Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1103 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

CDER 

Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section 

VIII) ................................................................................... 81 1.53 124 30 3,720 

Breakthrough Therapy Designation Requests (EPSC Section VI) .............................................................................. 71 1.08 77 70 5,390 

Fast Track Designation Requests (EPSC Section V) ......... 235 1.18 277 60 16,620 

Accelerated Approval Designation (EPSC Section VII) ...... 26 1.27 33 100 3,300 

Premeeting Packages (21 CFR 312.82) ............................. 163 1.01 165 100 16,500 

CDER Subtotal ............................................................. ........................ ........................ 676 ........................ 45,530 

CBER 

Priority Review Designation Request (EPSC Section VIII) 8 1 8 30 240 

Breakthrough Therapy Designation Request (EPSC Section VI) .............................................................................. 15 1.1 17 70 1,190 

Fast Track Designation Requests (EPSC Section VII) ....... 64 1.2 77 60 4,620 

RMAT Designation Requests (Regenerative Medicine 

Therapies for Serious Conditions Guidance (RMAT) 

Section III) ........................................................................

Guidance p 6) ...................................................................... 33 1.1 36 60 2,160 

Premeeting Packages (RMAT Section V) ........................... 146 1.9 277 100 27,700 

CBER Subtotal .............................................................. ........................ ........................ 415 ........................ 35,910 

Total ....................................................................... ........................ ........................ 1,091 ........................ 81,440 

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

Based on FY 2022 receipts, we 

estimate that for Center for Drug 

Evaluation and Research (CDER) 

products, 81 respondents will submit 

124 requests for priority review 

designation annually, and we assume 30 

hours are needed to prepare such a 

request. We estimate 71 respondents 

will submit 77 requests for breakthrough 

designation annually, and we assume 70 

hours are needed to prepare such a 

request. We estimate that 235 

respondents will submit 277 requests 

for fast-track designation requests 

annually, and we assume 60 hours are 

required to prepare such a request. We 

estimate 26 respondents will submit 33 

accelerated approval designation 

requests annually and we assume 100 

hours are required to prepare such a 

request. Finally, CDER received 165 premeeting package submissions from 163 

respondents. We assume 100 hours are 

needed to prepare a pre-meeting 

package. 

Similarly, also based on FY 2022 

receipts, we estimate that for CBER 

products, 8 applicants will submit 8 

requests for priority review designation 

annually, and we assume 30 hours are 

required to prepare such a request. We 

estimate 15 respondents will submit 17 

requests for breakthrough designation 

annually, and we assume 70 hours are 

needed to prepare such a request. We 

estimate that 64 respondents will 

submit 78 requests for fast-track 

designation annually, and we assume 60 

hours is required to prepare such a 

request. We also estimate 33 

respondents will submit 35 requests for 

RMAT designation annually and assume 

that 60 hours are needed to prepare each 

RMAT designation request. Finally, 

CBER received 283 pre-meeting package 

submissions from 146 respondents. We 

assume 100 hours are needed to prepare 

a pre-meeting package. 

Based on a review of the information 

collection since our last request for 

OMB approval, we have increased our 

burden estimate by 143 responses and 

10,350 hours to reflect actual 

submissions we have received. We 

attribute these changes to increased 

interest in the expedited programs, new 

expedited programs, and an increase in 

the number of submissions we received 

over the last few years. 

Dated: January 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00217 Filed 1–8–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Bureau of 

Health Workforce Performance Data 

Collection, OMB No. 0915–0061— 

Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 8, 2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 


khammond on DSKJM1Z7X2PROD with NOTICES
1104 Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 

within 30 days of publication of this 

notice to 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. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

Bureau of Health Workforce 

Performance Data Collection, OMB No. 

0915–0061—Revision. 

Abstract: Over 50 Bureau of Health 

Workforce (BHW) programs award 

grants to health professions schools and 

training programs across the United 

States to develop, expand, and enhance 

training, and to strengthen the 

distribution of the health workforce. 

