Agency Information Collection Activities; Proposed Collection; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water, 59742-59744 [2024-16100]
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59742
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR 201.56 and
201.57 pertaining to prescription
product labeling requirements have
been approved under OMB control
number 0910–0572; the collections of
information in 21 CFR parts 210 and
211 pertaining to current good
manufacturing practice have been
approved under OMB control number
0910–0139; the collections of
information in section 351(k) of the PHS
Act pertaining to biosimilar and
interchangeable biosimilar product
applications have been approved under
OMB control number 0910–0718; and
the collections of information in section
351 of the PHS Act and 21 CFR part 601
have been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: July 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
the Paperwork Reduction Act of 1995
(PRA).
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 21, 2023, the Agency
submitted a proposed collection of
information entitled ‘‘Survey on
Quantitative Claims in Direct-toConsumer Prescription Drug
Advertising’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0929. The
approval expires on June 30, 2027. A
copy of the supporting statement for this
information collection is available on
the internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16096 Filed 7–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2024–16128 Filed 7–22–24; 8:45 am]
[Docket No. FDA–2024–N–2931]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Microbiological
Testing and Corrective Measures for
Bottled Water
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
[Docket No. FDA–2023–N–0795]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Survey on Quantitative Claims in
Direct-to-Consumer Prescription Drug
Advertising
AGENCY:
Food and Drug Administration,
ddrumheller on DSK120RN23PROD with NOTICES1
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘Electronic
Records: Electronic Signatures’’ has
been approved by the Office of
Management and Budget (OMB) under
SUMMARY:
VerDate Sep<11>2014
18:47 Jul 22, 2024
Jkt 262001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 the procedure by
which both domestic and foreign bottled
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
water manufacturers that sell bottled
water in the United States maintain
records of microbiological testing and
corrective measures, in addition to
existing recordkeeping requirements.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
September 23, 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
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 23, 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.’’
E:\FR\FM\23JYN1.SGM
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Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–2931 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water.’’ 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.
59743
when appropriate, and other forms of
information technology.
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:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i), 129.80(g), and 129.80(h)
OMB Control Number 0910–0658—
Extension
This information collection supports
FDA regulations. The bottled water
regulations in parts 129 and 165 (21
CFR parts 129 and 165) require that if
any coliform organisms are detected in
weekly total coliform testing of finished
bottled water, followup testing must be
conducted to determine whether any of
the coliform organisms are Escherichia
coli (E. coli). The adulteration provision
of the bottled water standard (21 CFR
165.110(d)) provides that a finished
product that tests positive for E. coli
will be deemed adulterated under
section 402(a)(3) of the Federal Food,
Drug, and Cosmetic Act (21
U.S.C.342(a)(3)). In addition, the current
good manufacturing practice (CGMP)
regulations for bottled water in part 129
require that source water from other
than a public water system be tested at
least weekly for total coliform. If any
coliform organisms are detected in the
source water, bottled water
manufacturers are required to determine
whether any of the coliform organisms
are E. coli. Source water found to
contain E. coli is not considered water
of a safe, sanitary quality and would be
unsuitable for bottled water production.
Before a bottler may use source water
from a source that has tested positive for
E. coli, a bottler must take appropriate
measures to rectify or otherwise
eliminate the cause of the
contamination. A source previously
found to contain E. coli will be
considered negative for E. coli after five
samples collected over a 24-hour period
from the same sampling site are tested
and found to be E. coli negative.
Description of Respondents: The
respondents to this information
collection are domestic and foreign
bottled water manufacturers that sell
bottled water in the United States.
FDA estimates the burden of this
collection of information as follows:
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,
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
129.35(a)(3)(i), 129.80(h); bottlers subject to source water and
finished product testing.
129.80(g), 129.80(h); bottlers testing finished product only .......
129.35(a)(3)(i), 129.80(h); bottlers conducting secondary testing of source water.
VerDate Sep<11>2014
18:47 Jul 22, 2024
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Fmt 4703
Number of
records per
recordkeeper
Total
annual
records
Average burden
per
recordkeeping
Total
hours
319
6
1,914
0.08 (5 minutes) ...
153
95
3
3
5
285
15
0.08 (5 minutes) ...
0.08 (5 minutes) ...
23
1
Sfmt 4703
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59744
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section; activity
Total
annual
records
Average burden
per
recordkeeping
129.35(a)(3)(i), 129.80(h); bottlers rectifying contamination .......
3
3
9
Total .....................................................................................
..........................
........................
................
1 There
Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16100 Filed 7–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Total
hours
0.25 (15 minutes)
..............................
2
179
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
We therefore conclude that any
additional burden and costs in
recordkeeping based on followup testing
that is required if any coliform
organisms detected in the source water
test positive for E. coli are negligible.
Notice.
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Council on Migrant Health
(NACMH or Council) has scheduled a
public meeting.
SUMMARY:
October 22, 2024, 8:30 a.m.–5:00
p.m. Eastern Time and October 23,
2024, 8:30 a.m.–5:00 p.m. Eastern Time.
DATES:
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
This meeting will be held
in-person and via webinar. The address
of the meeting is 5600 Fishers Lane,
Rockville, MD 20857. Instructions for
joining the meeting by webinar will be
posted on the NACMH website 30
business days before the meeting date.
For meeting information updates, go to
the NACMH website at https://
ADDRESSES:
VerDate Sep<11>2014
19:29 Jul 22, 2024
Jkt 262001
www.hrsa.gov/advisory-committees/
migrant-health.
