83 FR 55318 - Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; Public Hearing; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 214 (November 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 214 (November 5, 2018)
| Page Range | 55318-55323 | |
| FR Document | 2018-24126 |
[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)] [Proposed Rules] [Pages 55318-55323] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-24126] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No. FDA-2018-N-3952] Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; Public Hearing; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies. DATES: The public hearing will be held on December 5, 2018, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons seeking to present at the public hearing must register by Friday, November 23, 2018. Persons seeking to attend, but not present at, the public hearing must register by Monday, December 3, 2018. Section II provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until Wednesday, January 2, 2019. ADDRESSES: The public hearing will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room A, Silver Spring, MD 20993-0002. Entrance for public hearing participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 Wednesday, January 2, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of Wednesday, January 2, 2019. 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. 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 [[Page 55319]] 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-3952 for ``Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; Public Hearing; Request 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 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.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the received electronic and written/paper comments, 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: Theresa Wells, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1202, Silver Spring, MD 20993, 703-380-3900, Theresa.wells@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Nearly all tobacco product use begins during youth and young adulthood (Ref. 1). While the current use of any tobacco product among U.S. middle and high school students has decreased from 2011-2017, there has been an alarming increase in e-cigarette use over this time. In fact, since 2014, e-cigarettes \1\ have been the most commonly used tobacco products among youth, used by 1.73 million (11.7 percent) high school students and 390,000 (3.3 percent) middle school students in 2017 (Ref. 2). Youth e-cigarette use raises a number of health concerns including risk of addiction to nicotine early on in life, potential harm to the developing adolescent brain, and exposure to chemicals including carbonyl compounds and volatile organic compounds known to have adverse health effects; the full range of possible health effects is not yet completely understood (Ref. 3). --------------------------------------------------------------------------- \1\ An e-cigarette is one type of electronic nicotine delivery system, which also includes e-cigars, e-hookah, vape pens, personal vaporizers, and electronic pipes. See https://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm and Ref. 2. --------------------------------------------------------------------------- On April 24, 2018, FDA announced its Youth Tobacco Prevention Plan. This plan focuses on three key strategies: Prevention of youth access to tobacco products, curbing the marketing of tobacco products aimed at youth, and educating teens about the dangers of using any tobacco products.\2\ FDA recently launched an expansion of its ``The Real Cost'' campaign to educate youth on the dangers of e-cigarette use \3\ and increased enforcement actions to address this critically important public health concern.\4\ --------------------------------------------------------------------------- \2\ https://www.fda.gov/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm. \3\ https://www.fda.gov/tobaccoproducts/publichealtheducation/publiceducationcampaigns/therealcostcampaign/default.htm. \4\ https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm. --------------------------------------------------------------------------- In addition to the prevention of initiation, which will be the cornerstone of any successful effort to curb youth e-cigarette use, FDA is also exploring additional approaches to address youth e-cigarette use. One such approach may be the development of drug therapies, as part of multimodal treatment strategies, including behavioral interventions, to support tobacco product cessation. To date, research on youth tobacco product cessation has been limited and focused on smoking (i.e., combustible products) cessation. One recent review found a paucity of data on either behavioral or drug therapies for smoking cessation in young people (age less than 20 years) and concluded that ``there continues to be a need for well-designed, adequately powered, randomized controlled trials of interventions for this population of smokers'' (Ref. 4). FDA is not aware of any research examining either drug or behavioral interventions for the cessation of youth or adult e- cigarette use. In contrast, there is a large body of research on adult smoking cessation, and multiple drugs for smoking cessation are approved for the adult population, including a variety of prescription and over-the-counter nicotine replacement therapy (NRT) products, as well as the prescription drugs varenicline and bupropion hydrochloride sustained release (see Appendix A). II. Purpose and Scope of the Public Hearing FDA is holding a public hearing to obtain the public's perspectives