Document ID: FDA-2011-N-0423-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Bioequivalence Data
Posted Date: 2011-06-10T04:00Z

[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34081-34082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14413]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the requirement for an 
abbreviated new drug application (ANDA) applicant to submit data from 
all bioequivalence (BE) studies the applicant conducts on a drug 
product formulation submitted for approval.

DATES: Submit either electronic or written comments on the collection 
of information by August 9, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 34082]]

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 BE studies, including studies that do 
not meet passing bioequivalence criteria, which are performed on a drug 
product formulation submitted for approval under an 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), 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 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 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]).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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.

    Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14413 Filed 6-9-11; 8:45 am]
BILLING CODE 4160-01-P