[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64338-64340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25741]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0543]


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 waiver requirement 
procedures that are recommended by the agency for 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 collection of 
information by December 29, 2008.

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: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug

[[Page 64339]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Waiver of In Vivo Demonstration of Bioequivalence of Animal Drugs in 
Soluble Powder Oral Dosage Form Products and Type A Medicated 
Articles--21 CFR Part 514 (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 
permitted the 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 the 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: (1) ``USP definition'' approach, or (2) ``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:

                     Table 1--Estimated Annual Reporting Burden for Water Soluble Powders\1\
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                      No. of         Annual Frequency       Total Annual        Hours per
                   Respondents         per Response          Responses           Response         Total Hours
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Same                            1                     1                  1                  5                  5
 formulation/
 manufacturing
 process
 approach
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Same API/                       5                     5                  5                 10                 50
 solubility
 approach
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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       Annual Frequency  of     Total Annual        Hours per
                   Respondents           Responses           Responses           Response         Total Hours
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Same                            2                     2                  2                  5                 10
 formulation/
 manufacturing
 process
 approach
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Same API/                      10                    10                 10                 20                200
 solubility
 approach
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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.


[[Page 64340]]

    The sources of the previous data are records of generic drug 
applications over the past 10 years.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-25741 Filed 10-28-08; 8:45 am]
BILLING CODE 4160-01-S