42778 Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Notices 

percent of Sumner Bank & Trust, 

Gallatin, Tennessee. 

2. The McGehee Bank Employee Stock 

Ownership Plan, McGhee, Arkansas; to 

acquire up to 35 percent of the voting 

shares of Southeast Financial Bankstock 

Corp., and thereby indirectly acquire 

voting shares of McGehee Bank, both in 

McGehee, Arkansas. 

Board of Governors of the Federal Reserve 

System, July 12, 2013. 

Margaret McCloskey Shanks, 

Deputy Secretary of the Board. 

[FR Doc. 2013–17133 Filed 7–16–13; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10494] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) 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 August 14, 2013: 

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) 395–6974 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 

http://www.cms.hhs.gov/ 

PaperworkReductionActof1995. 

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: 

Reports Clearance Office at (410) 786– 

1326. 

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: New collection; Title of 

Information Collection: Patient 

Protection and Affordable Care Act; 

Exchange Functions: Standards for 

Navigators and Non-Navigator 

Assistance Personnel; Consumer 

Assistance Tools and Programs of an 

Exchange and Certified Application 

Counselors; Use: Section 1413 of the 

Affordable Care Act directs the 

Secretary of HHS to establish, subject to 

minimum requirements, a streamlined 

enrollment system for qualified health 

plans offered through the Exchange and 

insurance affordability programs. In 

addition, section 1321(a)(1) of the 

Affordable Care Act directs and 

authorizes the Secretary to issue 

regulations setting standards for meeting 

the requirements under title I of the 

Affordable Care Act, with respect to, 

among other things, the establishment 

and operation of Exchanges. Pursuant to 

this authority, regulations establishing 

the certified application counselor 

program are being finalized at 45 CFR 

155.225. Specifically, 45 CFR 155.225(a) 

requires an Exchange to establish a 

certified application counselor program 

that complies with the requirements of 

the rule. Section 155.225(b)(1) allows 

each Exchange to designate certain 

organizations, including organizations 

designated by state Medicaid or CHIP 

agencies, which will certify their staff 

and volunteers to act as certified 

application counselors. In accordance 

with 45 CFR 155.225(b)(2), Exchanges 

may choose to certify directly 

individuals who seek to act as certified 

application counselors, designate 

certain organizations which will certify 

staff or volunteers to perform 

application services, or do both. Form 

Number: CMS–10494 (OCN: 0938– 

NEW); Frequency: Yearly, annually; 

Affected Public: Private sector (not-forprofit institutions), individuals or 

households, State, Local, or Tribal 

Governments; Number of Respondents: 

8,720; Total Annual Responses: 8,720; 

Total Annual Hours: 5,536. (For policy 

questions regarding this collection 

contact Tricia Beckmann at 301–492– 

4328.) 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2013–17149 Filed 7–15–13; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5506–N2] 

Medicare Program; Comprehensive 

ESRD Care Initiative; Extension of the 

Submission Deadlines for the Letters 

of Intent and Applications 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of extension of 

deadlines. 

SUMMARY: This notice reopens the Letter 

of Intent submission period for the 

Comprehensive ESRD Care initiative 

letters of intent. Letters of Intent are 

now due on or before July 19, 2013. All 

potential applicants must submit a 

Letter of Intent to be eligible to submit 


ehiers on DSK2VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 137 / Wednesday, July 17, 2013 / Notices 42779 

an application. The submission 

deadline for the application has been 

extended to August 1, 2013. 

DATES: Letter of Intent Submission 

Deadline: Interested organizations must 

submit a non-binding letter of intent on 

or before July 19, 2013, by an online 

form at: https:// 

cmsgov.secure.force.com/cec. 

Application Submission Deadline: 

Interested organizations must submit an 

application on or before August 1, 2013, 

as described on the Innovation Center 

Web site at: http://innovation.cms.gov/ 

initiatives/comprehensive-ESRD-care/ 

apply.html. Interested organizations 

should also continue to check the Web 

site for updates on this initiative. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Cohen, (410) 786–1829 or 

ESRD-CMMI@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Center for Medicare and 

Medicaid Innovation (Innovation 

Center) is interested in identifying 

models designed to improve care for 

beneficiaries with end-stage renal 

disease (ESRD). To promote seamless 

and integrated care for beneficiaries 

with ESRD, we are developing a 

comprehensive care delivery model to 

emphasize coordination of a full-range 

of clinical and non-clinical services 

across providers, suppliers, and settings. 

Through the Comprehensive ESRD Care 

Model, we seek to identify ways to 

improve the coordination and quality of 

care for this population, while lowering 

total per-capita expenditures under the 

Medicare program. We anticipate that 

the Comprehensive ESRD Care Model 

would result in improved health 

outcomes for beneficiaries with ESRD 

regarding the functional status, quality 

of life, and overall well-being, as well as 

increased beneficiary and caregiver 

engagement, and lower costs to 

Medicare through improved care 

coordination. 

On February 6, 2013, we published a 

notice in the Federal Register 

announcing a request for applications 

from organizations to participate in the 

testing of the Comprehensive ESRD Care 

Model, for a period beginning in 2013 

and ending in 2016, with a possible 

extension into subsequent years. 

In that notice, we stated that 

organizations interested in applying to 

participate in the testing of the 

Comprehensive ESRD Care Model must 

submit a non-binding letter of intent by 

March 15, 2013, and an application by 

May 1, 2013. 

II. Provisions of the Notice 

Since the publication of the February 

6, 2013 notice, several stakeholders 

have requested additional time to 

prepare their applications and form 

partnerships. Therefore, the Innovation 

Center is extending the following 

deadlines relating to the Comprehensive 

ESRD Care initiative: (1) The letter of 

intent submission period has been 

reopened. The deadline for submission 

of the letter of intent has been extended 

to July 19, 2013; and (2) the deadline for 

submission of the application has been 

extended to August 1, 2013. 

In the DATES section of this notice, we 

are including the new submissions 

deadlines. For additional information 

on the Comprehensive ESRD Care 

Model and how to apply, we refer 

readers to click on the Request for 

Applications located on the Innovation 

Center Web site at: http:// 

innovation.cms.gov/initiatives/ 

comprehensive-ESRD-care. 

(No. 93.773 Medicare—Hospital Insurance 

Program; and No. 93.774, MedicareSupplementary Medical Insurance Program) 

Dated: July 9, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2013–17131 Filed 7–16–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0754] 

Authorization of Emergency Use of an 

In Vitro Diagnostic for Detection of 

Middle East Respiratory Syndrome 

Coronavirus; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

for an in vitro diagnostic device for 

detection of Middle East Respiratory 

Syndrome Coronavirus (MERS-CoV), 

formerly known as Novel Coronavirus 

2012 or NCV–2012. FDA is issuing this 

Authorization under the Federal Food, 

Drug, and Cosmetic (the FD&C) Act, as 

requested by the Centers for Disease 

Control and Prevention (CDC). The 

Authorization contains, among other 

things, conditions on the emergency use 

of the authorized in vitro diagnostic 

device. The Authorization follows the 

determination by the Secretary of Health 

and Human Services (HHS) that there is 

a significant potential for a public 

health emergency that has a significant 

potential to affect national security or 

the health and security of U.S. citizens 

living abroad and that involves MERSCoV. On the basis of such 

determination, the Secretary also 

declared that circumstances exist 

justifying the authorization of 

emergency use of in vitro diagnostics for 

detection of MERS-CoV subject to the 

terms of any authorization issued under 

the FD&C Act. The Authorization, 

which includes an explanation of the 

reasons for issuance, is reprinted in this 

document. 

DATES: The Authorization is effective as 

of June 5, 2013. 

ADDRESSES: Submit written requests for 

single copies of the EUA to the Office 

of Counterterrorism and Emerging 

Threats, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 4121, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request or include a fax number to 

which the Authorization may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Luciana Borio, Assistant Commissioner 

for Counterterrorism Policy, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4118, Silver Spring, MD 20993–0002, 

telephone 301–796–8510 (this is not a 

toll free number). 

SUPPLEMENTARY INFORMATION:

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3), as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5), allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. With this 

EUAauthority, FDA can help assure that 

medical countermeasures may be used 

in emergencies to diagnose, treat, or 

prevent serious or life-threatening 

diseases or conditions caused by 

biological, chemical, nuclear, or 

radiological agents when there are no 

adequate, approved, and available 

alternatives. 


ehiers on DSK2VPTVN1PROD with NOTICES