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, 53161-53162 [2015-21645]
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Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
BILLING CODE 4184–01–P
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
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.)
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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19:04 Sep 01, 2015
Submit electronic
comments on the collection of
information to: https://
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.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–21727 Filed 9–1–15; 8:45 am]
AGENCY:
Submit either electronic or
written comments on the collection of
information by November 2, 2015.
DATES:
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53161
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
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53162
Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices
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
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
42
1
42
6
252
Rebuttal statement ...............................................................
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
Type of submission
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Posting approved labeling on application holder’s Web site
407
1
407
4
1,628
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Enterprise Rd., Horsham, PA 19044,
215–442–6117, FAX: 215–293–5923,
email: Meredith.kaganovskiy@
diaglobal.org; or Robert T. Dorsam, Food
and Drug Administration, Center for
Drug Evaluation and Research (CDER),
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002; 301–796–1623,
email: robert.dorsam@fda.hhs.gov.
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
I. Background
Food and Drug Administration/Drug
Information Association
Oligonucleotide-Based Therapeutics
Conference 2015
Oligonucleotide therapeutics
constitute a diverse and evolving class
of drug products that are being
developed for a wide variety of
indications. The FDA/DIA 2015
conference is a forum where regulators,
academics, and members of industry
will discuss the advances, challenges,
and opportunities in the field of
oligonucleotide therapeutics. This is the
sixth meeting in approximately eight
years where attendees will discuss
oligonucleotide therapeutics in clinical,
nonclinical, and chemistry tracks. The
meeting will provide updates on
advancements in this field, and will also
present time for stakeholders to discuss
challenges in the development and
regulation of oligonucleotide
therapeutics. Topics will be addressed
using presentations, panel discussions,
case studies, and a poster session to
facilitate discipline-specific and
multidisciplinary discussions. The goal
of the meeting is to provide a current
view of oligonucleotide therapeutics
and foster advancement in the field
through discussions among regulators,
academics, and industry members.
[FR Doc. 2015–21645 Filed 9–1–15; 8:45 am]
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research, in
cosponsorship with the Drug
Information Association (DIA), is
announcing a meeting entitled ‘‘FDA/
DIA Oligonucleotide-Based
Therapeutics Conference 2015’’ (FDA/
DIA 2015 conference). The purpose of
the meeting is to discuss advances,
safety, and challenges in the field of
oligonucleotide-based therapeutics.
DATES: The meeting will be held on
September 9 to September 10, 2015,
from 7 a.m. to 5 p.m. and September 11,
2015, from 7 a.m. to 12 noon.
ADDRESSES: The meeting will be held at
the Grand Hyatt Washington, 1000 H St.
NW., Washington, DC 20001.
FOR FURTHER INFORMATION CONTACT:
Meredith Kaganovskiy, Drug
Information Association (DIA), 800
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SUMMARY:
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II. Registration and Accommodations
A. Registration
There is a registration fee to attend
this meeting. The registration fee is
charged to help defray the costs of
facilities, meeting materials, and food.
Seats are limited, and registration will
be on a first-come, first-served basis.
To register, please complete
registration online at https://
www.diaglobal.org/. (FDA has verified
the Web address, but FDA is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register.) The
costs of registration for the different
categories of attendees are as follows:
Category
Industry Representatives ..........
Charitable Nonprofit/Academic
Government ..............................
Cost
$1,350
675
405
B. Accommodations
Attendees are responsible for their
own hotel accommodations. Attendees
making reservations at the Grand Hyatt
Washington are eligible for a reduced
rate of $209, not including applicable
taxes. This rate is available for a limited
number of rooms. To receive the
reduced rate, hotel reservations must be
made with onPeak and not directly with
the hotel. Contact information for
onPeak is as follows: Toll free in the
United States 1–855–355–0302 or 1–
212–532–1660. When calling, please
select option 1 for ‘‘Hotel Reservations,’’
and inform the phone agent that you are
making a reservation for Event #15011.
If you need special accommodations
due to a disability, please contact
Meredith Kaganovskiy (DIA) or Robert.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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: https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
