Document ID: FDA-2014-D-0397-0021
Agency: fda
Document Type: Notice
Title: Internet/Social Media Platforms With Character Space Limitations:
Presenting Risk and Benefit Information for Prescription Drugs and
Medical Devices; Draft Guidance for Industry; Reopening of the Comment Period
Posted Date: 2014-09-29T04:00Z

[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58357-58358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23063]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0397]

Internet/Social Media Platforms With Character Space Limitations: 
Presenting Risk and Benefit Information for 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Medical Devices; Draft Guidance for Industry; Reopening of the Comment 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.

-----------------------------------------------------------------------

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comment period for the notice of availability of the draft guidance 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 with Character Space 
Limitations: Presenting Risk and Benefit Information for 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this draft guidance before it begins work on the final version of the 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: Jean-Ah Kang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-1200.
    Regarding prescription human 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: Dorothy McAdams, 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, 301-
796-5732.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 18, 2014 (79 FR 34759), FDA 
announced the availability of a draft guidance for industry entitled 
``Internet/Social Media Platforms with Character Space Limitations: 
Presenting Risk and Benefit Information for 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, that choose to present benefit 
information should present both benefit and risk information within 
advertising and promotional labeling of their FDA-regulated medical 
products on electronic/digital platforms that are associated with 
character space limitations, specifically on the Internet and through 
social media or other technological venues. 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: 
Correcting Independent Third-Party Misinformation About 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

[[Page 58358]]

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. 2014-23063 Filed 9-26-14; 8:45 am]
BILLING CODE 4164-01-P