on the potential role drug therapies may play in the broader effort to eliminate youth e-cigarette and other tobacco product use, as well as the appropriate methods and study designs for evaluating youth e- cigarette cessation therapies and the safety and efficacy of such therapies. The Agency has determined that a public hearing is the most appropriate way to ensure public engagement on this issue, which is of great importance to the public health. FDA believes it is critical to obtain input across the medical and research fields, the pharmaceutical and tobacco industries, and among public health stakeholders (including adolescents) regarding approaches to eliminate youth e-cigarette and other tobacco product use, including exploring whether there is a need for drug therapies to support youth e-cigarette cessation, and if so, how FDA [[Page 55320]] can support the development of such therapies. Questions for Commenters To Address Considering the broad range of activities focused on this public health issue, FDA is interested in the public's view on approaches to eliminating e-cigarette and other tobacco product use among youth. Although FDA welcomes all feedback on any public health, scientific, regulatory or legal considerations relating to this topic, we particularly encourage commenters to consider the following questions as they prepare their comments or statements. Responses to questions should include supporting scientific justification. 1. FDA notes that the factors driving e-cigarette use among youth likely differ from those in the adult population. How might such differences impact the need for, or use of, drug therapies for e- cigarette cessation among youth? 2. FDA is interested in whether there is a population of youth e- cigarette users who would be likely to benefit from the use of drug therapies for e-cigarette cessation. What age groups (older adolescent vs. younger adolescent), patterns in tobacco use (duration and frequency of use), and clinical features (level of addiction, presence/ absence of comorbidities including psychiatric disease) might characterize this population? What types of products (NRT vs. non-NRT; prescription vs. over-the-counter) might be useful? 3. Describe the scientific, clinical, and societal factors that could either encourage or impede the conduct of clinical trials designed to evaluate drugs intended for youth e-cigarette cessation. What approaches could be used to encourage research and overcome barriers to research? 4. What methods and study designs are appropriate for assessing drug therapies for youth e-cigarette cessation? What are the appropriate control groups? What are the most informative endpoints and the best assessment tools to evaluate these endpoints? 5. Acknowledging that to date research has been limited, are there data available from the adult experience with smoking cessation that could potentially be leveraged in the effort to develop drug therapies for youth e-cigarette cessation? Have any drug therapies demonstrated potential to help adults discontinue e-cigarette use? Are there differences between adolescents and adults that impact the ability to extrapolate efficacy findings from the adult population to the adolescent population? Could existing NRT products be useful for youth e-cigarette cessation? 6. While this hearing is focused on the topic of e-cigarette use among youth, as e-cigarettes are currently the most commonly used form of tobacco in this population, FDA also welcomes comments regarding the potential need for drug therapies to support cessation of other tobacco products, including combustible products (i.e., cigarettes or cigars) and smokeless tobacco products, among youth and the issues impacting the development of such therapies. Registration and Requests for Oral Presentations: The FDA Conference Center at the White Oak location is a Federal facility with security procedures and limited seating. Attendance will be free and on a first-come, first-served basis. For those interested in presenting at the meeting, either with a formal oral presentation or as a speaker in the open public hearing session, please register by Friday, November 23, 2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. If you wish to attend either in person or by Webcast (see Streaming Webcast of the Public Hearing), please register for the hearing by Monday December 3, 2018, at https://www.eventbrite.com/e/fda-pediatric-tobacco-cessation-part-15-public-hearing-tickets-50167147288. Those without internet or email access can register and/or request to participate as an open public hearing speaker or a formal presenter by contacting Theresa Wells by the above dates (see FOR FURTHER INFORMATION CONTACT). FDA will try to accommodate all persons who wish to make a presentation. Formal oral presenters may use an accompanying slide deck, while those participating in the Open Public Hearing will have less allotted time than formal oral presenters and will deliver oral testimony only (no accompanying slide deck). Individuals wishing to present should identify the number of the specific question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. Individual organizations are limited to a single presentation slot. FDA will notify registered presenters of their scheduled presentation times. The time allotted for each presentation will depend on the number of individuals who wish to speak. Registered presenters making a formal oral presentation are encouraged to submit an electronic copy of their presentation (PowerPoint or PDF) to OMPTFeedback@fda.hhs.gov with the subject line ``Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies'' on or before Wednesday, November 28, 2018. Persons registered to present are encouraged to arrive at the hearing room early and check in at the onsite registration table to confirm their designated presentation time. Actual presentation times, however, may vary based on how the meeting progresses in real-time. An agenda for the hearing and any other background materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm620744.htm. If you need special accommodations because of a disability, please contact Theresa Wells (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the hearing. Streaming Webcast of the Public Hearing: For those unable to attend in person, FDA will provide a live Webcast of the hearing. To join the hearing via the Webcast, please go to https://collaboration.fda.gov/ptc120518. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Dockets Management Staff (see Comments). A transcript will also be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's website at https://www.fda.gov. III. Notice of Hearing Under 21 CFR Part 15 The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with 21 CFR part 15. The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner, the Center for Drug Evaluation and Research, and the Center for Tobacco Products. Under Sec. 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members can pose questions; they can question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C). Under Sec. 10.205, representatives of the media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public [[Page 55321]] administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in Sec. 15.30(b) (see Transcripts). To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in Sec. 15.30(h). IV. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1.* U.S. Department of Health and Human Services (2014). ``The Health Consequences of Smoking--50 Years of Progress: A Report of the Surgeon General.'' Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health available at: https://www.surgeongeneral.gov/library/reports/50-years-of-progress/index.html. 2.* Wang T.W., A. Gentzke, S. Sharapova, et al. (2018). ``Tobacco Product Use Among Middle and High School Students--United States, 2011-2017.'' Morbidity and Mortality Weekly Report (MMWR) 67:629- 633, available at https://www.cdc.gov/mmwr/volumes/67/wr/mm6722a3.htm). 3.* U.S. Department of Health and Human Services (2016). ``E- Cigarette Use Among Youth and Young Adults: A Report of the Surgeon General.'' Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health available at: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf. 4. Fanshawe T.R., W. Halliwell, N. Lindson, et al. (2017). ``Tobacco Cessation Interventions for Young People.'' Cochrane Database of Systematic Reviews, Rev.11:CD003289, available at https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003289.pub6/epdf/full. BILLING CODE 4164-01-P [GRAPHIC] [TIFF OMITTED] TP05NO18.010 [[Page 55322]] [GRAPHIC] [TIFF OMITTED] TP05NO18.011 [[Page 55323]] Dated: October 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-24126 Filed 11-2-18; 8:45 am] BILLING CODE 4164-01-C
![55318 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Proposed Rules
must be tested (Aviation flight crew are not required to apply drug testing to November 23, 2018. Persons seeking to
members and air traffic controllers); any applicants for whom the only attend, but not present at, the public
(c) An occupation identified in 49 suitable work is available in any or all hearing must register by Monday,
CFR 382.103 by the Federal Motor of the occupations listed. December 3, 2018. Section II provides
Carrier Safety Administration, in which (c) No State is required to drug test attendance and registration information.
the employee must be tested UC applicants under this part 620. Electronic or written comments will be
(Commercial drivers); accepted after the public hearing until
(d) An occupation identified in 49 § 620.5 Conformity and substantial
Wednesday, January 2, 2019.
compliance.
CFR 219.3 by the Federal Railroad ADDRESSES: The public hearing will be
Administration, in which the employee (a) In general. A State law
held at the FDA White Oak Campus,
must be tested (Railroad operating crew implementing the drug testing of
10903 New Hampshire Ave., Building
members); applicants for unemployment
31 Conference Center, the Great Room
(e) An occupation identified in 49 compensation must conform with—and
A, Silver Spring, MD 20993–0002.
CFR 655.3 by the Federal Transit the law’s administration must
Entrance for public hearing participants
Administration, in which the employee substantially comply with—the
(non-FDA employees) is through
must be tested (Public transportation requirements of this part 620 for
Building 1, where routine security
operators); purposes of certification under 42
check procedures will be performed. For
(f) An occupation identified in 49 CFR U.S.C. 502(a), governing State eligibility
parking and security information, please
199.2 by the Pipeline and Hazardous to receive Federal grants for the
refer to https://www.fda.gov/AboutFDA/
Materials Safety Administration, in administration of its UC program.
WorkingatFDA/BuildingsandFacilities/
which the employee must be tested (b) Resolving Issues of Conformity and
WhiteOakCampusInformation/
(Pipeline operation and maintenance Substantial Compliance. For the
ucm241740.htm.
crew members); purposes of resolving issues of
conformity and substantial compliance You may submit comments as
(g) An occupation identified in 46 follows. Please note that late, untimely
CFR 16.201 by the United States Coast with the requirements of this part 620,
the provisions of 20 CFR 601.5 apply. filed comments will not be considered.
