Document Requests:

Response Time to Congressional Committees Could Be Improved

HRD-87-45: Published: Apr 24, 1987. Publicly Released: Apr 24, 1987.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) procedures for responding to congressional requests for FDA documents.

GAO found that: (1) the FDA Office of Legislative Affairs (OLA) handles most congressional document requests; (2) other FDA offices send requested documents to OLA for review; (3) OLA reviews the documents for sensitivity, then sends them, with a document listing, to the requester; (4) FDA took an average of 41 days to respond to document requests, an average of 34 days late; (5) FDA identified a number of reasons for the delays, including staff shortages, cumbersome procedures, and nonmandatory response target dates; and (6) OLA reviews documents for trade secrets, even when other FDA offices have already done so.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: FDA disagreed with this recommendation and does not intend to implement it.

    Recommendation: FDA should require OLA to establish internal target dates for offices to meet in carrying out their responsibilities and require the Centers and other offices to either adhere to target dates or inform OLA of the reasons for any delays.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  2. Status: Closed - Implemented

    Comments: FDA instructed its legislative staff to negotiate new dates, when necessary, in its internal guidance developed for use in responding to congressional committee requests for information.

    Recommendation: FDA should require OLA to notify committees of reasons for delays, and attempt to negotiate a revised date when necessary. A record of these contacts should be made in OLA files, including agreements reached.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  3. Status: Closed - Not Implemented

    Comments: FDA disagreed with this recommendation and does not intend to implement it.

    Recommendation: FDA should direct OLA to not delay providing documents to the requester due to reviewing and questioning trade-secret determinations made by the Centers.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  4. Status: Closed - Implemented

    Comments: FDA issued internal guidance to OLA and other offices regarding their roles and responsibilities in responding to congressional committees.

    Recommendation: FDA should provide written guidance to OLA and other FDA offices on their roles and responsibilities for responding to congressional committee requests for documents. Such guidance should include a requirement that two sets of copies of requested documents be made at the same time.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  5. Status: Closed - Not Implemented

    Comments: FDA disagreed with this recommendation and does not intend to implement it.

    Recommendation: FDA should require OLA to release documents by the agreed-to due date in cases where documents would be delayed because the listing has not been completed. OLA should alert the committees and the ranking minority members that the listing is being prepared and will be provided later.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

 

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