89646 Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Sec. 806 [42 U.S.C. 2991d– 

1](a)(1) and Sec. 811 [42 U.S.C. 2992]. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–26230 Filed 11–12–24; 8:45 am] 

BILLING CODE 4184–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5057] 

Public Workshop on Optimizing the 

Use of Real-World Evidence in 

Regulatory Decision-Making for Drugs 

and Biological Products—Looking 

Forward; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a public workshop titled 

‘‘Optimizing the Use of Real-World 

Evidence in Regulatory DecisionMaking for Drugs and Biological 

Products—Looking Forward.’’ The 

purpose of the public workshop is to 

provide interested parties with an 

update on FDA’s current activities 

related to real-world evidence (RWE) 

and to share accomplishments, ongoing 

challenges, and future opportunities. 

The public workshop will discuss 

potential next steps to promote the 

continued evolution and consistent 

application of real-world data (RWD) in 

drug development. This public 

workshop will be convened and 

supported by a cooperative agreement 

between FDA and the Duke University, 

Duke-Margolis Institute for Health 

Policy. 

DATES: The public workshop will be 

held on December 12, 2024, from 12:30 

p.m. to 5 p.m., Eastern Time. Either 

electronic or written comments on this 

public workshop must be submitted by 

January 13, 2025. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held in-person at the Bethesda North 

Marriott & Conference Center, 5701 

Marinelli Rd., North Bethesda, MD 

20852 and virtually using the Zoom 

platform. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of January 13, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

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–N–5057 for ‘‘Optimizing the Use 

of Real-World Evidence in Regulatory 

Decision-Making for Drugs and 

Biological Products—Looking Forward.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: 

Dianne Paraoan, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–3161, 

Dianne.Paraoan@fda.hhs.gov or CDERRWE@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The volume and complexity of RWD 

available to support drug development 

have increased substantially over the 

past several decades. This increase, 

combined with enhanced computing 

power and emerging technologies, is 

transforming how drugs are developed. 


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Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 89647 

FDA published a ‘‘Framework for FDA’s 

Real-World Evidence Program’’ 

(Framework) (https://www.fda.gov/ 

media/120060/download?attachment) 

for drugs and biological products in 

2018. This Framework describes a 

multifaceted FDA program to evaluate 

the potential use of RWE in regulatory 

decision-making to help support the 

approval of a new indication for a drug 

already approved under section 505(c) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(c)) or to help support 

or satisfy drug post-approval study 

requirements. As described below, the 

growing reliance on RWD to assess 

pharmaceutical use, safety and 

effectiveness, and use of new 

technologies in these analyses will 

influence the generation of RWE to 

support regulatory decision-making. 

FDA’s RWE Program for drugs and 

biological products involves multiple 

components: guidance development to 

assist developers interested in using 

RWD to develop RWE and to support 

Agency decisions; internal processes 

that involve senior leadership in the 

evaluation of RWE and promote shared 

learning and consistency in applying 

the Framework; demonstration projects 

with a focus on evaluating/improving 

data quality and use of RWD, advancing 

study design, and developing rigorous 

evaluation tools; and external 

engagement, including listening 

sessions, presentations, publications, 

and international collaborations. In 

addition, the seventh iteration of the 

Prescription Drug User Fees Act 

included new RWE-related provisions, 

including the Advancing RWE Program 

that enables early discussions with 

sponsors regarding RWE-based study 

proposals and greater transparency 

around the submission of RWE to the 

Center for Drug Evaluation and Research 

(CDER) and the Center for Biologics 

Evaluation and Research. In related 

work, FDA has published guidance 

documents and/or discussion papers on 

digital health technologies and the use 

of artificial intelligence (AI). 

These activities lay a foundation for 

expansion of the use of RWD in 

evidence generation, but continued 

growth of these efforts requires 

increased coordination, knowledge 

management, internal support 

(including training), external visibility, 

and external engagement. 

II. Topics for Discussion at the Public 

Workshop 

FDA supports the continued 

evolution of using RWD to generate 

RWE that can support pre- and postmarket regulatory decision-making at 

FDA for drugs and biological products. 

Topics for this public workshop will 

focus on FDA’s current activities around 

RWE, ongoing accomplishments and 

challenges, and future opportunities. 

Advancing existing priorities and 

activities of the RWE Program remains 

a focus area, including promoting 

consistency in review processes of 

submissions that contain RWE, and 

leveraging the full potential of RWD as 

well as emerging technologies to inform 

the effectiveness and safety of drugs and 

biological products. 

To help facilitate the future direction 

of the RWE Program, FDA seeks input 

on the following questions. 

1. Regulators, sponsors, and other 

interested parties are gaining experience 

with RWE in regulatory submissions. 

What are critical issues that need to be 

addressed to further advance the use of 

RWE in regulatory decision-making for 

drugs and biological products? 

2. To advance our understanding of 

RWE, FDA has funded various 

demonstration (research) projects on 

topics such as RWD sources, study 

designs, and specific ‘‘tools.’’ What 

research priorities, including emerging 

technologies and AI, should CDER 

consider supporting? 

3. FDA has published RWD/RWE 

guidance documents focused on data 

considerations, study design, and 

regulatory considerations. What 

additional topics could be prioritized 

for consideration? 

4. FDA has utilized various 

mechanisms (e.g., public meetings, 

webinars, ‘‘listening sessions’’) to 

engage interested parties; the Agency 

has also facilitated discussions with 

international regulators. What are 

optimal communication and 

engagement strategies to interact with 

the external community regarding RWE? 

III. Participating in the Public 

Workshop 

Registration: To register for this 

hybrid public workshop, please visit the 

following website: https://duke.is/6/ 

y7t5. Please register for either in-person 

or virtual attendance and provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop inperson must register by December 6, 

2024, 11:59 p.m. Eastern Time. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. Registrants will 

receive confirmation when they have 

been accepted. 

If you need special accommodations 

due to a disability, please contact Luke 

Durocher at luke.durocher@duke.edu no 

later than December 6, 2024. 

Streaming of the Public Workshop: 

This public workshop will also be 

available via Zoom webinar to virtual 

attendees who register at https://

duke.is/6/y7t5. For more information 

about Zoom, please visit https://

support.zoom.us/hc/en-us/articles/ 

206175806-Frequently-asked-questions. 

Notice of this workshop is given 

pursuant to 21 CFR 10.65. 

Dated: November 6, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26297 Filed 11–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–P–2514] 

Determination That NUPLAZID 

(Pimavanserin Tartrate) Tablet, 

Equivalent 17 Milligram Base, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that NUPLAZID 

(pimavanserin tartrate) tablet, 

equivalent (EQ) 17 milligram (mg) base, 

was not withdrawn from sale for reasons 

of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for NUPLAZID 

(pimavanserin tartrate) tablet, EQ 17 mg 

base, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 


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