Loren Data's SAM Daily™

FBO DAILY ISSUE OF DECEMBER 17, 2003 FBO #0750
SOLICITATION NOTICE

Q -- Develop and prioritize list of drugs in accordance with best pharmaceuticals for Children Act of 2002

Notice Date

12/15/2003
 

Notice Type

Solicitation Notice
 

Contracting Office

Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, Rm 538, Rockville, MD, 20892-7663
 

ZIP Code

20892-7663
 

Solicitation Number

263-04-(DR)0016
 

Response Due

12/18/2003
 

Archive Date

12/18/2003
 

Point of Contact

Shirl Brinson, Purchasing Agent, Phone 301-402-3342, Fax 301-435-8679,
 

E-Mail Address

Brinson_S@od.nih.giv
 

Description

The contractor shall, for each drug on a list to be provided, perform a comprehenive assessment of the literature using a standardized search methodology, and document the search metholology, including all information about the drug in neonates and children under the age of l8. The contractor shall conduct an assessment of the literature to include a quantitative enumeration of the total number or feferences regarding the drug, as well as sub-totals for the following categories: case-reports and case series, observational studies, and clinical trials. The contractor shall provide separate enumeration by content of the references for the following sub-categories: PK/PD, data pharmacoepideiology (patterns of use to include indications for using the drug in pediatric populations, inpatient and outpatient frequency of user, age, sex and race/ethnicity patterns of use), efficacy, and safety. The contractor shall develop a summary format to access the quality and availability of data regarding PK/PD, efficacy and safety for each drug, and to identify research questions requiring further study for scientific of regulatory (labeling) purposes.
 

Place of Performance

Address: Bldg. 6100, Room 4A01, Rockville, MD 20852

Country: USA
 

Record

SN00489682-W 20031217/031215211836 (fbodaily.com)
 

Source

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

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