[Federal Register Volume 69, Number 148 (Tuesday, August 3, 2004)]
[Notices]
[Pages 46553-46555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17627]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0283]
Draft Guidance for Industry: Waivers of In Vivo Demonstration of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; 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availability of a draft guidance for industry (171) entitled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 This draft guidance describes the procedures that the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DATES: Submit written or electronic comments on the draft guidance by
October 18, 2004, to ensure their adequate consideration in preparation
of the final document. General comments on agency guidance documents
are welcome at any time. Written comments on the information collection
provisions must be received by October 4, 2004.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance document.
Submit written comments on the draft guidance and collection of
information 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Submit electronic comments on the draft guidance and collection of
information to http://www.fda.gov/dockets/ecomments. Comments should be
identified with the full title of the draft guidance and the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Technical issues: 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].
Administrative issues: Lonnie Luther, Center for Veterinary
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-8549, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Center for Veterinary Medicine (CVM) has written this guidance
to address a perceived need for agency guidance in its work with the
animal health industry. This draft 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. As CVM develops
policies on waivers involving other categories of animal drugs, it will
issue additional guidance.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C.
[[Page 46554]]
3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in
the Federal Register concerning each proposed collection of information
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing a notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Waivers of In Vivo Demonstration of Bioequivalence of Animal
Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles
Description: The Generic Animal Drug and Patent Term Registration
Act (GADPTRA) of 1988 permitted generic drug manufacturers to copy
those pioneer drug products that were no longer subject to patent or
other marketing exclusivity protection. The approval for marketing
these generic products is based, in part, upon a demonstration of
bioequivalence between the generic product and pioneer product. This
guidance clarifies circumstances under which FDA believes the
demonstration of bioequivalence required by the statute does not need
to be established on the basis of in vivo studies for soluble powder
oral dosage form products and Type A medicated articles. The data
submitted in support of the waiver request are necessary to validate
the waiver decision.
The requirement to establish bioequivalence through in vivo studies
(blood level bioequivalence or clinical endpoint bioequivalence) may be
waived for soluble powder oral dosage form products or Type A medicated
articles in either of two alternative ways. A biowaiver may be granted
if it can be shown that the generic soluble powder oral dosage form
product or Type A medicated article contains the same active and
inactive ingredient(s) and is produced using the same manufacturing
processes as the approved comparator product or article. Alternatively,
a biowaiver may be granted without direct comparison to the pioneer
product's formulation and manufacturing process if it can be shown that
the active pharmaceutical ingredient(s) (API) is the same as the
pioneer product, is soluble, and that there are no ingredients in the
formulation likely to cause adverse pharmacologic effects. For the
purpose of evaluating soluble powder oral dosage form products and Type
A medicated articles, solubility can be demonstrated in one of two
ways: ``USP definition'' approach or ``Dosage adjusted'' approach.
The respondents for this collection of information are
pharmaceutical companies manufacturing animal drugs. FDA estimates the
burden for this collection of information as follows in tables 1 and 2
of this document. The source of the above data is records of generic
drug applications over the past 10 years.
Table 1.--Estimated Annual Reporting Burden for Water Soluble Powders\1\
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Annual Frequency of Total Annual
No. of Respondents Responses Responses Hours per Response Total Hours
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Same formulation/manufacturing 1 1 1 5 5
process approach
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Same API/solubility approach 5 5 5 10 50
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Total Burden Hours .................... .................... .................... .................... 55
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Reporting Burden for Type A Medicated Articles\1\
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Annual Frequency of Total Annual
No. of Respondents Responses Responses Hours per Response Total Hours
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Same formulation/manufacturing 2 2 2 5 10
process approach
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Same API/solubility approach 10 10 10 20 200
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[[Page 46555]]
Total Burden Hours .................... .................... .................... .................... 210
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Significance of Guidance
This draft level 1 guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). This draft
guidance, when finalized, will represent 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.
IV. Comments
This draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES) regarding this draft guidance document. Two
paper copies of any comments are to be submitted, except that
individuals may submit one paper copy. Comments should 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 draft 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 CVM home page at http://www.fda.gov/cvm and from the
Division of Dockets Management Web site http://www.fda.gov/ohrms/dockets/default.htm.
Dated: July 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-17627 Filed 8-2-04; 8:45 am]
BILLING CODE 4160-01-S