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APPENDIX K ADMINISTRATION OF THE NRSA PROGRAM

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APPENDIX K1 19314 NRSA RULES AND REGULATIONS __APRIL 197 5 Title 42 Public Health CHAPTER I—PUBLIC HEALTH SERY'I<:E, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PART 66 NATIONAL RESEARCH SERVICE AWARDS On January 17, 1975 a notice of pro- posed rulemal;ing was published in the F1EDERAL REGISTER (40 FR 3074) PrOPOS- ing addition of ~ new Part 66 to 42 CF~ for tile purpose of implementing section 472 of tile Public Health Service Act, as added be the National Research Serv- ice Award Act of 1974 (Title I, Public Law 9:~-348), which authorized the Sec- retary of Health, Education, and Welfare to Natalie: (1) National Research Service Awards directly to individuals for bio- .2nedical and behavioral research and research training and (2) grants to in- stitutions to enable them to mal;e Na- tional Reseal ch Service Awards to in- dividuals for such research and research training. Interested persons were invited to sub- mit, on or before February 18. 1975, written components regal ding the pro- posed regulations. Several comments were received. A number of these were not concerned di:ec.tly with the regulations but rather questioned the desirability of the pay- back requirements in section 47.2(c) of the enabling legislation. Inasmuch as these requirements are nevertheless mandated by the legislation, none of the comments disputed the necessity for im- piementin~ such requirements in the regulations. The follow ing comments were re- cei~ed on the regulations themselves: 1. It ~ as urged that references to "optometry" and "podiatry" be included in §§ 66.102 (g) and (k). These refer- ences have been added to the final ver- sion of the regulations. 2. It was also suggested that the words "or equivalent degree" be added to ~ 66.102(j). This suggestion has been adopted. 3. In addition it was suggested that, in determining whether it would be an extreme hardship and against equity and good conscience to require payback, for pw poses of ~ 66.111, an added fac- tor to be considered should be whether the India idual had received sufficient training to be qualified to perform any of the various types of services that Would count as payback. Since this considera- tion might indeed be one factor to be ``eighed in making such determinations, an appropriate clause to that effect has been added to ~ 66.1 11. 4. The suggestion was made that ap- Dated: April 2, 1975. plications from individuals and organiza- tions in each State be reviewed by "a single State agency" and that awards be remade through that agency. This sug- gestiGn was not adopted, since section 472 contains no reference to State agen- cies but instead mandates review by co pencils of the National Institutes of Health and Alcohol, Drug Abuse, and Me2,ta1 Health Administration and directs that awards be made bar the Secreted y. Also, in general, awards of this lcind d not usually hate a major impact on the healths activities of States and local jurisdictions and are not sub- ject to the requi: ements in the Inter- gove~ nmcntal Cooperation Act of 1968 for reporting of grant info~ mation to States. 5. It was requested that further infor- mation be provided as to Pilot types of ' activity would constitute "biomedical and behavior al research or teaching" for purposes of the service payback re- quirement in ~ 66.110(a) (1). At this stage in the implementation of section .472, else Depa~tn~ent does not have suffi- cient expel fence ~ ith ~ egard to the operation of the payback requirement to be moo e explicit in the regulations. 6. It svas pointed out that many pro- g~ ems of reseal clot training last more than three years and urged that the limitation in ~ 66.106(b) be dropped. Taxis is not possible, since it reflects a statu- tory requirement in section 472(b) (41. Ifs any event, it may be waived for good cause under ~ 66.106(d). 7. With further regard to li 66.106(d), concern was exit essed as to whether "good cause" could be found only if the applicant proposed to complete both pre- doctoral and postdoctoral training un- der his or hci National Research Serv- ice Award. However, as ~ 66.106(d) indi- cates, the circumstance described was just an example of a situation in which "good cause" may be found to exist, de- pending on the facts of the particular case. 8. Objection was raised to the "full- ti~ne" r.~quirei-nent in ~ 66.103 (b ) because it might prevent the recipient ct an Award from engaging in other academic duties while carrying out research or re- search training under the Award. This requirement has long been a part of NIH and ADAMHA fellowship and train- in~ programs and is considered necessary to achieve the put poses of these pro- grams. 