83 FR 5102 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 24 (February 5, 2018)

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 ``Gonococcal Isolate Surveillance Project (GISP)''. The purpose of GISP is to monitor trends in antimicrobial resistance in N. gonorrhoeae strains in the United States in order to establish a scientific basis for the selection of gonococcal therapies and to allow proactive changes to treatment guidelines before widespread resistance and failures of treatment occur.

[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5102-5103]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02222]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0307; Docket No. CDC-2018-0019]


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 ``Gonococcal Isolate Surveillance 
Project (GISP)''. The purpose of GISP is to monitor trends in 
antimicrobial resistance in N. gonorrhoeae strains in the United States 
in order to establish a scientific basis for the selection of 
gonococcal therapies and to allow proactive changes to treatment 
guidelines before widespread resistance and failures of treatment 
occur.

DATES: CDC must receive written comments on or before April 6, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0019 by any of the following methods:

     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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 Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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; 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

    Gonococcal Isolate Surveillance Project (OMB Control Number 0920-
0307, Expiration 2/28/2019)--Revision--National Center for HIV/AIDS, 
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The Gonococcal Isolate Surveillance Project (GISP) was created in 
1986 to monitor trends in antimicrobial susceptibilities of N. 
gonorrhoeae strains in the United States. Data from GISP are used to 
establish a scientific basis for the selection of gonococcal therapies 
and to allow pro-active changes to treatment guidelines before 
widespread resistance and failures of treatment occur. To increase 
capacity to detect and monitor resistant gonorrhea and improve the 
specificity of GISP, this submission is a revision to include 
collection of additional isolates and data elements.
    The Centers for Disease Control and Prevention has designated N. 
gonorrhoeae as one of three ``urgent'' antibiotic resistance threats in 
the United States. The CDC is requesting a three-year OMB approval for 
this revision, which directly responds to the

[[Page 5103]]

National Strategy for Combating Antibiotic Resistant Bacteria by 
improving and strengthening surveillance of antimicrobial resistance 
through GISP. Additionally, data from GISP will also allow CDC to 
monitor and evaluate the effectiveness of public health interventions 
conducted to support the National Strategy for Combating Antibiotic 
Resistant Bacteria. There are no costs 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 respondents           Form name       respondents    responses per   response (in     (in hours)
                                                                    respondent        hours)
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Sentinel site conducting core   Demographic/                  20             240           11/60             880
 surveillance.                   Clinical Data.
Sentinel site conducting        Demographic/                  10             840           12/60           1,680
 enhanced surveillance.          Clinical Data.
Regional laboratory...........  Antimicrobial                  4           3,300           40/60           8,800
                                 Susceptibility
                                 Testing Results.
Regional laboratory...........  Control Strain                 4              48            5/60              16
                                 Susceptibility
                                 Testing.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          11,376
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-02222 Filed 2-2-18; 8:45 am]
 BILLING CODE 4163-18-P