3 years after the close of the budget period. Such records may be destroyed at the end of such 3-year period if the applicant has been notified of the completion of the Federal audit by such time. If the applicant has not been so notified, such records shall be retained (1) for 5 years after the close of the budget period or (2) until the grantee is notified of the completion of the Federal audit, whichever comes first. In all cases where audit questions have arisen before the expiration of such 5-year period, records shall be retained until resolution of all such questions. (b) Inspection and audit. Any application for a grant under these regulations shall constitute the consent of the applicant to inspections of the facilities, equipment, and other resources of the applicant at reasonable times by persons designated by the Secretary and to interview with principal staff members to the extent that such resources and personnel are, or will be, part of the project. In addition, the acceptance of any grant under these regulations shall constitute the consent of the grantee to inspections and fiscal audits by such persons of the supported activity and of records relating to the use of grant funds. § 51b.15 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 project, the interests of public health, or the conservation of grant funds. § 51b.16 Early termination and withholding of payments. Whenever the Secretary finds that a grantee has failed in a material respect to comply with the Act, the regulations of this part, or the terms of the grant, he may, on reasonable notice to the grantee, withhold further payments, and take such other action, including the termination of the grant, as he finds appropriate to carry out the purposes of the Act and regulations. Noncancelable obligations of the grantee properly incurred prior to the receipt of the notice of termination will be honored. The grantee shall be promptly notified of such termination in writing and given the reasons therefor. AUTHORITY: The provisions of this Part 52 issued under secs. 215, 301, 303, 204, 396, 103, 301, 304, 58 Stat. 690, as amended, 691, as amended, 70 Stat. 929, 79 Stat. 998, 1063, 81 Stat. 486, 504, 534; 42 U.S.C. 216, 241, 242a, 3253, 242b-6, 1857b, 1857g, 242b. Reorganization Plan No. 3 of 1966; 3 CFR 1966 Comp.; Reorganization Orders and Delegations of Mar. 13, Apr. 1, 1968 (33 F.R. 4894, 5426) and Jan. 17, 1969 (34 F.R. 1279). SOURCE: The provisions of this Part 52 appear at 28 F.R. 10420, Sept. 26, 1963, unless otherwise noted. Subpart A-Applicability and § 52.1 Applicability. The regulations of this part apply to grants for the support of health related research projects as set forth in § 52.10. They do not apply to general research support grants, demonstration grants, grants for studies in providing services outside hospitals, or other grants as may be authorized by law, such as grants for the construction of research facilities (see Part 57 of this chapter), for the construction of hospital or other medical facilities (see Part 53 of this chapter), or the award of fellowships (see Part 61 of this chapter), traineeships (see Part 63 of this chapter), or training grants (see Part 64 of this chapter). [28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968] § 52.2 Definitions. As used in this part: (a) "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 may be delegated. (b) "Project period" means the period of time, not exceeding 7 years, which the Secretary finds is reasonably required to initiate and conduct a research project meriting support by means of one or more research project grants within the scope of § 52.10, except that such period may be extended by the Secretary beyond 7 years solely to permit continuation or completion of the same approved project by use of funds previously awarded but remaining unencumbered by the grantee at the end of such 7 years. The project period may include the time required for initial staffing and acquisition of facilities and for the preparation and publication of the results of the project. The approval and support of a research project for the maximum project period shall not preclude additional support of that project beyond such period if such support of the continued project is requested, evaluated and approved on the same basis as a new or initial application in accordance with §§ 52.12 and 52.13. (c) "Principal investigator" means a single individual designated by the grantee in the grant application and approved by the Secretary, who is re sponsible for the scientific and technical direction of the project. [28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968; 35 F.R. 5469, Apr. 2, 1970] Subpart B-Eligibility, Award and Termination § 52.10 Nature and purpose of research project grant. A research project grant is the award by the Secretary of funds to an institution, organization or other person, hereinafter called the "grantee," to assist in meeting the costs of conducting for the benefit of the public health an identified activity or program, hereinafter termed the "project," that is intended and designed to establish, discover, develop, elucidate or confirm information or the underlying mechanisms relating to: (a) The cause, diagnosis, treatment, control or prevention of the physical or mental diseases, injuries, or impairments of man as authorized by sections 301, 303 and related provisions of the Public Health Service Act, as amended (42 U.S.C. 241, 242a); (b) The causes, effects, extent, prevention, and control of water pollution or air pollution as authorized by section 301 of the Public Health Service Act, as amended (42 U.S.C. 241) and section 103 of the Clean Air Act, as amended (42 U.S.C. 1857b); (c) The development, utilization, quality, organization and financing of services, facilities and resources of hospitals, facilities for long term care, or other medical facilities (including facilities for the mentally retarded), agencies, institutions or organizations or relating to development of new methods or improvement of existing methods of organization, delivery or financing of health services as authorized by section 304 of the Public Health Service Act, as amended (42 U.S.C. 242b); (d) The operation, financing, development, and application of new and improved methods of solid waste disposal (including devices and facilities therefor) as authorized under section 204 of the Solid Waste Disposal Act, as amended (42 U.S.C. 3253); (e) Medical library