
[Federal Register Volume 79, Number 123 (Thursday, June 26, 2014)]
[Notices]
[Pages 36320-36321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14927]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Requirements for Submission of Bioequivalence Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 25, 2014.

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: 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: 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.

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 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 or supplement 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 (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 of this document, 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 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 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]).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
314.94(a)(7)....................              84               1              84              72           6,048

[[Page 36321]]

 
314.96(a)(1)....................               1               1               1              72              72
314.97..........................               1               1               1              72              72
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,192
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14927 Filed 6-25-14; 8:45 am]
BILLING CODE 4164-01-P


