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

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 

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 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 

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). 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
53502 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). 

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 

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. 

ESTIMATE OF ANNUALIZED BURDEN HOURS

Type of 

respondent Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 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 

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 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: 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. 

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 

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 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by December 18, 2017. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES