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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89648 Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

NUPLAZID (pimavanserin tartrate) 

tablet, EQ 17 mg base, is the subject of 

NDA 207318, held by Acadia 

Pharmaceuticals, Inc., and initially 

approved on April 29, 2016. NUPLAZID 

is an atypical antipsychotic indicated 

for the treatment of hallucinations and 

delusions associated with Parkinson’s 

disease psychosis. 

In a letter dated January 8, 2019, 

Acadia Pharmaceuticals, Inc., notified 

FDA that NUPLAZID (pimavanserin 

tartrate) tablet, EQ 17 mg base, was 

being discontinued, and FDA moved the 

drug product to the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Zydus Pharmaceuticals (USA), Inc., 

submitted a citizen petition dated May 

22, 2024 (Docket No. FDA–2024–P– 

2514), under 21 CFR 10.30, requesting 

that the Agency determine whether 

NUPLAZID (pimavanserin tartrate) 

tablet, EQ 17 mg base, was withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that NUPLAZID 

(pimavanserin tartrate) tablet, EQ 17 mg 

base, was not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that NUPLAZID 

(pimavanserin tartrate) tablet, EQ 17 mg 

base, was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of 

NUPLAZID (pimavanserin tartrate) 

tablet, EQ 17 mg base, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list NUPLAZID 

(pimavanserin tartrate) tablet, EQ 17 mg 

base, in the ‘‘Discontinued Drug Product 

List’’ section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to NUPLAZID (pimavanserin tartrate) 

oral tablet, EQ 17 mg base, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: November 6, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26318 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–N–2275] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Produce 

Regulatory Program Standards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by December 

13, 2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

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. The title 

of this information collection is Produce 

Regulatory Program Standards. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

JonnaLynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A–12M, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Produce Regulatory Program Standards 

OMB Control Number 0910–NEW 

This information collection helps 

establish and implement FDA’s 

‘‘Produce Regulatory Program 

Standards.’’ Section 1012 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

399c) authorizes FDA to administer 

training and education programs for 

employees of State, local, Territorial, 

and Tribal food safety authorities 

relating to regulatory programs. Also, 

under section 205 of the FDA Safety 

Modernization Act (codified in 21 

U.S.C. 2224), FDA, together with the 

Centers for Disease Control and 

Prevention is directed to enhance 

foodborne illness surveillance to 

improve the collection, analysis, 

reporting, and usefulness of data on 

foodborne illnesses. As part of this 

effort, we have initiated programs that 

include developing and instituting 

regulatory standards intended to reduce 

the risk of foodborne illness through 

coordinated efforts with our strategic 

partners. Regulatory program standards 

establish a uniform foundation for the 

design and management of State, local, 

Tribal, and Territorial programs that 

have the responsibility for regulating 

human and animal food. Partnering 

with other regulatory officials also helps 

maximize limited resources in 


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