82 FR 53501 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 220 (November 16, 2017)

Page Range		53501-53503
FR Document		2017-24804

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 ``Strengthening United States Response to Resistant Gonorrhea (SURRG).'' The goal of the study is to strengthen the U.S response to resistant gonorrhea by enhancing state and local public health surveillance and program infrastructure, build capacity to support rapid detection and public health response to antibiotic-resistant gonorrhea, and advance the understanding of epidemiological factors contributing to antibiotic- resistant gonorrhea.

Federal Register, Volume 82 Issue 220 (Thursday, November 16, 2017)

[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53501-53503]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17BAN; Docket No. CDC-2017-0081]


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.

-----------------------------------------------------------------------

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 ``Strengthening 
United States Response to Resistant Gonorrhea (SURRG).'' The goal of 
the study is to strengthen the U.S response to resistant gonorrhea by 
enhancing state and local public health surveillance and program 
infrastructure, build capacity to support rapid detection and public 
health response to antibiotic-resistant gonorrhea, and advance the 
understanding of epidemiological factors contributing to antibiotic-
resistant gonorrhea.

DATES: Written comments must be received on or before January 16, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0081 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

    Strengthening U.S. Response to Resistant Gonorrhea (SURRG)--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 
(NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The purposes of Strengthening U.S. Response to Resistant Gonorrhea 
(SURRG) are to: (1) Improve national capacity to detect, monitor, and 
respond to emerging antibiotic-resistant gonorrhea; (2) understand 
trends in and factors contributing to antibiotic-resistant gonorrhea; 
and (3) build a robust evidence base for public health action. This 
information collection is important because: (1) Effective treatment of 
gonorrhea is critical to gonorrhea control and prevention; (2) 
untreated or inadequately treated gonorrhea can cause serious 
reproductive health complications, such as infertility; (3) Neisseria 
gonorrhoeae (the bacterium that causes gonorrhea) has consistently 
demonstrated the ability to develop resistance to the antibiotics used 
for treatment and may be developing resistance to the last remaining 
treatment option recommended by the CDC; and (4) antibiotic-resistant 
gonorrhea is extremely difficult to detect without enhanced 
surveillance and public health activities, such as SURRG, because 
healthcare providers rarely perform or have access to resistance 
testing for individual patients.
    SURRG will support rapid detection of resistant gonorrhea and get 
actionable information into the hands of healthcare providers (to 
support appropriate treatment of individual patients) and local health 
departments (to support rapid public health response to slow the spread 
of resistant infections).

[[Page 53502]]

    Jurisdictions participating in SURRG applied as part of a 
competitive process and will participate voluntarily. As an overview of 
SURRG, healthcare providers at participating clinics (sexually 
transmitted disease [STD] clinics affiliated with a single public 
health department or other participating non-STD clinic sites) will 
collect specimens for N. gonorrhoeae culture testing from men and women 
seeking care for possible gonorrhea. Specimens that demonstrate N. 
gonorrhoeae (called ``isolates'') will undergo antibiotic resistance 
testing within several days at the local public health laboratory. 
Laboratory results demonstrating resistance be rapidly communicated by 
the laboratory to the healthcare provider and designated health 
department staff member, who will initiate a field investigation.
    Researchers will interview the patient (from whom the resistant 
specimen was collected) about risk factors and recent contacts, and 
will re-test to ensure cure. The health department will interview 
recent contacts and test them for gonorrhea. The participating health 
departments will collect and transmit to CDC, demographic and clinical 
data about persons tested for and diagnosed with gonorrhea in the 
participating clinics, results of local antibiotic resistance testing, 
and information about field investigations.
    None of the data transmitted to CDC will contain any personally 
identifiable information. CDC will use the data to monitor resistance, 
understand risk factors for resistance, and identify new approaches to 
prevent the spread of resistance. CDC will receive transmitted data 
through its Secure Access Management Services (SAMS).
    SAMS is an approved federal information technology system that 
provides authorized and validated users secure and encrypted access to 
CDC file transfer applications. The encrypted data will be stored in a 
secure CDC server with strictly controlled and restricted access 
rights.
    Researchers will ship isolates each month to one of four Antibiotic 
Resistance Regional Laboratory Network (ARLN) laboratories for 
confirmatory antibiotic susceptibility testing and molecular 
characterization.
    Under the SURRG protocol, the local SURRG data managers from each 
of the funded jurisdictions will abstract STD clinic data for patients 
tested for gonorrhea, receive data from non-STD clinic healthcare sites 
about persons tested for gonorrhea, receive resistance testing 
laboratory results from local public health laboratories, abstract data 
about field investigations, and will merge the data. Every two months, 
the local SURRG data manager will clean the data, remove personally 
identifiable information, and transmit the data to CDC. We estimate 
these data processes will take 16 hours every two months. Annually, the 
local SURRG data manager will send a final cumulative data file. Seven 
data transmissions/responses will occur.
    Every two months, data managers at each of the participating non-
STD clinic health centers will abstract and clean data and securely 
transmit the data to the local SURRG data manager. We estimate that it 
will take three hours each time data managers at each non-STD SURRG 
location abstract, clean, and transmit SURRG data.
    Microbiologists at public health laboratories from each of the nine 
SURRG funded jurisdictions will conduct antibiotic resistance testing 
on all N. gonorrhoeae isolates from all STD clinic sites and non-STD 
clinic sites participating in SURRG. Each test takes approximately 10 
minutes of staff time, and testing of control strains will also be 
conducted approximately twice per week at each laboratory. On average, 
each jurisdiction will conduct approximately 600 resistance tests per 
year for patient care, plus 100 control strains per year for quality 
assurance. Thus, each grantee will perform approximately 700 tests per 
year. Every two months, a laboratory data manager will abstract test 
results and securely send the data file to the local SURRG data 
manager. We estimate that laboratory data managers will spend 
approximately one hour each time they abstract, clean, and transmit 
project data.
    Health department staff will interview any person diagnosed with 
antibiotic-resistant gonorrhea or have a case of gonorrhea of public 
health significance index case, a diagnosed person's social and sexual 
contacts, and the sexual contacts of the index case's sexual contacts.
    On average, each jurisdiction will identify four drug-resistant 
isolates each month. These isolates will spur field investigations, 
which will result in six additional interviews each month. We estimate 
120 interviews will occur annually at each site (annual 1,080 
interviews for the 9 sites). Each interview will take 30 minutes.
    The total estimated annual burden hours are 2,976. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of  respondent                               Form name                   respondents    responses per     response          hours
                                                                                                            respondent        (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Local SURRG data manager.......................  Facility, Laboratory and field Elements               9               7              16           1,008
Data manager at non-STD clinic health centers..  Non-STD clinic Elements................              18               6               3             324
Public Health Laboratory Microbiologist........  Laboratory Testing.....................               9             700           10/60           1,050
Public Health Laboratory Data Manager..........  Laboratory Elements....................               9               6               1              54
Gonorrhea Patients, Social and Sexual Contacts.  Field Investigation Elements...........           1,080               1           30/60             540
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,976
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 53503]]

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. 2017-24804 Filed 11-15-17; 8:45 am]
BILLING CODE 4163-18-P

Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53501

leadership; update of Legislation gonorrhea by enhancing state and local whether the information will have
Relating to the Evidence Based Policy public health surveillance and program practical utility;
Commission; update on National Health infrastructure, build capacity to support 2. Evaluate the accuracy of the
and Nutrition Examination Surveys rapid detection and public health agency’s estimate of the burden of the
Reports and Activities; update on response to antibiotic-resistant proposed collection of information,
Division of Health Care Statistics gonorrhea, and advance the including the validity of the
Reports and Activities; update on Vital understanding of epidemiological methodology and assumptions used;
Statistics activities; and update on factors contributing to antibiotic- 3. Enhance the quality, utility, and
International Activities of NCHS. resistant gonorrhea. clarity of the information to be
Requests to make oral presentations DATES: Written comments must be collected; and
should be submitted in writing to the received on or before January 16, 2018. 4. Minimize the burden of the
contact person listed below. All requests collection of information on those who
ADDRESSES: You may submit comments,
must contain the name, address, are to respond, including through the
identified by Docket No. CDC–2017–
telephone number, and organizational use of appropriate automated,
0081 by any of the following methods:
affiliation of the presenter. Written electronic, mechanical, or other
• Federal eRulemaking Portal:
comments should not exceed five technological collection techniques or
Regulations.gov. Follow the instructions
single-spaced typed pages in length and other forms of information technology,
for submitting comments.
must be received by December 26, 2017. • Mail: Leroy A. Richardson, e.g., permitting electronic submissions
Agenda items are subject to change as Information Collection Review Office, of responses.
priorities dictate. 5. Assess information collection costs.
Centers for Disease Control and
The Director, Management Analysis
Prevention, 1600 Clifton Road NE., MS– Proposed Project
and Services Office, has been delegated
D74, Atlanta, Georgia 30329. Strengthening U.S. Response to
the authority to sign Federal Register Instructions: All submissions received
notices pertaining to announcements of Resistant Gonorrhea (SURRG)—New—
must include the agency name and National Center for HIV/AIDS, Viral
meetings and other committee Docket Number. CDC will post, without
management activities, for both the Hepatitis, STD, and TB Prevention
change, all relevant comments to (NCHHSTP), Centers for Disease Control
Centers for Disease Control and Regulations.gov.
Prevention and the Agency for Toxic and Prevention (CDC).
Please note: Submit all comments
Substances and Disease Registry. through the Federal eRulemaking portal Background and Brief Description
Elaine L. Baker, (regulations.gov) or by U.S. mail to the The purposes of Strengthening U.S.
Director, Management Analysis and Services address listed above. Response to Resistant Gonorrhea
Office, Centers for Disease Control and FOR FURTHER INFORMATION CONTACT: To (SURRG) are to: (1) Improve national
Prevention. request more information on the capacity to detect, monitor, and respond
[FR Doc. 2017–24871 Filed 11–15–17; 8:45 am] proposed project or to obtain a copy of to emerging antibiotic-resistant
BILLING CODE 4163–19–P the information collection plan and gonorrhea; (2) understand trends in and
instruments, contact Leroy A. factors contributing to antibiotic-
Richardson, Information Collection resistant gonorrhea; and (3) build a
DEPARTMENT OF HEALTH AND Review Office, Centers for Disease robust evidence base for public health
HUMAN SERVICES Control and Prevention, 1600 Clifton action. This information collection is
Road NE., MS–D74, Atlanta, Georgia important because: (1) Effective
Centers for Disease Control and 30329; phone: 404–639–7570; Email: treatment of gonorrhea is critical to
Prevention omb@cdc.gov. gonorrhea control and prevention; (2)
[60Day–17–17BAN; Docket No. CDC–2017– SUPPLEMENTARY INFORMATION: Under the untreated or inadequately treated
0081] Paperwork Reduction Act of 1995 (PRA) gonorrhea can cause serious
(44 U.S.C. 3501–3520), Federal agencies reproductive health complications, such
Proposed Data Collection Submitted must obtain approval from the Office of as infertility; (3) Neisseria gonorrhoeae
for Public Comment and Management and Budget (OMB) for each (the bacterium that causes gonorrhea)
Recommendations collection of information they conduct has consistently demonstrated the
AGENCY: Centers for Disease Control and or sponsor. In addition, the PRA also ability to develop resistance to the
Prevention (CDC), Department of Health requires Federal agencies to provide a antibiotics used for treatment and may
and Human Services (HHS). 60-day notice in the Federal Register be developing resistance to the last
ACTION: Notice with comment period. concerning each proposed collection of remaining treatment option
information, including each new recommended by the CDC; and (4)
SUMMARY: The Centers for Disease proposed collection, each proposed antibiotic-resistant gonorrhea is
Control and Prevention (CDC), as part of extension of existing collection of extremely difficult to detect without
its continuing effort to reduce public information, and each reinstatement of enhanced surveillance and public
burden and maximize the utility of previously approved information health activities, such as SURRG,
government information, invites the collection before submitting the because healthcare providers rarely
general public and other Federal collection to the OMB for approval. To perform or have access to resistance
asabaliauskas on DSKBBXCHB2PROD with NOTICES

agencies to take this opportunity to comply with this requirement, we are testing for individual patients.
comment on proposed and/or publishing this notice of a proposed SURRG will support rapid detection
continuing information collections, as data collection as described below. of resistant gonorrhea and get actionable
required by the Paperwork Reduction The OMB is particularly interested in information into the hands of healthcare
Act of 1995. This notice invites comments that will help: providers (to support appropriate
comment on ‘‘Strengthening United 1. Evaluate whether the proposed treatment of individual patients) and
States Response to Resistant Gonorrhea collection of information is necessary local health departments (to support
(SURRG).’’ The goal of the study is to for the proper performance of the rapid public health response to slow the
strengthen the U.S response to resistant functions of the agency, including spread of resistant infections).

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Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53503

