Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 1497 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

National Program of Cancer Registries 

Cancer Surveillance System (OMB 

Control No. 0920–0469, Exp. 1/31/ 

2026)—Revision—National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

In 2021, the most recent year for 

which complete incidence information 

is available, almost 620,000 people died 

of cancer and more than 1.8 million 

were diagnosed with cancer. It is 

estimated that 17 million Americans are 

currently alive with a history of cancer. 

In the U.S., State/Territory-based central 

cancer registries (CCR) are the only 

method for systematically collecting and 

reporting population-based information 

about cancer incidence and outcomes 

such as survival. These data are used to 

measure the changing incidence and 

burden of each cancer; identify 

populations at increased or increasing 

risk; target preventive measures; and 

measure the success or failure of cancer 

control efforts in the United States. 

In 1992, Congress passed the Cancer 

Registries Amendment Act which 

established the National Program of 

Cancer Registries (NPCR). The NPCR 

provides support for State/Territorybased cancer registries that collect, 

manage, and analyze data about cancer 

cases. The State/Territory-based cancer 

registries report information to CDC 

through the National Program of Cancer 

Registries Cancer Surveillance System 

(NPCR CSS), (OMB Control No. 0920– 

0469). CDC plans to request OMB 

approval to continue collecting this 

information for three years. Data 

definitions will be updated to reflect 

changes in national standards for cancer 

diagnosis and coding. No changes to the 

total estimated annualized burden hours 

or number of respondents are 

anticipated. 

The NPCR CSS allows CDC to collect, 

aggregate, evaluate, and disseminate 

cancer incidence data at the national 

level. The NPCR CSS is the primary 

source of information for the United 

States Cancer Statistics (USCS), which 

CDC has published annually since 2002. 

The latest USCS report published in 

2024 provided cancer statistics for 98% 

of the U.S. population from all cancer 

registries in the United States. Prior to 

the publication of USCS, cancer 

incidence data at the national level were 

available for only 14% of the population 

of the United States. The NPCR CSS also 

allows CDC to monitor cancer trends 

over time, describe geographic variation 

in cancer incidence throughout the 

country, and provide incidence data on 

populations by race, ethnicity, and other 

demographic and tumor characteristics 

and data on rare cancers. These 

activities and analyses further support 

CDC’s planning and evaluation efforts 

for state and national cancer control and 

prevention. In addition, datasets can be 

made available for secondary analysis. 

Respondents are NPCR-supported 

CCRs in 46 U.S. States, three Territories, 

and the District of Columbia. Fifty CCRs 

submit data elements specified for the 

Standard NPCR CSS Report. Each CCR 

is asked to transmit two data files to 

CDC per year. The first NPCR CSS 

Standard file, submitted in January, is a 

preliminary report consisting of one 

year of data for the most recent year of 

available data. CDC evaluates the 

preliminary data for completeness and 

quality and provides a report back to the 

CCR. The second NPCR CSS Standard 

file, submitted in November, contains 

cumulative cancer incidence data from 

the first diagnosis year for which the 

cancer registry collected data with the 

assistance of NPCR funds (e.g., 1995) 

through 12 months past the close of the 

most recent diagnosis year (e.g., 2022). 

The cumulative file is used for analysis 

and reporting. The burden for each file 

transmission is estimated at two hours 

per response. Because cancer incidence 

data are already collected and 

aggregated at the state level, the 

additional burden of reporting the 

information to CDC is small. 

All information is transmitted to CDC 

electronically. Participation is required 

as a condition of the cooperative 

agreement with CDC. CDC requests 

OMB approval for an estimated 200 

annual burden hours. There are no costs 

to respondents except their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Central Cancer Registries in States, 

Territories, and the District of Columbia.

Standard NPCR CSS Report ........... 50 2 2 200 

Total ........................................... ........................................................... ........................ ........................ ........................ 200 

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. 2025–00163 Filed 1–7–25; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2025–0002] 

Establishing a Road Map for 

Accelerated Diagnosis and Treatment 

of HCV Infection in the United States 

AGENCY: Centers for Disease Control and 

Prevention, Health, and Human Services 

(HHS). 

ACTION: Notice of public meeting and 

request for comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) 

announces a two-day convening hosted 

and facilitated by the Association of 

Public Health Laboratories (APHL) to 

discuss hepatitis C diagnostics. Leaders 

from public health, laboratory, medical, 

academic, and industry sectors will 

have the opportunity to provide 

individual input, without building a 

consensus, on accelerating the diagnosis 

of current hepatitis C virus (HCV) 


lotter on DSK11XQN23PROD with NOTICES1
1498 Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 

infection. Members of the public with 

interest and expertise in diagnosing 

HCV infection are also invited to 

provide individual input. Specifically, 

the convening will focus on how to 

leverage the following hepatitis C 

diagnostic methods: same-day diagnosis 

and treatment, and viral-first testing. 

