Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability, 14401-14402 [2012-5775]
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Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices
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[FR Doc. 2012–5825 Filed 3–8–12; 8:45 am]
BILLING CODE 4184–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2005–D–0339]
Draft Guidance on Drug Safety
Information—FDA’s Communication to
the Public; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance titled
‘‘Drug Safety Information—FDA’s
Communication to the Public.’’ This
draft guidance updates and revises the
March 2007 guidance entitled ‘‘Drug
Safety Information—FDA’s
Communication to the Public.’’ This
draft guidance describes FDA’s current
approach to communicating important
drug safety information, including
emerging drug safety information, to the
public and the factors that influence
when the information is communicated.
The draft guidance was developed in
connection with the Center for Drug
Evaluation and Research’s (CDER’s)
Safety First Initiative.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 8, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:21 Mar 08, 2012
Jkt 226001
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Edward Staffa, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Rm. 1152, Silver
Spring, MD 20993, 301–796–5301.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled ‘‘Drug Safety
Information—FDA’s Communication to
the Public.’’ This draft guidance updates
and revises a March 2007 guidance of
the same name. It describes FDA’s
current approach to communicating
important drug safety information,
including emerging drug safety
information, to the public and the
factors that influence when the
information is communicated.
For many years, FDA has provided
information on drug risks and benefits
to health care professionals and patients
when that information has generated a
specific concern, usually waiting until
that information has been fully
evaluated and has prompted an action,
such as a revision to the drug’s
prescribing information. In recent years,
FDA has tended to make information on
potential drug risks available to the
public earlier, often while the Agency is
still evaluating the data and determining
whether any action is warranted. FDA
believes that timely communication of
important drug safety information will
give health care professionals, patients,
consumers, and other interested persons
access to the most current information
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
State
VA
VI
WA
WV
WI
WY
concerning the potential risks and
benefits of a marketed drug, helping
them to make more informed individual
treatment choices.
In the Federal Register of March 7,
2007 (72 FR 10224), FDA announced the
availability of a guidance titled ‘‘Drug
Safety Information—FDA’s
Communication to the Public.’’ FDA has
revised the 2007 guidance to provide
updated information about its approach
to communicating important drug safety
information, including FDA’s
development of a single, standardized
format for electronic drug safety
communications about marketed drugs.
In addition, the draft guidance describes
FDA’s posting of other safety
assessments on its Web site in
accordance with the requirements of the
Food and Drug Administration
Amendments Act of 2007 (FDAAA) and
to further our transparency objectives.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
replace the 2007 guidance and represent
the Agency’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
E:\FR\FM\09MRN1.SGM
09MRN1
14402
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
310.305, 314.80, 314.98, 600.80, and in
21 U.S.C. 379aa have been approved
under OMB Control Numbers 0910–
0230, 0910–0291, 0910–0308, and 0910–
0636.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.fda
.gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://
www.regulations.gov.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
I. Background
[FR Doc. 2012–5775 Filed 3–8–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0085]
Draft Guidance on Classifying
Significant Postmarket Drug Safety
Issues; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Classifying Significant Postmarket
Drug Safety Issues.’’ This draft guidance
describes FDA’s current approach to
classifying a significant postmarket drug
safety issue as a ‘‘priority’’ tracked
safety issue (TSI) or a ‘‘standard’’ TSI,
with the capability of elevating some
priority TSIs to an ‘‘emergency’’ status.
The draft guidance was developed in
connection with the Center for Drug
Evaluation and Research’s (CDER’s)
Safety First Initiative.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 8, 2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:21 Mar 08, 2012
Jkt 226001
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michie Hunt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6153, Silver Spring,
MD 20993–0002, 301–796–3504.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a draft guidance entitled ‘‘Classifying
Significant Postmarket Drug Safety
Issues.’’ This draft guidance describes
CDER’s current approach to determining
whether a significant postmarket drug
safety issue should be classified as a
‘‘priority,’’ as a ‘‘standard,’’ or as an
‘‘emergency’’ tracked safety issue (TSI).
CDER receives a constant flow of
information about potential drug safety
issues, and the seriousness of reported
problems varies widely. Those that
CDER determines to be significant safety
issues are tracked in the Center’s
Document Archiving, Reporting, and
Regulatory Tracking System (DARRTS),
a centralized data base that enables staff
working across the Center to share
information. To be considered
significant, the safety issue of concern
must meet certain criteria. In general,
CDER considers postmarket safety
issues to be significant if they have the
potential to lead to any of the following
actions:
• Withdrawal of an approved drug
from the market.
