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tion as a National Special Emphasis report shall consist of the following Center shall also contain the following: parts:

(1) A description of the areas of re- (1) The first part shall consist of a search which the applicant expects the factual summary of the proposed CenCenter to address by virtue of the par- ter, including a synopsis of the inforticular problems and characteristics of mation required under $67.104(c). If the the field of special emphasis;

applicant is applying for an award as a (2) A description of the nature of any National Special Emphasis Center a relationships with and access to health

factual summary of the information care delivery systems that would en

provided in accordance with $67.104(d) hance the ability to carry out research,

shall also be submitted. evaluations, and demonstrations in

(ii) The second part shall address the management, technology. or other

scientific and technical merit of the areas of special emphasis;

application and shall consist of a cri(3) A description of the procedures by tique of the proposal and an assesswhich special emphasis projects will be

ment of the adequacy of the applicant's selected including the methodology to

plan and available resources for meetbe utilised in ensuring that such

ing the requirements of $67.107. projects will be selected on the basis of

(ii) The third part, where appronational importance of the problem priate, shall address the scientific and being addressed and the unique poten

technical merit of the application for tal for definitive research on a prod an additional award for a National Spelem;

cial Emphasis Center. This part of the it A description of the resources report shall consist of a critique of the which the applicant plans to mate proposal and an assessment of the adeViable to enhance the sea en

quacy of the applicant's plan and avall.

sdie resources for meeting the addihas activities

tross requirements of $67.107. all desarron including a Sede

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mmends deferral, it shall specify the components of a local health care sysdditional information it deems nec- tem in which specific projects will be essary for an adequate review of the conducted and research findings tested. pplication.

(x) The integration of disciplinary in(b) Disposition. On the basis of the terests within the proposed Center and Secretary's evaluation of the applica- the coordination of he research proion and taking into consideration any gram with training and educational efecommendations made pursuant to forts. aragraph (a) of this section, the Sec

However, no grant may be awarded tary shall either (1) approve, (2) defer

which will result in more than twenty or a later decision or (3) disapprove ny application for grant assistance

per centum (20%) of all Centers sup

ported under this subpart being located nder this subpart. Such disapproval of

in any one HHS region, except that a application shall not preclude its re

this restriction shall not operate to onsideration if the application is reibmitted in the same or a revised ver

proscribe awarding at least two grants

under this subpart to institutions loon at a later date.

cated in any single HHS region; Pro17.106 Grant awards.

vided, That to the extent feasible, the

Secretary will make such grants as (a) General. (1) Within the limits of

will result in at least six Centers being nds available for such purpose, the

operational in each fiscal year. *cretary may award a grant to those plicants whose approved proposed

(2) In making any grant award the inters will in his judgment best pro

Secretary may add additional condiote the purposes of section 305(d) of

tions to or require specific modificae Act and this subpart, taking into

tions in the Center as proposed in the nsideration:

application including a different level (1) Recommendations made pursuant

of grant support from that requested in $67.105.

the application. In such cases the Sec(11) The appropriateness of the pro

retary will obtain either the written ised budget and the extent to which

agreement of the applicant to proceed e fiscal plan provides assurance that

on such basis prior to making any fective use would be made of grant

grant award or such condition or modinds.

fication will appear on the grant award (iii) The capability of the applicant

notice. demonstrated by organizational and (3) All grant awards shall be in writstitutional arrangements to success- ing. The Notice of Grant Awarded shall lly operate the proposed Center.

set forth the amount of funds awarded (iv) The qualifications, achieve- for the conduct of the Center during ents, and commitment of the senior the first budget period and the amount rsonnel.

of support recommended for the re(v) The strength and scientific integ- mainder of the project period. ty of the general program and ap (4) The project period for any grant oach of the proposed Center.

under this subpart shall be specified in (vi) The nature of the sponsoring in- the Notice of Grant Awarded and shall itution's commitment to the pro- begin no later than nine months folsed Center and the relative impor- lowing the date of such award. In no ince it ascribes to the endeavor.

case may a project period exceed five (vii) The past success and future po- years; Provided, That the approved untial of the proposed Center's person- project period may be extended for a el in receiving permanent and project period not to exceed six months beyond lated support from other sources. five years where the Secretary deter(viii) The extent to which a proposed mines on the basis of a request by the enter's planning process incorporates grantee prior to the termination of the ne concerns of pertinent constituents currently active grant that such addind reflects an awareness of significant tional time is needed to permit the use esearch problems in health services. of funds previously awarded but not ex(ix) The strength of the relationship pended. No additional support may be he proposed Center has developed with awarded for this period.

