A -- SOURCES SOUGHT FOR REGULATORY COMPLIANCE CENTER

Notice Date

May 3, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch, 6700-B Rockledge Drive, MSC 7612, Bethesda, MD, 20892-7612

ZIP Code

20892-7612

Solicitation Number

Reference-Number-SS-NIH-NIAID-DAIDS-02-08

Response Due

May 18, 2001

Point of Contact

Nancy Hershey, Contracting Officer, Phone 301-496-0195, Fax 301-402-0972, Email NHershey@niaid.nih.gov -- Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-402-0972, Email

E-Mail Address

Nancy Hershey (NHershey@niaid.nih.gov)

Description

THIS IS NOT A REQUEST FOR PROPOSALS AND DOES NOT COMMIT THE GOVERNMENT TO AWARD A CONTRACT NOW OR IN THE FUTURE. NO SOLICITATION IS AVAILABLE AT THIS TIME. BASED ON RESPOSES RECEIVED FROM THIS SOURCES SOUGHT, THIS ACQUISITION MAY BE SOLICITED AS A 100% SMALL BUSINESS SET-ASIDE, NAICS CODE 541710, WITH A SIZE STANDARD OF 500 EMPLOYEES. The Division of AIDS (DAIDS), of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is seeking capability statements from organizations having the capabilities and facilities to provide the Regulatory Affairs Branch (RAB) in DAIDS with regulatory and technical support to facilitate management of regulatory aspects of DAIDS-sponsored clinical trials. This critical contract support will be provided within a research environment and a consortium of multiple clinical trials groups, most of which are international in scope. These groups involve interaction with the clinical investigators and their institutions, the statistical and data analysis centers and operational centers of the groups, the Food and Drug Administration (FDA), the Office of Human Research Protection (OHRP), the pharmaceutical industry, HIV-infected patients and their advocates, populations at risk for HIV infection, and the DAIDS' scientific and administrative personnel to make key decisions about HIV treatment and prevention research issues and to implement and conduct clinical trials. As needed, the organization must have the demonstrated expertise and capabilities to: (1) provide regulatory and technical support to enable DAIDS to fulfill its responsibilities as a sponsor of a large portfolio of Investigational New Drug Applications (INDs); (2) manage the Serious Adverse Experience (SAE) System for both IND and non-IND studies; (3) coordinate concept sheet/protocol review and approval for DAIDS; (4) maintain the protocol registration and informed consent review systems; (5) assist in negotiation of clinical trials agreements with pharmaceutical collaborators; (6) interact in meetings and conference calls with the FDA; and other such activities as may be necessary to the successful conduct of DAIDS-sponsored clinical trials; (7) establish and maintain a computerized information system to produce reports and track information; and, (8) participate in electronic communication between DAIDS and clinical trials groups operational offices and sites for the purpose of information exchange. It is anticipated that a total of seven years will be required for this project with an estimated level-of-effort of 52,000 labor hours per year. Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as a principal investigator and/or project officer; (3) Facilities: availability and description of special facilities required to perform in the technical areas under consideration. A statement regarding industry security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Interested Small Business organizations that believe they possess the capabilities necessary to undertake this project should submit two (2) copies of their capability statement addressing each of the eight areas cited above. No collect calls will be accepted.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=R&P=Reference-Number-SS-NIH-NIAID-DAIDS-02-08&L=3465)

Record

Loren Data Corp. 20010507/ASOL007.HTM (D-123 SN50L089)