Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water, 18859-18860 [2025-07629]
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Federal Register / Vol. 90, No. 84 / Friday, May 2, 2025 / Notices
operated by the U.S. Department of
Homeland Security’s Customs and
Border Protection (CBP) and is a fullservice, multi-modal facility where CBP
officers inspect commercially owned
vehicles (COVs), privately owned
vehicles (POVs), and pedestrians.
CBP’s priority mission is homeland
security, with responsibilities for
improving security at and between U.S.
ports of entry (POEs), as well as
extending the zone of security beyond
the physical borders of the U.S. While
carrying out its mission, CBP facilitates
legitimate trade and travel through the
Nation’s borders in an effective and
efficient manner.
Purpose and Need for Action
The purpose of the proposed action is
for the GSA to support CBPs mission by
bringing the BOTA LPOE infrastructure
in line with current CBP land port
design standards and operational
requirements while addressing existing
deficiencies identified with ongoing
port operations. In order to bring the
BOTA LPOE in line with CBP’s design
standards and operational requirements,
action is needed to satisfy the following
overriding needs:
• Improve the capacity and
functionality of the LPOE to meet future
public demand, while maintaining the
capability to meet border security
initiatives.
• Ensure the safety and security for
the employees and the travelling public.
Proposed Action and Alternatives
Development
As part of project planning, the GSA
developed two (2) action alternatives as
potential means of implementing the
proposed action. The no action
alternative was also considered in the
EIS. Both action alternatives include the
phased razing of all existing buildings/
structures and infrastructure within the
existing LPOE boundaries and
construction of new buildings/
structures and supporting infrastructure.
Both action alternatives also include
minimal land acquisition in areas
immediately adjacent to the port.
khammond on DSK9W7S144PROD with NOTICES
Summary of Potential Impacts
The EIS identified, described, and
analyzed the potential effects of the
action alternatives developed to
implement the proposed action and the
no action alternative and documented
measures that could potentially avoid,
minimize, or mitigate any identified
adverse impacts.
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18859
GSA’s Preferred Alternative and
Environmentally Preferable Alternative
move in correcting these conditions
over time.
GSA considered the findings in the
Final EIS, stakeholder input, all public
comments, and tenant needs at the
LPOE to determine the preferred
alternative, including the
environmentally preferable alternative,
and has selected:
Viable Action Alternative 4—MultiLevel Modernization within the Existing
Port Boundaries with Minor Land
Acquisition Immediately Adjacent to the
Port (4 acres—TxDOT) and Elimination
of All Commercial Cargo Operations
which includes the following rationale.
• Balancing likely adverse impacts
(both short- and long-term) to the City
of El Paso, El Paso County, the
communities, residents, and citizens in
the immediate vicinity of the BOTA
LPOE and those near the other LPOEs
that would likely receive commercial
cargo traffic in the future.
• The likely impacts (both short- and
long-term) to the overall trucking/trade
industry in the region.
• The need to support CBP’s mission
by bringing the BOTA LPOE facilities in
line with current CBP land port design
standards (i.e., CBP Land Port of Entry
Design Standard [CBP 2023]) and
operational requirements while
addressing existing deficiencies
identified with the ongoing port
operations.
• The overall need to improve
operational efficiency, effectiveness,
security, and safety for the CBP staff and
cross-border travelers at the BOTA
LPOE.
This decision also takes into account
concerns voiced by the public which
were primarily centered around
commercial truck traffic at the port and
the associated noise and air quality
impacts to nearby residents. GSA’s data
collection and analysis as presented in
the Final EIS demonstrates that there are
likely existing environmental impacts in
the vicinity of the BOTA LPOE. These
largely relate to traffic (primarily
commercial truck traffic) and the
resulting effect on both local and
regional air quality and increases in
noise. Furthermore, GSA’s data
collection and analysis indicates that
should the No Action Alternative or
Action Alternative 1a be chosen for
implementation, these existing
conditions would likely degrade further
over time. GSA’s data collection and
analysis for Action Alternative 4 results
in no furtherance of any existing
impacts and represents a likely positive
Aaron Bollinger,
Acting Director, Facilities Management
Division (7PM), General Services
Administration-Public Building Service,
Greater Southwest Region.
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[FR Doc. 2025–07646 Filed 5–1–25; 8:45 am]
BILLING CODE 6820–AY–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2931]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 June 2,
2025.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
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 0910–0658. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 90, No. 84 / Friday, May 2, 2025 / Notices
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.
In the Federal Register of July 23,
2024 (89 FR 59742), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Five comments were
received, of which one was PRA-related
and supported necessity and practical
utility of the FDA’s recordkeeping
requirements in this collection of
information. Four comments were not
related to the PRA and will not be
addressed here.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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.
129.35(a)(3)(i), 129.80(h); bottlers rectifying
contamination.
Total ............................................................
1 There
Total
annual
records
Average burden per
recordkeeping
Total
hours
319
6
1,914
0.08 (5 minutes) ..........
153
95
3
285
0.08 (5 minutes) ..........
23
3
5
15
0.08 (5 minutes) ..........
1
3
3
9
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.
khammond on DSK9W7S144PROD with NOTICES
Number of
records per
recordkeeper
Number of
recordkeepers
21 CFR section; activity
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Substance Abuse and Mental Health
Services Administration
Prospective Grant of an Exclusive
Patent License: Size-Dependent Brain
and Lymphatic Distribution of
Macromolecular Drug Delivery
Platform
Correction
In notice document 2025–06878
beginning on page 16878 in the issue of
Tuesday, April 22, 2025, make the
following correction:
On page 16878, in the second column,
in the fifth line from the bottom, ‘‘April
22, 2025’’ should read ‘‘May 7, 2025’’.
[FR Doc. C1–2025–06878 Filed 5–1–25; 8:45 am]
BILLING CODE 0099–10–D
[FR Doc. 2025–07629 Filed 5–1–25; 8:45 am]
BILLING CODE 4164–01–P
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Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
Substance Abuse and Mental
Health Services Administration, HHS.
AGENCY:
ACTION:
Notice.
The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines) using
Urine and the laboratories currently
certified to meet the standards of the
Mandatory Guidelines using Oral Fluid.
SUMMARY:
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]]>Agencies
[Federal Register Volume 90, Number 84 (Friday, May 2, 2025)]
[Notices]
[Pages 18859-18860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07629]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2931]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 June 2, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
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 0910-0658. Also include the FDA docket
number found in brackets in the heading of this document.
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,
[email protected].
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.
[[Page 18860]]
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.
In the Federal Register of July 23, 2024 (89 FR 59742), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Five comments were received, of which one
was PRA-related and supported necessity and practical utility of the
FDA's recordkeeping requirements in this collection of information.
Four comments were not related to the PRA and will not be addressed
here.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Total Average burden
21 CFR section; activity Number of Number of records annual per Total
recordkeepers per 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.
129.35(a)(3)(i), 129.80(h); 3 3 9 0.25 (15 2
bottlers rectifying minutes).
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: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07629 Filed 5-1-25; 8:45 am]
BILLING CODE 4164-01-P
