82 FR 6367 - Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6367-6368 | |
| FR Document | 2017-01013 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Proposed Rules] [Pages 6367-6368] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01013] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of two draft guidance for industry that address manufacturer communications, one entitled ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and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
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules 6367
Appendices to Recordkeeping— DEPARTMENT OF HEALTH AND Electronic Submissions
Commission Voting Summary and HUMAN SERVICES Submit electronic comments in the
Chairman’s Statement following way:
Food and Drug Administration
Appendix 1—Commission Voting • Federal eRulemaking Portal:
Summary https://www.regulations.gov. Follow the
21 CFR Part 15
instructions for submitting comments.
On this matter, Chairman Massad and [Docket No. FDA–2016–N–1149] Comments submitted electronically,
Commissioners Bowen and Giancarlo including attachments, to https://
voted in the affirmative. No Manufacturer Communications www.regulations.gov will be posted to
Commissioner voted in the negative. Regarding Unapproved Uses of the docket unchanged. Because your
Approved or Cleared Medical comment will be made public, you are
Appendix 2—Statement of Chairman Products; Availability of Memorandum; solely responsible for ensuring that your
Timothy G. Massad Reopening of the Comment Period comment does not include any
I have said many times that it is AGENCY: Food and Drug Administration, confidential information that you or a
HHS. third party may not wish to be posted,
important for the CFTC to ensure its
ACTION: Reopening of comment period such as medical information, your or
rules are up-to-date in light of
related to public hearing; availability of anyone else’s Social Security number, or
technological changes, as outdated rules
memorandum. confidential business information, such
can create unnecessary burdens. That is as a manufacturing process. Please note
why I’m pleased we are unanimously SUMMARY: The Food and Drug that if you include your name, contact
issuing this proposed rulemaking, Administration (FDA) is reopening the information, or other information that
which is in keeping with that goal. comment period for the notification of identifies you in the body of your
Today’s proposal will modernize public hearing, published in the Federal comments, that information will be
recordkeeping and storage obligations Register of September 1, 2016 (81 FR posted on https://www.regulations.gov.
set forth in CFTC rules, and make them 60299) concerning our comprehensive • If you want to submit a comment
technology neutral. By doing so, it will review of our regulations and policies with confidential information that you
reduce costs for businesses and improve governing manufacturer do not wish to be made available to the
the quality of record preservation and communications regarding unapproved public, submit the comment as a
production. Among other things, the uses of approved or cleared medical written/paper submission and in the
products. FDA is also announcing that manner detailed (see ‘‘Written/Paper
proposal will provide greater flexibility
it has added a document to the docket Submissions’’ and ‘‘Instructions’’).
when it comes to how records must be
for the public hearing entitled
retained and produced. In this age ‘‘Memorandum: Public Health Interests Written/Paper Submissions
where terabytes of storage easily fit in and First Amendment Considerations Submit written/paper submissions as
one’s pocket, our rules should not refer Related to Manufacturer follows:
to microfiche or require paper records. Communications Regarding • Mail/Hand delivery/Courier (for
Today’s proposal is also an example Unapproved Uses of Approved or written/paper submissions): Division of
of how the Commission is focusing on Cleared Medical Products’’ Dockets Management (HFA–305), Food
issues related to technological change (Memorandum). The Memorandum and Drug Administration, 5630 Fishers
generally in our markets. In this regard, provides additional background on the Lane, Rm. 1061, Rockville, MD 20852.
there is much talk today about issues FDA is considering as part of its • For written/paper comments
innovations that may come from comprehensive review, including a submitted to the Division of Dockets
financial technology. While it is the role discussion of First Amendment Management, FDA will post your
of the private sector to develop considerations. In addition, elsewhere comment, as well as any attachments,
in this issue of the Federal Register, except for information submitted,
innovations, I believe it is our role to
FDA is announcing the availability of marked and identified, as confidential,
ensure that the Commission’s rules do
two draft guidance for industry that if submitted as detailed in
not stand in the way of their potential. address manufacturer communications,
Today’s proposal is a way to do just ‘‘Instructions.’’
one entitled ‘‘Drug and Device Instructions: All submissions received
that. Manufacturer Communications With must include the Docket No. FDA–
I thank the CFTC staff for their work Payors, Formulary Committees, and 2016–N–1149 for ‘‘Manufacturer
on this proposal and my fellow Similar Entities—Questions and Communications Regarding
Commissioners for their support. Answers,’’ and the other entitled Unapproved Uses of Approved or
[FR Doc. 2017–01148 Filed 1–18–17; 8:45 am] ‘‘Medical Product Communications That Cleared Medical Products; Public
Are Consistent With the FDA-Required Hearing; Requests for Comments.’’
BILLING CODE 6351–01–P
Labeling—Questions and Answers.’’ Received comments will be placed in
FDA is reopening the comment period the docket and, except for those
to provide the public an opportunity to submitted as ‘‘Confidential
review the Memorandum as it relates to Submissions,’’ publicly viewable at
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
the specific questions and issues https://www.regulations.gov or at the
identified in the notification of public Division of Dockets Management
hearing as well as review the two draft between 9 a.m. and 4 p.m., Monday
guidances and provide additional or through Friday.
