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tion as a National Special Emphasis Center shall also contain the following:

(1) A description of the areas of research which the applicant expects the Center to address by virtue of the particular problems and characteristics of the field of special emphasis;

(2) A description of the nature of any relationships with and access to health care delivery systems that would enhance the ability to carry out research, evaluations, and demonstrations in management, technology, or other areas of special emphasis;

(3) A description of the procedures by which special emphasis projects will be selected including the methodology to be utilized in ensuring that such projects will be selected on the basis of national importance of the problem being addressed and the unique potential for definitive research on a prob

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report shall consist of the following parts:

(i) The first part shall consist of a factual summary of the proposed Center, including a synopsis of the information required under §67.104(c). If the applicant is applying for an award as a National Special Emphasis Center a factual summary of the information provided in accordance with §67.104(d) shall also be submitted.

(ii) The second part shall address the scientific and technical merit of the application and shall consist of a critique of the proposal and an assessment of the adequacy of the applicant's plan and available resources for meeting the requirements of §67.107.

(iii) The third part, where appro priate, shall address the scientific and technical merit of the application for an additional award for a National Special Emphasis Center. This part of the report shall consist of a critique of the proposal and an assessment of the adequacy of the applicant's plan and available resources for meeting the additional requirements of §67.107.

(iv) The fourth part shall describe the panel's assessment of the relevance of the proposed program to regional or national health care issues.

(The fifth part shall consist of a set of recommendations to the Sec redacy with respect to the disposition of the application:

A The panel may recommend that the Secretary approve, disapprove, or deder a decision in order to gather fur

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>mmends deferral, it shall specify the Additional information it deems necssary for an adequate review of the \pplication.

(b) Disposition. On the basis of the Secretary's evaluation of the applicaion and taking into consideration any ecommendations made pursuant to aragraph (a) of this section, the Secetary shall either (1) approve, (2) defer ›r a later decision or (3) disapprove -ny application for grant assistance -nder this subpart. Such disapproval of n application shall not preclude its re- ɔnsideration if the application is reibmitted in the same or a revised veron at a later date.

$7.106 Grant awards.

(a) General. (1) Within the limits of ends available for such purpose, the cretary may award a grant to those plicants whose approved proposed nters will in his judgment best proote the purposes of section 305(d) of se Act and this subpart, taking into nsideration:

(i) Recommendations made pursuant $67.105.

(ii) The appropriateness of the proised budget and the extent to which

e fiscal plan provides assurance that fective use would be made of grant nds.

(iii) The capability of the applicant demonstrated by organizational and stitutional arrangements to successlly operate the proposed Center.

(iv) The

qualifications, achieveents, and commitment of the senior rsonnel.

(v) The strength and scientific integty of the general program and apoach of the proposed Center.

(vi) The nature of the sponsoring initution's commitment to the proosed Center and the relative imporince it ascribes to the endeavor.

(vii) The past success and future poential of the proposed Center's personel in receiving permanent and project elated support from other sources.

(viii) The extent to which a proposed enter's planning process incorporates he concerns of pertinent constituents nd reflects an awareness of significant esearch problems in health services. (ix) The strength of the relationship he proposed Center has developed with

components of a local health care system in which specific projects will be conducted and research findings tested.

(x) The integration of disciplinary interests within the proposed Center and the coordination of the research program with training and educational efforts.

However, no grant may be awarded which will result in more than twenty per centum (20%) of all Centers supported under this subpart being located in any one HHS region, except that this restriction shall not operate to proscribe awarding at least two grants under this subpart to institutions located in any single HHS region; Provided, That to the extent feasible, the Secretary will make such grants as will result in at least six Centers being operational in each fiscal year.

(2) In making any grant award the Secretary may add additional conditions to or require specific modifications in the Center as proposed in the application including a different level of grant support from that requested in the application. In such cases the Secretary will obtain either the written agreement of the applicant to proceed on such basis prior to making any grant award or such condition or modification will appear on the grant award notice.

(3) All grant awards shall be in writing. The Notice of Grant Awarded shall set forth the amount of funds awarded for the conduct of the Center during the first budget period and the amount of support recommended for the remainder of the project period.

(4) The project period for any grant under this subpart shall be specified in the Notice of Grant Awarded and shall begin no later than nine months following the date of such award. In no case may a project period exceed five years; Provided, That the approved project period may be extended for a period not to exceed six months beyond five years where the Secretary determines on the basis of a request by the grantee prior to the termination of the currently active grant that such additional time is needed to permit the use of funds previously awarded but not expended. No additional support may be awarded for this period.

(5) Neither the approval of any application nor the awarding of any grant shall commit or obligate the Federal Government in any way to make any additional, supplemental, continuation or other awards with respect to the Center or any part of the Center. For continuation support, grantees must make separate application annually and at such times and in such form as the Secretary may prescribe.

(b) Determination of grant amount. The amount of any grant shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or a designated portion of the direct costs of the Center plus an additional amount for the indirect costs, if any, which will be calculated by the Secretary either:

(1) On the basis of the estimate of the actual indirect costs reasonably related to the project; or

(2) On the basis of a percentage of all or a designated portion of the estimated direct costs of the project when there are reasonable assurances that the use of such percentage will not exceed the approximate actual indirect costs.

Such award may include an estimated provisional amount for indirect costs or for designated direct costs such as fringe benefit rates subject to upward (within the limits of available funds) as well as downward adjustments to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary.

(c) Supplemental awards. The Secretary may make supplemental awards during the course of any budget period of an approved Center where the Secretary finds on the basis of the applicant's written request and such progress and accounting reports as the Secretary may require that the amount of the award initially approved was less than the amount necessary to carry out the approved Center activities for that period. The Secretary may also make a supplemental award where in his judgment such an award is necessary for the preparation of data in suitable form for transmittal in accordance with §67.113. However, where the making of any supplemental award would result, in any budget period, in

supplemental awards exceeding twenty per centum (20%) of the original award for direct Center costs in that budget period, the Secretary will prior to making such award obtain the recommendation of the review panel which evaluated the Center's initial application. The review panel shall submit a written report to the Secretary which describes the current status of the Center, the basis for the request, the panels recommendation concerning the request and the potential consequences of any request that is disapproved.

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(d) Non-competing awards. Where a grantee has filed an application for continuation support and within the limits of funds available for this purpose, the Secretary may make a grant award for an additional budget period for any previously ap proved Center where the Secretary finds on the basis of such progress and accounting reports as may be required that the Center's activities during the current budget period justify continued support of the project for an additional budget period. Where the Secretary determines to continue support, the amount of grant award shall be deter mined in accordance with paragraph (b) of this section. Where the Secretary determines not to continue a project for an additional budget period, the grantee will be notified in writing before the end of the current budget period. In addition, where he determines such support is necessary, the Secretary may provide financial support for the orderly phase-out of the supported activity.

$67.107 Operational requirements.

(a) Any Center supported under this subpart shall:

(1) Have a full-time Director who possesses a demonstrated capacity for sustained productivity and leadership in health services research, demonstrations, and evaluations. The Director shall oversee the research program and the general operation of the Center and shall to the extent practicable directly participate in

research activities. Where the Director of a Center becomes unable to function in such capacity, the grantee shall so inform the Secretary as quickly as possible. With

in five (5) days, the grantee shall designate an Interim Director and inform the Secretary of the name of such individual. Within ninety (90) days, the grantee shall nominate an Acting Director who, if approved by the Secretary, shall serve in that capacity until the end of the budget period. The ailure to obtain Secretarial approval Of a new Director in the prescribed peiod of time shall result in immediate Huspension of the grant;

(2) Have such additional full-time #rofessional staff representing various lisciplines relevant to health services Fesearch as necessary to plan, establish

nd operate the proposed Center and to arry out or administer research Projects undertaken with the Center. The number and expertise of the staff hall be determined by the size of the roposed Center, the availability to it of staff resources other than its own Immediate staff, and the nature and cope of the problems which its reearch will address:

(3) Be located within an established cademic or research institution with wailable resources appropriate to the roposed activities to be conducted by he Center;

(4) Have written agreements with linical settings which provide for setWings appropriate for the initiation and valuation of experiments in health Services research;

(5) Select problems in health services for research, demonstrations and evalations respecting:

(1) The accessibility, acceptability, planning, organization, distribution, technology, utilization, quality, and financing of health services and systems; (ii) The supply and distribution, education and training, quality, utilization, organization, and cost of health manpower; and

(iii) The design, construction, utilization, organization, and cost of facilities and equipment on the basis of (A) their regional or national importance, (B) the unique potential for definitive research on the problem, (C) the opportunities for local application of the research findings;

(6) Provide educational opportunities, through formal mechanisms, for university students, health profes

sionals or other appropriate individuals;

(7) Provide for the dissemination of its research findings, subject to the requirements for confidentiality as set forth in section 308(d) of the Act and §67.112;

(8) Provide, through a formal mechanism, for consultations and technical assistance to concerned individuals and groups of the geographical area in which the Center will be located.

