57048 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices 

EXHIBIT 3—ESTIMATED ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Review of literature .................................................................................................................................................. $20,000 $20,000 

Cognitive interviews ................................................................................................................................................. 60,000 60,000 

Field test .................................................................................................................................................................. 90,000 90,000 

Data analyses .......................................................................................................................................................... 40,000 40,000 

Finalize survey ......................................................................................................................................................... 39,000 39,000 

AHRQ project management .................................................................................................................................... 50,000 50,000 

Total .................................................................................................................................................................. 299,000 299,000 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ healthcare 

research and healthcare information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: Aug 31 2011. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2011–23543 Filed 9–14–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Medical 

Expenditure Panel Survey—Insurance 

Component 2012–2013.’’ In accordance 

with the Paperwork Reduction Act, 44 

U.S.C. 3501–3521, AHRQ invites the 

public to comment on this proposed 

information collection. 

This proposed information collection 

was previously published in the Federal 

Register on June 30th, 2011 and allowed 

60 days for public comment. No 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

DATES: Comments on this notice must be 

received by October 17, 2011. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Medical Expenditure Panel Survey— 

Insurance Component 2012–2013 

Employer-sponsored health insurance 

is the source of coverage for 85 million 

current and former workers, plus many 

of their family members, and is a 

cornerstone of the U.S. health care 

system. The Medical Expenditure Panel 

Survey—Insurance Component (MEPS– 

IC) measures the extent, cost, and 

coverage of employer-sponsored health 

insurance on an annual basis. These 

statistics are produced at the National, 

State, and sub-State (metropolitan area) 

level for private industry. Statistics are 

also produced for State and Local 

governments. 

This research has the following goals: 

(1) To provide data for Federal 

policymakers evaluating the effects of 

National and State health care reforms; 

(2) to provide descriptive data on the 

current employer-sponsored health 

insurance system and data for modeling 

the differential impacts of proposed 

health policy initiatives; and 

(3) to supply critical State and 

National estimates of health insurance 

spending for the National Health 

Accounts and Gross Domestic Product. 

This study is being conducted by 

AHRQ through an interagency 

agreement with the U.S. Census Bureau 

and pursuant to AHRQ’s statutory 

authority to conduct surveys to collect 

data on the cost, use and quality of 

health care, including the types and 

costs of private health insurance. 42 

U.S.C. 299b–2(a). 

Method of Collection 

To achieve the goals of this project the 

following data collections for both 

private sector and state and local 

government employers will be 

implemented: 

(1) Prescreener Questionnaire—The 

purpose of the Prescreener 

Questionnaire, which is collected via 

telephone, varies depending on the 

insurance status of the establishment 

contacted. (Establishment is defined as 

a single, physical location in the private 

sector and a governmental unit in state 

and local governments.) For 

establishments that do not offer health 

insurance to their employees, the 

prescreener is used to collect basic 

information such as number of 

employees. Collection is completed for 

these establishments through this 

telephone call. For establishments that 

do offer health insurance, contact name 

and address information is collected 

that is used for the mailout of the 

establishment and plan questionnaires. 

Obtaining this contact information helps 

ensure that the questionnaires are 

directed to the person in the 

establishment best equipped to 

complete them. 


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Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices 57049 

(2) Establishment Questionnaire—The 

purpose of the mailed Establishment 

Questionnaire is to obtain general 

information from employers that 

provide health insurance to their 

employees. Information such as total 

active enrollment in health insurance, 

other employee benefits, waiting 

periods, and retiree health insurance is 

collected through the establishment 

questionnaire. 

