Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices 32119 

private health plans. As part of this 

evaluation, qualitative and quantitative 

data will be collected and analyzed to 

answer research questions focused on: 

(1) State initiative features and 

implementation, including various 

payment models; (2) practice 

characteristics, particularly medical 

home transformation; and (3) outcomes, 

including access to and coordination of 

care, clinical quality of care and patient 

safety, beneficiary experience with care, 

patterns of utilization, Medicare and 

Medicaid expenditures, and budget 

neutrality. This information will help 

CMS decide whether the MAPCP 

Demonstration model should be 

expanded under Medicare, and if so, 

what modifications and supports would 

be needed to implement similar 

innovations in other states and practices 

in the future. Form Number: CMS– 

10436 (OCN: 0938–New); Frequency: 

Yearly; Affected Public: Individuals and 

households; Number of Respondents: 

472 ; Total Annual Responses: 472; 

Total Annual Hours: 478 (For policy 

questions regarding this collection 

contact Suzanne Goodwin at 410–786– 

0226. For all other issues call 410–786– 

1326.) 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Medicare 

Enrollment Application for Clinics/ 

Group Practice and Certain Other 

Suppliers; Use: The primary function of 

the CMS–855B enrollment application 

for Clinics, Group Practices and Certain 

Other Suppliers is to gather information 

from the organization that tells us what 

it is, whether it meets certain 

qualifications to be a health care 

supplier, where it renders services and 

information necessary to establish the 

correct claims payment. The goal of 

evaluating and revising the CMS–855B 

enrollment application is to simplify 

and clarify the information collection 

without jeopardizing our need to collect 

specific information. The majority of the 

revisions are very minor in nature such 

as spelling and formatting corrections, 

removal of duplicate fields and 

instruction clarification for the 

organization/group. The Sections and 

Sub-Sections within the form are also 

being re-numbered and re-sequenced to 

create a more logical flow of the data 

collection. In addition, CMS is adding a 

data collection for an address to mail 

the periodic request for the revalidation 

of enrollment information (only if it 

differs from other addresses currently 

collected). Other than the revalidation 

mailing address described above, new 

data being collected in this revision 

package is a checkbox indicating 

whether or not an organization is 

wholly owned or operated by a hospital, 

the inclusion of a new supplier type 

(Centralized Flu Biller) and information 

on, if applicable, where the supplier 

stores its patient records electronically. 

Form Number: CMS–855B (OCN: 0938– 

New); Frequency: Yearly; Affected 

Public: Individuals and households; 

Number of Respondents: 31,000; Total 

Annual Responses: 31,000; Total 

Annual Hours: 103,000 (For policy 

questions regarding this collection 

contact Kim McPhillips at 410–786– 

5374. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

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

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office at (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by July 30, 2012: 

1. Electronically. You may submit 

your comments electronically to 

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

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Numberllll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: May 25, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–13207 Filed 5–30–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–305] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this 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 function; 

(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. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection. Title of 

Information Collection: External Quality 

Review Protocols. Use: The results of 

Medicare reviews, Medicare 

accreditation services, and Medicaid 

external quality reviews will be used by 

States in assessing the quality of care 

provided to Medicaid beneficiaries by 

managed care organizations and to 

provide information on the quality of 

care provided to the general public 

upon request. Protocols 1, 2, 3, 4, 5, 7, 

and the External Quality Review 

Background have been revised since the 

publication of the 60-day Federal 

Register notice on February 17, 2012 (77 

FR 9661). All of the revised protocols 

associated with the 60-day notice and 

this 30-day notice are in draft and must 

not be used until they are approved by 

OMB through the PRA process. Form 

Number: CMS–R–305 (OCN 0938–0786). 

Frequency of Reporting: Yearly. Affected 

Public: State, Local or Tribal 

Governments. Number of Respondents: 

42. Total Annual Responses: 70. Total 

Annual Hours: 415,643. (For policy 

questions regarding this collection 

contact Gary B. Jackson at 410–786– 


srobinson on DSK4SPTVN1PROD with NOTICES
32120 Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Notices 

1218. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

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

PaperworkReductionActof1995, or email 

your request, including your address, 

phone number, OMB number, and CMS 

document identifier, to Paperwork@cms.

hhs.gov, or call the Reports Clearance 

Office on (410) 786–1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on July 2, 2012. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: May 25, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division-B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–13206 Filed 5–30–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0495] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study on Consumer Responses to 

Nutrition Facts Labels With Various 

Footnote Formats and Declaration of 

Amount of Added Sugars 

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 study entitled ‘‘Experimental Study on 

Consumer Responses to Nutrition Facts 

Labels With Various Footnote Formats 

and Declaration of Amount of Added 

Sugars.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by July 30, 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: 

Domini Bean, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400T, Rockville, MD 20850, domini.

bean@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. 

Experimental Study on Consumer 

Responses to Nutrition Facts Labels 

With Various Footnote Formats and 

Declaration of Amount of Added 

Sugars—(OMB Control Number 0910– 

New) 

I. Background 

Under the Nutrition Labeling and 

Education Act of 1990 (Pub. L. 101– 

535), the Nutrition Facts label is 

required on most packaged foods and 

this information must be provided in a 

specific format in accordance with the 

provisions of § 101.9 (21 CFR 101.9). 

When FDA was determining which 

Nutrition Facts label format to require, 

the Agency undertook consumer 

research to evaluate alternatives (Refs. 1 

to 3). More recently, FDA conducted 

qualitative consumer research on the 

format of the Nutrition Facts label on 

behalf of the Agency’s Obesity Working 

Group (Ref. 4), which was formed in 

2003 and tasked with outlining a plan 

to help confront the problem of obesity 

in the United States (Ref. 5). In addition 

to conducting consumer research, in the 

Federal Register of November 2, 2007 

(72 FR 62149) FDA issued an Advance 

Notice of Proposed Rulemaking 

(ANPRM) entitled, ‘‘Food Labeling: 

Revision of Reference Values and 

Mandatory Nutrients’’ (the 2007 

ANPRM), which requested comments 

on a variety of topics related to a future 

proposed rule to update the 

presentation of nutrients and content of 

nutrient values on food labels. In the 

2007 ANPRM, the Agency included a 

request for comments on how 

consumers use the percent Daily Value 

in the Nutrition Facts label when 

evaluating the nutritional content of 

food items and making purchases. 

Research has suggested that 

consumers use the Nutrition Facts label 

in various ways, including, but not 

limited to, using the Nutrition Facts 

label to determine if products are high 

or low in a specific nutrient and to 

compare products (Ref. 6). One 

component of the Nutrition Facts label 

that serves as an aid in these uses is the 

percent Daily Value. Early consumer 

research indicated that the percent Daily 

Value format improved consumers’ 

abilities to make correct dietary 

judgments about a food in the context of 

a total daily diet (Ref. 3), which led FDA 

to require both quantitative and 

percentage declarations of nutrient 

Daily Values in the Nutrition Facts label 

in the 1993 Nutrition Labeling final rule 

(58 FR 2079, January 6, 1993). 

Research in subsequent years, 

however, suggested that consumers’ 

understanding and use of percent Daily 

Value may be somewhat inconsistent 


srobinson on DSK4SPTVN1PROD with NOTICES