoring 
institution of funds paid pursuant to the provisions of this subpart 
shall be paid to the United States as such interest is received by the 
sponsoring institution.



Sec. 61.22  Nondiscrimination.

    Attention is called to the fact that funds paid to a sponsoring 
institution

[[Page 354]]

pursuant to Sec. 61.11 in order to meet the expenses of the activities 
of a fellow are considered Federal financial assistance to such 
institution. The institution is thus subject in this respect to the 
prohibition against discrimination on the basis of race, color, or 
national origin imposed by title VI, Civil Rights Act of 1964, and the 
implementing Regulation of the Department of Health and Human Services 
(45 CFR part 80).



                      Subpart B_Service Fellowships

    Authority: 42 U.S.C. 209, 210, 216.

    Source: 31 FR 12098, Sept. 16, 1966, unless otherwise noted.



Sec. 61.30  Definitions.

    As used in this part:
    Continental United States does not include Hawaii or Alaska.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved may be delegated.
    Service Fellowship is one which requires the performance of 
services, either full or part time, for the Public Health Service.

[63 FR 9950, Feb. 27, 1998]



Sec. 61.31  Applicability.

    The regulations in this part apply to the establishment of service 
fellowships in the Public Health Service, the designation of persons to 
receive such fellowships, and the appointment of service fellows under 
authority of section 207(g) of the Public Health Service Act.



Sec. 61.32  Purpose of service fellowships.

    Service fellowships in the Public Health Service are for the purpose 
of encouraging and promoting research, studies, and investigations 
related to health. Such fellowships may be provided to secure the 
services of talented scientists for a period of limited duration for 
health-related research, studies, and investigations where the nature of 
the work or the character of the individual's services render customary 
employing methods impracticable or less effective.



Sec. 61.33  Establishment of service fellowships.

    All service fellowships shall be established by the Secretary. In 
establishing a service fellowship, or a series of service fellowships, 
the Secretary shall prescribe in writing the conditions (in addition to 
those provided in the regulations in this part) under which service 
fellows will be appointed and will hold their fellowships.

[63 FR 9950, Feb. 27, 1998]



Sec. 61.34  Qualifications.

    Scholastic and other qualifications shall be prescribed by the 
Secretary for each service fellowship, or series of service fellowships. 
Each individual appointed to a service fellowship shall:
    (a) Have presented satisfactory evidence of general suitability, 
including professional and personal fitness; and
    (b) Possess any other qualifications as reasonably may be 
prescribed.

[63 FR 9950, Feb. 27, 1998]



Sec. 61.35  Method of application.

    Application for a service fellowship shall be made in accordance 
with procedures established by the Secretary.

[63 FR 9950, Feb. 27, 1998]



Sec. 61.36  Selection and appointment of service fellows.

    The Secretary shall:
    (a) Prescribe a suitable professional and personal fitness review 
and an examination of the applicant's qualifications;
    (b) Designate in writing persons to receive service fellowships; and
    (c) Establish procedures for the appointment of service fellows.

[63 FR 9950, Feb. 27, 1998]



Sec. 61.37  Stipends, allowances, and benefits.

    (a) Stipends. Service fellows shall be entitled to such stipend as 
is authorized by the Secretary for each service fellowship or series of 
service fellowships.
    (b) Travel and transportation allowances. Under conditions 
prescribed by the Secretary, an individual appointed as a service fellow 
may be authorized

[[Page 355]]

personal travel allowances or transportation and per diem, travel 
allowances or transportation for his or her immediate family, and 
transportation of household goods and personal effects, in conjunction 
with travel authorized by the Secretary.
    (1) From place of residence, within or outside the continental 
United States, to first duty station,
    (2) For any change of duty station ordered by the Service during the 
term of the fellowship, and
    (3) From last duty station to the place of residence which he left 
to accept the fellowship, or to some other place at no greater cost to 
the Government.
    (4) A service fellow shall be entitled to travel allowances or 
transportation and per diem while traveling on official business away 
from his or her permanent duty station during the term of the 
fellowship. Except as otherwise provided herein, a service fellow shall 
be entitled to travel and transportation allowances authorized in this 
part at the same rates as may be authorized by law and regulations for 
other civilian employees of the Public Health Service. If a service 
fellow dies during the term of a fellowship, and the place of residence 
that was left by the service fellow to accept the fellowship was outside 
the continental United States, the payment of expenses of preparing the 
remains for burial and transporting them to the place of residence for 
interment may be authorized. In the case of deceased service fellows 
whose place of residence was within the continental United States, 
payment of the expenses of preparing the remains and transporting them 
to the place of residence for interment may be authorized as provided 
for other civilian employees of the Public Health Service.
    (c) Benefits. In addition to other benefits provided herein, service 
fellows shall be entitled to benefits as provided by law or regulation 
for other civilian employees of the Public Health Service.
    (d) Training. Service fellows are eligible for training at 
Government expense on the same basis as other civilian employees.

[31 FR 12098, Sept. 16, 1966, as amended at 63 FR 9950, Feb. 27, 1998]



Sec. 61.38  Duration of service fellowships.

    Initial appointments to service fellowships may be made for varying 
periods not in excess of 5 years. Such an appointment may be extended 
for varying periods not in excess of 5 years for each period in 
accordance with procedures and requirements established by the 
Secretary.

[63 FR 9951, Feb. 27, 1998]



PART 62_NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP AND LOAN REPAYMENT 

PROGRAMS--Table of Contents




       Subpart A_National Health Service Corps Scholarship Program

Sec.
62.1 What is the scope and purpose of the National Health Service Corps 
          scholarship program?
62.2 Definitions.
62.3 Who is eligible to apply for a scholarship program award?
62.4 To whom will scholarship program awards be available in addition to 
          those individuals pursuing courses of study leading to degrees 
          in medicine, osteopathy or dentistry?
62.5 How is application made for a scholarship program award?
62.6 How will individuals be selected to participate in the scholarship 
          program?
62.7 What will an individual be awarded for participating in the 
          scholarship program?
62.8 What does an individual have to do in return for the scholarship 
          program award?
62.9 Under what circumstances can the period of obligated service be 
          deferred to complete approved graduate training?
62.10 What will happen if an individual does not comply with the terms 
          and conditions of participating in the scholarship program?
62.11 When can a scholarship program payment obligation be discharged in 
          bankruptcy?
62.12 Under what circumstances can the service or payment obligation be 
          canceled, waived or suspended?
62.13 What are the limitations on the receipt of concurrent benefits?
62.14 What are the special provisions relating to recipients of awards 
          under the PH/NHSC scholarship training program who will also 
          receive awards under the scholarship program?

[[Page 356]]

     Subpart B_National Health Service Corps Loan Repayment Program

62.21 What is the scope and purpose of the National Health Service Corps 
          Loan Repayment Program?
62.22 Definitions.
62.23 How will individuals be selected to participate in the Loan 
          Repayment Program?
62.24 Who is eligible to apply for the Loan Repayment Program?
62.25 What does the Loan Repayment Program provide?
62.26 What does an individual have to do in return for loan repayments 
          received under the Loan Repayment Program?
62.27 What will happen if an individual does not comply with the terms 
          and conditions of participation in the Loan Repayment Program?
62.28 Under what circumstances can the service or payment obligation be 
          canceled, waived or suspended?
62.29 Under what circumstances can the Loan Repayment Program obligation 
          be discharged in bankruptcy?
62.30 What other regulations and statutes apply?

           Subpart C_Grants for State Loan Repayment Programs

62.51 What is the scope and purpose of the State Loan Repayment Program?
62.52 Definitions.
62.53 Who is eligible for this program?
62.54 What must applications for the State Loan Repayment Program 
          contain?
62.55 What State Program Elements are required to ensure similarity with 
          the NHSC Loan Repayment Program?
62.56 How are the Federal grant funds and State matching funds to be 
          used under this program?
62.57 How will States be selected to participate in this program?
62.58 What other regulations apply?

                   Subpart D_Special Repayment Program

62.71 What is the scope and purpose of the Special Repayment Program?
62.72 Definitions.
62.73 What are the procedures for participation in the Special Repayment 
          Program?
62.74 How much credit will a Program participant receive for monetary 
          repayments made, or approved service performed, before 
          beginning service under the Special Repayment Program?
62.75 Will individuals serving under the Special Repayment Program 
          receive credit for partial service?
62.76 How will amounts of money due under the option under section 
          204(c)(1) of Public Law 100-177 be required to be repaid?

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 751 of the Public Health 
Service Act, 90 Stat. 2281 (42 U.S.C. 294t), unless otherwise noted.

    Source: 45 FR 55429, Aug. 20, 1980, unless otherwise noted.



       Subpart A_National Health Service Corps Scholarship Program



Sec. 62.1  What is the scope and purpose of the National Health Service Corps 

scholarship program?

    These regulations apply to the award of scholarships under the 
National Health Service Corps Scholarship Program authorized by section 
751 of the Public Health Service Act (42 U.S.C. 294t) to students 
receiving academic training in medicine, osteopathy, dentistry, and 
other health professions. The purpose of this program is to assure an 
adequate supply of trained health professionals for the National Health 
Service Corps which is used by the Secretary to improve the delivery of 
health services in health manpower shortage areas.



Sec. 62.2  Definitions.

    As used in this part:
    Acceptable level of academic standing means the level at which a 
full-time student retains eligibility to continue in attendance in 
school under the school's standards and practices.
    Act means the Public Health Service Act, as amended.
    Approved graduate training means those programs of graduate training 
in medicine, osteopathy, dentistry or other health professions which (a) 
lead to eligibility for board certification or which provide other 
evidence of completion, and (b) have been approved by the appropriate 
health professions body as determined by the Secretary.
    Full-time student means an individual pursuing a course of study 
leading to a degree in medicine, osteopathy, dentistry or an equivalent 
credential for a particular health profession who is enrolled for a 
sufficient number of credit hours in any academic term to complete the 
course of study within not more than the number of academic terms 
normally required at the school.

[[Page 357]]

If an individual is enrolled in a school and is pursuing a course of 
study which is designed to be completed in more than 4 years, the 
individual will be considered a full-time student for only the last 4 
years of the course of study.
    Health manpower shortage area means the geographic area, the 
population group, the public or nonprofit private medical facility, or 
other public facility which has been determined by the Secretary to have 
a shortage of health manpower under section 332 of the Act and its 
implementing regulations (42 CFR part 5).
    National of the United States means a citizen of the United States 
or a person who, though not a citizen of the United States, owes 
permanent allegiance to the United States.
    Public Health and National Health Service Corps Scholarship Training 
Program, or PH/NHSC Scholarship Training Program, means the program 
authorized by section 225 of the Act as in effect on September 30, 1977, 
and repealed on October 1, 1977.
    Scholarship Program means the National Health Service Corps 
Scholarship Program authorized by section 751 of the Act (42 U.S.C. 
294t).
    Scholarship Program participant or participant means an individual 
whose application to the Scholarship Program has been approved and whose 
contract has been accepted and signed by the Secretary.
    School means a school of medicine, osteopathy, dentistry, or other 
health profession which (a) provides training leading to a degree of 
doctor of medicine, doctor of osteopathy, doctor of dentistry, or an 
equivalent credential for a particular health profession, and (b) which 
is accredited by a body or bodies recognized for accreditation purposes 
by the Secretary of Education.
    School year means all or part of the 12-month period from July 1 
through June 30 during which an applicant is enrolled in a school as a 
full-time student.
    Service means the United States Public Health Service.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    State means one of the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin 
Islands, Guam, American Samoa, and the Trust Territory of the Pacific 
Islands.



Sec. 62.3  Who is eligible to apply for a scholarship program award?

    (a) To be eligible for a scholarship under this part an applicant 
must:
    (1) Be accepted for enrollment, or be enrolled, as a full-time 
student in a school located in a State;
    (2) Be pursuing a course of study or program offered by the school 
leading to a degree in medicine, osteopathy, dentistry, or an equivalent 
credential for a particular health profession;
    (3) Be eligible for, or hold, an appointment as a commissioned 
officer in the Regular or Reserve Corps of the Service or be eligible 
for selection for civilian service in the National Health Service Corps;
    (4) Be a National of the United States; and
    (5) Submit an application to participate in the Scholarship Program 
together with a signed contract as described in section 751(f) of the 
Act.
    (b) Any applicant who owes an obligation for professional practice 
to a State or other entity under an agreement entered into before filing 
an application under this part is ineligible for an award unless a 
written statement satisfactory to the Secretary is submitted from the 
State or entity that (1) there is no potential conflict in fulfilling 
the service obligation to the State or entity and the Scholarship 
Program, and that (2) the Scholarship Program service obligation will be 
served before the service obligation for professional practice owed to 
the State or entity.
    (c) Any individual who receives a scholarship under the Indian 
Health Service Scholarship Program (section 757 of the Act) or the 
Scholarship Program for First-Year Students of Exceptional Financial 
Need (section 758 of the Act) is ineligible to participate in the 
Scholarship Program during the

[[Page 358]]

School year(s) for which the scholarships under sections 757 or 758 of 
the Act were awarded.



Sec. 62.4  To whom will scholarship program awards be available in addition to 

those individuals pursuing courses of study leading to degrees in medicine, 

osteopathy, or dentistry?

    The Secretary will, from time-to-time, publish in the Federal 
Register a list of those health professions in addition to medicine, 
osteopathy, and dentistry for which the National Health Service Corps 
has need and for which support is available. The Secretary will also 
publish any other eligibility criteria, in addition to those in Sec. 
62.3, that may be required to assure that participants can be utilized 
during their periods of obligated service in a manner that will best 
meet the needs of the National Health Service Corps.



Sec. 62.5  How is application made for a scholarship program award?

    Each individual desiring a scholarship under this part must submit 
an application (including a signed contract as required under section 
751(f) of the Act) in the form and at the time prescribed by the 
Secretary.



Sec. 62.6  How will individuals be selected to participate in the scholarship 

program?

    (a) General. In deciding which applications for participation in the 
Scholarship Program will be approved, the Secretary will place the 
applications into categories based upon the selection priorities 
described in paragraph (b) of this section. Except for continuation 
awards (see paragraph (e) of this section) the Secretary will then 
evaluate each applicant under paragraph (c) of this section.
    (b) Priorities. (1) First priority will be given to individuals who 
have previously received a scholarship under the PH/NHSC Scholarship 
Training Program, a scholarship under this Scholarship Program, or a 
scholarship under section 758 of the Act, authorizing scholarships for 
first-year students of exceptional financial need. (2) Second priority 
will be given to applicants who are entering their first year of study.
    (c) Selection. (1) In selecting participants, the Secretary will 
take into consideration those factors which he or she determines 
necessary to assure effective participation in the Scholarship Program. 
These factors may include, but not be limited to (i) work experience, 
(ii) community background, (iii) career goals, (iv) faculty 
recommendation, and (v) academic performance.
    (2) Special consideration will be given to (i) medical and 
osteopathic students who indicate their intention to enter family 
practice, internal medicine, pediatrics, or osteopathic general practice 
residencies, (ii) dental students who indicate their intention to 
undertake general practice training following graduation or who plan no 
postgraduate training, and (iii) those individuals who indicate an 
intent to pursue other types of clinical practice or specialized 
training for which the National Health Service Corps has a particular 
need.
    (d) Duration of Scholarship award. Subject to the availability of 
funds for the Scholarship Program, the Secretary will award a 
participant a scholarship under this part for a period of 1 school year.
    (e) Continuation awards. Subject to the availability of funds for 
the Scholarship Program, the Secretary will award a continuation 
scholarship if (1) the participant requests a continuation, (2) the 
award will not extend the total period of Scholarship Program support 
beyond 4 years, and (3) the participant is eligible for continued 
participation in the Scholarship Program.



Sec. 62.7  What will an individual be awarded for participating in the 

scholarship program?

    (a) Amount of scholarship. (1) A scholarship award for each school 
year will consist of (i) tuition, (ii) reasonable educational expenses, 
including required fees, books, supplies, and required educational 
equipment, and (iii) a monthly stipend for the 12-month period beginning 
with the first month of each school year in which the individual is a 
participant. For purposes of this section ``required fees'' means those 
fees which are charged by the

[[Page 359]]

school to all students pursuing a similar curriculum and ``required 
educational equipment'' means educational equipment which must be rented 
or purchased by all students pursuing a similar curriculum at that 
school.
    (2) The Secretary may enter into a contract with the school in which 
the participant is enrolled for the direct payment of tuition and 
reasonable educational expenses in the participant's behalf.
    (b) Payment of scholarship: Leave-of-absence; repeated course work. 
The Secretary will suspend scholarship payments to or on behalf of a 
participant if the school (1) approves a leave-of-absence for the 
participant for health, personal, or other reasons, or (2) requires the 
participant to repeat course work for which the Secretary has previously 
made scholarship payments under Sec. 62.7. However, if the repeated 
course work does not delay the participant's graduation date, 
scholarship payments will continue except for any additional costs 
relating to the repeated course work. Any scholarship payments suspended 
under this paragraph will be resumed by the Secretary upon notification 
by the school that the participant has returned from the leave-of-
absence or has completed the repeated course work and is pursuing as a 
full-time student the course of study for which the scholarship was 
awarded.



Sec. 62.8  What does an individual have to do in return for the scholarship 

program award?

    (a) General. Except as provided in paragraphs (d), (f), and (g) of 
this section, each participant is obligated to (1) become a member of 
the National Health Service Corps employed as a Commissioned Officer in 
the Regular or Reserve Corps of the Service or as a Federal civilian in 
the full-time clinical practice of the participant's profession and (2) 
serve in the health manpower shortage area to which the participant is 
assigned by the National Health Service Corps.
    (b) Beginning of service. (1) The period of obligated service will 
begin when the Scholarship Program participant begins to provide 
services in the health manpower shortage area to which he or she is 
assigned by the Secretary. Except for those participants who receive a 
deferral under Sec. 62.9 (a) or (b), this assignment will be made by 
the Secretary as soon as possible following: (i) the completion of the 
participant's course of study leading to a degree in medicine, 
osteopathy, dentistry, or an equivalent credential for a particular 
health profession, and (ii) appointment of the participant as a 
Commissioned Officer in the Regular or Reserve Corps of the Service or 
as a civilian member of the National Health Service Corps.
    (2) For purposes of this paragraph, ``appointment'' means only those 
appointments as Commissioned Officers in the Regular or Reserve Corps of 
the Service or as civilian members of the National Health Service Corps 
made specifically for the purpose of serving a participant's period of 
obligated service.
    (c) Duration of service. Except as provided in Sec. 62.14(b)(1), 
the period for which the Scholarship Program participant is obligated to 
serve is equal to 1 year for each school year for which the participant 
receives a scholarship award under this part, or 2 years, whichever is 
greater.
    (d) Service by detail. If the Secretary determines that there is no 
need in a health manpower shortage area for a member of the profession 
in which the Scholarship Program participant is obligated to provide 
service, the Scholarship Program participant may be detailed to serve 
the period of obligated service as a full-time member of the profession 
for which the participant has been trained, in any unit of the 
Department of Health and Human Services as the Secretary may determine.
    (e) Creditability of approved graduate training. Except as provided 
in Sec. 62.14(b)(2), no period of approved graduate training will be 
credited toward satisfying the period of obligated service incurred 
under the Scholarship Program.
    (f) Service under the National Research Service Award Program. (1) A 
Scholarship Program participant who demonstrates exceptional promise for 
medical research may perform the period of obligated service owed under 
this section by participating in the National

[[Page 360]]

Research Service Award Program for individual postdoctoral fellows 
authorized under section 472 of the Act.
    (2) Exceptional promise for medical research will be demonstrated if 
the participant applies for a National Research Service Award for 
individual postdoctoral fellows, is selected to participate in this 
research program, and accepts the offer of participation. A Scholarship 
Program participant in the National Research Service Award Program will 
receive credit toward satisfying the period of obligated service 
incurred under this section for any period of time he or she is engaged 
in activities which meet the service requirements of the National 
Research Service Award Program.
    (3) If the time served under the National Research Service Award 
Program is less than the total period of obligated service owed under 
the Scholarship Program, the participant will serve the remainder of the 
Scholarship Program service obligation (i) in activities which meet the 
criteria for service under the National Research Service Award Program, 
as approved by the Secretary or (ii) as a member of the National Health 
Service Corps providing health services in the full-time clinical 
practice of his or her health profession. A participant who fails to 
begin or complete the service requirements under the National Research 
Service Award Program may be subject to the default penalty under Sec. 
62.10(c) of this part and the default penalties under the National 
Research Service Award Program.
    (g) Release from service obligation to engage in private practice. 
The Secretary will release a participant from all or part of the service 
obligation if the participant applies for a release under section 753 of 
the Act and agrees in writing to engage for a period equal to the 
remaining period of the participant's service obligation in the full-
time private clinical practice of the participant's health profession, 
under the requirements of section 753 of the Act.



Sec. 62.9  Under what circumstances can the period of obligated service be 

deferred to complete approved graduate training?

    (a) Requested deferment. Upon the request of any participant 
receiving a degree from a school of medicine, osteopathy, or dentistry, 
veterinary medicine, optometry, podiatry or pharmacy, the Secretary will 
defer the beginning date of the obligated service to allow the 
participant to complete an approved graduate training program. The 
period of this deferment may not exceed (1) three years for any 
participant receiving a degree from a school of medicine, osteopathy or 
dentistry, or (2) one year for any participant receiving a degree from a 
school of veterinary medicine, optometry, podiatry or pharmacy. The 
Secretary may, however, extend this period of deferment if the Secretary 
determines that the extension is consistent with the needs of the 
National Health Service Corps.
    (b) Required deferment. Each participant receiving a degree in 
medicine or osteopathy who does not intend to enter training which can 
be completed within the deferment period granted under paragraph (a) of 
this section must complete at least one year of approved graduate 
training before beginning the period of obligated service. This one year 
of training must be in (1) an allopathic flexible first-year program 
whose sponsorship includes approved residencies in family practice, 
internal medicine, pediatrics, or a categorical first-year program in 
family practice, internal medicine, or pediatrics; (2) a rotating 
internship in osteopathic medicine; or (3) such other programs as the 
Secretary determines provides comparable experience. Any participant 
receiving a degree in medicine or osteopathy who fails to complete the 
one year of required training or an approved graduate training program 
for which a deferment was granted under paragraph (a) of this section 
will be subject to the default penalties of Sec. 62.10(c).
    (c) Altering deferment. Before altering the length or type of 
approved graduate training for which the period of obligated service was 
deferred under paragraphs (a) or (b) of this section,

[[Page 361]]

the participant must request and obtain the Secretary's approval of the 
alteration.
    (d) Additional terms of deferment. The Secretary may prescribe 
additional terms and conditions for deferment under paragraphs (a), (b), 
and (c) of this section as necessary to carry out the purposes of the 
Scholarship Program.
    (e) Beginning of service after deferment. Any participant whose 
period of obligated service has been deferred under paragraphs (a) or 
(b) of this section must begin the obligated service when the 
participant begins to provide health services in the health manpower 
shortage area to which he or she is assigned by the Secretary. This 
assignment will be made by the Secretary as soon as possible following 
(1) the completion of the requested or required graduate training for 
which the deferment was granted, and (2) appointment as a Commissioned 
Officer in the Regular or Reserve Corps of the Service or as a civilian 
member of the National Health Service Corps.



Sec. 62.10  What will happen if an individual does not comply with the terms 

and conditions of participating in the scholarship program?

    (a) If a participant, other than one described in paragraph (b) of 
this section, fails to accept payment or instructs the school not to 
accept payment of the scholarship provided by the Secretary, the 
participant must, in addition to any service or other obligation 
incurred under the contract, pay to the United States the amount of 
$1,500 liquidated damages. Payment of this amount must be made within 30 
days of the date on which the participant fails to accept payment of the 
scholarship award or instructs the school not to accept payment.
    (b) When a participant fails to maintain an acceptable level of 
academic standing, is dismissed from the school for disciplinary 
reasons, or voluntarily terminates the course of study or program for 
which the scholarship was awarded before completing the course of study 
or program, the participant must, instead of performing any service 
obligation, pay to the United States an amount equal to all scholarship 
funds awarded under Sec. 62.7. Payment of this amount must be made 
within 3 years of the date the participant becomes liable to make 
payment under this paragraph.
    (c) If a participant fails to begin or complete the period of 
obligated service incurred under Sec. 62.8, including failing to comply 
with the applicable terms and conditions of a deferment granted by the 
Secretary, the participant must pay to the United States an amount 
determined by the formula set forth in section 754(c) of the Act. 
Payment of this amount shall be made within 1 year of the date that the 
participant failed to begin or complete the period of obligated service, 
as determined by the Secretary.



Sec. 62.11  When can a scholarship program payment obligation be discharged in 

bankruptcy?

    In accordance with section 754(d)(3) of the Act, any payment 
obligation incurred under Sec. 62.10 may not be discharged in 
bankruptcy under title XI of the United States Code until 5 years after 
the date on which the payment obligation is due.



Sec. 62.12  Under what circumstances can the service or payment obligation be 

canceled, waived or suspended?

    (a) Any obligation of a participant for service or payment will be 
canceled upon the death of the participant.
    (b)(1) A participation may seek a waiver or suspension of the 
service or payment obligations incurred under this part by written 
request to the Secretary setting forth the bases, circumstances, and 
causes which support the requested action. The Secretary may approve a 
request for a suspension for a period of 1 year. A renewal of this 
suspension may also be granted.
    (2) The Secretary may waive or suspend any service or payment 
obligation incurred by a participant whenever compliance by the 
participant (i) is impossible, or (ii) would involve extreme hardship to 
the participant and if enforcement of the service or payment obligation 
would be against equity and good conscience.
    (c) Compliance by a participant with a service or payment obligation 
will be considered impossible if the Secretary determines, on the basis 
of information

[[Page 362]]

and documentation as may be required, that the participant suffers from 
a physical or mental disability resulting in the permanent inability of 
the participant to perform the service or other activities which would 
be necessary to comply with the obligation.
    (d) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against equity and good conscience, the Secretary, on 
the basis of information and documentation as may be required, will 
consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as physical or mental disability, terminal illness in the 
immediate family which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to perform the obligation incurred.



Sec. 62.13  What are the limitations on the receipt of concurrent benefits?

    Under section 741(f) or 836(h) of the Act, the Secretary may agree 
to repay a portion of an individual's educational loans in return for 
the individual's agreement to practice his or her profession in an area 
in need of health manpower. However, a Scholarship Program participant 
may not enter into an agreement with the Secretary under section 741(f) 
or 836(h) of the Act, until either:
    (a) The participant has completed the service obligation under the 
Scholarship Program,
    (b) The Secretary has recovered from the participant an amount 
determined under Sec. 62.10, or
    (c) Any service or payment obligation has been waived under Sec. 
62.12.

In no case shall a scholarship received under these regulations be 
considered an educational loan for the purposes of section 741(f) or 
836(h) of the Act.



Sec. 62.14  What are the special provisions relating to recipients of awards 

under the PH/NHSC scholarship training program who will also receive awards 

under the scholarship program?

    (a) Except as provided in paragraph (b) of this section, if a 
participant has previously received an award under the PH/NHSC 
Scholarship Training Program and also receives an award under the 
Scholarship Program, the terms and conditions of these regulations will 
apply to the participant's entire obligation incurred under both the PH/
NHSC Scholarship Training Program and the Scholarship Program.
    (b) If a participant has received an award under the PH/NHSC 
Scholarship Training Program and also receives an award under the 
Scholarship Program, the following conditions apply:
    (1) Period of obligated service--carry over. The period of obligated 
service owed by the participant is equal to the total number of school 
years for which scholarship support was awarded under both the PH/NHSC 
Scholarship Training Program and the Scholarship Program without regard 
to either Program's minimum support requirement under 42 CFR 62.7(a) 
(1976) as adopted on May 22, 1974 (see 39 FR 17962), and under Sec. 
62.8(c) of this part.
    (2) Credit for internship and residency training. (i) If a 
participant received a scholarship under the PH/NHSC Scholarship 
Training Program for any school year beginning before October 12, 1976, 
the participant will receive credit toward satisfying the periods of 
obligated service incurred under the PH/NHSC Scholarship Training 
Program and under Sec. 62.8 of this part for any periods of internship 
or residency training served in a Service or National Health Service 
Corps facility.
    (ii) If a participant received a scholarship for the first time 
during the 1977-78 school year under the PH/NHSC Scholarship Training 
Program, the participant will only receive 1 year of credit toward 
satisfying the period of obligated service incurred under the PH/NHSC 
Scholarship Training Program for internship or residency training served 
in a Service or National Health Service Corps facility.

[[Page 363]]

    (3) Default penalties. The PH/NHSC Scholarship Training Program 
default penalty will apply to a participant who fails to begin or 
complete the active duty service obligation incurred under that Program, 
and the Sec. 62.10 default penalties will apply to a participant who 
fails to begin or complete the service obligation incurred under Sec. 
62.8 of these regulations. In determining which default penalty to apply 
when an individual who has received a Scholarship award under both the 
PH/NHSC Scholarship Training Program and the Scholarship Program fails 
to begin or complete his service obligation, the service obligations 
will be considered to have been served in the order in which they were 
incurred.



     Subpart B_National Health Service Corps Loan Repayment Program

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338B of the Public Health 
Service Act, 101 Stat. 992 (42 U.S.C. 2541-1).

    Source: 54 FR 13462, Apr. 3, 1989, unless otherwise noted.



Sec. 62.21  What is the scope and purpose of the National Health Service Corps 

Loan Repayment Program?

    The regulations of this subpart apply to the award of health 
professions educational loan payments under the National Health Service 
Corps Loan Repayment Program authorized by section 338B of the Public 
Health Service Act (42 U.S.C. 2541-1). The purpose of the Program is to 
assure an adequate supply of trained health professionals for the 
National Health Service Corps. These professionals will be assigned by 
the Secretary to provide necessary health services to persons living in 
designated health manpower shortage areas.



Sec. 62.22  Definitions.

    The definitions in Sec. 62.2 of this part will apply for the 
purpose of this subpart, except for the definition of approved graduate 
training. The following definitions will also apply for purposes of this 
subpart:
    Approved graduate training means a program of graduate training in 
allopathic or osteopathic medicine, dentistry or other health profession 
which (a) leads to eligibility for board certification or which provides 
other evidence of completion, (b) has been approved by the appropriate 
health professions body as determined by the Secretary and (c) is in the 
specialty or type of training specified by the Program participant in 
the Loan Repayment Program Contract or, at the Program participant's 
request and at the Secretary's option, is in a specialty or area of 
training determined by the Secretary to be consistent with the needs of 
the National Health Service Corps.
    Commercial loans means loans made by banks, credit unions, savings 
and loan associations, insurance companies, schools, and other financial 
or credit institutions which are subject to examination and supervision 
in their capacity as lenders by an agency of the United States or of the 
State in which the lender has its principal place of business.
    Educational expenses means the costs of the health professions 
education, exclusive of the tuition, such as fees, books, supplies, and 
educational equipment and materials.
    Government loans means loans which are made by Federal, State, 
county or city agencies which are authorized by law to make such loans.
    Living expenses means the costs of room and board, transportation 
and commuting costs and other costs incurred during an individual's 
attendance at a health professions school.
    Loan Repayment Program means the National Health Service Corps Loan 
Repayment Program authorized by section 338B of the Act (42 U.S.C. 2541-
1).
    Loan Repayment Program Contract means the agreement, which is signed 
by an applicant and the Secretary, for the Loan Repayment Program 
wherein the applicant agrees to accept repayment of health professions 
educational loans and to serve in accordance with the provisions of 
section 338B of the Act and this subpart for a prescribed period of 
obligated service.
    Medically underserved area means health manpower shortage area as 
defined in Sec. 62.2.

[[Page 364]]

    Program participant means an individual whose application to the 
Loan Repayment Program has been approved and whose contract has been 
accepted and signed by the Secretary.
    Qualifying loans means government and commercial loans for actual 
costs paid for tuition, reasonable educational expenses, and reasonable 
living expenses relating to the obtainment of a degree in allopathic or 
osteopathic medicine, dentistry, or other health profession. Such loans 
must have documentation which is contemporaneous with the training 
received in a health professions school. If health professions 
educational loans are refinanced, the original documentation of the 
loan(s) will be required to be submitted to the Secretary to establish 
the contemporaneous nature of such loans.
    Reasonable educational and living expenses means those educational 
and living expenses which are equal to or less than the sum of the 
school's estimated standard student budgets for educational and living 
expenses for the degree program and for the year(s) during which the 
Program participant is/was enrolled in the school. However, if the 
school attended by the Program participant does/did not have a standard 
student budget or if a Program participant requests repayment for 
educational and living expenses which are in excess of the standard 
student budgets described in the preceding sentence, the Program 
participant must submit documentation, as required by the Secretary, to 
substantiate the reasonableness of all educational and living expenses 
incurred by the Program participant. To the extent that the Secretary 
determines, upon review of the Program participant's documentation, that 
all or a portion of the educational and living expenses are reasonable, 
these expenses will qualify for repayment.



Sec. 62.23  How will individuals be selected to participate in the Loan 

Repayment Program?

    (a) In determining which applications from eligible individuals for 
participation in the Loan Repayment Program will be accepted for 
consideration, the Secretary will apply the following criteria:
    (1) The extent to which an individual's training is in a health 
profession or specialty determined by the Secretary to be needed by the 
National Health Service Corps;
    (2) The individual's commitment to serve in medically underserved 
areas;
    (3) The availability of the individual for service, with highest 
consideration being given to individuals who will be available for 
service at the earliest dates;
    (4) The length of the individual's proposed service obligation, with 
greatest consideration being given to persons who agree to serve for 
longer periods of time; and
    (5) The individual's academic standing, prior professional 
experience in a health manpower shortage area, board certification, 
residency achievements, peer recommendations, depth of past residency 
practice experience and other criteria related to professional 
competence or conduct.
    (b) Among qualified applicants, the Secretary will give priority to 
applications from individuals whose health professions or specialties 
are most needed by the NHSC and who are, in the Secretary's judgement, 
most committed to practice in medically underserved areas.
    (c) By notice published in the Federal Register from time to time, 
the Secretary will specify the professions and specialties most needed 
by the National Health Service Corps.



Sec. 62.24  Who is eligible to apply for the Loan Repayment Program?

    (a) To be eligible to participate in the Loan Repayment Program an 
individual must:
    (1)(i) Be enrolled as a full-time student in the final year of a 
course of study or program approved by the Secretary which leads to a 
degree in allopathic or osteopathic medicine, dentistry or other health 
profession and which is offered by an accredited school in a State or
    (ii) Be enrolled in an approved graduate training program in 
allopathic or osteopathic medicine or dentistry or other health 
profession in a State, or
    (iii) Have a degree in allopathic or osteopathic medicine or 
dentistry or

[[Page 365]]

other health profession and have completed an approved graduate training 
program in a State (or received a waiver of the completion requirement 
under Sec. 62.26(d) of this subpart) and have a current and valid 
license to practice such health profession in a State;
    (2) Be eligible for, or hold, an appointment as a commissioned 
officer in the Regular or Reserve Corps of the Public Health Service or 
be eligible for selection for civilian service in the National Health 
Service Corps;
    (3) Submit an application to participate in the Loan Repayment 
Program; and
    (4) Sign and submit to the Secretary, at the time of the submission 
of such application, a written contract agreeing to accept repayment of 
health professions educational loans and to serve (in accordance with 
this subpart) for the applicable period of obligated service in a health 
manpower shortage area as determined by the Secretary.
    (b) Any individual who owes an obligation for health professional 
service to the Federal Government or a State or other entity under an 
agreement with such Federal, State or other entity is ineligible for the 
Loan Repayment Program unless such obligation will be completely 
satisfied prior to the beginning of service under this Program.
    (c) Individuals in breach of a written contract entered into under 
section 338A of the Act and liable to the United States under section 
338E(b) of the Act, in breach of a written contract entered into under 
section 225 of the Act (as in effect on September 30, 1977) and liable 
to the United States under section 225(f)(1) of the Act (as in effect on 
September 30, 1977) or in breach of any other obligation for health 
professional service to a Federal, State or local government entity are 
not eligible for participation in the Loan Repayment Program.

(Approved by the Office of Management and Budget under control number 
0915-0127)



Sec. 62.25  What does the Loan Repayment Program provide?

    (a) Loan repayment. For each year of service the individual agrees 
to serve, with a minimum of 2 years of obligated service, the Secretary 
may pay:
    (1) Except as provided in paragraph (a)(2) of this section, up to 
$20,000 per year of a Program participant's qualifying loans or
    (2) Up to $25,000 per year for a Program participant's qualifying 
loans if the Program participant agrees to provide obligated service in 
the Indian Health Service or a health facility or program operated by a 
tribe or tribal organization under the Indian Self-Determination Act.

The Secretary may establish different levels of annual loan repayment to 
encourage Program participants to serve in a manner which is in the best 
interest of the Loan Repayment Program. No loan repayments will be made 
for any professional practice performed prior to the effective date of 
the Loan Repayment Program Contract. Once a loan repayment contract has 
been signed by both parties, the Secretary will obligate such funds as 
will be necessary to ensure that sufficient funds will be available to 
make loan repayments for the duration of the period of obligated 
service.
    (b) Site visit. The Secretary may reimburse an individual for the 
actual and reasonable travel expenses associated with one trip from the 
individual's residence to a site for the purpose of evaluating such site 
for service under the Loan Repayment Program.
    (c) Tax liability payments. The Secretary may, upon a Program 
participant's written request, make payments in a reasonable amount, as 
determined by the Secretary, to reimburse the Program participant for 
all or part of the increased Federal, State and local tax liability 
resulting from loan repayments received under the Loan Repayment 
Program. To maximize the Federal resources available for placing 
participants in HMSAs, supplementary payments for increased tax 
liability will only be made under unusual circumstances, and in no cases 
will these tax liability payments exceed 20% of the annual amounts of 
the loans being repaid. Program participants wishing to receive tax 
liability payments must submit their requests for such payments in a 
manner prescribed by the Secretary and must provide the Secretary with 
any documentation the Secretary determines is necessary to

[[Page 366]]

establish a Program participant's increased tax liability. The Secretary 
will determine, based on the availability of funds and such other 
factors as the Secretary determines, the amounts of any such payments 
that may be made.

(Information collection requirements contained in paragraph (c) were 
approved by the Office of Management and Budget under control number 
0915-0131)

[54 FR 13462, Apr. 3, 1989, as amended at 57 FR 56996, Dec. 2, 1992]



Sec. 62.26  What does an individual have to do in return for loan repayments 

received under the Loan Repayment Program?

    (a) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec. 62.24(a)(1)(i) of this subpart must maintain 
full-time enrollment, at an acceptable level of academic standing, in 
that course of study until its completion. Upon completion of that 
course of study, a Program participant who received a degree in 
allopathic or osteopathic medicine must enter approved graduate training 
and a Program participant who received a degree in a health profession 
other than allopathic or osteopathic medicine may enter approved 
graduate training. Once a Program participant enters approved graduate 
training, he or she must also meet the requirements set forth in 
paragraphs (b) (1), (2), (3), and (4) of this section. If a Program 
participant who received a degree in a health profession other than 
allopathic or osteopathic medicine does not enter approved graduate 
training; service, in accordance with paragraph (e) of this section, 
must commence as soon as possible upon the Program participant's 
completion of the course of study leading to his or her health 
professions degree.
    (b) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec. 62.24(a)(1)(ii) of this subpart must: (1) 
Continue in his or her approved graduate training program at an 
acceptable level of academic standing; (2) provide the Secretary with 
annual documentation of continued participation in that approved 
graduate training program at an acceptable level of academic standing; 
(3) successfully complete that approved graduate training program; and 
(4) commence service, in accordance with paragraph (e) of this section, 
as soon as possible upon completion of approved graduate training.
    (c) A Program participant whose eligibility for the Loan Repayment 
Program is based on Sec. 62.24(a)(1)(iii) of this subpart must commence 
service, in accordance with paragraph (e) of this section, as soon as 
possible after the effective date of the Loan Repayment Program 
Contract.
    (d) If a Program participant fails to complete approved graduate 
training, the Secretary may, on his or her own initiative or at the 
Program participant's request, waive, for good cause, the completion 
requirement. Good cause will be deemed to exist if the Secretary 
determines that the Program participant has sufficient health 
professions training to be utilized by and make a substantial 
contribution to the National Health Service Corps. If waiver of the 
completion requirement in paragraph (b) of this section is granted; 
service, in accordance with paragraph (e) of this section, must commence 
as soon as possible after the granting of the waiver.
    (e) Except for Program participants who fail to complete their 
course of study leading to a health professions degree or who fail to 
complete approved graduate training and do not receive a waiver pursuant 
to paragraph (d) of this section, each program participant must:
    (1) Serve in a health manpower shortage area to which he or she is 
assigned by the Secretary as a member of the National Health Service 
Corps or serve pursuant to section 338D of the Act in a health manpower 
shortage area selected by the Secretary and
    (2) Accept employment in a full-time clinical practice of the 
Program participant's profession, as
    (i) A commissioned officer in the Regular or Reserve Corps of the 
Public Health Service,
    (ii) A civilian member of the National Health Service Corps who is 
an employee of the United States,
    (iii) A member of the National Health Service Corps who is not an 
employee of the United States, or

[[Page 367]]

    (iv) A private practitioner who is providing obligated service under 
the provisions of section 338D of the Act.
    (f) The minimum length of obligated service is two years, or such 
longer period as the Program participant may agree to. The maximum 
length of obligated service is four years. If a Program participant 
agrees to an original contract of two or three years, such contract may 
be extended, subject to the availability of appropriated funding, for 
one year or two years (up to the four-year maximum). A one-year 
extension will not reactivate the statutory minimum requirement of two 
years of service.

(Information collection requirements contained in paragraph (b)(2) were 
approved by the Office of Management and Budget under control number 
0915-0131)



Sec. 62.27  What will happen if an individual does not comply with the terms 

and conditions of participation in the Loan Repayment Program?

    Program participants who default on their Loan Repayment Program 
Contracts will be subject to the applicable monetary payment provisions 
set forth at section 338E of the Act. Payment of any amount owed under 
section 338E of the Act shall be made within one year of the date the 
participant breached his or her Loan Repayment Contract, as determined 
by the Secretary.



Sec. 62.28  Under what circumstances can the service or payment obligation be 

canceled, waived or suspended?

    A service or payment obligation under the Loan Repayment Program 
will be canceled or may be waived or suspended as provided in Sec. 
62.12 of this part of the regulations.



Sec. 62.29  Under what circumstances can the Loan Repayment Program obligation 

be discharged in bankruptcy?

    Any payment obligation incurred under Sec. 62.27 of this subpart 
may be released by a discharge in bankruptcy under title 11 of the 
United States Code only if such discharge is granted after the 
expiration of the five-year period beginning on the first date that 
payment was required, and only if the bankruptcy court finds that 
nondischarge of the obligation would be unconscionable.



Sec. 62.30  What other regulations and statutes apply?

    Other regulations and statutes which apply to this subpart include 
but are not limited to:

Debt Collection Act of 1982, Pub. L. 97-365 (5 U.S.C. 5514) including 
Section 4, Requirement that Applicant Furnish Taxpayer Identifying 
Number;
Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
Privacy Act of 1974 (5 U.S.C. 552a);
Section 215(a) of the Public Health Service Act, as amended (42 U.S.C. 
216(a)), for PHS commissioned officers, and 5 U.S.C. 3301 for civil 
service employees both of which authorize verification of an 
individual's suitability for employment;
Privacy Act of 1974; Alteration of System of Records, 52 FR 21622-21627, 
June 8, 1987, regarding the collection, maintenance and allowable use of 
personal information requested from program applicants.



           Subpart C_Grants for State Loan Repayment Programs

    Authority: Sec. 215 of the Public Health Service Act, 58 Stat. 690 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 338H of the Public Health 
Service Act, 101 Stat. 999 (42 U.S.C. 254q-1).

    Source: 54 FR 13464, Apr. 3, 1989, unless otherwise noted.



Sec. 62.51  What is the scope and purpose of the State Loan Repayment Program?

    The regulations of this subpart apply to the award of grants 
authorized by section 338H of the Public Health Service Act (42 U.S.C. 
254q-1) to support the establishment of State programs similar to the 
National Health Service Corps Loan Repayment Program authorized by 
section 338B of the Public Health Service Act (42 U.S.C. 2541-1). The 
purpose of this program is to improve the delivery of health services in 
medically underserved areas.



Sec. 62.52  Definitions.

    In addition to the definitions in Sec. 62.2 of this part, the 
following definitions will apply for purposes of this subpart:
    The definitions of Qualifying loans, Commercial loans, Government 
loans,

[[Page 368]]

Educational expenses, and Living expenses as contained in Sec. 62.22 of 
this part will apply for purposes of this subpart.
    Medically underserved area means health manpower shortage area or an 
area which has been designated by a State pursuant to standards 
described in Sec. 62.54(b)(1) of this subpart which the Secretary has 
deemed acceptable.
    State Loan Repayment Program or program means a State loan repayment 
program authorized under section 338H (42 U.S.C. 254q-1) of the Act.



Sec. 62.53  Who is eligible for this program?

    Any State is eligible to apply for a grant under this subpart.



Sec. 62.54  What must applications for the State Loan Repayment Program 

contain?

    (a) An application for a grant under this subpart shall be submitted 
to the Secretary at such time and in such form and manner as the 
Secretary requires.
    (b) The application shall contain a budget and narrative statement 
describing the manner in which the applicant intends to conduct the 
project and carry out the requirements of this subpart. In addition, 
applications must include:
    (1) A description of the State's standards for the designation of 
medically underserved areas, except that no description of designation 
standards will be required if the State elects to use health manpower 
shortage areas designated by the Secretary;
    (2) An assessment of the need and demand in medically underserved 
areas within the State for health professions manpower with special 
emphasis on individuals whose training is in a health profession or 
specialty identified by the Secretary pursuant to Sec. 62.23(b) of this 
part. This assessment should include such demographic indicators of the 
need as the economic accessibility of health care services in the State 
as measured by poverty levels, the percentage of the service area 
population without health insurance, and the health status of the 
population as measured by the rates of infant mortality, low birth 
weight, geographic barriers and other indicators;
    (3) A proposal for the placement of the health profession providers 
in medically underserved areas with the greatest need and demand in 
accordance with the need/demand assessment completed in compliance with 
paragraph (b)(2) of this section;
    (4) Adequate assurances that sufficient current year State funds are 
available to cover the non-Federal share of State Loan Repayment Program 
costs;
    (5) A description of how the program would meet the requirements of 
Sec. 62.55 to demonstrate its similarity to the NHSC Loan Repayment 
program;
    (6) A description of the source of, and plans for the use of, State 
matching funds;
    (7) A description of how the program would be coordinated with 
Federal, State and other organized activities within the State which 
relate to health manpower services and resources;
    (8) Identification of the State entity and key personnel who would 
administer the grant and a description of the qualifications and 
experience of that entity and its personnel concerning the State's 
health service delivery system and health manpower needs;
    (9) A description of the State's plans for administration of the 
State's Loan Repayment Program which may include such provisions as 
annual levels of loan repayment to be made under the program, the number 
of health professionals to be funded, the frequency and timing of the 
loan repayments, program incentives for longer periods of service, 
procedures for monitoring the service of program participants and 
placing professionals in default for failure to complete their service 
obligation, penalties for default, provisions for waivers and 
suspensions, and a description of the contract/obligation process to be 
used by the State to obligate individuals receiving State loan 
repayments;
    (10) A description of the State's need for Federal assistance in 
obtaining health professions resources and demonstrated inability to 
obtain such resources without Federal assistance;
    (11) A description of how the State will accord special 
consideration to

[[Page 369]]

medically underserved areas with large minority populations; and
    (12) The signature of an individual authorized to act for the State 
and to assume on behalf of the State the obligations imposed by the 
statute, the applicable regulations of this subpart and any additional 
conditions of the grant.

(Approved by the Office of Management and Budget under control number 
0915-0131)



Sec. 62.55  What State Program Elements are required to ensure similarity with 

the NHSC Loan Repayment Program?

    A State Loan Repayment Program supported under this subpart must:
    (a) Establish priorities for loan repayment applicants consistent 
with the provisions of Sec. 62.23 of this part;
    (b) Contract only with a person who is (1) enrolled as a full-time 
student in the final year of a course of study or program in an 
accredited school in a State leading to a degree in allopathic or 
osteopathic medicine, dentistry or other health profession, or (2) 
enrolled in an accredited graduate training program in a State in 
allopathic or osteopathic medicine or dentistry or other health 
profession, or (3) a practitioner licensed by a State who has completed 
training in an accredited graduate training program in allopathic or 
osteopathic medicine, dentistry or other health profession;
    (c) Provide that health professionals participating in a State Loan 
Repayment Program shall:
    (1) Serve for at least 2 years in a medically underserved area 
identified pursuant to Sec. 62.54(b)(3) of this subpart in the full-
time clinical practice of their profession,
    (2) Charge for his or her professional services at the usual and 
customary rate prevailing in the area in which such services are 
provided, except that if a person is unable to pay such charge, such 
person shall be charged at a reduced rate or not charged any fee,
    (3) In providing health services, not discriminate against any 
person on the basis of such person's ability to pay for such services or 
because payment for the health services provided to such person will be 
made under the insurance program established under part A or B of title 
XVIII of the Social Security Act or under a State plan for medical 
assistance approved under title XIX of such Act, and
    (4) Agree to accept an assignment under section 1842(b)(3)(B)(ii) of 
such Act for all services for which payment may be made under part B of 
title XVIII of such Act and enter into an appropriate agreement with the 
State agency which administers the State plan for medical assistance 
under title XIX of such Act to provide service to individuals entitled 
to medical assistance under the plan;
    (d) Repay qualifying loans for participating health professionals;
    (e) Provide that the loans of health professionals will be repaid on 
a periodic basis after the receipt of obligated services by such 
participant for such period; and



Sec. 62.56  How are the Federal grant funds and State matching funds to be 

used under this program?

    The Federal share of any program shall not exceed 75 percent of the 
cost of the approved State program. The Federal share must be used to 
repay the qualifying loans of health professionals. No portion of the 
Federal share shall be used to pay for administrative costs of any State 
Loan Repayment Program. The State's share of the program may be used to 
repay qualifying loans of health professionals or administrative costs 
of the State's Loan Repayment Program, or a combination of both. All 
program administrative costs are to be borne by the State. No portion of 
the State's share of the program shall consist of Federal funds.



Sec. 62.57  How will States be selected to participate in this program?

    Within the limits of funds available under section 338H of the Act, 
the Secretary may award grants to State applicants whose proposed Loan 
Repayment Programs will, in his or her judgment, best promote the 
purposes of section 338H of the Act, taking into account, among other 
pertinent factors:
    (a) The need of the State for health professions manpower;
    (b) The number and type of providers the State proposes to support 
through this program;

[[Page 370]]

    (c) The acceptableness of the State's standards for the designation 
of medically underserved areas and the appropriateness of the proposed 
placements of obligated providers;
    (d) The degree of similarity between the proposed State Loan 
Repayment Program and the National Health Service Corps Loan Repayment 
Program;
    (e) The adequacy of the qualifications, the administrative and 
managerial ability and the experience of the State staff to administer 
and carry out the proposed project;
    (f) The suitability of the applicant's approach and the degree to 
which the applicant's project is coordinated with Federal, State and 
other organized activities for meeting the State's health professions 
manpower needs and resources, including mechanisms for an ongoing 
evaluation of the program's activities;
    (g) The source and plans for use of the State match (including the 
percentage of the State's match that is proposed to be used for loan 
repayments), the degree to which the State match exceeds 25% or has 
increased over time, and the amount of the match relative to the needs 
and resources of the States; and
    (h) The extent to which special consideration will be extended to 
medically underserved areas with large minority populations.



Sec. 62.58  What other regulations apply?

    Other regulations which apply to this subpart include but are not 
limited to:

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 or benefiting from Federal financial assistance
45 CFR part 86--Nondiscrimination on the basis of sex in 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 50--Policies of general applicability: 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 92--Administrative Requirements for grants and cooperative 
agreements to State and local governments (effective October 1, 1988)



                   Subpart D_Special Repayment Program

    Authority: Sec. 215 of the Public Health Service Act 58 Stat. 690, 
as amended, 63 Stat. 35 (42 U.S.C. 216); sec. 204, Pub. L. 100-177, 101 
Stat. 1000.

    Source: 56 FR 56597, Nov. 6, 1991, unless otherwise noted.



Sec. 62.71  What is the scope and purpose of the Special Repayment Program?

    These regulations apply to the Special Repayment Program authorized 
under section 204 of Pub. L. 100-177, which provides a time-limited 
opportunity for persons who were, on November 1, 1987, in breach of a 
written contract under the Public Health and National Health Service 
Corps Scholarship Training Program or the National Health Service Corps 
Scholarship Program to satisfy their scholarship obligations through 
full-time clinical service. These regulations do not apply to any Public 
Health and National Health Service Corps Scholarship Training Program or 
National Health Service Corps Scholarship Program obligation which the 
Secretary has determined was completely satisfied through service or 
monetary payment prior to November 1, 1987. The purpose of this program 
is to supply trained health professionals for the National Health 
Service Corps, which is used by the Secretary to improve the delivery of 
health services in health manpower shortage areas.



Sec. 62.72  Definitions.

    In addition to the definitions in Sec. 62.2 of this part, the 
following definitions will apply for purposes of this subpart:
    Eligible defaulters means those individuals who, as of November 1, 
1987, were:
    (1) In breach of a written contract entered into under section 338A 
of the Act and liable to the United States

[[Page 371]]

under section 338E(b) of the Act and/or in breach of a written contract 
entered into under section 225 of the Act (as in effect on September 30, 
1977) and liable to the United States under section 225(f)(1) of the Act 
(as in effect on September 30, 1977); and
    (2) Not already serving their obligations on December 1, 1987, under 
a judgment, forbearance agreement, or other written agreement to serve.
    HPOL means the Health Manpower Shortage Area Placement Opportunity 
List described in section 204(b) of Pub. L. 100-177.
    Match means that the Secretary has received documentation of:
    (1) An offer of employment from a HPOL or SHPOL site which specifies 
at least the agreed upon salary and start date; and
    (2) The Program participant's acceptance of that offer. Provided, 
however, that if the Program participant would be self-employed, a match 
means that the Secretary has approved a program participant's private 
practice option application under section 338D(a) of the Act.
    Prior approved service means service performed prior to a Program 
participant's service start date under the Special Repayment Program:
    (1) As a member of the National Health Service Corps pursuant to an 
assignment by the Secretary under section 333 of the Act;
    (2) Under a written private practice option agreement signed by the 
Secretary pursuant to section 338D of the Act; or
    (3) In compliance with section 338C(e) of the Act.
    Program participant means an eligible defaulter whose contract under 
section 204 of Pub. L. 100-177 has been accepted and signed by the 
Secretary.
    Scholarship amount means the sum of any amounts paid to, or on the 
behalf of, a scholarship recipient under the PH/NHSC Scholarship 
Training Program and/or the Scholarship Program.
    SHPOL means the Supplemental Health Manpower Shortage Area Placement 
Opportunity List described in section 204(d) of Pub. L. 100-177.
    Special Repayment Program or Program means the program authorized by 
section 204 of Pub. L. 100-177.
    Total debt means the debt that would be owed by a Program 
participant under section 225(f)(1) of the Act, as in effect on 
September 30, 1977, and/or section 338E(b) of the Act, as if no payments 
had been made on the debt.



Sec. 62.73  What are the procedures for participation in the Special Repayment 

Program?

    (a) Notice of eligibility for participation in the program. On or 
before February 29, 1988, the Secretary will, subject to paragraph (h) 
of this section, send written notice to each eligible defaulter of the 
opportunity provided under this Program. The notice will be sent to the 
last known address of each eligible defaulter and will describe the 
special repayment options available under the Program.
    (b) Selection of repayment method. On or before May 29, 1988, 
eligible defaulters who wish to participate in this Program must sign 
and submit to the Secretary a written contract to provide service in 
accordance with either section 204(b) or section 204(c) of Pub. L. 100-
177. The election between section 204(b) and section 204(c) of Pub. L. 
100-177 is binding on the eligible defaulters.
    (c) Service sites. Program participants will receive a listing of 
approved sites appropriate to the service option they have selected. 
Program participants electing service under section 204(b) of Pub. L. 
100-177 will receive a HPOL. Program participants electing service under 
section 204(c) of Pub. L. 100-177 will receive a SHPOL. The HPOL or 
SHPOL sent to the Program participant will be specific to the Program 
participant's profession and his or her specialty training which is most 
needed by the National Health Service Corps. The Secretary is not 
required to identify placements for Program participants in a medical 
specialty for which the National Health service Corps has no need.
    (d) Time frames for matching and commencing service. If a program 
participant electing to serve under section 204(b) of Pub. L. 100-177 
chooses to serve at a remaining site on the 1988 HPOL, such participant 
must match to a site and must begin serving at the site by October 1, 
1988. If a Program

[[Page 372]]

participant electing to serve under section 204(b) of Pub. L. 100-177 
chooses to serve at a site on the 1989 HPOL, such participant must match 
to a HPOL site by February 15, 1989, and must begin service at the site 
by October 1, 1989. If a Program participant has elected to serve under 
section 204(c) of Pub. L. 100-177, such participant must match to a 
SHPOL site by May 15, 1989, and must begin service at that site by 
October 1, 1989.
    (e) Site visits. The Program participant is responsible for the 
costs of any site visit(s) and any other contact with the site to obtain 
employment at the site.
    (f) Effect of failure to meet established time frames. If a Program 
participant does not match to a site or begin service at that site 
within the time frames described in paragraph (d) of this section, the 
Secretary will determine that such individual is not relieved of his or 
her liability to the United States under the PH/NHSC Scholarship 
Training Program and/or Scholarship Program (including accrued interest 
and/or damages).
    (g) Service. Service must be performed in accordance with subpart II 
of part D of title III of the Act. Service credit will begin after a 
Program participant has matched to a HPOL or SHPOL site and has 
commenced service at that site in accordance with subpart II of part D 
of title III of the Act.
    (h) Secretary's exclusion authority. The Secretary is authorized, at 
any time, to deny or terminate an individual's participation in the 
Program for reasons related to the individual's professional competence 
or conduct.



Sec. 62.74  How much credit will a Program participant receive for monetary 

repayments made, or for approved service performed, before beginning service 

under the Special Repayment Program?

    (a) Prior approved service performed by a Program participant will 
be credited to the Program participant for the purpose of calculating 
the Program participant's remaining service obligation under this 
Program. Thus, the Program participant's remaining service obligation 
will be calculated by subtracting the number of days of the Program 
participant's prior approved service from the number of days of the 
Program participant's original service obligation under the PH/NHSC 
Scholarship Training Program and/or the Scholarship Program. If a 
Program participant has made monetary payments, his or her remaining 
service obligation will be reduced by converting the monetary payments 
into days of service credit as set forth in paragraph (b) or (c) of this 
section, whichever is applicable.
    (b) Program participants who elect to serve pursuant to section 
204(b) and section 204(c)(2) of Pub. L. 100-177, will not receive a 
refund of any amounts previously paid but will receive service credit 
for those payments as follows:
    (1) The number of days of service credit will be calculated by 
dividing the total amount paid by the Program participant prior to the 
Program participant's service start date by the total debt as of the 
service start date and multiplying the result of that division by the 
number of days of the participant's remaining service obligation (as 
determined by the formula set forth in the second sentence of paragraph 
(a) of this section).
    (2) If the Program participant defaults on a contract under this 
Program, prior monetary payments will not be credited to service but 
will be applied to the monetary debt owed by the Program participant.
    (c) Program participants who elect to serve under section 204(c)(1) 
of Pub. L. 100-177 must pay an amount equal to the scholarship amount. 
Any amounts paid by the Program participant prior to or after entry into 
the Program, in accordance with Sec. 62.76 of this subpart, will be 
used to reduce the Program participant's financial obligation incurred 
under section 204(c)(1) of Pub. L. 100-177. In some cases, the amounts 
paid before or after entry into the Program will exceed the scholarship 
amount. These payments in excess of the scholarship amount will be 
converted into days of service credit under the formula set forth in 
paragraph (b)(1) of this section. If a Program participant defaults on a 
contract under this option, the monies paid in excess of the scholarship 
amount will not be credited to service but will be credited toward the 
monetary debt owed by the

[[Page 373]]

Program participant under section 338E(b) of the Act or section 
225(f)(1) of the Act, as in effect on September 30, 1977. The 
scholarship amount paid upon entering this option will be forfeited.



Sec. 62.75  Will individuals serving under the Special Repayment Program 

receive credit for partial service?

    (a) With respect to obligations under the Scholarship Program, a 
credit will be allowed for partial service under the Special Repayment 
Program and will result in a reduction of the Program participant's 
financial obligation in accordance with the following formula:
[GRAPHIC] [TIFF OMITTED] TC13NO91.003

In which:

`A' is the amount the United States is entitled to recover;
`0' is the sum of the amounts paid to or on behalf of the Program 
participant under the Scholarship Program and the interest on such 
amounts which would be payable if, at the time the amounts were paid, 
they were loans bearing interest at the maximum legal prevailing rate, 
as determined by the Treasurer of the United States;
`t' is the sum of (1) the number of months of prior approved service 
plus (2) the number of months of the Program participant's period of 
obligated service under the Program including any additional months of 
service incurred pursuant to section 204(c)(2) of Pub. L. 100-177;
`s' is the number of months of prior approved service performed by the 
Program participant before commencing service under this Program; and
`r' is the number of months of service performed by the Program 
participant in compliance with this Program.

However, where a judgment has been entered against a Program 
participant, the formula will be revised such that:

`30' is the amount of the judgment representing the Program 
participant's liability under the Scholarship Program, including any 
accrued post judgment interest and excluding any monetary payments on 
the judgment which may have been made by the Program participant;
`t' is the sum of (1) the number of months of prior approved service 
performed by the Program participant after entry of the judgment but 
before commencing service under this Program plus (2) the number of 
months of the Program participant's period of obligated service under 
the Program including any additional months of service incurred pursuant 
to section 204(c)(2) of Pub. L. 100-177; and
`s' is the number of months of prior approved service performed by the 
Program participant after the entry of the judgment but before 
commencing service under this Program.

    (b) With respect to obligations under the PH/NHSC Scholarship 
Training Program, if a Program participant fails to complete the period 
of obligated service under the Program (including any additional months 
of service incurred pursuant to section 204(c)(1) of Pub. L. 100-177), 
no credit for partial service under this Program will be allowed.
    (c) Where participants have obligations under both the Scholarship 
Program and the PH/NHSC Scholarship Training Program, credit for service 
will be applied against the scholarship obligations in the order in 
which they were incurred.



Sec. 62.76  How will amounts of money due under the option under section 

204(c)(1) of Public Law 100-177 be required to be repaid?

    Program participants who elect to serve under section 204(c)(1) of 
Pub. L. 100-177 will be required to pay the full scholarship amount at 
least 60 days prior to the service start date specified in the 
documentation submitted to the Secretary.



PART 63_TRAINEESHIPS--Table of Contents




Sec.
63.1 To what programs do these regulations apply?
63.2 Definitions.
63.3 What is the purpose of traineeships?
63.4 What are the minimum qualifications for awards?
63.5 How will NIH make awards?
63.6 How to apply.
63.7 What are the benefits of awards?
63.8 What are the terms and conditions of awards?
63.9 How may NIH terminate awards?
63.10 Other HHS regulations and policies that apply.

    Authority: 42 U.S.C. 216, 282(b)(13), 284(b)(1)(C), 285a-2(b)(3), 
286b-3, 287c-21(a).

    Source: 60 FR 10719, Feb. 27, 1995, unless otherwise noted.

[[Page 374]]



Sec. 63.1  To what programs do these regulations apply?

    (a) The regulations in this part apply to research traineeships 
awarded by the Director, NIH, each director of a national research 
institute of NIH, the Director of the National Library of Medicine, and 
the Director of the National Center for Complementary and Alternative 
Medicine, or their designees, pursuant to sections 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, and 485(D)(a) of the Act, respectively.
    (b) The regulations of this part do not apply to research training 
under the National Research Service Award Program governed by 42 CFR 
part 66 or to the Mental Health Traineeship Program governed by 42 CFR 
part 64a.
    (c) Except as otherwise permitted under section 413(b)(3) of the 
Act, the regulations of this part do not apply to residency training of 
physicians or other health professionals.