new comments. • Confidential Submissions—To
DATES: Submit either electronic or submit a comment with confidential
written comments by April 19, 2017. information that you do not wish to be
ADDRESSES: You may submit comments made publicly available, submit your
as follows: comments only as a written/paper
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![6368 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Proposed Rules
submission. You should submit two At the public hearing on November 9 FDA is harmonizing the comment
copies total. One copy will include the and 10, 2016, a number of speakers periods for the notification of public
information you claim to be confidential presented legal views regarding the hearing and the two draft guidances, as
with a heading or cover note that states application of First Amendment all three documents relate to the
‘‘THIS DOCUMENT CONTAINS principles to firm communications overarching topic of firm
CONFIDENTIAL INFORMATION.’’ The regarding unapproved uses of approved communications regarding medical
Agency will review this copy, including or cleared medical products. Some products, and interested persons may
the claimed confidential information, in expressed the view that FDA had not wish to review all the documents before
its consideration of comments. The sufficiently discussed the First submitting comments to any of the
second copy, which will have the Amendment in the notification of public relevant dockets. FDA is requesting
claimed confidential information hearing. In response to these comments, comments on both draft guidances by
redacted/blacked out, will be available FDA is now placing the Memorandum April 19, 2017.
for public viewing and posted on in the docket for the public hearing to To allow interested parties an
https://www.regulations.gov. Submit provide additional background on the opportunity to review the Memorandum
both copies to the Division of Dockets issues it is considering as part of its and the two draft guidances, FDA is
Management. If you do not wish your review of its rules and policies relating reopening the comment period for the
name and contact information to be to firm communications regarding notification of public hearing for an
made publicly available, you can unapproved uses of approved or cleared additional 90 days, until April 19, 2017.
provide this information on the cover medical products, including a The Agency believes reopening the
sheet and not in the body of your discussion of First Amendment comment period for an additional 90
comments and you must identify this considerations. In the notification of days for the notification of public
information as ‘‘confidential.’’ Any public hearing, FDA requested hearing will allow adequate time for
information marked as ‘‘confidential’’ comments on a number of specific interested persons to submit comments
will not be disclosed except in issues and questions identified without significantly delaying Agency
accordance with 21 CFR 10.20 and other throughout the document. The decision making and policy
applicable disclosure law. For more Memorandum is intended to help development on these important issues.
information about FDA’s posting of advance the discussion of these topics, Dated: January 6, 2017.
comments to public dockets, see 80 FR and FDA is seeking input on the Jeremy Sharp,
56469, September 18, 2015, or access information in the Memorandum as it
Deputy Commissioner for Policy, Planning,
the information at: http://www.fda.gov/ relates to these issues and questions in Legislation, and Analysis.
regulatoryinformation/dockets/ the notification of public hearing.
[FR Doc. 2017–01013 Filed 1–18–17; 8:45 am]
default.htm. Furthermore, elsewhere in this issue
Docket: For access to the docket to of the Federal Register, FDA is
BILLING CODE 4164–01–P
read background documents or the announcing the availability of a draft
electronic and written/paper comments guidance for industry entitled ‘‘Drug
received, go to https:// and Device Manufacturer DEPARTMENT OF THE TREASURY
www.regulations.gov and insert the Communications With Payors,
docket number, found in brackets in the Formulary Committees, and Similar Internal Revenue Service
heading of this document, into the Entities—Questions and Answers,’’
‘‘Search’’ box and follow the prompts which provides answers to common 26 CFR Part 1
and/or go to the Division of Dockets questions regarding the communication
Management, 5630 Fishers Lane, Rm. of health care economic information [REG–127203–15]
1061, Rockville, MD 20852. about approved prescription drugs by
FOR FURTHER INFORMATION CONTACT: medical product firms to payors, RIN 1545–BN81
Kristin Davis, Office of Policy, Food and formulary committees, or other similar
Drug Administration, 10903 New entities. The draft guidance also Transfers of Certain Property by U.S.
Hampshire Ave., Bldg. 32, Rm. 4252, provides answers to common questions Persons to Partnerships With Related
Silver Spring, MD 20993, 301–796– related to firms’ communications about Foreign Partners
0418. investigational drugs and devices AGENCY: Internal Revenue Service (IRS),
SUPPLEMENTARY INFORMATION: In the (investigational products) to payors Treasury.
Federal Register of September 1, 2016 before FDA approval or clearance of ACTION: Notice of proposed rulemaking
(81 FR 60299), FDA published a such products. by cross-reference to temporary
notification of public hearing on firm Additionally, in this issue of the regulation.
communications regarding unapproved Federal Register, FDA is announcing
uses of approved or cleared medical the availability of a draft guidance for SUMMARY: In the Rules and Regulations
products. FDA is currently engaged in a industry entitled ‘‘Medical Product section of this issue of the Federal
comprehensive review of its regulations Communications That Are Consistent Register, temporary regulations are
and policies governing firms’ With the FDA-Required Labeling— being issued under sections 197, 704,
communications about unapproved uses Questions and Answers.’’ The guidance 721(c), and 6038B of the Internal
asabaliauskas on DSK3SPTVN1PROD with PROPOSALS
of approved or cleared medical provides information for medical Revenue Code (Code) that address
products, and the comments on the product firms about how FDA evaluates transfers of appreciated property by U.S.
notification of public hearing will their medical product communications, persons to partnerships with foreign
inform FDA’s policy development in including their promotional materials, partners related to the transferor. The
this area. that present information that is not temporary regulations affect U.S.
Interested persons were originally contained in the FDA-required labeling partners in domestic or foreign
given until January 9, 2017, to comment for the product but that may be partnerships. The text of the temporary
on the topics discussed in the consistent with the FDA-required regulations also serves as the text of
notification of public hearing. labeling for the product. these proposed regulations.
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Document Created: 2018-02-01 15:16:15
Document Modified: 2018-02-01 15:16:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Reopening of comment period related to public hearing; availability of memorandum. | |
| Dates | Submit either electronic or written comments by April 19, 2017. | |
| 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. | |
| FR Citation | 82 FR 6367 |
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