Document ID: FDA-2011-N-0237-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Applications for Approval to Market a New Drug; Postmarketing Reports; etc.
Posted Date: 2011-07-08T04:00Z

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40374-40375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17141]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0237]

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.

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

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 August 
8, 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 0910-0646. 
Also include the FDA 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: 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 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, 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.
    During the past several years, FDA has been reviewing annual 
reports it has received under Sec.  314.81(b)(2) (21 CFR 314.81(b)(2)) 
to discern whether an authorized generic drug is being marketed by the 
NDA holder. Based on information learned from this review and based on 
the number of annual reports the Agency currently receives under Sec.  
314.81(b)(2), we estimate that we will receive approximately 400 annual 
reports containing the information required under Sec.  
314.81(b)(2)(ii)(b), for authorized generic drugs that were marketed 
during the time period covered by an annual report submitted after 
January 1, 1999. Based on the number of sponsors that currently submit 
annual reports, we estimate that approximately 60 sponsors will submit 
these 400 annual reports with authorized generics. As indicated in 
table 1 of this document, we are estimating that the same number of 
annual reports will be submitted each year from the same number of 
sponsors containing the information required under Sec.  
314.81(b)(2)(ii)(b), and that the same number of copies of that portion 
of each annual report containing the authorized generic drug 
information will be submitted from the same number of sponsors. 
Concerning the hours per response, based on our estimate of 40 hours to 
prepare each annual report currently submitted under Sec.  
314.81(b)(2), we estimate that sponsors will need approximately 1 hour 
to prepare the information required under Sec.  314.81(b)(2)(ii)(b) for 
each authorized generic drug that was marketed during the time period 
covered by an annual report submitted after January 1, 1999; 
approximately 15 minutes to prepare the information required under 
Sec.  314.81(b)(2)(ii)(b) for each subsequent annual report; and 
approximately 3 minutes to submit to FDA a copy of that portion of each 
annual report containing the authorized generic drug information.
    In the Federal Register of April 13, 2011 (76 FR 20677), 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\
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   21 CFR 314.81(b)(2)(ii)(b)       respondents    reponses per      responses     response (in     Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
Authorized generic drug                       60             6.7             400               1             400
 information on first marketed
 generics in an annual report...
Authorized generic drug                       60             6.7             400           15/60             100
 information submitted in each
 subsequent annual report.......
The submission of a copy of that              60             6.7             400            3/60              20
 portion of each annual report
 containing authorized generic
 drug information...............
                                 -------------------------------------------------------------------------------

[[Page 40375]]

 
    Total.......................  ..............  ..............  ..............  ..............             520
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60.''

    Dated: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17141 Filed 7-7-11; 8:45 am]
BILLING CODE 4160-01-P