76482 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; Soma Kalb, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G318, 

Silver Spring, MD 20993–0002, 301– 

796–6359; or Paul Kluetz, Oncology 

Center of Excellence, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 22, Rm. 2223, Silver 

Spring, MD 20993, 301–796–9567. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Conducting Clinical Trials With 

Decentralized Elements.’’ Section 

3606(a) of the Consolidated 

Appropriations Act, 2023 directs FDA to 

issue a final guidance that includes 

recommendations to clarify and advance 

the use of DCTs to support the 

development of drugs and devices. This 

guidance fulfills the requirements set 

forth in section 3606(a)(2) of the 

Consolidated Appropriations Act, 2023. 

The content described in section 

3606(b) of the Consolidated 

Appropriations Act, 2023 is further 

addressed through this guidance’s 

reference to FDA’s guidance for 

industry, investigators, and other 

stakeholders entitled ‘‘Digital Health 

Technologies for Remote Data 

Acquisition in Clinical Investigations’’ 

(December 2023). 

In this guidance, a decentralized 

clinical trial (DCT) refers to a clinical 

trial that includes decentralized 

elements where trial-related activities 

occur at locations other than traditional 

clinical trial sites. These trial-related 

activities may take place at the location 

of trial participants (e.g., their homes) or 

in local healthcare facilities that are 

close to trial participants’ locations. 

FDA’s regulatory requirements are the 

same for trials that include 

decentralized elements and trials that 

do not include decentralized elements. 

DCTs may include the use of local 

healthcare providers and local clinical 

laboratory facilities in the management 

of trial participants and the use of 

telehealth and digital health 

technologies to acquire data remotely. 

By allowing remote participation and 

reducing the need to travel for face-toface visits, DCTs may enhance 

convenience for study participants, 

facilitate research on diseases affecting 

populations with limited mobility, and 

reduce the burden on caregivers. 

This guidance provides 

recommendations related to the 

incorporation of decentralized elements 

into clinical trials, including: (1) DCT 

design, conduct, and oversight; (2) 

conduct of remote clinical trial visits 

and activities including the use of local 

HCPs; (3) use of digital health 

technologies in DCTs; (4) the roles of 

sponsors and investigators in DCTs; (5) 

informed consent and institutional 

review board oversight of DCTs; (6) 

types of investigational products 

appropriate for study in DCTs; (7) 

packaging and shipping of 

investigational products in DCTs; (8) 

processes and procedures to ensure 

participant safety; and (9) use of 

software in DCTs. 

This guidance finalizes the draft 

guidance entitled ‘‘Decentralized 

Clinical Trials for Drugs, Biological 

Products, and Devices’’ issued on May 

3, 2023 (88 FR 27900). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance include: (1) removal of 

language regarding the requirement to 

maintain a task log of local HCPs, (2) 

clarification about challenges related to 

data variability in DCTs, (3) updates to 

responsibilities for ensuring 

qualifications of local HCPs, and (4) 

clarifications on the need for a physical 

location for inspections. In addition, 

editorial changes were made to improve 

clarity. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Conducting 

Clinical Trials With Decentralized 

Elements.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 11 pertaining to electronic 

records and signatures have been 

approved under OMB control number 

0910–0303. The collections of 

information in 21 CFR part 312 

pertaining to investigational new drug 

applications, including Form FDA 1572, 

have been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 812 

pertaining to investigational device 

exemption applications have been 

approved under OMB control number 

0910–0078. The collections of 

information in 21 CFR parts 50 and 56 

pertaining to the protection of human 

subjects, informed consent, and 

institutional review boards have been 

approved under OMB control number 

0910–0130. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/regulatory-information/

search-fda-guidance-documents, 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ 

biologics-guidances, or https://

www.regulations.gov. 

Dated: September 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21078 Filed 9–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–2052] 

Integrating Randomized Controlled 

Trials for Drug and Biological Products 

Into Routine Clinical Practice; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Integrating Randomized Controlled 

Trials for Drug and Biological Products 

Into Routine Clinical Practice.’’ FDA is 

publishing this draft guidance as part of 

a series of guidance documents under 

its Real-World Evidence (RWE) Program 

and to satisfy, in part, a mandate under 

the Federal Food, Drug, and Cosmetic 

Act to issue guidance about the use of 

RWE in regulatory decision-making. 

This draft guidance is intended to 

support the conduct of randomized 

controlled drug trials with streamlined 

protocols and procedures that can 

integrate research into routine clinical 

practice. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 17, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 76483 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–2052 for ‘‘Integrating 

Randomized Controlled Trials for Drug 

and Biological Products Into Routine 

Clinical Practice.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Heather Stone, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3348, 

Silver Spring, MD 20993–0002, 301– 

796–2274, Heather.Stone@fda.hhs.gov; 

or James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Integrating Randomized Controlled 

Trials for Drug and Biological Products 

Into Routine Clinical Practice.’’ This 

draft guidance is intended to support 

the conduct of randomized controlled 

drug trials with streamlined protocols 

and procedures that focus on essential 

data, allowing integration of research 

into routine clinical practice. Depending 

on the condition and the intervention to 

be studied, the spectrum of trial designs 

may range from those that are almost 

completely reliant on data acquired by 

the participant’s local healthcare 

providers during routine clinical 

practice visits to those that require 

significant supplementation with 

dedicated, research-specific activities 

for data collection conducted by trial 

staff. 

Traditional randomized controlled 

drug trials typically capture a large 

amount of protocol-specified patient 

information (e.g., patient characteristics, 

medical history, concomitant 

medications, vital signs, adverse events, 

laboratory results, measures of drug 

response, clinical status) at baseline and 

over the course of the trial. Some of 

these data are also collected in routine 

clinical practice, although the specific 

procedures and methods, timing of 

collection, and documentation formats 

typically differ from those in a clinical 

trial. Given the potential overlap in 

information collected, data for clinical 

research can, under appropriate 

circumstances, be obtained from routine 

clinical practice interactions, reducing 

the need for dedicated trial sites. 

This draft guidance applies to studies 

involving FDA-approved drugs being 

studied for new indications, 

populations, or doses; drug safety 

studies for FDA-approved drugs; other 

postmarketing studies; comparative 

effectiveness studies; and trials of 

unapproved drugs in later development 

when the safety profile is sufficiently 

characterized and the drug is 

appropriate to be administered and 

managed in the setting of routine 

clinical practice. This guidance does not 

address non-interventional 

(observational) studies. 

Among other things, the draft 

guidance provides considerations 


khammond on DSKJM1Z7X2PROD with NOTICES
76484 Federal Register / Vol. 89, No. 181 / Wednesday, September 18, 2024 / Notices 

regarding the roles and responsibilities 

of sponsors, investigators, healthcare 

institutions, and local healthcare 

providers and addresses using a quality 

by design approach to facilitate the 

conduct of trials in the clinical practice 

setting. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Integrating Randomized Controlled 

Trials for Drug and Biological Products 

Into Routine Clinical Practice.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; and the collections 

of information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 12, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21077 Filed 9–17–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Notice of Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; Cohort 

Studies of HIV/AIDS and Substance Use. 

Date: November 4, 2024. 

Time: 10:00 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Soyoun Cho, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC 6021, 

Bethesda, MD 20892, (301) 594–9460, 

Soyoun.cho@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Engaging Survivors of Sexual Violence and 

Trafficking in HIV and Substance Use 

Disorder Services. 

Date: November 6, 2024. 

Time: 11:30 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Marisa Srivareerat, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Office of Extramural Policy, National 

Institute on Drug Abuse, NIH, 301 North 

Stonestreet Avenue, MSC 6021, Bethesda, 

MD 20892, (301) 435–1258, 

marisa.srivareerat@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Harnessing Artificial Intelligence and 

Polypharmacology to Discover 

Pharmacotherapeutics for Substance Use 

Disorders. 

Date: November 13, 2024. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Devon Rene Oskvig, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC 6021, 

Bethesda, MD 20892, (301) 402–6965, 

devon.oskvig@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: September 12, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21152 Filed 9–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Basic 

Mechanisms of Cancer Health Disparities 

Study Section. 

Date: October 15–16, 2024. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Amy L Rubinstein, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5152, 

MSC 7844, Bethesda, MD 20892, 301–408– 

9754, email: rubinsteinal@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 


khammond on DSKJM1Z7X2PROD with NOTICES