[Federal Register Volume 89, Number 72 (Friday, April 12, 2024)]
[Notices]
[Pages 25877-25878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-24-1353]


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 ``Integrated Viral Hepatitis Surveillance and 
Prevention Funding for Health Departments (CDC-RFA-PS21-2103)'' 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 July 14, 2023, to obtain 
comments from the public and affected agencies. CDC received one non-
substantive comment related to the 60-day Federal Register 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

    Integrated Viral Hepatitis Surveillance and Prevention Funding for 
Health Departments (CDC-RFA-PS21-2103) (OMB Control No. 0920-1353, Exp. 
11/30/2024)--Revision--National Center for HIV, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) requests 3-
year OMB approval for the Extension of an information collection 
request (ICR) package (OMB #0920-1353 Exp. Date 11/30/2024). CDC is 
authorized under section 318 of the Public Health Service Act (42 
U.S.C. 247c) to collect information on viral hepatitis (VH) prevention 
and control projects.
    In 2021, CDC implemented activities under a new cooperative 
agreement Integrated Viral Hepatitis Surveillance and Prevention 
Funding for Health Departments (CDC-RFA-PS21-2103). Tools exist to 
prevent new cases of hepatitis A, hepatitis B, and hepatitis C, to 
treat people living with hepatitis B, and to cure people living with 
hepatitis C. Yet, new cases of VH continue to rise, many people 
infected with VH remain undiagnosed, and far too many VH-related deaths 
occur in the U.S. each year. The purpose of these activities is to 
enable state and local health departments to collect data to evaluate 
disease burden and trends and to analyze and disseminate that data to 
develop or refine recommendations, policies, and practices that will 
ultimately reduce the burden of VH in their jurisdictions. The goals of 
the activities are to reduce new VH infections, VH-related morbidity 
and mortality, and VH-related disparities and to establish 
comprehensive national VH surveillance, which are in accordance with 
the Division of Viral Hepatitis 2025 Strategic Plan. In addition, the 
cooperative agreement supports VH elimination planning in these 
jurisdictions and maximize access to testing, treatment, and prevention

[[Page 25878]]

services for populations at high risk for VH (including service 
provision in in high-impact settings).
    The activities of this cooperative agreement include three 
components. Component 1: Surveillance and Component 2: Prevention 
contain six strategies: 1.1, develop, implement, and maintain a plan to 
rapidly detect and respond to outbreaks for hepatitis A, B, and C; 1.2, 
collect, analyze, interpret, and disseminate data to characterize 
trends, and implement public health interventions for hepatitis A, 
acute hepatitis B and acute and chronic hepatitis C; 1.3 (contingent on 
available funding), collect, analyze, interpret, and disseminate data 
to characterize trends and implement public health interventions for 
chronic hepatitis B and perinatal hepatitis C; 2.1, support VH 
elimination planning and surveillance, and maximize access to testing, 
treatment, and prevention; 2.2 (contingent on available funding), 
increase access to HCV and HBV testing and referral to care in high-
impact settings; and 2.3 (contingent on available funding), improve 
access to services preventing VH among persons who inject drugs. 
Contingent on funding, a third, optional component (Component 3: 
Special Projects) will support improved access to prevention, 
diagnosis, and treatment of viral, bacterial, and fungal infections 
related to drug use in settings disproportionately affected by drug 
use.
    In 2023, CDC will also fund health department recipients to 
implement additional activities through supplemental funding. These 
activities relate to increasing access to VH testing and linkage to 
care in high-impact settings. Specific activities include increasing 
routine VH testing in high-impact settings; providing counseling, 
linkage to treatment, and referral to prevention services in high-
impact settings; and building public health laboratory capacity. These 
activities are similar to activities described in the cooperative 
agreement for Component 3 but provide additional funding to health 
department recipients to expand/increase these services in their 
jurisdictions.
    Performance measures are monitored to assess recipient performance, 
including quality of data, effective program implementation, and 
accountability of funds. Data collection via the Annual Performance 
Report is used for program accountability and to inform performance 
improvement.
    Outbreak reporting is submitted throughout the year. These data are 
a key component of national VH surveillance and are critical to 
determining both the level of VH activity within a jurisdiction as well 
as the effectiveness of each jurisdiction's approach to cluster and 
outbreak response. Required activities of this project include 
developing, implementing, and maintaining a plan to rapidly detect and 
respond to outbreaks for hepatitis A, hepatitis B, and hepatitis C and 
to report and notify CDC of outbreaks within 5 business days of 
identifying the outbreak. Timely reporting of clusters and outbreaks is 
essential to ensuring that recipients have the assistance they need to 
implement a prompt and effective response.
    In the first three years of this cooperative agreement, health 
department recipients worked toward establishing a jurisdictional 
framework to respond to VH-related outbreaks; assessed public health 
reporting of chronic and perinatal hepatitis C and chronic hepatitis B 
infection, and undetectable hepatitis C RNA and hepatitis B DNA 
laboratory results; increased engagement with community partners in 
elimination planning across their jurisdiction; and increased the level 
of hepatitis testing services in a variety of setting types (including 
linkage to care and treatment for individuals diagnosed with VH).
    With the data submitted through the Annual Performance Report data 
collection forms in Years 1-3, CDC assessed the progress of 
jurisdictions in meeting the deliverables of CDC-RFA-PS21-2103. 
Additionally, CDC developed and provided annual feedback reports to 
recipients to summarize progress made toward meeting the overarching 
objectives of the funding award which include: establishment of 
comprehensive national VH surveillance, reduced new VH infections, 
increased access to care for persons with VH, improved health outcomes 
for people with VH, reduced deaths among people with VH, reduced VH-
related health disparities and decreased overdose deaths. Specifically, 
jurisdictions reported developing VH outbreak response plans and 
elimination plans and serving persons who inject drugs, including 
number of clients tested for hepatitis B and hepatitis C and number of 
clients vaccinated against hepatitis A and hepatitis B.
    CDC requests OMB approval for an estimated 245 annual burden hours. 
There is no cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of      Avg. burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Health Departments....................  APR: Component 1........              59               1           70/60
Health Departments....................  APR: Component 2........              59               1           70/60
Health Departments....................  APR: Component 3........              20               1           70/60
Health Departments....................  Supplemental APR........               8               1           45/60
Health Departments....................  Initial Outbreak Report               59               2           20/60
                                         Form.
Health Departments....................  Outbreak Summary Report               59               2           20/60
                                         Form.
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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. 2024-07803 Filed 4-11-24; 8:45 am]
BILLING CODE 4163-18-P