
[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15764-15765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6391]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0747]


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 April 
16, 2012.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
Juanmanuel.vilela@fda.hhs.gov.

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 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

[[Page 15765]]

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.
    In the Federal Register of October 24, 2011 (76 FR 65733), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment, which, however, 
did not address the questions posed in 60-day notice regarding the 
collection of information. The comment supported the bioequivalence 
program but suggested a revision to the determination of 
bioequivalence, which relates to the substance of the scientific 
recommendations in the guidance document. Under FDA's good guidance 
practices regulations (21 CFR 10.115(f)(4)), the public may suggest at 
anytime that FDA revise a guidance document and under 21 CFR 
10.115(g)(5), FDA will revise guidance documents in response to 
comments when appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                    Table 1--Estimated Annual Reporting Burden for Water Soluble Powders \1\
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                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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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                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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: March 8, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6391 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P


