
[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65733-65734]
From the Federal Register Online via the Government Printing 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, 
juanmanuel.vilela@fda.hhs.gov.

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:

[[Page 65734]]



                    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]
BILLING CODE 4160-01-P


