A -- SOURCES SOUGHT (REVISED) FOR REGULATORY COMPLIANCE CENTER

Notice Date

July 30, 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-SS2-NIH-NIAID-DAIDS-02-08

Response Due

August 13, 2001

Point of Contact

Nancy Hershey, Contracting Officer, Phone 301-496-0193, Fax 301-402-0972, Email NHershey@niaid.nih.gov -- Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-402-0972, Email bs92y@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 CAPABILITY STATEMENTS 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. Due to redefining the regulatory responsibilities of this project, the previous Sources Sought Announcement (dated May 3, 2001) is hereby revised to read as stated below. The purpose of this Announcement is to emphasize the regulatory, clinical and technical expertise required for this project. 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 regulatory, clinical and technical expertise 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 will exist within a complex research environment and a consortium of multiple clinical trials groups which are increasingly international in scope. International research is predominantly conducted in countries with high prevalence of HIV/AIDS. The clinical trials networks to be supported include, but are not limited to: HIV Vaccine Trials Network (HVTN); HIV Prevention Trials Network (HPTN); Adult AIDS Clinical Trials Group (AACTG); Pediatric AIDS Clinical Trials Group (PACTG); Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT); The Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA); and Acute HIV Infection and Early Disease Research Program (AIEDRP). These networks interact with a complex research environment composed of, but not limited to, clinical investigators and their institutions, the statistical and data analysis centers, operational centers of the networks, the Food and Drug Administration (FDA), the Office of Human Research Protection (OHRP), the Fogarty International Center (FIC), the pharmaceutical industry, local and national Internal Review Board/Ethics Committees, patients with HIV/AIDS and their advocates, populations at risk for HIV infection, and the DAIDS' scientific and administrative personnel. These networks make key decisions about HIV/AIDS treatment and prevention research and conduct numerous clinical trials of all phases. =20 The clinical research organization must demonstrate capabilities to: (1) provide regulatory, clinical and technical expertise to enable DAIDS to fulfill its responsibilities as a sponsor of a large portfolio of Investigational New Drug (IND) Applications and other large clinical trials not conducted under IND; (2) manage the Serious Adverse Experience (SAE) System for both IND and non-IND studies of all phases; (3) provide technical ability to write concept sheet and protocol review summaries and related letters for DAIDS; (4) maintain the protocol registration and informed consent review systems; (5) develop in collaboration with DAIDS and the pharmaceutical industry lists of risks associated with approved/investigational drugs/vaccines used in DAIDS-sponsored clinical trials; (6) assist or lead in negotiation of clinical trials agreements with pharmaceutical collaborators; (7) coordinate and prepare for meetings and conference calls with the FDA, OHRP or other groups collaborating with the networks and other such activities as may be necessary to successfully conduct DAIDS-sponsored clinical trials; (8) establish and maintain a computerized information system to produce reports and track existing and evolving information related to major responsibilities of the contract; (9) provide extensive international travel of contractor staff and set up international conference calls for the purpose of providing updated information about regulatory issues and site regulatory responsibilities; and, (10) participate in electronic communication between DAIDS and clinical trials groups? operational offices and sites for the purpose of information exchange. =20 This new contract will be awarded as a performance-based contract with the emphasis being on the contractor?s ability to provide rapid response to requests for support to the Division of AIDS. It is anticipated that the period of performance for this contract will be a total of seven years with an estimated level-of-effort of 52,000 labor hours per year. Information submitted should be pertinent and specific in the area under consideration on each of the following qualifications: (1) Experience: an outline of previous regulatory projects, specific related work previously performed or being performed; (2) Personnel: name, professional qualifications and specific expertise of regulatory project directors, project managers, senior clinical research associates, medical officers, information technology experts, senior research nurses, and experts in intellectual property issues related to international clinical research; and (3) Facilities and Equipment: availability and description of facilities to maintain investigational new drug applications and necessary equipment to communicate with a large number of international sites in over thirty (30) countries. Any additional and pertinent qualifications (e.g. foreign language capabilities to translate protocol informed consents into frequently encountered foreign languages) pertaining to this announcement that would enhance our consideration and evaluation of the information provided should be included with your capability statement. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. No collect calls will be accepted. No facsimile transmissions will be accepted.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/NIAID/Reference-Number-SS2-NIH-NIAID -DAIDS-02-08/listing.html)

Record

Loren Data Corp. 20010801/ASOL012.HTM (D-211 SN50T3G1)