[Federal Register Volume 89, Number 158 (Thursday, August 15, 2024)]
[Notices]
[Pages 66417-66420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3379]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Laboratory Accreditation for Analyses of Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on FDA's Laboratory Accreditation for Analyses 
of Foods (LAAF).

DATES: Either electronic or written comments on the collection of 
information must be submitted by October 15, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing

[[Page 66418]]

system will accept comments until 11:59 p.m. Eastern Time at the end of 
October 15, 2024. Comments received by mail/hand delivery/courier (for 
written/paper submissions) will be considered timely if they are 
received 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-2024-N-3379 for ``Laboratory Accreditation for Analyses of Food.'' 
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, 240-402-7500.
     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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Laboratory Accreditation for Analysis of Foods--21 CFR Part 1, Subpart 
R

OMB Control Number 0910-0898--Extension

    This information collection helps to support implementation of 
FDA's statutory and regulatory authority governing our laboratory 
accreditation for analysis of foods program under Section 422 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350k) and 21 
CFR part 1, subpart R. FDA has statutory authority to establish a 
program for the testing of food by accredited laboratories; to 
establish a publicly available registry of recognized accreditation 
bodies and laboratories recognized by an accreditation body; and to 
require reports of any changes that would affect the recognition of 
such accreditation body or the accreditation of such laboratory.
    The regulations require respondents to maintain and electronically 
submit certain test results, reports, notifications, and other records 
to FDA. The submissions can be made through the FURLS Laboratory 
Accreditation for Analyses of Foods Program portal (FDA Industry 
Systems). User guides for the Accreditation Bodies and Accredited 
Laboratories can be found at the following links: https://www.fda.gov/media/156097/download?attachment and https://www.fda.gov/media/161685/download?attachment. The laboratory accreditation program helps fulfill

[[Page 66419]]

FDA's mandate to ensure the safety of the U.S. food supply and protect 
U.S. consumers by administering appropriate oversight of certain food 
testing that is of importance to public health. It also helps ensure 
that the testing is done in accordance with appropriate model 
standards, which will help produce consistently reliable and valid test 
results. You may access additional information about the laboratory 
accreditation program at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program. The public registry is 
available at https://datadashboard.fda.gov/ora/fd/laaf.htm.
    Respondents to the information collection are accreditation bodies 
seeking recognition from FDA, recognized accreditation bodies, 
laboratories seeking accreditation from recognized accreditation 
bodies, and accredited laboratories. Participation in this program is 
voluntary for laboratories and accreditation bodies; however, only 
recognized accreditation bodies would be able to accredit laboratories 
to conduct food testing as specified in the regulations.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                   Number of
   21 CFR section; activity        Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.1113 and                      8              44             352  2.2068 (2 hours            776.8
 1.1114; Accreditation bodies                                                    and 12 minutes).
 (ABs) application for
 recognition (one-time
 submission).
Sec.  Sec.   1.1113 and
 1.1114; ABs--application for
 renewal of recognition.
Sec.   1.1123; ABs--reports,
 notifications, and
 documentation requirements.
Sec.   1.1116(a) and (b); ABs--              1               3               3  3...............               9
 notices of intent to
 relinquish, records custodian.
Sec.  Sec.   1.1138 and                    160            63.5          10,160  1.8051(1 hour             18,340
 1.1139; laboratories--                                                          and 49 minutes).
 submission of application for
 LAAF-accreditation (one-time
 submission).
Sec.  Sec.   1.1149(a) and
 1.1152(c)(1), (2);
 laboratories--submission of
 sampling plan, sample
 collection report, and
 sampler qualifications.
Sec.  Sec.   1.1152(d) and
 1.1153(a); laboratories--
 qualification to submit
 abridged analytical reports
 (one-time submission).
Sec.   1.1153; laboratories--
 abridged analytical reports
 submissions.
Sec.   1.1149(c);
 laboratories--advance notice
 of sampling submissions.
Sec.   1.1152(f);
 laboratories--immediate
 notification.
Sec.   1.1140(a);                            2               3               6  1...............               6
 laboratories--notices of
 intent to relinquish, records
 custodian.
Sec.   1.1152(c)(4) and (5);                50               5             250  1.5 (1 hour and              375
 laboratories--validation and                                                    30 minutes).
 verification studies
 submissions.
Sec.  Sec.   1.1142; 1.1171;                 1               1               1  1...............               1
 1.1173; and 1.1174; requests
 in response to FDA action.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............          10,772  ................          19,508
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.


                             Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                   Number of                     Average burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
Sec.   1.1113; recordkeeping                 8               2               8  22..............             176
 associated with ISO/IEC
 17011:2017.
Sec.   1.1124; ABs--additional
 recordkeeping requirements a
 recognized accreditation body
 must maintain, for 5 years
 after the date of creation of
 the records, records created
 while it is recognized
 demonstrating its compliance
 with this subpart.
Sec.   1.1138; laboratories--                9               1               9  91.06 (91 hours              820
 becoming accredited to ISO/                                                     and 4 minutes).
 IEC 17025:2017 (one-time);
 Laboratories adding ISO 17025
 to become LAAF-accredited.

[[Page 66420]]

 
Sec.   1.1138; laboratories--              160               2             320  450.765 (450             144,245
 maintaining ISO/IEC 17025:                                                      hours and 46
 2017 accreditation.                                                             minutes).
Sec.   1.1154; laboratories--
 additional recordkeeping
 requirements; a LAAF-
 accredited laboratory must
 maintain, for 5 years after
 the date of creation, records
 created and received while it
 is LAAF-accredited that
 relate to compliance with
 this subpart.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............             345  ................         145,241
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    The burden we attribute to reporting and recordkeeping activities 
is assumed to be distributed among the individual elements of the 
respective information collection activities. Although we have not 
received a notice of intent to relinquish records since the last 
approval of this information collection, we include one response for 
the purpose of estimating burden.
    New information technology applications have more accurately 
calculated the number of food testing laboratories seeking 
accreditation and as a result the number of respondents to the 
information collection decreased (from 170 respondents in the currently 
approved collection to 160 respondents). Consequently, we have adjusted 
our burden estimate, which results in a decrease of 227 responses and 
9,303 burden hours from the currently approved information collection.

    Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-18277 Filed 8-14-24; 8:45 am]
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