(6) Neither the approval of any appli- supplemental awards exceeding twenty cation por the awarding of any grant per centum (20%) of the original award shall commit or obligate the Federal for direct Center costs in that budget Government in any way to make any period, the Secretary will prior to additional, supplemental, continuation making such award obtain the recor other awards with respect to the ommendation of the review padel Center or any part of the Center. For which evaluated the Center's initial apcontinuation support, grantees must plication. The review panel shall submake separate application annually mit a written report to the Secretary and at such times and in such form as which describes the current status of the Secretary may prescribe.

the Center, the basis for the request, (b) Determination of grant amount. The the panels recommendation concerning amount of any grant shall be deter- the request and the potential conmined by the Secretary on the basis of sequences of any request that is dishis estimate of the sum necessary for approved. all or a designated portion of the direct (d) Non-competing continuation costs of the Center plus an additional awards. Where a grantee has filed as amount for the indirect costs, if any, application for continuation support which will be calculated by the Sec- and within the limits of funds available retary either:

for this purpose, the Secretary may (1) On the basis of the estimate of the make a grant award for an additional actual indirect costs reasonably relat- budget period for any previously aped to the project; or

proved Center where the Secretary (2) On the basis of a percentage of all finds on the basis of such progress and or a designated portion of the esti- accounting reports as may be required mated direct costs of the project when that the Center's activities during the there are reasonable assurances that

current budget period justify continued the use of such percentage will not ex- support of the project for an additional ceed the approximate actual indirect budget period. Where the Secretary decosts.

termines to continue support, the Such award may include an estimated amount of grant award shall be deter provisional amount for indirect costs mined in accordance with paragraph (D) or for designated direct costs such as of this section. Where the Secretary defringe benefit rates subject to upward termines not to continue a project for (within the limits of available funds) as an additional budget period, the grantwell as downward adjustments to ac- ee will be notified in writing before the tual costs when the amount properly end of the current budget period. In adexpended by the grantee for provisional dition, where he determines such supitems has been determined by the Sec- port is necessary, the Secretary may retary.

provide financial support for the or(C) Supplemental awards. The Sec- derly phase-out of the supported activ retary may make supplemental awards ity. during the course of any budget period of an approved Center where the Sec

$67.107 Operational requirements. retary finds on the basis of the appli- (a) Any Center supported under this cant's written request and such subpart shall: progress and accounting reports as the (1) Have a full-time Director who posSecretary may require that the sesses a demonstrated capacity for susamount of the award initially approved tained productivity and leadership in was less than the amount necessary to health services research, demonstracarry out the approved Center activi- tions, and evaluations. The Director ties for that period. The Secretary may shall oversee the research program and also make a supplemental award where the general operation of the Center and in his judgment such an award is nec- shall to the extent practicable directly essary for the proparation of data in participate in research activities. suitable form for transmittal in ac- Where the Director of a Center be cordance with $67.113. However, where comes unable to function in such cathe making of any supplemental award pacity, the grantee shall so inform the would result, in any budget period, in Secretary as quickly as possible. With

n five (5) days, the grantee shall des- sionals or other appropriate individgnate an Interim Director and inform uals; he Secretary of the name of such indi- (7) Provide for the dissemination of idual. Within ninety (90) days, the its research findings, subject to the rerantee shall nominate an Acting Di- quirements for confidentiality as set ector who, if approved by the Sec- forth in section 308(d) of the Act and etary, shall serve in that capacity $67.112; ntil the end of the budget period. The (8) Provide, through a formal mechaailure to obtain Secretarial approval nism, for consultations and technical f a new Director in the prescribed pe- assistance to concerned individuals and iod of time shall result in immediate groups of the geographical area in uspension of the grant;

which the Center will be located. (2) Have such additional full-time (b) National Special Emphasis Cenrofessional staff representing various

ters shall, in addition to the requireisciplines relevant to health services ments of paragraph (a) of this section: esearch as necessary to plan, establish (1) Provide for the dissemination of nd operate the proposed Center and to

its research findings on a national arry out or administer research scale to groups and individuals particurojects undertaken with the Center.

larly concerned with the area of special The number and expertise of the staff

inquiry; hall be determined by the size of the

(2) Select problems in its area of speroposed Center, the availability to it

cial emphasis for research, demonstraf staff resources other than its own

tion and evaluation on the basis of the mmediate staff, and the nature and

national importance of the problem cope of the problems which its re

being addressed and the unique potenearch will address:

tial for definitive research;