The goal of the convening will be for 

each person to give their individual 

input, and not to build consensus. No 

discussions, recommendations, or 

advice to CDC will occur or be provided 

at the meeting. Day 1 will focus on the 

utility of point-of-care (POC) testing for 

accelerating same-day HCV diagnosis 

and rapid treatment i.nitiation. Day 2 

will focus on the utility of viral-first 

testing strategies for accelerating HCV 

diagnosis and treatment initiation in the 

United States. Following the meeting, 

APHL will prepare a meeting report 

summarizing the discussion and public 

comment received through 

regulations.gov, developed and 

documented as individual input to 

ensure thorough and complete input 

from partners. CDC and APHL will 

disseminate the APHL-prepared report 

as a reference for partners and industry 

to follow in developing and 

implementing future hepatitis C testing 

strategies. The final report will be added 

to docket CDC–2025–0002 once it is 

available. 

DATES: Written comments must be 

received on or before February 19, 2025. 

Times: February 11–12, 2025, 1:00– 

5:00 p.m. EST. 

Place: Virtual Meeting. 

To register for this virtual meeting on 

the public line (listen-only access), 

please use the following link: https://

webster.eventsair.com/hepatitis-2025- 

meeting/hcvattendee. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2025– 

0002 by either of the methods listed 

below. Do not submit comments by 

email. CDC does not accept comments 

by email. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Office of Policy and 

Communications, Division of Viral 

Hepatitis, National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention, Centers for Disease Control 

and Prevention, 1600 Clifton Road, MS 

US12–3 Atlanta, GA 30329–4018. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Maxwell R. Rowshandel, Office of 

Policy and Communications, Division of 

Viral Hepatitis, National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention, Centers for Disease Control 

and Prevention, 1600 Clifton Road, MS 

US12–3 Atlanta, GA 30329–4018, 

phone: 1 (202) 245–0627, email: 

dvhpolicy@cdc.gov. 

SUPPLEMENTARY INFORMATION: CDC 

announces a convening to discuss 

hepatitis C diagnostics. Interested 

parties are invited to provide public 

comment on regulations.gov in Docket 

CDC–2025–0002 on or before February 

19, 2025. 

Background 

More than 2.4 million adults in the 

United States are estimated to have 

hepatitis C virus (HCV) infection [Eric 

H, Hepatology 2024]. New infections 

continue to increase, primarily in 

association with injection drug use; 

nearly 67,400 cases of acute hepatitis C 

are estimated to have occurred in 2022 

[CDC 2022 VH Surv Rpt]. More than half 

of new infections progress to chronic 

infection [Seo S, Clin Gastro Hepatol 

2020]. Without treatment, HCV infection 

can lead to advanced liver disease, liver 

cancer, and death [Liang TF, Ann Intern 

Med 2000]. Since 2013, safe and 

effective treatment has been available 

that cures more than 95% of all treated 

persons, prevents future health 

complications, stops further 

transmission, and allows for the 

possibility of hepatitis C elimination 

[Falade-Nwulia O, Ann Intern Med 

2017]. 

Testing is the first step to accessing 

life-saving treatment; however, about 

one-third of people with hepatitis C in 

the United States are unaware of their 

infection [Lewis KC, CID 2024]. The 

Centers for Disease Control and 

Prevention (CDC) recommends hepatitis 

C screening for all adults at least once, 

all pregnant persons during every 

pregnancy, and all persons with risk for 

HCV infection, including periodic 

testing if risk persists [Schillie S, 

MMWR Recomm Rep 2020]. Current 

testing guidance for clinicians and 

laboratorians begins with a hepatitis C 

antibody (anti-HCV) test followed, when 

reactive, by a nucleic acid test (NAT) to 

detect HCV RNA to diagnose current 

infection [CDC MMWR 2013]. Updated 

operational guidance was provided to 

ensure completion of the two-step 

approach using specimens collected 

during a single patient encounter. 

(Cartwright EJ, MMWR 2023) 

A limitation of the antibody-first 

hepatitis C testing approach is that it 

takes an average of 7 to 8 weeks after 

HCV infection to develop a reactive 

HCV antibody (Abdel-Hamid M, Clin 

Micro 2002). Therefore, the current 

testing sequence fails to diagnose HCV 

infection in the window-phase/early 

acute phase, within the first 6 months 

following infection, and among 

immunocompromised people who may 

have delayed seroconversion. 

Fortunately, advancements in the 

diagnostic and regulatory landscape 

have created an opportunity to improve 

hepatitis C testing. Currently, there are 

two tests for viral markers that identify 

current HCV infection: (1) real-time (RT) 

polymerase chain reaction (PCR) testing 

of HCV ribonucleic acid (RNA) detects 

virus within 1 to 2 weeks of infection 

(Gowda C, Clin Infect Dis 2020); and (2) 

HCV core antigen (HCVcAg) testing, 

currently approved outside of the 

United States, that uses an 

immunoassay to detect HCV core 

antigen within 2 to 3 weeks of infection 

(Sepulveda-Crespo D, Rev Med Virol 

2023). Such virologic tests have become 

faster to perform and more accessible in 

a variety of care settings including 

closer to the point-of-care. 

