Document ID: FDA-2016-N-1149-0041
Agency: fda
Document Type: Proposed Rule
Title: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period
Posted Date: 2017-01-19T05:00Z

[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6367-6368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2016-N-1149]

Manufacturer Communications Regarding Unapproved Uses of Approved 
or Cleared Medical Products; Availability of Memorandum; Reopening of 
the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Reopening of comment period related to public hearing; 
availability of memorandum.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notification of public hearing, published in the 
Federal Register of September 1, 2016 (81 FR 60299) concerning our 
comprehensive review of our regulations and policies governing 
manufacturer communications regarding unapproved uses of approved or 
cleared medical products. FDA is also announcing that it has added a 
document to the docket for the public hearing entitled ``Memorandum: 
Public Health Interests and First Amendment Considerations Related to 
Manufacturer Communications Regarding Unapproved Uses of Approved or 
Cleared Medical Products'' (Memorandum). The Memorandum provides 
additional background on the issues FDA is considering as part of its 
comprehensive review, including a discussion of First Amendment 
considerations. In addition, elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of two draft guidance for 
industry that address manufacturer communications, one entitled ``Drug 
and Device Manufacturer Communications With Payors, Formulary 
Committees, and Similar Entities--Questions and Answers,'' and the 
other entitled ``Medical Product Communications That Are Consistent 
With the FDA-Required Labeling--Questions and Answers.'' FDA is 
reopening the comment period to provide the public an opportunity to 
review the Memorandum as it relates to the specific questions and 
issues identified in the notification of public hearing as well as 
review the two draft guidances and provide additional or new comments.

DATES: Submit either electronic or written comments by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1149 for ``Manufacturer Communications Regarding Unapproved 
Uses of Approved or Cleared Medical Products; Public Hearing; Requests 
for Comments.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper

[[Page 6368]]

submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kristin Davis, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, 
Silver Spring, MD 20993, 301-796-0418.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 1, 2016 
(81 FR 60299), FDA published a notification of public hearing on firm 
communications regarding unapproved uses of approved or cleared medical 
products. FDA is currently engaged in a comprehensive review of its 
regulations and policies governing firms' communications about 
unapproved uses of approved or cleared medical products, and the 
comments on the notification of public hearing will inform FDA's policy 
development in this area.
    Interested persons were originally given until January 9, 2017, to 
comment on the topics discussed in the notification of public hearing.
    At the public hearing on November 9 and 10, 2016, a number of 
speakers presented legal views regarding the application of First 
Amendment principles to firm communications regarding unapproved uses 
of approved or cleared medical products. Some expressed the view that 
FDA had not sufficiently discussed the First Amendment in the 
notification of public hearing. In response to these comments, FDA is 
now placing the Memorandum in the docket for the public hearing to 
provide additional background on the issues it is considering as part 
of its review of its rules and policies relating to firm communications 
regarding unapproved uses of approved or cleared medical products, 
including a discussion of First Amendment considerations. In the 
notification of public hearing, FDA requested comments on a number of 
specific issues and questions identified throughout the document. The 
Memorandum is intended to help advance the discussion of these topics, 
and FDA is seeking input on the information in the Memorandum as it 
relates to these issues and questions in the notification of public 
hearing.
    Furthermore, elsewhere in this issue of the Federal Register, FDA 
is announcing the availability of a draft guidance for industry 
entitled ``Drug and Device Manufacturer Communications With Payors, 
Formulary Committees, and Similar Entities--Questions and Answers,'' 
which provides answers to common questions regarding the communication 
of health care economic information about approved prescription drugs 
by medical product firms to payors, formulary committees, or other 
similar entities. The draft guidance also provides answers to common 
questions related to firms' communications about investigational drugs 
and devices (investigational products) to payors before FDA approval or 
clearance of such products.
    Additionally, in this issue of the Federal Register, FDA is 
announcing the availability of a draft guidance for industry entitled 
``Medical Product Communications That Are Consistent With the FDA-
Required Labeling--Questions and Answers.'' The guidance provides 
information for medical product firms about how FDA evaluates their 
medical product communications, including their promotional materials, 
that present information that is not contained in the FDA-required 
labeling for the product but that may be consistent with the FDA-
required labeling for the product.
    FDA is harmonizing the comment periods for the notification of 
public hearing and the two draft guidances, as all three documents 
relate to the overarching topic of firm communications regarding 
medical products, and interested persons may wish to review all the 
documents before submitting comments to any of the relevant dockets. 
FDA is requesting comments on both draft guidances by April 19, 2017.
    To allow interested parties an opportunity to review the Memorandum 
and the two draft guidances, FDA is reopening the comment period for 
the notification of public hearing for an additional 90 days, until 
April 19, 2017. The Agency believes reopening the comment period for an 
additional 90 days for the notification of public hearing will allow 
adequate time for interested persons to submit comments without 
significantly delaying Agency decision making and policy development on 
these important issues.

    Dated: January 6, 2017.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-01013 Filed 1-18-17; 8:45 am]
 BILLING CODE 4164-01-P