These programs are governed by titles 

III, VII, and VIII of the Public Health 

Service Act. Performance information is 

collected in the HRSA Performance 

Report for Grants and Cooperative 

Agreements. Data collection activities 

consisting of an annual progress report 

and an annual performance report 

satisfy statutory and programmatic 

requirements for performance 

measurement and evaluation (including 

specific title III, VII and VIII 

requirements), as well as Government 

Performance and Results Act of 1993, 

the Government Performance and 

Results Act Modernization Act of 2010, 

and the Foundations for Evidence-Based 

Policymaking Act of 2018 requirements. 

The performance measures were last 

revised in 2022 to ensure they 

addressed programmatic changes, met 

evolving program management needs, 

and responded to emerging workforce 

concerns. As these changes were 

successful, BHW will continue with its 

current performance management 

strategy and make additional changes 

that reduce burden, simplify reporting, 

reflect new Department of Health and 

Human Services and HRSA priorities, 

and enable longitudinal analysis of 

program performance. Specifically, an 

Excel upload feature was implemented 

for all programs to reduce burden. 

Questions on partnerships were revised 

and standardized across forms to 

understand the type and purposes of 

partnerships associated with grant 

funding. Employment-related questions 

were standardized across programs and 

forms to provide consistent outcomes on 

employment location, type of 

employment, and hiring organization. 

New questions were added for programs 

using apprenticeships. Specifically, 

questions were added to measure 

additional employment outcomes 

including role at the employment site 

and vulnerable populations served and 

to measure program satisfaction and 

types of competencies graduates were 

ready to perform. 

A 60-day notice published in the 

Federal Register on October 19, 2023, 

88 FR 72086–87. There was one public 

comment. The commenter was 

complementary of BHW’s efforts to 

consolidate performance data into one 

collection and raised questions related 

to collaborating with other departments 

on the data collection, defining 

apprenticeships, and making 

individual-level data publicly available. 

Specifically, the commenter asked how 

HRSA collaborates on data collection 

with agencies outside of the Department 

of Health and Human services. Our 

response to the commenter explained 

the data collected via this OMB package 

are performance metrics specific to 

HRSA grant programs and the data are 

used to meet obligations for 

performance budgeting. This is in 

alignment with the Government’s 

authorization to collect data to meet 

reporting requirements. The commenter 

also asked how HRSA defines 

apprenticeships and how it aligns with 

definitions from other agencies. HRSA 

responded that it uses the Department of 

Labor’s definition of apprentices and 

that it included questions from the 

Department of Labor’s Employment and 

Training Administration instrument to 

reduce reporting burden and made data 

comparable across the agencies. Lastly, 

the commenter requested that HRSA 

make more individual-level data 

available, but statute prohibits HRSA 

from doing so (see 42 U.S.C. 292 et seq.). 

There was a follow-up comment from 

the same commenter regarding HRSA 

working with external researchers to 

analyze data on workforce program 

participants. HRSA’s response was that 

HRSA does not work with external 

researchers to analyze data collected on 

workforce programs. Aggregated data is 

publicly available to external 

researchers via HRSA’s data warehouse. 

Need and Proposed Use of the 

Information: The purpose of the 

proposed data collection is to continue 

analysis and reporting of grantee 

training activities and education, 

identify details about the practice 

locations where trainees work (or plan 

to work) after program completion, and 

report outcomes of funded initiatives. 

Data collected from these grant 

programs will also provide a description 

of the program activities of 

approximately 1,828 reporting grantees 

to inform policymakers on the barriers, 

opportunities, and outcomes involved 

in health care workforce development. 

The proposed measures focus on four 

key outcomes: 

(1) increasing the workforce supply of 

well-educated practitioners in needed 

professions, 

(2) increasing the number of 

practitioners that practice in 

underserved and rural areas, 

(3) enhancing the quality of 

education, and 

(4) supporting educational 

infrastructure to increase the capacity to 

train more health professionals in high 

demand areas. 

