3818 Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices 

20993–0002, 240–506–4946, 

respectively at CBERVRBPAC@

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 

FDA’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 joining the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. The 

committee will meet in open session to 

discuss and make recommendations on 

the selection of strains to be included in 

the influenza virus vaccines for the 

2022–2023 influenza season. 

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 at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 

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 submitted to the 

Docket (see ADDRESSES) on or before 

February 23, 2022, will be provided to 

the committee. Comments received after 

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 

present, the names and addresses of 

proposed participants, and an 

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, 

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 

February 18, 2022. 

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 Prabhakara 

Atreya (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/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

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. 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. 

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, 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 16 / Tuesday, January 25, 2022 / Notices 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

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

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.

319 6 1,914 0.08 (5 minutes) ... 153 

§ 129.80(g) and (h); bottlers only subject to finished 

product testing.

95 3 285 0.08 (5 minutes) ... 23 

§§ 129.35(a)(3)(i) and 129.80(h); bottlers conducting 

secondary testing of source water.

3 5 15 0.08 (5 minutes) ... 1 

§§ 129.35(a)(3)(i) and 129.80(h); bottlers rectifying 

contamination.

3 3 9 0.25 (15 minutes) 2 

Total ....................................................................... ........................ ........................ ........................ .............................. 179 

1There 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 

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. 

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 

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 


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