9. Finally, it was requested that senior investigators be allowed to receive Na- tional Research Service Awards. There is no age limit on eligibility for these Awards, and senior investigators who apply therefor will be considered along with all other applicants. In addition to those additions and re- visions already noted, several minor changes have been made in the regu- lations, all editorial or technical in na- ture. This part shall become effective on May 2, 1975. THEODORE COOPER, Acting Assistant Secretary for Health. Approved: April24, 1975. CASPAR W. WEINBERGER, Secretary. Accordingly, Title 42 of the Code of Federal Regulations is amended by add- ing a new Part 66, as follows: FEDERAL REGISTER, VOL. 40, NO. 86 FRIDAY, MAY 2, 1 97S 143 Subpart to Direct Awards Sec. 66.10 1 Applicabllity. 66.102 Dc`finitions. 66.103 El~gibllity. 66.1 04 Application. 66.105 Requirements. 66.1 06 Awards. 66.107 Punnets to awardees. 66.108 Pa) meats to institutions. 66.109 TerminaLiOD. 66.110 Service, P3\l)9.CI;, and recovery red qUIreinentS. 66.11 1 Suspension, ~ ail en and Ca2ICe11&tIOn. 66.112 NO\1diSCrilDinatIOn. 66.1 13 H\\n1:~H Subjects; animal Welfare. 66.114 Publications. 66.i 15 Copyright. 66.116 I21\eOtiO11S and diSCOYerieS.. 66.117 Additional Conditions. Subpart B Institutional Grants SeC. 66.201 APP1iC3biiitY. 66.202 DeOnitiOnS. 66.203 Eligibility. 66.201 APP1ICatiOn. 66.205 Requirements. 66.206 Grant awards. 66.207 Payment. 66.208 Expenditure Of grant funds. 66.209 NOnd1SCriI21inatiOn. 6G.210 Human SUbjeCtS: animal Welfare. 66.211 APP1ICabI1itY Of 45 CF~ Part 74. 66.212 Progress and fiscal records and re- POrtS. 6G.213 Grantee accountability. 66.214 PUb1iCatiO2IS arid copyright. 66.2 15 AdditiOI1a1 Conditions. AUTHORITY: SeC. 2 1 5, 58 Stat. 690, as amended (42 U.S.C. 216!; SeC. 472, 88 Stat. 342 (42 U.S.C. 2891-1 ) . Subpart A Direst Awards § 6,6..1.01. Applicability. The regulations in this subpart are applicable to National Research Service Awards by the Secretary, under section 472(a) (1) (A) of the Public Health Serv- ice Act, as amended (42 U.S.C. 2891-1(~) (1) (A) ), to individuals for: (a) Biomed- ical and behavioral research at the National Institutes of Health and the Alcohol, r)rug Abuse, and Mental Health Administration in matters relating to else cause' diagnosis, prevention, and treatment of the disease (or diseases) or other health problems to which the ac- tivities of NIH and ADAMHA are di- rected. (b) training at NIH and ADAMHA of individuals to undertake such ~ esearch, f c ) biomedical and be- havioral research at non-Federal public and norm olit private institutions, and (d) predoctoral and postdoctoral trairl- ing at such institutions of individuals to under take such research. 66.102 Definitions. As used in this subpart: (a) "Act" means the Public Health Service Act, as amended. (by "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the De- partn~ent of Health, Education, and Welfare to whom the authority involved has been delegated. (c) "NIH" means the National In- stitutes chef Health.

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RULES bed REGULATIONS ~ d) "ADAMIlR" means the Alcoliol, Doug Abuse, arid Mental Health Admin- istrat~on. (e) "Nonprofit" as applied to any institution Cleans an institution Rich is a corporation or association no part of the net ea~ni:~~s of which inures or may lawfoily inure to the benefit of any p~ ivate she: eholder or individual. (I) "Award" means a National Re- sea~ch Service Award under section 472 of the Act (42 U.S.C. 289~-1). (g) "Residency" means post-graduate training, for doctors of medicine. oste- opathy, dentistry, op~on~et~y, and podi- at~:r, nurses, and other individuals pro- viding health case directly to patients, where the majority of their time is spent I'd non-research clinical training. (h) "National Health Set vice Corps" newels the Corps refereed to in section 329 of the Act `42 U.S.C. 254b). (i) "Noncitizen rational 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. l l 01 (a) (22) ) . (j) "P~edocto~al training" means training at else post-baccalau:eate level in a program leaclin~ to the award of a doctor of pl~ilosophy or science, or equiv- alent degree. (k) "Postdoctore l training" means tra~nir~g of individuals holding a doctor of philosophy, science, medicine. den- tist~r, osteopathy, optometry, podiatry, veterinary medicine, engineering, nursing sciences, public health, of equivalent degree. (G.103 Eli',i}~ilil`-. To be eligible for a National Research Service Award under this subpart an in- dividual nest: ha.) Be ~ citizen or noncitizen national of the United States or have been law- fulls admitted to the United States for permanent ~ esidence at the tinge Of application; and (b) Propose to engage in full-tIme biomedical or behavioral research, or training to tu~dertal;e such research, at Nut, ADAMHA, or a non-federal public or nonprofit private institution. § 66.101 .