83504 Federal Register / Vol. 89, No. 200 / Wednesday, October 16, 2024 / Notices 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Assessing Adoption and 

Implementation of the National Institute 

of Occupational Safety and Health’s 

(NIOSH) Outputs—New—National 

Institute of Occupational Safety and 

Health’s (NIOSH), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The Centers for Disease Control and 

Prevention (CDC), National Institute for 

Occupational Safety and Health 

(NIOSH), is requesting approval of a 

new Generic information collection for 

a period of three years under the project 

titled, ‘‘Assessing Adoption and 

Implementation of the National Institute 

of Occupational Safety and Health’s 

(NIOSH) Outputs.’’ 

With the continuation of the 

Government Performance and Results 

Act and the more recent passage of the 

Foundations of Evidence-Based Policy 

Making Act, there is an increased need 

for federal agencies to measure and 

demonstrate their impact. However, 

measuring impact is challenging, 

especially for organizations that have a 

science-driven mission because of the 

time it takes to move from basic to 

applied research. Demonstrating 

attribution (cause and effect 

relationships) is particularly challenging 

for research organizations. 

NIOSH research is often designed to 

collect implementation and adoption 

data through document reviews of 

NIOSH records, including grantee final 

reports, and through interviews with 

NIOSH researchers (federal employees). 

While commonly recognized metrics, 

these data sources are not 

comprehensive, representative, or 

informative of the adoption and 

implementation of NIOSH products and 

efforts. Further, the design and 

execution of research projects has 

hindered research and program leaders 

prioritizing information collections to 

understand and assess the adoption and 

implementation of research efforts and 

products. 

The proposed generic information 

collection package would allow 

researchers to expeditiously pursue 

efforts to provide NIOSH with critical 

information to inform mission-driven 

needs. Additionally, the proposed 

efforts go beyond simply measuring 

customer satisfaction and rather seek to 

advance NIOSH’s burden, need, and 

impact framework for future research 

while also endeavoring to execute the 

Office of Management and Budget’s 

(OMB) guidance regarding the 

Foundations of Evidence-Based 

Policymaking Act. 

Respondents are expected to consist 

of users and potential users of NIOSH 

products including subject matter 

expects, former NIOSH funding 

recipients, and intermediary and end 

users. CDC requests OMB approval for 

an estimated 17,150 total burden hours 

with an estimated annual burden of 

6,069 hours. There is no cost to 

respondents other than their time to 

participate. 

Estimated Annualized Burden Hours 

Type of respondent 

Type of data 

collection 

instrument 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Subject matter experts .................................... Survey instrument (single, pre and post, or 

poll) including demographics.

5,000 1 20/60 

Informed consent form ................................... 250 1 5/60 

Interview or focus group guide ...................... 250 1 1 

Former NIOSH funding recipients .................. Survey instrument (single, pre and post, or 

poll) including demographics.

200 1 20/60 

Informed consent form ................................... 25 1 5/60 

Interview or focus group guide ...................... 25 1 1 

Intermediary or end users (e.g., employers, 

workers, manufactures, labor/professional 

associations, policymakers).

Survey instrument (single, pre and post, or 

poll) including demographics.

10,000 1 20/60 

Informed consent form ................................... 650 1 5/60 

Interview or focus group guide ...................... 650 1 1 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–23859 Filed 10–15–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–P–4163] 

Determination That NOXAFIL 

(Posaconazole) Delayed-Release 

Tablets, 100 Grams 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, Agency, or we) 

has determined that NOXAFIL 

(posaconazole) delayed-release tablets, 

100 grams (g), was not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

this drug product, and it will allow FDA 

to continue to approve ANDAs that refer 

to the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: Awo 

Archampong-Gray, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 


lotter on DSK11XQN23PROD with NOTICES1
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 


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