Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20671 

misleading acts or practices alleged in 

the complaint. 

The proposed consent order contains 

provisions designed to prevent 

respondent from engaging in similar 

acts or practices in the future. 

Specifically, Part I of the proposed order 

addresses the allegedly unsubstantiated 

claims regarding the Oreck Halo. Part I 

covers any representation that the Oreck 

Halo or any other vacuum cleaner: 

(1) Reduces the risk of or prevents the 

flu; (2) reduces the risk of or prevents 

illnesses or ailments caused by bacteria, 

viruses, molds, or allergens, such as the 

common cold, diarrhea, upset stomachs, 

asthma and allergy symptoms; (3) will 

eliminate all or virtually all germs, 

bacteria, dust mites, molds, viruses or 

allergens from a user’s floor; and (4) will 

eliminate any percent or numerical 

quantity of germs, bacteria, dust mites, 

molds, viruses or allergens from a user’s 

floor. Part I also applies to 

representations that ultraviolet light is 

effective against germs, bacteria, dust 

mites, molds, viruses or allergens 

embedded in carpets. Part I prohibits 

Oreck from making any of the above 

representations unless the 

representation is non-misleading and, at 

the time of making such representation, 

Oreck possesses and relies upon 

competent and reliable scientific 

evidence that is sufficient in quality and 

quantity based on standards generally 

accepted in the relevant scientific fields, 

when considered in light of the entire 

body of relevant and reliable scientific 

evidence, to substantiate that the 

representation is true. The proposed 

order defines ‘‘competent and reliable 

scientific evidence’’ as ‘‘tests, analyses, 

research or studies that have been 

conducted and evaluated in an objective 

manner by qualified persons and are 

generally accepted in the profession to 

yield accurate and reliable results.’’ 

Part II of the proposed order addresses 

the allegedly unsubstantiated claims 

regarding the Oreck ProShield Plus. Part 

II covers any representation that the 

Oreck ProShield Plus or any other air 

cleaner: (1) Reduces the risk of or 

prevents the flu; (2) reduces the risk of 

or prevents illnesses or ailments caused 

by bacteria, viruses, molds, or allergens, 

such as the common cold, asthma and 

allergy symptoms; (3) will eliminate all 

or virtually all indoor airborne particles 

under normal living conditions; and 

(4) will eliminate any percent or 

numerical quantity of indoor air 

contaminants under normal living 

conditions. Part II prohibits Oreck from 

making any of the above representations 

unless the representation is nonmisleading and, at the time of making 

such representation, Oreck possesses 

and relies upon competent and reliable 

scientific evidence that is sufficient in 

quality and quantity based on standards 

generally accepted in the relevant 

scientific fields, when considered in 

light of the entire body of relevant and 

reliable scientific evidence, to 

substantiate that the representation is 

true. 

Part III of the proposed order 

prohibits respondent from making 

representations, other than 

representations covered under Parts I or 

II, about the absolute or comparative 

health benefits of any product, unless 

the representation is non-misleading, 

and, at the time of making such 

representation, respondent possesses 

and relies upon competent and reliable 

scientific evidence that is sufficient in 

quality and quantity based on standards 

generally accepted in the relevant 

scientific fields, when considered in 

light of the entire body of relevant and 

reliable scientific evidence, to 

substantiate that the representation is 

true. 

Part IV of the proposed order 

addresses the allegedly false claims that 

scientific tests prove that the Oreck Halo 

or ProShield Plus eliminate or virtually 

eliminate many common germs, viruses 

or allergens from the user’s floor or air. 

Part IV prohibits respondent, when 

advertising any product, from 

misrepresenting the existence, contents, 

validity, results, conclusions, or 

interpretations of any test, study, or 

research. 

Part VI of the proposed order requires 

the payment of $750,000 intended for 

redress to consumers. To facilitate the 

payment of redress, Part V of the 

proposed order requires Oreck to 

provide to the Commission a searchable 

electronic file containing the name and 

contact information of all consumers 

who purchased the Oreck Halo or the 

Oreck ProShield Plus from January 1, 

2009 through August 31, 2010. 

Part VII of the proposed order requires 

Oreck to send a letter to all of its 

franchisees requesting that they 

immediately stop using all advertising 

and marketing materials previously 

provided to them by Oreck. The 

required letter is appended to the 

proposed order as Attachment A. 

Parts VIII, IX, X and XI of the 

proposed order require respondent to 

keep copies of relevant advertisements 

and materials substantiating claims 

made in the advertisements; to provide 

copies of the order to its 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 XII 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. 2011–8757 Filed 4–12–11; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0321] 

30-Day Notice; Agency Information 

Collection Request; 30-Day Public 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection for public 

comment. Interested persons are invited 

to send comments regarding this burden 

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. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–5683. Send written comments and 

recommendations for the proposed 

information collections within 30 days 

of this notice directly to the OS OMB 

Desk Officer; faxed to OMB at 202–395– 

5806. 

Title: HHS Web Site Customer 

Satisfaction Survey—0990–0321— 

Reinstatement with change—Office of 

the Assistant Secretary for Public 

Affairs. 

mstockstill on DSKH9S0YB1PROD with NOTICES

20672 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

Abstract: The results of the HHS Web 

Site Customer Satisfaction Survey will 

be used to ensure that the content on the 

HHS Web sites meets visitor needs and 

expectations. The results will also 

determine if the site is easy to use and 

the content easy to understand. 

ESTIMATED ANNUALIZED BURDEN TABLE

Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

(in hrs.) 

