[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, [email protected].
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