[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
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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.
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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
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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.
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Total..................... .............. .............. 345 ................ 145,241
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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.
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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