Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 76855 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

Labeling requirements for prescription drugs; 

§§ 201.56 and 201.57.

414 1.326 549 3,349 ..................... 1,838,601 

Labeling applicable to medical gas containers; 

§§ 201.161(b) and 201.328.

260 1,663 432,380 0.17 (10 minutes) .. 73,505 

Exemption from barcode requirements § 201.25(d) ..... 2 1 2 24 .......................... 48 

Safety labeling required under section 505(o)(4) of 

the Federal Food, Drug, and Cosmetic Act (FD&C 

Act), and rebuttal statement.

36 1 36 6 ............................ 216 

Safety labeling changes; posting approved letter on 

application holder’s website.

351 1 351 4 ............................ 1,404 

Exceptions or alternatives to labeling requirements for 

human drug product held by SNS; § 201.26.

1 1 1 32 .......................... 32 

Hypertension claims; recommended labeling considerations.5 1 5 18 .......................... 90 

Total ...................................................................... ........................ ........................ 433,324 ............................... 1,913,896 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on our evaluation, we have 

retained the currently approved 

estimate that 414 applicants will 

prepare an average of 549 prescription 

drug labels annually, and assume it will 

require 3,349 hours to design, test, and 

submit to FDA as part of a new drug 

application or a biologics license 

application. 

New medical gas containers must 

meet applicable requirements found in 

21 CFR part 211, as well as specific 

labeling requirements in § 201.328. 

Consistent with statutory authority 

under the Consolidated Appropriations 

Act, 2017 (Pub. L. 115–31), we have 

revised the information collection to 

include burden associated new medical 

gas labeling requirements under 

§ 201.161(b), established by a final rule 

published in the Federal Register of 

June 18, 2024 (89 FR 51738). We 

estimate 260 respondents will incur 

burden for the design, testing, 

production, and submission of labeling 

for new medical gas containers as 

established in § 201.328 and assume an 

average of 10 minutes (0.17) is required 

for these activities. 

Based on our evaluation, few requests 

for exemption from barcode 

requirements are received and we have 

therefore made no changes to the 

currently approved estimate for this 

activity. Likewise, we have also retained 

the currently approved estimate for 

information collection activities 

associated with safety labeling 

requirements established in 

section505(o)(4) of the FD&C Act. 

Similarly, we retain the currently 

approved estimate for exceptions to 

labeling under § 201.26, however this 

activity was previously approved in 

OMB control number 0910–0614 and is 

a new element to the collection, adding 

1 response and 32 hours annually. 

Finally, we have combined activity 

elements associated with labeling 

recommendations regarding drug 

products that include a hypertension 

indication as discussed in the 

applicable guidance, reducing the 

overall estimate for this element by 4 

hours annually. 

Dated: September 16, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21436 Filed 9–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Funding, 

Poison Control Centers Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA is awarding 

supplemental funds in fiscal year 2024 

to provide coverage for calls to the tollfree Poison Help line that originate from 

Puerto Rico. The current program period 

of performance ends on August 31, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Maureen Perkins, MPH; Team Lead; 

Poison Control Program; Division of 

Child, Adolescent and Family Health; 

Maternal and Child Health Bureau; 

HRSA, at mperkins@hrsa.gov and 301– 

443–9163. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

New York City Health & Hospitals 

Corporation. 

Amount of Non-Competitive 

Award(s): One award of $265,188. 

Project Period: September 1, 2024, to 

August 31, 2025. 

Assistance Listing (CFDA) Number: 

93.253. 

Award Instrument: Supplement for 

Poison Control Services. 

Authority: 42 U.S.C. 300d–73 (title 

XII, 1273 of the Public Health Service 

Act). 