[65 FR 66512, Nov. 6, 2000]



Sec. 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 402(b)(13), 
405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of the Act 
which authorize research training or traineeships.
    Awardee means an individual awarded a traineeship under sections 
402(b)(13), 405(b)(1)(C), 413(b)(3), 472, 485D(a), or other sections of 
the Act which authorize research training or traineeships.
    Director means the Director, NIH, the director of a national 
research institute of NIH, the Director of the National Library of 
Medicine, and the Director of the National Center for Complementary and 
Alternative Medicine, or any official of NIH to whom the authority 
involved has been delegated.
    HHS means the Department of Health and Human Services.
    Misconduct in science shall have the same meaning as prescribed in 
Sec. 50.102 of this chapter.
    NIH means the National Institutes of Health.
    PHS means the Public Health Service.
    Traineeship means an award under the regulations of this part to a 
qualified individual for that person's subsistence and other expenses 
during the period that person is participating in the research training 
approved under the award.

[60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000]



Sec. 63.3  What is the purpose of traineeships?

    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 Sec. 63.8(a)).



Sec. 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

[[Page 375]]

particularly appropriate, and to the extent the Director finds it is 
consistent with the fulfillment of the purpose of the traineeship.



Sec. 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.



Sec. 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.



Sec. 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.



Sec. 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.



Sec. 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 has committed misconduct in 
science, is ineligible, or has materially failed to comply with the 
terms and

[[Page 376]]

conditions of the award or to carry out the purpose for which the award 
was made; or
    (c) If the awardee is convicted of a felony, or an offense involving 
any illegal drug or substance, or any offense involving a lack of 
financial integrity or business honesty; or
    (d) Because of programmatic changes or lack of funds.

[65 FR 66513, Nov. 6, 2000]



Sec. 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.
59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion of Women 
and Minorities as Subjects in Clinical Research. (Note: Interested 
persons should contact the Office of Research on Women's Health, NIH, 
Room 201, Building 1, MSC 0161, Bethesda, MD 20892-0161; telephone 301-
402-1770 (not a toll-free number) to obtain copies of this policy.)
59 FR 34496 (July 5, 1994)--NIH Guidelines for Research Involving 
Recombinant DNA Molecules. (Note: Interested persons should contact the 
Office of Biotechnology Activities, NIH, Suite 323, 6000 Executive 
Boulevard, MSC 7010, Bethesda, MD 20892-7010; telephone 301-496-9838 
(not a toll-free number) to obtain copies of the policy.)
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals'' (Revised September 1986), Office of Laboratory Animal Welfare, 
NIH. (Note: Interested persons should contact the Office of Laboratory 
Animal Welfare, NIH, Rockledge Building I, 6705 Rockledge Drive, Suite 
1050, MSC 7982, Bethesda, MD 20892-7982; telephone 301-496-7163 (not a 
toll-free number) to obtain copies of the policy.)

[60 FR 10719, Feb. 27, 1995, as amended at 65 FR 66513, Nov. 6, 2000]



PART 63a_NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS--Table of Contents




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, 2421(b)(3), 284(b)(1)(C), 285g-10, 
287c(b), 300cc-15(a)(1), 300cc-41(a)(3)(C), 7403(h)(2).

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



Sec. 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), 
452G, 485B(b), 2315(a)(1), and 2354(a)(3)(C) of the Act; and,
    (3) Grants awarded by the National Institute of Environmental Health

[[Page 377]]

Sciences, NIH, for the education and training of physicians in 
environmental 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).

[61 FR 55111, Oct. 24, 1996, as amended at 71 FR 42296, July 26, 2006]



Sec. 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 Sec. 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 Sec. 63a.1 to carry 
out one or more of the purposes set forth in Sec. 63a.3.



Sec. 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.



Sec. 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:
    (1) Training activities conducted by, or 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.



Sec. 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

[[Page 378]]

at the time and in the form and manner that the Secretary may require.



Sec. 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.



Sec. 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 Sec. 63a.1 and the regulations of this part.



Sec. 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.



Sec. 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.



Sec. 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:

[[Page 379]]

    (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.



Sec. 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 contact the Office of Recombinant DNA 
Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7010, 
Bethesda, MD 20892-7010 (301-496-9838; not a toll-free number) to obtain 
references to the current version and any amendments.]
``NIH Grants Policy Statement,'' (December 1, 2003). This version is 
located on the NIH Web site at: http://grants./policy/nihgps--2003/
index.htm.

    [Note: this policy is subject to change, and interested persons 
should contact the Office of Policy for Extramural Research 
Administration (OPERA), Office of Extramural Research, NIH, 6701 
Rockledge Drive, Suite 350, MSC 7974, Bethesda, Maryland 20892-7974, 
telephone 301-435-0938 (or toll-free 800-518-4726), to obtain references 
to the current version and any amendments. Information may also be 
obtained by contacting the OPERA Division of Grants Policy via e-mail at 
http://GrantsPolicy@mail.nih.gov. Previous versions of the NIH Grants 
Policy Statement are archived at http://grants.nih.gov/grantspolicy/
policy.htm.]
``Public Health Service Policy on Humane Care and Use of Laboratory 
Animals,'' Office of Laboratory Animal Welfare (Amended August, 2002).

    [Note: this policy is subject to change, and interested persons 
should contact the Office of Laboratory Animal Welfare, 6705

[[Page 380]]

Rockledge Drive, Suite 360, MSC 7982, Bethesda, Maryland 20892-7982, 
telephone 301-594-2382 (not a toll-free number), to obtain references to 
the current version and any amendments. Information may also be obtained 
by browsing the Office of Laboratory Animal Welfare Home Page site on 
the World Wide Web (http://www.grants.nih.gov/grants/olaw/olaw.htm).]

[61 FR 55111, Oct. 24, 1996, as amended at 71 FR 42296, July 26, 2006]



PART 64_NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS--Table of Contents




Sec.
64.1 Programs to which these regulations apply.
64.2 Definitions.
64.3 Who is eligible for a grant?
64.4 How to apply for a grant.
64.5 How are grant applications evaluated?
64.6 Awards.
64.7 What other conditions apply?
64.8 How may funds be used?
64.9 Other HHS regulations that apply.

    Authority: 42 U.S.C. 216, 286b-3.

    Source: 56 FR 29192, June 26, 1991, unless otherwise noted.



Sec. 64.1  Programs to which these regulations apply.

    (a) The regulations of this part apply to grants under section 472 
of the Public Health Service Act (42 U.S.C. 286b-3) to public and 
private nonprofit institutions 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 ``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).



Sec. 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 Sec. 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 Sec. 64.1(a).



Sec. 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.



Sec. 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.

[[Page 381]]

    (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 non-personal 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)



Sec. 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.



Sec. 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 regulations of this part (see Sec. 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.



Sec. 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.

[[Page 382]]

    (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)



Sec. 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.



Sec. 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.



PART 64a_OBLIGATED SERVICE FOR MENTAL HEALTH TRAINEESHIPS--Table of Contents




Sec.
64a.101 Purpose.
64a.102 To whom do these regulations apply?
64a.103 Definitions.
64a.104 What requirements are imposed upon grantees?
64a.105 What are the conditions of obligated service?

    Authority: Sec. 803, Pub. L. 96-398, 94 Stat. 1607-1608 (42 U.S.C. 
242a).

    Source: 46 FR 39979, Aug. 5, 1981, unless otherwise noted.



Sec. 64a.101  Purpose.

    This part establishes requirements to implement the service payback 
obligation of individuals who receive clinical traineeships in 
pyschology, psychiatry, social work, or nursing (that are not of limited 
duration or experimental nature) under section 303 of the Public Health 
Service Act.



Sec. 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.



Sec. 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

[[Page 383]]

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.).
    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.



Sec. 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 Sec. 
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, the names of the 
participants involved in the interview, and a statement that the 
interview included an explanation to the individual of the service 
payback requirement and the consequences of failing to fulfill the 
service payback requirement.

(Approved by the Office of Budget and Management under control number 
0930-0120)

[46 FR 39979, Aug. 5, 1981, as amended at 52 FR 18359, May 15, 1987]



Sec. 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

[[Page 384]]

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.
    (c) Duration of obligation. The period of service payback must equal 
the period of support under the clinical traineeship on a month for 
month basis.
    (d) Performance of the obligated service--(1) General requirements. 
The obligated service must consist of the provision of service for which 
the individual was trained (in the training program for which the 
clinical traineeship was received) and must be performed on a full-time 
basis (not less than 30 hours per week averaged over the obligated 
service period).
    (2) Preferred service. Except as provided under paragraph (d)(3) of 
this section, the individual must provide the obligated service in:
    (i) A public inpatient mental institution;
    (ii) Any entity which is receiving or has received a grant under the 
Mental Health Systems Act or the Community Mental Health Centers Act;
    (iii) A psychiatric manpower shortage area designated by the 
Secretary under section 332 of the Public Health Service Act and 42 CFR 
part 5;
    (iv) Any public or private nonprofit entity or in any nursing home 
(whether public, private nonprofit, or for profit) in which 50 percent 
or more of those served are within one or more of the following groups: 
Racial or ethnic minorities (American Indian or Alaskan Native, Asian or 
Pacific Islander, Black, Hispanic), chronically mentally ill, mentally 
retarded, criminal or delinquent populations, rape victims, physically 
handicapped, abusers of alcohol, or persons addicted to drugs or other 
substances, children and adolescents, the elderly, poverty populations, 
migrants, members of the armed forces (or veterans if seen in a Federal 
facility), residents of areas other than those defined as urbanized by 
the Department of Commerce, or any other special populations, such as 
groups of refugees or disaster victims, which are specifically 
designated by the Secretary for this purpose.
    (3) Alternate service. If the individual obtains the written 
approval of the Secretary, the individual may fulfill his or her 
obligation by:
    (i) Serving in any public or private nonprofit entity or in any 
nursing home (whether public, private nonprofit, or for profit) in which 
not less than 25 percent of those served are within one or more of the 
underserved population groups listed in paragraph (d)(2)(iv) of this 
section. The individual must demonstrate a service commitment of more 
than 50 percent of his or her time to the targeted populations.
    (ii) Teaching, conducting research, or conducting evaluation 
directed at improving alcohol, drug abuse or mental health services to 
one or more of the priority population groups listed in paragraph 
(d)(2)(iv) of this section, or working in a position which fosters the 
closer collaboration of health and alcohol, drug abuse or mental health 
services.
    (iii) Providing in a public or private nonprofit entity 
consultation, training and education, liaison, community support or 
other professional services for which the individual was trained when

[[Page 385]]

the individual's work is directed toward improving alcohol, drug abuse 
or mental health services to the priority populations listed in 
paragraph (d)(2)(iv) of this section.
    (e) Conditions for deferral or break in service, waiver, or 
cancellation. (1) Upon receipt of a written request showing good cause 
therefor by the individual having a payback obligation, the Secretary 
may:
    (i) Extend the period for beginning the obligated service (24 months 
after termination of the clinical traineeship), permit breaks in the 
required continuous service or extend the period for repayment under 
paragraph (g)(2) of this section, if it is determined that:
    (A) An extension or break in service is necessary for the completion 
of training;
    (B) Performance of the obligation must be delayed because a 
temporary disability makes present performance impossible; or
    (C) Performance of the obligation must be delayed because present 
performance would involve a substantial hardship and failure to extend 
the period would be against equity and good conscience.
    (ii) Waive, in whole or in part, the service payback and recovery 
requirements of this section if it is determined that fulfillment would 
be impossible because the individual is permanently and totally 
disabled.
    (iii) In making determinations under Sec. 64a.105(e)(1)(i)(C), the 
Secretary will take into consideration the following factors:
    (A) The individual's present financial resources and obligations;
    (B) The individual's estimated future financial resources and 
obligations;
    (C) The reasons for the individual's failure to complete the 
requirements within the prescribed period, such as problems of a 
personal nature;
    (D) The unavailability of employment opportunities appropriate to 
the individual's education and training; and
    (E) Any other extenuating circumstances.
    (2) Upon receipt of written notice giving evidence of a conflicting 
obligation under section 752 or 753 of the Act or of an election to 
fulfill an obligation under section 472 of the Act prior to an 
obligation under this section, the Secretary will extend the period for 
beginning service (24 months after termination of the clinical 
traineeship), permit breaks in the required continuous service or extend 
the period for repayment under paragraph (g)(1), as appropriate.
    (3) The service payback and recovery obligations of an individual 
will be cancelled upon the submission to the Secretary of a certificate 
of that individual's death or other evidence which the Secretary 
determines to be satisfactory.
    (f) Conflicting or multiple payback obligations. In any case where 
the individual has, in addition to a payback obligation incurred under 
this section, an obligation to perform service under section 752 or 753 
of the Act (because of receipt of a National Health Service Corps 
scholarship) or under section 472 of the Act (because of receipt of a 
National Research Service Award), or both, performance of the same 
activity may not be counted toward more than one of these obligations. 
In determining the order in which obligations must be fulfilled, 
obligations under section 752 or 753 take precedence over obligations 
incurred under this section. However, with respect to obligations under 
this section and 472, the individual may elect which obligation to 
fulfill first. Any individual who has an obligation under section 752 or 
753 or makes an election to fulfill an obligation under section 472 
prior to an obligation under this section, must give written notice to 
the Secretary as provided by paragraph (e)(3) of this section.
    (g) Recovery for failure to perform obligated service. (1) If an 
individual fails to begin or complete the obligated service in 
accordance with the requirements of paragraphs (a) through (f) of this 
section, that individual is obligated to repay the United States an 
amount equal to three times the cost of the award (including stipends 
and other trainee allowances) plus interest on that amount calculated 
for the total period since the trainee failed to perform the obligated 
service at the rate set by the Secretary of the Treasury

[[Page 386]]

for National Research Service Awards prevailing on the date on which the 
period of appointment begins, multiplied, in any case in which the 
service that was required has been performed in part, by the percentage 
which the length of service that was not performed is to the length of 
the service that was required to be performed. The amount will be 
determined under the following formula:
[GRAPHIC] [TIFF OMITTED] TC13NO91.004

where

A = the amount the United States is entitled to recover;
[thetas] = the cost of the clinical traineeship (including stipends and 
other trainee allowances);
m = the number of months since the trainee failed to perform obligated 
service;
i = the National Research Service Award rate on the date which the 
period of appointment begins divided by twelve;
t = the total number of months of the service obligation;
s = the number of months that have been served.

    (2) Unless the Secretary extends the repayment period as provided in 
paragraph (e) of this section, the individual shall pay to the United 
States the total amount which the United States is entitled to recover 
under paragraph (g)(1) of this section immediately upon the date that 
the individual fails to begin or complete the period of obligated 
service (including failing to comply with the applicable terms and 
conditions of an extension or break in service granted the individual) 
or upon the date that the individual indicates his or her intention not 
to fulfill the service obligation as determined by the Secretary. The 
amount is considered a debt owed to the United States, with interest 
accruing monthly upon the total debt as provided under paragraph (g)(1) 
of this section.

[46 FR 39979, Aug. 5, 1981, as amended at 52 FR 18359, May 15, 1987]



PART 65_NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE 

WORKER TRAINING--Table of Contents




Sec.
65.1 To what projects do these regulations apply?
65.2 Definitions.
65.3 Who is eligible to apply for a grant?
65.4 Project requirements.
65.5 How will applications be evaluated?
65.6 How long does grant support last?
65.7 For what purposes may grant funds be spent?
65.8 What additional Department regulations apply to grantees?
65.9 Additional conditions.

    Authority: 42 U.S.C. 9660a; 49 U.S.C. App. 1816.

    Source: 55 FR 42568, Oct. 22, 1990, unless otherwise noted.



Sec. 65.1  To what projects do these regulations apply?

    (a) The regulations in this part apply to:
    (1) The program of grants for the training and education of workers 
who are or are likely to be engaged in activities related to hazardous 
waste removal or containment, or emergency response that is authorized 
under section 126(g) of the SARA; and
    (2) The program of grants to support qualified non-profit 
organizations for the purpose of providing training and education to 
hazardous materials employees regarding: the safe unloading, loading, 
handling, storage, and transportation of hazardous materials; and, 
emergency preparedness for responding to accidents or incidents 
involving the transportation of hazardous materials that is authorized 
under section 118 of the HMTA.
    (b) Grants are available for curriculum and training materials 
development, technical support of training, direct student training, 
training program evaluation and related activities. Target populations 
for this training are workers and supervisors who are or are likely to 
be engaged in hazardous substance removal or other activities which 
expose or potentially expose these workers to hazardous substances in 
activities such as:

[[Page 387]]

    (1) Waste handling and processing at waste generators and active and 
inactive hazardous substance treatment, storage, and disposal 
facilities;
    (2) Clean up, removal, containment, or remedial actions at waste 
sites;
    (3) Hazardous substance emergency response;
    (4) Hazardous substance disposal site risk assessment and 
investigation, clean up, or remedial actions; and
    (5) Transportation of hazardous wastes.
    Target populations may also be regulated under standards promulgated 
by the Secretary of Labor, the Secretary of Transportation, the 
Administrator of the Environmental Protection Agency, and other agencies 
under section 126(g) of the SARA or section 106(b) of the HMTA.
    (c) Two types of grants are available: Program grants covering the 
full range of activities, including program development, direct worker 
training and education, and program evaluation; and planning grants 
under the SARA.
    (1) Planning grants are intended to assist organizations which 
demonstrate potential for providing hazardous worker training, but need 
additional developmental efforts prior to initiation of full curriculum 
development and training activities. A limited number of one-year 
planning grants may be funded at a level determined appropriate by the 
Director. After successful completion of a one-year planning grant, a 
recipient may apply for a full program grant on a competitive basis.
    (2) Full program grants will be awarded to organizations with 
demonstrated capability to provide worker health and safety training and 
education and demonstrated ability to identify, describe, and access 
target populations. Full program grantees must be able to immediately 
initiate curriculum development and worker training activities.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec. 65.2  Definitions.

    As used in this part:
    Award or grant means a grant or cooperative agreement made under 
section 126(g) of the SARA or section 118 of the HMTA.
    Director means the Director, National Institute of Environmental 
Health Sciences, or the Director's delegate.
    HHS means the Department of Health and Human Services.
    HMTA means the Hazardous Materials Transportation Act, as amended 
(49 U.S.C. App. 1801 et seq.).
    NIEHS means the National Institute of Environmental Health Sciences, 
an organizational component of the National Institutes of Health, as 
authorized by sections 401(b)(1)(L) and 463 of the Public Health Service 
Act (42 U.S.C. 281(b)(1)(L) and 285(l).
    NIH means the National Institutes of Health.
    Nonprofit as applied to any agency, organization, institution, or 
other entity means 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.
    SARA means the Superfund Amendments and Reauthorization Act of 1986, 
Public Law 99-499, as amended (42 U.S.C. 9601 et seq.).
    Stipend means a payment to an organization that is intended to help 
meet that organization's subsistence expenses for trainees during the 
training period.
    Training grant means an award of funds to an eligible entity for a 
project authorized under Sec. 65.1.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec. 65.3  Who is eligible to apply for a grant?

    Public and private nonprofit entities providing worker health and 
safety education and training may apply for grants under these 
regulations. Applicants for a grant may use services, as appropriate, of 
other public or private organizations necessary to develop, administer, 
or evaluate proposed worker training programs so long as the majority of 
the work is done by the applicant.



Sec. 65.4  Project requirements.

    In addition to meeting the requirements specified in the 
application, the instructions accompanying it, and the regulations 
referred to in Sec. 65.8, each

[[Page 388]]

applicant must meet the following requirements:
    (a) Two or more nonprofit organizations may join in a single 
application and share grant resources in order to maximize worker group 
coverage, enhance the effectiveness of training, and bring together 
appropriate academic disciplines and talents. Joint applications must 
describe the cooperative arrangements for program integration and 
effectiveness. Specific expertise, facilities, or services to be 
provided by each participating member must be identified.
    (b) Each applicant must detail the nature, duration, and purpose of 
the training for which the application is filed. The proposed training 
program must meet the standards promulgated by the Secretary of Labor 
and Secretary of Transportation under section 126(g) of the SARA or 
section 106(b) of the HMTA, and such additional requirements as the 
Director may prescribe to ensure appropriate health and safety training.
    (c) The applicant must provide assurance that the applicant will not 
discriminate in the selection of trainees or instructors on the basis of 
membership or nonmembership in a union.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec. 65.5  How will applications be evaluated?

    (a) The Director shall evaluate applications through the officers 
and employees, and experts and consultants engaged by the Director for 
that purpose. The Director's first level of 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 (including the 
ability to manage complex training programs), the adequacy of selection 
criteria for trainees for the project, the adequacy of the detailed 
training plan including provision for hands-on training, the adequacy of 
the applicant's resources available for the project, the amount of grant 
funds necessary for completion of its objectives, and how well the 
projects meet training criteria in OSHA's Hazardous Waste Operations and 
Emergency Response Regulation (29 CFR 1910.120) and/or how well they 
cover the target populations listed in Sec. 65.1(b). A second level of 
review will be conducted for program relevance.
    (b) Within the limits of funds available, the Director may award 
training grants to carry out those projects which have satisfied the 
requirements of the regulations of this part; are determined by the 
Director to be technically meritorious; and in the judgment of the 
Director best promote the purposes of the grant programs authorized by 
section 126(g) of the SARA or section 118 of the HMTA, the regulations 
of this part, and program priorities.

[55 FR 42568, Oct. 22, 1990; 59 FR 64141, Dec. 13, 1994]



Sec. 65.6  How long does grant support last?

    (a) The notice of grant award specifies how long NIEHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 1-5 
years.
    (b) 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 such 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 NIEHS 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.



Sec. 65.7  For what purposes may grant funds be spent?

