[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45215-45217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     Federal eRulemaking Portal: www.regulations.gov. Follow 
the instructions for submitting comments.
     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 www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.regulations.gov) 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: [email protected].

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.
                                                 ---------------------------------------------------------------
    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]
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