66860 Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 

Dated: September 21, 2023. 

Lawrence A. Tabak, 

Acting NIH Director, National Institutes of 

Health. 

[FR Doc. 2023–21233 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Request for Information (RFI): Inviting 

Comments and Suggestions on 

Opportunities and Challenges for the 

Collection, Use, and Sharing of RealWorld Data (RWD) Including Electronic 

Health Records, for National Institutes 

of Health (NIH) Supported Biomedical 

and Behavioral Research 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Request for information. 

SUMMARY: The purpose of this National 

Institutes of Health (NIH) Request for 

Information (RFI) is to solicit public 

comments on the use of Real-World 

Data (RWD), including Electronic Health 

Records, for Biomedical and Behavioral 

Research. 

DATES: The NIH RFI is open for public 

comment. To assure consideration, your 

response must be received by December 

14, 2023, 11:59 p.m. (ET). 

ADDRESSES: All comments must be 

submitted electronically on the 

submission website at https://

datascience.nih.gov/rfi-rwd. 

Responses must be received by 

11:59:59 p.m. (ET) on December 14, 

2023. 

Responses to this RFI are voluntary 

and may be submitted anonymously. 

You may voluntarily include your name 

and contact information with your 

response. If you choose to provide NIH 

with this information, NIH will not 

share your name and contact 

information outside of NIH unless 

required by law. 

Other than your name and contact 

information, please do not include any 

personally identifiable information or 

any information that you do not wish to 

make public. Proprietary, classified, 

confidential, or sensitive information 

should not be included in your 

response. The Government will use the 

information submitted in response to 

this RFI at its discretion. Other than 

your name and contact information, the 

Government reserves the right to use 

any submitted information on public 

websites, in reports, in summaries of the 

state of the science, in any possible 

resultant solicitation(s), grant(s), or 

cooperative agreement(s), or in the 

development of future funding 

opportunity announcements. This RFI is 

for informational and planning purposes 

only and is not a solicitation for 

applications or an obligation on the part 

of the Government to provide support 

for any ideas identified in response to 

it. Please note that the Government will 

not pay for the preparation of any 

information submitted or for use of that 

information. 

We look forward to your input and 

hope that you will share this RFI 

opportunity with your colleagues. 

FOR FURTHER INFORMATION CONTACT: 

Questions about this request for 

information should be directed to Dr. 

Susan Gregurick, 301–435–1923, RWDrfi@od.nih.gov, National Institutes of 

Health, Office of Data Science Strategy, 

9000 Rockville Pike, Bethesda, 

Maryland 20892. 

SUPPLEMENTARY INFORMATION: The 

National Institutes of Health (NIH) is 

requesting public comment on the use 

of Real World Data (RWD) for NIH 

supported biomedical and behavioral 

research, including opportunities for 

leveraging the benefits of RWD and 

strategies for responsible use. NIH also 

seeks to better understand community 

perspectives on the potential value and 

constraints—including scientific, 

administrative, legal, business, and 

bioethical—for the greater use of RWD 

in NIH-sponsored biomedical and 

behavioral research. This request for 

information (RFI) is in accordance with 

42 U.S.C. 281 as amended. 

Background 

Researchers are increasingly using 

data collected in real-world settings to 

augment traditional research studies, as 

well as develop more effective 

treatments and interventions for 

patients. These ‘‘real-world data 

(RWD)’’, defined by the U.S. Food and 

Drug Administration, are data relating to 

patient health status and/or the delivery 

of health care routinely collected from 

a variety of sources. Examples of RWD 

include data derived from electronic 

health records, medical claims data, 

data from product or disease registries, 

and data gathered from other sources 

(such as digital health technologies) that 

can inform on health status. While these 

data hold tremendous promise for 

biomedical and behavioral research, 

they can be collected from a variety of 

sources through multiple mechanisms, 

creating challenges for researchers and 

questions for those whose data are being 

shared. 

Importantly, NIH is committed to 

ensuring participant privacy and 

autonomy are protected in all NIHsupported research. As NIH establishes 

health-related research data platforms 

that include access to RWD, NIH 

continues to prioritize maximizing data 

access while upholding participant 

preferences regarding the collection and 

use of their data. Most recently, through 

the Advisory Committee to the NIH 

Director, (https://www.acd.od.nih.gov/ 

index.html), NIH staff met with 

stakeholders to better understand their 

perspectives on benefits and risks of 

combining and using human datasets, 

particularly from disparate sources (e.g., 

research and non-research settings) and 

how their data should be used in 

biomedical and behavioral research. 

NIH will continue working to 

incorporate these perspectives in its 

research studies to build trust and honor 

participant preferences. Input requested 

on this RFI will be used to inform NIH’s 

continuing development of guidance on 

the use of RWD for research and assist 

in the planning for appropriate 

mechanisms and programs for research 

with RWD. 

Information Requested 

NIH is requesting public comment on 

the use of RWD for NIH-supported 

biomedical and behavioral research, 

including opportunities for leveraging 

the benefits of RWD and strategies for its 

responsible use. NIH also seeks to better 

understand community perspectives on 

the potential value and constraints— 

including scientific, administrative, 

legal, business, and bioethical—for the 

increased use of RWD in biomedical and 

behavioral research. 

Response to this RFI is voluntary and 

may be submitted anonymously. 

Respondents are free to address any or 

all topics listed below, as well as other 

relevant topics, for NIH’s consideration. 

1. Scientific value and quality 

considerations for collection, use, and 

sharing of RWD in biomedical and 

behavioral research. NIH seeks broad 

input on how RWD is acquired and used 

in NIH-funded research, the 

demonstrated and anticipated value of 

RWD in research, and opportunities and 

challenges related to data standards and 

quality, representativeness, and 

potential biases for using RWD in 

research. Additionally, NIH is seeking 

information on: 

(a) Biomedical and behavioral 

research questions that could be 

investigated using RWD, including 

novel unanticipated insights that have 

been enabled by using RWD in research. 

(b) Barriers to using RWD in research, 

such as bias, underrepresentation of 

populations in data, and technical 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 187 / Thursday, September 28, 2023 / Notices 66861 

issues of data harmonization and 

linkage. 

2. Using RWD as part of the scientific 

paradigm, including open science, 

scientific rigor and reproducibility, and 

team science. NIH seeks broad input on 

the opportunities and challenges related 

to using RWD as part of the scientific 

process. 

(a) Approaches or methods for using 

RWD in collaborative teams and 

ensuring reproducibility. 

(b) How do researchers assess the 

validation and verification of RWD data 

that is used in research. 

(c) Appropriate open science practices 

and use of the FAIR principles (https:// 

www.nature.com/articles/sdata201618) 

for research using RWD and approaches 

for maximizing appropriate data sharing 

when expected by the NIH Policy for 

Data Management and Sharing (https:// 

sharing.nih.gov/data-management-andsharing-policy) or other policies. 

3. Administrative and logistical 

considerations for collecting, using, and 

sharing RWD for biomedical and 

behavioral research. NIH seeks broad 

input on the opportunities and 

challenges related to the process of 

acquiring, using, and making RWD 

available for biomedical and behavioral 

research, including: 

(a) Pros and cons of various 

approaches for obtaining RWD through 

algorithms, purchasing RWD through 

trusted parties, accessing RWD through 

secure enclaves, etc. 

(b) Considerations regarding 

licensing, costs, third party 

involvement, and restrictions for data 

use and sharing. 

(c) Availability/utility of emerging deidentification technologies and data 

storage/sharing considerations. 

4. Ethical considerations for using 

RWD for biomedical and behavioral 

research. NIH seeks broad input on the 

opportunities and challenges related to 

potential bioethical issues regarding the 

collection, use, and sharing of RWD, 

including: 

(a) Strategies for protecting 

participant privacy and autonomy. 

(b) Potential re-identification risks for 

RWD, including the technical feasibility 

of re-identifying linked data and the 

possibility of anonymity for patients, 

research participants, and their families. 

(c) Ethical implications of data as a 

‘‘commodity’’, in terms of buying and 

selling personal health data. 

This RFI is for planning purposes 

only and should not be construed as a 

solicitation for applications or 

proposals, or as an obligation in any 

way on the part of the United States 

Government. The Government will not 

pay for the preparation of any 

information submitted or for the 

Government’s use. Additionally, the 

Government cannot guarantee the 

confidentiality of the information 

provided. 

Dated: September 21, 2023. 

Tara A. Schwetz, 

Acting Principal Deputy Director, National 

Institutes of Health. 

[FR Doc. 2023–21239 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Establishment of the Social and 

Community Influences on Health 

Integrated Review Group 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

1001–1014), the Director, National 

Institutes of Health (NIH) announces the 

establishment of the Social and 

Community Influences on Health 

Integrated Review Group (IRG) as 

authorized by 42 U.S.C. 282(b)(16), 

section 402(b)(16) of the Public Health 

Service Act, as amended. 

The Director, NIH, has determined 

that the Social and Community 

Influences on Health IRG is in the 

public interest in connection with the 

performance of duties imposed on NIH 

by law, and that these duties can best be 

performed through the advice and 

counsel of the committee. 

The committee provides advice and 

recommendations on funding 

applications and proposals, including 

but not limited to, the scientific and 

technical merit of applications for 

grants-in-aid for research, research 

training, or research-related grants and 

cooperative agreements, or contract 

proposals relating to scientific areas 

relevant to social, interpersonal, 

community, and cultural influences on 

health, development, and well-being 

across the life span. 

Inquiries may be directed to Claire 

Harris, Director, Office of Federal 

Advisory Committee Policy, Office of 

the Director, National Institutes of 

Health, 6701 Democracy Boulevard, 

Suite 1000, Bethesda, Maryland 20892 

(Mail code 4875), Telephone (301) 496– 

2123, or Claire.Harris@nih.gov. 

Dated: September 21, 2023. 

Lawrence A. Tabak, 

Acting NIH Director, National Institutes of 

Health. 

[FR Doc. 2023–21234 Filed 9–27–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Board of Scientific 

Counselors, National Cancer Institute. 

This meeting will be a hybrid meeting 

held in-person and virtually and will be 

open to the public as indicated below 

with attendance limited to space 

available. Individuals who plan to 

attend in-person or view the virtual 

meeting and need special assistance or 

other reasonable accommodations, 

should notify the Contact Person listed 

below in advance of the meeting. The 

open session can be accessed from the 

NIH Videocast at the following link: 

http://videocast.nih.gov/. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in sections 

552b(c)(6), title 5 U.S.C., as amended for 

the review, discussion, and evaluation 

of individual intramural programs and 

projects conducted by the National 

Cancer Institute, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, National Cancer Institute. 

Date: November 13, 2023. 

Open: 10:00 a.m. to 10:30 a.m. 

Agenda: Remarks from the NCI Director. 

Closed: 10:30 a.m. to 4:00 p.m. 

Agenda: Personnel qualifications and 

performance, and competence of individual 

investigators. 

Name of Committee: Board of Scientific 

Counselors, National Cancer Institute. 

Date: November 14, 2023. 

Closed: 11:00 a.m. to 1:45 p.m. 

Agenda: Personnel qualifications and 

performance, and competence of individual 

investigators. 

Place: National Institute of Health, 

Building 31, C Wing, 6th Floor, Conference 

Room C, 9000 Rockville Pike, Bethesda, MD 

20892 (Hybrid Meeting). 

Contact Person: Brian E. Wojcik, Ph.D., 

Senior Review Administrator, Institute 

Review Office, Office of the Director, 

National Cancer Institute, National Institutes 

of Health, 9609 Medical Center Drive, Room 

3W414, Rockville, MD 20850, 240–276–5660, 

wojcikb@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 


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