Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 83505 

Hampshire Ave., Bldg. 51, Rm. 6243, 

Silver Spring, MD 20993–0002, 301– 

796–0110, Awo.Archampong-Gray@

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 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

NOXAFIL (posaconazole) delayedrelease tablets, 100 g, is the subject of 

NDA 205053, held by Merck Sharp & 

Dohme Corp., and initially approved on 

November 25, 2013. Noxafil delayedrelease tablets are indicated for the 

treatment of invasive aspergillosis in 

adults and pediatric patients 13 years of 

age and older. In addition, NOXAFIL is 

indicated for the prophylaxis of invasive 

Aspergillus and Candida infections in 

patients who are at high risk of 

developing these infections due to being 

severely immunocompromised, such as 

hematopoietic stem cell transplant 

recipients with graft-versus-host disease 

or those with hematologic malignancies 

with prolonged neutropenia from 

chemotherapy as follows; for NOXAFIL 

delayed-release tablets: adults and 

pediatric patients 2 years of age and 

older who weigh greater than 40 

kilograms. 

NOXAFIL (posaconazole) delayedrelease tablets, 100 g, is currently listed 

in the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Aizant Drug Research Solutions 

Private Limited, submitted a citizen 

petition dated September 2, 2024 

(Docket No. FDA–2024–P–4163), and 

amended on September 4, 2024, under 

21 CFR 10.30, requesting that the 

Agency determine whether NOXAFIL 

(posaconazole) delayed-release tablets, 

NDA 205053 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 NOXAFIL (posaconazole) 

delayed-release tablets, 100 g, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that NOXAFIL 

(posaconazole) delayed-release tablets, 

100 g, was withdrawn for reasons of 

safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of NOXAFIL 

(posaconazole) delayed-release tablets, 

100 g, 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 NOXAFIL 

(posaconazole) delayed-release tablets, 

100 g, 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. 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: October 9, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23811 Filed 10–15–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0281] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before November 15, 

2024. 

ADDRESSES: Submit your comments to 

Sherrette.Funn@hhs.gov or by calling 

(202) 795–7714. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 0990–0281–30D 

and project title for reference, to 

Sherrette A. Funn, email: 

Sherrette.Funn@hhs.gov, or call (202) 

795–7714 the Reports Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Prevention 

Communication Formative Research. 

Type of Collection: Extension. 

OMB No: 0990–0281—Office of 

Disease Prevention and Health 

Promotion. 

Abstract: The Office of Disease 

Prevention and Health Promotion 

(ODPHP) is focused on developing and 

disseminating health information to the 

public. ODPHP faces an increasingly 

urgent interest in finding effective ways 

to communicate health information to 


lotter on DSK11XQN23PROD with NOTICES1
83506 Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 

America’s diverse population. ODPHP 

strives to be responsive to the needs of 

America’s diverse audiences while 

simultaneously serving all Americans 

across a range of channels, from print to 

new communication technologies. To 

carry out prevention information efforts, 

ODPHP is committed to conducting 

formative and usability research to 

provide guidance on the development 

and implementation of their 

communication and education efforts. 

The information collected will be used 

to improve communication, products, 

and services that support key office 

activities including: Healthy People, 

Dietary Guidelines for Americans, Food 

Is Medicine, Physical Activity 

Guidelines for Americans, 

MyHealthfinder, the Move Your Way®

Campaign, the President’s Council on 

Sports, Fitness & Nutrition, health 

literacy and healthy aging. ODPHP 

communicates through its website 

(www.health.gov) and through other 

channels including social media, print 

materials, interactive training modules, 

and reports. This request builds on 

previous formative research approaches 

to place more emphasis on Web-based 

data collection to allow greater 

geographical diversity among 

respondents, to decrease respondent 

burden, and to save government costs. 

Data collection will be qualitative and 

quantitative and may include in-depth 

interviews, focus groups, web-based 

surveys, omnibus surveys, card sorting, 

and various forms of usability testing of 

materials and interactive tools to assess 

the public’s understanding of disease 

prevention and health promotion 

content, responses to prototype 

materials, and barriers to effective use. 

The program is requesting a 3-year 

extension of its clearance. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

In-depth interviews—Screener ............................................................................ 500 1 10/60 83 

In-depth interviews—Instrument .......................................................................... 167 1 1.00 167 

Focus groups—Screener ..................................................................................... 975 1 10/60 162.5 

Focus groups—Instrument .................................................................................. 325 1 1.50 487.5 

Intercept interviews .............................................................................................. 1750 1 5/60 146 

Cognitive testing of instruments—Screener ........................................................ 50 1 10/60 8 

Cognitive testing of instruments—Cognitive test ................................................. 17 1 2.00 34 

Web-based surveys—Screener ........................................................................... 10,000 1 5/60 833 

Web-based surveys—Survey .............................................................................. 3,333 1 15/60 833 

Omnibus surveys ................................................................................................. 700 1 10/60 117

Gatekeeper reviews ............................................................................................. 109 1 30/60 54 

Card sorting—Screener ....................................................................................... 200 1 10/60 33 

Card sorting—Card sort ....................................................................................... 67 1 1.00 67 

Usability and prototype testing of materials (print and web)—Screener ............. 600 1 10/60 100 

Usability and prototype testing of materials (print and web)—usability tests ..... 208 1 1.00 208 

Total .............................................................................................................. ...................... .......................... .................... 3,333 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2024–23795 Filed 10–15–24; 8:45 am] 

BILLING CODE 4150–32–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: Center for Scientific 

Review Special Emphasis Panel; Basic 

Biology of Blood, Heart, and Vasculature. 

Date: November 7, 2024. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Aisha Lanette Walker, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, 6701 Rockledge Drive, 

Bethesda, MD 20892, 301–594–3527, 

aisha.walker@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Oncology. 

Date: November 7–8, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Reigh-Yi Lin, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Rm. 4152, 

MSC 7846, Bethesda, MD 20892, (301) 827– 

6009, lin.reigh-yi@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; S10 

Instrumentation: Flow Cytometry. 

Date: November 7, 2024. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Jessica Smith, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 402–3717, jessica.smith6@

nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Pathogenic Eukaryotes. 

Date: November 7, 2024. 

Time: 2:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


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