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
1170 Federal Register / Vol. 76, No. 5 / Friday, January 7, 2011 / Notices 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 7, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0553. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

301–796–5156, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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— 

(OMB Control Number 0910–0553)— 

Extension 

Section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded. Section 351 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 262) establishes requirements 

that manufacturers of biological 

products must submit a license 

application for FDA review and 

approval prior to marketing a biological 

product for introduction into interstate 

commerce. 

In the Federal Register of November 

30, 2004 (69 FR 69606), FDA published 

a notice of availability of the guidance 

entitled ‘‘Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use.’’ 

The guidance document provides 

guidance for the voluntary use of 

selected symbols in place of text in 

labeling. It provides the labeling 

guidance required for: (1) In vitro 

diagnostic devices (IVDs), intended for 

professional use under 21 CFR 809.10, 

FDA’s labeling requirements for IVDs; 

and (2) FDA’s labeling requirements for 

biologics, including IVDs under 21 CFR 

parts 610 and 660. Under section 502(c) 

of the FD&C Act, a drug or device is 

misbranded, ‘‘* * *If any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ 

The guidance document recommends 

that a glossary of terms accompany each 

IVD to define the symbols used on that 

device’s labels and/or labeling. 

Furthermore, the guidance recommends 

an educational outreach effort to 

enhance the understanding of newly 

introduced symbols. Both the glossary 

and educational outreach information 

will help to ensure that IVD users will 

have enough general familiarity with the 

symbols used, as well as provide a quick 

reference for available materials, thereby 

further ensuring that such labeling 

satisfies the labeling requirements under 

section 502(c) of the FD&C Act and 

section 351 of the PHS Act. 

The likely respondents for this 

collection of information are IVD 

manufacturers who plan to use the 

selected symbols in place of text on the 

labels and/or labeling of their IVDs. 

The glossary activity is inclusive of 

both domestic and foreign IVD 

manufacturers. FDA receives 

submissions from approximately 689 

IVD manufacturers annually. The 

number of hours per response for the 

glossary and educational outreach 

activities were derived from 

consultation with a trade association 

and FDA personnel. The 4-hour 

estimate for a glossary is based on the 

average time necessary for a 

manufacturer to modify the glossary for 

the specific symbols used in labels or 

labeling for the IVDs manufactured. 

In the Federal Register of October 5, 

2010 (75 FR 61494), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section 502 of the FD&C Act/Section 351 of the PHS Act Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Glossary ............................................................................... 689 1 689 4 2,756 

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

Dated: January 3, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–74 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–2008–D–0610] 

Draft Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Medical Products and 

Dietary Supplements During an 

Influenza Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Postmarketing 

Adverse Event Reporting for Medical 

Products and Dietary Supplements 

During an Influenza Pandemic.’’ The 

draft guidance discusses FDA’s 

intended approach to enforcement of 

adverse event reporting requirements for 

drugs, biologics, medical devices, and 

dietary supplements during an 

influenza pandemic. The agency makes 

recommendations to industry for 

focusing limited resources on reports 


jdjones on DSK8KYBLC1PROD with NOTICES