[Federal Register Volume 85, Number 66 (Monday, April 6, 2020)]
[Proposed Rules]
[Pages 19114-19116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07171]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 11, 16, and 129
[Docket No. FDA-2019-N-3325]
RIN 0910-AH31
Laboratory Accreditation for Analyses of Foods; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period for the proposed
rule and for its information collection provisions.
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SUMMARY: The Food and Drug Administration (FDA or we) is
[[Page 19115]]
extending for a second time the comment period for the proposed rule,
and for the information collection related to the proposed rule,
entitled ``Laboratory Accreditation for Analyses of Foods'' that
appeared in the Federal Register of November 4, 2019. We are taking
this action in response to a request from several food industry
associations to extend open comment periods while their members focus
on continuity of critical infrastructure operations due to the recent
COVID-19 public health declaration. We also are taking this action to
keep the comment period for the information collection provisions
associated with the rule consistent with the comment period for the
proposed rule.
DATES: FDA is further extending the comment period on the proposed rule
published November 4, 2019 (84 FR 59452), which was first extended
February 28, 2020 (85 FR 11893). Submit either electronic or written
comments on the proposed rule by July 6, 2020. Submit comments on
information collection issues under the Paperwork Reduction Act of 1995
(PRA) by July 6, 2020 (see the ``Paperwork Reduction Act of 1995''
section of the proposed rule).
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 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 6, 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-2019-N-3325 for ``Laboratory Accreditation for Analyses of Foods.''
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.'' 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.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: Timothy McGrath, Food and Feed
Laboratory Operations, Office of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr., Rm. 3142, Rockville, MD 20857, 301-
796-6591, email: timothy.mcgrath@fda.hhs.gov.
With regard to the information collection: Domini Bean, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
email: PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 4, 2019 (84 FR 59452), we
published a proposed rule entitled ``Laboratory Accreditation for
Analyses of Foods'' with a 120-day comment period on the provisions of
the proposed rule and on the information collection provisions that are
subject to review by the Office of Management and Budget under the PRA
(44 U.S.C. 3501-3521). In the Federal Register of February 28, 2020 (85
FR 11893), we published an extension of the comment period for the
proposed rule, and for the information collection related to the
proposed rule, until April 6, 2020. The purpose of the first extension
was to allow interested persons an additional opportunity to consider
the proposal.
After we extended the comment period by 30 days, the outbreak of
COVID-19, the disease caused by the novel coronavirus, caused the World
Health Organization to declare a global pandemic.\1\ The President
subsequently proclaimed that the COVID-19 outbreak in the United States
constitutes a
[[Page 19116]]
national emergency.\2\ Soon thereafter the U.S. Department of Homeland
Security Cybersecurity and Infrastructure Security Agency issued
guidance identifying, for the COVID-19 pandemic, which infrastructure
sectors are critical to maintain necessary services and functions; one
is the food and agriculture sector.\3\
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\1\ See https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.
\2\ See https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
\3\ See https://www.cisa.gov/identifying-critical-infrastructure-during-covid-19.
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FDA has received a request for a 120-day extension of all open
comment periods for food-related proposed regulations, draft guidance
documents, and Federal Register notices to allow the food industry to
focus its efforts on COVID-19 response efforts and assuring that food
production continues without pause (Ref. 1). FDA has considered the
request in light of the role of the Food and Agriculture Sector in
maintaining critical infrastructure and recognizing that the comment
period currently is scheduled to close during the acute response to
COVID-19. We have concluded that it is reasonable to extend for
approximately 90 days the comment period for the Laboratory
Accreditation for Analyses of Foods proposed rule. The Agency believes
that this extension, together with the original 30-day extension,
allows adequate time for any interested persons to consider the
proposal fully and submit comments. We also are extending the comment
period for the information collection provisions to make the comment
period for the information collection provisions the same as the
comment period for the provisions of the proposed rule. To clarify, FDA
is requesting comment on all issues raised by the proposed rule.
II. Reference
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov.
1. Letter from Food & Beverage Issue Alliance to Frank Yiannas,
Deputy Commissioner for Food Policy and Response, and Susan T.
Mayne, Director of the Center for Food Safety and Applied Nutrition,
March 23, 2020.
Dated: April 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07171 Filed 4-3-20; 8:45 am]
BILLING CODE 4164-01-P