79378 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 

Marvel line of children’s multivitamin 

and mineral dietary supplements: (1) 

Disney Princess Complete; (2) Disney 

Princess Gummies; (3) Disney Pixar Cars 

Gummies; (4) Disney Winnie the Pooh 

Gummies; (5) Disney Tigger & Pooh 

Gummies; (6) Disney Pixar Finding 

Nemo Gummies; (7) Disney Pixar WallE Gummies; (8) Disney Pixar Toy Story 

Gummies; (9) Marvel Heroes Complete; 

and (10) Marvel Heroes Gummies 

(collectively, the ‘‘NBTY Products’’). 

According to the FTC complaint, 

Respondents represented, in 

advertisements, that the NBTY Products 

contained a significant amount of DHA 

(docosahexaenoic acid, a 

polyunsaturated Omega-3 fatty acid) or 

an amount comparable to 100 mg of 

DHA. The complaint alleges that this 

claim is false or misleading because, in 

fact, a daily serving of the NBTY 

products only contained either 0.1 mg of 

DHA (which is one thousandth of 100 

mg) or 0.05 mg of DHA (which is five 

ten-thousandths of 100 mg). 

The Commission also charges that 

Respondents represented that the DHA 

provided by a daily serving of the NBTY 

Products promoted healthy brain and 

eye development in children two years 

of age and older. The FTC alleges that 

this claim is false or misleading because 

Respondents failed to have evidence to 

substantiate it. 

The proposed consent order contains 

provisions designed to prevent 

Respondents from engaging in similar 

acts and practices in the future. Part I of 

the proposed order prohibits 

Respondents from misrepresenting that 

any product contains a specific 

ingredient or specific numerical amount 

of any ingredient. 

Part II of the proposed order prohibits 

Respondents from making any 

representations in advertising for any 

product about the health benefits, 

performance, or efficacy of the product, 

unless the representation is true and 

non-misleading. In addition, 

Respondents must possess competent 

and reliable scientific evidence 

sufficient in quality and quantity, when 

considered in light of the entire body of 

relevant and reliable scientific evidence, 

to support such claims as true. 

Part III of the proposed order states 

that the order does not prohibit 

Respondents from making 

representations for any drug that are 

permitted in labeling for that drug under 

any tentative or final standard 

promulgated by the FDA, or under any 

new drug application approved by the 

FDA. This part of the proposed order 

also states that the order does not 

prohibit Respondents from making 

representations for any product that are 

specifically permitted in labeling for 

that product by regulations issued by 

the FDA under the Nutrition Labeling 

and Education Act of 1990. 

Part IV of the proposed order requires 

Respondents to pay two million, one 

hundred thousand dollars ($2,100,000) 

to the Commission to be used for 

equitable relief, including restitution, 

consumer redress, and any attendant 

expenses for the administration of such 

equitable relief. 

Parts V through VIII of the proposed 

order require Respondents to keep 

copies of relevant advertisements and 

materials substantiating claims made in 

the advertisements; to provide copies of 

the order to certain personnel; to notify 

the Commission of changes in corporate 

structure that might affect compliance 

obligations under the order; and to file 

compliance reports with the 

Commission. Part IX provides that the 

order will terminate after twenty (20) 

years, with certain exceptions. 

The purpose of this analysis is to 

facilitate public comment on the 

proposed order, and it is not intended 

to constitute an official interpretation of 

the agreement and proposed order or to 

modify their terms in any way. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2010–31823 Filed 12–17–10; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0420] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Testing 

Communications on FDA-Regulated 

Products Used in Animals 

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 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 19, 

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–New and 

title ‘‘Testing Communications on FDA– 

Regulated Products Used in Animals.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, Juanmanuel.vilela@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. 

Testing Communications on FDA– 

Regulated Products Used In Animals— 

(OMB Control Number 0910–New) 

FDA’s Center for Veterinary Medicine 

(CVM) has authorization under section 

903(d)(2)(D) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(D)) to conduct educational 

and public information programs 

relating to the safety of CVM-regulated 

products. Further, CVM is authorized to 

conduct this needed research to ensure 

that these programs have the highest 

likelihood of being effective. Thus, CVM 

concludes that improving 

communications about the safety of 

regulated animal drugs, feed, food 

additives, and devices will involve 

many research methods, including 

individual in-depth interviews, mallintercept interviews, focus groups, selfadministered surveys, gatekeeper 

reviews, and omnibus telephone 

surveys. 

The information collected will serve 

three major purposes. First, as formative 

research, it will provide critical 

knowledge needed about target 

audiences to develop messages and 

campaigns about the use of animal 

drugs, feed, food additives, and devices. 

Knowledge of both the consumer and 

the veterinary professional decisionmaking processes will provide a better 

understanding of target audiences that 

FDA will need in order to design 

effective communication strategies, 

messages, and labels. These 

communications will aim to improve 

public understanding of the risks and 

benefits of using regulated animal drugs, 

feed, food additives, and devices by 

providing users with a better context in 

which to place risk information more 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79379 

completely. Second, as initial testing, it 

will allow FDA to assess the potential 

effectiveness of messages and materials 

in reaching and successfully 

communicating with their intended 

audiences. Testing messages with a 

sample of the target audience will allow 

FDA to refine messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. Third, as evaluative research, it 

will allow FDA to ascertain the 

effectiveness of the messages and the 

distribution method of these messages 

in achieving the objectives of the 

message campaign. Evaluation of 

campaigns is a vital link in continuous 

improvement of communications at 

FDA. 

In the Federal Register of August 19, 

2010 (75 FR 51271), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received comments 

from two individuals and one trade 

association. FDA acknowledges one 

request for additional details on the 

necessity and purpose of the 

information to be collected, but notes 

that comments were invited on FDA’s 

request for a generic clearance related to 

the formative testing of communications 

about veterinary products and products 

for animals. Under this generic 

clearance, details of individual studies 

(research questions, target audiences, 

methodologies, and consultants) will be 

tailored to specific communicationsrelated questions. For each study FDA 

requests under this clearance, FDA will 

provide OMB with these details on the 

information collection. The 

communication development process 

will inform the purpose of the data 

collection and the means by which the 

data will be collected. For very early 

message development, qualitative 

research such as in-depth interviews or 

focus groups will be appropriate. At 

later communication development 

stages, more quantitative data collection 

would be more useful. FDA plans to use 

the data collected under this generic 

clearance to inform its communications 

campaigns. The data will not be used for 

the purposes of making policy or 

regulatory decisions. 

Audience targets are also informed by 

the specific research question. 

Nonetheless, FDA provided more 

information by specifying some of the 

groups more likely to be targeted in 

tasks under this generic clearance, 

including: Consumers, pet owners, large 

animal producers, veterinarians, animal 

distributors, pet shop owners, 

stockyards staff and owners, abattoir 

owners or staff, grocery meat 

purchasers, agricultural extension 

agents, and professors of food science 

and related fields. 

Furthermore, comments related to 

ways to enhance the data collection and 

to assess FDA’s estimate of burden 

indicated that FDA should not limit 

itself to in-house expertise. FDA 

acknowledges that assistance may be 

requested from experts in other 

Government agencies. Depending on the 

specific research question to be 

addressed, FDA may consult experts in 

the United States Department of 

Agriculture and the United States 

Environmental Protection Agency. 

FDA received a comment relating to 

the cruelty and sadism of animal testing. 

In response to this comment, FDA notes 

that its notice was for public comment 

on data collection related to 

communication studies. No animal 

testing is involved. 

FDA received a comment that made a 

series of complaints against the Agency 

unrelated to its notice for public 

comment. Accordingly, those comments 

are not addressed in this document. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 U.S.C. 393(d)(2)(D) No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

Individual in-depth interviews ............................................ 360 1 360 .75 270 

General public focus group interviews ............................. 288 1 288 1.50 432 

Intercept interviews: Central location ................................ 200 1 200 .25 50 

Intercept interviews: Telephone 2 ...................................... 2,000 1 2,000 .08 160 

Self-administered surveys ................................................. 2,400 1 2,400 .25 600 

Gatekeeper reviews .......................................................... 300 1 300 .50 150 

Omnibus surveys .............................................................. 1,200 1 1,200 .17 204 

Total (general public) ........................................................ ............................ ............................ .............................. ............................ 1,866 

Veterinarian/scientific expert focus group interviews ....... 288 1 288 1.50 432 

Total (overall) ............................................................. ............................ ............................ .............................. ............................ 2,298 

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

2These are brief interviews with callers to test message concepts and strategies following their call-in request to an FDA Center 1–800 

number. 

Dated: December 7, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31891 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Defense Advanced Research Projects 

Agency and Food and Drug 

Administration Expanding In Vivo 

Biomarker Detection Devices 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing the following 

public workshop cosponsored with the 

Defense Advanced Research Projects 

Agency (DARPA): Expanding In Vivo 

Biomarker Detection Devices Workshop. 

The DARPA Defense Sciences Office 

and the FDA Center for Devices and 

Radiological Health (CDRH) are hosting 

a workshop to discuss current state-ofthe-art and innovative research 

opportunities in the area of in vivo 

analytical devices capable of measuring 

biomarkers that characterize normal 

biological processes, pathologic 


jlentini on DSKJ8SOYB1PROD with NOTICES