Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices 48987 

the plans and rates associated with the 

plans. 

Information that is to be collected 

from state high risk pools will be 

collected from The National Association 

of State Comprehensive Health 

Insurance Plans (NASCHIP) at this time. 

Updates to this information may be 

submitted voluntarily. The estimated 

hour burden on issuers for the Plan 

Finder data collection in the first year 

is estimated as 90,400 total burden 

hours, or 113 hours per organization. 

This estimate is based on an assumed 

average of 450 individual plan issuers 

and 700 small group plan issuers per 

each of the four quarterly collections. It 

includes 30 hours per organization for 

training and communication. 

Additionally, for each of the issuers it 

includes 11 hours of preparation time, 

one hour of login and upload time, two 

hours of troubleshooting and data 

review, and one half hour for attestation 

per organization per quarterly refresh. 

The estimated hour burden on the states 

is informed by the fact that they have 

already submitted the data once and 

only need to update. The overall hours 

estimate is 575, or 11.5 per Department 

of Insurance. This is premised on 2 

hours of training and communication, 8 

hours for data collection, and one half 

hour of submission. Form Number: 

CMS–10320 (OCN: 0938–1086); 

Frequency: Annually, quarterly; 

Affected Public: Business or other forprofits and States; Number of 

Respondents: 850; Total Annual 

Responses: 3,051; Total Annual Hours: 

91,225. (For policy questions regarding 

this collection, contact Joe Mercer at 

(301) 492–4265. 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. 

Interested parties are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. To ensure 

consideration of your comments and 

recommendations, they must be 

submitted in one of the following ways 

by September 13, 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: CMS–10320/OCN 0938– 

1086), Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 

Dated: August 10, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–20050 Filed 8–14–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–284] 

Agency Information Collection 

Activities: Proposed Collection; 

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) 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 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. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection. Title of 

Information Collection: Medicaid 

Statistical Information System (MSIS). 

Use: The Balanced Budget Act of 1997 

mandated that states report their 

Medicaid data via MSIS. MSIS is used 

by states and other jurisdictions to 

report fundamental statistical data on 

the operation of their Medicaid 

program. Data provided on eligibles, 

beneficiaries, payments and services are 

vital to those studying and assessing 

Medicaid policies and costs. Medicaid 

statistical data are routinely requested 

by CMS, Department agencies, the 

Congress and their research offices, state 

Medicaid agencies, research 

organizations, social service interest 

groups, universities and colleges, and 

the health care industry. The data 

provides the only national level 

information available on enrollees, 

beneficiaries, and expenditures. It also 

provides the only national level 

information available on Medicaid 

utilization. This information is the basis 

for analyses and for cost savings 

estimates for the Department’s cost 

sharing legislative initiatives to the 

Congress. The data is also crucial to 

CMS and HHS actuarial forecasts. Form 

Number: CMS–R–284 (OCN 0938–0345). 

Frequency: Quarterly. Affected Public: 

State, Local, or Tribal Governments. 

Number of Respondents: 51. Total 

Annual Responses: 204. Total Annual 

Hours: 2,040. (For policy questions 

regarding this collection contact Kay 

Spence. at 410–786–1617. 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. 

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 October 15, 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: CMS–R–284 (OCN 0938– 

0345), Room C4–26–05, 7500 Security 

Boulevard, Baltimore, Maryland 21244– 

1850. 


srobinson on DSK4SPTVN1PROD with NOTICES
48988 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices 

Dated: August 10, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–20051 Filed 8–14–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0871] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Studies on Consumer Responses to 

Nutrient Content Claims on Fortified 

Foods 

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 Studies 

on Consumer Responses to Nutrient 

Content Claims on Fortified Foods.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 15, 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 Studies on Consumer 

Responses to Nutrient Content Claims 

on Fortified Foods (OMB Control 

Number 0910–NEW) 

I. Background 

The Nutrition Labeling and Education 

Act gave FDA the authority to 

promulgate regulations which require 

almost all packaged foods to bear 

nutrition labeling. The law also allows 

manufacturers to provide other nutrition 

information on labels in the form of 

various types of statements, including 

claims, as long as such statements 

comply with the regulatory limits that 

govern the use of each type of statement. 

There are three types of claims that the 

food industry can voluntarily use on 

food labels: (1) Health claims, (2) 

nutrient content claims, and (3) 

structure/function claims. All claims 

must be truthful and not misleading 

(Ref. 1). 

The FDA’s policy on fortification (21 

CFR 104.20) establishes a set of 

principles that serve as a model for the 

rational addition of nutrients to foods. 

The FDA has an interest in the 

American public achieving and 

maintaining diets with optimal levels of 

nutritional quality, wherein healthy 

diets are composed of foods from a 

variety of nutrient sources. The FDA 

does not encourage the addition of 

nutrients to certain food products 

(including sugars or snack foods such as 

[cookies] candies, and carbonated 

beverages). FDA is interested in 

studying whether fortification of these 

foods could cause consumers to believe 

that substituting fortified snack foods 

for more nutritious foods would ensure 

a nutritionally sound diet. 

Research suggests consumer product 

perceptions and purchase decisions can 

be influenced by labeling statements 

and different labeling statements may 

have different influences (Refs. 2 

through 5). The FDA, as part of its effort 

to promote public health, proposes to 

conduct two related studies to explore 

consumer responses to expressed and 

implied nutrient content claims on the 

labels of snack foods such as cookies, 

carbonated beverages, and candy. Both 

studies will be controlled, randomized 

experiments. Study 1 will use a 15- 

minute Web-based questionnaire to 

collect information from 4,000 Englishspeaking adult members of an online 

consumer panel maintained by a 

contractor. Study 2 will use the same 

questionnaire and draw a sample of 

1,000 English-speaking adult 

participants from the same online 

consumer panel to test a subset of the 

experimental conditions employed in 

Study 1. Participants in Study 2 will 

also access the survey on the Web but 

will use a grocery-shopping simulation 

software program to participate in the 

study. Study 2 is expected to last 15 

minutes as well. 

The purpose for using both the regular 

Web-based application and the 

simulated shopping program is to be 

able to compare the two modes of data 

collection. One critique of experimental 

studies is that they may lack external 

validity—the ability to generalize the 

findings beyond the study setting 

because the study is very different from 

real life (Ref. 6). The grocery-shopping 

simulation software program may more 

closely mimic consumers’ real-life 

shopping experiences compared to the 

regular Web-based application and 

would therefore be expected to elicit 

survey responses similar to real-life food 

shopping. One study comparing 

simulated shopping with actual 

behavior concluded that consumers’ 

simulated purchase behaviors are highly 

predictive of their actual behavior (Ref. 

7). If proposed Study 1 and Study 2 

results are comparable, this will lend 

support to the external validity of online 

experimental study results. Researchers 

will endeavor to collect samples that 

reflect the U.S. Census on gender, 


srobinson on DSK4SPTVN1PROD with NOTICES