33444 Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices 

10 As used in these requests, the term 

‘‘advertising’’ means any communication that the 

institution uses to solicit business including, but 

not limited to, printed materials, the institution’s 

main internet page, radio advertisements, video 

advertisements disseminated via television, the 

Internet or any other means of online 

communication, and solicitations conducted via 

telephone. 

11 The requested documents should exclude any 

information for which prior customer authorization 

is required under the Right to Financial Privacy 

Act, 12 U.S.C. 3401, et seq. 

12 Although the Commission is currently in the 

process of developing regulations for these 

requirements, see 74 FR 18043 (Mar. 13, 2009), 

institutions lacking federal deposit insurance must 

comply with these statutory provisions regardless of 

the status of FTC’s regulations in this area. 

13 Hourly wages are averages based on mean 

hourly wages shown in http://www.bls.gov/oes/ 

2008/may/naics4_551100.htm#b11-0000 (May 2008 

‘‘National Industry-Specific Occupational 

Employment and Wage Estimates’’) for sales and 

marketing managers and legal occupations (lawyers, 

paralegals, and other legal support), respectively. 

names, signatures, addresses, account 

numbers, or any other personally 

identifying information. 

∑ Information (e.g. photographs) that 

demonstrates that the institution posts 

the disclosure required by 12 U.S.C. 

1831t(b)(2) at each station or window 

where it normally receives deposits, the 

institution’s principal place of business, 

and all the institution’s branches where 

it accepts deposits or opens accounts 

(excluding automated teller machines 

and point of sale terminals). 

∑ Copies of all non-identical 

advertising10 issued or continued in use 

within the previous three months. 

∑ Samples of the cards, forms, or other 

written materials the institution uses to 

comply with the signed 

acknowledgment requirements for new 

depositors pursuant to 12 U.S.C. 

1831t(b)(3). The samples should not 

include any individual consumer 

names, signatures, addresses, account 

numbers, or any other personally 

identifying information.11

The Commission will use the 

collected information in its efforts to 

ensure that the institutions are 

complying with the disclosures required 

by the 12 U.S.C. 1831t(b).12

B. Estimated Hours Burden 

Based upon its knowledge of the 

industry, the staff estimates, on average, 

that the time required to gather, 

organize, format, and produce such 

responses will average 8 hours per 

information request. Thus, allowing up 

to 200 recipients of the information 

requests, total burden would be 

approximately 1,600 hours. 

C. Estimated Cost Burden 

It is difficult to calculate with 

precision the labor costs associated with 

this data production, as they entail 

varying compensation levels of 

management and/or support staff among 

companies of different sizes. 

Managerial, legal, and clerical personnel 

may be involved in the information 

collection process. The FTC staff has 

assumed, conservatively, that 

managerial personnel and legal counsel 

will handle all of the tasks involved in 

gathering and producing responsive 

information, and has applied an average 

hourly wage of managerial time of 

$58.12/hour (4 hours per entity) and an 

average hourly wage of legal staff time 

of $40.87/hour (4 hours per entity).13

Thus, cumulatively, estimated labor 

costs for the information requests will 

be $79,192 (($58.12 x 800 hours + 

$40.87 x 800 hours)). The actual cost 

may be lower to the extent clerical 

personnel handle some of the tasks. 

FTC staff estimates that the capital or 

other non-labor costs associated with 

the information requests are minimal. 

We expect that industry members 

maintain most, if not all, of the 

requested material in the normal course 

of business because they must disclose 

the information to customers under 

existing law. 

By direction of the Commission. 

Donald S. Clark 

Secretary 

[FR Doc. E9–16518 Filed 7–10–09: 8:45 am] 

BILLING CODE: 6750 –01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

NTP Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM); Independent 

Scientific Peer Review Panel Report: 

Evaluation of the Validation Status of 

Alternative Ocular Safety Testing 

Methods and Approaches: Notice of 

Availability and Request for Public 

Comments 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Request for comments. 

SUMMARY: NICEATM, in collaboration 

with the Interagency Coordinating 

Committee on the Validation of 

Alternative Methods (ICCVAM), 

convened an independent international 

scientific peer review panel (hereafter, 

Panel) on May 19–21, 2009, to evaluate 

test methods and approaches with the 

potential to reduce and refine the use of 

animals for ocular safety testing. These 

evaluations included the following: 

• A proposal for the routine use of 

topical anesthetics, systemic analgesics, 

and humane endpoints to avoid and 

minimize pain and distress during in 

vivo ocular irritation testing. 

• The in vivo low volume eye test 

(LVET). 

• The use of the bovine corneal 

opacity and permeability (BCOP), the 

Cytosensor Microphysiometer® (CM), 

the isolated chicken eye (ICE), the 

isolated rabbit eye (IRE), and the hen’s 

egg test—chorioallantoic membrane 

(HET–CAM) test methods for identifying 

moderate and mild ocular irritants and 

substances not labeled as ocular 

irritants. 

• Nonanimal testing strategies that 

use the BCOP, CM, and/or EpiOcularTM

(EO) test methods to assess the eye 

irritation potential of antimicrobial 

cleaning products to determine their 

appropriate U.S. Environmental 

Protection Agency ocular hazard 

classification. 

The Panel report from this meeting is 

now available. The report contains (1) 

The Panel’s evaluation of the validation 

status of the test methods and testing 

strategies and (2) the Panel’s comments 

on the draft ICCVAM test method 

recommendations. NICEATM invites 

public comment on the Panel report. 

The report is available on the 

NICEATM–ICCVAM Web site at http:// 

iccvam.niehs.nih.gov/docs/ 

ocutox_docs/OcularPRPRept2009.pdf or 

by contacting NICEATM at the address 

given below. 

DATES: Written comments on the Panel 

report should be received by August 28, 

2009. 

ADDRESSES: NICEATM prefers that 

comments be submitted electronically 

by e-mail to niceatm@niehs.nih.gov. 

Comments can also be submitted via the 

NICEATM–ICCVAM Web site at http:// 

iccvam.niehs.nih.gov/contact/ 

FR_pubcomment.htm. Written 

comments can be sent by mail or fax to 

Dr. William S. Stokes, Director, 

NICEATM, NIEHS, P.O. Box 12233, 

Mail Stop: K2–16, Research Triangle 

Park, NC 27709; (fax) 919–541–0947. 

Courier address: NIEHS, NICEATM, 530 

Davis Drive, Room 2035, Durham, NC 

27713. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes, (telephone) 919–541– 

2384, (fax) 919–541–0947 and (e-mail) 

niceatm@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

NICEATM announced the convening 

of an independent scientific peer review 

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Federal Register / Vol. 74, No. 132 / Monday, July 13, 2009 / Notices 33445 

panel to review and comment on the 

draft background review documents 

(BRDs) and summary review documents 

(SRDs) and draft recommendations, as 

well as the availability of the draft 

documents for public comment, in 

March 2009 (74 FR 14556). The Panel 

met in public session on May 19–21, 

2009, at Consumer Product Safety 

Commission Headquarters in Bethesda, 

MD. The Panel reviewed the draft 

ICCVAM documents for completeness, 

errors, and omissions of any existing 

relevant data or information. The Panel 

then evaluated the information in the 

draft documents to determine the extent 

to which each of the applicable criteria 

for validation and acceptance of 

toxicological test methods (ICCVAM 

2003) had been appropriately addressed. 

The Panel then considered the ICCVAM 

draft recommendations and commented 

on the extent that the recommendations 

were supported by the information 

provided in the draft BRDs or SRDs. 

ICCVAM organized a 2005 

symposium (70 FR 18037) on 

Minimizing Pain and Distress in Ocular 

Toxicity Testing where experts 

recommended that topical anesthetics 

and systemic analgesics should be 

routinely administered before in vivo 

ocular safety testing to avoid or 

minimize pain and distress that might 

occur during and after the initial 

application of test substances. The 

experts also recommended that systemic 

analgesics should routinely be 

administered when there are clinical 

signs indicative of pain or distress. The 

experts further recommended that 

humane endpoints to end a study early 

should be identified and used routinely. 

ICCVAM requested data (72 FR 26396), 

compiled available information on the 

use of topical anesthetics, systemic 

analgesics, and humane endpoints 

during in vivo ocular safety testing, and 

developed draft recommendations for 

implementing such practices. 

In 2007, ICCVAM published (70 FR 

66451) recommendations on the use of 

four in vitro test methods (BCOP, ICE, 

IRE, HET–CAM) for identifying ocular 

corrosives and severe irritants for 

hazard classification and labeling 

purposes. The ICCVAM 

recommendations were submitted to 

and accepted by ICCVAM member 

agencies (more information at http:// 

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

ivocutox/ocu_recommend.htm). One of 

the ICCVAM recommendations was to 

consider the validation status of these 

four in vitro ocular test methods for 

identifying mild and moderate ocular 

irritants and substances not classified as 

ocular irritants. NICEATM and ICCVAM 

requested data (72 FR 31582), compiled 

available information, prepared draft 

BRDs assessing their current validation 

status for this purpose, and developed 

draft recommendations for their use. 

In January 2008, a BRD titled, An In 

Vitro Approach for EPA Labeling of 

Anti-Microbial Cleaning Products, was 

submitted to NICEATM for review. This 

BRD, prepared by the Institute for In 

Vitro Sciences in collaboration with the 

Alternative Testing Working Group 

(comprised of seven consumer product 

companies [Clorox, Colgate Palmolive, 

Dial, EcoLabs, Johnson Diversey, Procter 

and Gamble, and SC Johnson]), proposes 

a testing strategy that uses the CM ®, 

EpiOcularTM, and BCOP test methods to 

assess the eye irritation potential of 

antimicrobial cleaning products and to 

determine appropriate EPA ocular 

hazard classification categories for such 

products. NICEATM and ICCVAM 

reviewed the BRD, requested additional 

data and information (73 FR 18535), and 

compiled draft recommendations and a 

draft ICCVAM SRD. ICCVAM also 

reviewed the validation status of the 

LVET, which is proposed as a reference 

test method to partially substantiate the 

validity of the in vitro test methods used 

in the test strategy. 

Availability of the Peer Panel Report 

The Panel’s conclusions and 

recommendations are detailed in the 

Independent Scientific Peer Review 

Panel Report: Evaluation of the 

Validation Status of Alternative Ocular 

Safety Testing Methods and Approaches 

which is available along with the draft 

documents reviewed by the Panel and 

the draft ICCVAM test method 

recommendations at http:// 

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

PeerPanel09.htm. 

Request for Public Comments 

NICEATM invites the submission of 

written comments on the Panel report. 

When submitting written comments, 

please refer to this Federal Register 

notice and include appropriate contact 

information (name, affiliation, mailing 

address, phone, fax, e-mail, and 

sponsoring organization, if applicable). 

All comments received will be made 

publicly available via the NICEATM– 

ICCVAM Web site at http:// 

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

PeerPanel09.htm. ICCVAM will 

consider the Panel report along with 

public comments and comments made 

by the Scientific Advisory Committee 

on Alternative Toxicological Methods 

(SACATM) at their June 25–26, 2009 

meeting (74 FR 19562) when finalizing 

test method recommendations. Final 

ICCVAM recommendations will be 

published in ICCVAM test method 

evaluation reports, which will be 

forwarded to relevant Federal agencies 

for their consideration. The evaluation 

reports will also be available to the 

public on the NICEATM–ICCVAM Web 

site at http://iccvam.niehs.nih.gov/ 

methods/ocutox/ocutox.htm and by 

request from NICEATM (see ADDRESSES

above). 

Background Information on ICCVAM, 

NICEATM, and SACATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that use, generate, or disseminate 

toxicological information. ICCVAM 

conducts technical evaluations of new, 

revised, and alternative methods with 

regulatory applicability, and promotes 

the scientific validation and regulatory 

acceptance of toxicological test methods 

that more accurately assess the safety 

and hazards of chemicals and products 

and that refine, reduce, and replace 

animal use. The ICCVAM Authorization 

Act of 2000 (42 U.S.C. 285l–3) 

established ICCVAM as a permanent 

interagency committee of the NIEHS 

under NICEATM. NICEATM 

administers ICCVAM and provides 

scientific and operational support for 

ICCVAM-related activities. NICEATM 

and ICCVAM work collaboratively to 

evaluate new and improved test 

methods applicable to the needs of U.S. 

Federal agencies. Additional 

information about ICCVAM and 

NICEATM can be found on their Web 

site (http://iccvam.niehs.nih.gov). 

SACATM was established January 9, 

2002, and is composed of scientists from 

the public and private sectors (67 FR 

11358). SACATM provides advice to the 

Director of the NIEHS, ICCVAM, and 

NICEATM regarding the statutorily 

mandated duties of ICCVAM and 

activities of NICEATM. Additional 

information about SACATM, including 

the charter, roster, and records of past 

meetings, can be found at http:// 

ntp.niehs.nih.gov/ see ‘‘Advisory Board 

& Committees’’ (or directly at http:// 

ntp.niehs.nih.gov/go/167). 

Reference 

ICCVAM. 2003. ICCVAM Guidelines for the 

Nomination and Submission of New, 

Revised, and Alternative Test Methods. 

NIH Publication No. 03–4508. Research 

Triangle Park, NC: NIEHS. Available at: 

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

Dated: July 3, 2009. 

John R. Bucher, 

Associate Director, NTP. 

[FR Doc. E9–16388 Filed 7–10–09; 8:45 am] 

BILLING CODE 4140–01–P 

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