-~plic;~tio~. (a) Application for an Aboard under this subpart shall be made on a form ap- proved for that purpose by the Secretary. The completed fount, executed by the in- dividual applicant, squall be submitted to NIH or ADALIHA Ott or befog e such dates as the Secretary m a~ pi esc~ ibe. {b) Ire addition to any other pertinent information that tile Secretary may re- quire, each application shall set fortes in detail: (1) The applica~:t's educational back- g~ound and other q,~ali~catio~s and ex- pe: fence, u~cludillg p~ e; ions academic Ed professional de=: ees; <2) The subject area of the proposed research or training; (3) The proposed period of Award; (4) If the pi oposed period of Award is t~ excess of three >-ea. s, the Justifications for such req1test; and (5) The availability at the institution where the research or training would be conducted of resources and facilities nec- essary to carry out such research or training. (,t',.10o 11~'ire~ls. No Award shall be made to an individ- ual under this subpart unless: (a) The individual has submitted to the Secretary a written assurance (in such form as the Secretary may pre- scribe) that he or she will satisfy the re- quirements of § §.66.110 (a) and 66.110 (b) of this subpart; (b) If the proposed research or train- ing would take place at a nor-deal institution, such institution has sub- mitted a written assurance (in such form as the Sect etary may pi ascribe), ex- ecuted by a rep~eser~tative of the ix~sti- tution authorized to act for the institu- tion and to assume on behalf of the i~stitutior1 the obligations imposed by the terms and conditions of the Award in- cluding the regulations of this subpart indicating that the applicant has been accepted to the institution for the pu~- po,se of engaging in the research or t~ain- ing for which an Award is being sought, that the Award is not to be used to sup- port a residency, and that, in the event an Award is made, the institution will make available to the applicant any re- sou~ ces and facilities described in the ap- plication as necessary to carry out such r esearch of training (c) Effective July 1, 1975, the proposed research of training is in a subject area for which there is a need for pet sonnet as determined under section 473 of the Act (42 U.S.~. 2891-2); and (d) The individual has submitted a written assurance (in such form as the Secretary may prescribe) that the Award is not to be used to support a residency. (i6.106 AN ;~rd.~. (a) Within the limits of funds avail- able, the Secretary shall Bake Awards to those applicants: (1) Whose applications slave been re- viewed and recommended for approval lay appropriate advisory councils ~vithi NIH and ADAM; (2) Who have satisfied the ~en.~tire- n~e2:~ts of ~ 66.i05 of this subpart, arid (3) WI~ose proposed research or trair:- ing would, in the indg~nellt of the Sec~e- ta~y, best promote the put poses of sec- tion 472(a) (1) (A) of the Act, taking into consideration among other pertinent factors: (i) Tile scientific, technical, or educa- tioll?l ment of the particular proposal; (ii) The availability of resources arid facilities to carry it out (iii) The qualifications and experience of the applicant; and (iv) =~e degree of tile need for per- solmel ill the subject area of the Pio posed research o~ training. (b) All Awards shall be in writing and shall specify else period of the Award (which nary not exceed three years in the aggregate for any Individual unless the Secreted y for good cause shown Calves the applicatioll of this limitation EDERAL ESTER, VOt. 40, 190. 86—FRIDAY, MAY 2, 1975 144 19.310 to such individual), the total ~ econ, - mended stipends and allowances pro- vided for the entice period of the Award. the amount awarded for the initial year of said period (see § 66.107), and If the Award is made for research or training at a non-Federal institution) the amount of the payments to the institution for the cost of services provided the a~a~dee by such institution during the initial year of said period (see ~ 66.108). (c) Neither the approval of any al,- plication nor any Award shall commit of obligate the United States in any way to make any additional, supplemental, con- tinuation, or other Award with respect to any apI,~o;,ed application or portion thereof. (d) In determining what constitutes "good cause" for purposes of paragraph (b) of this section, the Secretary shall take into account such factors as whether the applicant proposes to complete both predoctoral and postdoctoral training programs under the Award or whether the applicant proposes to pursue a con~- bined program leading to the degrees of doctor of medicine and doctor of philosophy. 66.107 13.~` ~~c~s to an ardees. (a) Individuals receiving Away ds shall be entitled to such stipends and allow- ances as the Secretary may designate, talking into account such factors as the needs of the program, the cost of living, and the availability of funds. (b) Payments of stipends and allow- ances shall, at the discretion of the Sec- ~etar~r, be mule to the awardee or the sporlsonng institution for payment to tile awardee. § 6~6.10~ -I to i~~tit~tio~~~. (a) Sphere an Award is nude to an individual under this subpart for reseal c!~ or training at ~ noll-Pederal public ol. nones ofit private institution, the l,.~sti- tution 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 such individual by the institutions. The amount of any such payments to anY institution shall be determined by the Secretary based upon the reasonable cos ;s to the institution of estabI,shing and maintaining tile quality of its bio- n~edical and behavior al research arid . . . training programs. (b) Payments to tile institution urger this section may be made either ill ad- `~ance of by ~ ay of ~ eimbursen~en t, as prescribed by the Secretary. 6G.109 Ter'~i~.~tio~. (~) The Secretary may terminate a~l Ale ard prior to its normal expire tool date: (1) At the written request of tile a~sardee; or (2) If the Secretary fields that the a~sa.rdee has Laterally failed to comply with the terms and conditions of tin" Award or to ca1ry out the purpose for which it was made. ( b) In the eyelet an AL ard is ter- mi~ated the Secretary shall notify the

