Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period, 58775-58776 [2018-25347]

Download as PDF Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices Board of Governors of the Federal Reserve System, November 15, 2018. Yao-Chin Chao, Assistant Secretary of the Board. [FR Doc. 2018–25338 Filed 11–20–18; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities, President’s Committee for People With Intellectual Disabilities Administration for Community Living, HHS. ACTION: Notice. AGENCY: The President’s Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee’s 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format. DATES: Webinar/Conference Call: Wednesday, December 5, 2018 from 9:00 a.m. to 10:00 a.m. (EST). FOR FURTHER INFORMATION CONTACT: Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202–795–7334. Fax: 202–795–7334. Email: Allison.Cruz@ acl.hhs.gov. SUMMARY: The purpose of this virtual meeting is to discuss the Committee’s preparation of the PCPID 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. Webinar/Conference Call: The webinar/conference call is scheduled for Wednesday, December 5, 2018, 9:00 a.m. to 10:00 a.m. (EST) and may end early if discussions are finished. Instructions to Participate in the Webinar/Conference Call on Wednesday, December 5, 2018: Please dial: (888) 949–2790; Pass Code: 1989852 Background Information on the Committee: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) khammond on DSK30JT082PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expanding employment opportunities; (B) connecting people to services; (C) supporting families and caregivers; (D) strengthening the networks; and (E) protecting rights and preventing abuse. Dated: November 15, 2018. Julie Hocker, Commissioner, Administration on Disabilities (AoD). [FR Doc. 2018–25375 Filed 11–20–18; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3522] Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of September 28, 2018. In the notice, FDA invited interested parties to provide information on specific topics related to the labeling of plant-based products with names that include the names of dairy foods such as ‘‘milk,’’ ‘‘cultured milk,’’ ‘‘yogurt,’’ and ‘‘cheese.’’ We are extending the comment period to give interested parties more time to comment. DATES: FDA is extending the comment period on the notice published in the Federal Register of September 28, 2018 (83 FR 49103). Submit either electronic or written comments by January 28, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 28, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery SUMMARY: PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 58775 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–3522 for ‘‘Use of the Names of Dairy Foods in the Labeling of PlantBased Products.’’ 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 E:\FR\FM\21NON1.SGM 21NON1 khammond on DSK30JT082PROD with NOTICES 58776 Federal Register / Vol. 83, No. 225 / Wednesday, November 21, 2018 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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: Mabel Lee, Center Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2371. SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 2018 (83 FR 49103), FDA published a notice with a 60-day comment period inviting interested parties to provide information on specific topics related to the labeling of plant-based products with names that include the names of dairy foods such as ‘‘milk,’’ ‘‘cultured milk,’’ ‘‘yogurt,’’ and ‘‘cheese.’’ The information will inform our development of an approach to the labeling of plant-based products that consumers may substitute for dairy foods. We asked that comments be submitted by November 27, 2018. We have received requests for a 120day extension of the comment period for the notice. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to the questions VerDate Sep<11>2014 16:08 Nov 20, 2018 Jkt 247001 that appeared in the notice requesting data and other evidence in support of answers. We have considered the requests and are extending the comment period for another 60 days, until January 28, 2019. We believe that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying any potential further action on these important issues. Dated: November 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–25347 Filed 11–20–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0500] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 21, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0572. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products OMB Control Number 0910–0572— Extension FDA’s regulations governing the content and format of labeling for human prescription drug and biological products were revised in the Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling rule) to require that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements. These revisions were intended to make it easier for health care practitioners to access, read, and use information in prescription drug labeling; to enhance the safe and effective use of prescription drug products; and to reduce the number of adverse reactions resulting from medication errors because of misunderstood or incorrectly applied drug information. Currently, § 201.56 (21 CFR 201.56) requires that prescription drug labeling contain certain information in the format specified in either § 201.57 (21 CFR 201.57) or § 201.80 (21 CFR 201.80), depending on when the drug was approved for marketing. Section 201.56(a) sets forth general labeling requirements applicable to all prescription drugs. Section 201.56(b) specifies the categories of new and more recently approved prescription drugs subject to the revised content and format requirements in §§ 201.56(d) and 201.57. Section 201.56(c) sets forth the schedule for implementing these revised content and format requirements. Section 201.56(e) specifies the sections and subsections, required and optional, for the labeling of older prescription drugs not subject to the revised format and content requirements. Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include a ‘‘Highlights of Prescribing Information’’ section. The ‘‘Highlights’’ section provides a concise extract of the most important information required under § 201.57(c) (the Full Prescribing Information (FPI)), as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to E:\FR\FM\21NON1.SGM 21NON1

Agencies

[Federal Register Volume 83, Number 225 (Wednesday, November 21, 2018)]
[Notices]
[Pages 58775-58776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25347]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3522]


Use of the Names of Dairy Foods in the Labeling of Plant-Based 
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice that appeared in the Federal Register of 
September 28, 2018. In the notice, FDA invited interested parties to 
provide information on specific topics related to the labeling of 
plant-based products with names that include the names of dairy foods 
such as ``milk,'' ``cultured milk,'' ``yogurt,'' and ``cheese.'' We are 
extending the comment period to give interested parties more time to 
comment.

DATES: FDA is extending the comment period on the notice published in 
the Federal Register of September 28, 2018 (83 FR 49103). Submit either 
electronic or written comments by January 28, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 28, 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.

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-3522 for ``Use of the Names of Dairy Foods in the Labeling 
of Plant-Based Products.'' 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

[[Page 58776]]

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.gpo.gov/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: Mabel Lee, Center Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28, 
2018 (83 FR 49103), FDA published a notice with a 60-day comment period 
inviting interested parties to provide information on specific topics 
related to the labeling of plant-based products with names that include 
the names of dairy foods such as ``milk,'' ``cultured milk,'' 
``yogurt,'' and ``cheese.'' The information will inform our development 
of an approach to the labeling of plant-based products that consumers 
may substitute for dairy foods. We asked that comments be submitted by 
November 27, 2018.
    We have received requests for a 120-day extension of the comment 
period for the notice. The requests conveyed concern that the current 
60-day comment period does not allow sufficient time to develop 
meaningful or thoughtful responses to the questions that appeared in 
the notice requesting data and other evidence in support of answers.
    We have considered the requests and are extending the comment 
period for another 60 days, until January 28, 2019. We believe that a 
60-day extension allows adequate time for interested persons to submit 
comments without significantly delaying any potential further action on 
these important issues.

    Dated: November 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25347 Filed 11-20-18; 8:45 am]
BILLING CODE 4164-01-P
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