With CDC support, the Association of 

Public Health Laboratories (APHL) held 

a 2-day convening of key stakeholders 

and subject matter experts in October 

2021 to identify high-priority diagnostic 

tools needed to advance diagnosis of 

current HCV infection and linkage to 

treatment in a range of clinical and 

nonclinical settings. The published 

meeting report called for the US Food 

and Drug Administration (FDA) to 

reclassify HCV diagnostic tests from 

class III to class II, supported the 

availability of an FDA-cleared rapid 

CLIA-waived point-of-care (POC) HCV 

viral detection test, and encouraged 

CDC to review and update 

recommendations for HCV testing to 

identify current HCV infection, 

including testing sequences that detect 

HCV viral markers in the first step. 

(https://www.aphl.org/aboutAPHL/ 

publications/Documents/ID-HCV-2021- 

Meeting-Report.pdf). 

Subsequent to the APHL-led meeting: 

D In November 2021, the FDA 

reclassified hepatitis C diagnostic tests 

from class III devices to class II devices 

with special controls (510k), providing 

a new, lower-barrier opportunity for 

manufacturers to introduce new 

hepatitis C diagnostic tools for FDA 

review, including tests that were 

available at that time outside of the 

United States, such as a nucleic acid test 

(NAT) for HCV RNA detection in a POC 

format and an assay for HCVcAg. 


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Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 1499 

D In January 2024, CDC affirmed 

existing viral-first testing 

recommendations among people with 

recent HCV exposure (https://

www.cdc.gov/hepatitis-c/hcp/diagnosistesting/#:∼:text=HCV%20RNA%20

testing%20for,a%20

syringe%20service%20program); 

D In January 2024, CDC began the 

process of updating HCV testing 

guidance for clinicians and 

laboratorians, including evaluating 

testing strategies for the general 

population that include tests for viral 

markers in the first testing step (e.g., 

‘‘viral-first’’); and 

D In June 2024, the FDA authorized 

an HCV RNA CLIA-waived near pointof-care test for the diagnosis of current 

HCV infection. 

Public Participation and Public 

Comment 

Public engagement will entail listenonly observation of information shared 

on day 1 and day 2. If members of the 

public have input on the questions 

asked during the meeting, those public 

comments can be collected through 

regulations.gov using Docket CDC– 

2025–0002 on or before February 19, 

2025, and will be included in the final 

meeting report. Written comments must 

be submitted on or before February 19, 

2025. 

Please note that comments received, 

including attachments and other 

supporting materials, are part of the 

public record and are subject to public 

disclosure. Comments will be posted on 

https://www.regulations.gov. Therefore, 

do not include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. If 

you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be on 

public display. CDC will review all 

submissions and may choose to redact, 

or withhold, submissions containing 

private or proprietary information such 

as Social Security numbers, medical 

information, inappropriate language, or 

duplicate/near duplicate examples of a 

mass-mail campaign. Do not submit 

comments by email. CDC does not 

accept comment by email. 

Noah Aleshire, 

Chief Regulatory Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2025–00204 Filed 1–7–25; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–25–24FS] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Needle 

Exchange Utilization Survey (NEXUS)’’ 

to the Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on May 28, 2024, to obtain 

comments from the public and affected 

agencies. CDC received one comment 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

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 

Needle Exchange Utilization Survey 

(NEXUS)—New—National Center for 

HIV, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The opioid crisis in the U.S. has led 

to steep increases in overdose, Hepatitis 

C Virus (HCV) incidence, and HIV 

clusters and outbreaks among people 

who inject drugs (PWID). These 

alarming trends indicate an urgent need 

to strengthen interventions to prevent 

morbidity and mortality and 

transmission of infectious disease 

among PWID. Syringe services programs 

(SSPs) are evidence-based, highly 

effective prevention programs that have 

expanded in many areas in the United 

States to respond to the increasing 

needs of providing HIV and HCV 

prevention and other health and social 

services to PWID and their 

communities. Due to an increase in HCV 

and HIV related to injection drug use 

(IDU), it is now critical to understand 

current patterns of IDU for the 

prevention of these infectious diseases 

and other injection related harms. Data 

to inform these prevention efforts are 

needed nationally, particularly from 

non-urban settings that have 

experienced increases in IDU and where 

current surveillance activities are nonexistent or limited. 

The purpose of the Needle Exchange 

Utilization Survey (NEXUS) is to 

develop a surveillance system to 

monitor drug use, prevention behaviors, 

and the infectious disease consequences 

of drug use in 6–15 select urban and 

non-urban areas of the U.S. that the 

opioid crisis has impacted. Such a 

surveillance system is needed to inform 

prevention efforts and policy. The 

specific objectives of the project are to 

assess the following among persons who 

inject drugs who are recruited in SSPs 

and their peers who use drugs through 

peer-driven recruitment: (1) drug use 

and sexual behaviors, injection risk 

networks, receipt of prevention services, 

and barriers to prevention and care; and 

(2) the prevalence of HIV and HCV 

infections. 


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