Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 50221 

Background Information on ICCVAM, 

NICEATM, and SACATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that require, use, generate, or 

disseminate toxicological and safety 

testing information. ICCVAM conducts 

technical evaluations of new, revised, 

and alternative safety testing methods 

with regulatory applicability and 

promotes the scientific validation and 

regulatory acceptance of toxicological 

and safety testing methods that more 

accurately assess the safety and hazards 

of chemicals and products and that 

reduce, refine (decrease or eliminate 

pain and distress), 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 

ICCVAM, provides scientific and 

operational support for ICCVAM-related 

activities, and conducts independent 

validation studies to assess the 

usefulness and limitations of new, 

revised, and alternative test methods 

and strategies. NICEATM and ICCVAM 

welcome the public nomination of new, 

revised, and alternative test methods 

and strategies for validation studies and 

technical evaluations. Additional 

information about NICEATM and 

ICCVAM can be found on the 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov). 

SACATM was established in response 

to the ICCVAM Authorization Act 

[Section 285l–3(d)] and is composed of 

scientists from the public and private 

sectors. SACATM advises ICCVAM, 

NICEATM, and the Director of the 

NIEHS and NTP regarding statutorily 

mandated duties of ICCVAM and 

activities of NICEATM. SACATM 

provides advice on priorities and 

activities related to the development, 

validation, scientific review, regulatory 

acceptance, implementation, and 

national and international 

harmonization of new, revised, and 

alternative toxicological test methods. 

Additional information about SACATM, 

including the charter, roster, and 

records of past meetings, can be found 

at http://ntp.niehs.nih.gov/go/167. 

References 

AWA. 2010. Animal Welfare Act. 7 U.S.C. 

2131 et seq. Public Law 89–544. Available: 

http://www.aphis.usda.gov/ 

animal_welfare/downloads/awa/awa.pdf. 

CPSC. 2010. Hazardous Substances and 

Articles; Administration and Enforcement 

Regulations. 16 CFR part 1500. Available: 

http://www.gpo.gov/fdsys/pkg/CFR-2010- 

title16-vol2/xml/CFR-2010-title16-vol2- 

part1500.xml. 

EPA. 1998. Health Effects Test Guideline, 

OPPTS 870.2400 Acute Eye Irritation. 

Washington, DC: U.S. Environmental 

Protection Agency. Available: http:// 

iccvam.niehs.nih.gov/SuppDocs/FedDocs/ 

EPA/EPA_870_2400.pdf. 

FHSA. 2008. 15 U.S.C. 1261–1278. Public 

Law 86–613. Available: http:// 

www.cpsc.gov/businfo/fhsa.pdf. 

Haseman JK, Allen DG, Lipscomb EA, Truax 

JF, Stokes WS. 2011. Using fewer animals 

to identify chemical eye hazards: Revised 

criteria necessary to maintain equivalent 

hazard classification [published online 

ahead of print]. Regul Toxicol Pharmacol. 

Available: http://dx.doi.org/10.1016/ 

j.yrtph.2011.06.006. 

OECD. 2002. Test No. 405: Acute Eye 

Irritation/Corrosion. In: OECD Guidelines 

for the Testing of Chemicals, Section 4: 

Health Effects. Paris:OECD Publishing. 

Available: http://www.oecd-ilibrary.org/ 

content/book/9789264070646-en. 

PHS. 2002. Public Health Service Policy on 

Humane Care and Use of Laboratory 

Animals. Bethesda, MD: Office of 

Laboratory Animal Welfare, National 

Institutes of Health. Available: http:// 

grants.nih.gov/grants/olaw/references/ 

phspol.htm. 

Dated: August 3, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–20537 Filed 8–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

International Workshop on Alternative 

Methods for Human and Veterinary 

Rabies Vaccine Testing: State of the 

Science and Planning the Way Forward 

AGENCY: Division of the National 

Toxicology Program (DNTP), National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health (NIH), HHS. 

ACTION: Announcement of a Workshop; 

Call for Abstract Submissions. 

SUMMARY: The NTP Interagency Center 

for the Evaluation of Alternative 

Toxicological Methods (NICEATM) 

announces an ‘‘International Workshop 

on Alternative Methods for Human and 

Veterinary Rabies Vaccine Testing: State 

of the Science and Planning The Way 

Forward.’’ This workshop will bring 

together scientists from government, 

industry, and academia to review the 

current state of the science and 

validation status of methods and 

approaches that may reduce, refine, or 

replace animal use in human and 

veterinary rabies vaccine potency 

testing, and to develop an 

implementation strategy to achieve 

global acceptance and use of these 

alternatives. Attendance is open to the 

public at no charge and limited only by 

the available space. Abstracts for 

scientific posters for display at the 

workshop are also invited (see 

SUPPLEMENTARY INFORMATION). 

DATES: The workshop is scheduled for 

October 11–13, 2011. Sessions will 

begin at 8:30 a.m. each day and end at 

approximately 6 p.m. on October 11 and 

12 and at 12 p.m. on October 13. The 

deadline for registration is September 

30, 2011. Due to U.S. Department of 

Agriculture (USDA) security 

requirements, onsite registration at the 

workshop will not be available. The 

deadline for submission of poster 

abstracts is September 16, 2011. 

ADDRESSES: The workshop will be held 

at the Center for Veterinary Biologics at 

the USDA National Centers for Animal 

Health, 1920 Dayton Avenue, Ames, 

Iowa 50010. Individuals with 

disabilities who need accommodation to 

participate in this event should contact 

Ms. Debbie McCarley at voice 

telephone: 919–541–2384 or e-mail: 

mccarley@niehs.nih.gov. TTY users 

should contact the Federal TTY Relay 

Service at 800–877–8339. Requests 

should be made at least 5 business days 

in advance of the event. 

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 

Rabies is one of the oldest known 

zoonotic diseases and is responsible for 

at least 55,000 human deaths worldwide 

each year (World Health Organization 

[WHO], 2010). Rabies vaccines serve a 

vital role in preventing further deaths 

and controlling the disease in certain 

animal populations. An estimated 15 

million people receive post-exposure 

vaccine prophylaxis each year due to 

actual or suspected exposures to the 

rabies virus. In the United States and 

other developed countries, rabies 

vaccines have effectively eliminated 

domestic rabies virus strains. Prior to 

the release of each production lot of 

vaccine, regulatory authorities require 

demonstration of potency and safety. 

Potency and safety testing of rabies 

vaccines requires large numbers of 

laboratory animals and involves 

significant pain and distress. New 

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50222 Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 

methods and approaches are sought that 

(1) are more humane and use fewer or 

no animals; (2) are faster, less 

expensive, and more accurate; and (3) 

are safer for laboratory workers. 

A recent international workshop 

organized by NICEATM, the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM), and its international 

partners identified rabies vaccines as 

one of the three highest priorities for 

future research, development, and 

validation of alternative test methods 

that could further reduce, refine, and 

ultimately replace animal use for 

potency and safety testing. Organizing 

an international workshop to assess the 

current state of the science and way 

forward for alternative methods for 

rabies vaccine potency testing was 

identified as a high priority. Based on 

recent scientific and technological 

advances, several alternative approaches 

to rabies vaccine potency testing have 

been proposed or are currently 

available. This international workshop 

will bring together scientific experts 

from government, industry, and 

academia to review these methods and 

to define efforts necessary to achieve 

global acceptance and implementation. 

The workshop is organized by 

NICEATM, ICCVAM, the European 

Centre for the Validation of Alternative 

Methods (ECVAM), the Japanese Center 

for the Validation of Alternative 

Methods (JaCVAM), and Health Canada. 

Preliminary Workshop Agenda 

Day 1 Tuesday, October 11, 2011 

• Welcome and Overview of 

Workshop Goals and Objectives 

• Rabies Vaccines for Humans and 

Animals: Public Health Perspectives 

• Current Requirements and 

Guidance on Product-Specific 

Validation of Alternatives for Veterinary 

Rabies Vaccine Potency Testing 

• Current Requirements and 

Guidance on Product-Specific 

Validation of Alternatives for Human 

Rabies Vaccine Potency Testing 

• International Guidelines for Rabies 

Vaccine Potency Testing 

Æ WHO 

Æ World Organisation for Animal 

Health (OIE) 

• Incorporating Reduction, 

Refinement, and Replacement (the 

‘‘3Rs’’) Into Human and Veterinary 

Rabies Vaccine Potency Testing: An 

Industry Perspective 

• Critical Analysis of the In Vivo 

Potency Challenge Test for Inactivated 

Rabies Vaccines 

• Serological Methods for Human and 

Veterinary Rabies Vaccine Potency 

Testing: Overview and Validation Status 

• In Vitro Antigen Quantification 

Assays for Rabies Vaccine Potency 

Testing 

• Application of Consistency 

Parameters and Integrated Approaches 

to Reduce and Replace Animal Use for 

Rabies Vaccine Potency Testing 

• Vaccine Adjuvants and their Impact 

on Antigen Quantification Methods 

• Current NIH Research on Improved 

Rabies Vaccines 

Day 2 Wednesday, October 12, 2011 

• Breakout Session #1: Serologic 

Methods for Rabies Vaccine Potency 

Testing 

• Breakout Session #2: Non-Animal 

Approaches to Rabies Vaccine Potency 

Testing: Antigen Quantification and 

Integrated Approaches 

Day 3 Thursday, October 13, 2011 

• Breakout Session #2 (continued): 

