[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Page 58359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23064]



[[Page 58359]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0447]


Internet/Social Media Platforms: Correcting Independent Third-
Party Misinformation About Prescription Drugs and Medical Devices; 
Draft Guidance for Industry; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of availability of the draft guidance 
entitled ``Internet/Social Media Platforms: Correcting Independent 
Third-Party Misinformation About Prescription Drugs and Medical 
Devices,'' published in the Federal Register of June 18, 2014. FDA is 
reopening the comment period in response to a request for additional 
time and to allow interested persons more time to submit comments.

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 comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments by October 29, 
2014.

ADDRESSES: Submit electronic comments 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:
    Regarding human prescription drugs: Julie Chronis, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-1200.
    Regarding human prescription biological products: Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.
    Regarding animal prescription drugs: Thomas Moskal, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9300.
    Regarding medical devices for human use: Deborah Wolf, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002, 
301-796-5732.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 18, 2014 (79 FR 34760), FDA 
announced the availability of a draft guidance for industry entitled 
``Internet/Social Media Platforms: Correcting Independent Third-Party 
Misinformation About Prescription Drugs and Medical Devices.'' In that 
document, FDA requested comments on the draft guidance, which responds 
to (among other things) stakeholder requests for specific guidance. The 
draft guidance describes FDA's current thinking on how manufacturers, 
packers, and distributors of prescription human and animal drugs and 
medical devices for human use, including biological products, should 
respond, if they choose to respond, to misinformation related to a 
firm's own FDA-approved or cleared products when that information is 
created or disseminated by independent third parties. The draft 
guidance also updates and clarifies FDA's policies on the correction of 
misinformation created or disseminated by independent third parties on 
the Internet or through social media platforms, regardless of whether 
that misinformation appears on a firm's own forum, an independent 
third-party forum, or a Web site. The draft guidance represents FDA's 
current thinking on specific aspects of FDA's evolving consideration of 
social media platforms and other Internet-related matters. FDA actively 
continues to review, analyze, and develop approaches to a variety of 
topics related to the labeling and advertising of medical products, 
including the development of this and other guidance addressing the use 
of social media platforms and the Internet.
    Interested persons were originally given until September 16, 2014, 
to submit comments on the draft guidance.

II. Request for Comments

    Following publication of the June 18, 2014, notice, FDA received a 
request for additional time to develop meaningful and thoughtful 
comments, especially in light of the concurrent comment period with 
another draft guidance entitled ``Internet/Social Media Platforms with 
Character Space Limitations: Presenting Risk and Benefit Information 
for Prescription Drugs and Medical Devices'' published elsewhere in 
this volume of the Federal Register.
    FDA has considered the request and will reopen the comment period 
for an additional 30 days. The Agency believes that an additional 30 
days allows adequate time for interested persons to submit comments 
without significantly delaying the Agency's consideration of these 
important issues.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23064 Filed 9-26-14; 8:45 am]
BILLING CODE 4164-01-P