(3) Provide, through a formal mecha(3) Be located within an established

nism, for consultations and technical cademic or research institution with

assistance appropriate to its area of vailable resources appropriate to the rroposed activities to be conducted by

special expertise to concerned individ

uals and groups on a national scale; he Center;

and (4) Have written agreements with

(4) Employ all of the resources made linical settings which provide for set

available to the Center by virtue of its ings appropriate for the initiation and

National Special Emphasis designation valuation of experiments in health

in planning, conducting and monitorervices research;

ing research, training, technical assist(5) Select problems in health services

ance, and other appropriate activities or research, demonstrations and eval

solely in its area of special emphasis. iations respecting: (1) The accessibility, acceptability, 867.108 Grant payments. lanning, organization, distribution,

The Secretary shall from time to echnology, utilization, quality, and fi

time make payments to the grantee of lancing of health services and systems;

all or a portion of any grant award, ei(i) The supply and distribution, edu

ther by way of reimbursement for exation and training, quality, utiliza- penses incurred in the budget period, or ion, organization, and cost of health

in advance for expenses to be incurred, nanpower; and

to the extent he determines such pay(ili) The design, construction, utiliza- ments are necessary to promote ion, organization, and cost of facilities prompt initiation and advancement of and equipment on the basis of (A) their the approved Center. The amounts othregional or national importance, (B) erwise payable to any grantee shall be the unique potential for definitive re- reduced by: search on the problem, (C) the opportu- (a) Amounts equal to the fair market nities for local application of the re- value of any equipment or supplies fursearch findings;

nished to such grantee at their request (6) Provide educational opportuni- by the Secretary for the purpose of ties, through formal mechanisms, for planning, establishing or operating the university students, health profes- Center; and

(b) Amounts equal to the pay, allow- (c) Grant funds used for remodeling, ances, traveling expenses, and related alteration or repairs shall be subject to personnel expenses attributable to the the conditions that the grantee shall performance of services by an officer or comply with the requirements of Execemployee of the government in connec- utive Order 11246, 30 FR 12319 (Septemtion with such Center, if such officer or ber 24, 1966), as amended, and with the employee was assigned or detailed by applicable rules, regulations, and prothe Secretary at the request of the cedures prescribed pursuant thereto. grantee to perform such services.

8 67.111 Publications and copyright. 8 67.109 Use of project funds.

(a) Copyright. Except as may other(a) Any funds granted pursuant to wise be provided under the terms and this subpart shall be expended by the conditions of the award, the grantee is grantee solely for planning, establish- free to copyright any book or other ing or operating the approved Center in copyrightable materials developed accordance with the Act, the regula- under the grant, subject to & royaltytions of this subpart, the terms and free, nonexclusive and irrevocable 1conditions of the award, and the appli- cense of the Department to reproduce, cable cost principles prescribed in sub- publish, alter or otherwise use, and to part Q of 45 CFR part 74.

authorize others to use the work for (b) The grantee may not in whole or Government purposes. In any case in in part delegate or transfer this respon- which a copyright has been obtained, sibility for the use of such funds to any the Secretary shall be so notified. other person, or other legal entity, (b) Publications. Any reports, papers, without the specific prior written ap statistics, or other materials developed proval of the Secretary.

from work supported in whole or in (c) Prior approval by the Secretary is part by an award made under this subrequired whenever there is to be a sig- part shall be submitted to the Secnificant change in the scope or nature retary. The Secretary may make such of the Center's approved activities. materials available and disseminate

the material on as broad a basis as 867.110 Nondiscrimination.

practicable and in such form as to (a) Attention is called to the require- make such materials understandable. ments of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 20000

$67.112 Confidentiality. et seq.) and in particular section 601 of No information obtained by a Center such Act which provides that no person in the course of its health services re in the United States shall on account search activities directly supported of race, color, or national origin be ex- under this subpart may be used for any cluded from participation in, be denied purpose other than the purpose for the benefits of, or be subjected to dis- which it was supplied (which shall incrimination under any program or ac- clude the disclosure of such informativity receiving Federal financial as- tion to the Secretary for carrying out sistance. Regulations implementing his responsibilities under the Health title VI which applies to grants made Services Research, Health Statistics, under this subpart have been issued by and Medical Libraries Act of 1974 (Pub. the Secretary with the approval of the L. 93-353), unless authorized under reg. President (45 CFR part 80).

ulations of the Secretary. Further, (b) Attention is called to the require- such information may not be published ments of section 504 of the Rehabilita- or released in other than statistical tion Act of 1973, as amended, which form if the person who supplied the inprovides that no otherwise qualified formation or who is described in it is handicapped person in the United identifiable unless such person has ; States shall, solely by reason of his signed a written consent on such forms handicap, be excluded from participa- and in such manner as the Secretary tion in, be denied the benefits of, or be may prescribe. For purposes of this secsubjected to discrimination under any tion and $67.113, the term "directly program or activity receiving Federal supported”, as it relates to health serta financial assistance.

ices research, demonstration, or eval

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