[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68787-68788]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27881]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0164]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry on Safety Labeling Changes; Implementation of the Federal
Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 (the PRA).
DATES: Fax written comments on the collection of information by
December 17, 2012.
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-NEW and
title ``Draft Guidance for Industry on Safety Labeling Changes;
Implementation of Section 505(o)(4) of the Federal Food, Drug, and
Cosmetic Act.'' Also include the FDA 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., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.
Draft Guidance for Industry on Safety Labeling Changes; Implementation
of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act--(OMB
Control Number 0910-New)
This draft guidance provides information on the implementation of
section 901 of the Food and Drug Administration Amendments Act of 2007,
which authorizes FDA to require certain drug and biological product
application holders to make safety related labeling changes based upon
new safety information that becomes available after the drug or
biological product is approved under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) or the Public Health Service Act. FDA plans
to request safety labeling changes by sending a notification letter to
the application holder. Under section 505(o)(4)(B) of the FD&C Act (21
U.S.C. 355(o)(4)(B)), the application holder must respond to FDA's
notification by submitting a labeling supplement or notifying FDA that
the applicant does not believe the labeling change is warranted and
submitting a statement detailing the reasons why the application holder
does not believe a change is warranted (a rebuttal statement).
The submission of rebuttal statements may result in the collection
of information that is not already approved by OMB. Based on FDA's
experience thus far with safety labeling changes requirements under
section 505(o)(4) of the FD&C Act, FDA estimates that approximately six
application holders will elect to submit approximately one rebuttal
statement each year and that each rebuttal statement will take
approximately 6 hours to prepare.
In addition, in the draft guidance, the Agency states that new
labeling prepared in response to a safety labeling change notification
should be available on the application holder's Web site within 10
calendar days of approval, which may result in the collection of
information that is not already approved by OMB. FDA estimates that
approximately 197 application holders will post new labeling one time
each year in response to a safety labeling change notification and that
the posting of the labeling will take approximately 4 hours to prepare.
In the Federal Register of April 13, 2011 (76 FR 20686), FDA
published a 60-day notice requesting public comment on the draft
version of this guidance. None of the comments we received pertained to
the information collection provisions.
FDA estimates the burden of the collections of information that
have not already been approved by OMB is as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Rebuttal statement....................................... 6 1 6 6 36
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 68788]]
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Annual frequency Total annual Hours per
Type of submission respondents per disclosure disclosures disclosure Total hours
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Post approved labeling on application holder's Web site.. 197 1 197 4 788
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to previously approved collections
of information. Specifically, the draft guidance describes: Labeling
supplements for new drug applications, abbreviated new drug
applications, and biologics license applications submitted under 21 CFR
314.70, 314.71, 314.97, and 601.12, and the content and format of
prescription drug labeling submitted under 21 CFR 201.56 and 201.57.
These collections of information are subject to review by OMB under the
PRA and are approved under OMB control numbers 0910-0001, 0910-0338,
and 0910-0572. Section V of the draft guidance refers to the guidance
entitled ``Formal Dispute Resolution: Appeals Above the Division
Level,'' which describes collections of information approved under OMB
control number 0910-0430.
Dated: November 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27881 Filed 11-15-12; 8:45 am]
BILLING CODE 4160-01-P