Document ID: FDA-2019-N-3325-0088
Agency: fda
Document Type: Proposed Rule
Title: Laboratory Accreditation for Analyses of Foods; Extension of Comment
Period
Posted Date: 2020-04-06T04:00Z

[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