83 FR 30180 - The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 124 (June 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 124 (June 27, 2018)
| Page Range | 30180-30182 | |
| FR Document | 2018-13831 |
[Federal Register Volume 83, Number 124 (Wednesday, June 27, 2018)] [Notices] [Pages 30180-30182] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13831] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2381] The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's nutrition innovation strategy, including: A standard icon or symbol for the claim ``healthy''; a more efficient review strategy for evaluating qualified health claims; statements or claims that could facilitate innovation to promote healthful eating patterns; approaches for modernizing standards of identity; possible changes that could make ingredient information more consumer friendly; and FDA's educational campaign for consumers about the updated Nutrition Facts Label that consumers will be seeing in the marketplace. DATES: The public meeting will be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by August 27, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the Hilton Washington DC/ Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. For more information on the hotel see http://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-rockville-hotel-and-executive-meeting-ctr-IADMRHF/index.html. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. [[Page 30181]] Electronic comments must be submitted on or before August 27, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 27, 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 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-2018-N-2381 for ``FDA's Comprehensive, Multi-Year Nutrition Innovation Strategy.'' 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: For questions about registering for the meeting or to register by phone: Melissa Schroeder, SIDEM, 1775 Eye St, NW, Suite 1150, Washington, DC 20006, 240-393-4496, [email protected]. For general questions about the meeting or for special accommodations due to a disability: Juanita Yates, Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1731, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA plays a critical role in promoting public health by, among other things, ensuring that food labeling provides consumers with reliable, evidence-based information so that they can make informed choices about the foods they purchase in order to maintain and improve their health through diet and nutrition. On January 11, 2018, FDA released its 2018 Strategic Policy Roadmap (https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm591993.htm), which focuses, in part, on efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease. The roadmap highlights FDA's commitment to finding approaches to advance policies that better achieve these goals. On March 29, 2018, FDA Commissioner Dr. Scott Gottlieb, M.D. announced a comprehensive, multi-year FDA Nutrition Innovation Strategy (hereinafter the ``FDA Nutrition Innovation Strategy'') (to access the speech, visit https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm). The Nutrition Innovation Strategy seeks to promote public health through improved nutrition, encourage industry innovation to create healthy products that consumers seek, and address ways for consumers to identify those products. In implementing the Nutrition Innovation Strategy, FDA is committed to providing opportunities for public input to help with these initiatives. Early and active engagement from stakeholders and the public will help to inform FDA's thinking and policy actions. II. Topics for Discussion at the Public Meeting FDA will host a 1-day meeting to provide stakeholders and other interested persons an opportunity to have an in-depth discussion on various aspects of the FDA Nutrition Innovation Strategy and to provide input on ways to modernize FDA's approach to better protect public health while removing barriers to industry innovation. FDA expects that the topics addressed at the meeting will include the following (a more detailed agenda will be made available prior to the meeting): Considering using a standard icon to denote the claim ``healthy'' on food labels. [[Page 30182]] Creating a more efficient review strategy for evaluating qualified health claims on food labels. Discussing new or enhanced labeling statements or claims that could facilitate innovation to produce more healthful foods and more healthful consumer food choices. Modernizing the standards of identity to provide more flexibility for the development of healthier products, while making sure consumers have accurate information about these food products. Providing opportunities to make ingredient information more helpful to consumers. FDA's educational campaign for consumers about the updated Nutrition Facts Label. We invite interested parties to provide information on the above and other topics related to the FDA Nutrition Innovation Strategy. III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following website: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by July 19, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Juanita Yates (see FOR FURTHER INFORMATION CONTACT) no later than July 12, 2018. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments and requests to participate in the focused sessions. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by July 12, 2018, midnight Eastern Time. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by July 16, 2018. Speakers will be limited to making oral remarks; there will not be an opportunity to display materials such as slide shows, videos, or other media during the meeting. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Streaming Webcast of the Public Meeting: This public meeting will also be webcast. Webcast participants are asked to preregister at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Other Issues for Consideration: A summary of key information on participating in the meeting follows: Table 1--Information on Participation in the Meeting -------------------------------------------------------------------------------------------------------------------------------------------------------- Submit either Date Address Preregister Electronic address Request to make an Special electronic or oral presentation accommodations written comments -------------------------------------------------------------------------------------------------------------------------------------------------------- July 26, 2018 from 8:30 a.m. Hilton Washington July 19, 2018: https:// July 12, 2018..... July 12, 2018: Submit Comments until 5:30 p.m. EDT. DC/Rockville Closing date for www.fda.gov/Food/ closing date to to: https:// Hotel, 1750 registration. NewsEvents/ request special www.regulations.g Rockville Pike, WorkshopsMeetings accommodations ov, or Dockets Rockville, MD Conferences/ due to a Management Staff 20852. default.htm. disability. (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. -------------------------------------------------------------------------------------------------------------------------------------------------------- Dated: June 22, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13831 Filed 6-26-18; 8:45 am] BILLING CODE 4164-01-P
![30180 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices
Jeffrey M. Zirger, coordinate at least one community DC 20201, attention: Cecelia Aldridge or
Acting Chief, Information Collection Review announcement and at least one by calling (202) 795–7293 or by email
Office, Office of Scientific Integrity, Office community outreach event to inform Cecelia.Aldridge@acl.hhs.gov.
