[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20161-20163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07838]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21EE; Docket No. CDC-2021-0033]


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. This new 
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 June 15, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0033 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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

[[Page 20162]]

Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; 
phone: 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--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    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 the National Notifiable 
Diseases Surveillance System (NNDSS) 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 is implementing 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 the activities under a new cooperative agreement 
is to enable states 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.
    The activities of the new cooperative agreement are separated into 
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.
    Performance measures will be 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 will also be 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 will be used for surveillance data 
collection submitted to the National Notifiable Diseases Surveillance 
System (NNDSS). De-identified data, including national VH surveillance 
data, will be submitted to CDC electronically per each jurisdiction's 
usual mechanism. Recipients will submit other required quantitative and 
qualitative performance measure data annually via an Annual Performance 
Report and as needed for outbreak reporting. CDC requests approval for 
an estimated 6,688 annual burden hours. There are no other costs to 
respondents other than their time.

[[Page 20163]]



                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
      Type of respondent            Form name       respondents    responses per   response  (in    burden  (in
                                                                    respondent        hours)          hours)
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Health Departments............  Viral Hepatitis               51             381           20/60           6,477
                                 Case Report
                                 Form.
Health Departments............  APR: Component 1              59               1               1              59
Health Departments............  APR: Component 2              59               1               1              59
Health Departments............  APR: Component 3              14               1               1              14
Health Departments............  Initial Outbreak              59               2           20/60              39
                                 Report Form.
Health Departments............  Outbreak Summary              59               2           20/60              39
                                 Report Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,688
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-07838 Filed 4-15-21; 8:45 am]
BILLING CODE 4163-18-P