[Federal Register Volume 86, Number 15 (Tuesday, January 26, 2021)]
[Notices]
[Pages 7097-7098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-21CH; Docket No. CDC-2021-0005]


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 Serological Assay Development: 
Brucella spp. Rough Strains. This proposed collection will involve 
specimen collection and relevant clinical information from individuals 
exposed to rough strains of Brucella spp., or cases of brucellosis due 
to infection with rough strains of Brucella spp.

DATES: CDC must receive written comments on or before March 29, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0005 by any of the following methods:
    <bullet> Federal eRulemaking Portal: Regulations.gov. 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-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 Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
<a href="/cdn-cgi/l/email-protection#bbd4d6d9fbd8dfd895dcd4cd"><span class="__cf_email__" data-cfemail="a7c8cac5e7c4c3c489c0c8d1">[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; and
    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.
    5. Assess information collection costs.

Proposed Project

    Serological Assay Development: Brucella spp. Rough Strains--New--
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Brucellosis is a zoonotic disease caused by Brucella spp., which 
are Gram-negative, intracellular bacterial pathogens. Annually, 500,000 
human cases of brucellosis occur worldwide. Though isolation of the 
organism can help identify the causative species of infection, this 
method is not always possible due to laboratory biosafety capacity 
requirements and specimen availability. In some of these instances, 
serological methods are helpful for diagnosis. Serial serological 
methods are also useful for monitoring individuals who have had known 
exposures to smooth Brucella spp. for seroconversion, which can help 
detect potential infection and reduce time to diagnosis and treatment.
    The proposed data collection will help to understand the frequency 
of exposures to rough strain Brucella spp. in the United States, 
identify specific antigens associated with rough strain Brucella 
infections, develop high-sensitivity and high-specificity serological 
diagnostic assays based on recognition of these antigens, and to better 
understand the human humoral immune response to rough Brucella strains. 
Data collected will be used to create a bank of specimens to help 
develop additional tools for safer and more timely diagnosis of 
brucellosis caused by rough strains of Brucella spp.
    CDC will collect specimens and medical/surveillance record 
abstractions from individuals exposed to rough strains of Brucella 
spp., and individuals with confirmed diagnosis of brucellosis as a 
result of infection from rough strains of Brucella spp.
    CDC requests approval for three years. The estimated annualized 
burden hours are 55. There is no cost to respondents other than their 
time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total  burden
      Type of respondent            Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Patient (specimen collection).  N/A.............              10               1               5              50

[[Page 7098]]

 
Health department.............  Clinical/                     10               1             0.5               5
                                 exposure
                                 information.
                                                 ---------------------------------------------------------------
    Total.....................                                                                                55
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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. 2021-01622 Filed 1-25-21; 8:45 am]
BILLING CODE 4163-18-P


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