• Withdrawal of an approved
indication.
• Limitations of a use in a specific
population or subpopulation.
• Additions or modifications to the
Contraindications or Warnings and
Precautions sections of the labeling, to
the Medication Guide or other required
Patient Package Insert, including safety
labeling changes required under the
Food and Drug Administration
Amendments Act (FDAAA).
• Establishment of or changes to the
proprietary name/container label/
labeling/packaging to reduce the
likelihood of medication errors.
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
• Establishment or modification of a
risk evaluation and mitigation strategy
(REMS).
• A requirement that a sponsor
conduct a safety-related postmarket
clinical trial or observational
epidemiological study.
• The conduct of a safety-related
observational epidemiological study by
FDA.
Since the DARRTS safety tracking
function was introduced in 2007, about
1,000 TSIs have been entered into the
system. Although all of these issues are
considered significant, not all TSIs are
equally urgent. Furthermore, CDER does
not have adequate resources to manage
all TSIs equally rapidly. In the past,
prioritization of the TSIs has been
handled informally and on a case-bycase basis, without an agreed upon
framework for establishing priority.
The Center is now seeking to establish
a formal framework for assessing the
relative urgency of TSIs, so that CDER
can direct resources more effectively
toward the issues that pose the greatest
potential risk for patients. This
framework will classify TSIs as
‘‘priority’’ or ‘‘standard’’ for CDER
review. In addition, the Center will
recognize a special ‘‘emergency’’
category for certain priority TSIs. The
use of a formal framework is intended
to ensure that staff working in different
offices across CDER reaches similar
conclusions about the relative urgency
of TSIs, and help them direct attention
to those that need to be addressed most
expeditiously. It will also inform CDER
decisions about public drug safety
communications, so that health care
practitioners and patients receive timely
information about safety risks with the
greatest public health significance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
E:\FR\FM\09MRN1.SGM
09MRN1
Agencies
[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14401-14402]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5775]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2005-D-0339]
Draft Guidance on Drug Safety Information--FDA's Communication to
the Public; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance titled ``Drug Safety Information--
FDA's Communication to the Public.'' This draft guidance updates and
revises the March 2007 guidance entitled ``Drug Safety Information--
FDA's Communication to the Public.'' This draft guidance describes
FDA's current approach to communicating important drug safety
information, including emerging drug safety information, to the public
and the factors that influence when the information is communicated.
The draft guidance was developed in connection with the Center for Drug
Evaluation and Research's (CDER's) Safety First Initiative.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Edward Staffa, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 1152, Silver Spring, MD 20993, 301-796-5301.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Drug Safety Information--FDA's Communication to the Public.'' This
draft guidance updates and revises a March 2007 guidance of the same
name. It describes FDA's current approach to communicating important
drug safety information, including emerging drug safety information, to
the public and the factors that influence when the information is
communicated.
For many years, FDA has provided information on drug risks and
benefits to health care professionals and patients when that
information has generated a specific concern, usually waiting until
that information has been fully evaluated and has prompted an action,
such as a revision to the drug's prescribing information. In recent
years, FDA has tended to make information on potential drug risks
available to the public earlier, often while the Agency is still
evaluating the data and determining whether any action is warranted.
FDA believes that timely communication of important drug safety
information will give health care professionals, patients, consumers,
and other interested persons access to the most current information
concerning the potential risks and benefits of a marketed drug, helping
them to make more informed individual treatment choices.
In the Federal Register of March 7, 2007 (72 FR 10224), FDA
announced the availability of a guidance titled ``Drug Safety
Information--FDA's Communication to the Public.'' FDA has revised the
2007 guidance to provide updated information about its approach to
communicating important drug safety information, including FDA's
development of a single, standardized format for electronic drug safety
communications about marketed drugs. In addition, the draft guidance
describes FDA's posting of other safety assessments on its Web site in
accordance with the requirements of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and to further our transparency
objectives.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will replace the 2007 guidance and represent the Agency's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget
[[Page 14402]]
(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR 310.305, 314.80, 314.98,
600.80, and in 21 U.S.C. 379aa have been approved under OMB Control
Numbers 0910-0230, 0910-0291, 0910-0308, and 0910-0636.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5775 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P