[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]
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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.
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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]
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