6594 Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices 

response; (2) Six focus groups per year, 10 

respondents each (to test education products and 

Web sites), 2 hours per response; and (3) Ten 

usability sessions per year, 12 respondents per Web 

site (to test the usability of FTC Web sites by 

inviting people to complete common tasks on those 

sites), 1 hour per response. 

5 In particular, the written request for confidential 

treatment that accompanies the comment must 

include the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. See 

FTC Rule 4.9(c), 16 CFR 4.9(c). 

Frequency of Response: Once per 

request. 

Annual Responses: 1,680. 

Average Minutes Per Response: 22 

(rounded to nearest whole minute). 

Burden Hours: 615. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

number assigned to the FTC to conduct 

past activities under this program is 

3084–0159. 

Request for Comment: Under the PRA, 

44 U.S.C. 3501–3521, federal agencies 

must obtain approval from OMB for 

each collection of information they 

conduct or sponsor. ‘‘Collection of 

information’’ means agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. 44 U.S.C. 

3502(3); 5 CFR 1320.3(c). As required by 

section 3506(c)(2)(A) of the PRA, the 

FTC is providing this opportunity for 

public comment before requesting that 

OMB extend the existing paperwork 

clearance for the regulations noted 

herein. 

Pursuant to Section 3506(c)(2)(A) of 

the PRA, the FTC invites comments on: 

(1) Whether the proposed information 

collection is necessary, including 

whether the information will be 

practically useful; (2) the accuracy of 

our burden estimates, including 

whether the methodology and 

assumptions used are valid; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) ways to minimize the burden of the 

collection of information. All comments 

should be filed as prescribed in the 

ADDRESSES section above, and must be 

received on or before April 7, 2014. 

You can file a comment online or on 

paper. For the FTC to consider your 

comment, we must receive it on or 

before April 7, 2014. Write ‘‘FTC 

Generic Clearance ICR, Project No. 

P035201’’ on your comment. Your 

comment—including your name and 

your state—will be placed on the public 

record of this proceeding, including, to 

the extent practicable, on the public 

Commission Web site, at http://

www.ftc.gov/os/publiccomments.shtm. 

As a matter of discretion, the 

Commission tries to remove individuals’ 

home contact information from 

comments before placing them on the 

Commission Web site. 

Because your comment will be made 

public, you are solely responsible for 

making sure that your comment doesn’t 

include any sensitive personal 

information, like anyone’s Social 

Security number, date of birth, driver’s 

license number or other state 

identification number or foreign country 

equivalent, passport number, financial 

account number, or credit or debit card 

number. You are also solely responsible 

for making sure that your comment 

doesn’t include any sensitive health 

information, like medical records or 

other individually identifiable health 

information. In addition, don’t include 

any ‘‘[t]rade secret or any commercial or 

financial information which is obtained 

from any person and which is privileged 

or confidential . . .,’’ as provided in 

Section 6(f) of the FTC Act, 15 U.S.C. 

46(f), and FTC Rule 4.10(a)(2), 16 CFR 

4.10(a)(2). If you want the Commission 

to give your comment confidential 

treatment, you must file it in paper 

form, with a request for confidential 

treatment, and you have to follow the 

procedure explained in FTC Rule 4.9(c), 

16 CFR 4.9(c).5 Your comment will be 

kept confidential only if the FTC 

General Counsel grants your request in 

accordance with the law and the public 

interest. 

Postal mail addressed to the 

Commission is subject to delay due to 

heightened security screening. As a 

result, we encourage you to submit your 

comments online, or to send them to the 

Commission by courier or overnight 

service. To make sure that the 

Commission considers your online 

comment, you must file it at https://

ftcpublic.commentworks.com/ftc/

genericclearance by following the 

instructions on the web-based form. If 

this Notice appears at http://

www.regulations.gov/#!home, you also 

may file a comment through that Web 

site. 

