FDAAA Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
The recently enacted U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII, Section 801 mandates the expansion of the clinical trials data bank (ClinicalTrials.gov). The new provisions require additional information to be submitted to the databank, including expanded information on clinical trials and information on the results of clinical trials. Additional information for individuals or organizations registering clinical trials in the ClinicalTrials.gov data bank is available on the National Library of Medicine (NLM) Protocol Registration System (PRS) website.
One FDAAA provision in Section 801, 42 U.S.C. 282(j)(5)(B), requires that a certification form accompany certain human drug, biological, and device product submissions made to FDA. At the time of submission of an application under sections 505, 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the Public Health Service Act (PHS Act) (21 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act (21 U.S.C. 360(k)), such application or submission must be accompanied by a certification that all applicable requirements of section 402(j) of the PHS Act have been met. Where available, such certification must include the appropriate ClinicalTrials.gov identifiers (NCT numbers).
Based on the timeframes under which the new FDAAA submission requirements take effect, the certifications must be submitted to FDA beginning no later than December 26, 2007. The official certification form, Form FDA 3674 titled "Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j)),” is now available on FDA's Web site. The Federal Register notice (TXT) (PDF) announcing the clearance process for the form under the Paperwork Reduction Act (44 U.S.C. 3507(j)) is also available.