    Individuals receiving training shall be entitled only to the 
stipends and allowances included in a budget approved

[[Page 389]]

by the Director, taking into account the cost of living and such other 
factors as the needs of the program and the availability of funds.



Sec. 65.8  What additional Department regulations apply to grantees?

    Several other regulations and policies apply to grants under this 
part. These include, but are not 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--Government-wide debarment and suspension 
(nonprocurement) and government-wide 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 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 Health and 
Human Services programs and 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.



Sec. 65.9  Additional conditions.

    The Director may with respect to any award impose additional 
conditions prior to, or at the time of, any award when, in the 
Director's judgment, such conditions are necessary to assure the 
carrying out of the purposes of the award, the interest of the public 
health, or the conservation of funds awarded.



PART 65a_NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS 

SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS--Table of Contents




Sec.
65a.1 To what programs do these regulations apply?
65a.2 Definitions.
65a.3 Who is eligible to apply for a grant?
65a.4 What are the program requirements?
65a.5 How to apply.
65a.6 How will applications be evaluated?
65a.7 Awards.
65a.8 How long does grant support last?
65a.9 What are the terms and conditions of award?
65a.10 For what purposes may grant funds be spent?
65a.11 Other HHS regulations and policies that apply.

    Authority: 42 U.S.C. 216, 9660(a).

    Source: 61 FR 55114, Oct. 24, 1996, unless otherwise noted.



Sec. 65a.1  To what programs do these regulations apply?

    (a) The regulations of this part apply to the award of grants to 
support programs for basic research and training directed towards 
understanding, assessing, and attenuating the adverse effects on human 
health resulting from exposure to hazardous substances, as authorized 
under section 311(a) of the Act (42 U.S.C. 9660(a)). The purpose of 
these programs is to carry out coordinated, multi-component, 
interdisciplinary research consisting of at least three or more 
biomedical research projects relating to hazardous substances and at 
least one non-biomedical research project in the fields of ecology, 
hydrogeology, and/or engineering, and including the training of 
investigators as part of the grantee's overall program.
    (b) The regulations of this part also apply to cooperative 
agreements awarded to support the programs described 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),

[[Page 390]]

    (2) Research, demonstration, and training support under the NIH 
Center Grants programs (see part 52a of this chapter),
    (3) Research training support under traineeship programs (see parts 
63 and 64a of this chapter), or
    (4) Research training support under the NIH AIDS Research Loan 
Repayment Program authorized under section 487A of the Public Health 
Service Act, as amended (42 U.S.C. 288-1).



Sec. 65a.2  Definitions.

    As used in this part:
    Act means the Comprehensive Environmental Response, Compensation, 
and Liability Act of 1980, as amended (42 U.S.C. 9601 et seq.).
    Award or grant means a grant or cooperative agreement awarded under 
section 311(a) of the Act (42 U.S.C. 9660(a)).
    Director means the Director of the National Institute of 
Environmental Health Sciences, or the Director's delegate.
    HHS means the Department of Health and Human Services.
    Institution of higher education means an educational institution in 
any state which (1) admits as regular students only persons having a 
certificate of graduation from a school providing secondary education, 
or the recognized equivalent of such a certificate, (2) is legally 
authorized within the state to provide a program of education beyond 
secondary education, (3) provides an educational program for which it 
awards a bachelor's degree or provides not less than a two-year program 
which is acceptable for full credit toward a bachelor's degree, (4) is a 
public or other nonprofit institution, and (5) is accredited by a 
nationally recognized accrediting agency or association or, if not so 
accredited, (i) is an institution with respect to which the Secretary of 
Education has determined that there is satisfactory assurance, 
considering the resources available to the institution, the period of 
time, if any, during which it has operated, the effort it is making to 
meet accreditation standards, and the purpose for which this 
determination is being made, that the institution will meet the 
accreditation standards of a nationally recognized accrediting agency or 
association within a reasonable time, or (ii) is an institution whose 
credits are accepted, on transfer, by not less than three institutions 
which are so accredited, for credit on the same basis as if transferred 
from an institution so accredited. The term also includes any school 
which provides not less than a one-year program of training to prepare 
students for gainful employment in a recognized occupation and which 
meets the provisions of paragraphs (1), (2), (4), and (5) of this 
definition. The term also includes a public or nonprofit private 
educational institution in any state which, in lieu of the requirement 
in paragraph (1), admits as regular students persons who are beyond the 
age of compulsory school attendance in the state in which the 
institution is located and who meet the requirements of section 1091(d) 
of title 20 U.S. Code, as amended. For purposes of this definition, the 
Secretary of Education publishes a list of nationally recognized 
accrediting agencies or associations which that official determines to 
be reliable authority as to the quality of training offered. This list 
is found in the brochure, ``Nationally Recognized Accrediting Agencies 
and Associations Criteria and Procedures for Listing by the U.S. 
Secretary of Education and Current List.''

    [Note: This brochure is subject to change, and interested persons 
should contact the U.S. Department of Education Office of Post-Secondary 
Education, Accreditation and State Liaison Division, ROB 3, 7th and D 
Streets, S.W., Room 37-15, Washington, DC 20202-5244 (202-708-7417; not 
a toll-free number) to obtain a current version of the brochure and any 
amendments.]

    NIEHS means the National Institute of Environmental Health Sciences, 
an organizational component of the National Institutes of Health, as 
authorized under sections 401(b) and 463 of the Public Health Service 
Act, as amended (42 U.S.C. 281(b) and 185l).
    NIH means the National Institutes of Health.
    Nonprofit, as applied to any agency, organization, institution, or 
other entity, means a corporation or association

[[Page 391]]

no part of the net earnings of which insures or may lawfully inure to 
the benefit of any private shareholder or individual.
    PHS means the Public Health Service.
    Program means the activity to carry out research and training 
supported by a grant under this part.
    Program director means the single individual designated by the 
grantee in the grant application and approved by the Director, who is 
responsible for the scientific and technical direction of the research 
component and the conduct of the training component under a program.
    Project period means the period of time, from one to five years, 
specified in the notice of grant award that NIEHS intends to support a 
proposed program without requiring the program awardee to recompete for 
funds.
    Secretary means, unless the context otherwise requires, the 
Secretary of Health and Human Services or other official of HHS to whom 
the authority involved is delegated.



Sec. 65a.3  Who is eligible to apply for a grant?

    (a) Except as otherwise prohibited by law, any public or private 
nonprofit institution of higher education may apply for an award under 
this part.
    (b) Awardee institutions may carry out portions of the research or 
training components of an award through contracts with appropriate 
organizations, including:
    (1) Generators of hazardous wastes;
    (2) Persons involved in the detection, assessment, evaluation, and 
treatment of hazardous substances;
    (3) Owners and operators of facilities at which hazardous substances 
are located; and
    (4) State and local governments.



Sec. 65a.4  What are the program requirements?

    The applicant shall include the following in its proposed program 
for which support is requested under this part:
    (a) Basic research component. The program shall include three or 
more meritorious biomedical research projects, including epidemiologic 
studies relating to the study of the adverse effects of hazardous 
substances on human health, and at least one meritorious project 
involving hydrogeologic or ecologic research which shall cumulatively 
address:
    (1) Methods and technologies to detect hazardous substances in the 
environment;
    (2) Advanced techniques for the detection, assessment, and 
evaluation of the effects of these substances on human health;
    (3) Methods to assess the risks to human health presented by these 
substances; and
    (4) Basic biological, chemical, and/or physical methods to reduce 
the amount and toxicity of these substances.
    (b) Training component. The program shall include the following 
kinds of training, as part of or in conjunction with the basic research 
component:
    (1) Graduate training in environmental and occupational health and 
safety and in public health and engineering aspects of hazardous waste 
control; and/or
    (2) Graduate training in the geosciences, including hydrogeology, 
geological engineering, geophysics, geochemistry, and related fields, 
necessary to meet professional personnel needs in the public and private 
sectors and to carry out the purposes of the Act; and
    (3) Worker training relating to handling hazardous substances, which 
includes short courses and continuing education for state and local 
health and environmental agency personnel and other personnel engaged in 
the handling of hazardous substances, in the management of facilities at 
which hazardous substances are located, and in the evaluation of the 
hazards to human health presented by these facilities.



Sec. 65a.5  How to apply.

    Each institution desiring a grant under this part must submit an 
application at the time and in the form and manner as the Secretary may 
require.

[[Page 392]]



Sec. 65a.6  How will applications be evaluated?

    The Director shall evaluate applications through the officers and 
employees, experts, consultants, or groups engaged by the Director for 
that purpose, including review by the National Advisory Environmental 
Health Sciences Council in accordance with peer review requirements set 
forth in part 52h of this chapter. The Director's first level of 
evaluation will be for technical 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 applicant's resources available for the 
program, and the amount of grant funds necessary for completion of its 
objectives. A second level of review will be conducted by the National 
Advisory Environmental Health Sciences Council.



Sec. 65a.7  Awards.

    Criteria. Within the limits of available funds, the Director may 
award grants to carry out those programs which:
    (a) Are determined by the Director to be meritorious; and
    (b) In the judgment of the Director, best promote the purposes of 
the grant program, as authorized under section 311(a) of the Act and the 
regulations of this part, and best address program priorities.



Sec. 65a.8  How long does grant support last?

    (a) The notice of grant award specifies how long NIEHS intends to 
support the project without requiring the grantee to recompete for 
funds. This period, called the project period, may be for 1-5 years.
    (b) 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 at the time and in the form 
and manner as 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 a 
determination by the Director 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 
Director, provided a continuation award is made. If at any time during a 
budget period it becomes apparent to the Director 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 Director may adjust the 
amounts awarded by withdrawing the excess.



Sec. 65a.9  What are the terms and conditions of awards?

    In addition to being subject to other applicable regulations (see 
Sec. 65a.11), grants awarded under this part are subject to the 
following terms and conditions:
    (a) Material changes. Except as otherwise provided by 45 CFR 74.25, 
the grantee may not materially change the quality, nature, scope, or 
duration of the program unless the written approval of the Director is 
obtained prior to the change.
    (b) Additional conditions. The Director may impose additional 
conditions prior to the award of any grant under this part if it is 
determined by the Director that the conditions are necessary 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.

[[Page 393]]



Sec. 65a.10  For what purposes may grant funds be spent?

    A grantee shall spend 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 award, and the applicable 
cost principles prescribed in 45 CFR 74.27.



Sec. 65a.11  Other HHS regulations and policies that apply.

    Several other HHS regulations and policies apply to awards under 
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
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
42 CFR part 52h--Scientific peer review of research grant applications 
and research and development contract projects
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 contact the Office of Recombinant DNA Activities, NIH, Suite 323, 
6000 Executive Boulevard, MSC 7010, Bethesda, MD 20892-7010 (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 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 (asknih@odrockm1.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, HIH (Revised 
September 1986).

    Note: This policy is subject to change, and interested persons 
should contact the Office for Protection for Research Risks, NIH, Suite 
3B01, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20852-7507 (301-
496-7005; not a toll-free number) to obtain references to the current 
version and any amendments.]



PART 66_NATIONAL RESEARCH SERVICE AWARDS--Table of Contents




                         Subpart A_Direct Awards

Sec.
66.101 Applicability.
66.102 Definitions.
66.103 Eligibility.
66.104 Application.

[[Page 394]]

66.105 Requirements.
66.106 Awards.
66.107 Payments to awardees.
66.108 Payments to institutions.
66.109 Termination.
66.110 Service, payback, and recovery requirements.
66.111 Suspension, waiver, and cancellation.
66.112 Other HHS regulations and policies that apply.
66.113 Publications.
66.114 Copyright.
66.115 Additional conditions.

                     Subpart B_Institutional Grants

66.201 Applicability.
66.202 Definitions.
66.203 Eligibility.
66.204 Application.
66.205 Requirements.
66.206 Grant awards.
66.207 Other HHS regulations and policies that apply.
66.208 Additional conditions.

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

    Source: 48 FR 24880, June 3, 1983, unless otherwise noted.



                         Subpart A_Direct Awards



Sec. 66.101  Applicability.

    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).

[66 FR 29499, May 31, 2001]



Sec. 66.102  Definitions.

    As used in this subpart:
    (a) Act means the Public Health Service Act, as amended.
    (b) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (c) Nonprofit institution means a corporation or association in 
which no part of the net earnings inures or may lawfully inure to the 
benefit of any private shareholder or individual.
    (d) Award means a National Research Service Award under section 487 
of the Act (42 U.S.C. 288).
    (e) Residency means post-graduate training for doctors of medicine, 
osteopathy, dentistry, optometry, and podiatry, nurses, and other 
individuals providing health care directly to patients, in which the 
majority of the time is spent in non-research clinical training.
    (f) Noncitizen national of the United States means a person who, 
though not a citizen of the United States, owes permanent allegiance to 
the United States [8 U.S.C. 1101(a) (22)].
    (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 the 
award of a baccalaureate in science or equivalent degree.
    (h) Postdoctoral training means training of individuals holding a 
doctor of philosophy, science, medicine, dentistry, osteopathy, 
optometry, podiatry, veterinary medicine, engineering, nursing sciences, 
public health, or equivalent degree.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29499, May 31, 2001]



Sec. 66.103  Eligibility.

    To be eligible for a National Research Service Award an individual 
must:
    (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.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]

[[Page 395]]



Sec. 66.104  Application.

    (a) Eligible individuals may apply for an Award using the form and 
by the dates the Secretary prescribes.
    (b) In addition to any other pertinent information that the 
Secretary may require, each application shall detail:
    (1) The applicant's educational background and other qualifications 
and experience, including previous academic and professional degrees;
    (2) The subject area of the proposed research or training;
    (3) The proposed period of Award:
    (4) If the proposed period of Award would provide the individual 
with aggregate support in excess of five years at the predoctoral level 
or three years at the postdoctoral level, the justification for this 
request; and
    (5) The availability of necessary resources and facilities at the 
institution where the research or training would be conducted.

(Approved by the Office of Management and Budget under control number 
0925-0002)

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec. 66.105  Requirements.

    The Secretary shall make an Award to an individual under this 
subpart only if:
    (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 Sec. 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:
    (1) The applicant has been accepted to the institution for the 
purpose of engaging in the research or training for which an Award is 
being sought;
    (2) The Award will not be used to support a residency; and
    (3) In the event an Award is made the institution will make 
available to the applicant any resources and facilities described in the 
application as necessary to carry out the research or training; and
    (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.

(Approved by the Office of Management and Budget under control number 
0925-0002)

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec. 66.106  Awards.

    (a) Within the limits of funds available, the Secretary shall make 
Awards to those applicants:
    (1) Who have satisfied the requirements of Sec. 66.105; and
    (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:
    (i) The scientific, technical, or educational merit of the 
particular proposal;
    (ii) The availability of resources and facilities to carry it out;
    (iii) The qualifications and experience of the applicant; and
    (iv) The need for personnel in the subject area of the proposed 
research or training.
    (b) In making Awards, the Secretary shall take account of the 
Nation's overall need for biomedical research by giving special 
consideration to physicians who agree to undertake a minimum of two 
years of biomedical research.
    (c) All Awards shall be in writing. Each shall specify:
    (1) The period of the Award;
    (2) The total recommended stipends and allowances provided for the 
entire Award period;
    (3) The amount awarded for the intitial year of that period (see 
Sec. 66.107); and
    (4) The amount of the payments to the institution for the cost of 
services provided the awardee by the institution during the initial year 
of that period (see Sec. 66.108).
    (d) Neither the approval of any application nor any Award shall 
commit or obligate the United States in any way to make additional, 
supplemental, continuation, or other Award with respect

[[Page 396]]

to any approved application or portion thereof.
    (e) No individual may receive an aggregate of more than five years 
of support at the predoctoral level and three years at the postdoctoral 
level unless the Secretary waives, for good cause shown, this limitation 
for the individual. In determining what constitutes ``good cause,'' the 
Secretary shall take into account such factors as whether the applicant 
proposes to pursue a combined program leading to the degrees of doctor 
of medicine and doctor of philosophy.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29500, May 31, 2001]



Sec. 66.107  Payments to awardees.

    (a) Individuals receiving Awards shall be entitled to the stipends, 
tuition, fees, and allowances the Secretary may designate, taking into 
account the cost of living, and such other factors as the needs of the 
program and the availability of funds.
    (b) The Secretary shall pay stipends, tuition, fees and allowances 
to the awardee or the sponsoring institution for payment to the awardee.



Sec. 66.108  Payments to institutions.

    The institution shall be entitled to an allowance to help defray the 
cost of support services (including the cost of faculty salaries, 
supplies, equipment, general research support, and related items) 
provided to the individual by the institution. The Secretary shall 
determine the amount of payments based upon reasonable costs to the 
institution of establishing and maintaining the quality of research and 
training programs for which it receives support under this subpart. The 
Secretary may make payments to the institution either in advance or by 
way of reimbursement.



Sec. 66.109  Termination.

    (a) The Secretary may terminate an Award prior to its normal 
expiration date:
    (1) At the written request of the awardee; or
    (2) If the Secretary finds that the awardee has materially failed to 
comply with the terms and conditions of the Award or to carry out the 
purpose for which it was made.
    (b) In the event an Award is terminated, the Secretary shall notify 
the awardee in writing of this determination, the reasons for 
termination, the effective date, and any procedural rights available.



Sec. 66.110  Service, payback, and recovery requirements.

    (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 Sec. 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:
[GRAPHIC] [TIFF OMITTED] TR31MY01.005


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.


[[Page 397]]


    (e) Except as provided in Sec. 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.

[66 FR 29500, May 31, 2001]



Sec. 66.111  Suspension, waiver, and cancellation.

    (a) The Secretary may extend the period for undertaking service 
described in Sec. 66.110(c), permit breaks in the continuous service 
required under Sec. 66.110(c), or extend the period of repayment under 
Sec. 66.110(e) if the Secretary determines that:
    (1) An extension or break in service is necessary so the individual 
may complete his or her research training;
    (2) Completion during the period would be impossible because the 
individual is temporarily disabled; or
    (3) Completion during the period would involve a substantial 
hardship to the individual and failure to extend to the period would be 
against equity and good conscience.
    (b) The Secretary may waive, in whole or in part, the obligation of 
the individual to repay pursuant to Sec. 66.110(d) if the Secretary 
determines that:
    (1) Fulfillment would be impossible because the individual is 
permanently and totally disabled; or
    (2) Fulfillment would involve a substantial hardship to the 
individual and enforcement of the obligation would be against equity and 
good conscience.
    (c) In making determinations under Sec. 66.111 (a)(3) and (b)(2), 
the Secretary will take into consideration such factors as:
    (1) The individual's present financial resources and obligations;
    (2) The individual's estimated future financial resources and 
obligations;
    (3) The reasons for the individual's failure to complete the 
requirements within the prescribed period, such as problems of a 
personal nature;
    (4) The extent to which the individual has been engaged in 
activities encompassed by Sec. 66.110(a) and (b);
    (5) Whether the individual has received sufficient training to be 
qualified to perform any such activities;
    (6) The unavailability of employment opportunities appropriate to 
the individual's education and training; and
    (7) Any other extenuating circumstances.
    (d) Any obligations of any individual under this subpart will be 
cancelled upon the death of that individual.

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983, as amended at 66 
FR 29500, May 31, 2001]



Sec. 66.112  Other HHS regulations and policies that apply.

    Several other regulations and policies may apply to individuals and 
institutions receiving payments under this subpart. These include, but 
are not 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 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
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

[[Page 398]]

obtain references to the current version and any amendments.

[49 FR 38116, Sept. 27, 1984, as amended at 66 FR 29500, May 31, 2001]



Sec. 66.113  Publications.

    Publication, distribution, and disposition of all manuscripts and 
other materials resulting from an Award shall be subject to the 
conditions that all such materials shall bear appropriate 
acknowledgement of Department of Health and Human Services support and 
that the awardee shall furnish copies of these manuscripts or other 
materials as the Secretary may reasonably request.



Sec. 66.114  Copyright.

    Where the work accomplished under an Award results in a book or 
other copyrightable material, the author is free to copyright the work, 
but the United States reserves a royalty-free, nonexclusive, and 
irrevocable license to reproduce, publish, or otherwise use, and to 
authorize others to use, all copyrightable or copyrighted material 
resulting from the Award.



Sec. 66.115  Additional conditions.

    The Secretary may with respect to any Award or class of Awards 
impose additional conditions prior to or at the time of any Award when 
in the Secretary's judgment such conditions are necessary to assure the 
carrying out of the purposes of the Award, the interests of the public 
health, or the conservation of funds awarded.



                     Subpart B_Institutional Grants



Sec. 66.201  Applicability.

    The regulations in this subpart apply to grants under section 487 of 
the Public 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.

[66 FR 29500, May 31, 2001]



Sec. 66.202  Definitions.

    The definitions in Sec. 66.102 of subpart A of this part apply to 
this subpart.

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983]



Sec. 66.203  Eligibility.

    To be eligible for a grant under this subpart, an applicant must be:
    (a) A public or nonprofit private institution; and
    (b) Located in a State, the District of Columbia, Puerto Rico, the 
Virgin Islands, the Canal Zone, Guam, American Samoa, or the Trust 
Territory of the Pacific Islands.



Sec. 66.204  Application.

    (a) Application for a grant under this subpart shall be made on a 
form approved for that purpose by the Secretary. Applicants shall submit 
completed forms on or before the dates the Secretary may prescribe.
    (b) In addition to any other pertinent information that the 
Secretary may require, each application shall set forth in detail:
    (1) The subject area or areas in which the proposed research or 
training will be conducted;
    (2) The resources and facilities available for use by recipients of 
Awards in carrying out this research or training;
    (3) The names, qualifications, and experience of the program 
director and principal staff members who will be responsible for the 
proposed program;
    (4) The criteria to be employed in selecting recipients of Awards;
    (5) The estimated number of recipients of Awards under the grant;
    (6) The proposed project period and a detailed budget and 
justification for the amount of grant funds requested; and
    (7) Proposed methods for monitoring and evaluating the performance 
of individual recipients of Awards, as well as the overall program.

