81_FR_63956 81 FR 63776 - Menu Labeling Public Workshop; Public Meeting

81 FR 63776 - Menu Labeling Public Workshop; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 180 (September 16, 2016)

Page Range63776-63777
FR Document2016-22337

The Food and Drug Administration (FDA or we) is announcing a third public meeting to discuss menu labeling requirements. We announced the first two public meetings in a separate Federal Register notice earlier this year. The purpose of the public meetings is to help the regulated industry comply with the requirements of the menu labeling final rule.

Federal Register, Volume 81 Issue 180 (Friday, September 16, 2016) 
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Notices]
[Pages 63776-63777]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22337]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Menu Labeling Public Workshop; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
third public meeting to discuss menu labeling requirements. We 
announced the first two public meetings in a separate Federal Register 
notice earlier this year. The purpose of the public meetings is to help 
the regulated industry comply with the requirements of the menu 
labeling final rule.

DATES: See ``How to Participate in the Public Meeting'' in the 
SUPPLEMENTARY INFORMATION section of this document for dates, times, 
and addresses of the public meeting, closing date for advance 
registration, requesting special accommodations due to disability, and 
other information.

ADDRESSES: See ``How to Participate in the Public Meeting'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: For questions about registering for 
this meeting or for special accommodations due to disability, contact 
Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, 
Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, email: 
[email protected].
    For general questions about the public meeting, contact Loretta A. 
Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-
2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71156), we 
published a final rule on nutrition labeling of standard menu items in 
restaurants and similar retail food establishments; the rule is 
codified at Title 21 of the Code of Federal Regulations, section 
101.11. The final rule implements section 403(q)(5)(H) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)), 
which, in general, requires that restaurants and similar retail food 
establishments that are part of a chain with 20 or more locations, 
doing business under the same name, and offering for sale substantially 
the same menu items, provide calorie information for standard menu 
items (including food on display and self-service food); provide, upon 
request, additional written nutrition information for standard menu 
items; and comply with other requirements described in section 
403(q)(5)(H) of the FD&C Act.
    On December 18, 2015, the President signed the Consolidated 
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the 
Consolidated Appropriations Act states that none of the funds made 
available under the Consolidated Appropriations Act may be used to 
implement, administer, or enforce the final rule entitled ``Food 
Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments'' until 1 year after the date of 
publication of a Level 1 guidance with respect to nutrition labeling of 
standard menu items in

[[Page 63777]]

restaurants and similar retail food establishments.
    In the Federal Register of May 5, 2016 (81 FR 27067), we announced 
the availability of the guidance for industry entitled ``A Labeling 
Guide for Restaurants and Retail Establishments Selling Away-From-Home 
Foods--Part II (Menu Labeling Requirements in Accordance with 21 CFR 
101.11).'' The guidance uses a question and answer format and is 
intended to help restaurants and similar retail food establishments 
covered by the final rule comply with the nutrition labeling 
requirements of the final rule. In accordance with the Consolidated 
Appropriations Act, 2016, enforcement of the final rule will commence 
May 5, 2017.
    We have made education of the menu labeling requirements a high 
priority, and this is our third menu labeling workshop to educate 
interested members of the public, especially the regulated industry, 
about the menu labeling requirements. We announced the first two public 
meetings in a separate Federal Register notice on June 15, 2016 (81 FR 
39056). Interested persons can continue to submit general questions to 
[email protected].

II. Purpose and Format of the Public Meeting

    The purpose of this public meeting is to help the regulated 
industry comply with the requirements of the menu labeling final rule. 
On the morning of day one of the meeting, we will give a slide 
presentation on the menu labeling requirements. (Please note the slide 
presentation will only be presented on day one.) The afternoon of day 
one and all of day two will consist of consultation sessions with FDA 
staff where individual companies (limited to two members per company) 
may discuss their specific questions and concerns. Each consultation 
session is limited to 15 minutes to help ensure that enough time is 
available to accommodate each company that requests a consultation. We 
recommend that participants in the consultation session prepare their 
questions in advance due to the limited time available.

III. How To Participate in the Public Meeting

    We encourage all persons who wish to attend the meeting to register 
in advance of the meeting and to indicate whether they are requesting a 
consultation session. There is no fee to register for the public 
meeting, and registration will be on a first-come, first-served basis. 
Early registration is recommended to facilitate planning of the 
consultation sessions and because seating is limited. We encourage you 
to use electronic registration if possible (see the address in table 
1).
    Table 1 provides information on participation in the public 
meeting.

