Notice2024-30230
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation for Analyses of Foods
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 89 Issue 244 (Thursday, December 19, 2024)</title>
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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103836-103838]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30230]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3379]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 21, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
[[Page 103837]]
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0898. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="015153405275606767416765602f6969722f666e77">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Laboratory Accreditation for Analysis of Foods
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 (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. We are clarifying that the information collection includes the
use of an electronic information collection system (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: <a href="https://www.fda.gov/media/156097/download?attachment">https://www.fda.gov/media/156097/download?attachment</a> and <a href="https://www.fda.gov/media/161685/download?attachment">https://www.fda.gov/media/161685/download?attachment</a>. The laboratory accreditation program
helps fulfill 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: <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program">https://www.fda.gov/food/food-safety-modernization-act-fsma/fda-recognized-accreditation-bodies-laboratory-accreditation-analyses-foods-laaf-program</a>. The public
registry is available at <a href="https://datadashboard.fda.gov/ora/fd/laaf.htm">https://datadashboard.fda.gov/ora/fd/laaf.htm</a>.
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.
In the Federal Register of August 15, 2024 (89 FR 66417), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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.
[[Page 103838]]
\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.
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.
We calculate the number of food testing laboratories seeking
accreditation based on the number of applicants. 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: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30230 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
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