80 FR 53161 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 170 (September 2, 2015)

Page Range		53161-53162
FR Document		2015-21645

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.)

Federal Register, Volume 80 Issue 170 (Wednesday, September 2, 2015)

[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53161-53162]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                                                                        Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rebuttal statement.................................................              42                1               42                6              252
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
     Type of submission          Number of     disclosures per    Total annual    Average burden    Total hours
                                respondents       respondent      disclosures     per disclosure
----------------------------------------------------------------------------------------------------------------
Posting approved labeling on             407                1              407                4           1,628
 application holder's Web
 site.......................
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53161

DC 20447, Attn: ACF Reports Clearance DATES: Submit either electronic or Guidance for Industry on Safety
Officer. All requests should be written comments on the collection of Labeling Changes—Implementation of
identified by the title of the information information by November 2, 2015. Section 505(o)(4) of the Federal Food,
collection. Email address: Drug, and Cosmetic Act (OMB Control
infocollection@acf.hhs.gov. ADDRESSES: Submit electronic Number 0910–0734)—Extension
OMB Comment: OMB is required to comments on the collection of
information to: http:// Section 505(o)(4) of the FD&C Act (21
make a decision concerning the U.S.C. 355(o)(4)) authorizes FDA to
collection of information between 30 www.regulations.gov. Submit written
comments on the collection of require, and if necessary, order labeling
and 60 days after publication of this changes if FDA becomes aware of new
document in the Federal Register. information to the Division of Dockets
safety information that FDA believes
Therefore, a comment is best assured of Management (HFA–305), Food and Drug
should be included in the labeling of
having its full effect if OMB receives it Administration, 5630 Fishers Lane, Rm.
certain prescription drug and biological
within 30 days of publication. Written 1061, Rockville, MD 20852. All products approved under section 505 of
comments and recommendations for the comments should be identified with the the FD&C Act or section 351 of the PHS
proposed information collection should docket number found in brackets in the Act (42 U.S.C. 262). Section 505(o)(4) of
be sent directly to the following: Office heading of this document. the FD&C Act applies to prescription
of Management and Budget, Paperwork drug products with an approved new
FOR FURTHER INFORMATION CONTACT: FDA
Reduction Project, Fax: 202–395–7285, drug application (NDA) under section
Email: OIRA_SUBMISSION@ PRA Staff, Office of Operations, Food
and Drug Administration, 8455 505(b) of the FD&C Act, biological
OMB.EOP.GOV, Attn: Desk Officer for products with an approved biologics
the Administration for Children and Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@ license application under section 351 of
Families. the PHS Act, or prescription drug
fda.hhs.gov.
Robert Sargis, products with an approved abbreviated
Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Under the new drug application under section
[FR Doc. 2015–21727 Filed 9–1–15; 8:45 am] PRA (44 U.S.C. 3501–3520), Federal 505(j) of the FD&C Act if the reference
Agencies must obtain approval from the listed drug with an approved NDA is
BILLING CODE 4184–01–P
Office of Management and Budget not currently marketed. Section
(OMB) for each collection of 505(o)(4) imposes timeframes for
DEPARTMENT OF HEALTH AND information they conduct or sponsor. application holders to submit and FDA
HUMAN SERVICES ‘‘Collection of information’’ is defined staff to review such changes, and gives
in 44 U.S.C. 3502(3) and 5 CFR FDA new enforcement tools to bring
Food and Drug Administration about timely and appropriate labeling
1320.3(c) and includes Agency requests
changes. The guidance provides
or requirements that members of the
[Docket No. FDA–2011–D–0164] information on the implementation of
public submit reports, keep records, or
the new provisions, including a
provide information to a third party. description of the types of safety
Agency Information Collection Section 3506(c)(2)(A) of the PRA (44
Activities; Proposed Collection; labeling changes that ordinarily might
U.S.C. 3506(c)(2)(A)) requires Federal be required under the new legislation,
Comment Request; Guidance for
Agencies to provide a 60-day notice in how FDA plans to determine what
Industry on Safety Labeling Changes—
Implementation of Section 505(o)(4) of the Federal Register concerning each constitutes new safety information, the
the Federal Food, Drug, and Cosmetic proposed collection of information, procedures involved in requiring safety
Act including each proposed extension of an labeling changes, and enforcement of
existing collection of information, the requirements for safety labeling
AGENCY: Food and Drug Administration, before submitting the collection to OMB changes.
HHS. for approval. To comply with this FDA requires safety labeling changes
ACTION: Notice. requirement, FDA is publishing notice by sending a notification letter to the
of the proposed collection of application holder. Under section
SUMMARY: The Food and Drug information set forth in this document. 505(o)(4)(B), the application holder
Administration (FDA) is announcing an must respond to FDA’s notification by
With respect to the following
opportunity for public comment on the submitting a labeling supplement or
collection of information, FDA invites
proposed collection of certain notifying FDA that the applicant does
comments on: (1) Whether the proposed
information by the Agency. Under the not believe the labeling change is
Paperwork Reduction Act of 1995 (the collection of information is necessary
warranted and submitting a statement
PRA), Federal Agencies are required to for the proper performance of FDA’s
detailing the reasons why the
publish notice in the Federal Register functions, including whether the
application holder does not believe a
concerning each proposed collection of information will have practical utility; change is warranted (a rebuttal
information, including each proposed (2) the accuracy of FDA’s estimate of the statement).
extension of an existing collection of burden of the proposed collection of Based on FDA’s experience to date
information, and to allow 60 days for information, including the validity of with safety labeling changes
public comment in response to the the methodology and assumptions used; requirements under section 505(o)(4),
(3) ways to enhance the quality, utility,
mstockstill on DSK4VPTVN1PROD with NOTICES

notice. This notice solicits comments on we estimate that approximately 42
the requirement to make safety related and clarity of the information to be application holders will elect to submit
labeling changes based upon new safety collected; and (4) ways to minimize the approximately one rebuttal statement
information that becomes available after burden of the collection of information each year and that each rebuttal
the drug or biological product is on respondents, including through the statement will take approximately 6
approved under the Federal Food, Drug, use of automated collection techniques, hours to prepare.
and Cosmetic Act (the FD&C Act) or the when appropriate, and other forms of In addition, in the guidance, FDA
Public Health Service Act (PHS Act.) information technology. states that new labeling prepared in

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Document Created: 2018-02-26 10:11:09
Document Modified: 2018-02-26 10:11:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by November 2, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 53161

80 FR 53161 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 170 (September 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration