60 day FRN

Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
leadership; update of Legislation
Relating to the Evidence Based Policy
Commission; update on National Health
and Nutrition Examination Surveys
Reports and Activities; update on
Division of Health Care Statistics
Reports and Activities; update on Vital
Statistics activities; and update on
International Activities of NCHS.
Requests to make oral presentations
should be submitted in writing to the
contact person listed below. All requests
must contain the name, address,
telephone number, and organizational
affiliation of the presenter. Written
comments should not exceed five
single-spaced typed pages in length and
must be received by December 26, 2017.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–24871 Filed 11–15–17; 8:45 am]
BILLING CODE 4163–19–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

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SUMMARY:

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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 antibioticresistant 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:
omb@cdc.gov.
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

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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 antibioticresistant 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).

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

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).

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 antibioticresistant 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.

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 nonSTD SURRG location abstract, clean,
and transmit SURRG data.
Microbiologists at public health
laboratories from each of the nine

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ESTIMATE OF ANNUALIZED BURDEN HOURS
Average
burden per
response
(hours)

Number of
responses per
respondent

Type of
respondent

Form name

Local SURRG data manager ............

Facility, Laboratory and field Elements.
Non-STD clinic Elements .................

9

7

16

1,008

18

6

3

324

Laboratory Testing ...........................

9

700

10/60

1,050

Laboratory Elements ........................

9

6

1

54

Field Investigation Elements ............

1,080

1

30/60

540

..........................................................

........................

........................

........................

2,976

Data manager at non-STD clinic
health centers.
Public Health Laboratory Microbiologist.
Public Health Laboratory Data Manager.
Gonorrhea Patients, Social and Sexual Contacts.
Total ...........................................

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Number of
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Total burden
hours

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10237]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.

SUMMARY:

Comments on the collection(s) of
information must be received by the
OMB desk officer by December 18, 2017.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR, Email:
OIRA_submission@omb.eop.gov.

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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
Web site address at https://
www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
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. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Applications for
Part C Medicare Advantage, 1876 Cost
Plans, and Employer Group Waiver
Plans to Provide Part C Benefits; Use:
This information collection includes the
process for organizations wishing to
provide healthcare services under MA
and/or MA–PD plans must complete an
application annually, file a bid, and
receive final approval from CMS. The
application process has two options for
applicants that include: Request for new
MA product or request for expanding
the service area of an existing product.
This collection process is the only
mechanism for MA and/or MA–PD
organizations to complete the required
application process. CMS utilizes the
application process as the means to
review, assess and determine if
applicants are compliant with the

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current requirements for participation in
the Medicare Advantage program and to
make a decision related to contract
award. Form Number: CMS–10237
(OMB control number: 0938–0935);
Frequency: Yearly; Affected Public:
Private sector (Business or other Forprofits and Not-for-profit institutions);
Number of Respondents: 380; Total
Annual Responses: 380; Total Annual
Hours: 6,246. (For policy questions
regarding this collection contact Stacy
Davis at 410–786–7813.)
Dated: November 13, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–24816 Filed 11–15–17; 8:45 am]
BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10401]

Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected; and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.

SUMMARY:

Comments on the collection(s) of
information must be received by the
OMB desk officer by December 18, 2017.

DATES:

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