Document ID: FDA-2013-N-0523-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Posted Date: 2013-09-06T04:00Z

[Federal Register Volume 78, Number 173 (Friday, September 6, 2013)]
[Notices]
[Pages 54898-54899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21681]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 or we) 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 October 
7, 2013.

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 0910-0646. 
Also include the FDA 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, 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.

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 (Pub. L. 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.
    In the Federal Register of May 10, 2013 (78 FR 27404), 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 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 per response           Total hours
                                                respondents     respondent       responses
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Submission of authorized generic drug                     70               7             490  0.50 (30 minutes).........................             245
 information in each annual report.
Submission of authorized generic drug                     20               1              20  1.........................................              20
 information on first marketed generics in
 an annual report.
Submission of a copy of that portion of each              70               7             490  0.05 (3 minutes)..........................              25
 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.

[[Page 54899]]

    Dated: September 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21681 Filed 9-5-13; 8:45 am]
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