Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water, 3818-3819 [2022-01370]
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Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
20993–0002, 240–506–4946,
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default.htm. Scroll down to the
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February 23, 2022, will be provided to
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February 23, 2022, and by March 2,
2022, will be taken into consideration
by FDA. Oral presentations from the
public will be scheduled on March 3,
2022, between approximately 1:30 p.m.
and 2:30 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
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17:19 Jan 24, 2022
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present, the names and addresses of
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indication of the approximate time
requested to make their presentation on
or before February 17, 2022. 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,
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February 18, 2022.
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01368 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4130]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
SUMMARY:
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Frm 00065
Fmt 4703
Sfmt 4703
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 February
24, 2022.
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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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.
Recordkeeping Requirements for
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
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
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25JAN1
Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices
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.
3819
In the Federal Register of November
1, 2021 (86 FR 60258), 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 RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
Total annual
records
Average burden
per recordkeeping
Total hours
§§ 129.35(a)(3)(i) and 129.80(h); bottlers subject to
both source water and finished product testing.
§ 129.80(g) and (h); bottlers only subject to finished
product testing.
§§ 129.35(a)(3)(i) and 129.80(h); bottlers conducting
secondary testing of source water.
§§ 129.35(a)(3)(i) and 129.80(h); bottlers rectifying
contamination.
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
Total .......................................................................
........................
........................
........................
1 There
..............................
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.
Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01370 Filed 1–24–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Tribal Management Grant Program
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
records per
recordkeeper
Announcement Type: New.
Funding Announcement Number:
HHS–2022–IHS–TMD–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.228.
Key Dates
Application Deadline Date: April 25,
2022.
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17:19 Jan 24, 2022
Jkt 256001
Earliest Anticipated Start Date: June
9, 2022.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for grants for the
Tribal Management Grant (TMG)
Program. This program is authorized
under the Snyder Act, 25 U.S.C. 13; the
Transfer Act, 42 U.S.C. 2001(a); and the
Indian Self-Determination and
Education Assistance Act (ISDEAA),
Public Law (Pub. L.) 93–638, as
amended, 25 U.S.C. 5322(b)(2) and 25
U.S.C. 5322(e). This program is
described in the Assistance Listings
located at https://sam.gov/content/home
(formerly known as the CFDA) under
93.228.
Background
The TMG Program is a competitive
grant program that is capacity building
and developmental in nature and has
been available for federally recognized
Indian Tribes and Tribal Organizations
(T/TO) since shortly after enactment of
the ISDEAA in 1975. The TMG Program
was established to assist T/TOs to
prepare for assuming all or part of
existing IHS programs, functions,
services, and activities (PFSAs) and
further develop and improve Tribal
health management capabilities. The
TMG Program provides competitive
grants to T/TOs to establish goals and
performance measures for current health
programs, assess current management
capacity to determine if new
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
components are appropriate, analyze
programs to determine if a T/TO’s
management is practicable, and develop
infrastructure systems to manage or
organize PFSAs.
Purpose
The purpose of this program is to
enhance and develop health
management infrastructure and assist
T/TOs in assuming all or part of existing
IHS PFSAs through a Title I ISDEAA
contract and assist established Title I
ISDEAA contractors and Title V
ISDEAA compactors to further develop
and improve management capability. In
addition, Tribal Management Grants are
available to T/TOs under the authority
of 25 U.S.C. 5322(e) for the following:
1. Obtaining technical assistance from
providers designated by the T/TO
(including T/TOs that operate mature
contracts) for the purposes of program
planning and evaluation, including the
development of any management
systems necessary for contract
management, and the development of
cost allocation plans for indirect cost
rates.
2. planning, designing, monitoring,
and evaluating Federal programs serving
T/TOs, including Federal administrative
functions.
II. Award Information
Funding Instrument—Grant
Estimated Funds Available
The total funding identified for fiscal
year (FY) 2022 is approximately
$2,465,000. Individual award amounts
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 87, Number 16 (Tuesday, January 25, 2022)]
[Notices]
[Pages 3818-3819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-4130]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Recordkeeping
Requirements for 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 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 February 24, 2022.
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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Recordkeeping Requirements for 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
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
[[Page 3819]]
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 November 1, 2021 (86 FR 60258), 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 Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 129.35(a)(3)(i) and 129.80(h); 319 6 1,914 0.08 (5 minutes)........................ 153
bottlers subject to both source water and
finished product testing.
Sec. 129.80(g) and (h); bottlers only 95 3 285 0.08 (5 minutes)........................ 23
subject to finished product testing.
Sec. Sec. 129.35(a)(3)(i) and 129.80(h); 3 5 15 0.08 (5 minutes)........................ 1
bottlers conducting secondary testing of
source water.
Sec. Sec. 129.35(a)(3)(i) and 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: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01370 Filed 1-24-22; 8:45 am]
BILLING CODE 4164-01-P
