
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78740-78741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31696]


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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; Guidance for Industry 
on Safety Labeling Changes--Implementation of Section 505(o)(4) 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.

DATES: Fax written comments on the collection of information by January 
19, 2016.

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 0910-0734. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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.

Guidance for Industry on Safety Labeling Changes--Implementation of 
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act, OMB 
Control Number 0910-0734--Extension

    Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require, and if 
necessary, order labeling changes if FDA becomes aware of new safety 
information that FDA believes should be included in the labeling of 
certain prescription drug and biological products approved under 
section 505 of the FD&C Act or section 351 of the PHS Act (42 U.S.C. 
262). Section 505(o)(4) of the FD&C Act applies to prescription

[[Page 78741]]

drug products with an approved new drug application (NDA) under section 
505(b) of the FD&C Act, biological products with an approved biologics 
license application under section 351 of the PHS Act, or prescription 
drug products with an approved abbreviated new drug application under 
section 505(j) of the FD&C Act if the reference listed drug with an 
approved NDA is not currently marketed. Section 505(o)(4) imposes 
timeframes for application holders to submit and FDA staff to review 
such changes, and gives FDA new enforcement tools to bring about timely 
and appropriate labeling changes. The guidance provides information on 
the implementation of the new provisions, including a description of 
the types of safety labeling changes that ordinarily might be required 
under the new legislation, how FDA plans to determine what constitutes 
new safety information, the procedures involved in requiring safety 
labeling changes, and enforcement of the requirements for safety 
labeling changes.
    FDA requires safety labeling changes by sending a notification 
letter to the application holder. Under section 505(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).
    Based on FDA's experience to date with safety labeling changes 
requirements under section 505(o)(4), we estimate that approximately 42 
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 guidance, FDA 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. FDA estimates that approximately 407 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 September 2, 2015 (80 FR 53161), 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\
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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.................................................              42                1               42                6              252
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                         Type of submission                             Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
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Posting approved labeling on application holder's Web site.........             407                1              407                4            1,628
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\1\ There are no capital costs or operating and maintenance costs associated with this collect of information.


    Dated: December 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31696 Filed 12-16-15; 8:45 am]
BILLING CODE 4164-01-P