of the Associate Director for Science, Office and assist eligible American Indian, Dated: June 20, 2018.
of the Director, Centers for Disease Control Alaska Native or Native Hawaiian elders
and Prevention. Mary Lazare,
about the benefits available to them
[FR Doc. 2018–13793 Filed 6–26–18; 8:45 am] Principal Deputy Administrator.
through Medicare Part D, the Low
[FR Doc. 2018–13811 Filed 6–26–18; 8:45 am]
BILLING CODE 4163–18–P Income Subsidy, the Medicare Savings
BILLING CODE 4154–01–P
Program or Medicare prevention
benefits and screenings and counsel
DEPARTMENT OF HEALTH AND those who are eligible.
HUMAN SERVICES DEPARTMENT OF HEALTH AND
II. Award Information HUMAN SERVICES
Administration for Community Living ACL/AoA has a total budget of
Food and Drug Administration
Availability of Program Application $270,000 for the Tribes and will provide
Instructions for Tribal MIPPA Program a grant of at least $1,000 to each Older [Docket No. FDA–2018–N–2381]
Funds Americans Act Title VI Native American
grantee. ACL reserves the right to adjust The Food and Drug Administration’s
Title: Medicare Beneficiary Outreach funding levels subject to the number of Comprehensive, Multi-Year Nutrition
and Assistance Program: Funding for applications received and availability of Innovation Strategy; Public Meeting;
Title VI Native American Programs. funds. ACL/AoA will award grants of at Request for Comments
Announcement Type: Initial. least $1,000 to each Title VI Native AGENCY: Food and Drug Administration,
Funding Opportunity Number: HHS– American grantee for a period of 12 HHS.
2018–ACL–MITRB–1802. months. The example of at least $1,000
Statutory Authority: The statutory ACTION: Notice of public meeting;
per event is for illustrative purposes request for comments.
authority for grants under this program only. All expenditures must be properly
announcement is contained in documented and allowable per the SUMMARY: The Food and Drug
Subsection (a)(1)(B) of section 119 of the terms and conditions of the grant award. Administration (FDA or we) is
Medicare Improvements for Patients and The anticipated award date is on or announcing the following public
Providers Act of 2008, as amended by before September 30, 2018. meeting entitled ‘‘FDA’s
section 3306 of the Patient Protection Comprehensive, Multi-Year Nutrition
and Affordable Care Act, section 610 of III. Eligibility Criteria and Other
Innovation Strategy.’’ The purpose of
the American Taxpayer Relief Act of Requirements
the public meeting is to give interested
2012, section 1110 of the Pathway for Only current Older Americans Act persons an opportunity to discuss FDA’s
SGR Reform Act of 2013, and section Title VI Native American Program nutrition innovation strategy, including:
110 of the Protecting Access to Medicare grantees are eligible to apply for this A standard icon or symbol for the claim
Act of 2014, and section 208 of the funding opportunity. Cost Sharing or ‘‘healthy’’; a more efficient review
Medicare Access and CHIP Matching is not required. strategy for evaluating qualified health
Reauthorization Act of 2015 (MACRA). claims; statements or claims that could
Catalog of Federal Domestic IV. Submission Information
facilitate innovation to promote
Assistance (CFDA) Number: 93.071. The program instructions and one- healthful eating patterns; approaches for
Dates: The deadline date for the page application template for this modernizing standards of identity;
submission of applications is 11:59PM funding opportunity are available at possible changes that could make
EST August 17, 2018. www.grants.gov. At the website, search ingredient information more consumer
I. Funding Opportunity Description for HHS–2018–ACL–MITRB–1802. friendly; and FDA’s educational
To receive consideration, signed campaign for consumers about the
Section 110 of the Protecting Access applications must be submitted by 11:59
to Medicare Act of 2014 extended updated Nutrition Facts Label that
p.m. Eastern time on August 17, 2018. consumers will be seeing in the
funding for outreach and assistance for No applications will be accepted after
low income programs under the marketplace.
