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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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tablet, EQ 17 mg base, was withdrawn 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 219 / Wednesday, November 13, 2024 / Notices 89649 

administering FDA regulations 

pertaining to the manufacturing/ 

processing, packing, or holding of food 

for consumption in the United States. 

The Produce Regulatory Program 

Standards (PRPS) are the result of 

external collaboration and coordination 

with the Association of Food and Drug 

Officials (AFDO), the National 

Association of State Departments of 

Agriculture (NASDA), and state produce 

regulatory programs. FDA, NASDA, 

AFDO, and states worked 

collaboratively to develop the content of 

the PRPS. A copy of the standards and 

accompanying worksheets and forms is 

available in the Federal Register docket 

for this notice. We recommend that 

State and Territorial produce safety 

regulatory programs use these program 

standards as the framework to design 

and manage their produce safety 

regulatory programs. The states that 

assisted in the development of PRPS 

were representative of the 43 State and 

Territorial programs regulatory 

programs enrolled currently conducting 

produce safety inspections via funding 

from a cooperative agreement grant, 

‘‘The FDA’s Cooperative Agreement 

Program for States and Territories to 

Implement a National Produce Safety 

Program, PAR–21–174,’’ (this program 

also includes 4 programs which do not 

conduct inspections). For more 

information on this cooperative 

agreement, we invite you to visit our 

website at: https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/grants-and-cooperativeagreements/fda-state-produce-safetyimplementation-cooperative-agreementprogram. 

The PRPS identifies and includes 

resource and training material for the 

following standards: regulatory 

foundations; training; inspection; 

product-specific illnesses, outbreaks 

and hazard response; compliance and 

enforcement; industry and community 

relations; program assessments; and 

product sampling and testing. We 

recommend using the worksheets and 

forms contained in the standards, 

however, alternate forms that are 

equivalent may be used. The 

educational worksheets and resource 

materials include recordkeeping and 

reporting activities that help FDA verify 

participation and successful completion 

of the respective requirements. In the 

first year of enrollment, information is 

used to conduct a baseline selfassessment to determine whether the 

materials meet the elements of each 

standard. In subsequent years, we use 

the information to conduct a 

comprehensive review and evaluate 

program effectiveness and participation. 

We modify the program standards based 

on the ongoing assessments as well as 

comments and informal feedback 

obtained from participants. 

Description of Respondents: 

Respondents are State Departments of 

Agriculture or Health regulatory 

officials who enroll in the PRPS (State 

or Territorial governments). Currently 

we estimate 43 respondents to the 

information collection based on 

expected participation. 

In the Federal Register of June 28, 

2024 (89 FR 54009), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

that did not pertain to the information 

collection. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Respondent Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

State or Territorial Governments; Maintenance of data 

records consistent with the PRPS ................................... 48 11 528 85.36 45,072 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: October 30, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26209 Filed 11–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Charter Renewal for the Advisory 

Committee on Heritable Disorders in 

Newborns and Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

Department of Health and Human 

Services is hereby giving notice that the 

Advisory Committee on Heritable 

Disorders in Newborns and Children 

(ACHDNC) charter has been renewed. 

DATES: The effective date of charter 

renewal is November 10, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Leticia Manning, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, 18N38A, Rockville, Maryland 

20857; 301–443–8335; or lmanning@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of Health and Human 

Services (Secretary) on the development 

of newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices, 

recommends improvements in the 

national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

conditions for screening on the 

Recommended Uniform Screening 

Panel, following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is 1 

year from the Secretary’s adoption of the 

condition for screening. 

The charter renewal for the ACHDNC 

was approved on October 29, 2024. The 

filing date is November 10, 2024. 

Renewal of the ACHDNC charter 


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