[Federal Register Volume 67, Number 172 (Thursday, September 5, 2002)]
[Notices]
[Pages 56849-56850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22566]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0146]


Final 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final 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 final guidance announces the Center for 
Veterinary Medicine's (CVM's) policy regarding the circumstances under 
which CVM intends to not accept for review submissions filed during the 
investigation of a new animal drug and notify the sponsor that CVM 
intends not to review the submission.

DATES:  Submit written or electronic comments at any time.

ADDRESSES: Submit written comments on this final guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. All comments should be 
identified with the full title of the guidance and the docket number 
found in brackets in the heading of this document.
    Submit written requests for single copies of the final 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 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the final guidance document.

FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 301-827-1796, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 4, 2001 (66 FR 17914), FDA 
published a notice of availability for a draft guidance entitled ``How 
the Center for Veterinary Medicine Intends to Handle Deficient 
Submissions Filed During the Investigation of a New Animal Drug,'' 
giving interested persons until July 3, 2001, to submit comments.
    CVM determined that there was a need for such a guidance for two 
reasons: (1) Having reviewers attempt to review submissions that have 
significant deficiencies is an inefficient use of CVM's limited 
resources, and (2) its practice of keeping submissions requiring 
significant additional information or rehabilitation ``active,'' (i.e., 
in the review queue), has contributed to a backlog in the review of 
pending submissions. This final guidance for industry and reviewers 
announces CVM's policy regarding the circumstances under which CVM 
intends to not accept for review submissions filed during the 
investigation of a new animal drug, notify the sponsor that the 
submission will not be reviewed, and remove the submission from the 
review queue.
    CVM's primary goal is to approve safe and effective new animal 
drugs in a timely manner. To further this goal, CVM's responsibility is 
to ensure the quality of the review process. On the other hand, it is 
the sponsor's responsibility to ensure the quality of its submissions.
    The quality of a submission can prevent or severely hinder its 
review. Poor quality submissions can be impossible or difficult to 
review. FDA received comments to the draft guidance suggesting that the 
problem CVM attributes to poor quality submissions is in part the 
variation in format and content of submissions as required by 
individual reviewers. However, an informal survey of reviewers in the 
Office of New Animal Drug Evaluation (ONADE) revealed that submissions 
were deficient because, among other things: They contained data 
discrepancies, incorrect statistical analyses, final reports that did 
not reflect actual data, electronic copies of data that did not match 
paper copies of raw data, or no documentation of drug source. ONADE has 
also received supplemental applications in which sponsors submitted the 
same data or information for the supplement that they submitted for the 
original application, i.e., without changing the relevant indications 
or conditions of use for which the supplement was submitted.
    CVM has determined that it can no longer expend time and resources 
attempting to review submissions that have significant deficiencies. 
Poor quality submissions decrease the efficiency of the new animal drug 
application review and approval process by diverting limited resources 
from the review of submissions that are complete. Furthermore, as one 
comment to the draft guidance noted, a sponsor who submits a quality 
submission should not have its submission wait in the queue while a 
reviewer spends an inordinate amount of time reviewing a poor quality 
submission.
    The final guidance clarifies that ONADE should use criteria and 
procedures similar to those found in 21 CFR 514.110 to determine 
whether it will not accept a submission for review, i.e., refuse to 
review the submission further. ONADE should, among other reasons, not 
review a submission if on its face the information is so inadequate 
that the submission is clearly not reviewable. ONADE should consider a 
submission to be inadequate if the numbers or types of errors in the 
submission or flaws in the development plan, call into question the 
quality of the entire submission to the extent it is deemed by ONADE 
that the submission cannot reasonably be reviewed.
    ONADE should notify the sponsor by letter within 60 days of the 
receipt of the submission of its decision not to accept the submission 
for review. The letter notifying the sponsor that ONADE will not accept 
the submission for review should summarize in detail commensurate with 
the quality of the submission the reasons it cannot be

[[Page 56850]]

reviewed. A sponsor who submits a deficient submission should not 
resubmit the submission until the submission has been reviewed 
rigorously for accuracy and completeness.
    Refusing to review deficient submissions is only part of CVM's 
strategy to facilitate the timely approval of safe and effective new 
animal drugs. CVM intends to continue issuing guidance that will 
clarify approval requirements and the procedures and formats for 
various types of submissions. CVM intends to balance the need for 
guidance with the need to complete pending review work. CVM encourages 
sponsors to request presubmission conferences to reach agreement on 
investigational and approval requirements for specific new animal 
drugs. In addition, CVM continues to encourage sponsors to submit 
protocols for studies that are key to approval to CVM for review well 
in advance of beginning the studies. Finally, CVM is committed to 
continuing to work to improve its processes and approve safe and 
effective new animal drugs in a timely manner.
    This level 1 final guidance document is being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). This 
guidance represents the agency's current thinking on its handling of 
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 as long as it satisfies the requirements of applicable statutes 
and regulations.

II. Comments

    As with all of FDA's guidance, the public is encouraged to submit 
written or electronic comments with new data or other new information 
pertinent to this guidance. FDA will periodically review the comments 
in the docket and, where appropriate, will amend the guidance. The 
public will be notified of any such amendments through a notice in the 
Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain a copy of the final 
guidance document entitled ``Guidance for Industry and Reviewers: ``How 
the Center for Veterinary Medicine Intends to Handle Deficient 
Submissions Filed During Investigation of a New Animal Drug'' from the 
CVM home page at http://www.fda.gov/cvm.

    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22566 Filed 9-4-02; 8:45 am]
BILLING CODE 4160-01-S