[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20677-20679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8820]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
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...............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 520
----------------------------------------------------------------------------------------------------------------
\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