Agency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foods, 66417-66420 [2024-18277]
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
and technical issues important to FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
keeping pace with technical and
scientific developments, including in
regulatory science, input into the
Agency’s research agenda, and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency-sponsored
intramural and extramural scientific
research programs. The meeting will be
open to the public.
DATES: The meeting will be held
virtually on October 7, 2024, from 9 a.m.
to 2 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked
questions about FDA advisory
committee meetings may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Rakesh Raghuwanshi, Office of the
Chief Scientist, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring,
MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov; or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. The Science
Board to FDA will receive an update
from the New Alternative Methods
subcommittee and will hear details
about FDA’s reorganization scheduled
for implementation on October 1, 2024,
that includes significant updates to the
Office of the Chief Scientist and the
creation of a unified Human Foods
Program.
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FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link.
The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before September 30,
2024, will be provided to the committee.
Oral presentations from the public will
be scheduled between approximately 12
p.m. and 1 p.m. Eastern Time. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before September 20, 2024. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 23, 2024.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Rakesh
Raghuwanshi (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
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66417
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
Dated: August 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–18263 Filed 8–14–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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.
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• 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-201509-18/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, PRAStaff@fda.hhs.gov.
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
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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
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
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-safetymodernization-act-fsma/fda-recognizedaccreditation-bodies-laboratoryaccreditation-analyses-foods-laafprogram. 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
66419
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
§§ 1.1113 and 1.1114; Accreditation bodies
(ABs) application for recognition (one-time
submission).
§§ 1.1113 and 1.1114; ABs—application for
renewal of recognition.
§ 1.1123; ABs—reports, notifications, and
documentation requirements.
§ 1.1116(a) and (b); ABs—notices of intent
to relinquish, records custodian.
§§ 1.1138 and 1.1139; laboratories—submission of application for LAAF-accreditation (one-time submission).
§§ 1.1149(a) and 1.1152(c)(1), (2); laboratories—submission of sampling plan,
sample collection report, and sampler
qualifications.
§§ 1.1152(d) and 1.1153(a); laboratories—
qualification to submit abridged analytical
reports (one-time submission).
§ 1.1153; laboratories—abridged analytical
reports submissions.
§ 1.1149(c); laboratories—advance notice of
sampling submissions.
§ 1.1152(f); laboratories—immediate notification.
§ 1.1140(a); laboratories—notices of intent
to relinquish, records custodian.
§ 1.1152(c)(4) and (5); laboratories—validation and verification studies submissions.
§§ 1.1142; 1.1171; 1.1173; and 1.1174; requests in response to FDA action.
Total .......................................................
1 There
2 Totals
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per response
2.2068 (2 hours and 12 minutes).
Total hours
8
44
352
776.8
1
3
3
160
63.5
10,160
2
3
6
50
5
250
1
1
1
1 ............................................
1
........................
........................
10,772
...............................................
19,508
3 ............................................
1.8051(1 hour and 49 minutes).
9
18,340
1 ............................................
1.5 (1 hour and 30 minutes)
6
375
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
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21 CFR section; activity
§ 1.1113; recordkeeping associated with
ISO/IEC 17011:2017.
§ 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.
§ 1.1138; laboratories—becoming accredited
to ISO/IEC 17025:2017 (one-time); Laboratories adding ISO 17025 to become
LAAF-accredited.
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Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
8
2
8
22 ..........................................
176
9
1
9
91.06 (91 hours and 4 minutes).
820
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Federal Register / Vol. 89, No. 158 / Thursday, August 15, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
§ 1.1138; laboratories—maintaining ISO/IEC
17025: 2017 accreditation.
§ 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.
160
2
320
450.765 (450 hours and 46
minutes).
144,245
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]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Richard L. Eckert, Ph.D. (Respondent),
who was a Professor, Chair of the
Department of Biochemistry and
Molecular Biology, and Deputy Director
of the University of Maryland and
Stewart Greenebaum Comprehensive
Cancer Center, University of Maryland,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Aug 14, 2024
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Baltimore (UMB). Respondent engaged
in research misconduct in research
supported by U.S. Public Health Service
(PHS) funds, specifically National
Cancer Institute (NCI), National
Institutes of Health (NIH), grants R01
CA211909, R01 CA184027, R01
CA131074, R01 CA131064, R01
CA092201, R01 CA109196, P30
CA134274, and P30 CA043703, National
Institute of Arthritis and
Musculoskeletal and Skin Diseases
(NIAMS), NIH, grants R21 AR065266,
R01 AR046494, R01 AR053851, R01
AR060388, P30 AR039750, R01
AR041456, R01 AR049713, and R01
AR045357, National Eye Institute (NEI),
NIH, grants P30 EY011373 and T32
EY007157, and National Institute of
General Medical Sciences (NIGMS),
NIH, grant R01 GM043751. The
questioned research was included in
two (2) grant applications submitted for
PHS funds, specifically R01 CA233450–
01 and R01 CA233450–01A1 submitted
to NCI, NIH. The administrative actions,
including debarment for a period of
eight (8) years, were implemented
beginning on August 1, 2024, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Sheila Garrity, JD, MPH, MBA, Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Richard L. Eckert, Ph.D., University of
Maryland, Baltimore (UMB): Based on
the report of an investigation conducted
by UMB and additional analysis
conducted by ORI in its oversight
review, ORI found that Dr. Richard L.
Eckert (Respondent), former Professor,
Chair of the Department of Biochemistry
and Molecular Biology, and Deputy
Director of the University of Maryland
and Stewart Greenebaum
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Comprehensive Cancer Center, UMB,
engaged in research misconduct in
research supported by PHS funds,
specifically NCI, NIH, grants R01
CA211909, R01 CA184027, R01
CA131074, R01 CA131064, R01
CA092201, R01 CA109196, P30
CA134274, and P30 CA043703, NIAMS,
NIH, grants R21 AR065266, R01
AR046494, R01 AR053851, R01
AR060388, P30 AR039750, R01
AR041456, R01 AR049713, and R01
AR045357, NEI, NIH, grants P30
EY011373 and T32 EY007157, and
NIGMS, NIH, grant R01 GM043751. The
questioned research was included in
two (2) grant applications submitted for
PHS funds, specifically R01 CA233450–
01 and R01 CA233450–01A1 submitted
to NCI, NIH.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying and/
or fabricating data in the following
thirteen (13) published papers and two
(2) PHS grant applications:
• Inhibition of YAP function
overcomes BRAF inhibitor resistance in
melanoma cancer stem cells.
Oncotarget. 2017 Nov 22; 8(66):110257–
110272. doi: 10.18632/oncotarget.22628
(hereafter referred to as ‘‘Oncotarget
2017’’).
• The Bmi-1 helix-turn and ring
finger domains are required for Bmi-1
antagonism of (-) epigallocatechin-3gallate suppression of skin cancer cell
survival. Cell Signal. 2015
Jul;27(7):1336–44. doi: 10.1016/
j.cellsig.2015.03.021 (hereafter referred
to as ‘‘Cell Signal 2015’’). Erratum in:
Cell Signal. 2021 Jun;82:109952. doi:
10.1016/j.cellsig.2021.109952.
• P38d regulates p53 to control
p21Cip1 expression in human
epidermal keratinocytes. J Biol Chem.
2014 Apr 18; 289(16):11443–11453. doi:
10.1074/jbc.M113.543165 (hereafter
referred to as ‘‘J Biol Chem. 2014’’).
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
