[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14401-14402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5775]


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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Draft Guidance on Drug Safety Information--FDA's Communication to 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.

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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availability of a draft guidance titled ``Drug Safety Information--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 This draft guidance updates and 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 This draft guidance describes 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The draft guidance was developed in connection with the Center for Drug 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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]
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