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19316 awardee in writing of this detern~i~ation, the reasons therefor, the effective date, arid any procedural lights available. ('(I. I 10 Serb it c, p:'yl,`~` k. u'~! ~ `~' ''` erg real irk. (a ~ Each individual who receives an Award shall upon completion thereof: ( 11 Engage in biomedical of behav- io~al research or teaching for ~ period en to the period of support, or t2' If the Secretary determines that these are no suitable research or teach- in~ positions available to such individual, and if such individual is ~ physician. dentist, nurse, or other individual traipsed to provide health care directly to indi`,~idual patients, and if the Secretary so authorizes such individual, in lieu of engaging in research or training: (i! Serene as a member of the National Health Service Corps for a period equal to the period of support; (ii) Serve in his specialty in pi ivate practice in a geographic area designated by the Secretary as requiring that spe- cialty for 20 months for each twelve months of support; or (iii) Provide services in his specialty for a health maintenance organization to Which payments may be made under sec- tion 1876 of Title XVIII of the Social Security Act and which serves an un- derserved population (as defined in sec- tion 13G2 (7) of the Act) for 20 months for each 12 months of support; or (3 ) If the Secretary determines that there are no suitable research or teach- ing positions available to an individual, and if such individual is not trained to provide health care directly to individual patients, and if the Secretary so author- izes such individual, in lieu of engaging in research or teaching, engage in a health activity appropriate to his edu- cation and training for 20 months for each 12 months of support. (b' Except as provided in section 111 of this subpart, an individual to whom the requirement for service in paragraph (a) of this section is applicable must be- gin to undertake such service on ~ con- tinuous basis within two years after the termination of his or her Aboard. (c) If an individual fails to undertake or perform such service in accordance with the requirements of paragraph (b) of this section, the United States squall be entitled to recover from such individual an amount determined in accordance with the formula: A (t—(IDS) in which "A: is the amount the United States is entitled to recover; "~3" is the sum of the total amount of stipends paid under one or more Awards to such indi- vidual and the interest on such amount which would be payable if at the time it was paid it was a loan bearing interest at a rate fixed by the Secretary of the Treasurer after taking into consideration private consumer rates of interest pre- vailing at the time the Award was made; "t" is total number of months in such individual's service obligation; and "s" is the number of months of such obliga- RULES AbID REGULATIONS tion served by hint in accordance with paragon Pal (a) of this sections. (d, E.~;ce~'t as p~ovidecl in ~ 66.1.11 of this subgoal S. any amount which the United States is entitled to recover under parag~ aloft ( c ) squall, within the three- year period beginning on the date the United States becomes entitled to recover ducts amount, be paid to the United States. UP l any amount dole the United States under paragraph (c) of this sec- tion on account of any Award is paid, there shall accrue to the United States Intel e.st on such amount at the same rate as that fixed by the Sect etary of the To ensue y under pal agraph (c) of this section to determine else amount due the United States. 66.111 ~uspcnsio~, Tier Anal '.~- ce1 ~ ;` t iota. ' ( a ~ The Secre'ua~ y may extend the period for undertaking service prescribed in ~ 66.110(b) of this subpart, permit breaks in service under ~ 66.110(b), or extend the period for repayment under ~ 66.110(di if the Secretary determines that: ( 1 ) Such an extension or breal: in service is necessary so the individual may complete his or her- reseal ch training; ( 2 ) Completion during said period would be impossible because the indi- vidual is temporarily disabled; or (3 ) Completion due ing said period would involve an extreme hardship to such individual and failure to extend such period would be against equity and good conscience. (b) The Secretary may waive, in whole of in part, the obligations of such indi- v~dual to repay pursuant to ~ 66.110(c) if the Secretary determines that: ( ~ ) Fulfillment would be impossible