Guard, in which the employee must be Electronic comments must be submitted
tested (Crewmembers and maritime Molly E. Conway, on or before Wednesday, January 2,
credential holders on a commercial 2019. The https://www.regulations.gov
Acting Assistant Secretary for Employment
vessel); and Training, Labor . electronic filing system will accept
(h) An occupation specifically
[FR Doc. 2018–23952 Filed 11–2–18; 8:45 am] comments until 11:59 p.m. Eastern Time
identified in Federal law as requiring an
BILLING CODE 4510–FW–P at the end of Wednesday, January 2,
employee to be tested for controlled
2019. Comments received by mail/hand
substances;
delivery/courier (for written/paper
(i) An occupation specifically
DEPARTMENT OF HEALTH AND submissions) will be considered timely
identified in the State law of that State
HUMAN SERVICES if they are postmarked or the delivery
as requiring an employee to be tested for
service acceptance receipt is on or
controlled substances; and
(j) An occupation where the State has Food and Drug Administration before that date. You may submit
a factual basis for finding that comments as follows:
employers hiring employees in that 21 CFR Part 15
Electronic Submissions
occupation conduct pre- or post-hire [Docket No. FDA–2018–N–3952]
Submit electronic comments in the
drug testing as a standard eligibility
Eliminating Youth Electronic Cigarette following way:
requirement for obtaining or
and Other Tobacco Product Use: The • Federal eRulemaking Portal:
maintaining employment in the
Role for Drug Therapies; Public https://www.regulations.gov. Follow the
occupation.
Hearing; Request for Comments instructions for submitting comments.
§ 620.4 Testing of unemployment Comments submitted electronically,
compensation applicants for the unlawful AGENCY: Food and Drug Administration, including attachments, to https://
use of a controlled substance. HHS. www.regulations.gov will be posted to
(a) States may require drug testing for ACTION: Notification of public hearing; the docket unchanged. Because your
unemployment compensation request for comments. comment will be made public, you are
applicants, as defined in § 620.2, for the solely responsible for ensuring that your
unlawful use of one or more controlled SUMMARY: The Food and Drug comment does not include any
substances, as defined in § 620.2, as a Administration (FDA or the Agency) is confidential information that you or a
condition of eligibility for announcing a public hearing to discuss third party may not wish to be posted,
unemployment compensation, if the its efforts to eliminate youth electronic such as medical information, your or
individual is one for whom suitable cigarette (e-cigarette) use as well as anyone else’s Social Security number, or
work, as defined in State law, as defined other tobacco product use, with a focus confidential business information, such
in § 620.2 of, is only available in an on the potential role of drug therapies as a manufacturing process. Please note
occupation that regularly conducts drug to support youth e-cigarette cessation that if you include your name, contact
testing as identified under § 620.3. and the issues impacting the information, or other information that
(b) A State conducting drug testing as development of such therapies. identifies you in the body of your
a condition of unemployment DATES: The public hearing will be held comments, that information will be
compensation eligibility, as provided in on December 5, 2018, from 9 a.m. to 5 posted on https://www.regulations.gov.
paragraph (a) of this section, may only p.m. The public hearing may be • If you want to submit a comment
elect to require drug testing of extended or may end early depending with confidential information that you
applicants for whom the only suitable on the level of public participation. do not wish to be made available to the
work is available in one or more of the Persons seeking to present at the public public, submit the comment as a
occupations listed under § 620.3. States hearing must register by Friday, written/paper submission and in the
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![Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Proposed Rules 55323
Dated: October 30, 2018. • Federal eRulemaking Portal: with a heading or cover note that states
Leslie Kux, https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
Associate Commissioner for Policy. instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ We
[FR Doc. 2018–24126 Filed 11–2–18; 8:45 am] Comments submitted electronically, will review this copy, including the
BILLING CODE 4164–01–C including attachments, to https:// claimed confidential information, in our
www.regulations.gov will be posted to consideration of comments. The second
the docket unchanged. Because your copy, which will have the claimed
DEPARTMENT OF HEALTH AND comment will be made public, you are confidential information redacted/
HUMAN SERVICES solely responsible for ensuring that your blacked out, will be available for public
comment does not include any viewing and posted on https://
Food and Drug Administration confidential information that you or a www.regulations.gov. Submit both
third party may not wish to be posted, copies to the Dockets Management Staff.
