Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability, 14401-14402 [2012-5775]

Download as PDF Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Notices 14401 STATE DOMESTIC VIOLENCE COALITIONS AS DESIGNATED BY THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ADMINISTRATION FOR CHILDREN AND FAMILIES, ADMINISTRATION ON CHILDREN, YOUTH AND FAMILIES AS OF DECEMBER 2011—Continued Coalition name City Virginia Sexual & Domestic Violence Action Alliance ......................................................... Virgin Islands Domestic Violence and Sexual Assault Council .......................................... Washington State Coalition Against Domestic Violence ..................................................... West Virginia Coalition Against Domestic Violence ............................................................ Wisconsin Coalition Against Domestic Violence ................................................................. Wyoming Coalition Against Domestic Violence & Sexual Assault ...................................... Richmond ..................................................... Kingshill ........................................................ Seattle .......................................................... Elkview ......................................................... Madison ........................................................ Laramie ........................................................ [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CODE 4184–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0339] Draft Guidance on Drug Safety Information—FDA’s Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled ‘‘Drug Safety Information—FDA’s Communication to the Public.’’ This draft guidance updates and revises the March 2007 guidance entitled ‘‘Drug Safety Information—FDA’s Communication to the Public.’’ This draft guidance describes FDA’s current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors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 The draft guidance was developed in connection with the Center for Drug Evaluation and Research’s (CDER’s) Safety First Initiative.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

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