Notice2023-14953
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 14, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments (CDC-RFA- PS21-2103). This data collection is for viral hepatitis (VH) case reporting data collected from the National Notifiable Diseases Surveillance System (NNDSS) which provides the primary population-based data used to describe the epidemiology of VH in the United States and for annual reporting of surveillance, prevention, and epidemiology performance measures via an Annual Performance Report.
Full Text
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<title>Federal Register, Volume 88 Issue 134 (Friday, July 14, 2023)</title>
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[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45215-45217]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-14953]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1353; Docket No. CDC-2023-0059]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled, Integrated Viral Hepatitis
Surveillance and Prevention Funding for Health Departments (CDC-RFA-
PS21-2103). This data collection is for viral hepatitis (VH) case
reporting data collected from the National Notifiable Diseases
Surveillance System (NNDSS) which provides the primary population-based
data used to describe the epidemiology of VH in the United States and
for annual reporting of surveillance, prevention, and epidemiology
performance measures via an Annual Performance Report.
DATES: CDC must receive written comments on or before September 12,
2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0059 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
Email: <a href="/cdn-cgi/l/email-protection#4b2426290b282f28652c243d"><span class="__cf_email__" data-cfemail="640b0906240700074a030b12">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
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
three-year
[[Page 45216]]
OMB approval for the Revision of an information collection package (OMB
Control No. 0920-1353, Exp. Date 11/30/2024). CDC is authorized under
Sections 304 and 306 of the Public Health Service Act (42 U.S.C. 242b
and 242k) to collect information on cases of viral hepatitis (VH). Data
collected by NNDSS (OMB Control No. 0920-0728) are the primary data
used to monitor the extent and characteristics of the VH burden in the
United States. VH surveillance data are used to describe trends in VH
incidence, prevalence, and characteristics of infected persons and are
used widely at the federal, state, and local levels for planning and
evaluating prevention programs and health-care services and to allocate
funding for prevention and care.
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, B, and 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 US 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 services for populations
at high risk for viral hepatitis (including service provision in in
high-impact settings).
The activities of this cooperative agreement include two components
(Component 1: Surveillance, and Component 2: Prevention), containing
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, an 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 fund health department recipients to implement
additional activities through supplemental funding. These activities
relate to increasing access to viral hepatitis 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 the same activities described in the cooperative
agreement (Component 2) 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 are submitted throughout the year.
These data, which complement case data as another key component of
national viral hepatitis surveillance, are critical to determining both
the level of viral hepatitis activity within a jurisdiction as well as
the effectiveness of each jurisdiction's approach to cluster and
outbreak response. A standardized Case Report Form is used for
surveillance data collection submitted to the National Notifiable
Diseases Surveillance System (NNDSS). De-identified data including
national VH surveillance data are submitted to CDC electronically per
each jurisdiction's usual mechanism. Recipients submit other required
quantitative and qualitative performance measure data annually via an
Annual Performance Report and as needed for outbreak reporting.
In the first two 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 HCV and chronic HBV infection, and
undetectable HCV RNA and HBV 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 Year 1 and Year 2, CDC assessed the progress of
jurisdictions in meeting the deliverables of CDC-RFA-PS21-2103.
Additionally, CDC developed and provided 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 HBV and HCV and number of clients vaccinated against HAV and
HBV.
CDC requests OMB approval for an estimated 6,657 annual burden
hours. There are no costs to respondents other than their time.
[[Page 45217]]
Estimated Annualized Burden Hours
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Number of Avg. burden Total annual
Type of respondent Form name Number of responses per per response burden (in
respondents respondent (in hours) hours)
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Health Departments............ Viral Hepatitis 51 381 20/60 6,412
Case Report
Form.
Health Departments............ APR: Component 1 59 1 70/60 69
Health Departments............ APR: Component 2 59 1 70/60 69
Health Departments............ APR: Component 3 20 1 70/60 23
Health Departments............ Supplemental APR 8 1 45/60 6
Health Departments............ Initial Outbreak 59 2 20/60 39
Report Form.
Health Departments............ Outbreak Summary 59 2 20/60 39
Report Form.
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Total..................... ................ .............. .............. .............. 6,657
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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. 2023-14953 Filed 7-13-23; 8:45 am]
BILLING CODE 4163-18-P
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