use of grant funds as the Secretary may find necessary to carry out the purposes of this subpart.

§ 66.213 Grantee accountability.

(a) All payments made by the Secretary shall be recorded by the grantee in accounting records separate from the records of all other grant funds, including funds derived from other grant awards. With respect to each approved program the grantee shall account for the sum total of all amounts paid by presenting or otherwise making available to the Secretary, satisfactory evidence of expenditures for direct and indirect costs meeting the requirements of this subpart.

(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 such grant, shall be accounted for as follows:

(1) State and local governments. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, royalties shall be accounted for as provided in 45 CFR 74.44.

(2) Grantees other than State and local governments. Where the grantee is not a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, royalties shall be accounted for as follows:

(i) Patent royalties, whether received during or after the grant period, shall be governed by agreements between the Assistant Secretary for Health, Department of Health, Education, and Welfare, and the grantee, pursuant to the Department's patent regulations (45 CFR Parts 6 and 8).

(ii) Copyright royalties, whether received during or after the grant period, shall first be used to reduce the Federal share of the grant to cover the costs of publishing or producing the materials, and any royalties in excess of the costs of publishing or producing the materials shall be distributed in accordance with Chapter 1-420 of the Department of Health, Education, and Welfare Grants Administration Manual.

§ 66.214 Publications and copyright.

(a) State and local governments. Where the grantee is a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, the Department of Health, Education, and Welfare copyright requirement set forth in 45 CFR 74.140 shall apply with respect to any book or other copyrightable materials developed or resulting from an activity supported by a grant under this subpart.

(b) Grantees other than State and local governments. Where the grantee is not a State or local government as those terms are defined in Subpart A of 45 CFR Part 74, except as may otherwise be provided under the terms and conditions of the grant award, the grantee may copyright without prior approval any publications, films, or similar materials developed or resulting from an activity supported by a grant under this subpart, subject to a royalty-free nonexclusive, and irrevocable license or right in the United States to reproduce, translate, publish, use, disseminate and dispose of such materials, and to authorize others to do so.

§ 66.215 Additional conditions.

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

§ 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, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved has been delegated.

(c) "Nonprofit" as applied to a private entity, means that no part of the net earnings of such entity inures or may lawfully inure to the benefit of any shareholder or individual.

(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, supplemental or continuation support 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.

(g) "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 Center, 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 compe

tition for a grant award and designation 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.

(i) "Grantee" means the public or nonprofit private entity that receives a grant under section 305(d) of the Act and this subpart and assumes legal and financial responsibility for the funds awarded and for the performance of the grant supported activity.

(j) "Director" means a single individual, designated by the grantee in the grant application and approved by the Secretary, who is responsible for the scientific, technical, and administrative direction of the Center.

§ 67.103 Eligibility.

Any public or nonprofit private entity located in a State is eligible to apply for a grant under this subpart; Provided, That no entity is eligible for assistance for more than one Center at any one time.

§ 67.104 Application.

(a) An application for a grant under this subpart shall be submitted to the Secretary at such time and in such manner as the Secretary may prescribe. '

(b) The application shall be executed by an individual authorized to act for the applicant and to assume on behalf of the applicant the obligations imposed by the Act, the regulations of this subpart and the terms and conditions of any grant award.

(c) In addition to such other pertinent information as the Secretary may require, an application for a grant under this subpart shall contain the following:

(1) A description of the manner in which the applicant intends to plan

'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, Maryland 20852, Room 15-35.

and establish a Center, including a timetable for making the proposed Center operational;

(2) A description of the staff of the proposed Center, including their qualifications, 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;

(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 designation 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 problem;

(4) A description of the resources which the applicant plans to make available to enhance the special emphasis activities;

(5) A description including a budget, of the proposed Center's plan for disseminating its research findings to groups and individuals particularly concerned with the area of special emphasis; and

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

§ 67.105 Evaluation and disposition of applications.

(a) Evaluation. (1) All applications for a grant under this subpart will be

submitted by the Secretary for review to a panel of experts who are neither officers or employees of the United States and who possess qualifications necessary to evaluate both the applicant's proposed method of planning, establishing and operating a Center and the potential of the proposed Center to make a valuable scientific contribution (hereinafter referred to as the review panel).

(2) The review panel to which an application has been submitted pursuant to paragraph (a)(1) of this section shall make a written report to the Secretary on each application so submitted. Each 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 appropriate, 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.

(v) The fifth part shall consist of a set of recommendations to the Secretary with respect to the disposition of the application:

(A) The panel may recommend that the Secretary approve, disapprove, or defer a decision in order to gather further information on an application for support as a Health Services Research Center. If the panel recommends approval, it shall also provide its recom

mendation regarding an appropriate project period and an appropriate level of support. If it recommends deferral, it shall specify the additional information it deems necessary for an adequate review of the application.

(B) The panel may also recommend that the Secretary approve, disapprove, or defer a decision in order to gather further information on an application for additional support as a National Special Emphasis Center. If the panel recommends approval, it shall also provide its recommendation regarding an appropriate project period and an appropriate level of support. If it recommends deferral, it shall specify the additional information it deems necessary for an adequate review of the application.

(b) Disposition. On the basis of the Secretary's evaluation of the application and taking into consideration any recommendations made pursuant to paragraph (a) of this section, the Secretary shall either (1) approve, (2) defer for a later decision or (3) disapprove any application for grant assistance under this subpart. Such disapproval of an application shall not preclude its reconsideration if the application is resubmitted in the same or a revised version at a later date.

§ 67.106 Grant awards.

(a) General. (1) Within the limits of funds available for such purpose, the Secretary may award a grant to those applicants whose approved proposed Centers will in his judgment best promote the purposes of section 305(d) of the Act and this subpart, taking into consideration:

(i) Recommendations made pursuant to § 67.105.

(ii) The appropriateness of the proposed budget and the extent to which the fiscal plan provides assurance that effective use would be made of grant funds.

(iii) The capability of the applicant as demonstrated by organizational and institutional arrangements to successfully operate the proposed Center.

(iv) The qualifications, achievements, and commitment of the senior personnel.

(v) The strength and scientific integrity of the general program and approach of the proposed Center.

(vi) The nature of the sponsoring institution's commitment to the proposed Center and the relative importance it ascribes to the endeavor.

(vii) The past success and future potential of the proposed Center's personnel in receiving permanent and project related support from other

sources.

(viii) The extent to which a proposed Center's planning process incorporates the concerns of pertinent constituents and reflects an awareness of significant research problems in health services.

(ix) The strength of the relationship the 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 HEW region, except that this restriction shall not operate to proscribe awarding at least two grants under this subpart to institutions located in any single HEW 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