science and related activities and for the development and/or dissemination of new knowledge, techniques, systems, and equipment for processing, storing, retrieving, and distributing information pertaining to sci ences related to health, as authorized by section 396 of the Public Health Service Act (42 U.S.C. 280b-6). [35 F.R. 5469, Apr. 2, 1970] § 52.11 Eligibility for grant. (a) Persons eligible. Except where otherwise prohibited by law, any individual, corporation, public or private institution or agency, or other legally accountable person found by the Secretary to be authorized and qualified by scientific or other relevant competence to carry out a proposed research project in accordance with the regulations of this part shall be eligible for a grant award except: (1) Federal agencies or institutions not specifically authorized by law to receive such a grant; (2) Any corporation, institution, agency or other such person, other than an individual, that is organized or operated for profit; and (3) Any individual, corporation, institution, agency or other such person who, having previously received a grant award has failed wilfully and materially in the judgment of the Secretary to comply with accounting or other requirements applicable to such prior award, such disqualification to continue until terminated in the public interest by the Secretary. (b) Projects eligible. Any project found by the Secretary to be a research project within the meaning of § 52.10 shall be eligible for a grant award. Eligible projects may consist of laboratory, clinical, population, field, statistical, basic, applied or other types of investigations, studies or experiments, or combinations thereof, and may either be limited to one, or a particular aspect of a, problem or subject, or may consist of two or more related problems or subjects for concurrent or consecutive investigation and involving multiple disciplines, facilities and resources. [28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968] § 52.12 Application for grant. Any person desiring a grant award under § 52.11 may file application therefor with the Secretary on such forms as he may prescribe. Such application shall set forth the nature, duration, purpose, and plan of the research project, the name and qualifications of the principal investigator and the qualifications of the principal staff members to be responsible for the project, the total facilities and resources that will be available, a justification of the amount of grant funds requested, and such other pertinent information as the Secretary may require. The application shall be executed by an individual authorized to act for the institution or other applicant and to assume on behalf of the applicant the obligations imposed by the terms and conditions of any award, including the regulations of this part. [35 F.R. 5469, Apr. 2, 1970] § 52.13 Evaluation and disposition of applications. (a) Evaluation. All applications filed in accordance with § 52.12 shall be evaluated by the Secretary through such officers and employees and such experts or consultants engaged for this purpose as he determines are specially qualified in the areas of research involved in the project, including review by an appropriate National Advisory Council or other body as may be required by law. The Secretary's evaluation shall take into account among other pertinent factors the scientific merit and significance of the project, the competency of the proposed staff in relation to the type of research involved, the feasibility of the project, the likelihood of its producing meaningful results, the proposed project period, and the adequacy of the applicant's resources available for the project and the amount of grant funds necessary for completion. (b) Disposition. On the basis of his evaluation of an application pursuant to paragraph (a) of this section and subject to such approvals, recommendations or consultations by the appropriate National Advisory Council or other body as may be required by law, the Secretary shall (1) approve, (2) defer because of either lack of funds or a need for further evaluation, or (3) disapprove support of the proposed project in whole or in part. With respect to approved projects, the Secretary shall determine the project period during which the project may be supported. Any deferral or disapproval of an application shall not preclude its reconsideration or a reapplication. [28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9821, July 9, 1968] § 52.14 Grant awards. (a) General. Within the limits of funds available for such purpose, the Secretary shall award a grant to those applicants whose approved projects will in his judgment best promote the purposes of § 52.10. The date specified by the Secretary as the beginning of the project period shall be no later than 9 months following the date of any initial or new award statement unless the Secretary finds that because of the nature of a project or the grantee's particular circumstances earlier assurance of grant support is required to initiate the project. All grant awards shall be in writing, shall set forth the amount of funds granted, which may include an estimated provisional amount for indirect costs or for designated direct costs (such as hospital per diem rates or fringe benefit rates) subject to adjustment as set forth below. and shall constitute for such amounts the encumbrance of Federal funds available for such purpose on the date of the award. Within the limits of available funds, provisional amounts shall be subject to upward as well as downward adjustment to actual costs when the amount properly expended by the grantee for provisional items has been determined by the Secretary. All amounts awarded, whether provisional or otherwise, remain subject to accountability as provided under Subpart E of this part. (b) Determination of award amount. The amount of any award shall be determined by the Secretary on the basis of his estimate of the sum necessary for all or a designated portion of direct project costs (as set forth in §§ 52.31 and 52.33) for either the project period or for such lesser period as he may designate in making the award, plus an additional amount, if any, for overhead or indirect costs (as set forth in § 52.32). Neither the approval of any project nor a grant award shall commit or obligate the United States in any way to make any additional, supplemental, continuation or other award with respect to any approved