Document ID: FDA-2014-N-0809-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Bioequivalence Data
Posted Date: 2014-12-16T05:00Z

[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74727-74728]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29425]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0809]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements for 
Submission of Bioequivalence Data

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 January 
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 0910-0630. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 74728]]

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.
    Requirements for Submission of In Vivo Bioequivalence Data--21 CFR 
parts 314 and 320.

OMB Control Number 0910-0630--Extension

    In the Federal Register of January 16, 2009 (74 FR 2849), the 
Agency published a final rule revising FDA regulations to require 
applicants to submit data on all bioequivalence (BE) studies, including 
studies that do not meet passing bioequivalence criteria, which are 
performed on a drug product formulation submitted for approval under an 
abbreviated new drug application (ANDA), or in an amendment or 
supplement to an ANDA that contains BE studies. In the final rule, FDA 
amended 314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97 (21 CFR 
314.94(a)(7)(i), 314.96(a)(1), 320.21(b)(1), and 314.97) to require an 
ANDA applicant to submit information from all BE studies, both passing 
and nonpassing, conducted by the applicant on the same drug product 
formulation as that submitted for approval under an ANDA, amendment, or 
supplement.
    In table 1, FDA has estimated the reporting burden associated with 
each section of this requirement. FDA believes that the majority of 
additional BE studies will be reported in ANDAs (submitted under 
314.94), rather than supplements (reported in 314.97) because it is 
unlikely than an ANDA holder will conduct BE studies with a drug after 
the drug has been approved. With respect to the reporting of additional 
BE studies in amendments (submitted under 314.96), this should also 
account for a small number of reports because most BE studies will be 
conducted on a drug prior to the submission of the ANDA and will be 
reported in the ANDA itself.
    FDA estimates applicants will require approximately 120 hours of 
staff time to prepare and submit each additional complete BE study 
report and approximately 60 hours of staff time for each additional BE 
summary report. The Agency believes that a complete report will be 
required approximately 20 percent of the time, while a summary will 
suffice approximately 80 percent of the time. Based on a weighted-
average calculation using the information presented previously in this 
document, the submission of each additional BE study is expected to 
take 72 hours of staff time ([120 x 0.2] + [60 x 0.8]).
    In the Federal Register of June 26, 2014 (79 FR 36320), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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314.94(a)(7)....................              84               1              84              72           6,048
314.96(a)(1)....................               1               1               1              72              72
314.97..........................               1               1               1              72              72
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    Total.......................  ..............  ..............  ..............  ..............           6,192
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29425 Filed 12-15-14; 8:45 am]
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