because the individual is permanently and totally disabled; or ( 2 ~ Fulfillment would involve an ex- treme hardship to such individual and enforcement of such obligation would be against equity and good conscience. (c) In making determinations under §§ 66.111(~) (3) and (b) (2), the Secre- tary 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 India idual's failure to complete such requirements within the prescribed pet iod, such as problems of a personal nature; (4) The extent to which the individ- ual has been engaged in activities en- compassed by § 66.110 (a); (5 ) vi hether the individual has re- ceived sufficient training to be qualified to pet for m any such activities; and (6) The unavailability of employment opportunities appropriate to the indi- vidualts education and training. (di Any obligation of any individual under this .subpa~t will be cancelled upon the death of such individual. 6~. I 1~ ~on~1i``ri'~i''.~tion. Attention is called to the fact that funds paid to an insti tution under FEDERAL REGISTER, VOL. 40, NO. 86—FRIDAY, MAY 2, 145 ~ 66.108 of this stthpa~t are considered Federal financial assistance to such in- stitution. The institution is plus subject to: fa) The prohibition against discrimi- ~ation or, tile basis of race, color, or national origin imposed by Title VI of th Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq. ~ and tile implement- ing regulation of the Decal talent of Health, Educations and Welfare (45 CAR Part 80); ( bi The prohibition against discrim- i~ation on the basis of sex imposed by Title IX of the Education Amendments of 1972 and in particular section 901 of such Act (20 U.S.C. 1681); and (c) The prohibition against discri~n- ination against the handical)ped imposed by section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794). 6(i.113 Hlll~l.lll ~ll~jects; ~lnill?:ll wel- fare. Where the application is for research or training at a non-Federal public or non-profit private institution, no Award may be made under taxis subpart unless said institution has complied with: (a) 45 CF~ Part 46 and any other ap- plicable requirements pertaining to the protections of human subj ects. (b) Chapter 1-43 of the Department of Health, Education, and Welfare Grants Administration Manual ~ and any other applicable ~ equirements concern- ing animal welfare. § 66.1 14 Pt~l~lications. Publication, distribution, and disposi- tion of all manuscripts and other ma- terials resulting from an Award shall be subject to the conditions that all such materials shall bear appropriate ac- knowledgment of Department of Health, Education, and Welfare support and that the awardee shall furnish such copies of these manuscripts or other materials as the Secretary may reasonably request. § 66.1 1~ Copyri~.l~. 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 tosser all copyright- able or copyrighted material resulting from the Award. § 6fi.116 In' entions find discoveries. (a' Any Award is subject to the reg- ulations of the Department of Health, Education, and Welfare set forth in 45 CER Parts 6 and 8, as amended. Such regulations shall apply to any activity for which Award funds are in fact used, whether within tile scope of the Award as approved or otherwise. Each such in- vention or disco-v ery shall be promptly and fully reported to the Assistant Sec- retary for Health, Department of Health, Education, and Welfare. ( b ) Determination as to ownership and disposition of rights to such lnven- tion or discovery, including whether a patent application shall be filed, and, i! 975

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RULES AND REGULATIONS so, the manner of obtaining,, administer- ing, and disposir~g of rights under any patent application of patent which may issue shall be made either: ( 1 ) By the Assistant Secretary for Health, whose decision shall be final, or (2) Where an Award is made to an individual for research or training at a non-Federal public or nonprofit private institution having a separate formal in- stitutional patent agreement with the Department of Health, Education, and § G6.117 Ad~lition.~l con~litio'~. The Secretary may with respect to any Award or class of Awards impose additional conditions prior to or at the time of any Aboard When in hits 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 § 66.201 Applicability. The regulations in this subpart are ap- plicable to grants under section 472(a) (1) (13) of the Public Health Service Act, as amended (42 U.S.~. 289~-l(a) (1) (B) ), to non-Federal public institutions and to nonprofit private institutions to enable such institutions to make to indi- viduals selected by them Hational Re- search Service Awards for research arid predoctoral and postdoctoral training to ur~dertal;e such research in matters re- lating to the cause, diagnosis,, preven- tior`, and treatment of the disease (or diseases) of other health problems to which the activities of the National In- stitutes of Health and the Alcohol, Drug Abuse, and Mental Health Auministra~- tion are directed. G6.202 DefIniti`'rls. The definitions in ~ 66.102 of subpart A of this part shall apply as Doll to this subpart. § 66.203 ~1imil)ilit'. To be eligible for a grant under this subpart, an applicant must be: (a) A no~-Federal public or nonprofit private institution; and (b) Located in a State, the District of Columbia, Peter to Rico the Virgin Is- lands, tile Canal Zone, Guam, American Samoa, or the Trust Territo, ~ of the Pacific Islands. 