Likely Respondents: Respondents are 

awardees of BHW health professions 

grant programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices 1105 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Direct Financial Support Program ....................................... 619 1 619 2.7 1,671.3 

Infrastructure Program ......................................................... 219 1 219 4.8 1,051.2 

Multipurpose or Hybrid Program .......................................... 1,044 1 1,044 3.1 3,236.4 

Total .............................................................................. 1,882 ........................ 1,882 ........................ 5,958.9 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–00210 Filed 1–8–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with section 

1111(g) of the Public Health Service Act, 

and the Federal Advisory Committee 

Act, this notice announces that the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(ACHDNC or Committee) has scheduled 

a public meeting. Information about the 

ACHDNC and the agenda for this 

meeting can be found on the ACHDNC 

website at https://www.hrsa.gov/ 

advisory-committees/heritabledisorders/index.html. 

DATES: Monday, January 29, 2024, from 

10 a.m. to 5 p.m. Eastern Time (ET) and 

Tuesday, January 30, 2024, from 10 a.m. 

to 3 p.m. ET. 

ADDRESSES: This meeting will be held in 

person with webcast options. While this 

meeting is open to the public, advance 

registration is required. Please visit the 

ACHDNC website for information on 

registration, https://www.hrsa.gov/ 

advisory-committees/heritabledisorders/index.html, by the deadline of 

12 p.m. ET on Friday, January 26, 2024. 

Instructions on how to access the 

meeting via webcast will be provided 

upon registration. If you are a nonUnited States citizen who would like to 

attend the January meeting in-person, 

please contact ACHDNC@hrsa.gov by 

January 11, 2024. 

FOR FURTHER INFORMATION CONTACT: Kim 

Morrison, Maternal and Child Health 

Bureau, HRSA, 5600 Fishers Lane, 

Room, Rockville, Maryland 20857; 301– 

822–4978; or ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of Health and Human 

Services (Secretary) on the development 

of newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices, 

recommends improvements in the 

national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

additional conditions for screening on 

the Recommended Uniform Screening 

Panel (RUSP), following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is one 

year from the Secretary’s adoption of the 

condition for screening. 

During the January 29–30, 2024, 

meeting, ACHDNC will hear from 

experts in the fields of public health, 

medicine, heritable disorders, rare 

disorders, and newborn screening. 

Agenda items include the following 

topics: 

(1) A possible presentation on 

qualitative research that focuses on 

family perspectives; 

(2) Updates from Committee ad hoc 

topic groups. Potential topics include: 

the nomination process and revisions to 

the decision matrix; 

(3) An update on the evidence review 

of Duchenne muscular dystrophy 

nomination; and 

(4) Presentation of the final evidencebased review report on the Krabbe 

disease condition nomination for 

possible inclusion on the RUSP. 

Following this report presentation, the 

ACHDNC expects to vote on the second 

meeting day, on January 30, 2024, 

whether to recommend to the Secretary 

adding Krabbe disease to the RUSP 

(with potential implications under 

section 2713 of the Public Health 

Service Act, as noted above). 

The agenda for this meeting includes 

a potential vote to recommend a 

nominated condition (Krabbe disease) 

be added by the Secretary to the RUSP. 

Agenda items are subject to change as 

priorities dictate. Information about the 

ACHDNC, including a roster of members 

and past meeting summaries, is also 

available on the ACHDNC website. 

Members of the public also will have 

the opportunity to provide comments on 

any or all of the above agenda items. 

Public participants may request to 

provide general oral comments and may 

submit written statements in advance of 

the scheduled meeting. Oral comments 

will be honored in the order they are 

requested and may be limited as time 

allows. Subject to change: members of 

the public registered to submit oral 

public comments on Krabbe disease are 

tentatively scheduled to provide their 

statements on Tuesday, January 30, 

2024. Members of the public registered 

to provide oral public comments on all 

other newborn screening related topics 

are tentatively scheduled to provide 


khammond on DSKJM1Z7X2PROD with NOTICES