83 FR 45454 - Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 174 (September 7, 2018)

Page Range		45454-45455
FR Document		2018-19367

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.'' The draft guidance, when finalized, will advise firms that manufacturer, market, or distribute dietary supplements of FDA's intent to exercise enforcement discretion if a firm wishes to specify the amount of a live microbial in colony forming units (CFUs) in addition to the currently required unit of measure (milligrams) in the Supplement Facts label.

Federal Register, Volume 83 Issue 174 (Friday, September 7, 2018)

[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Pages 45454-45455]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-19367]

[[Page 45454]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]

Policy Regarding Quantitative Labeling of Dietary Supplements
Containing Live Microbials; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Policy Regarding Quantitative Labeling of Dietary Supplements
Containing Live Microbials.'' The draft guidance, when finalized, will
advise firms that manufacturer, market, or distribute dietary
supplements of FDA's intent to exercise enforcement discretion if a
firm wishes to specify the amount of a live microbial in colony forming
units (CFUs) in addition to the currently required unit of measure
(milligrams) in the Supplement Facts label.

DATES: Submit either electronic or written comments on the draft
guidance by November 6, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): 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-2011-D-0376 for ``Policy Regarding Quantitative Labeling of Dietary
Supplements Containing Live Microbials: Draft Guidance for Industry.''
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 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.'' 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Dietary Supplement Programs, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Steven Tave, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2878.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry
entitled ``Policy Regarding Quantitative Labeling of Dietary
Supplements Containing Live Microbials.'' We are issuing the draft
guidance consistent with our good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
The draft guidance, when finalized, would advise firms that
manufacture, market, or distribute dietary supplements of FDA's intent
to exercise enforcement discretion with respect to declaration of live
microbial quantity in CFUs, in addition to the quantitative amount by
weight declaration required by regulation, within the Supplement Facts
label of dietary supplements containing live microbials, provided that
certain conditions are met.

II. Electronic Access

Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the

[[Page 45455]]

FDA website listed in the previous sentence to find the most current
version of the guidance.

III. Paperwork Reduction Act

This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 101.36 have been approved under
OMB control number 0910-0381.

Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19367 Filed 9-6-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45455

