Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 26395 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP), 

NTP Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM); Peer Review 

Panel Report on Five In Vitro Pyrogen 

Test Methods: 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 scientific 

peer review panel meeting on February 

6, 2007, to evaluate the validation status 

of five in vitro pyrogen test methods 

proposed as replacements for the Rabbit 

Pyrogen Test (RPT). The peer review 

panel (‘‘the Panel’’) report from this 

meeting is now available. The report 

contains (1) the Panel’s evaluation of the 

validation status of the methods and (2) 

the Panel’s comments and conclusions 

on draft ICCVAM test method 

recommendations. NICEATM invites 

public comment on the Panel’s report. 

The report is available on the 

NICEATM/ICCVAM Web site at (http:// 

iccvam.niehs.nih.gov/methods/pyrogen/ 

pyrogen.htm) or by contacting 

NICEATM (see FOR FURTHER

INFORMATION CONTACT below). 

DATES: Written comments on the Panel 

report should be received by June 25, 

2007. 

ADDRESSES: Comments should 

preferably be submitted electronically 

via the NICEATM/ICCVAM Web site: 

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

FR_pubcomment.htm. Comments can 

also be submitted by e-mail to 

niceatm@niehs.nih.gov. Written 

comments can be sent by mail or fax to 

Dr. William S. Stokes, NICEATM 

Director, NIH/NIEHS, P.O. Box 12233, 

MD EC–17, Research Triangle Park, NC 

27709, (fax) 919–541–0947, (e-mail) 

niceatm@niehs.nih.gov. Courier address: 

NICEATM, 79 T.W. Alexander Drive, 

Building 4401, Room 3128, Research 

Triangle Park, NC 27709. 

FOR FURTHER INFORMATION CONTACT: 

Other correspondence should be 

directed to Dr. William S. Stokes, 

NICEATM Director (919–541–2384 or 

niceatm@niehs.nih.gov). 

SUPPLEMENTARY INFORMATION 

Background 

The European Centre for the 

Validation of Alternative Methods 

(ECVAM) submitted five in vitro 

pyrogen test methods to ICCVAM for 

evaluation in 2006. The proposed test 

methods include: 

1. The Human Whole Blood 

(WB)/IL–1 In Vitro Pyrogen Test: 

Application of Cryopreserved Human 

WB 

2. The Monocytoid Cell Line Mono 

Mac 6 (MM6)/IL–6 In Vitro Pyrogen Test 

3. The Human PBMC/IL–6 In Vitro 

Pyrogen Test 

4. The Human WB/IL–1 In Vitro 

Pyrogen Test 

5. The Human WB/IL–6 In Vitro 

Pyrogen Test 

These test methods are based on the 

measurement of proinflammatory 

cytokines released from either fresh or 

cryopreserved human blood cells or a 

human monocytoid line in response to 

the presence of Gram-negative 

endotoxin in parenteral 

pharmaceuticals. NICEATM and 

ICCVAM prepared a comprehensive 

background review document (BRD) 

that included the available data for the 

five test methods and a separate 

document containing ICCVAM test 

method recommendations. At the peer 

review meeting, the Panel reviewed the 

BRD and evaluated the extent to which 

the ICCVAM criteria for validation and 

acceptance had been adequately 

addressed for the intended purpose of 

these test methods. The Panel also 

provided comments on the ICCVAM 

draft test method recommendations 

regarding the proposed usefulness and 

limitations, standardized protocols, 

performance standards, and future 

studies. The Panel’s conclusions and 

recommendations on the five in vitro 

pyrogen test methods are described in 

the Peer Review Panel Final Report: Five 

In Vitro Pyrogen Test Methods (available 

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

methods/pyrogen/pyrogen.htm). The 

draft BRD and the draft test method 

recommendations are available at http:// 

iccvam.niehs.nih.gov/methods/pyrogen/ 

pyrogen.htm. 

Request for Comments 

NICEATM invites the submission of 

written comments on the Panel’s report. 

When submitting written comments 

please refer to this Federal Register 

notice and include appropriate contact 

information (name, affiliation, mailing 

address, phone, fax, email, and 

sponsoring organization, if applicable). 

All comments received by the deadline 

listed above will be placed on the 

NICEATM/ICCVAM Web site (http:// 

ntp-apps.niehs.nih.gov/iccvampb/ 

searchPubCom.cfm) and made available 

to ICCVAM. In addition, there will be an 

opportunity for oral public comments 

on the Panel’s report during a meeting 

of the Scientific Advisory Committee on 

Alternative Toxicological Methods 

(SACATM) scheduled for June 12, 2007. 

Information concerning the SACATM 

meeting will be published in a separate 

Federal Register notice and available on 

the SACATM website: (http:// 

ntp.niehs.nih.gov/go/7441). Any written 

comments on the Panel report received 

prior to June 7, 2007, will be distributed 

to SACATM. 

ICCVAM will consider the Panel 

report along with the SACATM and 

public comments as it finalizes 

recommendations for the five in vitro 

pyrogen test methods. An ICCVAM test 

method evaluation report, which 

includes the ICCVAM final 

recommendations, will be forwarded to 

appropriate federal agencies for their 

consideration. This report will also be 

available to the public on the 

NICEATM/ICCVAM Web site and by 

request from NICEATM. 

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 

scientific validation and regulatory 

acceptance of toxicological test methods 

that more accurately assess 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, available at 

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

about_docs/PL106545.pdf) establishes 

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 Federal agencies. Additional 

information about ICCVAM and 

NICEATM can be found at the ICCVAM/ 

NICEATM Web site (http:// 

iccvam.niehs.nih.gov). 

Additional information about 

SACATM, including the charter, roster, 

and records of past meetings, can be 

found at http://ntp.niehs.nih.gov/go/ 

167. 


sroberts on PROD1PC70 with NOTICES
26396 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 

Dated: April 30, 2007. 

Samuel H. Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E7–8896 Filed 5–8–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP), 

NTP Interagency Center for the 

Evaluation of Alternative Toxicological 

Methods (NICEATM); Request for Data 

on the Use of Topical Anesthetics and 

Systemic Analgesics for In Vivo Eye 

Irritation Testing 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: Request for data on the use of 

topical anesthetics and systemic 

analgesics for in vivo ocular irritation 

testing. 

SUMMARY: The Interagency Coordinating 

Committee on the Validation of 

Alternative Methods (ICCVAM) and 

NICEATM request the submission of 

data and information on the use of 

topical anesthetics and systemic 

analgesics for alleviating pain and 

distress in rabbits during eye irritation 

testing. They also request the 

submission of information about other 

procedures and strategies that may 

reduce or eliminate pain and distress 

associated with in vivo eye irritation 

methods. 

DATES: Data should be received by June 

25, 2007. 

ADDRESSES: Data should be sent by mail, 

fax, or e-mail to Dr. William S. Stokes, 

Director, NICEATM, NIEHS, P.O. Box 

12233, MD EC–17, Research Triangle 

Park, NC, 27709, (fax) 919–541–0947, (email) niceatm@niehs.nih.gov. Courier 

address: NICEATM, 79 T.W. Alexander 

Drive, Building 4401, Room 3128, 

Research Triangle Park, NC 27709. 

FOR FURTHER INFORMATION CONTACT: Dr. 

William S. Stokes, NICEATM Director, 

(phone) 919–541–2384 or 

niceatm@niehs.nih.gov. 

SUPPLEMENTARY INFORMATION 

Background 

The U.S. Environmental Protection 

Agency (EPA) nominated to ICCVAM 

several activities relevant to reducing, 

replacing, or refining the use of rabbits 

in the current in vivo eye irritation test 

method (Federal Register Vol. 69, No. 

57, pages 13859–13861, March 24, 

2004). One activity is to review ways to 

alleviate pain and suffering that might 

arise from current in vivo eye irritation 

testing. ICCVAM endorsed this activity 

with a high priority and recommended 

that NICEATM review the data currently 

available on the use of topical 

anesthetics and/or systemic analgesics 

to reduce animal pain and distress. 

As part of this review, NICEATM 

requests the submission of data from 

completed studies on the use of topical 

anesthetics and/or systemic analgesics 

for in vivo ocular irritancy testing. These 

data will be used to evaluate the 

validation status of the use of topical 

anesthetics and/or analgesics to reduce 

pain and distress for in vivo testing 

situations. ICCVAM and NICEATM also 

request the submission of information 

and data from in vivo methods, 

procedures, and/or strategies that may 

reduce or eliminate the pain and 

suffering associated with current in vivo 

eye irritation methods. 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

federal regulatory and research agencies 

that use or generate 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, or 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 the ICCVAM and 

provides scientific and operational 

support for ICCVAM-related activities. 

Additional information about NICEATM 

and ICCVAM can be found at the 

following Web site: http:// 

iccvam.niehs.nih.gov. 

Dated: April 30, 2007. 

Samuel H. Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences and National 

Toxicology Program. 

[FR Doc. E7–8898 Filed 5–8–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration on Aging 

Purpose of Notice: Availability of 

Funding Opportunity Announcement 

Funding Opportunity Title/Program 

Name: Aging and Disability Resource 

Center Initiative: Integrating Access to 

Long-Term Care. 

Announcement Type: Initial. 

Funding Opportunity Number: HHS–

2007–AoA–DR–0707. 

Statutory Authority: The Older 

Americans Act of 2006, Public Law 

109–365. 

Catalog of Federal Domestic 

Assistance (CFDA) Number: 93.048, 

Title IV and Title II, Discretionary 

Projects. 

Dates: The deadline date for the 

submission of applications is June 29, 

2007. 

I. Funding Opportunity Description 

In FY 2003, the Administration on 

Aging (AoA) and the Centers for 

Medicare & Medicaid Services (CMS) 

formed a historic partnership to launch 

the Aging and Disability Resource 

Center (ADRC) demonstration grant 

initiative. The goal of the ADRC 

program is to empower individuals to 

make informed choices and to 

streamline access to long term support 

services. AoA and CMS share a vision 

to have Resource Centers in every 

community serving as highly visible and 

trusted places where people of all ages 

can turn for information on the full 

range of long term support options and 

a single point of entry to public long 

term support programs and benefits. 

ADRCs are a resource for both public 

and private-pay individuals. They serve 

older adults, younger individuals with 

disabilities, family caregivers, as well as 

persons planning for future long term 

support needs. ADRCs are also a 

resource for health and long term 

support professionals and others who 

provide services to older adults and to 

people with disabilities. Since FY 2003, 

43 states have received three year grants 

from AoA and CMS to design and 

implement ADRC demonstrations 

serving the elderly and at least one other 

target population of adults with 

disabilities in at least one community. 

An ADRC Program Announcement 

published in FY 2003 resulted in the 

funding of twelve states that year with 

an additional twelve states funded to 

develop ADRC programs in FY 2004. 

Nineteen additional states were funded 

to develop ADRC programs based on a 

Program Announcement published in 


sroberts on PROD1PC70 with NOTICES