ept for the last budget period of the ect period) by at least two memof the same peer group which rered the proposal in accordance with 14. Such group shall review the apition for continuation support and e recommendations to the Secry concerning the disposition of application based upon its evalua

of:

The appropriateness of the mannent of the project and allocation sources within the project,

The adequacy and appropriateness de plan for the carrying out of the ect during the budget period in t of the accomplishments during ious budget periods, and

The reasonableness of the prod budget for the subsequent budget ɔd where the Secretary determines Continue support, the amount of git award shall be determined in actance with paragraph (b) of this sec

Where the Secretary determines to continue a project for an addial budget period, the grantee will otified in writing before the end of current budget period.

17 Project requirements.

project supported under this subt must be conducted in accordance h the following requirements:

1) The project shall be carried out in ordance with the approved applica

5) The principal investigator shall responsible for the conduct of the ject unless replaced by another indimal found by the Secretary to be alified to carry out such responsibiles. Where the principal investigator comes unable to function in such cacity, the Secretary shall be notified soon as possible.

7.18 Grant payments.

The Secretary will from time to time ake payments to the grantee of all or portion of any grant award, either by ay of reimbursement for expenses inarred in the budget period, or in adance for expenses to be incurred, to he extent he determines such paynents are necessary to promote rompt initiation and advancement of

performance of services by an officer or employee of the government in connection with such approved project, if such officer or employee was assigned or detailed by the Secretary at the request of the grantee to perform such services.

$67.19 Use of project funds.

(a) Any funds granted pursuant to this subpart shall be expended by the grantee solely for carrying out the approved project 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 approved project.

$67.20 Termination.

The termination of any grant under this subpart will be governed by the relevant provisions of subpart M of 45 CFR part 74 and the terms and conditions of the grant award. Where a grantee unilaterally terminates a portion of a grant, the Secretary may terminate such grant in whole where he determines that the remaining portion of the grant will not accomplish the purposes for which the grant was made. §67.21 Nondiscrimination.

Recipients of grants under this subpart are advised that in addition to complying with the terms and conditions of these regulations, the following laws and regulations are applicable:

(a) Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) and its im

plementing regulation, 45 CFR part 80 (prohibiting discrimination in Federally assisted programs on the ground of race, color, or national origin).

(b) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 974) and its implementing regulation, 45 CFR part 84 (prohibiting discrimination in Federally assisted programs on the basis of handicap).

(c) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.) and its implementing regulation, 45 CFR part 86 (prohibiting discrimination on the basis of sex in Federally assisted education programs).

(d) Executive Order 11246, 30 FR 12319 (September 24, 1965), as amended, and with the applicable rules, regulations, and procedures prescribed pursuant thereto.

§ 67.22 Human subjects and animal welfare.

(a) No award may be made under this subpart unless the applicant has complied with 45 CFR part 46 and other applicable requirements pertaining to the protection of human subjects.

(b) No award may be made under this subpart unless the applicant has complied with chapter 1-43 of the Department of Health and Human Services Grants Administration Manual and any other requirements concerning animal welfare.

§67.23 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. $67.24 Confidentiality.

No information obtained by a grantee in the course of its health services research, evaluation, or demonstration activities 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 responsibil ities 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 informa tion 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 pre scribe.

$67.25 Control of data.

Except as otherwise provided on the terms and conditions of the award and subject to the confidentiality require ments of §67.24, all data collected or a sembled for the purposes of carryis out health services research, des onstration, or evaluation projects sup ported under this subpart shall made available to the Secretary up request.

$67.26 Grantee accountability.

(a) Accounting for grant award pa ments. All payments made by the Se retary shall be recorded by the grants in accounting records separate fr the records of all other funds, includa funds derived from other grant awar With respect to each approved proje the grantee shall account for the sud total of all amounts paid by presentin or otherwise making available eviden satisfactory to the Secretary of penditures for direct and indirect cos meeting the requirements of this part: Provided, however, That when amount awarded for indirect costs based on a predetermined fixed-pe centage of estimated direct costs, amount allowed for indirect costs s be computed on the basis of such p determined fixed-percentage rates

plied to the total or a selected element of the reimbursable direct costs incurred.

(b) Accounting for royalties. Royalties received by grantees from copyrights on publications or other works developed under the grant, or from patents or inventions conceived or first actually reduced to practice in the course of or under grant shall be accounted for as follows:

(1) Royalties received during the period of grant support as a result of copyrights or patents shall be retained by the grantee and in accordance with the terms and conditions of the grant, be disposed of under either, or a combination of the following options:

(1) Used by the grantee for any purposes that further the objectives of the legislation under which the grant was made.

(ii) Deducted from the total project costs for the purpose of determining the net costs on which the Federal share of costs will be based.

(2) Royalties received after the completion or termination of grant support shall be disposed of as follows:

(1) Patent royalties shall be governed by agreements between the Assistant Secretary for Health, Department of Health and Human Services, and the rantee pursuant to the Department's atent regulations (45 CFR parts 6 and

).

(ii) Copyright royalties may be reained by the grantee, unless the terms nd conditions of the grant or a spe¡fic agreement negotiated between the ecretary and the grantee provide othrwise, except State or local governent grantees which receive royalties I excess of $200 a year shall return the ederal share of the excess amount omputed by applying the percentage Federal participation in the cost of le grant supported project to the exss amount) to the Federal Governent, unless specific agreement prodes otherwise.

(c) Grant closeout—(1) Date of final acunting. In addition to such other speal and periodic accounting as the cretary may require, a grantee shall nder with respect to each approved oject a full account, as provided rein, as of the termination of grant pport which shall be at the end of the

project period or the date of any termination of grant support pursuant to the applicable provisions of subpart M of 45 CFR part 74 and the terms and conditions of the grant award.

