[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2598-2599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-782]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 17, 2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0575. 
Also include the FDA 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 Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of October 29, 2008 (73 FR 64338), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 2599]]



                    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
----------------------------------------------------------------------------------------------------------------
Same                            1                     1                  1                  5                  5
 formulation/
 manufacturing
 process
 approach
----------------------------------------------------------------------------------------------------------------
Same API/                       5                     5                  5                 10                 50
 solubility
 approach
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Same                            2                     2                  2                  5                 10
 formulation/
 manufacturing
 process
 approach
----------------------------------------------------------------------------------------------------------------
Same API/                      10                    10                 10                 20                200
 solubility
 approach
----------------------------------------------------------------------------------------------------------------
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.

    The sources of the previous data are records of generic drug 
applications over the past 10 years.

    Dated: January 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-782 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S