11130 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

D. Speaker Declaration 

On the day of the meeting, before the 

end of the meeting, all primary speakers 

and 5-minute speakers must provide a 

brief written summary of their 

comments and conclusions to the 

HCPCS Public Meeting Coordinator. 

Each primary speaker and 5-minute 

speaker must declare in their 

presentation at the meeting, as well as 

in their written summary, whether they 

have any financial involvement with the 

manufacturers or competitors of any 

items being discussed; this includes any 

payment, salary, remuneration, or 

benefit provided to that speaker by the 

manufacturer or the manufacturer’s 

representatives. 

E. Written Comments From Meeting 

Attendees 

Written comments will be accepted 

from the general public and meeting 

registrants anytime up to the date of the 

public meeting at which a request is 

discussed. Comments must be sent to 

the address listed in the ADDRESSES

section of this notice. 

Meeting attendees may also submit 

their written comments at the meeting. 

Due to the close timing of the public 

meetings, subsequent workgroup 

reconsiderations, and final decisions, 

we are able to consider only those 

comments received in writing by the 

close of the public meeting at which the 

request is discussed. 

IV. Security, Building, and Parking 

Guidelines 

The meetings are held within the 

CMS Complex which is not open to the 

general public. Visitors to the complex 

are required to show a valid U.S. 

Government issued photo identification, 

preferably a driver’s license, at the time 

of entry. Participants will also be subject 

to a vehicular search before access to the 

complex is granted. Participants not in 

possession of a valid identification or 

who are in possession of prohibited 

items will be denied access to the 

complex. Prohibited items on Federal 

property include but are not limited to, 

alcoholic beverages, illegal narcotics, 

explosives, firearms or other dangerous 

weapons (including pocket knives), 

dogs or other animals except service 

animals. Once cleared for entry to the 

complex participants will be directed to 

parking by a security officer. 

In order to ensure expedited entry 

into the building it is recommended that 

participants have their ID and a copy of 

their written meeting registration 

confirmation readily available and that 

they do not bring laptops or large/bulky 

items into the building. Participants are 

reminded that photography on the CMS 

complex is prohibited. CMS has also 

been declared a tobacco free campus 

and violators are subject to legal action. 

In planning arrival time, we recommend 

allowing additional time to clear 

security. Individuals who are not 

registered in advance will not be 

permitted to enter the building and will 

be unable to attend the meeting. The 

public may not enter the building earlier 

than 45 minutes before the convening of 

the meeting each day. 

Guest access to the complex is limited 

to the meeting area, the main lobby, and 

the cafeteria. If a visitor is found outside 

of those areas without proper escort 

they may be escorted out of the facility. 

Also be mindful that there will be an 

opportunity for everyone to speak and 

we request that everyone waits for the 

appropriate time to present their 

product or opinions. Disruptive 

behavior will not be tolerated and may 

result in removal from the meetings and 

escort from the complex. No visitor is 

allowed to attach USB cables, thumb 

drives or any other equipment to any 

CMS information technology (IT) system 

or hardware for any purpose at anytime. 

Additionally, CMS staff is prohibited 

from taking such actions on behalf of a 

visitor or utilizing any removable media 

provided by a visitor. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

demonstration or to support a 

presentation. Special arrangements and 

approvals are required at least 2 weeks 

prior to each public meeting in order to 

bring pieces of equipment or medical 

devices. These arrangements need to be 

made with the public meeting 

coordinator. It is possible that certain 

requests made in advance of the public 

meeting could be denied because of 

unique safety, security or handling 

issues related to the equipment. A 

minimum of 2 weeks is required for 

approvals and security procedures. 

Any request not submitted at least 2 

weeks in advance of the public meeting 

will be denied. 

CMS policy requires that every 

foreign national (as defined by the 

Department of Homeland Security is 

‘‘an individual who is a citizen of any 

country other than the United States’’) 

is assigned a host (in accordance with 

the Department Foreign Visitor 

Management Policy, Appendix C, 

Guidelines for Hosts and Escorts). The 

host/hosting official is required to 

inform the Division of Critical 

Infrastructure Protection (DCIP) at least 

12 business days in advance of any visit 

by a foreign national. Foreign nationals 

will be required to produce a valid 

passport at the time of entry. 

