83 FR 2393 - Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 11 (January 17, 2018)

Page Range		2393-2394
FR Document		2018-00683

The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of October 31, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Federal Register, Volume 83 Issue 11 (Wednesday, January 17, 2018)

[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Proposed Rules]
[Pages 2393-2394]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-00683]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2017-N-0763]
RIN 0910-AH43

Food Labeling: Health Claims; Soy Protein and Coronary Heart
Disease; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the proposed rule that appeared in the Federal
Register of October 31, 2017. We are taking this action in response to
requests for an extension to allow interested persons additional time
to submit comments.

DATES: FDA is extending the comment period on the proposed rule
published on October 31, 2017 (82 FR 50324). Submit either electronic
or written comments by March 19, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 19, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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

[[Page 2394]]

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-0763 for ``Food Labeling: Health Claims; Soy Protein and
Coronary Heart Disease.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff 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 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.'' We will review
this copy, including the claimed confidential information, in our
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 Dockets Management Staff. 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:
https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Crystal Rivers, Center for Food Safety
and Applied Nutrition (HFS-830), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1444.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 31, 2017,
FDA published a proposed rule to revoke our regulation authorizing the
use of health claims on the relationship between soy protein and
coronary heart disease on the label or in the labeling of foods. We
proposed this action based on our review of the totality of publicly
available scientific evidence currently available and our tentative
conclusion that such evidence does not support our previous
determination that there is significant scientific agreement among
qualified experts for a health claim regarding the relationship between
soy protein and reduced risk of coronary heart disease. We provided a
75-day comment period for the proposed rule.
We have received requests for a 60-day extension of the comment
period for the proposed rule. Each request conveyed concern that the
current comment period does not allow sufficient time to develop a
meaningful or thoughtful response to the proposed rule.
FDA has considered the requests and is extending the comment period
for the proposed rule until March 19, 2018. We believe that this
extension allows adequate time for interested persons to submit
comments without significantly delaying rulemaking on these important
issues.

Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00683 Filed 1-12-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Proposed Rules 2393

§ 10.75 Internal agency review of 517A decision under § 10.75 of this Dated: January 10, 2018.
decisions. chapter must be addressed to the next Leslie Kux,
* * * * * organizational level or higher above the Associate Commissioner for Policy.
(e) Each request by an interested individual who made the decision; [FR Doc. 2018–00646 Filed 1–16–18; 8:45 am]
person for review of a decision within submitted in electronic format in BILLING CODE 4164–01–P
the Center for Devices and Radiological accordance with section 745A(b) of the
Health shall also comply with § 800.75 Federal Food, Drug, and Cosmetic Act;
of this chapter. marked ‘‘Appeal: Request for DEPARTMENT OF HEALTH AND
Supervisory Review;’’ and received by HUMAN SERVICES
PART 800—GENERAL CDRH no later than 30 days after the
■ 3. The authority citation for part 800 date of the decision involved. Any such Food and Drug Administration
is revised to read as follows: request for supervisory review not
received by CDRH within 30 days after 21 CFR Part 101
Authority: 5 U.S.C. 551–559; 21 U.S.C.
301–399f.
the date of the decision involved is not [Docket No. FDA–2017–N–0763]
eligible for review. Except as provided
■ 4. In part 800, add § 800.75 to subpart in paragraph (b)(1)(ii) or (iii) of this RIN 0910–AH43
C to read as follows: section, FDA will render a decision
Food Labeling: Health Claims; Soy
§ 800.75 Requests for supervisory review within 45 days of the request for Protein and Coronary Heart Disease;
of certain decisions made by the Center for supervisory review. Extension of Comment Period
Devices and Radiological Health. (ii) A person requesting supervisory
(a) The following definitions shall review under paragraph (b)(1)(i) may AGENCY: Food and Drug Administration,
apply to this section: request an in-person meeting or HHS.
(1) FDA means the Food and Drug teleconference with the supervisor Proposed rule; extension of
ACTION:
Administration. reviewing the request for supervisory comment period.
(2) 517A decision means a significant review. Except as provided in paragraph
decision made by the Center for Devices SUMMARY: The Food and Drug
(b)(1)(iii) of this section, if a request for
and Radiological Health, as set forth in Administration (FDA or we) is
in-person meeting or teleconference is
section 517A of the Federal Food, Drug, extending the comment period for the
included in the request for supervisory
and Cosmetic Act, and includes one of proposed rule that appeared in the
review to CDRH, CDRH will schedule
the following decisions: Federal Register of October 31, 2017.
the meeting or teleconference to occur
(i) A substantially equivalent order We are taking this action in response to
within 30 days of receipt of the request.
under § 807.100(a)(1) of this chapter, or requests for an extension to allow
Except as provided in paragraph
a not substantially equivalent order interested persons additional time to
(b)(1)(iii) of this section, a decision will
under § 807.100(a)(2) of this chapter; submit comments.
be rendered within 30 days of such
(ii) An approval order under meeting or teleconference. DATES: FDA is extending the comment
§ 814.44(d) of this chapter, an period on the proposed rule published
(iii) The timeframes for CDRH to on October 31, 2017 (82 FR 50324).
approvable letter under § 814.44(e) of
render a decision provided in (b)(1)(i) Submit either electronic or written
this chapter, a not approvable letter
and (ii), and the timeframe to schedule comments by March 19, 2018.
under § 814.44(f) of this chapter, or an
an in-person meeting or teleconference
order denying approval under § 814.45 ADDRESSES: You may submit comments
review in (b)(1)(ii) of this section do not
of this chapter; as follows. Please note that late,
apply, if a matter related to the 517A
(iii) An approval order under untimely filed comments will not be
decision under review is referred by
§ 814.116(b) of this chapter, an considered. Electronic comments must
CDRH to external experts, such as an
approvable letter under § 814.116(c) of be submitted on or before March 19,
advisory committee, as provided in
this chapter, a not approvable letter 2018. The https://www.regulations.gov
§ 10.75(b) of this chapter.
under § 814.116(d) of this chapter, or an electronic filing system will accept
order denying approval under § 814.118 (2) An initial or sequential request for comments until midnight Eastern Time
of this chapter; supervisory review within CDRH under at the end of March 19, 2018. Comments
(iv) A grant or denial of a request for § 10.75 of this chapter of a decision received by mail/hand delivery/courier
breakthrough device designation under other than a 517A decision that is not (for written/paper submissions) will be
section 515C of the Federal Food, Drug, received by CDRH within 60 days after considered timely if they are
and Cosmetic Act; the date of the decision involved will be postmarked or the delivery service
(v) An approval order under denied as untimely, unless CDRH, for acceptance receipt is on or before that
§ 812.30(a) of this chapter or a good cause, permits the request to be date.
disapproval order under § 812.30(c) of filed after 60 days. An initial or
sequential request for supervisory Electronic Submissions
this chapter;
(vi) A failure to reach agreement letter review within CDRH of a decision other Submit electronic comments in the
under section 520(g)(7) of the Federal than a 517A decision must be addressed following way:
Food, Drug, and Cosmetic Act; or to the next organizational level or higher • Federal eRulemaking Portal:
(vii) A clinical hold determination above the individual who made the https://www.regulations.gov. Follow the
ethrower on DSK3G9T082PROD with PROPOSALS

under section 520(g)(8) of the Federal decision; submitted in electronic format instructions for submitting comments.
Food, Drug, and Cosmetic Act. in accordance with section 745A(b) of Comments submitted electronically,
(3) CDRH means the Center for the Federal Food, Drug, and Cosmetic including attachments, to https://
Devices and Radiological Health. Act, when applicable; marked, ‘‘Appeal: www.regulations.gov will be posted to
(b) Submission of request. Request for Supervisory Review’’ in the the docket unchanged. Because your
(1) Review of 517A decisions. subject line of the electronic request; comment will be made public, you are
(i) An initial or sequential request for and sent to the CDRH Ombudsman at solely responsible for ensuring that your
supervisory review within CDRH of a CDRHOmbudsman@fda.hhs.gov. comment does not include any

VerDate Sep<11>2014 16:35 Jan 16, 2018 Jkt 244001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\FR\FM\17JAP1.SGM 17JAP1

Document Created: 2018-10-26 09:56:02
Document Modified: 2018-10-26 09:56:02

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		Proposed rule; extension of comment period.
Dates		FDA is extending the comment period on the proposed rule published on October 31, 2017 (82 FR 50324). Submit either electronic or written comments by March 19, 2018.
Contact		Crystal Rivers, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1444.
FR Citation		83 FR 2393
RIN Number		0910-AH43

83 FR 2393 - Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 11 (January 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration