[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]
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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.
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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:///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published a notice of availability for a draft guidance for industry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://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://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