[Federal Register: July 19, 2005 (Volume 70, Number 137)]
[Notices]               
[Page 41406-41407]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy05-55]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0167] (formerly Docket No. 03D-0167)

 
Guidance for Industry on Dispute Resolution Procedures for 
Science-Based Decisions on Products Regulated by the Center for 
Veterinary Medicine; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (79) entitled 
``Guidance for Industry: Dispute Resolution Procedures for Science-
Based Decisions on Products Regulated by the Center for Veterinary 
Medicine (CVM).'' This guidance document describes dispute resolution 
procedures by which sponsors, applicants, or manufacturers of FDA-
regulated products for animals may request review of science-based 
decisions. This guidance does not address procedures for handling 
issues associated with FDA's new initiative to enhance pharmaceutical 
good manufacturing practices (GMPs).

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit written comments on this guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http:///www.fda.gov/dockets/ecomments.
 Comments should be identified with the 

full title of the guidance and the docket number found in brackets in 
the heading of this document. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Marcia Larkins, Center for Veterinary 
Medicine (HFV-7), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 301-827-4535, e-mail: mlarkins@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 2003 (68 FR 27094), FDA 
published a notice of availability for a draft guidance for industry 
entitled ``Dispute Resolution Procedures for Science-Based Decisions on 
Products Regulated by the Center for Veterinary Medicine (CVM)'' giving 
interested persons until August 4, 2003, to submit comments on the 
draft guidance and until July 18, 2003, to comment on the information 
collection. FDA considered all comments received and, where 
appropriate, made changes in the guidance.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance

[[Page 41407]]

practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on dispute resolution and the procedures 
regarding requests for review of scientific controversies relating to 
decisions affecting animal drugs or other products regulated by CVM. 
The document does not create or confer any rights for or on any person 
and will not operate to bind FDA or the public. Alternative methods may 
be used as long as they satisfy the requirements of the applicable 
statutes and regulations. If an applicant wants to discuss an 
alternative approach, the applicant should contact FDA staff 
responsible for implementing the guidance. If the applicant cannot 
identify appropriate FDA staff, the applicant should call the CVM 
Ombudsman at 301-827-4535.

III. Paperwork Reduction Act of 1995

    FDA is announcing that a collection of information entitled ``Final 
Guidance for Industry on Dispute Resolution Procedures for Science-
Based Decisions on Products Regulated by the Center for Veterinary 
Medicine'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. In the Federal 
Register of May 19, 2003 (68 FR 27094), the agency announced that the 
proposed information collection had been submitted to OMB for review 
and clearance under 44 U.S.C. 3507. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0566. The approval expires on June 30, 2008. A copy 
of the supporting statement for this information collection is 
available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. Comments

    As with all FDA's guidances, the public is encouraged to submit 
written or electronic comments with new data or other new information 
pertinent to this guidance. FDA periodically will review the comments 
in the docket, and where appropriate, will amend the guidance. The 
agency will notify the public of any such amendments through a document 
in the Federal Register.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in the 
brackets in the heading of this document. A copy of the documents and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Copies of the guidance document entitled ``Guidance for Industry: 
Dispute Resolution Procedures for Science-Based Decisions on Products 
Regulated by the Center for Veterinary Medicine (CVM)'' may be obtained 
on the Internet from the CVM home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.


    Dated: July 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14137 Filed 7-18-05; 8:45 am]

BILLING CODE 4160-01-S