If you file your comment on paper, 

write ‘‘FTC Generic Clearance ICR, 

Project No. P035201’’ on your comment 

and on the envelope, and mail or deliver 

it to the following address: Federal 

Trade Commission, Office of the 

Secretary, Room H–113 (Annex J), 600 

Pennsylvania Avenue NW., Washington, 

DC 20580. If possible, submit your 

paper comment to the Commission by 

courier or overnight service. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before April 7, 2014. You can find more 

information, including routine uses 

permitted by the Privacy Act, in the 

Commission’s privacy policy, at http:// 

www.ftc.gov/ftc/privacy.htm. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2014–02216 Filed 2–3–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–5511–N] 

Medicare and Medicaid Programs; 

Solicitation for Proposals for the 

Frontier Community Health Integration 

Project Demonstration 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice provides eligible 

entities with the information necessary 

to apply for participation in the Frontier 

Community Health Integration Project 

(FCHIP) demonstration. The 

demonstration is designed to better 

integrate the delivery of acute care, 

extended care and other health care 

services, and improve access to care for 

Medicare and Medicaid beneficiaries 

residing in very sparsely populated 

areas. A competitive application process 

will be used to select eligible entities for 

participation in this demonstration. The 

demonstration is planned for up to 3 

years. 

DATES: Applications will be considered 

timely if we receive them on or before 

5 p.m., eastern standard time (E.S.T.) on 

May 5, 2014. 

ADDRESSES: Mail one unbound original 

and two copies to: Centers for Medicare 

& Medicaid Services, Attention: Steven 

Johnson, 7500 Security Boulevard, Mail 

Stop: WB–06–05, Baltimore, Maryland 

21244–1850. 

In addition, an email copy in MS 

Word or PDF must be sent to: FCHIP@

cms.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Steven Johnson, (410) 786–3332 or 

FCHIP@cms.hhs.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices 6595 

SUPPLEMENTARY INFORMATION: Please 

refer to file code CMS–5511–N on the 

application. Applicants are required to 

submit one unbound original and two 

copies to the address listed in the 

ADDRESSES section of this notice. In 

addition, an email copy in MS Word or 

PDF must be sent to: FCHIP@

cms.hhs.gov. Because of staffing and 

resource limitations, we cannot accept 

applications by facsimile (FAX) 

transmission. Applications postmarked 

after the closing date, or postmarked on 

or before the closing date but not 

received in time, will be considered 

late. 

I. Background 

A. Legislative Authority 

Section 123 of the Medicare 

Improvements for Patients and 

Providers Act of 2008, (MIPPA) (Pub. L. 

110–275) as amended by section 3126 of 

the Patient Protection and Affordable 

Care Act (Pub. L. 111–148), authorizes 

a demonstration project on community 

health integration models in certain 

rural counties to develop and test new 

models for the delivery of health care 

services to better integrate the delivery 

of acute care, extended care and other 

health care services, and improve access 

to care for Medicare and Medicaid 

beneficiaries residing in very sparsely 

populated areas. 

The authorizing legislation defines 

distinct roles for this demonstration for 

the Centers for Medicare & Medicaid 

Services (CMS) and the Health 

Resources and Services Administration 

(HRSA) in developing and 

implementing this project. HRSA was 

charged with awarding grants to eligible 

entities for the purpose of technical 

assistance and informing the Secretary 

of the Department of Health and Human 

Services (Secretary) on the specific 

needs of frontier communities, while 

CMS is to conduct a demonstration 

testing alternative reimbursement and 

administrative strategies. 

This demonstration is commonly 

known as the Frontier Community 

Health Integration Project (FCHIP). CMS 

is hereby requesting applications for 

participation in this demonstration from 

eligible entities as defined in Section 

123(d)(1)(B) of MIPPA. CMS interprets 

the eligible entity definition as meaning 

critical access hospitals (CAHs) that 

receive funding through the Rural 

Hospital Flexibility Program. The 

statute limits the Demonstration to no 

more than 4 States; it also restricts 

eligibility to CAHs within States with at 

least 65 percent of counties with 6 or 

less persons per square mile. With 

respect to these requirements, CMS is 

limiting applications to CAHs in Alaska, 

Montana, Nevada, North Dakota, and 

Wyoming. 

The authorizing legislation mandates 

that the project last for 3 years. The law 

authorizes waiver of such provisions of 

the Medicare and Medicaid programs as 

are necessary to conduct the 

demonstration project. The authorizing 

legislation also requires the 

demonstration to be budget neutral, that 

is, to be structured such that Medicare 

expenditures under the demonstration 

do not to exceed the amount which the 

Secretary estimates would have been 

paid if the demonstration project were 

not implemented. This notice references 

CMS’s request for proposals for the 

FCHIP demonstration, which sets forth 

project guidelines, conditions of 

participation, payment methodology, 

and application instructions. 