21 CFR Part 101 such as medical information, your or If you do not wish your name and
[Docket No. FDA–2018–D–1459] anyone else’s Social Security number, or contact information to be made publicly
confidential business information, such available, you can provide this
Food Labeling: Serving Sizes of Foods as a manufacturing process. Please note information on the cover sheet and not
That Can Reasonably Be Consumed at that if you include your name, contact in the body of your comments and you
One Eating Occasion, Reference information, or other information that must identify this information as
Amounts Customarily Consumed, identifies you in the body of your ‘‘confidential.’’ Any information marked
Serving Size-Related Issues, Dual- comments, that information will be as ‘‘confidential’’ will not be disclosed
Column Labeling, and Miscellaneous posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
Topics; Draft Guidance for Industry; • If you want to submit a comment and other applicable disclosure law. For
Availability with confidential information that you more information about FDA’s posting
do not wish to be made available to the of comments to public dockets, see 80
AGENCY: Food and Drug Administration, public, submit the comment as a FR 56469, September 18, 2015, or access
HHS. written/paper submission and in the the information at: https://www.gpo.gov/
ACTION: Notification of availability. manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions Docket: For access to the docket to
announcing the availability of a draft read background documents or the
Submit written/paper submissions as
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follows:
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• Mail/Hand Delivery/Courier (for
Can Reasonably Be Consumed At One www.regulations.gov and insert the
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Eating Occasion, Reference Amounts docket number, found in brackets in the
Management Staff (HFA–305), Food and
Customarily Consumed, Serving Size- heading of this document, into the
Drug Administration, 5630 Fishers
Related Issues, Dual-Column Labeling, ‘‘Search’’ box and follow the prompts
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and Miscellaneous Topics.’’ The draft • For written/paper comments and/or go to the Dockets Management
guidance, when finalized, will provide submitted to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
questions and answers on topics related Staff, FDA will post your comment, as Rockville, MD 20852.
primarily to implementing two final well as any attachments, except for You may submit comments on any
rules, one entitled ‘‘Food Labeling: information submitted, marked and guidance at any time (see 21 CFR
Serving Sizes of Foods That Can identified, as confidential, if submitted 10.115(g)(5)).
Reasonably Be Consumed At One Eating as detailed in ‘‘Instructions.’’ Submit written requests for single
Occasion; Dual-Column Labeling; Instructions: All submissions received copies of the draft guidance to the Office
Updating, Modifying, and Establishing must include the Docket No. FDA– of Nutrition and Food Labeling, Center
Certain Reference Amounts Customarily 2018–D–1459 for ‘‘Food Labeling: for Food Safety and Applied Nutrition,
Consumed; Serving Size for Breath Serving Sizes of Foods That Can Food and Drug Administration, 5001
Mints; and Technical Amendments,’’ Reasonably Be Consumed At One Eating Campus Dr., College Park, MD 20740.
and the other entitled ‘‘Food Labeling: Occasion, Reference Amounts Send two self-addressed adhesive labels
Revision of the Nutrition and Customarily Consumed, Serving Size- to assist that office in processing your
Supplement Facts Labels.’’ This draft Related Issues, Dual-Column Labeling, request. See the SUPPLEMENTARY
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issues for dual-column labeling, Guidance for Industry.’’ Received access to the draft guidance.
products that have limited space for comments will be placed in the docket FOR FURTHER INFORMATION CONTACT:
nutrition labeling, and additional issues and, except for those submitted as Jillonne Kevala, Center for Food Safety
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written comments on the draft guidance or at the Dockets Management Staff College Park, MD 20740, 240–402–1450.
by January 4, 2019 to ensure that we between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION:
consider your comment on the draft through Friday.
• Confidential Submissions—To I. Background
guidance before we begin work on the
final version of the guidance. submit a comment with confidential We are announcing the availability of
ADDRESSES: You may submit comments information that you do not wish to be a draft guidance for industry entitled
on any guidance at any time as follows: made publicly available, submit your ‘‘Food Labeling: Serving Sizes of Foods
comments only as a written/paper That Can Reasonably Be Consumed At
Electronic Submissions submission. You should submit two One Eating Occasion, Reference
Submit electronic comments in the copies total. One copy will include the Amounts Customarily Consumed,
following way: information you claim to be confidential Serving Size-Related Issues, Dual-
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Document Created: 2018-11-03 00:28:07
Document Modified: 2018-11-03 00:28:07
| 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 | Notification of public hearing; request for comments. | |
| Dates | The public hearing will be held on December 5, 2018, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons seeking to present at the public hearing must register by Friday, November 23, 2018. Persons seeking to attend, but not present at, the public hearing must register by Monday, December 3, 2018. Section II provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until Wednesday, January 2, 2019. | |
| Contact | Theresa Wells, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1202, Silver Spring, MD 20993, 703-380-3900, [email protected] | |
| FR Citation | 83 FR 55318 |
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