this date. Submit your signed
Medicare Improvements for Patients and application via: DATES: The public meeting will be held
Providers Act (MIPPA). Older (1) Email to MIPPA.Grants@ on July 26, 2018, from 8:30 a.m. until
Americans Act (OAA) Title VI Native acl.hhs.gov. Include the State, Name of 5:30 p.m. Eastern Time. Submit either
American Programs can fill an Tribe, and Title VI Part A Grant Number electronic or written comments on this
important role in providing valuable and the words ‘‘MIPPA Application’’ in public meeting by August 27, 2018. See
support to help eligible Native the subject line; or the SUPPLEMENTARY INFORMATION section
American elders in accessing the Low (2) Overnight mail (FedEx, UPS, or for registration date and information.
Income Subsidy program (LIS), USPS) to: Administration for ADDRESSES: The public meeting will be
Medicare Savings Program (MSP), Community Living, Office of Grants held at the Hilton Washington DC/
Medicare Part D, Medicare prevention Management, 330 C Street SW, Suite Rockville Hotel, 1750 Rockville Pike,
benefits and screenings and in assisting 1136B, Washington, DC 20201; Rockville, MD 20852. For more
beneficiaries in applying for benefits. Attention: Yi-Hsin Yan. information on the hotel see http://
daltland on DSKBBV9HB2PROD with NOTICES
The purpose of these MIPPA grants will www3.hilton.com/en/hotels/maryland/
be to help inform eligible Native V. Agency Contacts hilton-washington-dc-rockville-hotel-
American elders about these benefits. Direct inquiries regarding this funding and-executive-meeting-ctr-IADMRHF/
The Administration for Community opportunity to U.S. Department of index.html.
Living (ACL) seeks certification from Health and Human Services, You may submit comments as
OAA Title VI Native American Administration for Community Living, follows. Please note that late, untimely
programs that they will use the funds to Administration on Aging, Washington, filed comments will not be considered.
VerDate Sep<11>2014 16:58 Jun 26, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\27JNN1.SGM 27JNN1](https://thefederalregister.org/doc/83_FR_30304/page/1.svg)
![30182 Federal Register / Vol. 83, No. 124 / Wednesday, June 27, 2018 / Notices
• Creating a more efficient review Registration is free and based on received by July 12, 2018, midnight
strategy for evaluating qualified health space availability, with priority given to Eastern Time. We will determine the
claims on food labels. early registrants. Persons interested in amount of time allotted to each
• Discussing new or enhanced attending this public meeting must presenter and the approximate time
labeling statements or claims that could register by July 19, 2018, midnight each oral presentation is to begin, and
facilitate innovation to produce more Eastern Time. Early registration is will select and notify participants by
healthful foods and more healthful recommended because seating is July 16, 2018. Speakers will be limited
consumer food choices. limited; therefore, FDA may limit the to making oral remarks; there will not be
• Modernizing the standards of number of participants from each an opportunity to display materials such
identity to provide more flexibility for organization. Registrants will receive as slide shows, videos, or other media
the development of healthier products, confirmation when they have been during the meeting. No commercial or
while making sure consumers have accepted. promotional material will be permitted
accurate information about these food If you need special accommodations to be presented or distributed at the
products. due to a disability, please contact public meeting.
• Providing opportunities to make Streaming Webcast of the Public
Juanita Yates (see FOR FURTHER
ingredient information more helpful to Meeting: This public meeting will also
INFORMATION CONTACT) no later than July
consumers. be webcast. Webcast participants are
• FDA’s educational campaign for 12, 2018.
Requests for Oral Presentations: asked to preregister at https://
consumers about the updated Nutrition
During online registration you may www.fda.gov/Food/NewsEvents/
Facts Label.
