Document ID: FDA-2013-N-0523-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; etc.
Posted Date: 2013-05-10T04:00Z

[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27404-27405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11127]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]

Agency Information Collection Activities: Proposed Collection; 
Comment Request; Applications for Food and Drug Administration Approval 
To Market a New Drug; Postmarketing Reports; Reporting Information 
About Authorized Generic Drugs

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 information collection 
contained in the requirements for reporting information about 
authorized generic drugs in an annual report.

DATES: Submit either electronic or written comments on the collection 
of information by July 9, 2013.

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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-

[[Page 27405]]

400B, Rockville, MD 20857, 301-796-7726, Ila.mizrachi@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.

Applications for Food and Drug Administration Approval To Market a New 
Drug; Postmarketing Reports; Reporting Information About Authorized 
Generic Drugs--(OMB Control Number 0910-0646)--Extension

    In the Federal Register of July 28, 2009 (74 FR 37163), FDA 
published a final rule that required, under Sec.  314.81(b)(2)(ii)(b) 
(21 CFR 314.81(b)(2) (ii)(b)), the holder of a new drug application 
(NDA) to notify the Agency if an authorized generic drug is marketed by 
clearly including this information in annual reports in an easily 
accessible place and by sending a copy of the relevant portion of the 
annual reports to a central contact point. We took this action as part 
of our implementation of the Food and Drug Administration Amendments 
Act (Public Law 110-85), which requires that FDA publish a list of all 
authorized generic drugs included in an annual report after January 1, 
1999, and that the Agency update the list quarterly. We initially 
published this list on June 27, 2008, on the Internet and notified 
relevant Federal Agencies that the list was published, and we will 
continue to update it.
    Based on the number of annual reports the Agency currently receives 
under Sec.  314.81(b)(2) containing authorized generic drug 
information, we estimate that we will receive approximately 500 annual 
reports containing the required information on authorized generic 
drugs. Based on the number of sponsors that currently submit these 
annual reports, we estimate that approximately 70 sponsors will submit 
these 500 annual reports. We estimate that each sponsor will need 
approximately 30 minutes to include the required information on 
authorized generic drugs in each annual report.
    We also estimate that we will receive authorized generic drug 
information on first marketed generics in approximately 20 annual 
reports from approximately 20 sponsors, and that each sponsor will need 
approximately 1 hour to include the required information in each annual 
report.
    We also estimate that we will receive a copy of that portion of 
each annual report containing the authorized generic drug information 
for approximately 500 annual reports from approximately 70 sponsors, 
and that each sponsor will need approximately 3 minutes to submit a 
copy of that portion of each annual report containing the authorized 
generic drug information.
    FDA estimates the burden of this collection of information is as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
  21 CFR 314.81(b)(2)(ii)(b)       Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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Submission of authorized                    70               7             490  0.5 (30 minutes)             245
 generic drug information in
 each annual report.
Submission of authorized                    20               1              20  1...............              20
 generic drug information on
 first marketed generics in an
 annual report.
Submission of a copy of that                70               7             490  0.05 (3 minutes)              25
 portion of each annual report
 containing authorized generic
 drug information.
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    Total.....................  ..............  ..............  ..............  ................             290
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11127 Filed 5-9-13; 8:45 am]
BILLING CODE 4160-01-P