(2) Final settlement. There shall be payable to the United States as final settlement with respect to each approved project the total sum of (i) any amount not accounted for pursuant to paragraph (a) of this section and (ii) any other amounts due pursuant to the applicable provisions of 45 CFR part 74 and the terms and conditions of the grant award. Such total sum shall constitute a debt owed by the grantee to the United States and shall be recovered from the granteee or its successors or assignees by set-off or other action as provided by law.

Subpart B-Grants for Health
Services Research Centers

AUTHORITY: Sec. 215, 58 Stat. 690 (42 U.S.C. 216), sec. 305/d), as amended, 88 Stat. 364; (42 U.S.C. 242c(d)).

(d) Project period means the total period of time for which support for a project has been approved as specified in the grant award document. Such approval does not commit or obligate the Federal government to any additional,

$67.101 Purpose and scope.

(a) The regulations of this subpart are applicable to the award of grants under section 305(d) of the Public Health Service Act, as amended, to assist in meeting the costs of planning, establishing and operating multidisciplinary Health Services Research Centers by providing support for both permanent staff composed of experts from different disciplines and the administrative costs of carrying out multidisciplinary health services research, evaluations and demonstrations respecting:

(1) The accessibility, acceptability, planning, organization, distribution, technology, utilization, quality, and financing of health services and systems;

(2) The supply and distribution, education and training, quality, utilization, organization, and cost of health manpower; and

(3) The design, construction, utilization, and cost of facilities and equipment.

(b) Additional support awarded under this subpart, for National Special Emphasis Centers is intended to support staff, research, demonstration, and evaluation projects, training programs, and administrative costs for activities appropriate to the particular area of special emphasis.

$67.102 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.

(6) Nonprofit as applied to a private entity, means that no part of the net earrings of such entity inures or may inure to the benefit of any der or individual.

beyond the current budget period.

(e) Budget period means the interval of time (usually 12 months) into which the project has been divided for budgetary and reporting purposes and for which the Government has made a financial commitment to fund a particular project.

(f) Center means a Health Services Research Center supported under this subpart.

(8) National Special Emphasis Center mean a Center which directs a substantial portion of its efforts in research training, technical assistance, and other appropriate activities to a particular aspect of health care delivery specified by the Secretary and requiring a particular kind of scientific expertise. Such Centers shall include:

(1) A Health Care Technology Center, which shall focus on all forms of technology, including computers and electronic devices, and its applications in health care delivery;

(2) A Health Care Management Certer, which shall focus on the improvement of administration and organization in the health field, the training and retraining of administrators of health care enterprises, and the development of leaders, planners and policy analysts in the health field; and

(3) Such other Centers as the Secretary shall deem appropriate, provided that formal notification of the competition for a grant award and designstion as a National Special Emphasis Center under this subpart shall be made at least ninety (90) days prior to the closing date for filing applications for Center grants.

(h) State means one of the 50 States, the District of Columbia, Puerto Rico, Guam, Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.

(1) Grantee means the public or nonprofit private entity that receives & grant under section 305(d) of the Act and this subpart and assumes legal and financial responsibility for the funds

67.104 Application.

- (a) An application for a grant under his subpart shall be submitted to the ecretary at such time and in such anner as the Secretary may precribe.1

(b) The application shall be executed y an individual authorized to act for he applicant and to assume on behalf f the applicant the obligations imosed by the Act, the regulations of This subpart and the terms and condilons of any grant award.

(c) In addition to such other pertient information as the Secretary may equire, an application for a grant nder this subpart shall contain the ollowing:

(1) A description of the manner in which the applicant intends to plan and establish a Center, including a imetable for making the proposed Center operational;

(2) A description of the staff of the proposed Center, including their qualilications, academic training, responsibilities and functions;

(3) A description of the manner in which the staff will be organized and supervised to carry out the proposed activities of the Center;

(4) A description of the applicant's plan for providing at the Center educational opportunities to students, health professionals and other appropriate individuals;

'Applications and instructions are available from the Director, Review and Advisory Services, National Center for Health Services Research, Health Resources Administration, 5600 Fishers Lane, Rockville, MD 20852, Room 15-35.

(5) A description of the applicant's plan for sharing the knowledge and expertise of the Center's staff by providing technical assistance to appropriate organizations and individuals and through other forms of public and community services;

(6) A description of the applicant's plan for disseminating the Center's research findings to appropriate forums;

(7) A description of the need of the region in which the proposed Center will be located for a Center and a description of the areas of research which the applicant expects the Center to address by virtue of particular problems and characteristics of the local health care delivery system;

(8) A description of the organizational structure of the applicant and the nature of any relationship with and access to health care delivery systems in which research activities can be undertaken and research findings tested;

(9) A description of the procedures by which research projects will be selected, including the methodology to be utilized in ensuring that such projects will be selected on the basis of (i) the regional or national importance of the problem to be addressed, (ii) the unique potential for definitive research on a problem, and (iii) opportunities for local application of the research findings;

(10) A budget which allocates the total support both by type of expenditure and by the activities identified in paragraphs (c) (1), (4), (5), (6), and (9) of this section;

(11) A description of the resources which the applicant plans to make available to the proposed Center;

(12) A description of the proposed Center's relationships with other academic institutions and research organizations with regard to the impact of such relationships on the quality and scope of the Center's research and the responsiveness of its project selection to local, regional and national priorities; and

(13) Assurances satisfactory to the Secretary that the Center will meet the operational requirements of § 67.107 when it becomes operational.

(d) In addition to the material specified in paragraph (c) of this section, an application for a grant with a desig