We invite interested parties to provide indicate if you wish to present during a WorkshopsMeetingsConferences/
information on the above and other public comment session or participate default.htm.
topics related to the FDA Nutrition in a specific session, and which topic(s) Transcripts: Please be advised that as
Innovation Strategy. you wish to address. We will do our soon as a transcript of the public
best to accommodate requests to make meeting is available, it will be accessible
III. Participating in the Public Meeting public comments and requests to at https://www.regulations.gov. It may
Registration: To register for the public participate in the focused sessions. be viewed at the Dockets Management
meeting, please visit the following Individuals and organizations with Staff (see ADDRESSES). A link to the
website: https://www.fda.gov/Food/ common interests are urged to transcript will also be available on the
NewsEvents/WorkshopsMeetings consolidate or coordinate their internet at https://www.fda.gov/Food/
Conferences/default.htm. Please provide presentations, and request time for a NewsEvents/WorkshopsMeetings
complete contact information for each joint presentation, or submit requests for Conferences/default.htm.
attendee, including name, title, designated representatives to participate Other Issues for Consideration: A
affiliation, address, email, and in the focused sessions. All requests to summary of key information on
telephone. make oral presentations must be participating in the meeting follows:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Request to make Special Submit either electronic or
Date Address Preregister Electronic address an oral presentation accommodations written comments
July 26, 2018 from Hilton Washington July 19, 2018: Clos- https://www.fda.gov/ July 12, 2018 ......... July 12, 2018: clos- Submit Comments to: https://
8:30 a.m. until DC/Rockville ing date for reg- Food/ ing date to re- www.regulations.gov, or
5:30 p.m. EDT. Hotel, 1750 istration. NewsEvents/ quest special ac- Dockets Management Staff
Rockville Pike, WorkshopsMeeti- commodations (HFA–305), Food and Drug
Rockville, MD ngsConferences/ due to a disability. Administration, 5630 Fish-
20852. default.htm. ers Lane, Rm. 1061, Rock-
ville, MD 20852.
Dated: June 22, 2018. seventh meeting of the Tick-Borne www.hhs.gov/ash/advisory-committees/
Leslie Kux, Disease Working Group (Working tickbornedisease/meetings/index.html.
Associate Commissioner for Policy. Group) on July 24, 2018, from 10:00 a.m. FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–13831 Filed 6–26–18; 8:45 am] to 4:00 p.m., Eastern Time. The seventh James Berger, Office of HIV/AIDS and
BILLING CODE 4164–01–P meeting will be an on-line meeting held Infectious Disease Policy, Office of the
via webcast. The Working Group will Assistant Secretary for Health,
review and vote on the content of the Department of Health and Human
DEPARTMENT OF HEALTH AND five chapters that will be included in Services; via email at tickbornedisease@
HUMAN SERVICES the Working Group’s Report to hhs.gov or by phone at 202–795–7697.
Congress. SUPPLEMENTARY INFORMATION: The
Meeting of the Tick-Borne Disease Working Group invites public comment
Working Group DATES: The on-line meeting will be held on issues related to the Working Group’s
AGENCY: Office of HIV/AIDS and on July 24, 2018, from 10:00 a.m. to 4:00 charge. Comments may be provided
Infectious Disease Policy, Office of the p.m. Eastern Time. over the phone during the meeting or in
daltland on DSKBBV9HB2PROD with NOTICES
Assistant Secretary for Health, Office of ADDRESSES: This will be an on-line writing. Persons who wish to provide
the Secretary, Department of Health and comments by phone should review
meeting that is held via webcast.
Human Services. directions at https://www.hhs.gov/ash/
Members of the public may attend the
ACTION: Notice. advisory-committees/tickbornedisease/
meeting via webcast. Instructions for meetings/index.html before submitting a
SUMMARY:The Department of Health and attending this virtual meeting will be request via email at tickbornedisease@
Human Services (HHS) announces the posted prior to the meeting at: https:// hhs.gov on or before July 19, 2018.
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Document Created: 2018-11-06 09:52:27
Document Modified: 2018-11-06 09:52:27
| 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 public meeting; request for comments. | |
| Dates | The public meeting will be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. Eastern Time. Submit either electronic or written comments on this public meeting by August 27, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | For questions about registering for the meeting or to register by phone: Melissa Schroeder, SIDEM, 1775 Eye St, NW, Suite 1150, Washington, DC 20006, 240-393-4496, [email protected] | |
| FR Citation | 83 FR 30180 |
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