(Approved by the Office of Management and Budget under control number 
0925-0022)



Sec. 66.205  Requirements.

    (a) No Award shall be made to an individual from a grant under this 
subpart unless:

[[Page 399]]

    (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 Sec. 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;
    (3) The Award includes a provision for termination in the event the 
recipient is found by the institution to have materially failed to 
comply with the terms and conditions of the Award or to carry out the 
purpose for which it was made; and
    (4) The Award is not to be used to support a residency.
    (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 Sec. 
66.106(e) of subpart A of this part, waives the application of the 
limitation with respect to that individual;
    (c) The provisions of Sec. Sec. 66.110 and 66.111 of subpart A of 
this part constitute terms and conditions of any Award made from a grant 
under this subpart.

(Approved by the Office of Management and Budget under control number 
0925-0022)

[48 FR 24880, June 3, 1983; 48 FR 33710, July 25, 1983, as amended at 66 
FR 29501, May 31, 2001]



Sec. 66.206  Grant awards.

    (a) Within the limits of funds available, the Secretary shall award 
grants to those applicants:
    (1) Whose applications have been reviewed and recommended for 
approval by the appropriate national advisory council or board;
    (2) Who have satisfied the requirements of Sec. 66.105; and
    (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:
    (i) The scientific, technical, or educational merit of the proposed 
program;
    (ii) The adequacy of the resources and facilities available to the 
applicant;
    (iii) The qualifications and experience of the program director and 
principal staff members;
    (iv) The degree of the need for personnel in the subject area or 
areas of the proposed research or training;
    (v) The extent to which the applicant, in making Awards, gives 
special consideration to physicians who agree to undertake a minimum of 
two years of biomedical research;
    (vi) The administrative and management capability of the applicant;
    (vii) The reasonableness of the proposed budget in relation to the 
proposed program; and
    (viii) The adequacy of the methods for monitoring and evaluating the 
performance of individual recipients and the overall program.
    (b) The notice of grant award specifies how long HHS intends to 
support the project without requiring the project to recompete for 
funds. This period, called the project period, will usually be for 3-5 
years.
    (c) 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 such 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 HHS that continued funding is in the best interest of 
the government.
    (d) Neither the approval of any application nor the award of any 
grant commits or obligates the United States in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of any approved application.

[48 FR 24880, June 3, 1983, as amended at 66 FR 29501, May 31, 2001]

[[Page 400]]



Sec. 66.207  Other HHS regulations and policies that apply.

    Several other regulations and policies apply to grants under this 
subpart. These include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
42 CFR part 50, subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought.
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 (non 
procurement) 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 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
48 FR 24556--Guidelines for Research Involving Recombinant DNA Molecules 
published by the National Institutes of Health
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.

[49 FR 38116, Sept. 27, 1984, as amended at 66 FR 29501, May 31, 2001]

    Editorial Note: At 66 FR 20752, May 31, 2001, in Sec. 66.207, the 
entry for 48 FR 24556 was revised. However, no new entry was set forth.



Sec. 66.208  Additional conditions.

    The Secretary may, with respect to any grant award, impose 
additional conditions prior to or at the time of any award when in the 
Secretary's judgment those conditions are necessary to assure or protect 
advancement of the approved program, the interests of the public health, 
or the conservation of grant funds.



PART 67_AGENCY FOR HEALTH CARE POLICY AND RESEARCH GRANTS AND CONTRACTS--Table of Contents




  Subpart A_Research Grants for Health Services Research, Evaluation, 
                Demonstration, and Dissemination Projects

Sec.
67.10 Purpose and scope.
67.11 Definitions.
67.12 Eligible applicants.
67.13 Eligible projects.
67.14 Application.
67.15 Peer review of applications.
67.16 Evaluation and disposition of applications.
67.17 Grant award.
67.18 Use of project funds.
67.19 Other applicable regulations.
67.20 Confidentiality.
67.21 Control of data and availability of publications.
67.22 Additional conditions.

    Subpart B_Peer Review of Contracts for Health Services Research, 
          Evaluation, Demonstration, and Dissemination Projects

67.101 Purpose and scope.
67.102 Definitions.
67.103 Peer review of contract proposals.
67.104 Confidentiality.
67.105 Control of data and availability of publications.

    Authority: Pub. L. 103-43, 107 Stat. 214-215, Pub. L. 102-410, 106 
Stat. 2094-2101 and sec. 6103, Pub. L. 101-239, 103 Stat. 2189-2208, 
Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6); and 
sec. 1142, Social Security Act (42 U.S.C. 1320b-12).

    Source: 62 FR 12908, Mar. 18, 1997, unless otherwise noted.

[[Page 401]]



  Subpart A_Research Grants for Health Services Research, Evaluation, 

                Demonstration, and Dissemination Projects



Sec. 67.10  Purpose and scope.

    The regulations of this subpart apply to the award by AHCPR of 
grants and cooperative agreements under:
    (a) Title IX of the Public Health Service Act to support research, 
evaluation, demonstration, and dissemination projects, including 
conferences, on health care services and systems for the delivery of 
such services, as well as to establish and operate multidisciplinary 
health services research centers.
    (b) Section 1142 of the Social Security Act to support research on 
the outcomes, effectiveness, and appropriateness of health care services 
and procedures, including but not limited to, evaluations of alternative 
services and procedures; projects to improve methods and data bases for 
outcomes, effectiveness, and other research; dissemination of research 
information and clinical guidelines, conferences, and research on 
dissemination methods.



Sec. 67.11  Definitions.

    As used in this subpart--
    Administrator means the Administrator and any other officer or 
employee of the Agency for Health Care Policy and Research to whom the 
authority involved may be delegated.
    Agency for Health Care Policy and Research (AHCPR) means that unit 
of the Department of Health and Human Services established by section 
901 of the Public Health Service Act.
    Direct costs means the costs that can be identified specifically 
with a particular cost objective, such as compensation of employees for 
the time and effort devoted specifically to the approved project, and 
the costs of materials acquired, consumed, or expended specifically for 
the purpose of the approved project.
    Grant means an award of financial assistance as defined in 45 CFR 
parts 74 and 92, including cooperative agreements.
    Grantee means the organizational entity or individual to which a 
grant, including a cooperative agreement, under Title IX of the Public 
Health Service Act or section 1142 of the Social Security Act and this 
subpart is awarded and which is responsible and accountable both for the 
use of the funds provided and for the performance of the grant-supported 
project or activities. The grantee is the entire legal entity even if 
only a particular component is designated in the award document.
    Nonprofit as applied to a private entity, means that no part of the 
net earnings of such entity inures or may lawfully inure to the benefit 
of any shareholder or individual.
    Peer review group means a panel of experts, established under 
section 922(c) of the PHS Act, who by virtue of their training or 
experience are eminently qualified to carry out the duties of such peer 
review group as set out in this subpart. Officers and employees of the 
United States may not constitute more than 25 percent of the membership 
of any such group under this subpart.
    PHS Act means the Public Health Service Act, as amended.
    Principal investigator means a single individual, designated in the 
grant application and approved by the Administrator, who is responsible 
for the scientific and technical direction of the project.
    Social Security Act means the Social Security Act, as amended.



Sec. 67.12  Eligible applicants.

    Any public or nonprofit private entity or any individual is eligible 
to apply for a grant under this subpart.



Sec. 67.13  Eligible projects.

    Projects for research, evaluations, demonstrations, dissemination of 
information (including research on dissemination), and conferences, 
related to health care services and the delivery of such services, are 
eligible for grant support. These include, but are not limited to, 
projects in the following categories:
    (a) Effectiveness, efficiency, and quality of health care services;
    (b) Outcomes of health care services and procedures;

[[Page 402]]

    (c) Clinical practice, including primary care and practice-oriented 
research;
    (d) Health care technologies, facilities, and equipment, including 
assessments of health care technologies and innovative approaches to 
such assessments, and technology diffusion;
    (e) Health care costs and financing, productivity, and market 
forces;
    (f) Health promotion and disease prevention;
    (g) Health statistics and epidemiology;
    (h) Medical liability;
    (i) AID/HIV infection, particularly with respect to issues of access 
and delivery of health care services;
    (j) Rural health services;
    (k) The health of low-income, minority, elderly, and other 
underserved populations, including women and children; and
    (l) Information dissemination and research on dissemination 
methodologies, directed to health care providers, practitioners, 
consumers, educators, review organizations, and others.



Sec. 67.14  Application.

    (a) To apply for a grant, an entity or individual must submit an 
application in the form and at the time that the Administrator requires. 
The application must be signed by an individual authorized to act for 
the applicant and to assume on behalf of the applicant the obligations 
imposed by the PHS Act and the Social Security Act, as pertinent, the 
regulations of this subpart, and any additional terms or conditions of 
any grant awarded.
    (b) In addition to information requested on the application form, 
the applicant must provide such other information as the Administrator 
may request.



Sec. 67.15  Peer review of applications.

    (a) General procedures for peer review. (1) All applications for 
support under this subpart will be submitted by the Administrator for 
review to a peer review group, in accordance with section 922(a) of the 
PHS Act, except that applications eligible for review under section 
922(d)(2) of the PHS Act (``small grants'') may be reviewed under 
adjusted procedures in accordance with paragraph (b) of this section.
    (2) Members of the peer review group will be selected based upon 
their training and experience in relevant scientific and technical 
fields, taking into account, among other factors:
    (i) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) 
completed by the individual and/or the individual's pertinent experience 
and expertise;
    (ii) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (iii) The extent of the professional recognition received by the 
individual as reflected by awards and other honors received from 
scientific and professional organizations outside the Department of 
Health and Human Services;
    (iv) The need of the peer review group to include within its 
membership experts representing various areas of specialization within 
relevant scientific and technical fields, or specific health care 
issues; and
    (v) Appropriate representation based on gender, racial/ethnic 
origin, and geography.
    (3) Review by the peer review group under paragraph (a) of this 
section is conducted by using the criteria set out in paragraph (c) of 
this section.
    (4) The peer review group to which an application has been submitted 
under paragraph (a) of this section shall make a written report to the 
Administrator on each application, which shall contain the following 
parts:
    (i) The first part of the report shall consist of a factual summary 
of the proposed project, including a description of its purpose, 
scientific approach, location, and total budget.
    (ii) The second part of the report shall address the scientific and 
technical merit of the proposed project with a critique of the proposed 
project with regard to the factors described in paragraphs (c)(1)(i) 
through (c)(1)(x) or (c)(2)(i) through (c)(2)(vii) of this section as 
applicable. This portion of the report shall include a set of 
recommendations to the Administrator

[[Page 403]]

with respect to the disposition of the application based upon its 
scientific and technical merit. The peer review panel may recommend to 
the Administrator that an application:
    (A) Be given consideration for funding,
    (B) Be deferred for a later decision, pending receipt of additional 
information, or
    (C) Not be given further consideration.
    (iii) For each application recommended for further consideration by 
the Administrator, the report shall also provide a priority score based 
on the scientific and technical merit of the proposed project, and make 
recommendations on the appropriate project period and level of support. 
The report may also address, as applicable, the degree to which the 
proposed project relates to AHCPR-announced priorities.
    (b) Procedural adjustments for small grants. (1) The Administrator 
may make adjustments in the peer review procedures established in 
accordance with paragraph (a) of this section for grant applications 
with total direct costs that do not exceed the amount specified in 
section 922(d)(2) of the PHS Act, hereafter referred to as ``small 
grants.''
    (2) Non-Federal and Federal experts will be selected by the 
Administrator for the review of small grant applications on the basis of 
their training and experience in particular scientific and technical 
fields, their knowledge of health services research and the application 
of research findings, and their special knowledge of the issue(s) being 
addressed or methods and technology being used in the specific proposal.
    (3) Review of applications for small grants may be by a review group 
established in accordance with paragraph (a) of this section, or by 
individual field readers, or by an ad hoc group of reviewers.
    (4) The review criteria set forth in paragraph (c) of this section 
shall be used for the review of small grant applications.
    (5) Each reviewer or group of reviewers to whom an application has 
been submitted under paragraph (b) of this section shall make a written 
report to the Administrator on each application. Each report shall 
summarize the findings of the review and provide a recommendation to the 
Administrator on whether the application should be given further 
consideration. For applications recommended for further consideration, 
the report may also address, as applicable, the degree to which the 
proposed project relates to AHCPR-announced priorities.
    (c) Review criteria. The review criteria set out in this paragraph 
apply to both applications reviewed by peer review panels in accordance 
with paragraph (a) of this section, and applications for small grants 
reviewed in accordance with paragraph (b) of this section.
    (1) General review criteria. In carrying out a review under this 
section for grants (other than conference grants), the following review 
criteria will be taken into account, where appropriate:
    (i) The significance and originality from a scientific or technical 
standpoint of the goals of the project;
    (ii) The adequacy of the methodology proposed to carry out the 
project;
    (iii) The availability of data or the adequacy of the proposed plan 
to collect data required in the analyses;
    (iv) The adequacy and appropriateness of the plan for organizing and 
carrying out the project;
    (v) The qualifications and experience of the principal investigator 
and proposed staff;
    (vi) The reasonableness of the budget and the time frame for the 
project, in relation to the work proposed;
    (vii) The adequacy of the facilities and resources available to the 
grantee;
    (viii) The extent to which women and minorities are adequately 
represented in study populations;
    (ix) Where an application involves activities which could have an 
adverse effect upon humans, animals, or the environment, the adequacy of 
the proposed means for protecting against or minimizing such effects; 
and
    (x) Any additional criteria that may be announced by the 
Administrator from time to time for specific categories of grant 
applications (e.g., proposed projects for support of research centers) 
eligible for support under this subpart.

[[Page 404]]

    (xi) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as applicable.
    (2) Review criteria for conference grants. In carrying out reviews 
of conference grants under paragraphs (a) and (b) of this section, the 
following review criteria will be taken into account, as appropriate:
    (i) The significance of the proposed conference, specifically the 
importance of the issue or problem being addressed, including 
methodological or technical issues for dealing with the development, 
conduct, or use of health services research;
    (ii) The qualifications of the staff involved in planning and 
managing the conference;
    (iii) The adequacy of the facilities and other resources available 
for the conference;
    (iv) the appropriateness of the proposed budget, including other 
sources of funding;
    (v) The extent to which the health concerns of women and minorities 
will be addressed in the conference topic(s), as appropriate;
    (vi) The plan for evaluating and disseminating the results of the 
conference; and
    (vii) Any additional criteria that may be announced by the 
Administrator.
    (viii) In addition to the scientific and technical criteria above, 
peer reviewers may be asked to consider the degree to which a proposed 
project addresses any special AHCPR priorities that have been announced 
by the Administrator, as appropriate.
    (d) Conflict of interest. (1) Members of peer review groups will be 
screened for potential conflicts of interest prior to appointment and 
will be required to follow Department policies and procedures consistent 
with the Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635), Executive Order 12674 (as modified by 
Executive Order 12731).
    (2) In addition to any restrictions referenced under paragraph 
(d)(1) of this section:
    (i) No member of a peer review group (or individual reviewer) may 
participate in or be present during any review by such group of a grant 
application in which, to the member's knowledge, any of the following 
has a financial interest:
    (A) The member or his or her spouse, minor child, or partner;
    (B) Any organization in which the member is serving as an officer, 
director, trustee, general partner, or employee; or
    (C) Any organization with which the member is negotiating or has any 
arrangement concerning prospective employment or other similar 
association, and further;
    (ii) In the event that any member of a peer review group or his or 
her spouse, parent, child, or partner is currently or expected to be the 
principal investigator or member of the staff responsible for carrying 
out any research or development activities contemplated as part of a 
grant application, that member of the group, or the group, may be 
disqualified from the review and the review conducted by another group 
with the expertise to do so. An ad hoc group selected in accordance with 
Sec. 67.15(a), or Sec. 67.15(b) as applicable, may also be used for 
the review. Any individual reviewer to whom the conditions of this 
paragraph apply would also be disqualified as a reviewer.
    (iii) No member of a peer review group or individual may participate 
in any review under this subpart of a specific grant application for 
which the member has had or is expected to have any other responsibility 
or involvement (whether preaward or postaward) as an officer or employee 
of the United States.
    (3) Where permissible under the standards and order(s) cited in 
paragraph (d)(1) of this section, the Administrator may waive the 
requirements in paragraph (d)(2) of this section if it is determined 
that there is no other practical means for securing appropriate expert 
advice on a particular grant application.

[62 FR 12909, Mar. 18, 1997, as amended at 62 FR 37124, July 10, 1997]

[[Page 405]]



Sec. 67.16  Evaluation and disposition of application.

    (a) Evaluation. After appropriate peer review in accordance with 
Sec. 67.15, the Administrator will evaluate applications recommended 
for further consideration, taking into account, among other factors:
    (1) The degree to which the purposes of Title IX of the PHS Act and 
section 1142 of the Social Security Act, as applicable, are being 
addressed;
    (2) Recommendations made by reviewers pursuant to Sec. 67.15;
    (3) Any recommendations made by the National Advisory Council for 
Health Care Policy, Research, and Evaluation, as applicable;
    (4) The appropriateness of the budget;
    (5) The extent to which the research proposal and the fiscal plan 
provide assurance that effective use will be made of grant funds;
    (6) The demonstrated business management capability of the 
applicant;
    (7) The demonstrated competence and skill of the staff, especially 
the senior personnel, in light of the scope of the project;
    (8) The probable usefulness of the results of the project for 
dealing with national health care issues, policies, and programs; and
    (9) The degree to which AHCPR-announced priorities or purposes are 
being addressed.
    (b) Disposition. On the basis of the evaluation of the application 
as provided in paragraph (a) of this section, the Administrator shall: 
give consideration for funding, defer for a later decision, pending 
receipt of additional information, or give no further consideration for 
funding, to any application for a grant under this subpart; except that 
the Administrator may not fund an application which has not been 
recommended for further consideration as a result of peer review in 
accordance with Sec. 67.15. A recommendation against further 
consideration shall not preclude reconsideration, if the application is 
revised, responding to issues and questions raised during the review, 
and resubmitted for peer review at a later date.



Sec. 67.17  Grant award.

    (a) Within the limits of available funds, the Administrator may 
award grants to those applicants whose projects are being considered for 
funding, which in the judgment of the Administrator, will promote best 
the purposes of Title IX of the PHS Act and (if applicable) section 1142 
of the Social Security Act, AHCPR priorities, and the regulations of 
this subpart.
    (b) The Notice of Grant Award specifies how long the Administrator 
intends to support the project without requiring the project to 
recompete for funds. This period, called the project period, will 
usually be for 3-5 years, except for small grants, which usually are 1 
year awards. The project period as specified in the Notice of Grant 
Award shall begin no later than 9 months following the date of the 
award, except that the project period must begin in the same fiscal year 
as that from which funds are being awarded.
    (c) Upon request from the grantee, Department grants policy permits 
an extension of the project period for up to 12 months, without 
additional funds, when more time is needed to complete the research. The 
Administrator may approve a request for an additional extension of time 
based on unusual circumstances with written justification submitted by 
the grantee, prior to the completion of the project period. In no case 
will an additional extension of more than 12 months be approved.
    (d) Generally, a grant award will be for 1 year, and subsequent 
continuation awards will be for 1 year at a time. A grantee must submit 
a separate continuation application to have the support continued for 
each subsequent year. Decisions regarding continuation awards and the 
funding level of such 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 Administrator that continuation is in the best 
interest of the Federal Government.

[[Page 406]]

    (e) 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.
    (f) Small grants. For particular categories of small grants, such as 
dissertation research support, the Administrator may establish a limit 
on total direct costs to be awarded. Any categorical limits will be 
announced in advance of the deadline for receipt of applications for 
such small grants.
    (g) Supplemental awards. (1) Except for small grants, supplemental 
awards that would exceed 20 percent of the AHCPR approved direct costs 
of the project during the project period, or that request an increase in 
funds to support a change or a significant expansion of the scope of the 
project, will be reviewed as competing supplemental grants in accordance 
with Sec. 67.15(a). A supplemental award for preparation of data in 
suitable form for transmittal in accordance with Sec. 67.21 shall be 
excluded from the 20 percent aggregate.
    (2) In the case of small grants, as defined in section 922(d)(2) of 
the PHS Act, the Administrator will not approve a supplemental award 
during the project period (excluding any supplemental award for 
preparation of data in suitable form for transmittal in accordance with 
Sec. 67.21) that will, in the aggregate, exceed 10 percent of the AHCPR 
approved direct costs of the project.
    (h) Noncompeting continuation awards. Each project with a project 
period in excess of 2 years and with direct costs over the project 
period in excess of the amount specified in section 922(d)(2) may be 
reviewed during the second budget period and during each subsequent 
budget period by at least two members of the peer review group that 
reviewed the initial application, or individuals who participated in 
that review, to the extent practicable. Recommendations to the 
Administrator for continuation support will be based upon evaluation of:
    (1) The progress of the project in meeting project objectives;
    (2) The appropriateness of the management of the project and 
allocation of resources within the project;
    (3) The adequacy and appropriateness of the plan for carrying out 
the project during the budget period in light of the accomplishments 
during previous budget periods; and
    (4) The reasonableness of the proposed budget for the subsequent 
budget period.



Sec. 67.18  Use of project funds.

    Grant funds must be spent solely for carrying out the approved 
project in accordance with Title IX of PHS Act, section 1142 of the 
Social Security Act (if applicable), the regulations of this subpart, 
the terms and conditions of the award, and the provisions of 45 CFR part 
74, or part 92 for State and local government grantees.



