[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52289-52291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0307; Docket No. CDC-2015-0072]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

AGENCY: The Centers for Disease Control and Prevention (CDC).

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 to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
extension of the information collection entitled The Gonococcal Isolate 
Surveillance Project (GISP), which is the only source in the United 
States of national, regional, and site-specific gonococcal antibiotic 
resistance information that provides information to support informed 
and scientifically-based treatment recommendations.
    To request more information on the below proposed project or to 
obtain a copy of the information collection plan and instruments, call 
404-639-7570 or send comments to Leroy A. Richardson, 1600 Clifton 
Road, MS-D74, Atlanta, GA 30333 or send an email to [email protected].

DATES: Written comments must be received on or before October 27, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0072 by any of the following methods:
     Federal eRulemaking Portal: Regulation.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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    The Gonococcal Isolate Surveillance Project (GISP), (OMB No.0920-
0307 exp. 08/31/2016)--Extension--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP),

[[Page 52290]]

Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The objectives of GISP are: (1) To monitor trends in antibiotic 
resistance of Neisseria gonorrhoeae strains in the United States and 
(2) to characterize resistant specimens. Surveillance of N. gonorrhoeae 
antibiotic resistance is important because: (1) Nearly all gonococcal 
infections are treated empirically (meaning that healthcare providers 
have to decide how to treat their patients without having resistance 
testing results for individual patients upon which to base clinical 
decision-making) and susceptibility/resistance testing data are not 
routinely available in clinical practice; (2) N. gonorrhoeae has 
consistently demonstrated the ability to develop resistance to the 
antibiotics used for treatment; (3) effective treatment of gonorrhea is 
a critical component of gonorrhea control and prevention, and (4) 
untreated or inadequately treated gonorrhea can cause serious 
reproductive health complications.
    GISP is the only source in the United States of national, regional, 
and site-specific gonococcal antibiotic resistance information. GISP 
provides information to support informed and scientifically-based 
treatment recommendations.
    GISP was established in 1986 as a voluntary surveillance project 
and now involves 5 regional laboratories and 30 publicly funded 
sexually transmitted disease (STD) clinics around the country. The STD 
clinics submit up to 25 gonococcal specimens (or isolates) per month to 
the regional laboratories, which measure the ability of the specimens 
to resist the effects of multiple antibiotics. Limited demographic and 
clinical information corresponding to the isolates (and that do not 
allow identification of the patient) are submitted directly by the 
clinics to CDC.
    During 1986-2015, GISP has demonstrated the ability to effectively 
achieve its objectives. The emergence of resistance in the United 
States to penicillin, tetracyclines, and fluoroquinolones among N. 
gonorrhoeae isolates was identified through GISP. Increased prevalence 
of fluoroquinolone-resistant N. gonorrhoeae (QRNG), as documented by 
GISP data, prompted CDC to update treatment recommendations for 
gonorrhea in CDC's Sexually Transmitted Diseases Treatment Guidelines, 
2006 and to release an MMWR article stating that CDC no longer 
recommended fluoroquinolones for treatment of gonococcal infections. 
Information from GISP thus allowed public health officials to change 
treatment recommendations before resistance became widespread, ensuring 
that patients were able to be successfully treated. Recently, GISP 
isolates demonstrated increasing minimum inhibitory concentrations of 
cefixime, which can be an early warning of impending resistance. This 
worrisome trend prompted CDC to again update treatment recommendations 
and no longer recommend the use of cefixime as first-line treatment for 
gonococcal infections.
    Under the GISP protocol, each of the 30 clinics submit an average 
of 20 isolates per clinic per month (i.e. 240 times per year) recorded 
on Form 1: Demographic/Clinical Data. The estimated time for clinical 
personnel to abstract data for Form 1: Demographic/Clinical Data is 11 
minutes per response.
    Each of the five Regional laboratories receives and processes an 
approximately 20 isolates from each referring clinic per month (i.e. 
121 isolates per regional laboratory per month [based on 2011 specimen 
volume]) using Form 2: Antimicrobial Susceptibility Testing. For Form 
2: Antimicrobial Susceptibility Testing, the annual frequency of 
responses per respondent is 1,452 (121 isolates x 12 months). Based on 
previous laboratory experience, the estimated burden of completing Form 
2 for each participating laboratory is 1 hour per response, which 
includes the time required for laboratory processing of the patient's 
isolate, gathering and maintaining the data needed, and completing and 
reviewing the collection of information. For Form 3: Control Strain 
Susceptibility Testing, a ``response'' is defined as the processing and 
recording of Regional laboratory data for a set of seven control 
strains. It takes approximately 12 minutes to process and record the 
Regional laboratory data on Form 3 for one set of seven control 
strains, of which there are 4 sets. The number of responses per 
respondent is 48 (4 sets x 12 months).
    The total estimated annual burden hours are 8,628. Respondents 
receive federal funds to participate in this project. There are no 
additional costs to respondents other than their time.

                                       Estimate of Annualized Burden Hours
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                                                                     Number of    Average burden   Total annual
      Type of respondents           Form name        Number of     responses per   per response     burden (in
                                                    respondents     respondent      (in hours)        hours)
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Clinic........................  Demographic                   30             240           11/60           1,320
                                 Clinical Data
                                 Form 1.
Laboratory....................  Antimicrobial                  5           1,452               1           7,260
                                 Susceptibility
                                 Testing Form 2.
                                Control Strain                 5              48           12/60              48
                                 Susceptibility
                                 Testing Form 3.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           8,628
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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. 2015-21345 Filed 8-27-15; 8:45 am]
 BILLING CODE 4163-18-P