Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Notices 79377 

1The comment must be accompanied by an 

explicit request for confidential treatment, 

including the factual and legal basis for the request, 

and must identify the specific portions of the 

comment to be withheld from the public record. 

The request will be granted or denied by the 

Commission’s General Counsel, consistent with 

applicable law and the public interest. See FTC 

Rule 4.9(c), 16 CFR 4.9(c). 

Board of Governors of the Federal Reserve 

System, December 15, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–31851 Filed 12–17–10; 8:45 am] 

BILLING CODE 6210–01–P 

FEDERAL TRADE COMMISSION 

[File No. 102 3080] 

NBTY, Inc.; Analysis of Proposed 

Consent Order To Aid Public Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed Consent Agreement. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

Federal law prohibiting unfair or 

deceptive acts or practices or unfair 

methods of competition. The attached 

Analysis to Aid Public Comment 

describes both the allegations in the 

draft complaint and the terms of the 

consent order—embodied in the consent 

agreement—that would settle these 

allegations. 

DATES: Comments must be received on 

or before January 14, 2011. 

ADDRESSES: Interested parties are 

invited to submit written comments 

electronically or in paper form. 

Comments should refer to ‘‘NBTY, File 

No. 102 3080’’ to facilitate the 

organization of comments. Please note 

that your comment—including your 

name and your State—will be placed on 

the public record of this proceeding, 

including on the publicly accessible 

FTC Web site, at http://www.ftc.gov/os/ 

publiccomments.shtm. 

Because comments will be made 

public, they should not include any 

sensitive personal information, such as 

an individual’s Social Security Number; 

date of birth; driver’s license number or 

other State identification number, or 

foreign country equivalent; passport 

number; financial account number; or 

credit or debit card number. Comments 

also should not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, comments should not include 

any ‘‘[t]rade secret or any commercial or 

financial information which is obtained 

from any person and which is privileged 

or confidential * * *.,’’ as provided in 

Section 6(f) of the FTC Act, 15 U.S.C. 

46(f), and Commission Rule 4.10(a)(2), 

16 CFR 4.10(a)(2). Comments containing 

material for which confidential 

treatment is requested must be filed in 

paper form, must be clearly labeled 

‘‘Confidential,’’ and must comply with 

FTC Rule 4.9(c), 16 CFR 4.9(c).1

Because paper mail addressed to the 

FTC is subject to delay due to 

heightened security screening, please 

consider submitting your comments in 

electronic form. Comments filed in 

electronic form should be submitted by 

using the following Web link: https:// 

ftcpublic.commentworks.com/ftc/nbty 

and following the instructions on the 

Web-based form. To ensure that the 

Commission considers an electronic 

comment, you must file it on the Webbased form at the Web link: https:// 

ftcpublic.commentworks.com/ftc/nbty. 

If this Notice appears at http:// 

www.regulations.gov/search/index.jsp, 

you may also file an electronic comment 

through that Web site. The Commission 

will consider all comments that 

regulations.gov forwards to it. You may 

also visit the FTC Web site at http:// 

www.ftc.gov/ to read the Notice and the 

news release describing it. 

A comment filed in paper form 

should include the ‘‘NBTY, File No. 102 

3080’’ reference both in the text and on 

the envelope, and should be mailed or 

delivered to the following address: 

Federal Trade Commission, Office of the 

Secretary, Room H–135 (Annex D), 600 

Pennsylvania Avenue, NW., 

Washington, DC 20580. The FTC is 

requesting that any comment filed in 

paper form be sent by courier or 

overnight service, if possible, because 

U.S. postal mail in the Washington area 

and at the Commission is subject to 

delay due to heightened security 

precautions. 

The Federal Trade Commission Act 

(‘‘FTC Act’’) and other laws the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives, 

whether filed in paper or electronic 

form. Comments received will be 

available to the public on the FTC Web 

site, to the extent practicable, at 

http://www.ftc.gov/os/ 

publiccomments.shtm. As a matter of 

discretion, the Commission makes every 

effort to remove home contact 

information for individuals from the 

public comments it receives before 

placing those comments on the FTC 

Web site. More information, including 

routine uses permitted by the Privacy 

Act, may be found in the FTC’s privacy 

policy, at http://www.ftc.gov/ftc/ 

privacy.shtm. 

FOR FURTHER INFORMATION CONTACT: 

Devin Domond (202–326–2610), Bureau 

of Consumer Protection, 600 

Pennsylvania Avenue, NW., 

Washington, DC 20580. 

SUPPLEMENTARY INFORMATION: Pursuant 

to section 6(f) of the Federal Trade 

Commission Act, 38 Stat. 721, 15 U.S.C. 

46(f), and § 2.34 the Commission Rules 

of Practice, 16 CFR 2.34, notice is 

hereby given that the above-captioned 

consent agreement containing a consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement, and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained from the FTC 

Home Page (for December 13, 2010), on 

the World Wide Web, at http:// 

www.ftc.gov/os/actions.shtm. A paper 

copy can be obtained from the FTC 

Public Reference Room, Room 130–H, 

600 Pennsylvania Avenue, NW., 

Washington, DC 20580, either in person 

or by calling (202) 326–2222. 

Public comments are invited, and may 

be filed with the Commission in either 

paper or electronic form. All comments 

should be filed as prescribed in the 

ADDRESSES section above, and must be 

received on or before the date specified 

in the DATES section. 

Analysis of Agreement Containing 

Consent Order to Aid Public Comment 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) has accepted, 

subject to final approval, an agreement 

containing a consent order from NBTY, 

Inc., NatureSmart LLC, and Rexall 

Sundown, Inc. (collectively, 

‘‘Respondents’’). 

The proposed consent order has been 

placed on the public record for thirty 

(30) days for receipt of comments by 

interested persons. Comments received 

during this period will become part of 

the public record. After thirty (30) days, 

the Commission will again review the 

agreement and the comments received, 

and will decide whether it should 

withdraw from the agreement and take 

appropriate action or make final the 

agreement’s proposed order. 

This matter involves the advertising 

and promotion of the following 

products in Respondents’ Disney/ 


jlentini on DSKJ8SOYB1PROD with NOTICES
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 


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