66.201 \ppliL;ltio'`. (a) Each institution desiring a grant under this subpart shall submit an ap- plication on a fount approved for treat purpose bit tile Sect, on or before such dates as the Secretary may pi e- scribe. Such application shall be executed by an India idual authorized to act for the ~ The Department of Health, Education, and Welfare Grants Adn~i~istration Flannel is available for public inspection arid copy- ina at tine Department's arid Regional offices' lnformatio~ chatters listed in 4a CFR § 5.31 and may be pureed from tile Superir~- tende~t of Docket. U.S. C~vernme~t Printing Once, Washi:~gt~n, D.C. 20402. Welfare, by the institutions in accordance witty that agreement. applicant and to assume on behalf of the applicant the obligations imposed by the tee ms and conditions of the grant, including the regulations of this subpart. (b) In addition to any other pertinent information that the Secretary may re- qui~e, each application shall set forth in detail: ( 1 ) The subj cot area or areas in which the proposed research or training will be conducted; (2) The resources and facilities avail- able to the applicant for use by recipi- ents of Awards in carrying out sucks research or training; (3) The names, qualifications, and ex- perience of the program director and principal staff members who will be re- sponsible for tile proposed program; (4) The criteria to be employed in se- lecting individuals to be recipients of Awards; (a) The estimated number of recipi- ents of Awards under the grant; ( 6! The proposed period of support and a detailed budget and justification for the amount of grant funds re- quested; and (7) Proposed methods for monitoring and evaluating the performaIlce of indi- vidual r ecipients of Awards, as well as tile of erall pi ogram. (i6.20;> I{~{llire~llellts. ( a ) No Award shall be made to an individual under a grant pursuant to this subpart unless: ( 1 ) The individual has submitted to the Secretary a written assurance (in such form as the Secretary may pre- scribe ) that he or she will satisfy the requirements of §§ 66.110 (a) and (b) of subpart A of this part; (2) Effective July 1, 1975, such Award is for research or training in a subject area for which there is a need for per- sonnel, as determined under section 473 of the Act ( 42 U.S.C. 2891-2 ); (3) The individual is a citizen or non- citizen national of the United States or has been lawfully admitted to the United States for permanent residence at the time of application; ( 4 ) The Award includes a provision for termination in the event tale recipi- ent is found by the institution to ha',te materially failed to comply witty the terms and conditions of the Award or to carry out the purpose for which it fleas made; and (a) The Aboard is not to be used to sup- port a ~ esidency. ( ~ ) No An ard shall be made to an individual under such grant which ex- ceeds three sears in the aggregate unless else Sect etary for good cause shots n as provided ill ~ 66.106(d) of subpart A of this part, waives the application of this limitation to such individual. (c) The provisions of §§ 66.110 and 66.111 of subpart A of this part constitute terns and conditions of ally Afford made under a grant }pursuant to this subpart. 6fi.~(~fi (,r;~t ;I~ ;~r`3~. (a) Within the limits of funds avail- able, the Secretary shall award grants to those applicants: FEDERAL REGISTER, VOL. 40, NO. 86 FRIDAY, MAY 2, ~ 975 146 19317 (1) Whose applications have been re- viewed and recommended for approval by appropriate advisory councils within NIll and ADAMHA; (2) Who have satisfied the ~equire- ments of § 66.205 of this subpart; and (3) Whose proposed programs would, in the judgment of the Secretary. best promote the purposes of section 472(a) (1) (B) of the Act, taking into consider- ation among other pertinent factors: (i) The scientific, technical, or educa- tional merit of the proposed program: ( ii ) The adequacy of the resources and facilities available to the applicant; (iii) The qualifications and experience of the prom atn director and prinCiI,a staff members; (iv) The degree of the need iot per- sonnel in the subject area or areas of the proposed research or training; (v) The administrative and mana- gerial capability of the applicant; (vi) The reasonableness of the pro- posed budget in relation to the proposed program; and (vii) The adequacy of the methods for monitoring and evaluating the perform- ance of individual recipients and the overall program. (b! All grant awards shall be in writ- ing and shall specify the period of s~p- port, the total recommended amount of funds for the entire period of support, the approved budget for the initial b~d- get period, and the amount awarded for the initial budget period. (c) Neither the