Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 2065 

can reduce, refine, or replace the use of 

animals for vaccine potency and safety 

testing is one of the four highest 

priorities of the Interagency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM), an interagency committee of 

the Federal government administered by 

NICEATM. 

To address this priority, NICEATM 

and ICCVAM, along with international 

partners organized an ‘‘International 

Workshop on Alternative Methods To 

Reduce, Refine, and Replace the Use of 

Animals in Vaccine Potency and Safety 

Testing: State of the Science and Future 

Directions,’’ which took place on 

September 14–16, 2010 at NIH in 

Bethesda, Maryland. The report of the 

workshop is now available. 

Workshop Goals and Outcomes 

The goals of the workshop were to (1) 

review the state of the science of 

alternative methods currently available 

and/or accepted for use that can reduce, 

refine (enhance animal well-being and 

lessen or avoid pain and distress), and 

replace animal use in vaccine potency 

and safety testing, and discuss ways to 

promote their implementation; (2) 

identify knowledge and data gaps that 

should be addressed to develop 

alternative methods that can further 

reduce, refine, and/or replace the use of 

animals in vaccine potency and safety 

testing; and (3) identify and prioritize 

research, development, and validation 

efforts needed to address these 

knowledge and data gaps in order to 

advance alternative methods for vaccine 

potency and safety testing while 

ensuring the protection of human and 

animal health. 

The workshop report is comprised of 

27 papers that summarize the plenary 

session presentations and the 

conclusions and recommendations 

developed by the workshop participants 

during six breakout group sessions. The 

report recommends vaccines that should 

have the highest priority for future 

reduction, refinement, and replacement 

efforts. Other key recommendations 

include: 

• Procedures such as earlier humane 

endpoints should be developed and 

implemented immediately to reduce or 

avoid the pain and distress experienced 

by animals for vaccines that still require 

live-agent challenge testing. Until nonanimal tests are available, development 

of serological assays should also be 

considered as a way to avoid challenge 

testing. 

• Specific non-animal approaches 

that have successfully replaced animals 

for some vaccine potency testing should 

be developed for vaccines currently 

requiring animals through 

identification, purification, and 

characterization of vaccine protective 

antigens. 

• International harmonization and 

cooperation efforts and closer 

collaborations between human and 

veterinary vaccine researchers should be 

enhanced in order to support more 

rapid progress towards reduction, 

refinement, and replacement of animal 

use for vaccine testing. 

The workshop was organized by 

NICEATM and ICCVAM in partnership 

with the European Centre for the 

Validation of Alternative Methods, the 

Japanese Center for the Validation of 

Alternative Methods, and Health 

Canada. The workshop was cosponsored by the Society of Toxicology. 

Background Information on NICEATM 

and ICCVAM 

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. The ICCVAM 

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

285l-3) established ICCVAM as a 

permanent interagency committee of the 

NIEHS under NICEATM. ICCVAM 

conducts technical evaluations of new, 

revised, and alternative 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, or replace animal use. 

NICEATM administers ICCVAM, 

provides scientific and operational 

support for ICCVAM technical 

evaluations and 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 Federal 

agencies. Additional information about 

NICEATM and ICCVAM can be found 

on the NICEATM–ICCVAM Web site 

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

Dated: January 6, 2012. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2012–563 Filed 1–12–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–12–0530] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

EEOICPA Dose Reconstruction 

Interviews and Forms (0920–0530, 

Expiration 03/30/2012)—Extension— 

National Institute for Occupational 

Safety and Health (NIOSH), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

On October 30, 2000, the Energy 

Employees Occupational Illness 

Compensation Program Act of 2000 

(42 U.S.C. 7384–7385) was enacted. 

This Act established a federal 

compensation program for employees of 

the Department of Energy (DOE) and 

certain of its contractors, subcontractors 

and vendors, who have suffered cancers 

and other designated illnesses as a 

result of exposures sustained in the 

production and testing of nuclear 

weapons. 

Executive Order 13179, issued on 

December 7, 2000, delegated authorities 

assigned to ‘‘the President’’ under the 

Act to the Departments of Labor, Health 

and Human Services, Energy and 

Justice. The Department of Health and 

Human Services (DHHS) was delegated 

the responsibility of establishing 

methods for estimating radiation doses 

received by eligible claimants with 

cancer applying for compensation. 

NIOSH is applying the following 

methods to estimate the radiation doses 

of individuals applying for 

compensation. 

