Document ID: FDA-2011-N-0423-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements for Submission of Bioequivalence Data
Posted Date: 2011-10-05T04:00Z

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61710-61711]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25686]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0423]

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 
November 4, 2011.

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 e-mailed 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.

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.

Requirements for Submission of 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 BE criteria, which are performed on a 
drug product formulation submitted for approval under an abbreviated 
new drug application (ANDA), or in an amendment to an ANDA that 
contains BE studies. In the final rule, FDA amended Sec. Sec.  
314.94(a)(7)(i), 314.96(a)(1), 314.97, and 320.21(b)(1), 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 of this document, FDA has estimated the reporting burden 
associated with each section of the rule. FDA believes that the 
majority of additional BE studies will be reported in ANDAs (submitted 
under Sec.  314.94), rather than supplements (reported in Sec.  
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 
Sec.  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 it 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 above, 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 10, 2011 (76 FR 34081), 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)....................              49               1              49              72           3,528
314.96(a)(1)....................               1               1               1              72              72
314.97..........................               1               1               1              72              72
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    Total.......................  ..............  ..............  ..............  ..............           3,672
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 61711]]

    Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25686 Filed 10-4-11; 8:45 am]
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