                                  Table 1--Information on Menu Labeling Meeting
----------------------------------------------------------------------------------------------------------------
               Activity                          Date              Electronic address            Address
----------------------------------------------------------------------------------------------------------------
Public meeting.......................  November 16 and 17,      .......................  Holiday Inn Hotel &
                                        2016, 8 a.m. to 4:30                              Suites Oakland
                                        p.m.                                              Airport, 77
                                                                                          Hegenberger Rd.,
                                                                                          Oakland, CA 94621.
Advance registration.................  by November 9, 2016....  http://www.cvent.com/d/  We encourage you to use
                                                                 zfq6sm.                  electronic
                                                                                          registration if
                                                                                          possible.\1\
Request special accommodations due to  by November 9, 2016....  .......................  See FOR FURTHER
 a disability.                                                                            INFORMATION CONTACT.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via mail, fax, or email. Please include your name, title, firm name, address, and
  phone and fax numbers in your registration information and send to: Cindy de Sales, The Event Planning Group,
  8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, email:
  [email protected].

IV. Transcripts

    Transcripts of the workshop will not be prepared.

    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22337 Filed 9-15-16; 8:45 am]
 BILLING CODE 4164-01-P

63776 Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices heading of this document, into the guidance practices regulation (21 CFR DATES: See ‘‘How to Participate in the ‘‘Search’’ box and follow the prompts 10.115). The draft revised guidance, Public Meeting’’ in the SUPPLEMENTARY and/or go to the Division of Dockets when finalized, will represent the INFORMATION section of this document Management, 5630 Fishers Lane, Rm. current thinking of FDA on ‘‘Waivers for dates, times, and addresses of the 1061, Rockville, MD 20852. from the Requirement to Demonstrate public meeting, closing date for advance Submit written requests for single Bioequivalence of Animal Drugs in registration, requesting special copies of the guidance to the Policy and Soluble Powder Oral Dosage Form accommodations due to disability, and Regulations Staff (HFV–6), Center for Products and Type A Medicated other information. Veterinary Medicine, Food and Drug Articles.’’ It does not establish any ADDRESSES: See ‘‘How to Participate in Administration, 7519 Standish Pl., rights for any person and is not binding the Public Meeting’’ in the Rockville, MD 20855. Send one self- on FDA or the public. You can use an SUPPLEMENTARY INFORMATION section of addressed adhesive label to assist that alternative approach if it satisfies the this document. office in processing your requests. See requirements of the applicable statutes FOR FURTHER INFORMATION CONTACT: For the SUPPLEMENTARY INFORMATION section and regulations. questions about registering for this for electronic access to the draft revised III. Paperwork Reduction Act of 1995 meeting or for special accommodations guidance document. This draft revised guidance refers to due to disability, contact Cindy de FOR FURTHER INFORMATION CONTACT: previously approved collections of Sales, The Event Planning Group, 8720 Charli Long, Center for Veterinary Georgia Ave., Suite 801, Silver Spring, Medicine (HFV–170), Food and Drug information that are subject to review by the Office of Management and Budget MD 20910, 240–316–3207, FAX: 240– Administration, 7500 Standish Pl., 652–6002, email: rsvp@tepgevents.com. Rockville, MD 20855, 240–402–0850, (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The For general questions about the public charli.long-medrano@fda.hhs.gov. meeting, contact Loretta A. Carey, SUPPLEMENTARY INFORMATION: collections of