[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.
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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