[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Proposed Rules]
[Pages 21795-21796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08182]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 130

[Docket No. FDA-1995-N-0062]


Food Standards; General Principles and Food Standards 
Modernization; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the proposed rule that appeared in the Federal 
Register of May 20, 2005. The proposed rule, entitled ``Food Standards; 
General Principles and Food Standards Modernization,'' would establish 
a set of general principles for food standards for FDA to use when 
considering whether to establish, revise, or eliminate a food standard. 
The proposed rule was issued jointly with the U.S. Department of 
Agriculture (USDA) and, while FDA will continue to engage with USDA 
regarding the proposed rule, we are extending the comment period to 
allow interested persons additional time to submit comments.

DATES: We are extending the comment period on the proposed rule that 
published in the Federal Register of May 20, 2005 (70 FR 29214). Submit 
either electronic or written comments by July 20, 2020.

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 July 20, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 20, 2020. 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-1995-N-0062 for ``General Principles and Food Standards 
Modernization; Reopening of the Comment Period.'' 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://

[[Page 21796]]

www.govinfo.gov/content/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: Rumana Yasmeen, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-6060.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 2005 (70 
FR 29214), FDA and USDA jointly issued a proposed rule entitled ``Food 
Standards; General Principles and Food Standards Modernization,'' as a 
first step in instituting a process to modernize FDA definitions and 
standards of identity (and standards of quality and fill of container) 
consistent with section 401 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 341), and USDA's definitions and standards of identity or 
composition under the Federal Meat Inspection Act and the Poultry 
Products Inspection Act (21 U.S.C. 607(c) and 457(b)) (and standards of 
fill of container). The proposed rule, if finalized, would establish 
general principles that FDA and USDA would consider when determining 
whether to establish, revise, or eliminate a food standard.
    Interested persons were originally given until August 18, 2005, to 
comment on the proposed rule. In the Federal Register of February 21, 
2020 (85 FR 10107), we announced that we were reopening the comment 
period for an additional 60 days so that we could receive new data, 
information, or further comments only on FDA-specific aspects of the 
proposed rule, including 13 general principles which we would consider 
when establishing, revising, or eliminating a food standard. The 
reopened comment period was scheduled to end on April 21, 2020.
    We have received requests for an extension of the comment period 
for the proposed rule, which conveyed concern that the current 60-day 
comment period does not allow sufficient time to develop a meaningful 
or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 90 days, until July 20, 2020. We believe that 
a 90-day extension allows adequate time for interested persons to 
submit comments without significantly delaying rulemaking on these 
important issues.

    Dated: April 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-08182 Filed 4-17-20; 8:45 am]
 BILLING CODE 4164-01-P