FOR FURTHER INFORMATION CONTACT: Liz
Rhee, NACMH Designated Federal
Official (DFO), Office of Policy and
Program Development, Bureau of
Primary Health Care, HRSA, 5600
Fishers Lane, Rockville, MD 20857;
301–443–1082 or
hrsabphcoppdnacmh@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACMH
advises, consults with, and makes
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning the
activities under section 217 of the
Public Health Service Act, as amended
(42 U.S.C. 218). Specifically, NACMH
provides recommendations concerning
policy related to the organization,
operation, selection, and funding of
migrant health centers and other entities
that receive grants and contracts under
section 330 of the Public Health Service
Act (42 U.S.C. 254b). NACMH meets
twice each calendar year, or at the
discretion of the DFO, in consultation
with the NACMH Chair.
The agenda items for the October
meeting will include topics and issues
related to migratory and seasonal
agricultural worker health, including
impacts of heat and wildfire smoke,
farmworker data, and best practices for
fostering partnerships between
farmworkers, health centers, growers,
and community organizations. Refer to
the NACMH website listed above for all
current and updated information
concerning the October 2024 NACMH
meeting, including a draft agenda that
will be posted 30 calendar days before
the meeting.
Members of the public will have the
opportunity to provide written
comments to the Council prior to the
meeting. Written statements should be
sent to Liz Rhee, DFO, using the contact
information above, at least 3 business
days prior to the meeting. All public
comments will be reviewed by the
Council for consideration during the
meeting, as time permits.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
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Fmt 4703
Sfmt 4703
notify Liz Rhee using the contact
information listed above at least 10
business days prior to the meeting.
Registration is required to attend the
meeting. Registration and meeting
attendance instructions will be posted
on the NACHM website 30 business
days prior to the meeting date. Since
this meeting occurs in a federal
government building, attendees must go
through a security check to enter the
building. Non-U.S. citizen attendees
must notify HRSA of their planned
attendance at least 20 business days
prior to the meeting to facilitate their
entry into the building. All attendees are
required to present government-issued
identification prior to entry.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–16119 Filed 7–22–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Literature Selection
Technical Review Committee.
The meeting will be open to the
public as indicated below. Individuals
who plan to attend as well as those who
need special assistance, such as sign
language interpretation or other
reasonable accommodations, must
notify the Contact Person listed below
in advance of the meeting. The open
session will be videocast and can be
accessed from the NIH Videocasting and
Podcasting website (https://videocast.
nih.gov/).
The meeting is devoted to the review
and evaluation of journals for potential
indexing by the National Library of
Medicine and will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(9)(B), Title 5 U.S.C., as
amended. Premature disclosure of the
E:\FR\FM\23JYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Notices]
[Pages 59742-59744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2931]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Microbiological Testing and Corrective Measures for
Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the procedure by which both
domestic and foreign bottled water manufacturers that sell bottled
water in the United States maintain records of microbiological testing
and corrective measures, in addition to existing recordkeeping
requirements.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 23, 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 system will accept comments until
11:59 p.m. Eastern Time at the end of September 23, 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.''
[[Page 59743]]
Instructions: All submissions received must include the Docket No.
FDA-2024-N-2931 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping Requirements for
Microbiological Testing and Corrective Measures for Bottled Water.''
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m.,
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Microbiological Testing and Corrective Measures for Bottled Water--21
CFR 129.35(a)(3)(i), 129.80(g), and 129.80(h)
OMB Control Number 0910-0658--Extension
This information collection supports FDA regulations. The bottled
water regulations in parts 129 and 165 (21 CFR parts 129 and 165)
require that if any coliform organisms are detected in weekly total
coliform testing of finished bottled water, followup testing must be
conducted to determine whether any of the coliform organisms are
Escherichia coli (E. coli). The adulteration provision of the bottled
water standard (21 CFR 165.110(d)) provides that a finished product
that tests positive for E. coli will be deemed adulterated under
section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C.342(a)(3)). In addition, the current good manufacturing practice
(CGMP) regulations for bottled water in part 129 require that source
water from other than a public water system be tested at least weekly
for total coliform. If any coliform organisms are detected in the
source water, bottled water manufacturers are required to determine
whether any of the coliform organisms are E. coli. Source water found
to contain E. coli is not considered water of a safe, sanitary quality
and would be unsuitable for bottled water production. Before a bottler
may use source water from a source that has tested positive for E.
coli, a bottler must take appropriate measures to rectify or otherwise
eliminate the cause of the contamination. A source previously found to
contain E. coli will be considered negative for E. coli after five
samples collected over a 24-hour period from the same sampling site are
tested and found to be E. coli negative.
Description of Respondents: The respondents to this information
collection are domestic and foreign bottled water manufacturers that
sell bottled water in the United States.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section; activity Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
129.35(a)(3)(i), 129.80(h); 319 6 1,914 0.08 (5 minutes)........ 153
bottlers subject to source
water and finished product
testing.
129.80(g), 129.80(h); bottlers 95 3 285 0.08 (5 minutes)........ 23
testing finished product only.
129.35(a)(3)(i), 129.80(h); 3 5 15 0.08 (5 minutes)........ 1
bottlers conducting secondary
testing of source water.
[[Page 59744]]
129.35(a)(3)(i), 129.80(h); 3 3 9 0.25 (15 minutes)....... 2
bottlers rectifying
contamination.
--------------------------------------------------------------------------------
Total...................... ............... .............. ......... ........................ 179
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. The current CGMP regulations already reflect the time and
associated recordkeeping costs for those bottlers that are required to
conduct microbiological testing of their source water, as well as total
coliform testing of their finished bottled water products. We therefore
conclude that any additional burden and costs in recordkeeping based on
followup testing that is required if any coliform organisms detected in
the source water test positive for E. coli are negligible.
Dated: July 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16100 Filed 7-22-24; 8:45 am]
BILLING CODE 4164-01-P
