[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Register, FDA is announcing the availability of two draft guidance for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