[Federal Register Volume 66, Number 65 (Wednesday, April 4, 2001)]
[Notices]
[Page 17914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0146]


Draft Guidance for Industry and Reviewers on How the Center for 
Veterinary Medicine Intends to Handle Deficient Submissions Filed 
During the Investigation of a New Animal Drug; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft guidance for industry and reviewers 
(#119) entitled ``How the Center for Veterinary Medicine Intends to 
Handle Deficient Submissions Filed During the Investigation of a New 
Animal Drug.'' This draft guidance is neither final nor is it in effect 
at this time. This draft guidance announces the Center for Veterinary 
Medicine's (CVM) policy regarding the circumstances under which CVM 
intends to discontinue review of submissions filed during the 
investigation of a new animal drug, notify the sponsor that review has 
been discontinued, and remove the submission from the queue.

DATES: Submit written comments on the draft guidance at any time; 
however, comments should be submitted by July 3, 2001, to ensure their 
adequate consideration in preparation of the final document.

ADDRESSES: Submit written comments 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 full title 
of the draft guidance and the docket number found in brackets in the 
heading of this document. Persons without Internet access may submit 
written requests for single copies of the draft guidance to the 
Communications Staff (HFV-12), Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one 
self-addressed adhesive label to assist that office in processing 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gail L. Schmerfeld (HFV-100), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855, 301-594-1620, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the draft guidance for 
industry (#119) entitled ``How the Center for Veterinary Medicine 
Intends to Handle Deficient Submissions Filed During the Investigation 
of a New Animal Drug.'' This guidance announces CVM's policy regarding 
the circumstances under which CVM intends to discontinue review of 
submissions filed during the investigation of a new animal drug, notify 
the sponsor that review has been discontinued, and remove the 
submission from the queue.
    CVM's Office of New Animal Drug Evaluation (ONADE) currently has a 
significant backlog in the number of submissions pending review. This 
has prompted ONADE to look at its review process. ONADE found that one 
of the significant inefficient uses of reviewer resources is the number 
of submissions received by ONADE that require significant additional 
information or rehabilitation in order for ONADE to complete its 
review. ONADE's practice has been to keep a submission ``active'' 
pending the submission of additional information from sponsors.
    Instead of keeping deficient submissions ``active'' pending the 
submission of additional or revised information, ONADE intends to 
handle them under the policy set out in this draft guidance. If ONADE 
finds minor deficiencies, ONADE should request an amendment. But, if 
ONADE finds that a submission is significantly deficient, ONADE should 
notify the sponsor that it intends to discontinue review of the 
submission and remove it from the queue. This policy will permit ONADE 
to focus on reviewing quality submissions that contain all the 
information necessary for ONADE to evaluate the submission, thereby 
facilitating new animal drug approvals.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). The draft guidance represents the agency's current 
thinking on handling deficient submissions filed during the 
investigation of a new animal drug. 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 statutes and regulations.

II. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance document. Submit written 
comments to ensure adequate consideration in preparation of the final 
document by July 3, 2001. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of the draft guidance document entitled ``How the Center for 
Veterinary Medicine Intends to Handle Deficient Submissions Filed 
During the Investigation of a New Animal Drug'' may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm/.

    Dated: March 28, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-8200 Filed 4-3-01; 8:45 am]
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