In performance of its dose 

reconstruction responsibilities, under 

the Act, NIOSH is providing voluntary 

interview opportunities to claimants (or 

their survivors) individually and 

providing them with the opportunity to 

mstockstill on DSK4VPTVN1PROD with NOTICES

2066 Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices 

assist NIOSH in documenting the work 

history of the employee by 

characterizing the actual work tasks 

performed. In addition, NIOSH and the 

claimant may identify incidents that 

may have resulted in undocumented 

radiation exposures, characterizing 

radiological protection and monitoring 

practices, and identify co-workers and 

other witnesses as may be necessary to 

confirm undocumented information. In 

this process, NIOSH uses a computer 

assisted telephone interview (CATI) 

system, which allows interviews to be 

conducted more efficiently and quickly 

as opposed to a paper-based interview 

instrument. Both interviews are 

voluntary and failure to participate in 

either or both interviews will not have 

a negative effect on the claim, although 

voluntary participation may assist the 

claimant by adding important 

information that may not be otherwise 

available. 

NIOSH uses the data collected in this 

process to complete an individual dose 

reconstruction that accounts, as fully as 

possible, for the radiation dose incurred 

by the employee in the line of duty for 

DOE nuclear weapons production 

programs. After dose reconstruction, 

NIOSH also performs a brief, voluntary 

final interview with the claimant to 

explain the results and to allow the 

claimant to confirm or question the 

records NIOSH has compiled. This will 

also be the final opportunity for the 

claimant to supplement the dose 

reconstruction record. 

At the conclusion of the dose 

reconstruction process, the claimant 

submits a form to confirm that the 

claimant has no further information to 

provide to NIOSH about the claim at 

this time. The form notifies the claimant 

that signing the form allows NIOSH to 

forward a dose reconstruction report to 

DOL and to the claimant, and closes the 

record on data used for the dose 

reconstruction. Signing this form does 

not indicate that the claimant agrees 

with the outcome of the dose 

reconstruction. The dose reconstruction 

results will be supplied to the claimant 

and to the DOL, the agency that will 

utilize them as one part of its 

determination of whether the claimant 

is eligible for compensation under the 

Act. 

There is no cost to respondents other 

than their time. The total estimated 

annual burden hours are 4,900. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Initial interview ............................................................................................................................. 4,200 1 1 

Conclusion form ........................................................................................................................... 8,400 1 5/60 

Kimberly Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–583 Filed 1–12–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–12–0740] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. 

To request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call (404) 639–7570 and 

send comments to Kimberly Lane, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D74, Atlanta, GA 30333 or 

send an email to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Medical Monitoring Project (MMP)— 

(OMB No. 0920–0740 Exp: 5/31/2012)— 

Revision—National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

This proposed data collection 

supplements the HIV/AIDS surveillance 

programs in 23 selected state and local 

health departments, which collect 

information on persons diagnosed with, 

living with, and dying from HIV 

infection and AIDS and will incorporate 

data elements from two data collections: 

Supplement to HIV/AIDS Surveillance 

(SHAS) project (0920–0262) and the 

Adult/Adolescent Spectrum of HIV 

Disease (ASD). Both projects stopped 

data collection in 2004. Although CDC 

receives surveillance data from all U.S. 

states, these supplemental surveillance 

data are needed to make populationbased national estimates of key 

indicators, related to the quality of HIVrelated ambulatory care, the severity of 

need for HIV-related care and services, 

and HIV-related behaviors and clinical 

outcomes. 

This project collects data on behaviors 

and clinical outcomes from a probability 

sample of HIV-infected adults receiving 

care in the U.S. through in-person or 

telephone interviews and abstraction of 

medical records. Information is also 

extracted from HIV case surveillance 

records for a dataset, referred to as the 

minimum dataset, which is used to 

assess non-response bias, for quality 

control, to improve the ability of MMP 

to monitor ongoing care and treatment 

of HIV-infected persons, and to make 

inferences from the MMP sample to 

HIV-infected persons in care nationally. 

No other Federal agency collects 

nationally representative populationbased behavioral and clinical 

information from HIV-infected adults in 

care. The data are expected to have 

significant implications for policy, 

program development, and resource 

allocation at the state/local and national 

levels. 

The Centers for Disease Control and 

Prevention request approval for a 

mstockstill on DSK4VPTVN1PROD with NOTICES