2228 Federal Register / Vol. 89, No. 9 / Friday, January 12, 2024 / Notices 

INCLUSION AND EXCLUSION CRITERIA BY POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY

DESIGN (PICOTS)—Continued 

PICOTS elements Inclusion criteria Exclusion criteria 

Timing .................................. • At least 4 weeks .......................................................... • Less than 4 weeks. 

Settings ................................ • All except hospital and acute care .............................. • Hospital and acute care. 

Study design ........................ • Randomized controlled trials .......................................

• Nonrandomized controlled trials, including quasi-experimental and controlled before-and-after studies. 

• Prospective cohort studies. 

• Nested case-control studies. 

• Relevant systematic reviews, or meta-analyses (used 

for identifying additional studies). 

• In vitro studies, nonoriginal data (e.g., narrative reviews, scoping reviews, editorials, letters, or erratum), retrospective cohort studies, case series, qualitative studies, cost-benefit analysis, cross-sectional 

(i.e., nonlongitudinal) studies, survey. 

Publications .......................... • Studies published in English only ...............................

• Studies published in peer-reviewed journals. 

• Studies published at and after the year 2000. 

• Non-English language studies. 

Abbreviations: CVD = cardiovascular disease; GI = gastrointestinal; HDL = high-density lipoprotein; KQ = Key Question; LDL = low-density 

lipoprotein PICOTS = populations, interventions, comparators, outcomes, timing, and settings; RCT = randomized controlled trial; TC = total cholesterol; U.S. = United States. 

Dated: January 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–00505 Filed 1–11–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; CAREWare Customer 

Satisfaction and Usage Survey, OMB 

No. 0906–xxxx–New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with of the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 12, 

2024. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

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: 

Information Collection Request Title: 

CAREWare Customer Satisfaction and 

Usage Survey, OMB No. 0906–xxxx– 

New. 

Abstract: HRSA developed 

CAREWare, a software application first 

released in 2000, to help meet the data 

collection and reporting needs of Ryan 

White HIV/AIDS Program (RWHAP) 

grant recipients. The secure software is 

a free, electronic health and social 

support services information system for 

RWHAP grant recipients and their 

subrecipients to assist in the data 

requirement submissions that inform 

the development of the Ryan White 

HIV/AIDS Program Service Report, the 

AIDS Drug Assistance Program Data 

Report, the Ending the HIV Epidemic 

Initiative Triannual Report, and the 

voluntary Clinical Quality Measures 

Performance Measures module. Over 

time, the software has evolved into a 

comprehensive health information 

system and is now the source of more 

than half of all the RWHAP client-level 

data received from recipients and 

subrecipients of RWHAP grant funding. 

CAREWare software manages HIV 

clinical and support service data from 

more than 360,000 client records in 48 

states; Washington, DC; Puerto Rico; 

and the U.S. Virgin Islands. 

The CAREWare software application 

contains customizable modules for 

tracking demographic information, 

services, medications, laboratory test 

results, immunization history, diagnoses 

(updated with International 

Classification of Diseases, Tenth 

Revision codes), referrals to outside 

agencies, and an appointment 

scheduler. There is a custom report 

generator and a performance measures 

module that supports quality of care 

initiatives at the provider level. The 

software also has several ways to import 

data from third-party sources, including 

commercial labs and other electronic 

health records (using both Health Level 

Seven and simple Comma Separated 

Value-formatted files), HIV surveillance 

systems, and for RWHAP Part B AIDS 

Drug Assistance Programs, pharmacy 

benefit programs. The software and user 

support materials can be accessed here: 

https://hab.hrsa.gov/program-grantsmanagement/careware. Finally, 

CAREWare supports users through an 

experienced helpdesk with ongoing 

software maintenance issues and 

enhancements to the user interface. 

HRSA is proposing a customer 

satisfaction survey to gather feedback 

from CAREWare users regarding their 

experiences and satisfaction with the 

software platform and to obtain 

suggestions for improvement. 

A 60-day Federal Register Notice 

(FRN) was published in the Federal 

Register on October 20, 2023 (Volume 

88, No. 202, pages 72493–94). There was 

one out-of-scope public comment 

received in response to the FRN. 

Need and Proposed Use of the 

Information: HRSA aims to understand 

CAREWare users’ needs and concerns 

by collecting information on current 

software features and inquiring about 

opportunities to improve the user 

experience and product features. The 

survey will address the software’s 

functionality and how well it meets the 

data collection, reporting, and quality 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 9 / Friday, January 12, 2024 / Notices 2229 

management needs of the CAREWare 

user. The feedback will enable HRSA to 

assess, benchmark, and improve 

customer satisfaction with RWHAP 

grant recipients. 

Likely Respondents: RWHAP 

recipients and providers who use 

CAREWare to produce data files for the 

Ryan White HIV/AIDS Program Service 

Report, the AIDS Drug Assistance 

Program Data Report, the Ending the 

HIV Epidemic Initiative Triannual 

Report, and the voluntary Clinical 

Quality Measures Performance 

Measures module. 

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. 

A pilot with seven RWHAP grant 

recipients concluded on November 20, 

2023, one month after the 60-day FRN 

publication date of October 20, 2023. 

The pilot resulted in a lesser burden 

estimate than initially reported in the 

60-day FRN. 

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 

CAREWare User Survey ..................................................... 1,160 1 1,160 0.88 1,021 

Total .............................................................................. 1,160 1 1,160 0.88 1,021 

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. 2024–00534 Filed 1–11–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Small Business Innovation 

Research (SBIR) Phase II Program Contract 

Solicitation (PHS 2022–1) Topic 109— 

Development of Monoclonal Antibodymediated Interventions to Combat Malaria 

(N01). 

Date: February 6, 2024. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F36, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Noton K. Dutta, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F36, Rockville, MD 

20852, 240–669–2857, noton.dutta@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: January 9, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–00556 Filed 1–11–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; HHS–NIH–CDC–SBIR PHS 

2024–1 Phase I: Alternatives to Benzathine 

Penicillin for Treatment of Syphilis (Topic 

134). 

Date: February 12, 2024. 

Time: 11:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F52A 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Shilpakala Ketha, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 


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