[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Notices]
[Page 8596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2291]


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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://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: 
[email protected].

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published a notice of availability for a draft guidance document 
entitled ``Draft Guidance for Industry: Waivers of In Vivo 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://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://www.fda.gov/cvm and from the Division of Dockets Management Web site at 
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