SOLICITATION NOTICE
B -- Regulatory Affairs Support
- Notice Date
- 1/11/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Bethesda, MD, 20892
- ZIP Code
- 20892
- Solicitation Number
- N01DA-5-8852
- Response Due
- 3/17/2005
- Point of Contact
- Kim Louth, Contract Specialist, Phone (301) 443-6677, Fax (310) 443-7595, - Nancy Hurd, Contracting Officer, Phone (301) 443-6677, Fax (301) 443-7595,
- E-Mail Address
-
klouth@nida.nih.gov, nh31d@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- THIS REQUIREMENT IS A 100% SMALL BUSINESS SET-ASIDE. The North American Industrial Classification Code (NAICS) identified for this requirement is 541990. The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified organizations having the capability to provide regulatory affairs support that includes the preparing, compiling, indexing and filing of Initial Investigational New Drug (IND) Applications, Annual Reports for ongoing INDs held by NIDA, Protocol Amendments as needed for ongoing INDs held by NIDA, Information Amendments as needed for ongoing INDs held by NIDA, and Ad Hoc regulatory documents for submission and registration with regulatory agencies. The contractor will 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 we will award one fixed price contract for a three year period of performance with two option years. RFP No. N01-DA-5-8852 will be available electronically on or about 1/31/2005. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.nida.nih.gov/RFP/RFPList.html). Please note that the RFP for this acquisition will be streamlined to include only the Work Statement, Deliverables, Reporting Requirements, Special Requirements, Mandatory Qualifications, Technical Evaluation Criteria, and other necessary Proposal Preparation Instructions. However, all information required for the submission of an offer will be contained in or accessible through the streamlined electronic RFP package. Response to the RFP will be due on or about 3/17/2005. This advertisement does not commit the Government to award a contract. See Numbered Notes 1 and 26. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (11-JAN-2005). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 20-APR-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIDA-01/N01DA-5-8852/listing.html)
- Record
- SN00793126-F 20050422/050421090323 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |