61504 Federal Register / Vol. 69, No. 201 / Tuesday, October 19, 2004 / Notices 

and Eukaryotic Genetics and Molecular 

Biology. 

Date: November 3–5, 2004. 

Time: 7 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Mary P. McCormick, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2208, 

MSC 7890, Bethesda, MD 20892, (301) 435–

1047, mccormim@csr.nih.gov.

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Fetal Basis 

for Adult Disease. 

Date: November 3–4, 2004. 

Time: 7 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Ray Bramhall, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6046 F, 

MSC 7892, Bethesda, MD 20892, (910) 458–

1871, bramhalr@csr.nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS.)

Dated: October 7, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–23350 Filed 10–18–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

National Institute of Environmental 

Health Sciences (NIEHS); National 

Toxicology Program (NTP); NTP 

Interagency Center for the Evaluation 

of Alternative Toxicological Methods 

(NICEATM): Availability of Updated 

Standardized In Vitro Cytotoxicity Test 

Method Protocols for Estimating Acute 

Oral Systemic Toxicity; Request for 

Existing In Vivo and In Vitro Acute 

Toxicity Data 

Summary: NICEATM announces the 

availability of two updated standardized 

in vitro cytotoxicity test method 

protocols to estimate acute oral systemic 

toxicity in rodents. These two test 

methods were previously recommended 

by the Interagency Coordinating 

Committee on the Validation of 

Alternative Methods (ICCVAM) for 

selecting starting doses for in vivo acute 

oral systemic toxicity tests (Federal 

Register Vol. 66, No. 189, pages 49686–

49687, September 28, 2001). This 

approach can reduce the number of 

animals required for acute oral toxicity 

testing. NICEATM also requests the 

submission of existing and future data 

on chemicals and products tested for 

both acute oral systemic toxicity and in 

vitro cytotoxicity using the standardized 

test method protocols mentioned in this 

notice. These data will be used to 

further evaluate the usefulness and 

limitations of cytotoxicity methods for 

estimating in vivo acute oral toxicity. 

The data will also be used to establish 

a database to support the investigation 

of other test methods necessary to 

improve the accuracy of in vitro 

assessments of acute systemic toxicity. 

Availability of Standardized Test 

Method Protocols for Estimating 

Starting Doses for In Vivo Acute Oral 

Toxicity Tests 

Updated standardized protocols for 

two neutral red uptake assays using 

either BALB/c 3T3 cells or normal 

human keratinocytes are now available 

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

methods/invitro.htm. These test method 

protocols have been improved to 

maximize intra- and inter-laboratory 

reproducibility and are currently being 

used for the final phase of a joint 

NICEATM-European Center for the 

Validation of Alternative Methods 

(ECVAM) validation study. NICEATM 

recommends that these updated test 

method protocols be used in place of 

standard operating procedures 

previously recommended by ICCVAM 

for two cytotoxicity test methods to 

estimate starting doses for in vivo acute 

oral toxicity tests (ICCVAM, 2001b). 

Submission of Chemical and Protocol 

Information/Test Data 

In vivo and in vitro acute toxicity 

testing data for chemicals or products 

should be sent by mail, fax or e-mail to 

NICEATM [Dr. William S. Stokes, 

Director, NICEATM, NIEHS, PO Box 

12233, MD EC–17, Research Triangle 

Park, NC 27709, (phone) 919–541–2384, 

(fax) 919–541–0947, (e-mail) 

iccvam@niehs.nih.gov]. Data will be 

accepted at any time. Data submitted 

within the next 9 months will be 

considered during an evaluation of the 

validation status of the two cytotoxicity 

methods anticipated in late 2005. 

Chemical and protocol information/test 

data submitted in response to this notice 

may be incorporated in future 

NICEATM and ICCVAM reports and 

publications as appropriate. 

When submitting chemical and 

protocol information/test data, please 

reference this Federal Register notice 

and provide appropriate contact 

information (name, affiliation, mailing 

address, phone, fax, e-mail, and 

sponsoring organization, as applicable). 

NICEATM prefers data to be 

submitted as copies of pages from study 

notebooks and/or study reports, if 

available. Raw data and analyses 

available in electronic format may also 

be submitted. Each submission for a 

chemical should preferably include the 

following information, as appropriate: 

• Common and trade name 

• Chemical Abstracts Service Registry 

Number (CASRN) 

• Chemical and/or product class 

• Commercial source 

• In vitro basal cytotoxicity test 

protocol used 

• In vitro cytotoxicity test results 

• In vivo acute oral toxicity test 

protocol used 

• Individual animal responses at each 

observation time (if available) 

• The extent to which the study 

complied with national or international 

Good Laboratory Practice (GLP) 

guidelines

• Date and testing organization 

Those persons submitting data on 

chemicals tested for in vitro basal 

cytotoxicity are referred to the standard 

test-reporting template recommended 

for the High Production Volume (HPV) 

program at http://www.epa.gov/

chemrtk/toxprtow.htm or at http://

iccvam.niehs.nih.gov/methods/

invitro.htm. In vivo data for the same 

chemicals should be reported as 

recommended in the test reporting 

section of the current Environmental 

Protection Agency (EPA) guideline for 

acute oral toxicity (EPA, 2002). 

Submitted data will be used to further 

evaluate the usefulness and limitations 

of in vitro cytotoxicity data for 

estimating acute oral toxicity, and will 

be included in a database to support the 

investigation of other test methods 

necessary to improve the accuracy of in 

vitro assessments of acute systemic 

toxicity. 

History 

In September 2001, the ICCVAM 

recommended that in vitro cytotoxicity 

test methods be considered as a tool for 

estimating starting doses for in vivo 

acute systemic toxicity testing studies 

(Federal Register Vol. 66, No. 189, 

pages 49686–49687, September 28, 

2001.) The recommendations were 

based on the Report of the International 

Workshop on In Vitro Methods for 

Assessing Acute Systemic Toxicity 

(ICCVAM, 2001a). The Guidance 

Document on Using In Vitro Data to 

Estimate In Vivo Starting Doses for 

Acute Toxicity (ICCVAM, 2001b) was 

Federal Register / Vol. 69, No. 201 / Tuesday, October 19, 2004 / Notices 61505

also made available at that time. The 

guidance document provided standard 

operating procedures for two 

cytotoxicity test methods and 

instructions for using these assays to 

estimate starting doses for in vivo 

testing. 

Federal agency responses to the 

ICCVAM test method recommendations 

were announced on March 10, 2004 

(Federal Register Vol. 69, No. 47, pages 

11448–11449). Federal agencies agreed 

to encourage, to the extent applicable, 

the use of in vitro tests for determining 

starting doses for acute systemic toxicity 

testing. Furthermore, EPA specifically 

encouraged those participating in the 

HPV Challenge Program to consider 

using the recommended in vitro tests as 

a supplemental component in 

conducting any new in vivo acute oral 

toxicity studies for the program (http:/

/www.epa.gov/chemrtk/toxprtow.htm). 

A NICEATM–ECVAM validation 

study was initiated in 2002 to evaluate 

the usefulness of the two neutral red 

uptake cytotoxicity assays currently 

available for predicting starting doses 

for in vivo acute oral toxicity tests. 

During the pre-validation phases of the 

study, the test method protocols were 

further standardized and revised to 

improve their intra- and inter-laboratory 

reproducibility. NICEATM recommends 

using the revised test method protocols 

rather than the standard operating 

procedures outlined in the guidance 

document (ICCVAM, 2001b.) The 

guidance document should be consulted 

for the procedure for calculating starting 

doses using in vitro cytotoxicity data. 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 

fifteen Federal regulatory and research 

agencies that use, generate, or 

disseminate toxicological information. 

ICCVAM promotes the development, 

validation, regulatory acceptance, and 

national and international 

harmonization of toxicological test 

methods that more accurately assess the 

safety or hazards of chemicals and 

products, and test methods that refine, 

reduce and replace animal use. The 

ICCVAM Authorization Act of 2000 

(available at http://

iccvam.niehs.nih.gov/about/

PL106545.htm) established ICCVAM as 

a permanent interagency committee of 

the NIEHS under the NICEATM. 

NICEATM administers the ICCVAM and 

provides scientific support for ICCVAM 

and 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 following 

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

References

EPA. 2002. Health Effects Test Guidelines, 

OPPTS 870.1100, Acute Oral Toxicity, EPA 

712–C–02–190. Available at: http://

www.epa.gov/opptsfrs/OPPTS_Harmonized/

870_Health_Effects_Test_Guidelines/Series/

870–1100.pdf.

ICCVAM (Interagency Coordinating 

Committee on the Validation of Alternative 

Methods). 2001a. Report of the international 

workshop on in vitro methods for assessing 

acute systemic toxicity. NIH Publication 01–

4499. Research Triangle Park, NC: National 

Institute for Environmental Health Sciences. 

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

ICCVAM. 2001b. Guidance document on 

using in vitro data to estimate in vivo starting 

doses for acute toxicity. NIH Publication 01–

4500. Research Triangle Park, NC: National 

Institute for Environmental Health Sciences. 

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

Dated: October 6, 2004. 

Samuel H. Wilson, 

Deputy Director, National Institute of 

Environmental Health Sciences.

[FR Doc. 04–23335 Filed 10–18–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[CGD17–04–002] 

Cook Inlet Regional Citizen’s Advisory 

Committee; Charter Renewal

AGENCY: Coast Guard, DHS.

ACTION: Notice of recertification.

SUMMARY: The Coast Guard has 

recertified the Cook Inlet Regional 

Citizen’s Advisory Council for the 

period covering September 1, 2004 

through August 31, 2005. Under the Oil 

Terminal and Oil Tanker Environmental 

Oversight Act of 1990, the Coast Guard 

may certify on an annual basis an 

alternative voluntary advisory group in 

lieu of a regional citizens’ advisory 

council for Cook Inlet, Alaska. This 

advisory group monitors the activities of 

terminal facilities and crude oil tankers 

under the Cook Inlet Program 

established by the statute.

DATES: The Cook Inlet Regional Citizen’s 

Advisory Council is certified through 

August 31, 2005.

ADDRESSES: You may request a copy of 

the recertification letter by writing to 

Commander, Seventeenth Coast Guard 

District (mor), P.O. Box 25517, Juneau, 

AK 99802–5517.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Andrew Vanskike, 

Seventeenth Coast Guard District (mor), 

907–463–2818.

SUPPLEMENTARY INFORMATION: 

Background And Purpose 

On September 1, 2004, the Coast 

Guard recertified the Cook Inlet 

Regional Citizen’s Advisory Council 

(CIRCAC) through August 31, 2005. 

Under the Oil Terminal and Oil Tanker 

Environmental Oversight Act of 1990 

(33 U.S.C. 2732), the Coast Guard may 

certify, on an annual basis, an 

alternative voluntary advisory group in 

lieu of a regional citizens’ advisory 

council for Cook Inlet, Alaska. This 

advisory group monitors the activities of 

terminal facilities and crude oil tankers 

under the Cook Inlet Program 

established by Congress, 33 U.S.C. 2732 

(b). 

On September 16, 2002, the Coast 

Guard published a notice of policy on 

revised recertification procedures for 

alternative voluntary advisory groups in 

lieu of councils at Prince William 

Sound and Cook Inlet, AK (67 FR 58440, 

58441). This revised policy indicated 

that applicants seeking recertification in 

2003 and 2004 need only submit a 

streamlined application and public 

comments would not be solicited prior 

to recertification.

Dated: September 24, 2004. 

James C. Olson, 

Rear Admiral, U.S. Coast Guard, Commander, 

Seventeenth Coast Guard District.

[FR Doc. 04–23370 Filed 10–18–04; 8:45 am] 

BILLING CODE 4910–15–M

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Notice of Adjustment of Countywide 

Per Capita Impact Indicator

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Notice.

SUMMARY: FEMA gives notice that the 

countywide per capita impact indicator 

under the Public Assistance program for 

disasters declared on or after October 1, 

2004 will be increased.

DATES: Effective October 1, 2004 and 

applies to major disasters declared on or 

after October 1, 2004.

FOR FURTHER INFORMATION CONTACT:

James A. Walke, Recovery Division, 

Federal Emergency Management