TABLE 1—RECIPIENT AND AWARD AMOUNT

Grant No. Award recipient name State Award amount 

H4BHS15477 ................................................... New York City Health & Hospitals Corporation .................................. NY $265,188 


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76856 Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices 

Justification: This non-competitive 

supplement will award $265,188 to New 

York City Health & Hospitals 

Corporation to fund the New York City 

Poison Control Center (NYCPCC) to 

provide coverage of calls to the toll-free 

Poison Help line originating from Puerto 

Rico from September 1, 2024, through 

August 31, 2025. The Poison Control 

Program ensures that individuals can 

call a national toll-free Poison Help line 

(1–800–222–1222) to connect to a local 

poison control center in a poisoning 

emergency. As required by statute, calls 

to the Poison Help line must be directed 

to poison control centers that are 

accredited. In the most recent Notice of 

Funding Opportunity, HRSA–24–045, 

no application was received to respond 

to calls from Puerto Rico. To ensure 

uninterrupted poison control center 

coverage for Puerto Rico, HRSA 

identified NYCPCC as an accredited 

center that is capable of responding to 

Puerto Rico’s approximately 5,000 calls 

annually. NYCPCC historically has been 

able to provide temporary coverage for 

Puerto Rico’s calls on an ad hoc basis 

and has the qualifications, experience, 

and personnel to do so on a longer-term 

basis. Funds will be used for project 

activities within the scope of the current 

award (as announced in HRSA–24–045); 

supplemental funds will support 

NYCPCC to provide coverage to calls to 

the Poison Help line originating from 

Puerto Rico for a period of 1 year. 

Future funds for coverage for Puerto 

Rico may be made available in a Notice 

of Funding Opportunity for a project 

period of September 1, 2025, to August 

31, 2028, subject to the availability of 

funding for the activity. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–21402 Filed 9–18–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Supplemental Award; Alumni 

Peer Navigator Services Pilot 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice of supplemental award. 

SUMMARY: HRSA will provide 

supplemental award funds in fiscal year 

2024 to the current recipient of the 

Supporting Healthy Start (HS) 

Performance Project cooperative 

agreement (HRSA–24–038) to support 

the second year of the Alumni Peer 

Navigator (APN) Services Pilot. 

FOR FURTHER INFORMATION CONTACT: 

Aaron M. Lopata, MD, MPP, Senior 

Medical Officer, Division of HS and 

Perinatal Services, Maternal and Child 

Health Bureau, HRSA, at alopata@

hrsa.gov and (312) 315–4270. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient(s) of the Award: 

The National Institute for Children’s 

Health Quality (NICHQ). 

Amount of Competitive or NonCompetitive Award(s): $601,851. 

Supplemental funding for similar 

activities may be considered in future 

years, subject to the availability of 

funding for the activity and the 

satisfactory performance of the 

recipient. 

Project Period: June 1, 2024, to May 

31, 2029. 

Assistance Listing (CFDA) Number: 

93.926. 

Award Instrument: Supplement. 

Authority: 42 U.S.C. 254c–8 (title III, 

330H of the Public Health Service Act). 

TABLE 1—RECIPIENT AND AWARD AMOUNTS

Grant No. Award recipient name City, State Award 

amount 

UF5MC32750 .......................... National Institute for Children’s Health Quality ........................ Boston, MA ............................. $601,851 

Justification: NICHQ, as the current 

HS Technical Assistance Support 

Center, and recipient of the Supporting 

HS Performance Project, provides 

national support to all HRSA HS project 

grantees. The supplemental funds will 

support new and continued APN 

activities. APN activities aim to reduce 

infant mortality rates, address 

disparities in maternal and infant health 

outcomes, and address social 

determinants of health. APNs are former 

HS participants who have navigated 

complex and often disparate health, 

education, and social services. These 

former HS participants, known as ‘‘peer 

navigators,’’ help current HS families by 

providing guidance and information 

about public benefits and help to 

address issues such as food insecurity, 

unstable housing, and lack of 

transportation. 

NICHQ will use supplemental funds 

to support HS grantees to implement 

this peer-to-peer workforce model, the 

APN Services Pilot. The APN Services 

Pilot was previously known as the 

Benefits Bundle Pilot. The APN Services 

Pilot is an interagency collaboration 

between the Department of Health and 

Human Services and the Office of 

Management and Budget/U.S. Digital 

Service. 

The pilot consists of five HS projects 

in Florence, SC, Atlanta, GA, Baton 

Rouge, LA, Los Angeles, CA and 

Stoneville, Mississippi. 

Carole Johnson, 

Administrator. 

[FR Doc. 2024–21407 Filed 9–18–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 


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