Non-Animal Approaches to Rabies 

Vaccine Potency Testing: Antigen 

Quantification and Integrated 

Approaches 

• Breakout Session #3: The In Vivo 

Potency Challenge Test for Inactivated 

Rabies Vaccines: Refinement and 

Reduction Opportunities 

• Closing Session: Review of 

Workshop Conclusions and 

Recommendations 

Registration 

Registration information, tentative 

agenda, and additional meeting 

information are available on the 

workshop Web site (http:// 

iccvam.niehs.nih.gov/meetings/ 

RabiesVaccWksp-2011/ 

RabiesVaccWksp.htm) and upon request 

from NICEATM (see FOR FURTHER

INFORMATION CONTACT). 

Call for Abstracts 

NICEATM and ICCVAM invite the 

submission of abstracts for scientific 

posters to be displayed during this 

workshop. Posters should address 

current research, development, 

validation, and/or regulatory acceptance 

of alternative methods that may reduce, 

refine, and/or replace the use of animals 

for human or veterinary rabies vaccine 

potency testing. The body of the abstract 

is not to exceed 400 words. Key 

references relevant to the abstract may 

be included after the abstract body; 

however, the length of the abstract and 

references should not exceed one page. 

All submissions should be at least 12- 

point font and all margins for the 

document should be no less than one 

inch. Title information should include 

the names of all authors and associated 

institutions. The name, address, phone 

number, fax number, and email address 

for the corresponding or senior author 

should be provided at the end of the 

abstract. 

Abstracts must include the following 

information, when applicable: (1) A 

statement indicating whether animals or 

humans were used in studies, (2) a 

statement by the senior author certifying 

that use of animals or animal tissues 

was carried out in accordance with 

applicable laws, regulations, and 

guidelines, and that the studies were 

approved by the appropriate 

Institutional Animal Care and Use 

Committee or equivalent, and (3) a 

statement that all human studies were 

conducted in accordance with 

applicable laws, regulations, and 

guidelines, and that the studies were 

approved by the appropriate 

Institutional Review Board or 

equivalent. 

Abstracts must be submitted by e-mail 

to niceatm@niehs.nih.gov. The deadline 

for abstract submission is September 16, 

2011. The corresponding author will be 

notified regarding the abstract’s 

acceptance within 10 working days of 

the submission deadline. Guidelines for 

poster presentations will be sent to the 

corresponding authors. 

Background Information on ICCVAM 

and NICEATM 

ICCVAM is an interagency committee 

composed of representatives from 15 

Federal regulatory and research agencies 

that require, use, generate, or 

disseminate toxicological and safety 

testing information. ICCVAM conducts 

technical evaluations of new, revised, 

and alternative safety testing methods 

with regulatory applicability and 

promotes the scientific validation and 

regulatory acceptance of toxicological 

and safety testing methods that more 

accurately assess the safety and hazards 

of chemicals and products and that 

reduce, refine (decrease or eliminate 

pain and distress), 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 

ICCVAM, provides scientific and 

operational support for ICCVAM-related 

activities, and conducts independent 

validation studies to assess the 

usefulness and limitations of new, 

revised, and alternative test methods 

and strategies. NICEATM and ICCVAM 

welcome the public nomination of new, 

revised, and alternative test methods 

and strategies applicable to the needs of 

U.S. Federal agencies. Additional 

information about ICCVAM and 

NICEATM can be found on the 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 156 / Friday, August 12, 2011 / Notices 50223 

NICEATM–ICCVAM Web site (http:// 

iccvam.niehs.nih.gov). 

References 

WHO. 2010. Rabies vaccines: WHO 

Position paper. Weekly Epidemiological 

Record 85(32):309–320. 

Dated: August 3, 2011. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2011–20540 Filed 8–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice To Change Catalog of Federal 

Domestic Assistance (CFDA) Number 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice provides public 

announcement of CDC’s intent to award 

two awards to eligible applicants of 

State or Territorial Public Health 

Newborn Bloodspot Screening 

Programs. These activities are proposed 

by the above-mentioned grantees in 

their FY 2011 applications submitted 

under funding opportunity CDC–RFA– 

EH11–001, ‘‘Program to Support New 

Implementation of State or Territorial 

Public Health Laboratory Capacity for 

Newborn Bloodspot Screening of Severe 

Combined Immune Deficiency (SCID) 

(U01), ’’ Catalog of Federal Domestic 

Assistance Number (CFDA): 93.070. 

Approximately $900,000 in funding will 

be awarded to the grantees for the 

implementation of newborn screening 

for SCID. 

Accordingly, CDC adds the following 

information to the previously published 

funding opportunity announcement of 

EH11–001: 

Authority: Authorized under Section 301 

of the Public Health Service Act, [42 U.S.C. 

241], as amended. 

CFDA #: 93.070 Environmental Public 

Health Emergency Response. 

Award Information 

Type of Award: New Competing 

Cooperative Agreement. 

Approximate Total Current Fiscal 

Year ACA Funding: $900,000. 

Anticipated Number of Awards: 2. 

Fiscal Year Funds: 2011. 

Anticipated Award Date: September 

1, 2011. 

Application Selection Process 

Funding will be awarded to 

applicants based on results from the 

peer review panel ranking 

recommendations. 

Funding Authority 

CDC will add the authority to that 

which is reflected in the published 

Funding Opportunity CDC–RFA–EH11– 

001. The revised funding authority 

language will read: 

—Authorized under Section 301 of the 

Public Health Service Act, [42 U.S.C. 

241], as amended. 

DATES: The effective date for this action 

is the date of publication of this Notice 

and remains in effect until the 

expiration of the project period of the 

funded applications. 

FOR FURTHER INFORMATION CONTACT: Beth 

Gardner, Extramural Team Lead, 

National Center for Environmental 

Health, Centers for Disease Control and 

Prevention, 4770 Buford Hwy., Atlanta, 

GA 30341, telephone (770) 488–0572, email Bgardner@cdc.gov. 

SUPPLEMENTARY INFORMATION: None. 

Dated: August 3, 2011. 

James Stephens, 

Director of the Office of Science Quality, 

Centers for Disease Control and Prevention. 

[FR Doc. 2011–20507 Filed 8–11–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (45 FR 67772–76, dated 

October 14, 1980, and corrected at 45 FR 

69296, October 20, 1980, as amended 

most recently at 76 FR 47189–47190, 

dated August 4, 2011) is amended to 

reflect the reorganization of the Center 

for Global Health, Centers for Disease 

Control and Prevention. 

Section C–B, Organization and 

Functions, is hereby amended as 

follows: After the title and functional 

statements for the Division of Global 

Disease Detection and Emergency 

Response (CWJ), insert the following: 

Global Immunization Division (CWK). 

The Global Immunization Division 

(GID) protects the health of Americans 

and global citizens by preventing 

disease, disability, and death worldwide 

from vaccine-preventable diseases. In 

carrying out its mission, GID: (1) 

Provides national leadership and 

coordination of the CGH efforts to 

eradicate polio, control or eliminate 

measles, strengthen routine 

immunization programs, introduce new 

and under-utilized vaccines, and 

promote safe injection practices, in 

collaboration with international 

organizations and CDC Centers/ 

Institute/Offices; (2) provides short- and 

long-term consultation and technical 

assistance to the WHO, UNICEF, and 

foreign countries involved in global 

immunization activities and participates 

in international advisory group 

meetings on immunization issues; (3) 

administers grants to WHO, Pan 

American Health Organization (PAHO), 

UNICEF, and other international 

partners as appropriate for the provision 

of technical, programmatic, and 

laboratory support, and vaccine 

procurement for initiatives to support 

global immunization targets; (4) designs 

and participates in international 

research, monitoring, and evaluation 

projects to increase the effectiveness of 

immunization strategies as may be 

developed; (5) develops strategies to 

improve the technical skills and 

problem-solving abilities of program 

managers and health care workers in 

other countries; (6) refines strategies 

developed for the eradication or control 

of vaccine-preventable diseases in the 

Western Hemisphere for 

implementation in other parts of the 

world; (7) assists other countries, WHO, 

and other partners to improve 

surveillance for polio, measles, and 

other vaccine preventable diseases 

(VPDs); (8) prepares articles based on 

findings for publication in international 

professional journals and presentation 

at international conferences; (9) 

collaborates with other countries, WHO, 

UNICEF, and advocacy groups to ensure 

the availability of sufficient funds to 

purchase an adequate supply of polio, 

measles, and other vaccines, and funds 

for technical support for use in 

eradication and control efforts; and (10) 

provides technical and operational 

leadership for CDC’s activities in 

support of the immunization initiatives 

such as Global Alliance for Vaccines 

and Immunization and the Global 

Immunization Vision and Strategies. 

Office of the Director (CWK1). (1) 

Provides leadership, management, and 

oversight for all division activities; (2) 

provides coordination of budgeting and 

liaison with CGH, and FMO on budget 

and spending; (3) provides coordination 

and oversight of the division’s 

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