
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53161-53162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21645]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0164]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the 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 requirement 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 (PHS Act.)

DATES: Submit either electronic or written comments on the collection 
of information by November 2, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments 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 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: 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: (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.

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 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 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

[[Page 53162]]

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.
    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             407                1              407                4           1,628
 application holder's Web
 site.......................
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\1\ There are no capital costs or operating and maintenance costs associated with this collect of information.


    Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21645 Filed 9-1-15; 8:45 am]
BILLING CODE 4164-01-P