Attendees that are foreign nationals 

need to identify themselves as such, and 

provide the following information for 

security clearance to the public meeting 

coordinator by the date specified in the 

DATES section of this notice: 

• Visitor’s full name (as it appears on 

passport). 

• Gender. 

• Country of origin and citizenship. 

• Biographical data and related 

information. 

• Date of birth. 

• Place of birth. 

• Passport number. 

• Passport issue date. 

• Passport expiration date. 

• Dates of visits. 

• Company Name. 

• Position/Title. 

Dated: February 13, 2012. 

Marilyn Tavenner 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–3969 Filed 2–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3259–PN] 

Medicare Program; Application by the 

American Association of Diabetes 

Educators (AADE) for Continued 

Recognition as a National 

Accreditation Organization for 

Accrediting Entities To Furnish 

Outpatient Diabetes Self-Management 

Training 

AGENCY: Centers for Medicare & 

Medicare Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

announces the receipt of an application 

from the American Association of 

Diabetes Educators for continued 

recognition as a national accreditation 

program for accrediting entities that 

wish to furnish outpatient diabetes selfmanagement training to Medicare 

beneficiaries. The statute requires that 

we publish a notice identifying the 

national accreditation body making the 

request, describing the nature of the 

request, and providing at least a 30-day 

public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on March 26, 2012. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 11131 

ADDRESSES: In commenting, please refer 

to file code CMS–3259–PN. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (Fax) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3259–PN, P.O. Box 8016, 

Baltimore, MD 21244–8016. Please 

allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3259–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. (Because access 

to the interior of the Hubert H. 

Humphrey Building is not readily 

available to persons without Federal 

government identification, commenters 

are encouraged to leave their comments 

in the CMS drop slots located in the 

main lobby of the building. A stamp-in 

clock is available for persons wishing to 

retain a proof of filing by stamping in 

and retaining an extra copy of the 

comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your comments 

to the Baltimore address, please call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Leach, (410) 786–4282. 

Kristin Shifflett, (410) 786–4133. Maria 

Hammel, (410) 786–1775. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://www.regulations.

gov. Follow the search instructions on 

that Web site to view public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive outpatient 

Diabetes Self-Management Training 

(DSMT) when ordered by the physician 

(or qualified non-physician practitioner) 

treating the beneficiary’s diabetes, 

provided certain requirements are met. 

Pursuant to our regulations at 42 CFR 

410.141(e)(3), we use national 

accrediting organizations to assess 

whether provider entities meet 

Medicare requirements when providing 

services for which Medicare payment is 

made. If a provider entity is accredited 

by an approved accrediting 

organization, it is ‘‘deemed’’ to meet 

applicable Medicare requirements. 

Under section 1865(a)(1)(B) of the 

Social Security Act (the Act), a national 

accreditation organization must have an 

agreement in effect with the Secretary 

and meet the standards and 

requirements specified by the Secretary 

in 42 CFR part 410, subpart H, to qualify 

for deeming authority. The regulations 

pertaining to application procedures for 

national accreditation organizations for 

DSMT are specified at § 410.142 (CMS 

process for approving national 

accreditation organizations). 

A national accreditation organization 

applying for deeming authority must 

provide us with reasonable assurance 

that the accrediting organization 

requires accredited entities to meet 

requirements that are at least as 

stringent as our requirements. 

We may approve and recognize a 

nonprofit organization with 

demonstrated experience in 

representing the interests of individuals 

with diabetes to accredit entities to 

furnish training. The accreditation 

organization, after being approved and 

recognized by us, may accredit an entity 

to meet one of the sets of quality 

standards in § 410.144 (Quality 

standards for deemed entities). 

Section 1865(a)(2) of the Act further 

requires that we review the applying 

accreditation organization’s 

requirements for accreditation, as 

follows: 

• Survey procedures. 

• Ability to provide adequate 

resources for conducting required 

surveys. 

• Ability to supply information for 

use in enforcement activities. 

• Monitoring procedures for 

providers found out of compliance with 

the conditions or requirements. 

• Ability to provide us with necessary 

data for validation. 

We then examine the national 

accreditation organization’s 

accreditation requirements to determine 

if they meet or exceed the Medicare 

conditions as we would have applied 

them. Section 1865(a)(3)(A) of the Act 

requires that we publish a notice 

identifying the national accreditation 

body making the request within 30 days 

of receipt of a completed application. 

