1168 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Pre-Existing 

Health Insurance Plan and Supporting 

Regulations; Use: On March 23, 2010, 

the President signed into law H.R. 3590, 

the Patient Protection and Affordable 

Care Act (Affordable Care Act), Public 

Law 111–148. Section 1101 of the law 

establishes a ‘‘temporary high risk health 

insurance pool program’’ (which has 

been named the Pre-Existing Condition 

Insurance Plan, or PCIP) to provide 

health insurance coverage to currently 

uninsured individuals with pre-existing 

conditions. The law authorizes HHS to 

carry out the program directly or 

through contracts with states or private, 

non-profit entities. 

We are requesting an extension of this 

package because this information is 

needed to assure that PCIP programs are 

established timely and effectively. This 

request is being made based on 

regulations and guidance that have been 

issued and contracts which have been 

executed by HHS with States or an 

entity on their behalf participating in 

the PCIP program. PCIP is also referred 

to as the temporary qualified high risk 

insurance pool program, as it is called 

in the Affordable Care Act, but we have 

adopted the term PCIP to better describe 

the program and avoid confusion with 

the existing state high risk pool 

programs. Form Number: CMS–10339 

(OMB#: 0938–1100); Frequency: 

Reporting—On occasion; Affected 

Public: State governments; Number of 

Respondents: 51; Total Annual 

Responses: 2,652; Total Annual Hours: 

36,924. (For policy questions regarding 

this collection contact Laura Dash at 

410–786–8623. 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 

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: March 8, 2011. 

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 Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: January 4, 2011. 

Kenneth Cohen, 

Director, Executive Secretariat & Regulatory 

Affairs, Office of Consumer Information and 

Insurance Oversight. 

[FR Doc. 2011–140 Filed 1–6–11; 8:45 am] 

BILLING CODE 4120–01–U–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0001] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Health and Diet 

Survey 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA’s Health and Diet Survey. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 8, 2011. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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, 

including each proposed extension of an 

existing 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. 

Health and Diet Survey (OMB Control 

Number 0910–0545—Extension) 

FDA is seeking extension of OMB 

approval for the Health and Diet Survey, 

which is a voluntary consumer survey 


jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 1169 

intended to gauge and track consumer 

attitudes, awareness, knowledge, and 

behavior regarding various topics 

related to health, nutrition and physical 

activity. The authority for FDA to 

collect the information derives from 

FDA’s Commissioner of Food and Drugs 

authority provided in section 903(d)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 393(d)(2)). 

The survey consists of two 

independent data collection activities. 

One collection, entitled ‘‘Health and 

Diet Survey—General Topics,’’ tracks a 

broad range of consumer attitudes, 

awareness, knowledge, and self-reported 

behaviors related to key diet and health 

issues. The other collection, entitled 

‘‘Health and Diet Survey—Dietary 

Guidelines Supplement,’’ will provide 

FDA with updated information about 

consumer attitudes, awareness, 

knowledge, and behavior regarding 

various elements of nutrition and 

physical activity based on the key 

recommendations of the Dietary 

Guidelines for Americans, which are 

jointly issued by the Department of 

Health and Human Services and the 

U.S. Department of Agriculture every 

5 years. 

The information to be collected with 

the Health and Diet Survey—General 

Topics will include: (1) Awareness of 

diet-disease relationships, (2) food and 

dietary supplement label use, (3) dietary 

practices including strategies to lose or 

maintain weight, and (4) awareness and 

knowledge of dietary fats. This survey 

has been repeated approximately every 

3 years over the course of the past 

several years for the purpose of tracking 

changes and trends in public opinions 

and consumer behavior, with some new 

questions added or omitted or partially 

modified each iteration in response to 

current events. In the next 3 years, FDA 

plans to field the Health and Diet 

Survey—General Topics in 2012 and 

anticipates that it might have the need 

for additional iterations in 2014. The 

information to be collected with the 

Health and Diet Survey—Dietary 

Guidelines Supplement will include: (1) 

Awareness and sources of information, 

(2) attitudes toward diet and physical 

activity, and (3) practice and knowledge 

related to recommended behaviors. The 

survey will also ask about perceptions 

and use of Federal nutrition 

information, special diet, weight status, 

health status, and demographics. In the 

next 3 years, FDA anticipates to field 

the Health and Diet Survey—Dietary 

Guidelines Supplement in 2011–2012. 

FDA and other Federal Agencies will 

use the information from the Health and 

Diet Survey to evaluate and develop 

strategies and programs to encourage 

and help consumers adopt healthy 

lifestyles. The information will also 

help FDA and other Federal Agencies 

evaluate and track consumer awareness 

and behavior as outcome measures of 

their achievement in improving public 

health. 

Description of Respondents: The 

respondents are adults, age 18 and 

older, drawn from the 50 States and the 

District of Columbia. Participation will 

be voluntary. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

General Topics: Pretest ....................................................... 27 1 27 0.25 7 

General Topics: Screener .................................................... 10,000 1 10,000 0.02 200 

General Topics: Survey ....................................................... 3,000 1 3,000 0.25 750 

Dietary Guidelines Supplement: Screener .......................... 4,000 1 4,000 0.02 80 

Dietary Guidelines Supplement: Survey .............................. 1,200 1 1,200 0.22 264 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,301 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA bases its estimate of the number 

of respondents and the hours per 

response on its experience with 

previous Health and Diet Surveys. Prior 

to the administration of the Health and 

Diet Survey—General Topics, the 

Agency plans to conduct a pretest to 

identify and resolve potential problems. 

The pretest will be conducted with 27 

participants; we estimate that it will 

take a respondent 15 minutes (0.25 

hours) to complete the pretest, for a total 

of 6.75 hours, rounded to 7. The Agency 

will use a screener to select an eligible 

adult respondent in each household to 

participate in the survey. For the Health 

and Diet Survey—General Topics data 

collection activity, a total of 10,000 

individuals in the 50 States and the 

District of Columbia will be screened by 

telephone. We estimate that it will take 

a respondent 1.2 minutes (0.02 hours) to 

complete the screening, for a total of 200 

hours. We estimate that 3,000 eligible 

adults will participate in the survey, 

each taking 15 minutes (0.25 hours), for 

a total of 750 hours. For the Health and 

Diet Survey—Dietary Guidelines 

Supplement data collection activity, 

4,000 individuals in the 50 States and 

the District of Columbia will be 

screened by telephone. We estimate that 

it will take a respondent 1.2 minutes 

(0.02 hours) to complete the screening 

questions, for a total of 80 hours. Of 

these respondents, 1,200 will complete 

the survey. We estimate that it will take 

a respondent 13 minutes (0.22 hours) to 

complete the entire survey, for a total of 

264 hours. Thus, the total estimated 

burden is 1,301 hours. 

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–85 Filed 1–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0492] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices: 

Recommended Glossary and 

Educational Outreach To Support Use 

of Symbols on Labels and in Labeling 

of In Vitro Diagnostic Devices Intended 

for Professional Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 


jdjones on DSK8KYBLC1PROD with NOTICES