Sec. 67.19  Other applicable regulations.

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

37 CFR part 401--Inventions and patents
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
42 CFR part 50 subpart F--Responsibility of applicants for promoting 
objectivity in research for which PHS funding is sought
45 CFR part 16--Procedures of the departmental grant appeals board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
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 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

[[Page 407]]

45 CFR part 91--Nondiscrimination on the basis of age in DHHS programs 
or activities receiving Federal financial assistance
45 CFR part 92--Uniform administrative requirements for grants and 
cooperative agreements with State and local governments
45 CFR part 93--New restrictions on lobbying



Sec. 67.20  Confidentiality.

    The confidentiality of identifying information obtained in the 
course of conducting or supporting grant and cooperative agreement 
activities under this subpart is protected by section 903(c) of the PHS 
Act. Specifically:
    (a) No information obtained in the course of conducting or 
supporting grant and cooperative agreement activities under this 
subpart, if the entity or individual supplying the information or 
described in it is identifiable, may be used for any purpose other than 
the purpose for which it was supplied, unless the identifiable entity or 
individual supplying the information or described in it has consented to 
such other use, in the recorded form and manner as the Administrator may 
require; and
    (b) No information obtained in the course of grant and cooperative 
agreement activities conducted or supported under this subpart maybe 
published or released in other form if the individual who supplied the 
information or who is described in it is identifiable, unless such 
individual has consented, in the recorded form and manner as the 
Administrator may require, to such publication or release.



Sec. 67.21  Control of data and availability of publications.

    Except as otherwise provided in the terms and conditions of the 
award and subject to the confidentiality requirements of section 903(c) 
of the PHS Act, section 1142(d) of the Social Security Act, and Sec. 
67.20 of this subpart:
    (a) All data collected or assembled for the purpose of carrying out 
health services research, evaluation, demonstration, or dissemination 
projects supported under this subpart shall be made available to the 
Administrator, upon request:
    (b) All publications, reports, papers, statistics, or other 
materials developed from work supported, in whole or in part, by an 
award made under this subpart must be submitted to the Administrator in 
a timely manner. All such publications must include an acknowledgement 
that such materials are the results of, or describe, a grant activity 
supported by AHCPR;
    (c) The AHCPR retains a royalty-free, non-exclusive, and irrevocable 
license to reproduce, publish, use, or disseminate any copyrightable 
material developed in the course of or under a grant for any purpose 
consistent with AHCPR's statutory responsibilities, and to authorize 
others to do so for the accomplishment of AHCPR purposes; and
    (d) Except for identifying information protected by section 903(c) 
of the PHS Act, the Administrator, as appropriate, will make information 
obtained with AHCPR grant support available, and arrange for 
dissemination of such information and material on as broad a basis as 
practicable and in such form as to make them as useful as possible to a 
variety of audiences, including health care providers, practitioners, 
consumers, educators, and policymakers.



Sec. 67.22  Additional conditions.

    The Administrator may, with respect to any grant awarded under this 
subpart, impose additional conditions prior to or at the time of any 
award when in the Administrator's judgment such conditions are necessary 
to assure or protect advancement of the approved project, the interest 
of the public health, or the conservation of grant funds.



    Subpart B_Peer Review of Contracts for Health Services Research, 
          Evaluation, Demonstration, and Dissemination Projects



Sec. 67.101  Purpose and scope.

    (a) The regulations of this subpart apply to the peer review of 
contracts under:
    (1) Title IX of the Public Health Service Act to support research, 
evaluation, demonstration, and dissemination projects, including 
conferences, on health care services and systems for

[[Page 408]]

the delivery of such services; and development of clinical practice 
guidelines, quality standards, performance measures, and review 
criteria.
    (2) Section 1142 of the Social Security Act to support research on 
the outcomes, effectiveness, and appropriateness of health care services 
and procedures, including, but not limited to, evaluations of 
alternative services and procedures; projects to improve methods and 
data bases for outcomes and effectiveness research; dissemination of 
research information and clinical practice guidelines, as well as 
quality standards, performance measures, and review criteria; 
conferences; and research on dissemination methods.
    (b) The regulations of this subpart also contain provisions 
respecting confidentiality of research data, control of data, and 
availability of information.



Sec. 67.102  Definitions.

    Contract proposal means a written offer to enter into a contract 
submitted to a contracting officer by an individual or non-Federal 
organization, and including at a minimum a description of the nature, 
purpose, duration, cost of project and methods, personnel, and 
facilities to be utilized in carrying out the requirements of the 
contract.
    Peer review group means a panel of experts, as required by section 
922(c) of the PHS Act, established to conduct technical and scientific 
review of contract proposals and to make recommendations to the 
Administrator regarding the merits of such proposals.
    Request for proposals means a Government solicitation to prospective 
offerors, under procedures for negotiated contracts, to submit a 
proposal to fulfill specific agency requirements based on terms and 
conditions defined in the solicitation. The solicitation contains 
information sufficient to enable all offerors to prepare competitive 
proposals, and is as complete as possible with respect to: The nature of 
work to be performed; descriptions and specifications of items to be 
delivered; performance schedule; special requirements, clauses or other 
circumstances affecting the contract; and criteria by which the 
proposals will be evaluated.



Sec. 67.103  Peer review of contract proposals.

    (a) All contract proposals for AHCPR support will be submitted by 
the Administrator for review to a peer review group, as required in 
section 922(a) of the PHS Act. Proposals will be reviewed in accordance 
with the Federal Acquisition Regulations and the Health and Human 
Services Acquisition Regulations (48 CFR Ch. I and III) and the 
requirements of the pertinent Request for Proposal.
    (b) Establishment of peer review groups. In accordance with section 
922(c) of the PHS Act, the Administrator shall establish such peer 
review groups as may be necessary to review all contract proposals 
submitted to AHCPR.
    (c) Composition of peer review groups. The peer review groups shall 
be composed of individuals, in accordance with section 922(c) of the PHS 
Act, as amended, who by virtue of their training or experience are 
eminently qualified to carry out the duties of such a peer review group. 
Officers and employees of the United States may not constitute more than 
25 percent of the membership of any such group. Members of the peer 
review group will be selected based upon their training or experience in 
relevant scientific and technical fields, taking into account, among 
other factors:
    (1) The level of formal education (e.g., M.A., Ph.D., M.D., D.N.Sc.) 
completed by the individual and/or, as appropriate, the individual's 
pertinent experience and expertise;
    (2) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (3) The extent of the professional recognition received by the 
individual as reflected by awards and other honors received from 
scientific and professional organizations outside the Department of 
Health and Human Services;
    (4) The need of the peer review group to include in its membership 
experts representing various areas of specialization in relevant 
scientific and technical fields, or specific health care issues; and

[[Page 409]]

    (5) Appropriate representation based on gender, racial/ethnic 
origin, and geography, to the extent practicable.
    (d) Term of peer review group members. Notwithstanding section 
922(c)(3) of the PHS Act, members of peer review groups appointed to 
review contract proposals will be appointed to such groups for a limited 
period of time, as determined by the Administrator; such as on an annual 
basis, or until the peer review of the contract proposals is completed, 
or until the expiration of the contract(s) awarded as a result of the 
peer review.
    (e) Conflict of interest. (1) Members of peer review groups will be 
screened for potential conflicts of interest prior to appointment and 
will be required to follow Department policies and procedures consistent 
with the Standards of Ethical Conduct for Employees of the Executive 
Branch (5 CFR part 2635) and Executive Order 12674 (as modified by 
Executive Order 12731).
    (2) In addition to any restrictions referenced under paragraph 
(e)(1) of this section:
    (i) No member of a peer review group may participate in or be 
present during any review by such group of a contract proposal in which, 
to the member's knowledge, any of the following has a financial 
interest:
    (A) The member or his or her spouse, minor child, or partner;
    (B) Any organization in which the member is serving as an officer, 
director, trustee, general partner, or employee; or
    (C) Any organization with which the member is negotiating or has any 
arrangement concerning prospective employment or other similar 
association, and further;
    (ii) In the event any member of a peer review group or his or her 
spouse, parent, child, or partner is currently or expected to be the 
project director or member of the staff responsible for carrying out any 
contract requirements as specified in the contract proposal, that member 
is disqualified and will be replaced as appropriate.



Sec. 67.104  Confidentiality.

    Identifying information obtained in the course of conducting AHCPR 
contract activities under this subpart is protected by section 903(c) of 
the PHS Act. Specifically:
    (a) No information obtained in the course of conducting AHCPR 
contract activities under this subpart, if the entity or individual 
supplying the information or described in it is identifiable, may be 
used for any purpose other than the purpose for which it was supplied, 
unless the identifiable entity or individual supplying the information 
or described in it has consented to such other use, in the recorded form 
and manner as the Administrator may require.
    (b) No information obtained in the course of conducting AHCPR 
contract activities under this subpart may be published or released in 
other form if the individual who supplied the information or who is 
described in it is identifiable, unless such individual has consented, 
in the recorded form and manner as the Administrator may require, to 
such publication or release.



Sec. 67.105  Control of data and availability of publications.

    (a) Data will be collected, maintained, and supplied as provided in 
each contract subject to the confidentiality requirements of section 
903(c) of the PHS Act, section 1142(d) of the Social Security Act, and 
Sec. 67.104 of this subpart.
    (b) All publications, reports, papers, statistics, or other 
materials developed from work supported in whole or in part by contracts 
under Title IX of the PHS Act or section 1142 of the Social Security 
Act, if applicable, must be submitted to the Administrator in accordance 
with the terms of the contract. All publications must include an 
acknowledgment that such materials are the results of, or describe, a 
contractual activity supported by AHCPR.
    (c) In accordance with 48 CFR 52.227-14, unless otherwise specified 
in the contract, AHCPR will retain a license to use, disclose, 
reproduce, prepare derivative works from, distribute copies to the 
public, and perform publicly and display publicly any copyrightable 
materials produced under a contract for any purpose consistent with 
AHCPR's statutory responsibilities, and to have or permit others to do 
so for accomplishment of AHCPR purposes.

[[Page 410]]

    (d) Except for identifying information protected by section 903(c) 
of the PHS Act, the Administrator, as appropriate, will make information 
provided in accordance with paragraphs (a) and (b) of this section 
available, and arrange for dissemination of such information and 
materials on as broad a basis as practicable and in such form as to make 
them as useful as possible to a variety of audiences, including health 
care providers, practitioners, consumers, educators, and policymakers.



PART 68a_NATIONAL INSTITUTES OF HEALTH (NIH) CLINICAL RESEARCH LOAN REPAYMENT 

PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS (CR-LRP)--Table of 

Contents




Sec.
68a.1 What is the scope and purpose of the NIH Clinical Research Loan 
          Repayment Program for Individuals from Disadvantaged 
          Backgrounds (CR-LRP)?
68a.2 Definitions.
68a.3 Who is eligible to apply?
68a.4 Who is eligible to participate?
68a.5 Who is ineligible to participate?
68a.6 How do individuals apply to participate in the CR-LRP?
68a.7 How are applicants selected to participate in the CR-LRP?
68a.8 What does the CR-LRP provide to participants?
68a.9 What loans qualify for repayment?
68a.10 What does an individual have to do in return for loan repayments 
          received under the CR-LRP?
68a.11 How does an individual receive loan repayments beyond the initial 
          two-year contract?
68a.12 What will happen if an individual does not comply with the terms 
          and conditions of participation in the CR-LRP?
68a.13 Under what circumstances can the service or payment obligation be 
          canceled, waived, or suspended?
68a.14 When can a CR-LRP payment obligation be discharged in bankruptcy?
68a.15 Additional conditions.
68a.16 What other regulations and statutes apply?

    Authority: 42 U.S.C. 288-5.

    Source: 63 FR 58312, Oct. 30, 1998, unless otherwise noted.



Sec. 68a.1  What is the scope and purpose of the NIH Clinical Research Loan 

Repayment Program for Individuals from Disadvantaged Backgrounds (CR-LRP)?

    This part applies to the award of educational loan payments under 
the NIH Clinical Research Loan Repayment Program for Individuals from 
Disadvantaged Backgrounds (CR-LRP) authorized by section 487E of the 
Public Health Service Act (42 U.S.C. 288-5). The purpose of this program 
is to recruit and retain appropriately qualified health professionals, 
who are from disadvantaged backgrounds and have substantial educational 
debt relative to income, to conduct clinical research as NIH employees.



Sec. 68a.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Applicant means an individual who applies to, and meets the 
eligibility criteria for the CR-LRP.
    Approved clinical research means clinical research approved by the 
Clinical Research Loan Repayment Committee.
    Clinical privileges means the delineation of privileges for patient 
care granted to qualified health professionals by the NIH Medical 
Executive Committee or other appropriate credentialing board.
    Clinical research means activities which qualify for inclusion as 
clinical research in the CR-LRP as determined by the Clinical Research 
Loan Repayment Committee.
    Clinical Research Loan Repayment Committee (CR-LRC) means the 
scientific board assembled to review, rank, and approve or disapprove 
Clinical Research Loan Repayment Program applications. The CR-LRC is 
composed of NIH scientific staff and co-chaired by the Associate 
Director for Clinical Research, NIH, and the Associate Director for 
Research on Minority Health, NIH. Members are nominated by the Deputy 
Director, Intramural Research, NIH, and the co-chairs, and appointed by 
the Director, NIH.
    Clinical Research Loan Repayment Program (CR-LRP or Program) means 
the

[[Page 411]]

NIH Clinical Research Loan Repayment Program for Individuals from 
Disadvantaged Backgrounds authorized by section 487E of the Act, as 
amended.
    Clinical Research Loan Repayment Program (CR-LRP or Program) 
contract refers to the agreement, which is signed by an applicant and 
the Secretary, wherein the applicant from a disadvantaged background 
agrees to engage in clinical research as an employee of the NIH and the 
Secretary agrees to repay qualified educational loans for a prescribed 
period as specified in this part.
    Clinical researcher means an NIH employee with clinical privileges 
who is conducting approved clinical research.
    Commercial loans means loans made by banks, credit unions, savings 
and loan associations, not-for-profit organizations, insurance 
companies, schools, and other financial or credit institutions which are 
subject to examination and supervision in their capacity as lending 
institutions by an agency of the United States or of the State in which 
the lender has its principal place of business.
    Current payment status means that a qualified educational loan is 
not past due in its payment schedule as determined by the lending 
institution.
    Debt threshold refers to the minimum amount of qualified educational 
debt an individual must have, on his/her program eligibility date, in 
order to be eligible for Program benefits and, for purposes of 
eligibility under this part, debt threshold means that the qualified 
educational debt must equal or exceed 20 percent of an individual's 
annual NIH salary on his/her program eligibility date.
    Educational expenses means the cost of the health professional's 
education, including the tuition expenses and other educational expenses 
such as fees, books, supplies, educational equipment and materials, and 
laboratory expenses.
    Government loans means loans made by Federal, State, county, or city 
agencies which are authorized by law to make such loans.
    Individual from disadvantaged background means an individual who:
    (1) Comes from an environment that inhibited the individual from 
obtaining the knowledge, skill and ability required to enroll in and 
graduate from a health professions school; or
    (2) Comes from a family with an annual income below a level based on 
low-income thresholds according to family size published by the U.S. 
Bureau of the Census, adjusted annually for changes in the Consumer 
Price Index, and adjusted by the Secretary for use in all health 
professions programs. The Secretary periodically publishes these income 
levels in the Federal Register.
    Institute, Center, or Agency (ICA) means an institute, center, or 
agency of the National Institutes of Health.
    Living expenses means the reasonable cost of room and board, 
transportation and commuting costs, and other reasonable costs incurred 
during an individual's attendance at an educational institution.
    Participant means an individual whose application to the CR-LRP has 
been approved and whose Program contract has been executed by the 
Secretary.
    Program means the NIH Clinical Research Loan Repayment Program for 
Individuals from Disadvantaged Backgrounds.
    Program eligibility date means the date on which an individual's 
Program contract is executed by the Secretary and that individual is 
engaged in approved clinical research as an employee of the NIH.
    Qualified educational loans and interest/debt include Government and 
commercial educational loans and interest for:
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and (3) reasonable living expenses, 
including the cost of room and board, transportation and commuting 
costs, and other reasonable living expenses incurred.
    Reasonable educational and living expenses means those educational 
and living expenses which are equal to or less than the sum of the 
school's estimated

[[Page 412]]

standard student budget for educational and living expenses for the 
degree program and for the year(s) during which the participant was 
enrolled in school. If there is no standard budget available from the 
school or if the participant requests repayment for educational and 
living expenses which exceed the standard student budget, reasonableness 
of educational and living expenses incurred must be substantiated by 
additional contemporaneous documentation, as determined by the 
Secretary.
    Repayable debt means the portion, as established by the Secretary, 
of an individual's total qualified educational debt relative to the NIH 
salary, which can be paid by the CR-LRP. Specifically, qualifying 
educational debt amounts in excess of 50 percent of the debt threshold 
will be considered for repayment.
    Salary means base pay plus quarters, subsistence, and variable 
housing allowances, if applicable.
    School means undergraduate, graduate, and health professions schools 
which are accredited by a body or bodies recognized for accreditation 
purposes by the Secretary of Education.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    Service means the Public Health Service.
    State means one of the fifty States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. 
Virgin Islands, Guam, American Samoa, and the Trust Territory of the 
Pacific Islands (the Federated States of Micronesia, the Republic of the 
Marshall Islands, and the Republic of Palau).
    Withdrawal means a request by a participant, prior to the Program 
making payments on his or her behalf, for withdrawal from Program 
participation. A withdrawal is without penalty to the participant and 
without obligation to the Program.



Sec. 68a.3  Who is eligible to apply?

    To be eligible to apply to the CR-LRP, an individual must be a 
citizen, national, or permanent resident of the United States; hold a 
M.D., Ph.D., D.O., D.D.S., D.M.D., A.D.N./B.S.N., or equivalent degree; 
have, on his/her program eligibility date, qualified educational debt 
equal to or in excess of the debt threshold; and be an individual from a 
disadvantaged background.



Sec. 68a.4  Who is eligible to participate?

    To be eligible to participate in the CR-LRP, an applicant must have 
the recommendation of the employing ICA Scientific Program Director, the 
concurrence of the employing ICA Director, and the approval of the CR-
LRC. Since participation in the Program is contingent, in part, upon 
employment with NIH, a Program contract may not be awarded to an 
applicant until an employment commitment has been made by the employing 
ICA Personnel Department.



Sec. 68a.5  Who is ineligible to participate?

    The following individuals are ineligible for CR-LRP participation:
    (a) Persons who are not eligible applicants as specified under 
section 68a.3;
    (b) Persons who owe an obligation of health professional service to 
the Federal Government, a State, or other entity, unless a deferral is 
granted for the length of his/her service obligation under the CR-LRP. 
The following are examples of programs which have a service obligation: 
Physicians Shortage Area Scholarship Program, National Research Service 
Award Program, Public Health Service Scholarship, National Health 
Service Corps Scholarship Program, Armed Forces (Army, Navy, or Air 
Force) Professions Scholarship Program, Indian Health Service 
Scholarship Program, and the NIH AIDS Research Loan Repayment Program.
    (c) Persons who are not NIH employees, such as Intramural Research 
Training Award (IRTA) recipients, Visiting Fellows, National Research 
Service Award (NRSA) recipients, Guest Researchers or Special 
Volunteers, NIH-National Research Council (NRC) Biotechnology Research 
Associates Program participants, and Intergovernmental Personnel Act 
(IPA) participants; or

[[Page 413]]

    (d) Persons who do not have clinical privileges.



Sec. 68a.6  How do individuals apply to participate in the CR-LRP?

    An application for participation in the CR-LRP shall be submitted to 
the NIH office which is responsible for the Program's administration, in 
such form and manner as the Secretary may prescribe.



Sec. 68a.7  How are applicants selected to participate in the CR-LRP?

    To be selected for participation in the CR-LRP, applicants must 
satisfy the following requirements:
    (a) Applicants must meet the eligibility requirements specified in 
Sec. 68a.3 and Sec. 68a.4.
    (b) Applicants must not be ineligible for participation as specified 
in Sec. 68a.5.
    (c) Applicants must be selected for approval by the CR-LRC, based 
upon a review of their applications.



Sec. 68a.8  What does the CR-LRP provide to participants?

    (a) Loan repayments: For each year of service the individual agrees 
to serve, with a minimum of 2 years of obligated service, the Secretary 
may pay up to $20,000 per year of a participant's repayable debt.
    (b) Under Sec. 68a.8(a), the Secretary will make payments in the 
discharge of debt to the extent appropriated funds are available for 
these purposes.



Sec. 68a.9  What loans qualify for repayment?

    (a) The CR-LRP will repay participants' lenders the principal, 
interest, and related expenses of qualified Government and commercial 
educational loans obtained by participants for the following:
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (3) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other living expenses as 
determined by the Secretary.
    (b) The following educational loans are ineligible for repayment 
under the CR-LRP:
    (1) Loans obtained from other than a government entity or commercial 
lending institution;
    (2) Loans for which contemporaneous documentation is not available;
    (3) Loans or portions of loans obtained for educational or living 
expenses which exceed the standard of reasonableness as determined by 
the participant's standard school budget for the year in which the loan 
was made, and are not determined by the Secretary to be reasonable based 
on additional documentation provided by the individual;
    (4) Loans, financial debts, or service obligations incurred under 
the following programs: Physicians Shortage Area Scholarship Program 
(Federal or State), National Research Service Award Program, Public 
Health and National Health Service Corps Scholarship Training Program, 
National Health Service Corps Scholarship Program, Armed Forces (Army, 
Navy, or Air Force) Health Professions Scholarship Program, Indian 
Health Service Program, and similar programs, upon determination by the 
Secretary, which provide loans, scholarships, loan repayments, or other 
awards in exchange for a future service obligation;
    (5) Any loan in default or not in a current payment status;
    (6) Loan amounts which participants have paid or were due to have 
paid prior to the program eligibility date; and
    (7) Loans for which promissory notes have been signed after the 
program eligibility date.



