[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68787-68788]
From the Federal Register Online via the Government Publishing 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of Management and Budget Review; Comment Request; Draft Guidance for 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 [email protected]. 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title ``Draft Guidance for Industry on Safety Labeling Changes; 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, [email protected].

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Draft Guidance for Industry on Safety Labeling Changes; Implementation 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    This draft guidance provides information on the implementation of 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