FDA website listed in the previous forth in the National Organ Transplant the data collection plans and
sentence to find the most current Act of 1984, as amended. instruments, contact: Ms. Diane Dean,
version of the guidance. The charter renewal for the ACOT Director, Division of Grants Compliance
was approved on August 31, 2018, and Oversight, Office of Policy for
III. Paperwork Reduction Act
which will also stand as the filing date. Extramural Research Administration,
This draft guidance refers to Renewal of the ACOT charter gives Office of Extramural Research, National
previously approved collections of authorization for the Committee to Institutes of Health, 6705 Rockledge
information found in FDA regulations. operate until August 31, 2020. Drive, Room 3525, Bethesda, MD 20892,
These collections of information are A copy of the ACOT charter is or call non-toll-free number (301) 435–
subject to review by the Office of available on the ACOT website at: 0930 or Email your request, including
Management and Budget (OMB) under http://www.organdonor.gov/legislation/ your address to: deand@
the Paperwork Reduction Act of 1995 advisory.html. A copy of the charter can od31em1.od.nih.gov.
(44 U.S.C. 3501–3520). The collections also be obtained by accessing the FACA
of information in 21 CFR 101.36 have SUPPLEMENTARY INFORMATION: This
database that is maintained by the proposed information collection was
been approved under OMB control Committee Management Secretariat
number 0910–0381. previously published in the Federal
under the General Services Register on March 16, 2018, (FR 83
Dated: August 31, 2018. Administration. The website for the pages 11763–11765) and allowed 60
Leslie Kux, FACA database is http:// days for public comment. One public
Associate Commissioner for Policy. www.facadatabase.gov/. comment was received. The purpose of
[FR Doc. 2018–19367 Filed 9–6–18; 8:45 am] Amy P. McNulty, this notice is to allow an additional 30
BILLING CODE 4164–01–P Acting Director, Division of the Executive days for public comment.
Secretariat. The National Institutes of Health may
[FR Doc. 2018–19454 Filed 9–6–18; 8:45 am] not conduct or sponsor, and the
DEPARTMENT OF HEALTH AND respondent is not required to respond
BILLING CODE 4165–15–P
HUMAN SERVICES to, an information collection that has
been extended, revised, or implemented
Charter Renewal for the Advisory on or after October 1, 1995, unless it
Committee on Organ Transplantation DEPARTMENT OF HEALTH AND
HUMAN SERVICES displays a currently valid OMB control
AGENCY: Health Resources and Services number.
Administration (HRSA), The National Institutes of Health In compliance with Section
Department of Health and Human 3507(a)(1)(D) of the Paperwork
Services (HHS). Submission for OMB Review; 30-Day Reduction Act of 1995, the National
ACTION: Notice of charter renewal.
Comment Request; Responsibility of Institutes of Health (NIH) has submitted
Applicants for Promoting Objectivity in to the Office of Management and Budget
SUMMARY: HHS is hereby giving notice Research for Which Public Health (OMB) a request for review and
that the Advisory Committee on Organ Service (PHS) Funding is Sought and approval of the information collection
Transplantation (ACOT) has been Responsible Prospective Contractors listed below.
rechartered. The effective date of the (Office of the Director) Proposed Collection: Responsibility of
renewed charter is August 31, 2018. Applicants for Promoting Objectivity in
AGENCY: National Institutes of Health,
FOR FURTHER INFORMATION CONTACT: Research for which Public Health
HHS.
Robert Walsh, Executive Secretary, Service (PHS) Funding is Sought 42 CFR
Advisory Committee on Organ ACTION: Notice. part 50 subpart F and Responsible
Transplantation, Health Resources and SUMMARY: In compliance with the Prospective Contractors 45 CFR part 94,
Services Administration, Department of Paperwork Reduction Act of 1995, the 0925–0417, expiration date 2/28/2015,
Health and Human Services, Room National Institutes of Health (NIH) has REINSTATEMENT WITHOUT
08W60, 5600 Fishers Lane, Rockville, submitted to the Office of Management CHANGE, Office of Policy for
Maryland 20857. Phone: (301) 443– and Budget (OMB) a request for review Extramural Research Administration
6839; fax: (301) 594–6095; email: and approval of the information (OPERA), Office of Extramural Research
rwalsh@hrsa.gov. collection listed below. (OER), National Institutes of Health
SUPPLEMENTARY INFORMATION: The ACOT
DATES: Comments regarding this
(NIH).
was authorized by section 121.12 of the Need and Use of Information
information collection are best assured
amended Final Rule of the Organ Collection: This request is for Office of
of having their full effect if received
Procurement and Transplantation Management and Budget (OMB)
within 30-days of the date of this
Network (OPTN) (42 CFR part 121). In approval of a Reinstatement Without
publication.
accordance with the Federal Advisory Change of a currently approved
Committee Act (FACA), Public Law 92– ADDRESSES: Written comments and/or collection resulting from the
463, it was initially chartered on suggestions regarding the item(s) development of revised regulations
September 1, 2000, and was renewed at contained in this notice, especially regarding the Responsibility of
the appropriate intervals. regarding the estimated public burden Applicants for Promoting Objectivity in
The ACOT provides advice to the and associated response time, should be Research for which PHS Funding is
Secretary on all aspects of organ directed to the: Office of Management Sought (42 CFR part 50, subpart F) and
daltland on DSKBBV9HB2PROD with NOTICES

donation, procurement, allocation, and and Budget, Office of Regulatory Affairs, Responsible Prospective Contractors (45
transplantation, and on such other OIRA_submission@omb.eop.gov or by CFR part 94). The purpose of these
matters that the Secretary determines. fax to 202–395–6974, Attention: Desk regulations is to promote objectivity in
The recommendations of the ACOT will Officer for NIH. research by requiring institutions to
facilitate the Department’s efforts to FOR FURTHER INFORMATION CONTACT: To establish standards to ensure that there
oversee the Organ Procurement and request more information on the is no reasonable expectation that the
Transplantation Network (OPTN), as set proposed project or to obtain a copy of design, conduct, or reporting of PHS-

VerDate Sep<11>2014 17:55 Sep 06, 2018 Jkt 244001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

Document Created: 2018-09-07 00:15:41
Document Modified: 2018-09-07 00:15:41

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		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the draft guidance by November 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Steven Tave, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2878.
FR Citation		83 FR 45454

83 FR 45454 - Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 174 (September 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration