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Submitting Debarment Certification Statements October 1998

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

Section 306(k) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 335a(k)), as amended by the Generic Drug Enforcement Act of 1992 (GDEA), requires that drug product applicants certify that they did not and will not use in any capacity the services of any debarred persons in connection with a drug product application. If the application is an abbreviated new drug application (ANDA), it must also include a list of all convictions described under section 306(a) and (b) of the Act (21 U.S.C. 335a(a) and (b)) that occurred within the previous 5 years and were committed by the applicant or affiliated persons responsible for the development or submission of the ANDA.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.