project or portion thereof, but this provision shall not preclude the Secretary from making upward adjustments to actual costs as to amounts awarded on a provisional basis as provided in paragraph (a) of this section. (c) Multiple, concurrent, initial awards. Whenever a research project involves a number of different but related problems, activities or disciplines so as to require evaluation by different groups, or whenever support for a project could be more effectively administered by separate handling of separate aspects of the project, the Secretary may evaluate and approve two or more concurrent applications each dealing with one or more specified aspects of the project, and he may make two or more concurrent grant awards with respect to such a project. (d) Supplemental and continuation awards. The Secretary may from time to time within the project period make additional grant awards with respect to any approved project continued without change except as provided in § 52.20 (b) and (c) where he finds, on the basis of such progress and accounting reports as he may require, either that (1) the amount of any prior award was less than the amount necessary to carry out the approved project within the period used for estimating the amount of such prior award (a supplemental grant), or (2) the progress made within the period with respect to which any prior awards were made justifies support for an additional, specified portion, or the remainder, of the project period (a continuation grant). The amount of any supplemental or continuation grant shall be determined as provided in paragraph (b) of this section. (e) Payments. The Secretary shall from time to time make payments to a grantee of all or a portion of any grant award, either in advance or by way of reimbursement for expenses to be incurred or incurred in the project period, to the extent he determines such payments necessary to promote prompt initiation and advancement of the approved project. All such payments shall be recorded by the grantee in accounting records separate from all other fund accounts, including funds derived from other grant awards. Amounts paid shall be available for expenditure by the grantee in accordance with the regulations of this part throughout the project period subject to such limitations as the Secretary may prescribe. (f) Award for continuation of project under new grantee. The Secretary, upon application in accordance with the provisions of § 52.12 and without further action by a Council or other body, may make a grant to any institution or other person eligible under § 52.11 for continuation of a currently supported project for which a grant was previously made to another institution or person, provided he finds that the change in the conduct of the project is consonant with the previous evaluation and approval of the project under § 52.13. [28 F.R. 10420, Sept. 26, 1963, as amended at 29 F.R. 9831, July 22, 1964; 33 F.R. 9821, July 9, 1968] § 52.15 Termination. (a) Discontinuance by agreement. Whenever in the judgment of the Secretary and the grantee, continuation of an approved project would produce results of no value in furthering the purposes of § 52.10, grant support shall be terminated. (b) Termination by Secretary. Any grant award may be revoked or terminated by the Secretary in whole or in part at any time within the project period whenever in his judgment he determines that the grantee has failed in a material respect to comply with the regulations of this part. The grantee shall be promptly notified in writing of any such determination and given the reasons therefor. (c) Termination by the grantee. A grantee may at any time terminate or cancel its conduct of an approved project by notifying the Secretary in writing setting forth the reasons for such termination. (d) Accounting. Upon any termination, the grantee shall render an accounting pursuant to Subpart E of this part: Provided, however, That to the extent the termination is due in the judgment of the Secretary to no fault of the grantee, credit shall be allowed for the amount required to settle at minimum costs any noncancellable obligations properly incurred by the grantee prior to receipt of notice of termination. [28 F.R. 10420, Sept. 26, 1963, as amended at 35 F.R. 5469, Apr. 2, 1970] Subpart C-Grant Conditions- proach or other aspects of the project that would expedite achievement of the project's research objectives, including changes that grow out of the approved project and serve the best scientific strategy. Whenever the grantee and the principal investigator are uncertain as to whether a change complies with these provisions, the question shall be referred to the Secretary for a final determination. (c) Changes in project period. The project period determined pursuant to § 52.13(b) may be extended by the Secretary, with or without additional grant support, for such an additional period as he determines may be required to complete, or fulfill the purposes of, the approved project provided the total period as extended does not exceed 7 years except with respect to the grantee's unencumbered balances as provided in § 52.2(b). [28 F.R. 10420, Sept. 26, 1963, as amended at 33 F.R. 9822, July 9, 1968] § 52.21 Principal investigators. All grant awards shall be subject to the condition that the principal investigator designated in the application as responsible for the conduct of the approved project shall continue responsible for the duration of the project period. Whenever any such investigator shall become unavailable for any reason to discharge this responsibility, the grant shall be terminated and an accounting rendered as provided in § 52.15 unless the grantee replaces such investigator with another person found by the Secretary to be qualified to direct and conduct the approved project. § 52.22 Inventions or discoveries. Any grant award pursuant to § 52.14 is subject to the regulations of the Department of Health, Education, and Welfare as set forth in 45 CFR Parts 6 and 8, as amended. Such regulations shall apply to any activity for which grant funds are in fact used whether within the scope of the project as approved or otherwise. Appropriate measures shall be taken by the grantee and by the Secretary to assure that no contracts, assignments or other arrangements inconsistent with the grant obligation are continued or entered into and that all personnel involved in the supported activity are aware of and comply with such obligation. Labora |