The notice must describe the nature of 

the request and provide at least a 30-day 

public comment period. We have 210 

days from receipt of the request to 

publish a finding of approval or denial 

of the application. If we recognize an 

accreditation organization in this 

manner, any entity accredited by the 

national accreditation body’s CMSapproved program for that service will 

be ‘‘deemed’’ to meet the Medicare 

conditions for coverage. 

II. Provisions of the Proposed Notice 

The purpose of this notice is to notify 

the public of the American Association 

of Diabetes Educators’ (AADE) request 

for the Secretary’s approval of its 

accreditation program for outpatient 

DSMT services. The AADE submitted 

all the necessary materials to enable us 

to make a determination concerning its 

request for re-approval as a deeming 

organization for DSMTs. AADE was 

initially accredited on March 27, 2009, 

for a period of 3 years. This application 

was determined to be complete on 

January 13, 2012. This notice also 

solicits public comments on the ability 

of the AADE to continue to develop 

standards that meet or exceed the 

Medicare conditions for coverage, and 

apply them to entities furnishing 

outpatient DSMT. 


srobinson on DSK4SPTVN1PROD with NOTICES
11132 Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices 

Conditions for Coverage and 

Requirements for Outpatient Diabetes 

Self-Management Training Services 

The regulations specifying the 

Medicare conditions for coverage for 

outpatient diabetes self-management 

training services are located in 42 CFR 

parts 410, subpart H. These conditions 

implement section 1861(qq) of the Act, 

which provides for Medicare Part B 

coverage of outpatient DSMT services 

specified by the Secretary. 

Under section 1865(a)(2) of the Act 

and our regulations at § 410.142 (CMS 

process for approving national 

accreditation organizations) and 

§ 410.143 (Requirements for approved 

accreditation organizations), we review 

and evaluate a national accreditation 

organization based on (but not 

necessarily limited to) the criteria set 

forth in § 410.142(b). 

We may conduct on-site inspections 

of a national accreditation 

organization’s operations and office to 

verify information in the organization’s 

application and assess the 

organization’s compliance with its own 

policies and procedures. The onsite 

inspection may include, but is not 

limited to, reviewing documents, 

auditing documentation of meetings 

concerning the accreditation process, 

evaluating accreditation results or the 

accreditation status decision making 

process, and interviewing the 

organization’s staff. 

Notice Upon Completion of Evaluation 

Upon completion of our evaluation, 

including evaluation of comments 

received as a result of this notice, we 

will publish a notice in the Federal 

Register announcing the result of our 

evaluation. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773 Medicare-Hospital 

Insurance Program; and No. 93.774, 

Medicare-Supplementary Medical Insurance 

Program) 

Dated: February 10, 2012. 

Marilyn Tavenner, 

Acting CMS Administrator, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2012–4277 Filed 2–23–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0145] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Improving Food 

Safety and Defense Capacity of the 

State and Local Level: Review of State 

and Local Capacities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a survey entitled ‘‘Improving Food 

Safety and Defense Capacity of the State 

and Local Level: Review of State and 

Local Capacities.’’ The data collection 

will obtain knowledge of State and local 

capacities including food safety defense 

staffing and expertise, laboratory 

capacities, and information systems to 

support food and feed safety and 

defense. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 24, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Ila S. Mizrachi, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 

301–796–7726, 

Ila.Mizrachi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

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. 

‘‘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 provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (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 on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Improving Food Safety and Defense 

Capacity at the State and Local Level: 

Review of State and Local Capacities— 

(OMB Control Number 0910—New) 

The Food Safety Modernization Act 

(FSMA) (Pub. L. 111–353) states that a 

review must be conducted to assess the 

State and local capacities to show needs 

for enhancement in the areas or staffing 

levels, laboratory capacities, and 

information technology systems. This 

mandate is referenced again in FSMA 

section 110 stating that a review of 

current food safety and food defense 

capabilities must be presented to 

Congress no later than 2 years after the 

date of enactment (enactment date 

January 4, 2011). In order to facilitate 

this review, this team must distribute a 


srobinson on DSK4SPTVN1PROD with NOTICES