Agency Forms Undergoing Paperwork Reduction Act Review, 2065-2066 [2012-583]
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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
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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
(https://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]
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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
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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
Number of
respondents
Type of respondent
Initial interview .............................................................................................................................
Conclusion form ...........................................................................................................................
Kimberly Lane,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2012–583 Filed 1–12–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–0740]
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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
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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
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4,200
8,400
Average
burden per
response
(in hours)
Responses
per
respondent
1
1
1
5/60
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
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]]>Agencies
[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2065-2066]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-583]
-----------------------------------------------------------------------
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
[[Page 2066]]
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
----------------------------------------------------------------------------------------------------------------
Average burden
Type of respondent Number of Responses per per response
respondents respondent (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]
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