[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65733-65734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27392]
[[Page 65733]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0747]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Waiver of In Vivo Demonstration of Bioequivalence of
Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A
Medicated Articles
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the current burden hours on
regulated industry of complying with the guidance underlying this
collection of information.
DATES: Submit either electronic or written comments on the collection
of information by December 23, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, PI50-400B, 1350
Piccard Dr., Rockville, MD 20850, 301-796-7651,
[email protected].
SUPPLEMENTARY INFORMATION: Under 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(c) 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. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing 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.
Agency Information Collection Activities; Proposed Collection; Comment
Request; Waiver of In Vivo Demonstration of Bioequivalence of Animal
Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated
Articles--21 CFR 514.1(b)(7) and (b)(8) (OMB Control Number 0910-
0575)--Extension
The Center for Veterinary Medicine has written this guidance to
address a perceived need for Agency guidance in its work with the
animal health industry. 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.
The Generic Animal Drug and Patent Term Registration Act of 1988
(Pub. L. 100-670) 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.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
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Number of
Number of Responses per Total Annual Average Burden Total Hours
Respondents Respondent Responses per Response
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Same Formulation/Manufacturing 1 1 1 5 5
Process Approach...............
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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No. of
No. of Responses per Total Annual Average Burden Total Hours
Respondents Respondent Responses per Response
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Same Formulation/Manufacturing 2 2 2 5 10
Process Approach...............
Same API/Solubility Approach.... 10 10 10 20 200
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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.
Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27392 Filed 10-21-11; 8:45 am]
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