[Federal Register Volume 63, Number 191 (Friday, October 2, 1998)]
[Notices]
[Pages 53060-53061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0713]


Draft Guidance for Industry on Submitting Debarment Certification 
Statements; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Submitting 
Debarment Certification Statements.'' The draft guidance addresses the 
most commonly asked questions about debarment certification statements 
and information requirements under the Federal Food, Drug, and Cosmetic 
Act (the act) and is intended to assist in the submission of 
applications for human, animal, and biologic drug products, export 
applications for certain

[[Page 53061]]

unapproved products, and supplements to certain drug product 
applications.

DATES:  Written comments on the draft guidance document may be 
submitted by December 1, 1998. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES:  Copies of this draft guidance are available on the Internet 
at http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/
cber/guidelines.htm. Submit written comments on the draft guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Leanne Cusumano, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
draft guidance entitled ``Submitting Debarment Certification 
Statements.'' Section 306(k) of the act (21. U.S.C. 335a(k)) states 
that drug product applications are to include a certification that the 
applicant did not and will not use in any capacity the services of any 
person who has been debarred under sections 306(a) or (b) of the act. 
Additionally, section 306(k) of the act requires that abbreviated new 
drug applications (ANDA's) and supplements to ANDA's providing for a 
different or additional use and submitted on or after June 1, 1992, 
contain a list of all convictions of the applicant and affiliated 
persons responsible for the development or submission of such 
application that have occurred within the last 5 years and for which a 
person can be debarred.
    Since section 306(k) of the act became effective in 1992, FDA has 
received a number of requests for clarification. This draft guidance 
addresses the most commonly asked questions about the certification and 
information requirements and should be helpful to those submitting the 
following drug product applications to FDA: (1) New drug applications, 
(2) ANDA's, (3) new animal drug applications, (4) abbreviated new 
animal drug applications, (5) export applications for certain 
unapproved products, (6) biological license applications, and (7) 
supplements to certain drug product applications. The draft guidance 
was prepared by the Debarment Task Force at FDA.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on debarment certification statements. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute, 
regulations, or both.
    Submit written requests for single copies of the draft guidance 
entitled ``Submitting Debarment Certification Statements'' to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; or the 
Communications and Education Branch (HFV-12), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Requests should be identified with the docket number found in 
brackets in the heading of this document. Send one self-addressed 
adhesive label to assist the office in processing your request.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: September 4, 1998.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 98-26424 Filed 10-1-98; 8:45 am]
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