Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 01, 2003 FBO #0610
SOLICITATION NOTICE

R -- Drugs and Lactation

Notice Date

7/30/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, National Library of Medicine, 8600 Rockville Pike, Bethesda, MD, 20894
 

ZIP Code

20894
 

Solicitation Number

03-193-NSD
 

Response Due

8/14/2003
 

Archive Date

8/29/2003
 

Point of Contact

Neha Dhir, Contract Specialist, Phone (301) 496-6546, Fax (301) 402-0642, - Karen Riggs, Contracting Officer, Phone 301 496-6546, Fax 301 402-0642,
 

E-Mail Address

dhirn@mail.nlm.nih.gov, kr33v@nih.gov
 

Description

It is the intent of the National Library of Medicine (NLM) to negotiate on a sole source basis under authority of FAR 6.302 with Phillip O. Anderson, Pharm.D. of San Diego, California for the professional services of creating a database on possible adverse effects of prescription and nonprescription drugs and diagnostic agents in infants that result from transmission during human breast-feeding. The period of performance shall be for a one-year base period with four (4) option years. Specifically, the contractor will 1) write subject protocols to document the standard record format for data fields within the database, the case evaluation methodology, the electronic format for submission of data and the project management plan the database creation and maintenance, 2) compile and organize professional and scientific literature relating to drug use during human lactation, 3) evaluate case reports and other published literature and provide possible drug effects on maternal lactation and in breast-fed infants, indicating a quantifiable probably causation, 4) create database records which include the drug names (at the generic level and include, at a minimum, United State Adopted Names and British Approved Names), drug class(es) pharmacologic and pharmacokinetic data . Information shall also be provided with respect to those drugs that present no safety problems where published literature specifically makes that determination. The NLM determined that Phillip O. Anderson, Pharm.D. is uniquely qualified to perform the above professional services. Dr. Anderson offers a vast collection of records on drugs and breastfeeding that contains over 3,100 bibliographic citations from world literature, including translated foreign language articles. These references, with their associated studies and reported adverse drug effects in breastfed infants, have already been critically evaluated by Dr. Anderson and professional colleagues at the University of California. Dr. Anderson is willing to make available to NLM his extensive resource collection and the professional efforts that have already been expended to evaluate all case studies at no cost to NLM. Dr. Anderson, a nationally recognized authority on drug use and lactation, brings a wealth of experience to this project. He has served as Director of the Drug Information Service, University of California San Diego Medical Center for 24 years. He is a Fellow of the American Society of Health-System Pharmacists and has served on numerous professional and scientific boards and committees. For over 20 years, Dr. Anderson has managed a telephone service that receives about 1,000 calls annually on drugs and lactation from nursing mothers, and from health care professionals throughout the United States. He has authored a dozen book chapters and peer-reviewed articles concerning drugs and lactation, and has made relevant international, national, state and local presentation that follow. In September 2000, he was invited to make a formal presentation to a joint meeting of the Subcommittee on Pregnancy Labeling and Anti-Infective Drugs Pediatric Subcommittee of the U.S. Food and Drug Administration. This service will be procured under FAR Part 13 (Simplified Acquisitions.) This is not a Request for Quotations (RFQ), nor is an RFQ available, however, all responsible and responsive sources may submit a proposal that will be considered by the NLM. Firms/Individuals interested in responding to this notice must be able to provide the professional services as specified above. Responses should demonstrate the firm/individual?s ability to meet the government?s requirements. Responses are required within 15 (fifteen) calendar days from the publication date of this notice. NLM synopsis No. 03-193/NSD shall be noted on all correspondence to this announcement.
 

Place of Performance

Address: 3907 Gresham St #8, San Diego, CA

Zip Code: 92109

Country: USA
 

Record

SN00386997-W 20030801/030730213421 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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