[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Proposed Rules]
[Pages 11893-11894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03944]


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

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.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending 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 for an extension to allow interested persons additional time 
to consider the proposal. 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 extending the comment period on the proposed rule 
published November 4, 2019 (84 FR 59452). Submit either electronic or 
written comments on the proposed rule by April 6, 2020. Submit comments 
on information collection issues under the Paperwork Reduction Act of 
1995 (PRA) by April 6, 2020 (see the ``Paperwork Reduction Act of 
1995'' section).

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 April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments

[[Page 11894]]

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, Staff Director, 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: [email protected].
    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: [email protected].

SUPPLEMENTARY INFORMATION: 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 (OMB) under the PRA (44 U.S.C. 3501-3521).
    FDA has received a request for a 30-day extension of the comment 
period on the proposed rule to allow interested persons additional time 
to consider the proposal. FDA has considered the request and is 
granting the extension of the comment period to allow interested 
persons additional opportunity to consider the proposal. 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. The Agency believes that this extension allows adequate 
time for any interested persons to fully consider the proposal and 
submit comments.

    Dated: February 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03944 Filed 2-27-20; 8:45 am]
 BILLING CODE 4164-01-P