(b) National Special Emphasis Centers shall, in addition to the requirements of paragraph (a) of this section:

(1) Provide for the dissemination of its research findings on a national scale to groups and individuals particularly concerned with the area of special inquiry;

(2) Select problems in its area of special emphasis for research, demonstration and evaluation on the basis of the national importance of the problem being addressed and the unique potential for definitive research;

(3) Provide, through a formal mechanism, for consultations and technical assistance appropriate to its area of special expertise to concerned individuals and groups on a national scale; and

(4) Employ all of the resources made available to the Center by virtue of its National Special Emphasis designation in planning, conducting and monitoring research, training, technical assistance, and other appropriate activities solely in its area of special emphasis.

$67.108 Grant payments.

The Secretary shall from time to time make payments to the grantee of all or a portion of any grant award, either by way of reimbursement for expenses incurred in the budget period, or in advance for expenses to be incurred, to the extent he determines such payments are necessary to promote prompt initiation and advancement of the approved Center. The amounts otherwise payable to any grantee shall be reduced by:

(a) Amounts equal to the fair market value of any equipment or supplies furnished to such grantee at their request by the Secretary for the purpose of planning, establishing or operating the Center; and

(b) Amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the government in connection with such Center, if such officer or employee was assigned or detailed by the Secretary at the request of the grantee to perform such services.

§ 67.109 Use of project funds.

(a) Any funds granted pursuant to this subpart shall be expended by the grantee solely for planning, establishing or operating the approved Center in accordance with the Act, the regulations of this subpart, the terms and conditions of the award, and the applicable cost principles prescribed in subpart Q of 45 CFR part 74.

(b) The grantee may not in whole or in part delegate or transfer this responsibility for the use of such funds to any other person, or other legal entity, without the specific prior written approval of the Secretary.

(c) Prior approval by the Secretary is required whenever there is to be a significant change in the scope or nature of the Center's approved activities.

§ 67.110 Nondiscrimination.

(a) Attention is called to the requirements of title VI of the Civil Rights Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in particular section 601 of such Act which provides that no person in the United States shall on account of race, color, or national origin be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. Regulations implementing title VI which applies to grants made under this subpart have been issued by the Secretary with the approval of the President (45 CFR part 80).

(b) Attention is called to the requirements of section 504 of the Rehabilitation Act of 1973, as amended, which provides that no otherwise qualified handicapped person in the United States shall, solely by reason of his handicap, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.

(c) Grant funds used for remodeling, alteration or repairs shall be subject to the conditions that the grantee shall comply with the requirements of Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, and with the applicable rules, regulations, and procedures prescribed pursuant thereto. §67.111 Publications and copyright.

(a) Copyright. Except as may otherwise be provided under the terms and conditions of the award, the grantee is free to copyright any book or other copyrightable materials developed under the grant, subject to a royaltyfree, nonexclusive and irrevocable license of the Department to reproduce, publish, alter or otherwise use, and to authorize others to use the work for Government purposes. In any case in which a copyright has been obtained, the Secretary shall be so notified.

(b) Publications. Any reports, papers, statistics, or other materials developed from work supported in whole or in part by an award made under this subpart shall be submitted to the Secretary. The Secretary may make such materials available and disseminate the material on as broad a basis as practicable and in such form as to make such materials understandable.

$67.112 Confidentiality.

No information obtained by a Center in the course of its health services research activities directly supported under this subpart may be used for any purpose other than the purpose for which it was supplied (which shall include the disclosure of such information to the Secretary for carrying out his responsibilities under the Health Services Research, Health Statistics, and Medical Libraries Act of 1974 (Pub. L. 93-353), unless authorized under regulations of the Secretary. Further, such information may not be published or released in other than statistical form if the person who supplied the information or who is described in it is identifiable unless such person has signed a written consent on such forms and in such manner as the Secretary may prescribe. For purposes of this section and §67.113, the term "directly supported", as it relates to health services research, demonstration, or eval

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