A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for the appointment of scientific advisory committees to make recommendations concerning scientific matters raised in the course of proceedings under sections 505 and 507 of that act relating to new drugs and certification of antibiotics.

Summary

Provides for the appointment of scientific advisory committees to be composed of experts nominated by the National Academy of Sciences, qualified in the subject matter involved, and of adequately diversified professional background, to make recommendations concerning scientific matters raised in the course of proceedings relating to approval of new drugs and certification of antibiotics under the Federal Food, Drug, and Cosmetic Act. States that in any such proceeding the applicant, manufactures, sponsor, or the Secretary of Health, Education, and Welfare may request referral of any matter requiring the exercise of scientific judgment to an advisory committee for a report and recommendations. Stipulates that within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time is necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before itiu, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. States that within thrity days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall by order act upon the petition or other proposal, or confirm or modify any order previously issued with respect to the approval of applications for new drugs or certification of antibiotics.

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1 official file

• Introduced in House

  summary · EN · 5 February 1974

  Open at official source

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