[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Notices]
[Page 8596]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe06-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0283]
Guidance for Industry on Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles; 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 (171) entitled
``Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in
Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles.'' This guidance describes the procedures that the agency
recommends for the review of requests for waiver of in vivo
demonstration of bioequivalence for generic soluble powder oral dosage
form products and Type A medicated articles.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: 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
on the guidance via the Internet at 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.
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.
FOR FURTHER INFORMATION CONTACT: Marilyn Martinez, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7577, e-mail:
marilyn.martinez@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 3, 2004 (69 FR 46553), FDA
published a notice of availability for a draft guidance document
entitled ``Draft Guidance for Industry: Waivers of In Vivo
Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral
Dosage Form Products and Type A Medicated Articles'' giving interested
persons until October 18, 2004, to submit comments on the draft
guidance and until October 4, 2004, to comment on the information
collection. FDA considered all comments received and, where
appropriate, made changes in the guidance. The final guidance differs
from the draft guidance in the following ways: (1) The relationship
between granting or denying a waiver based on a demonstration of
bioequivalence and granting or denying a generic approval based on the
safety of a biomass Type A article has been clarified; (2) the nature
of the information needed to support, and the applicability of, the
``Comparison of Formulations'' approach described in the guidance has
been clarified; (3) the title of table 1 of the guidance has been
clarified; (4) one value in table 2 of the guidance has been updated;
and (5) other relatively minor editing has been done to clarify the
substance of the document. There were no comments directed specifically
at the collection of information.
II. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance represents
the agency's current thinking on the topic. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternate method may be used as long as it satisfies
the requirements of applicable statutes and regulations.
III. Paperwork Reduction Act of 1995
FDA is announcing that a collection of information entitled
``Guidance for Industry: Waivers of In Vivo Demonstration of
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form
Products and Type A Medicated Articles'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995. In the Federal Register of October 24, 2005 (70 FR 61451), the
agency announced that the proposed information collection had been
submitted to OMB for review and clearance under 44 U.S.C. 3507.
According to the Paperwork Reduction Act of 1995, a collection of
information should display a valid OMB control number. The valid OMB
control number for this collection of information is 0910-0575. It
expires on January 31, 2009. A copy of the supporting statement 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 notice
in the Federal Register.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments at any time. Submit a
single copy of electronic comments or two paper copies of any comments,
except that individuals may submit one paper copy. Comments are to 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 Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Copies of the guidance document entitled ``Waivers of In Vivo
Demonstration of Bioequivalence of Certain Animal Drugs in Soluble
Powder Oral Dosage Form Products and Type A Medicated Articles'' may be
obtained from the Center for Veterinary Medicine's Home Page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm
and from the Division of Dockets Management Web site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
Dated: February 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2291 Filed 2-16-06; 8:45 am]
BILLING CODE 4160-01-S