United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1996-03-19 monographic deposited born digital 51 p. GA 1.13:HEHS-96-30 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-96-30 P0b002ee18037512a f:he96030 DGPO 2010-08-12 2011-03-24 GAOREPORTS-HEHS-96-30 machine generated eng fdlp REPORT GAOREPORTS-HEHS-96-30 HEHS-96-30 Laboratories Test facilities Site selection Cost effectiveness analysis Federal facility relocation Obsolete facilities Food and drug law Federal agency reorganization Product safety Letter Report HEHS

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plan to consolidate its Office of Regulatory Affairs' (ORA) 18 field laboratories for product testing, focusing on: (1) the validity of projected cost savings and operational efficiencies; and (2) site selection criteria.<p/>GAO found that: (1) the 20-year consolidation plan, known as ORA 21, proposes to create 5 mega-laboratories and 4 special-purpose laboratories; (2) ORA based its plan on the belief that its current facilities are old, need costly repairs, and do not meet the needs for conducting regulatory science in the future; (3) ORA may have overstated the consolidation plan's projected cost savings because ORA made several assumptions about replacement costs, construction costs, and space and staffing requirements; (4) the plan's claims for achieving greater operational efficiencies are also questionable, and ORA did not substantiate claims regarding obsolete equipment, supervisor/analyst ratios, laboratory efficiency, and staff relocation; and (5) ORA conducted limited analysis of the relative efficiency of proposed laboratory sites and based its site selections on areas where it believed that it would receive congressional funding approval. https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-96-30/html/GAOREPORTS-HEHS-96-30.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-96-30/pdf/GAOREPORTS-HEHS-96-30.pdf GAO/HEHS-96-30 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-96-30 Letter Report GAO/HEHS-96-30; FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable; Laboratories Test facilities Site selection Cost effectiveness analysis Federal facility relocation Obsolete facilities Food and drug law Federal agency reorganization Product safety Title 21 Section 301 21 U.S.C. 301