[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)
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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