Document ID: FDA-2011-N-0237-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2011-04-13T04:00Z

[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20677-20679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8820]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

[[Page 20678]]

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 requirements for a New Drug Application (NDA) holder to notify 
the Agency if an authorized generic drug is marketed by clearly 
including this information in an easily accessible place in the annual 
report and by sending a copy of the relevant portion of the annual 
report to a central contact point in the Agency.

DATES: Submit either electronic or written comments on the collection 
of information by June 13, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit 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 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., 
P150-400B, 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.

Applications for Food and Drug Administration Approval To Market a New 
Drug; Postmarketing Reports; Reporting Information About Authorized 
Generic Drugs--21 CFR 314.81(b)(2)--(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 an 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
   21 CFR 314.81(b)(2)(ii)(b)       respondents    reponses per     respondents    response  (in    Total hours
                                                    respondent                        hours)
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Authorized generic drug                       60             6.7             400               1             400
 information on first marketed
 generics in an annual report
 under Sec.
 314.81(b)(2)(ii)(b)............
Authorized generic drug                       60             6.7             400           15/60             100
 information submitted in each
 subsequent annual report.......

[[Page 20679]]

 
The submission of a copy of that              60             6.7             400            3/60              20
 portion of each annual report
 containing authorized generic
 drug information...............
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    Total.......................  ..............  ..............  ..............  ..............             520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8820 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P