information referred to in the guidance entitled ‘‘Waivers from the Center for Food Safety and Applied I. Background Requirement to Demonstrate Nutrition (HFS–820), Food and Drug Bioequivalence of Animal Drugs in Administration, 5001 Campus Dr., FDA is announcing the availability of Soluble Powder Oral Dosage Form College Park, MD 20740, 240–402–2371. a draft revised guidance for industry #171 entitled ‘‘Waivers from the Products and Type A Medicated SUPPLEMENTARY INFORMATION: Requirement to Demonstrate Articles’’ have been approved under I. Background Bioequivalence of Animal Drugs in OMB control number 0910–0575. In the Federal Register of December 1, Soluble Powder Oral Dosage Form IV. Electronic Access 2014 (79 FR 71156), we published a Products and Type A Medicated Articles.’’ This draft revised guidance Persons with access to the Internet final rule on nutrition labeling of document describes how the Center for may obtain the draft revised guidance at standard menu items in restaurants and Veterinary Medicine (CVM) intends to either http://www.fda.gov/ similar retail food establishments; the evaluate requests for waiving the AnimalVeterinary/ rule is codified at Title 21 of the Code requirement for submitting data GuidanceComplianceEnforcement/ of Federal Regulations, section 101.11. demonstrating the bioequivalence of GuidanceforIndustry/default.htm or The final rule implements section animal drugs in soluble powder oral http://www.regulations.gov. 403(q)(5)(H) of the Federal Food, Drug, dosage form products and Type A and Cosmetic Act (the FD&C Act) (21 Dated: September 9, 2016. medicated articles. It expands upon U.S.C. 343(q)(5)(H)), which, in general, Leslie Kux, requires that restaurants and similar CVM’s Bioequivalence Guidance,2 Associate Commissioner for Policy. particularly the section on Criteria for retail food establishments that are part [FR Doc. 2016–22339 Filed 9–15–16; 8:45 am] of a chain with 20 or more locations, Waiver of In Vivo Bioequivalence Study. This draft revised guidance BILLING CODE 4164–01–P doing business under the same name, document is intended to provide and offering for sale substantially the clarification of the scientific basis for same menu items, provide calorie DEPARTMENT OF HEALTH AND information for standard menu items concepts and recommendations HUMAN SERVICES conveyed in the original guidance. In (including food on display and self- addition, the table containing estimated service food); provide, upon request, Food and Drug Administration gastric volumes for each of the various additional written nutrition information animal species has been revised. [Docket No. FDA–2016–N–0001] for standard menu items; and comply However, applicants may propose an with other requirements described in Menu Labeling Public Workshop; section 403(q)(5)(H) of the FD&C Act. alternative gastric volume value for a Public Meeting particular species when using the On December 18, 2015, the President dosage adjusted approach. No new AGENCY: Food and Drug Administration, signed the Consolidated Appropriations concepts have been introduced in this HHS. Act, 2016 (Pub. L. 114–113). Section 747 draft revised guidance and its scope has ACTION: Notice of public meeting. of the Consolidated Appropriations Act not been modified. states that none of the funds made SUMMARY: The Food and Drug available under the Consolidated II. Significance of Guidance Administration (FDA or we) is Appropriations Act may be used to This level 1 draft revised guidance is announcing a third public meeting to implement, administer, or enforce the mstockstill on DSK3G9T082PROD with NOTICES being issued consistent with FDA’s good discuss menu labeling requirements. We final rule entitled ‘‘Food Labeling; announced the first two public meetings Nutrition Labeling of Standard Menu 2 CVM Guidance for Industry #35, in a separate Federal Register notice Items in Restaurants and Similar Retail ‘‘Bioequivalence Guidance,’’ November 8, 2006 (see earlier this year. The purpose of the Food Establishments’’ until 1 year after page 7): http://www.fda.gov/downloads/ AnimalVeterinary/ public meetings is to help the regulated the date of publication of a Level 1 GuidanceComplianceEnforcement/ industry comply with the requirements guidance with respect to nutrition GuidanceforIndustry/UCM052363.pdf. of the menu labeling final rule. labeling of standard menu items in VerDate Sep<11>2014 17:55 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1

Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Notices 63777 restaurants and similar retail food regulated industry, about the menu 15 minutes to help ensure that enough establishments. labeling requirements. We announced time is available to accommodate each In the Federal Register of May 5, 2016 the first two public meetings in a company that requests a consultation. (81 FR 27067), we announced the separate Federal Register notice on June We recommend that participants in the availability of the guidance for industry 15, 2016 (81 FR 39056). Interested consultation session prepare their entitled ‘‘A Labeling Guide for persons can continue to submit general questions in advance due to the limited Restaurants and Retail Establishments questions to CalorieLabeling@ time available. Selling Away-From-Home Foods—Part fda.hhs.gov. III. How To Participate in the Public II (Menu Labeling Requirements in II. Purpose and Format of the Public Meeting Accordance with 21 CFR 101.11).’’ The Meeting guidance uses a question and answer The purpose of this public meeting is We encourage all persons who wish to format and is intended to help to help the regulated industry comply attend the meeting to register in advance restaurants and similar retail food with the requirements of the menu of the meeting and to indicate whether establishments covered by the final rule labeling final rule. On the morning of they are requesting a consultation comply with the nutrition labeling day one of the meeting, we will give a session. There is no fee to register for requirements of the final rule. In slide presentation on the menu labeling the public meeting, and registration will accordance with the Consolidated requirements. (Please note the slide be on a first-come, first-served basis. Appropriations Act, 2016, enforcement presentation will only be presented on Early registration is recommended to of the final rule will commence May 5, day one.) The afternoon of day one and facilitate planning of the consultation 2017. all of day two will consist of sessions and because seating is limited. We have made education of the menu consultation sessions with FDA staff We encourage you to use electronic labeling requirements a high priority, where individual companies (limited to registration if possible (see the address and this is our third menu labeling two members per company) may discuss in table 1). workshop to educate interested their specific questions and concerns. Table 1 provides information on members of the public, especially the Each consultation session is limited to participation in the public meeting. TABLE 1—INFORMATION ON MENU LABELING MEETING Activity Date Electronic address Address Public meeting ............................... November 16 and 17, 2016, 8 ....................................................... Holiday Inn Hotel & Suites Oak- a.m. to 4:30 p.m. land Airport, 77 Hegenberger Rd., Oakland, CA 94621. Advance registration ...................... by November 9, 2016 ................... http://www.cvent.com/d/zfq6sm .... We encourage you to use elec- tronic registration if possible.1 Request special accommodations by November 9, 2016 ................... ....................................................... See FOR FURTHER INFORMA- due to a disability. TION CONTACT. 1 You may also register via mail, fax, or email. Please include your name, title, firm name, address, and phone and fax numbers in your reg- istration information and send to: Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240–316– 3207, FAX: 240–652–6002, email: rsvp@tepgevents.com. IV. Transcripts available. Individuals who plan to Any interested person may file written attend and need special assistance, such comments with the committee by forwarding Transcripts of the workshop will not the statement to the Contact Person listed on be prepared. as sign language interpretation or other this notice. The statement should include the reasonable accommodations, should Dated: September 13, 2016. name, address, telephone number and when notify the Contact Person listed below applicable, the business or professional Leslie Kux, in advance of the meeting. The meeting affiliation of the interested person. Associate Commissioner for Policy. will also be videocast and can be In the interest of security, NCI Shady Grove [FR Doc. 2016–22337 Filed 9–15–16; 8:45 am] accessed from the NIH Videocasting and has instituted stringent procedures for BILLING CODE 4164–01–P Podcasting Web site (http:// entrance into the NCI Shady Grove building. videocast.nih.gov/). Visitors will be asked to show one form of identification (for example, a government- Name of Committee: Frederick National issued photo ID, driver’s license, or passport) DEPARTMENT OF HEALTH AND Laboratory Advisory Committee to the and to state the purpose of their visit. HUMAN SERVICES National Cancer Institute. Information is also available on the Date: October 21, 2016. Institute’s/Center’s home page: http:// National Institutes of Health Time: 2:00 p.m. to 4:00 p.m. deainfo.nci.nih.gov/advisory/fac/fac.htm, Agenda: Report from the FNLAC RAS where an agenda and any additional National Cancer Institute; Notice of information for the meeting will be posted Meeting Workgroup. when available. Place: National Cancer Institute Shady Pursuant to section 10(a) of the Grove, 9609 Medical Center Drive, Room (Catalogue of Federal Domestic Assistance Federal Advisory Committee Act, as Program Nos. 93.392, Cancer Construction; mstockstill on DSK3G9T082PROD with NOTICES TE406, Rockville, MD 20850, (Virtual amended (5 U.S.C. App.), notice is 93.393, Cancer Cause and Prevention Meeting). Research; 93.394, Cancer Detection and hereby given of a virtual meeting of the Contact Person: Peter L. Wirth, Ph.D., Diagnosis Research; 93.395, Cancer Frederick National Laboratory Advisory Executive Secretary, Division of Extramural Treatment Research; 93.396, Cancer Biology Committee to the National Cancer Activities, National Cancer Institute, National Research; 93.397, Cancer Centers Support; Institute. Institutes of Health, 9609 Medical Center 93.398, Cancer Research Manpower; 93.399, The meeting will be open to the Drive, Room 7W514, Bethesda, MD 20892, Cancer Control, National Institutes of Health, public, with attendance limited to space 240–276–6434, wirthp@mail.nih.gov. HHS) VerDate Sep<11>2014 17:55 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\16SEN1.SGM 16SEN1


Document Created: 2016-09-16 00:25:24
Document Modified: 2016-09-16 00:25:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meeting.
DatesSee ``How to Participate in the Public Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for dates, times,
ContactFor questions about registering for this meeting or for special accommodations due to disability, contact Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, email: [email protected]
FR Citation81 FR 63776 
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