Total burden 

hours 

Survey .............................................................................................................. 48,000 1 12/60 9,600 

Mary Forbes, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2011–8796 Filed 4–12–11; 8:45 am] 

BILLING CODE 4150–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Recommendations on In Vitro Ocular 

Safety Testing Methods and Strategies 

and Routine Use of Topical 

Anesthetics, Systemic Analgesics, and 

Humane Endpoints for Ocular Safety 

Testing 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Notice of availability. 

SUMMARY: U.S. Federal agency responses 

to ICCVAM test method 

recommendations on alternative testing 

methods and strategies proposed to 

further reduce and refine the use of 

animals for assessing the ocular hazard 

potential of chemicals and products are 

now available. ICCVAM recommended a 

pain management procedure that should 

always be used to avoid pain and 

distress when it is determined necessary 

to conduct the rabbit eye test for 

regulatory safety purposes. ICCVAM 

also recommended the Cytosensor 

Microphysiometer (CM) test method as 

a screening test (1) to identify some 

types of substances that will not cause 

sufficient injury to require eye hazard 

labeling and (2) to identify some types 

of substances that may cause permanent 

or severe eye injuries. ICCVAM 

previously forwarded recommendations 

to Federal agencies and made these 

recommendations available to the 

public (75 FR 57027). In accordance 

with the ICCVAM Authorization Act of 

2000 (42 U.S.C. 285l–3), agencies have 

notified ICCVAM in writing of their 

findings and ICCVAM is making these 

responses available to the public. 

Federal agency responses are available 

on the NICEATM–ICCVAM Web site at 

http://iccvam.niehs.nih.gov/methods/ 

ocutox/Transmit-2010.htm. The 

ICCVAM recommendations are 

provided in ICCVAM test method 

evaluation reports that are available on 

the NICEATM–ICCVAM Web site at 

http://iccvam.niehs.nih.gov/methods/ 

ocutox/OcuAnest-TMER.htm, http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

MildMod-TMER.htm, http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

AMCP–TMER.htm, and http:// 

iccvam.niehs.nih.gov/methods/ocutox/ 

LVET.htm. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes, Director, NICEATM, 

NIEHS, P.O. Box 12233, Mail Stop: K2– 

16, Research Triangle Park, NC 27709, 

(telephone) 919–541–2384, (fax) 919– 

541–0947, (e-mail) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, NIEHS, Room 2034, 530 

Davis Drive, Morrisville, NC 27560. 

SUPPLEMENTARY INFORMATION: 

Background 

The U.S. Environmental Protection 

Agency (EPA) requested that ICCVAM 

(1) evaluate the current validation status 

of the bovine corneal opacity and 

permeability (BCOP), hen’s egg test– 

chorioallantoic membrane (HET–CAM), 

isolated chicken eye (ICE), and isolated 

rabbit eye (IRE) test methods; (2) 

identify in vivo ocular toxicity reference 

data to support the validation of in vitro 

test methods; (3) explore ways of 

alleviating pain and distress from 

current in vivo ocular safety testing; and 

(4) review the state of the science and 

the availability of in vitro test methods 

for assessing mild or moderate ocular 

irritants. The highest priority activity, 

an evaluation of the BCOP, HET–CAM, 

ICE, and IRE test methods for their 

usefulness and limitations for 

identifying potential ocular corrosives 

and severe irritants, was completed in 

2006 (NIH Publication No. 07–4517). 

Based on this evaluation, U.S. Federal 

agencies subsequently accepted the 

BCOP and ICE test methods for certain 

regulatory testing purposes without the 

need for animal testing. The 

Organisation for Economic Co-operation 

and Development (OECD) subsequently 

adopted the BCOP and ICE test methods 

in 2009 as international OECD Test 

Guidelines 437 and 438, respectively 

(OECD 2009a, OECD 2009b). The 

International Organization for 

Standardization (ISO) adopted the 

BCOP and ICE test methods as ISO 

Standard 10993–10 in 2010 (ISO 2010). 

ICCVAM recently completed 

additional test method evaluations 

relevant to the original EPA nomination 

and a subsequent EPA request that 

ICCVAM evaluate a proposed in vitro 

testing strategy for identifying the ocular 

hazard potential of antimicrobial 

cleaning products. Information is 

provided about ICCVAM’s evaluation 

and the committee’s recommendations 

for the alternative testing methods and 

strategies proposed to further reduce 

and refine the use of animals for 

assessing the ocular hazard potential of 

chemicals and products in four 

ICCVAM Test Method Evaluation 

Reports: (1) Recommendations for 

Routine Use of Topical Anesthetics, 

Systemic Analgesics, and Humane 

Endpoints to Avoid or Minimize Pain 

and Distress in Ocular Safety Testing 

(NIH Publication No. 10–7514), (2) 

Current Validation Status of In Vitro 

Test Methods Proposed for Identifying 

Eye Injury Hazard Potential of 

Chemicals and Products (NIH 

Publication No. 10–7553), (3) Current 

Validation Status of a Proposed In Vitro 

Testing Strategy for U.S. Environmental 

Protection Agency Ocular Hazard 

Classification and Labeling of 

Antimicrobial Cleaning Products (NIH 

Publication No. 10–7513), and (4) 

Recommendation to Discontinue Use of 

the Low Volume Eye Test for Ocular 

Safety Testing (NIH Publication No. 

10–7515). 

Agency Responses to ICCVAM 

Recommendations 

In September 2010, ICCVAM 

forwarded final test method 

recommendations for ocular safety 

testing methods and strategies to U.S. 

Federal agencies for consideration, in 

accordance with the ICCVAM 

Authorization Act of 2000 (42 U.S.C. 

mstockstill on DSKH9S0YB1PROD with NOTICES