approval of any ap- plication nor any grant award shall com- mit or obligate the United States in any way to make any additional, supplemen- tal, continuation, or other grant award with respect to any approved appl~ca- tio~ or portion thereof. (d) The amount of any grant award shall be determined by the Secretary on the basis of his estimate of the sum necessary during the budget period: (1) To provide stipends and allow ances to individual recipients of Awards and pay- ments to the institution, as determined in accordance with §§ 66.107ta) and 66.108(a) of subpart A of this part, and (2 ) otherwise to carry out the grant al` arc. 636~.2(~` I';1~1~1~1t. The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in ad- vance or by way of reimburse net. for expenses incurred or to be incurred in accordance with its approved applica- tio~. (~.~(~l I,xl,~dit~re of OCR for page 141
.1931~3 approval by the Secretary, be carried forward arid remain available for obliga- tio~ during the remainder of the period of support, sub.iect to such limitations as the Sect etary may prescribe. The amount of any subsequent award will take into consideration unobligated grant funds remaining ifs the grant ac- cou~t. At the end of tile pet iod of support any unobligated grant funds ~e- n~ai~g ifs the giant account must be refunded to the United States. 66.209 No~`Ii.~' i'~,i,~'io',. (a! Attention is called to the ~equire- n~ents of Title VI of the Civil Rights Act of 1964 ~ 78 Stat. 252, 42 U.S.C. 2000d et seq.) Rich provides that no person in the United States shall, Ott the grounds of race, color, or national origin, be ex- cluded frown participation in, be denied the benefits of, of he subjected to dis- crimination under an: program or ac- tivity recei`'ing Federal Facial assist- ance. A r egulation 1n~plementing such Title VI. which is applicable to grants made under this subpart, has been issued by the Secretary of Healtl,, Education, and Welfare with the approval of the President (45 CUR Part 80). (b) Attention is also called to the te- quirements of Title IX of the Education A~nendr~ents off 1972 and ill particular to section 901 of such Act (20 U.S.C. 1681) which provides that no person in the United States shall, on the basis of sex, be excluded fit om participation in, be denied the benefits of, or be subjected to discrimination under any education pro- g~n or activity receiving Federal fir~an- cial assistance. (c) Grant funds used for alterations and renovations shall be subject to the conditions that the grantee shall comply with tile ~ equirements of Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, and zenith the ap- pl~cable rules, regulations, and proce- dures prescribed put suant thereto. (d) Attention is called to the requi~e- ~nents of section 504 of the Rehabilita- tion Act of 1973, as amended (29 U.S.C. 794), which provides that no otherwise qualified handicapped individual in the United States shall, solely by reason of his handicap, be excluded from partici- pation In, be denied the benefits of, or be subjected to discrimination sunder any program or activity receiving Federal fi- nancial assistance. § 66.210 ~~l .C`~l~jects; :1~2~;11 w~l- [are. No grant award may be made under this subpart t unless the applicant has complied with: (a) 45 CFR Part 46 and add other ap- plicable requirements pertaining to the protection of human subjects. (b) Chapter 1-43 of the Department of Health, Education, and Welfare RULES AND REGULATIONS Grants Adn~inistration Manual 1 arid alar other applicable ~equi~ernents concer~- i~g animal ~ elf3~re. 66.211 ;~}~1>lic;'l~ility of ·~a C.~1t Art 74. The provisions of 45 CER Pal t 74, establishing uniform administrative ~~- quiremcnts and cost pi icicles, shall apply to all grants under this subpart to State and local governments as these terms are cief~ned u~ Subpart A of that Past 74. Tile relevant provisions of the following subparts of Part 74 shall also apply to grants to all other grantee organizatior~s under this subpart: 4 5 C FR PART 7 Subpart A General. B C D Cash Depositories, Bonding and Insurance. Retention and Custodial Rcq~irem^nts for Records. F Grant-Rclated Income. G Matching arid Cost SharlIlg. K Grant Pat novena Requirements. L Bridget Revision Procedures. PI Grant Closeout :Suspension, arid Tcr- mination. O Property. Q Cost Principles. § G6.212 1,rogrc.ss a~1 fiscal recouple ;~d rapports. Each grant award shall requite that the grantee ~naintai~ such progress and fiscal records and file with the Secre- ta~y, such ogress and fiscal reports re- lating to the conduct and resmelts of the apes oved go ant and the use of go ant funds as the Secretary may find neces- sa~y to carter out the purposes of this subpart. § 6G.~13 Grantee ;~ccou~t;~,ility. (a) All payments made by the Sec~e- t.~y shall be recorded by the grantee ill accounting records separate fit om the decor ds of all other grant funds, includ- ing funds derived from other grant awards. VVith respect to each approved p~ogra~n the grantee shall account for the sum total of all amounts paid by presenting or otherwise making avail- able to the Secretary, satisfactory evi- dence of expenditures for direct and in- direct costs meeting the ~eq,.~irements of this submit t. (b) Accounting for royalties. Royalties received by grantees from copyrights on publications or other works developed under the giant, or from patents or in- ventions conceived o" first actually re- duce<1 to practice in the course of of un- der such giant, sl:all he accounted for as follows: The Department of Health, Education, and Welfare Grants Administration biannual is available for public inspection and copy- ing at the Departmellt's and Regional Of- fices' illformation collters listed in 4~5 CFR § 5.31 and may be Chased from the Su- perinte~dent of Documents, U.~. Government Printing Office, Washington, D.C. 20402. FEDERAL REGISTER, YOL 40, NO. 86~FRIDAY, MAY 2, 1975 ~ ~ 7 ~1 ) Si.lte ant local governments. Where tile grantee is a State or local gove~e~t as tl~ose ter Ifs are defined h~ subunit A of 4o CFR Part 74, royalties squall be accounted for as I:'ro~ided ill 45 CFR 74.44. (2) Go antecs other titan State ancl local gourmets. NN71~e~e tl~c gate is not a State or loc.~1 got e~nn~ent as those t'~!2ns a~ e defined in subpart A of 45 CFR Pal t `4, rot alties shall be ac- co~te`1 for as follows: (i) Patent ~ of allies, Better received dating of after tile =~ant period, shall be go;'erned be ag:cen~enis between tile As- sistant Secreted ~ for Health, Sepal t- ~nent of Health, Education, and NVelfa~e and the g: antee, pursuant to the De partmeIlt'~ patent regulations (45 CFR Parts 6 alla 8). (ii) Cop: right rot allies, Nether re- ceiYed derring of after the grant period shall first be used to reduce the Federal Sloane of tile grant to corer the costs of publishing or producing the materials, arid any royalties in excess of the costs of publisi~g or producing the materials shall be distributed in accordance with Chapte: 1-~4 2 0 Of the Department of Health, Ecincation, and 'welfare Giants Adn~imstratio2~ Dual. § 66.~14 Public. ions Ed cop' right. (a) State and local gove~nents. Where the g: antes is a State or local government as tinge terms are defined in subpart A of 45 CFR Part 74, the De- part~ent of Health, Education, and Wel- [are copyright requirement set forth in 45 CEPR 74.140 shall apply with respect to ally book or oti-~er copyrightable n~a- te~ ials developed or resulting front an activity supported by a grant under this subpart. (a) Grantees other than State and local novel nments. Where the grantee is not a State or local government as those terms are defined ill subpart A of 45 CER Part 74, except as nay oti~er- Vise be provided under the terns and conditions of the grant an are, the grantee may copyright It lot prior ap- pro;~1 any publications, films, of similar Elates ials des eloped or resulting from an activity supported by ~ giant under this subpart, subject to a ro~alty-free non- exclu:;i; e, arid Ire evocable license or ~ ight in the United States to reproduce, trans- late, publish, use, diseminate and dis- pose of such materials, and to authorize others to do so. G6.21 ~ t`I`Titiona1 co~3itio~s. The Secretary, Noah with respect to ens giant afford impose additional con- ditions prior to or at the time of any award when in his judgment such condl- tions are necessary to assure or protect advance~ne:~t of the approved program., the interests of the public health, or else conservation of grant funds. PER Doc.~11388 Filed ~-75;8:45 am

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APPENDIX K2 NRSA RULES AND REGULATIONS- -MAY 19 7 7 Title 42 Phallic llealth 1 CHAPTER I—PUBLIC HEALTH SERVICE Dr.~'ARTMEN'T O' F;EA'TH, EDlJCAT.Cr] At~'D WELFAR`; PART 6fi~N'4TIChI,tL RESEARCH SERY'l(:E AWARDS Arr.ena~ment To Permit (undergraduate Train.n" AGENCY: Department of IIealth, Eci~- cation, and Welfare e, Public Health Service. ACTION: Final ~ ule technical amend- ment. SUA1~IA~Y: This rue redefines the term "p~edo^tcra.1 training" in tile ~'a- tional Research Sc~-vice Award regula.- tions. This revision encompasses uncle;- grad~ate research train~..~ and is nec- cssarg in order to make the re~!atio~,s Conway Blip the express intent of Come ess. E=EC=lE DA't f;: June 9, 1977. FOR FURTHER LYFOR^~IATION COl`- TACT: E:l~vard Barium, Program Director, Iinorit,, Access to Research Careers Pi ogram, NIG.~IS, NIH, Bethesda, Maryland 20014 (301-49~73~7). SUPPLE~IENTAP~Y ~FORMATIC,~: Section 4,~ of the Public Health Service Act authorizes the Sec~e1;~sr of Healti~. Education, and We1fa~ ~ to make: < 1 ) National Research Service Swat ds di- rectl!r to incli~iduals for biomedical ar,d behavioral rcs^;~rch arid p~eciocto~al and postOcctc~al trail to en~acc ill such research, and `2) grants to insci'`utions to enable them to ma., e Nations Re- £~l'Cll Service Awards to indivi,cl~als for such research arid training. finis legi.sla- tion was im~'emcntcd by regulations published in the ~ F:~ERAL REGISTER O.! play 2, 1975 (4U It's 1'9314), `~2~d codified ifs 42 CER Part 66. Section 60.102 of those regulations ~le- fl~;es "p~eclocto~l training,' to meals "at minute at tile l~ost-b.~ccalaureatc lo ci ire OCR for page 141