(3) Plan Questionnaire—The purpose 

of the mailed Plan Questionnaire is to 

collect plan-specific information on 

each plan (up to four plans) offered by 

establishments that provide health 

insurance to their employees. This 

questionnaire obtains information on 

total premiums, employer and employee 

contributions to the premium, and plan 

enrollment for each type of coverage 

offered—single, employee-plus-one, and 

family—within a plan. It also asks for 

information on deductibles, copays, and 

other plan characteristics. This 

information is needed in order to 

provide the tools for Federal, State, and 

academic researchers to evaluate current 

and proposed health policies and to 

support the production of important 

statistical measures for other Federal 

agencies. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

respondent’s time to provide the 

requested data. The Prescreener 

questionnaire will be completed by 

31,552 respondents and takes about 5 1⁄2

minutes to complete. The Establishment 

questionnaire will be completed by 

25,839 respondents and takes about 23 

minutes to complete. The Plan 

questionnaire will be completed by 

23,230 respondents and will require an 

average of 2.1 responses per respondent. 

Each Plan questionnaire takes about 11 

minutes to complete. The total 

annualized burden hours are estimated 

to be 21,440 hours. 

Exhibit 2 shows the estimated 

annualized cost burden associated with 

the respondents’ time to participate in 

this data collection. The annualized cost 

burden is estimated to be $614,256. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Prescreener Questionnaire .............................................................................. 31,552 1 0.09 2,840 

Establishment Questionnaire ........................................................................... 25,839 1 0.38 9,819 

Plan Questionnaire .......................................................................................... 23,230 2.1 0.18 8,781 

Total .......................................................................................................... 80,621 na na 21,440 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total cost 

burden 

Prescreener Questionnaire .............................................................................. 31,552 2,840 28.65 $81,366 

Establishment Questionnaire ........................................................................... 25,839 9,819 28.65 281,314 

Plan Questionnaire .......................................................................................... 23,230 8,781 28.65 251,576 

Total .......................................................................................................... 80,621 21,440 na 614,256 

*Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code—1141, at http://www.bls.gov/ 

oes/current/oes_nat.htm#13–0000 (U.S. Department of Labor, Bureau of Labor Statistics.) 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated 

annualized cost of this data collection. 

The total cost over the 2 years of this 

clearance is $22,954,000. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

[$ thousands] 

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $3,338 $1,669 

Data Collection Activities ......................................................................................................................................... 7,789 3,895 

Data Processing and Analysis ................................................................................................................................. 7,789 3,895 

Project Management ................................................................................................................................................ 2,925 1,463 

Overhead ................................................................................................................................................................. 1,113 557 

Total .................................................................................................................................................................. 22,954 11,477 

Note: Components may not sum to Total due to rounding. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ healthcare 

research and healthcare information 


wreier-aviles on DSKGBLS3C1PROD with NOTICES
57050 Federal Register / Vol. 76, No. 179 / Thursday, September 15, 2011 / Notices 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: Aug 31 2011. 

Carolyn M. Cancy, 

Director. 

[FR Doc. 2011–23539 Filed 9–14–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0400] 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2011–0014] 

Approaches to Reducing Sodium 

Consumption; Establishment of 

Dockets; Request for Comments, Data, 

and Information 

AGENCY: Food and Drug Administration, 

HHS; Food Safety and Inspection 

Service, USDA. 

ACTION: Notice; establishment of 

dockets; request for comments, data, 

and information. 

SUMMARY: The Food and Drug 

Administration (FDA) and the Food 

Safety and Inspection Service (FSIS) are 

announcing the establishment of 

dockets to obtain comments, data, and 

evidence relevant to the dietary intake 

of sodium as well as current and 

emerging approaches designed to 

promote sodium reduction. FDA and 

FSIS are particularly interested in 

research that will help both 

organizations understand current and 

emerging practices by industry in 

sodium reduction in foods; current 

consumer understanding of the role of 

sodium in hypertension and other 

chronic illnesses, sodium consumption 

practices; motivation and barriers in 

reducing sodium in their food intakes; 

and issues associated with the 

development of targets for sodium 

reduction in foods to promote reduction 

of excess sodium intake. Excess sodium 

intake is linked to increased risk of 

heart disease and stroke. FDA and FSIS 

recognize ongoing efforts by a number of 

members of the restaurant and packaged 

food industries to reduce sodium and 

appreciate the complexities of reducing 

sodium in foods. Continued input and 

support from industry and other 

stakeholders are important to support 

further progress on this significant 

public health issue. 

DATES: Submit either electronic or 

written comments and data and 

information by November 29, 2011. 

