DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

U -- SOURCES SOUGHT FOR A RESEARCH PARTICIPATION PROGRAM POC Deborah Striegel, Contracting Officer, (301) 827-7169 The Food and Drug Administration(FDA) has a requirement for a Research Participation Program to provide practical training experiences through temporary fellowship appointments for domestic and foreign predoctoral and postdoctoral scientists, engineers, and physicians. Such practical training experience shall be derived through the conduct and support of intramural research/projects or regulatory assessments performed on-site at the various FDA Centers, and Office of Regulatory Affairs(ORA) offices and laboratories located throughout the United States. All studies/projects will be relevant or pertinent to the needs and mission of the FDA. The practical research training opportunities will be extended to domestic and foreign predoctoral and postdoctoral scientists, physicians, and engineers having a background or interest in medical, biological, chemical, toxicological, mathematical/statistical, engineering, physics, or related sciences and engineering. By the sensitive nature of some FDA functions, however, some research, projects, or regulatory assessments may not be able to accept foreign nationals and permanent resident aliens. Predoctoral appointments will include college students pursuing baccalaureate, masters, or doctoral degrees (part-time while in school full-time or full-time while school is not in session), predoctoral summer students and junior and senior high school teachers. Postdoctoral appointments, except for college/university faculty appointments, will include recipients of doctoral degrees within five years prior to the start of their appointment. Clerical or administrative appointments are not accommodated by this program. Appointees will be selected by an FDA program official of the various FDA Centers or Office of Regulatory Affairs from applications provided by the organization administering the Research Participation Program for assignment to a laboratory or office designated by the FDA program official. Appointees will be bound by the "Rules of the Facility" where they are assigned. The participant will not be an FDA employee or an employee of the organization administering the Research Participation Program, but rather be assigned to an FDA Center, or the Office of Regulatory Affairs office, or laboratory upon acceptance of a Terms of Agreement with the organization administering the program. There is no commitment to future employment by the host organization or others. Accordingly, because of the temporary nature of these appointments and the program intent, only J-1 (Exchange Visitor Program) or F-1 (Student in Academic or Language Program) visas will be employed for foreign nationals. Appointments will be for one year renewable annually for up to four(4) years maximum. Appointments during the year may be full-time, part-time, combination of full-time/part-time, or intermittent. Because of the training nature of the appointment, participants may be required to produce a product or provide a service. The participant shall receive a fellowship award. Fellowship award amounts shall follow existing FDA guidelines for education and experience. Adjustments to fellowship awards may be made locally at FDA Centers or Office of Regulatory Affairs offices or laboratories for purposes of pay comparability with existing office/laboratory policies and practices. Participants receive no fringe benefits, but must have health and medical insurance coverage. The FDA is interested in identifying those sources that can provide for the operation and administration of this FDA-wide Research Participation Program. The program requires: the development, publication and distribution(nationally) to an appropriate audience of all program announcements; and appropriate applications; the recruitment, through accredited(Medical/Scientific) colleges and/or universities, and scientific journals, as deemed necessary, of fellows to participate in research training experiences; issuing individual fellowship awards; monitoring all fellows to include selection, extensions, terminations; all administrative duties associated with payment of stipends, travel relocation expense from port of entry; obtaining all necessary J-1 or F-1 visas for participants; and providing travel relocation arrangements from port of entry. It is estimated that the FDA will sponsor approximately 100 fellowships annually, at various educational levels and stipend levels over the next five(5) years. The number of fellowships may vary from year to year as funding is made available by the various FDA organizations participating. It is anticipated that organizations performing this program requirement will have close affiliations with accredited academic institutions. Consortiums with Historically Black Colleges and Universities (HBCU's) are encouraged. Interested sources having the required specialized expertise are requested to submit capability information of 10 pages or less indicating the ability to perform the effort described herein. Responses should include the following: Name and address of organization, contact point including telephone number, and description of relevant prior experience performing similar programs. This synopsis is for information purposes only and is not to be construed as a solicitation or as an obligation on the part of the Government to issue a Request for Proposal or award a contract, nor will the Government pay for information solicited. Respondents will not be notified of the results of the evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this synopsis or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Technical questions should be directed to: Stephen Douglas (870)543-7375. Procurement related questions should be directed to: Deborah Striegel (301)827-7169. Responses are due by August 31, l998. Please submit or fax (301) 827-7106 one copy of your response to: Food and Drug Administration, OFACS, Attn: D. Striegel, Contracts Operations Branch, HFA-512, OFAC Bldg. Rm. 2129, 5600 Fishers Lane, Rockville, MD 20857 (if using regular mail) or 5630 Fishers Lane, Rockville, MD 20852 (if using express or hand carried mail service). Posted 08/10/98 (W-SN234877). (0222)

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