Leroy A. Richardson, To obtain copies of a supporting current requirements for participation in
Chief, Information Collection Review Office, statement and any related forms for the the Medicare Advantage program and to
Office of Scientific Integrity, Office of the proposed collection(s) summarized in make a decision related to contract
Associate Director for Science, Office of the this notice, you may make your request award. Form Number: CMS–10237
Director, Centers for Disease Control and using one of following: (OMB control number: 0938–0935);
Prevention. 1. Access CMS’ Web site address at Frequency: Yearly; Affected Public:
[FR Doc. 2017–24804 Filed 11–15–17; 8:45 am] Web site address at https:// Private sector (Business or other For-
BILLING CODE 4163–18–P www.cms.gov/Regulations-and- profits and Not-for-profit institutions);
Guidance/Legislation/Paperwork Number of Respondents: 380; Total
ReductionActof1995/PRA-Listing.html. Annual Responses: 380; Total Annual
DEPARTMENT OF HEALTH AND 2. Email your request, including your Hours: 6,246. (For policy questions
HUMAN SERVICES address, phone number, OMB number, regarding this collection contact Stacy
and CMS document identifier, to Davis at 410–786–7813.)
Centers for Medicare & Medicaid
Paperwork@cms.hhs.gov. Dated: November 13, 2017.
Services
3. Call the Reports Clearance Office at
William N. Parham, III,
[Document Identifier: CMS–10237] (410) 786–1326.
Director, Paperwork Reduction Staff, Office
FOR FURTHER INFORMATION CONTACT: of Strategic Operations and Regulatory
Agency Information Collection William Parham at (410) 786–4669. Affairs.
Activities: Submission for OMB SUPPLEMENTARY INFORMATION: Under the [FR Doc. 2017–24816 Filed 11–15–17; 8:45 am]
Review; Comment Request Paperwork Reduction Act of 1995 (PRA) BILLING CODE 4120–01–P
AGENCY: Centers for Medicare & (44 U.S.C. 3501–3520), federal agencies
Medicaid Services, HHS. must obtain approval from the Office of
Management and Budget (OMB) for each DEPARTMENT OF HEALTH AND
ACTION: Notice. collection of information they conduct HUMAN SERVICES
SUMMARY: The Centers for Medicare & or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C. Centers for Medicare & Medicaid
Medicaid Services (CMS) is announcing
3502(3) and 5 CFR 1320.3(c) and Services
an opportunity for the public to
comment on CMS’ intention to collect includes agency requests or [Document Identifiers: CMS–10401]
information from the public. Under the requirements that members of the public
Paperwork Reduction Act of 1995 submit reports, keep records, or provide Agency Information Collection
(PRA), federal agencies are required to information to a third party. Section Activities: Submission for OMB
publish notice in the Federal Register 3506(c)(2)(A) of the PRA (44 U.S.C. Review; Comment Request
concerning each proposed collection of 3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the AGENCY: Centers for Medicare &
information, including each proposed Medicaid Services, HHS.
extension or reinstatement of an existing Federal Register concerning each
proposed collection of information, ACTION: Notice.
collection of information, and to allow
a second opportunity for public including each proposed extension or
reinstatement of an existing collection SUMMARY: The Centers for Medicare &
comment on the notice. Interested Medicaid Services (CMS) is announcing
persons are invited to send comments of information, before submitting the
collection to OMB for approval. To an opportunity for the public to
regarding the burden estimate or any comment on CMS’ intention to collect
other aspect of this collection of comply with this requirement, CMS is
publishing this notice that summarizes information from the public. Under the
information, including the necessity and Paperwork Reduction Act of 1995
utility of the proposed information the following proposed collection(s) of
information for public comment: (PRA), federal agencies are required to
collection for the proper performance of publish notice in the Federal Register
the agency’s functions, the accuracy of 1. Type of Information Collection
Request: Revision of a currently concerning each proposed collection of
the estimated burden, ways to enhance information, including each proposed
the quality, utility, and clarity of the approved collection; Title of
Information Collection: Applications for extension or reinstatement of an existing
information to be collected; and the use collection of information, and to allow
of automated collection techniques or Part C Medicare Advantage, 1876 Cost
Plans, and Employer Group Waiver a second opportunity for public
other forms of information technology to comment on the notice. Interested
minimize the information collection Plans to Provide Part C Benefits; Use:
This information collection includes the persons are invited to send comments
burden. regarding the burden estimate or any
process for organizations wishing to
DATES: Comments on the collection(s) of provide healthcare services under MA other aspect of this collection of
information must be received by the and/or MA–PD plans must complete an information, including the necessity and
OMB desk officer by December 18, 2017. application annually, file a bid, and utility of the proposed information
ADDRESSES: When commenting on the receive final approval from CMS. The collection for the proper performance of
proposed information collections, application process has two options for the agency’s functions, the accuracy of
please reference the document identifier applicants that include: Request for new the estimated burden, ways to enhance
the quality, utility, and clarity of the
asabaliauskas on DSKBBXCHB2PROD with NOTICES

or OMB control number. To be assured MA product or request for expanding
consideration, comments and the service area of an existing product. information to be collected; and the use
recommendations must be received by This collection process is the only of automated collection techniques or
the OMB desk officer via one of the mechanism for MA and/or MA–PD other forms of information technology to
following transmissions: OMB, Office of organizations to complete the required minimize the information collection
Information and Regulatory Affairs, application process. CMS utilizes the burden.
Attention: CMS Desk Officer, Fax application process as the means to DATES:Comments on the collection(s) of
Number: (202) 395–5806 OR, Email: review, assess and determine if information must be received by the
OIRA_submission@omb.eop.gov. applicants are compliant with the OMB desk officer by December 18, 2017.

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Document Created: 2017-11-16 03:52:57
Document Modified: 2017-11-16 03:52:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before January 16, 2018.
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]
FR Citation		82 FR 53501

82 FR 53501 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 82, Issue 220 (November 16, 2017)

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