
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20229-20230]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08635]



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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 May 15, 
2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@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)(7-8) (OMB Control Number 0910-0575)--
Extension

    The Center for Veterinary Medicine (CVM) issued guidance for 
industry (GFI) #171 entitled ``Waivers of In Vivo Demonstration of 
Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form 
Products and Type A Medicated Articles'' to describe 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 (GADPTRA) 
of 1988 (Pub. L. 100-670) permitted generic animal drug manufacturers 
to copy those pioneer animal 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.
    In the Federal Register of January 12, 2015 (80 FR 1506), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received, however it did not 
respond to any of the four information collection topics solicited and 
is therefore not addressed by the Agency.
    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
 CVM Guidance for industry #171      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.......................  ..............  ..............  ..............  ..............              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
 CVM Guidance for industry #171      Number 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...............

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Same API/solubility approach....              10              10              10              20             200
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    Total.......................  ..............  ..............  ..............  ..............             210
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08635 Filed 4-14-15; 8:45 am]
 BILLING CODE 4164-01-P