ADDRESSES: FDA: Submit electronic 

comments and data and information to 

http://www.regulations.gov. Submit 

written comments and data and 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

submissions must include the Agency 

name and docket number FDA–2011– 

N–0400. 

FSIS: Submit electronic comments 

and data and information to http:// 

www.regulations.gov. Submit written 

comments and data and information to 

the Docket Clerk, U.S. Department of 

Agriculture, Food Safety and Inspection 

Service, FSIS Docket Room, 1400 

Independence Avenue, SW., Patriots 

Plaza 3, Mailstop 3782, Room 163A, 

Washington, DC 20250–3700. All 

submissions must include the Agency 

name and docket number FSIS–2011– 

0014. 

FOR FURTHER INFORMATION CONTACT: 

FDA: Richard E. Bonnette, Center for 

Food Safety and Applied Nutrition 

(HFS–255), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835, 

240–402–1235. 

FSIS: Rosalyn Murphy-Jenkins, 

Director, Labeling and Program Delivery 

Division, Office of Policy and Program 

Development, Food Safety and 

Inspection Service, U.S. Department of 

Agriculture, USDA, FSIS, OPPD, LPDD 

Stop Code 3784, Patriots Plaza III, 8– 

161A, 1400 Independence Avenue, SW., 

Washington, DC 20250–3700. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Research shows that excess sodium 

consumption is a contributory factor in 

the development of hypertension, which 

is a leading cause of heart disease and 

stroke (Ref. 1), the first and fourth 

leading causes of death in the United 

States, respectively (Ref. 2). Research 

also shows that the increase in blood 

pressure seen with aging, common to 

most Western countries, is not observed 

in populations that consume low 

sodium diets (Refs. 3 and 4) and that the 

U.S. population consumes far more 

sodium than recommended (Ref. 5 and 

7). Moreover, dietary reduction of 

sodium can lower blood pressure as has 

been demonstrated in the Dietary 

Approaches to Stop Hypertension 

(DASH)-Sodium trial (Ref. 6). Because 

over three-quarters of sodium in the diet 

of the U.S. population is added during 

manufacturing of foods and preparation 

of restaurant foods, reduction in sodium 

consumption in the United States 

involves reduction in the sodium 

content of food in the U.S. marketplace 

(Refs. 5 and 7). 

In this document, we refer primarily 

to ‘‘sodium,’’ a component of sodium 

chloride, commonly known as ‘‘salt.’’ 

Most but not all sodium is added to food 

in the form of salt and we are interested 

in all sources of sodium added to foods. 

The comments, data, and evidence 

regarding sodium reduction obtained by 

the establishment of these dockets will 

provide important information about 

current and emerging practices and 

approaches designed to reduce excess 

sodium intake, primarily coming from 

salt. 

A. Sodium: Current and Recommended 

Intake 

According to national food survey 

data from the ‘‘What We Eat in America, 

National Health and Nutrition 

Examination Survey (NHANES) 2007– 

2008,’’ estimated average sodium intake 

from foods among persons in the United 

States aged 2 years or older is 

approximately 3,300 milligrams per day 

(mg/d) (excluding salt added at the 

table) (Ref. 8). Most of this sodium 

comes from salt used in the manufacture 

or preparation of foods (Ref. 9). In 2005, 

the IOM set a Tolerable Upper Intake 

Level (UL) for sodium at 2,300 mg/d and 

an Adequate Intake (AI) at 1,500 mg/d 

for those 9 to 50 years of age, including 

pregnant and lactating women (AIs are 

lower for those 0–8 years of age and for 

those over 50 years of age) (Ref. 1). The 

2010 Dietary Guidelines for Americans 

recommendations are to ‘‘reduce daily 

sodium intake to less than 2,300 

milligrams (mg) and further reduce 

intake to 1,500 mg among persons who 

are 51 and older and those of any age 

who are African American or have 

hypertension, diabetes, or chronic 

kidney disease.’’ The 1,500 mg 

recommendation applies to about half of 

the U.S. population (Ref. 7). Current 

sodium intake is substantially higher 


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