B -- REGULATORY AFFAIRS SUPPORT

Notice Date

April 20, 2001

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Blvd, Rm 3105 (MSC 9543), Bethesda, MD, 20892-9543

ZIP Code

20892-9543

Solicitation Number

N01DA-1-8818

Response Due

June 13, 2001

Point of Contact

Patricia Mummaugh, Contract Specialist, Phone (301) 443-6677, Fax (301) 443-7595, Email pm69j@nih.gov

E-Mail Address

Patricia Mummaugh (pm69j@nih.gov)

Description

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations having the capability to provide regulatory affairs support that includes preparing, compiling, indexing and filing (1) Initial Investigational New Drug (IND) Applications; (2) annual reports for ongoing INDs held by NIDA; (3) protocol amendments as needed for ongoing INDs held by NIDA; (4) information amendments as needed for ongoing INDs held by NIDA; and, (5) ad hoc regulatory documents for submission and registration with regulatory agencies. The Contractor must ensure that the regulatory submissions are in accordance with Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) guidelines, and Good Clinical Practice (GCP) guidelines where appropriate. It is anticipated that one (1) cost-plus-fixed fee, completion-type contract will be awarded for a period of one year with two option years. Optional reports and amendments also may be included. RFP No. N01DA-1-8818 will be available electronically on or about May 9, 2001, and may be accessed through the NIDA website at the following address: (URL: http://www.nida.nih.gov/RFP/RFPList.html). All information required for the submission of an offer will be contained in the electronic RFP package. Please note that the RFP for this requisition will be streamlined to include only the Work Statement, Deliverables and Reporting Requirements, Special Requirements and Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. Following proposal submission and the initial review process, offerors comprising the competitive range may be requested to provide additional documentation to the Contracting Officer. Response to the RFP will be due on or about June 13, 2001. This advertisement does not commit the Government to award a contract. The proposed contract is 100% set aside for Small Business concerns. Offers from concerns other than Small Business will not be considered. See numbered Notes 1 and 26.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=N01DA-1-8818&L=3067)

Record

Loren Data Corp. 20010424/BSOL007.HTM (D-110 SN50J8W6)