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GAO-04-194R 1 (2003-10-23)

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       Accountability * Integrity * Reliability
United States General Accounting Office
Washington, DC 20548

          B-293043


          October 23, 2003

          The Honorable Judd Gregg
          Chairman
          The Honorable Edward M. Kennedy
          Ranking Minority Member
          Committee on Health, Education, Labor, and Pensions
          United States Senate

          The Honorable W.J. Billy Tauzin
          Chairman
          The Honorable John D. Dingell
          Ranking Minority Member
          Committee on Energy and Commerce
          House of Representatives

          Subject: Department of Health and Human Services, Food and DrugAdministration:
                  Prior Notice of Imported Food Under the Public Health Security and
                  Bioterrorism Preparedness and Response Act of 2002

          Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a
          major rule promulgated by the Department of Health and Human Services, Food and
          Drug Administration (FDA), entitled Prior Notice of Imported Food Under the
          Public Health Security and Bioterrorism Preparedness and Response Act of 2002
          (RIN: 0910-AC41). We received the rule on October 10, 2003. It was published in the
          Federal Register as an interim final rule; request for comments on October 10,
          2003. 68 Fed. Reg. 58974.

          The interim final rule requires submission to the FDA of prior notice of food,
          including animal feed, that is imported or offered for import into the United States.
          The rule implements the Public Health Security and Bioterrorism Preparedness and
          Response Act of 2002.

          Enclosed is our assessment of the FDA's compliance with the procedural steps
          required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.
          Our review indicates that the FDA complied with the applicable requirements.

          If you have any questions about this report, please contact James W. Vickers,
          Assistant General Counsel, at (202) 512-8210. The official responsible for GAO
          evaluation work relating to the subject matter of the rule is Robert Robinson,


GAO-04-194R

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