Sec. 68a.10  What does an individual have to do in return for loan repayments 

received under the CR-LRP?

    Individuals must agree to be engaged in approved clinical research, 
as employees of the NIH, for a minimum initial period of two consecutive 
years.

[[Page 414]]



Sec. 68a.11  How does an individual receive loan repayments beyond the initial 

two-year contract?

    An individual may apply for and the Secretary may grant extension 
contracts for one-year periods, if there is sufficient debt remaining to 
be repaid and the individual is engaged in approved clinical research as 
an NIH employee.



Sec. 68a.12  What will happen if an individual does not comply with the terms 

and conditions of participation in the CR-LRP?

    (a) Absent withdrawal (see Sec. 68a.2) or termination under 
paragraph (d) of this section, any participant who fails to complete the 
minimum two-year service obligation required under the Program contract 
will be considered to have breached the contract and will be subject to 
assessment of monetary damages and penalties as follows:
    (1) Participants who leave during the first year of the initial 
contract are liable for amounts already paid by the NIH on behalf of the 
participant plus an amount equal to $1,000 multiplied by the number of 
months of the original service obligation.
    (2) Participants who leave during the second year of the contract 
are liable for amounts already paid by the NIH on behalf of the 
participant plus $1,000 for each unserved month.
    (b) Payments of any amount owed under paragraph (a) of this section 
shall be made within one year of the participant's breach (or such 
longer period as determined by the Secretary).
    (c) Participants who sign a continuation contract for any year 
beyond the initial two-year period and fail to complete the one-year 
period specified are liable for the pro rata amount of any benefits 
advanced beyond the period of completed service.
    (d) Terminations will not be considered a breach of contract in 
cases where such terminations are beyond the control of the participant 
as follows:
    (1) Terminations for cause or for convenience of the Government will 
not be considered a breach of contract and monetary damages will not be 
assessed.
    (2) Occasionally, a participant's research assignment may evolve and 
change to the extent that the individual is no longer engaged in 
approved clinical research. Similarly, the research needs and priorities 
of the ICA and/or the NIH may change to the extent that a determination 
is made that the health professional's skills may be better utilized in 
a non-clinical research assignment. Under these circumstances, the 
following will apply:
    (i) Program participation and benefits will cease as of the date an 
individual is no longer engaged in approved clinical research; and
    (ii) Normally, job changes of this nature will not be considered a 
breach of contract on the part of either the NIH or the participant. 
Based on the recommendation of the ICA Director and concurrence of the 
Secretary, the participant will be released from the remainder of his or 
her service obligation without assessment of monetary penalties. The 
participant in this case will be permitted to retain all Program 
benefits made or owed by NIH on his/her behalf up to the date the 
individual is no longer engaged in approved clinical research, except 
the pro rata amount of any benefits advanced beyond the period of 
completed service.



Sec. 68a.13  Under what circumstances can the service or payment obligation be 

canceled, waived, or suspended?

    (a) Any obligation of a participant for service or payment to the 
Federal Government under this part will be canceled upon the death of 
the participant.
    (b) The Secretary may waive or suspend any service or payment 
obligation incurred by the participant upon request whenever compliance 
by the participant:
    (1) Is impossible,
    (2) Would involve extreme hardship to the participant, or
    (3) If enforcement of the service or payment obligation would be 
against equity and good conscience.
    (4) The Secretary may approve a request for a suspension of the 
service or payment obligations for a period of 1 year. A renewal of this 
suspension may also be granted.
    (c) Compliance by a participant with a service or payment obligation 
will be

[[Page 415]]

considered impossible if the Secretary determines, on the basis of such 
information and documentation as may be required, that the participant 
suffers from a physical or mental disability resulting in the permanent 
inability of the participant to perform the service or other activities 
which would be necessary to comply with the obligation.
    (d) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against equity and good conscience, the Secretary, on 
the basis of such information and documentation as may be required, will 
consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as a physical or mental disability or terminal illness in 
the immediate family, which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to perform the obligation incurred.



Sec. 68a.14  When can a CR-LRP payment obligation be discharged in bankruptcy?

    Any payment obligation incurred under Sec. 68a.12 may be discharged 
in bankruptcy under Title 11 of the United States Code only if such 
discharge is granted after the expiration of the five-year period 
beginning on the first date that payment is required and only if the 
bankruptcy court finds that a nondischarge of the obligation would be 
unconscionable.



Sec. 68a.15  Additional conditions.

    When a shortage of funds exists, participants may be funded 
partially, as determined by the Secretary. However, once a CR-LRP 
contract has been signed by both parties, the Secretary will obligate 
such funds as necessary to ensure that sufficient funds will be 
available to pay benefits for the duration of the period of obligated 
service unless, by mutual written agreement between the Secretary and 
the applicant, specified otherwise. Benefits will be paid on a quarterly 
basis after each service period unless specified otherwise by mutual 
written agreement between the Secretary and the applicant. The Secretary 
may impose additional conditions as deemed necessary.



Sec. 68a.16  What other regulations and statutes apply?

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

Debt Collection Act of 1982, Pub. L. 97-365 (5 U.S.C. 5514);
Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
Federal Debt Collection Procedures Act of 1990, Pub. L. 101-647 (28 
U.S.C. 1); and
Privacy Act of 1974 (5 U.S.C. 552a).



PART 68c_NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 

CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM--Table of 

Contents




Sec.
68c.1 What is the scope and purpose of the National Institute of Child 
          Health and Human Development (NICHD) Contraception and 
          Infertility Research Loan Repayment Program (CIR-LRP)?
68c.2 Definitions.
68c.3 Who is eligible to apply?
68c.4 Who is eligible to participate?
68c.5 Who is ineligible to participate?
68c.6 How do individuals apply to participate in the CIR-LRP?
68c.7 How are applicants selected to participate in the CIR-LRP?
68c.8 What does the CIR-LRP provide to participants?
68c.9 What loans qualify for repayment?
68c.10 What does an individual have to do in return for loan repayments 
          received under the CIR-LRP?
68c.11 How does an individual receive loan repayments beyond the initial 
          two-year contract?
68c.12 What will happen if an individual does not comply with the terms 
          and conditions of participation in the CIR-LRP?
68c.13 Under what circumstances can the service or payment obligation be 
          canceled, waived, or suspended?
68c.14 When can a CIR-LRP payment obligation be discharged in 
          bankruptcy?
68c.15 Additional conditions.
68c.16 What other regulations and statutes apply?

    Authority: 42 U.S.C. 288-2.

[[Page 416]]


    Source: 67 FR 17651, Apr. 11, 2002, unless otherwise noted.



Sec. 68c.1  What is the scope and purpose of the National Institute of Child 

Health and Human Development (NICHD) Contraception and Infertility Research 

Loan Repayment Program (CIR-LRP)?

    This part applies to the award of educational loan payments under 
the National Institute of Child Health and Human Development (NICHD) 
Contraception and Infertility Research Loan Repayment Program (CIR-LRP) 
authorized by section 487B of the Public Health Service Act (42 U.S.C. 
288-2). The purpose of this CIR-LRP is the recruitment and retention of 
highly qualified health professionals to conduct contraception and/or 
infertility research.



Sec. 68c.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Allied health professional means:
    (1) A physician assistant; or
    (2) A research assistant with at least a bachelor's degree and 
applicable career goals.
    Applicant means an individual who applies to, and meets the 
eligibility criteria for the CIR-LRP.
    Commercial loans means loans made by banks, credit unions, savings 
and loan associations, not-for-profit organizations, insurance 
companies, schools, and other financial or credit institutions which are 
subject to examination and supervision in their capacity as lending 
institutions by an agency of the United States or of the State in which 
the lender has its principal place of business.
    Contraception and Infertility Research Loan Repayment Program (CIR-
LRP or Program) means the NICHD Contraception and Infertility Research 
Loan Repayment Program authorized by section 487B of the Act.
    Contraception and Infertility Research Loan Repayment Program (CIR-
LRP or Program) contract refers to the agreement, which is signed by an 
applicant and the Secretary, wherein the applicant agrees to participate 
in research on infertility or contraceptive development and the 
Secretary agrees to repay qualified educational loans for a prescribed 
period as specified in this part.
    Contraception and Infertility Research Loan Repayment Program (CIR-
LRP or Program) Panel means a board assembled to review, rank, and 
approve or disapprove CIR-LRP applications. The Panel is composed of the 
Deputy Director, NICHD, representatives of NICHD's Office of 
Administrative Management, respective Program Officers of the Center for 
Population Research, and other special consultants as required.
    Contraceptive development means research whose ultimate goal is to 
provide new or improved means of preventing pregnancy.
    Educational expenses means the cost of the health professional's 
education, including the tuition expenses and other educational expenses 
such as fees, books, supplies, educational equipment and materials, and 
laboratory expenses.
    Government loans means loans made by Federal, State, county, or city 
agencies which are authorized by law to make such loans.
    Health professional means an individual who is a physician, Ph.D-
level scientist, nurse, or a graduate student or postgraduate research 
fellow working toward a degree that will enable them to practice in one 
of those professions.
    Infertility research means research whose long-range objective is to 
evaluate, treat or ameliorate conditions which result in the failure of 
couples to either conceive or bear young.
    Living expenses means the reasonable cost of room and board, 
transportation and commuting costs, and other reasonable costs incurred 
during an individual's attendance at an educational institution.
    Eligible NICHD-supported extramural site means a site funded by 
NICHD that can be identified as one of the following:
    (1) A Cooperative Specialized Contraception and Infertility Research 
Center;
    (2) A Cooperative Specialized Research Center in Reproduction 
Research;
    (3) A Women's Reproductive Health Research Career Development 
Center; and

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    (4) Reproductive Medicine Unit identified as a clinical site for the 
National Cooperative Reproductive Medicine Network, or other sites as 
designated by the Director.
    NICHD intramural laboratory means a laboratory that is supported by 
the NICHD intramural research program.
    Panel means the NICHD Contraception and Infertility Research Loan 
Repayment Program Panel.
    Participant means an individual whose application to the CIR-LRP has 
been approved and whose Program contract has been executed by the 
Secretary.
    Qualified educational loans include Government and commercial 
educational loans, interest and related expenses for--
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (3) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other reasonable living 
expenses incurred.
    Reasonable educational and living expenses means those educational 
and living expenses which are equal to or less than the sum of the 
school's estimated standard student budget for educational and living 
expenses for the degree program and for the year(s) during which the 
participant was enrolled in school. If there is no standard budget 
available from the school or if the participant requests repayment for 
educational and living expenses which exceed the standard student 
budget, reasonableness of educational and living expenses incurred must 
be substantiated by additional contemporaneous documentation, as 
determined by the Secretary.
    Research on infertility or contraceptive development means 
activities which qualify for participation in the CIR-LRP as determined 
by the Program Panel.
    School means undergraduate, graduate, and health professions schools 
which are accredited by a body or bodies recognized for accreditation 
purposes by the Secretary of Education.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.
    Service means the Public Health Service.
    State means one of the fifty States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. 
Virgin Islands, Guam, American Samoa, and the Trust Territory of the 
Pacific Islands (the Federated States of Micronesia, the Republic of the 
Marshall Islands, and the Republic of Palau).
    Withdrawal means an individual's cessation of participation in the 
Program pursuant to a request by that participant that is implemented by 
the Secretary prior to the Program making payments on the participant's 
behalf. A withdrawal is without penalty to the participant and without 
obligation to the Program.



Sec. 68c.3  Who is eligible to apply?

    To be eligible to apply to the CIR-LRP, an individual must be a 
qualified health or allied health professional who is at the time of 
application, or will be at the time of inception into the CIR-LRP, 
engaged in employment/training at an NICHD intramural laboratory or an 
eligible NICHD-supported extramural site.



Sec. 68c.4  Who is eligible to participate?

    To be eligible to participate in the CIR-LRP, the applicant must 
have institutional assurance of employment/affiliation with the NICHD 
intramural laboratory or eligible NICHD-supported extramural site and 
approval of the CIR-LRP Panel, must meet the criteria specified in Sec. 
68c.3, and not be ineligible to participate under Sec. 68c.5.



Sec. 68c.5  Who is ineligible to participate?

    The following individuals are ineligible for CIR-LRP participation:
    (a) Persons who are not eligible applicants as specified under Sec. 
68c.3;

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    (b) Persons who owe an obligation of health professional service to 
the Federal Government, a State, or other entity. The following are 
examples of programs which have a service obligation: Physicians 
Shortage Area Scholarship Program, National Research Service Award 
Program, Public Health Service Scholarship, National Health Service 
Corps Scholarship Program, Armed Forces (Army, Navy, or Air Force) 
Professions Scholarship Program, Indian Health Service Scholarship 
Program, National Health Service Corp Loan Repayment Program, and NIH 
loan repayment programs.



Sec. 68c.6  How do individuals apply to participate in the CIR-LRP?

    An application for participation in the CIR-LRP shall be submitted 
to the Center for Population Research, NICHD, NIH, which is responsible 
for the Program's administration, in such form and manner as the 
Secretary may prescribe.



Sec. 68c.7  How are applicants selected to participate in the CIR-LRP?

    To be selected for participation in the CIR-LRP, applicants must 
satisfy the following requirements:
    (a) Applicants must meet the eligibility requirements specified in 
Sec. 68c.3 and Sec. 68c.4.
    (b) Applicants must not be ineligible for participation as specified 
in Sec. 68c.5.
    (c) Applicants must propose repayment of a loan that meets the 
requirements of Sec. 68c.9.
    (d) Applicants must be selected for approval by the CIR-LRP Panel 
based upon a review of their applications.



Sec. 68c.8  What does the CIR-LRP provide to participants?

    (a) Loan repayments. Upon receipt of an individual's written 
commitment to serve a minimum initial period of two years of obligated 
service in accordance with this part, the Secretary may pay up to 
$35,000 per year of a participant's repayable debt for each year the 
individual serves.
    (b) Under paragraph (a) of this section, the Secretary will make 
payments in the discharge of debt to the extent appropriated funds are 
available for that purpose. When a shortage of funds exists, 
participants may be funded partially, as determined by the Secretary. 
However, once a CIR-LRP contract has been signed by both parties, the 
Secretary will obligate such funds as necessary to ensure that 
sufficient funds will be available to pay benefits for the duration of 
the period of obligated service unless otherwise specified by mutual 
written agreement between the Secretary and the applicant. Benefits will 
be paid on a quarterly basis after each service period unless otherwise 
specified by mutual written agreement between the Secretary and the 
applicant.



Sec. 68c.9  What loans qualify for repayment?

    (a) The CIR-LRP will repay participants' lenders the principal, 
interest, and related expenses of qualified Government and commercial 
educational loans obtained by participants for the following:
    (1) Undergraduate, graduate, and health professional school tuition 
expenses;
    (2) Other reasonable educational expenses required by the school(s) 
attended, including fees, books, supplies, educational equipment and 
materials, and laboratory expenses; and
    (3) Reasonable living expenses, including the cost of room and 
board, transportation and commuting costs, and other living expenses as 
determined by the Secretary.
    (b) The following educational loans are ineligible for repayment 
under the CIR-LRP:
    (1) Loans obtained from other than a government entity or commercial 
lending institution;
    (2) Loans for which contemporaneous documentation is not available;
    (3) Loans or portions of loans obtained for educational or living 
expenses which exceed the standard of reasonableness as determined by 
the participant's standard school budget for the year in which the loan 
was made, and are not determined by the Secretary to be reasonable based 
on additional documentation provided by the individual;
    (4) Loans, financial debts, or service obligations incurred under 
the following programs: Physicians Shortage

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Area Scholarship Program (Federal or State), National Research Service 
Award Program, Public Health and National Health Service Corps 
Scholarship Training Program, National Health Service Corps Scholarship 
Program, Armed Forces (Army, Navy, or Air Force) Health Professions 
Scholarship Program, Indian Health Service Program, and similar 
programs, upon determination by the Secretary, which provide loans, 
scholarships, loan repayments, or other awards in exchange for a future 
service obligation;
    (5) Any loan in default or not in a current payment status;
    (6) Loan amounts which participants have paid or were due for 
payment prior to inception into the CIR-LRP; and
    (7) Loans for which promissory notes have been signed after the 
individual's acceptance into the CIR-LRP.



Sec. 68c.10  What does an individual have to do in return for loan repayments 

received under the CIR-LRP?

    Individuals must make a written commitment in accordance with this 
part to conduct, and must actually conduct research with respect to 
contraception and/or infertility at an NICHD intramural laboratory or an 
eligible NICHD-supported extramural site for a minimum initial period of 
two years.



Sec. 68c.11  How does an individual receive loan repayments beyond the initial 

two-year contract?

    An individual may apply for and the Secretary may grant extension 
contracts for one-year periods, if there is sufficient debt remaining to 
be repaid and the individual is engaged in research on infertility or 
contraceptive development at an NICHD intramural laboratory or eligible 
NICHD-supported extramural site.



Sec. 68c.12  What will happen if an individual does not comply with the terms 

and conditions of participation in the CIR-LRP?

    (a) Absent withdrawal (see Sec. 68c.2) or termination under 
paragraph (d) of this section, any participant who fails to begin or 
complete the minimum two-year service obligation required under the 
Program contract, will be considered to have breached the contract and 
will be subject to assessment of monetary damages and penalties as 
follows:
    (1) Participants who leave during the first year of the initial 
contract are liable for amounts already paid by the CIR-LRP on behalf of 
the participant plus an amount equal to $1,000 multiplied by the number 
of months of the original two-year service obligation.
    (2) Participants who leave during the second year of the contract 
are liable for amounts already paid by the NICHD on behalf of the 
participant plus $1,000 for each unserved month.
    (b) Participants who sign a continuation contract for any year 
beyond the initial two-year period and fail to complete the one-year 
period specified are liable for the pro rata amount of any benefits 
advanced beyond the period of completed service plus an amount equal to 
the number of months of obligated service that were not completed by the 
participant multiplied by $1,000.
    (c) Payments of any amount owed under paragraph (a) or (b) of this 
section shall be made within one year of the participant's breach (or 
such longer period as determined by the Secretary).
    (d) Terminations will not be considered a breach of contract in 
cases where such terminations are beyond the control of the participant 
as follows:
    (1) Terminations for cause or for convenience of the Government that 
are not based upon a breach or default of the participant will not be 
considered a breach of contract and monetary damages will not be 
assessed.
    (2) The participant transfers to another NICHD intramural laboratory 
or eligible NICHD-supported extramural site, in which case the 
participant remains bound to any and all obligations of the contract.
    (3) The participant transfers to a site other than an NICHD 
intramural laboratory or eligible NICHD-supported extramural site, in 
which case the participant may not be assessed monetary penalties if, in 
the judgement of the CIR-LRP Panel, the participant continues to engage 
in contraception and/or infertility research for any remaining period of 
obligated service as set forth in the contract.

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Sec. 68c.13  Under what circumstances can the service or payment obligation be 

canceled, waived, or suspended?

    (a) Any obligation of a participant for service or payment to the 
Federal Government under this part will be canceled upon the death of 
the participant.
    (b)(1) The Secretary may waive or suspend any service or payment 
obligation incurred by the participant upon request whenever compliance 
by the participant:
    (i) Is impossible;
    (ii) Would involve extreme hardship to the participant; or
    (iii) If enforcement of the service or payment obligation would be 
against equity and good conscience.
    (2) The Secretary may approve a request for a suspension of the 
service or payment obligations for a period of 1 year. A renewal of this 
suspension may also be granted.
    (c) Compliance by a participant with a service or payment obligation 
will be considered impossible if the Secretary determines, on the basis 
of information and documentation as may be required, that the 
participant suffers from a physical or mental disability resulting in 
the permanent inability of the participant to perform the service or 
other activities which would be necessary to comply with the obligation.
    (d) In determining whether to waive or suspend any or all of the 
service or payment obligations of a participant as imposing an undue 
hardship and being against equity and good conscience, the Secretary, on 
the basis of information and documentation as may be required, will 
consider:
    (1) The participant's present financial resources and obligations;
    (2) The participant's estimated future financial resources and 
obligations; and
    (3) The extent to which the participant has problems of a personal 
nature, such as a physical or mental disability or terminal illness in 
the immediate family, which so intrude on the participant's present and 
future ability to perform as to raise a presumption that the individual 
will be unable to perform the obligation incurred.



Sec. 68c.14  When can a CIR-LRP payment obligation be discharged in 

bankruptcy?

    Any payment obligation incurred under Sec. 68c.12 may be discharged 
in bankruptcy under Title 11 of the United States Code only if such 
discharge is granted after the expiration of the five-year period 
beginning on the first date that payment is required and only if the 
bankruptcy court finds that a nondischarge of the obligation would be 
unconscionable.



Sec. 68c.15  Additional conditions.

    In order to protect or conserve Federal funds or to carry out the 
purposes of section 487B of the Act, or of this subpart, the Secretary 
may impose additional conditions as a condition of any approval, waiver 
or suspension authorized by this subpart.



Sec. 68c.16  What other regulations and statutes apply?

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

    Debt Collection Act of 1982, Public Law 97-365 (5 U.S.C. 5514);
    Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
    Federal Debt Collection Procedures Act of 1990, Public Law 101-647 
(28 U.S.C. 1); and
    Privacy Act of 1974 (5 U.S.C. 552a).

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