[Code of Federal Regulations] [Title 42, Volume 1] [Revised as of October 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR52h.2] [Page 222-223] TITLE 42--PUBLIC HEALTH CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 52h--SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS--Table of Contents Sec. 52h.2 Definitions. As used in this part: (a) Act means the Public Health Service Act, as amended. (b) Project period has the same meaning as in 42 CFR part 52. (c) Budget period means the interval of time (usually 12 months) into which the project period is divided for budgetary and reporting purposes. (d) Awarding official 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; Except that, where the Act specifically authorizes another official to make awards in connection with a particular program, the ``awarding official'' shall mean said other official and any other officer or employee of the Department of Health and Human Services to whom the authority involved has been delegated. (e) Peer review group means a group of experts qualified by training and experience in particular scientific or technical fields to give expert advice, in accordance with the provisions of this part, on the scientific and technical merit of grant applications or contract projects in those fields. (f) Research means systematic study directed toward new or fuller knowledge and understanding of the subject studied. [[Page 223]] (g) Development means the systematic use of knowledge and understanding gained from research, directed toward creating useful materials, devices, systems, or methods. (h) Research and development contract project means an identified, circumscribed activity, involving a single contract or two or more similar, related, or interdependent contracts, intended and designed to acquire new or fuller knowledge and understanding of a subject and/or to use such knowledge and understanding to develop useful materials, devices, systems, or methods. The terms include (but are not limited to) development and utilization of resources, testing, demonstrations, clinical trials, preparation of reports, and production of experimental or test models necessary or incidental to a research and/or development activity, but exclude quantity production and routine product testing and quality control. (i) Project concept means the basic purpose, scope, and objectives of the project. (j) Project approach means the methodology to be followed and the resources needed in carrying out the project. (k) Contract proposal means a written offer to enter into a contract, submitted to an awarding official by an individual or non- Federal organization, and including as a minimum a description of the nature, purpose, duration, and cost of the project and the methods, personnel, and facilities to be utilized in carrying it out. (l) Solicited contract proposal has the same meaning as in 41 CFR 3- 1.353(b)(2). (m) Unsolicited contract proposal has the same meaning as in 41 CFR 3-4.5201. (n) Request for proposals means a Government solicitation to prospective offerors, under procedures for negotiated contracts, to submit a proposal to fulfill specific agency requirements based on terms and conditions defined in the request for proposals. The request for proposals contains information sufficient to enable all offerors to prepare competitive proposals, and is as complete as possible with respect to: Nature of work to be performed; descriptions and specifications of items to be delivered; performance schedule; special requirements clauses, or other circumstances affecting the contract; format for cost proposals; and evaluation criteria by which the proposals will be evaluated.