The FCHIP demonstration is designed 

to improve access to certain services, 

the delivery of which is often not 

feasible at low volumes under current 

Medicare reimbursement but if 

integrated into the local delivery 

system, would lead to improved 

outcomes and greater efficiency in 

health care service delivery. Integration 

of services is intended as an 

intervention that is directed by the 

various providers serving the 

community so that the specific health 

care needs of residents are addressed in 

appropriate settings—either inpatient, 

outpatient, or at home. The desired 

outcome is to increase access to health 

care services, with the objective of 

supporting certain services so as to 

allow them to be financially feasible 

given the low patient volumes of a 

remote and sparsely populated area. 

Another objective is to decrease the 

number of avoidable hospital 

admissions, readmissions, and 

avoidable transfers to tertiary facilities, 

such that there is no net increase in 

Medicare spending for the affected 

population. To address the goal of 

increasing access with no net cost 

increase, we have identified four types 

of services for which this demonstration 

will provide financial support, and 

promote community health 

integration—these are: Nursing facility 

care within the CAH, telemedicine, 

ambulance, and home health. We have 

selected these services on the basis of 

research and literature review. 

Applicants should identify additional 

services of one or more of these types, 

beyond what is currently available. 

Applicants must address the need for 

these services, including how they 

enhance patient care options and the 

ability of beneficiaries to remain in their 

communities; and how quality of these 

services will be maintained, to assure 

care can safely be provided locally. We 

will also work in the development 

process of this project with State 

Medicaid agencies on their proposals for 

Medicaid-specific reimbursement 

mechanisms to support access to 

community-based health care services. 

B. FCHIP Applications 

In keeping with the authorizing 

legislation in section 123 of MIPPA, 

entities that meet the eligibility 

requirements will be able to apply for 

the demonstration. Specifically, an 

eligible entity must be located in either 

Alaska, Montana, Nevada, North Dakota, 

or Wyoming although CMS will select 

no more than 4 States to participate in 

the demonstration. Each entity in its 

application will be required to describe 

a proposal to enhance health-related 

services so as to complement those 

currently provided within the 

community and reimbursed by 

Medicare, Medicaid, or other third-party 

payers. The applicant must describe an 

integrated system of services and 

explain how these will better serve the 

community’s health-related needs. 

An entity applying for the 

demonstration will be required to 

demonstrate linkages (either ownership 

or contractual) with the providers of the 

identified additional services, such as 

nursing home, telemedicine, home 

health agency, or ambulance service. 

Specifically, to be approved for payment 

of telemedicine services under the 

demonstration’s payment methodology, 

the applicant must demonstrate 

effective arrangements with distant site 

specialists who will participate in 

telemedicine linkages with providers 

within the communities. In addition, to 

be approved for ambulance services, the 

applicants must show transfer 

arrangements with essential providers. 

Each applicant will be asked to 

submit an analysis of how its proposed 

project will be budget neutral and/or 

achieve cost savings. This will include 

projections of the number of patients 

that will gain access to services within 

the community that are supported by 

the demonstration, the cost of these 

services, and the resulting cost savings 

from averting transfers to out-of-area 

hospitals and/or avoidable 

hospitalizations. The applicant will be 

evaluated on the plausibility of this 

analysis, the ability to support 

projections with clinical evidence and 

the sensitivity of cost outcomes to the 

stated assumptions of change in services 

and patient behavior. 

Interested and eligible parties can 

obtain complete solicitation and 

supporting information on the CMS 

mstockstill on DSK4VPTVN1PROD with NOTICES

6596 Federal Register / Vol. 79, No. 23 / Tuesday, February 4, 2014 / Notices 

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

initiatives/index.html. Paper copies can 

be obtained by writing to Steven 

Johnson at the address listed in the 

ADDRESSES section of this notice. 

II. Collection of Information 

Requirements 

The information collection 

requirements associated with this notice 

are subject to the Paperwork Reduction 

Act of 1995; however, the information 

collection requirements are currently 

approved under the information 

collection request associated with OMB 

control number 0938–0880 entitled 

‘‘Medicare Waiver Demonstration 

Applicant.’’ Applicants must submit the 

Medicare Waiver Demonstration 

Application to be considered for this 

program. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: August 20, 2013. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2014–02062 Filed 1–31–14; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0053] 

Designation of High-Risk Foods for 

Tracing; Request for Comments and 

for Scientific Data and Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments 

and for scientific data and information. 

SUMMARY: The Food and Drug 

Administration (‘‘FDA’’ or ‘‘we’’) is 

announcing the opening of a docket to 

obtain comments and scientific data and 

information that will help us to 

implement the section of the FDA Food 

Safety Modernization Act (FSMA) that 

requires FDA to designate high-risk 

foods. We are providing an opportunity 

for interested parties to submit 

comments and scientific data and 

information that will help us develop 

our process for implementing this 

provision. 

DATES: Submit electronic or written 

comments and scientific data and 

information by April 7, 2014. 

ADDRESSES: You may submit comments 

and scientific data and information, 

identified by Docket No. FDA–2014–N– 

0053, by any of the following methods: 

Electronic Submissions 

Submit electronic comments and 

scientific data and information in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 

and scientific data and information. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2014–N–0053 for this 

notice. All comments and scientific data 

and information received may be posted 

without change to 

http://www.regulations.gov, including 

any personal information provided. For 

additional information on submitting 

comments and scientific data and 

information, see the ‘‘Comments’’ 

heading of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read background documents or 

comments and scientific data and 

information received, go to 

http://www.regulations.gov and insert 

the docket number found in brackets in 

the heading of this document into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sherri Dennis, Center for Food Safety 

and Applied Nutrition (HFS–005), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–1914. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. FDA Food Safety Modernization Act 

Provision Requiring Designation of 

High-Risk Foods 

On January 4, 2011, the President 

signed the FDA Food Safety 

Modernization Act (FSMA) (Pub. L. 

111–353) into law. Section 204 of FSMA 

requires, among other things, the 

designation of high-risk foods. 

Specifically, section 204(d)(2)(A) of 

FSMA requires FDA to designate highrisk foods for which additional 

recordkeeping requirements are 

appropriate and necessary to protect the 

public health, and to do so not later 

than 1 year after the date of enactment 

of FSMA (and thereafter, if necessary). 

Section 204(d)(2)(B) requires FDA to 

publish the list of high-risk foods on the 

Internet Web site of FDA at the time 

when FDA issues final rules to establish 

the additional recordkeeping 

requirements for high-risk foods. 

Section 204(d)(2)(A) of FSMA 

specifically states that the designation of 

high-risk foods must be based on the: (1) 

Known safety risks of a particular food, 

including the history and severity of 

foodborne illness outbreaks attributed to 

such food, taking into consideration 

foodborne illness data collected by the 

Centers for Disease Control and 

Prevention; (2) likelihood that a 

particular food has a high potential risk 

for microbiological or chemical 

contamination or would support the 

growth of pathogenic microorganisms 

due to the nature of the food or the 

processes used to produce such food; (3) 

point in the manufacturing process of 

the food where contamination is most 

likely to occur; (4) likelihood of 

contamination and steps taken during 

the manufacturing process to reduce the 

possibility of contamination; (5) 

likelihood that consuming a particular 

food will result in a foodborne illness 

due to contamination of the food; and 

(6) likely or known severity, including 

health and economic impacts, of a 

foodborne illness attributed to a 

particular food. 

Through this notice, we are 

establishing a docket to provide an 

opportunity for interested parties to 

provide comments and scientific data 

and information that will help us refine 

our draft approach to identifying highrisk foods, as required by section 

204(d)(2) of FSMA. Section I.B 

summarizes our tentative draft approach 

for the review and evaluation of data to 

designate high-risk foods. Attached as a 

reference to this notice is a draft 

approach document in which we 

describe the process and methodology 

we are considering using for designating 

high-risk foods. After reviewing 

comments received in response to this 

notice on the draft approach described 

here, we plan to further revise the 

approach as necessary. We also 

anticipate that the approach will be 

reviewed by scientific experts (‘‘peer 

reviewed’’). 

While section 204(d)(2)(A) of FSMA 

includes a statutory deadline within 1 

year of the enactment of FSMA, FDA is 

issuing this notice to solicit comments 

and scientific data and information that 

will help us refine our draft approach to 

identifying high-risk foods. In section 

II.B, there are a number of specific 

mstockstill on DSK4VPTVN1PROD with NOTICES