Attachment 2 60 Day FRN All_Flu_Hosp

Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices

mstockstill on PROD1PC66 with NOTICES

NIEHS, P.O. Box 12233, MD EC–17,
Research Triangle Park, NC 27709,
(phone) 919–541–2384, (fax) 919–541–
0947, (e-mail) [email protected].
Courier address: NICEATM, NIEHS, 79
T.W. Alexander Drive, Building 4401,
Room 3128, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
In 2003, the Scientific Advisory
Committee on Alternative Toxicological
Methods (SACATM) and U.S.
Environmental Protection Agency (EPA)
recommended that ICCVAM review the
validation status of screening test
methods that could be used to identify
severe and irreversible ocular effects.
ICCVAM unanimously agreed that the
four in vitro test methods (IRE, ICE,
BCOP, and HET–CAM) nominated by
EPA should have high priority for
evaluation. On March 24, 2004,
NICEATM published a Federal Register
notice (Vol. 69, No. 57, pp. 13859–
13861) requesting all available data on
these four in vitro ocular irritancy test
methods and corresponding data from
in vivo rabbit eye test methods, as well
as any human exposure data (obtained
either from ethical human studies or by
accidental exposure). NICEATM
subsequently compiled data and
information on each test method and
released four draft BRDs for public
comment on November 3, 2004 (Federal
Register, Vol. 69, No. 212, pp. 64081–
64082).
On January 11–12, 2005, NICEATM,
on behalf of ICCVAM, convened an
expert panel meeting to independently
assess the validation status of these four
test methods. The panel’s report was
released in March 2005 (Federal
Register, Vol. 70, No. 53, pp 13513).
Public comments at this meeting
indicated that additional data on these
in vitro test methods could be made
available; therefore, the panel
recommended that NICEATM obtain the
additional data and reanalyze the
accuracy and reliability of each test
method. On February 28, 2005,
NICEATM again solicited in vitro data
on these four test methods and
corresponding in vivo data (Federal
Register, Vol. 70, No. 38, pp. 9661–
9662). The revised analyses were
published on July 26, 2005, as an
addendum to the draft BRDs (Federal
Register, Vol. 70, No. 142, pp. 43149).
NICEATM, on behalf of ICCVAM,
reconvened the panel on September 19,
2005, to discuss the addendum to the
draft BRDs (Federal Register, Vol. 70,
No. 174, pp. 53676–53677). An
addendum to the panel report was
published in November 2005 (Federal

VerDate Aug<31>2005

22:03 Nov 23, 2007

Jkt 214001

Register, Vol. 70, No. 211, pp. 66451).
At its December 2005 meeting, the
SACATM discussed and provided
comments on the panel report and
addendum (Federal Register, Vol. 70,
No. 216, pp. 68069–68070) (minutes
from that meeting are available at
http://ntp.niehs.nih.gov/go/8202).
ICCVAM considered the expert panel
report and its addendum, public
comments, SACATM comments, and
the draft BRDs and their addendums in
finalizing its recommendations on the
validation status of these four test
methods. The ICCVAM Test Method
Evaluation Report includes the ICCVAM
recommendations on the use of each test
method, as well as recommended test
method protocols, recommendations for
further optimization and validation
studies, recommended reference
substances for future validation studies,
the panel report and its addendum, and
Federal Register notices. The four final
BRDs, which provide the supporting
documentation for this report, are
available as separate documents. The
ICCVAM Test Method Evaluation
Report and the supporting final BRDs
were forwarded to U.S. Federal agencies
for their consideration for regulatory
acceptance as required by the ICCVAM
Authorization Act of 2000 (42 U.S.C.
285l–3). Agencies’ responses to the test
method recommendations will be
posted on the ICCVAM/NICEATM Web
site as they are received.
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
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, and replace
animal use. The ICCVAM Authorization
Act of 2000 established 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 U.S.
Federal agencies. Additional
information about ICCVAM and
NICEATM can be found on their Web
site (http://iccvam.niehs.nih.gov).
SACATM was established January 9,
2002, and is composed of scientists from

PO 00000

Frm 00029

Fmt 4703

Sfmt 4703

65965

the public and private sectors (Federal
Register, Vol. 67, No. 49, page 11358).
SACATM provides advice to the
Director of the NIEHS, to ICCVAM, and
to NICEATM regarding the statutorily
mandated duties of ICCVAM and
activities of NICEATM. Additional
information about SACATM, including
the charter, roster, and records of past
meetings, can be found at http://
ntp.niehs.nih.gov/ see ‘‘Advisory Board
& Committees’’ (or directly at http://
ntp.niehs.nih.gov/go/167).
Dated: November 13, 2007.
Samuel H. Wilson,
Acting Director, National Institute of
Environmental Health Sciences and National
Toxicology Program.
[FR Doc. E7–22906 Filed 11–23–07; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–08–08AB]

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 404–639–5960 and
send comments to Maryam Daneshvar,
Acting CDC Reports Clearance Officer,
1600 Clifton Road, MS–D 74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
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.

E:\FR\FM\26NON1.SGM

26NON1

65966

Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices

Proposed Project
All Age Influenza Hospitalization
Surveillance (Flu Hosp)—New—
National Center for Immunization and
Respiratory Diseases (NCIRD), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is requesting OMB approval for
a data collection system that will assist
public health officials to better monitor
and assess severe forms of influenza
disease resulting in hospitalization.
Approval is sought for an Adult Case
Report Form and a Pediatric Case Report
Form. The Adult Case Report Form will
be used to collect information on
patients over the age of 18 years old,
and the Pediatric Case Report form will
be used for patients under 18 years and
younger. The primary difference
between the two forms is that the Adult
Case Report form includes collection of
information related to Statin use, and
the Pediatric Case Report form does not.
Adult surveillance will consist of two
phases, a prospective data collection,
and a retrospective discharge audit.
Therefore, approval is also sought for

outbreaks so that immediate prevention
measures can be taken. Most of the data
collection instrument can be completed
from review of the hospital medical
records. If none of these resources are
available, the patient or their proxy may
be interviewed.
CDC and its participating partners
will also perform a discharge audit to
assess the completeness of the case
surveillance data by conducting an
evaluation of the hospitalized influenza
cases found by Flu Hosp versus an
independent, administrative hospital
dataset. Each of the ten participating
sites will complete standardized forms
that describe the evaluation process and
the number of cases missed by Flu
Hosp, in aggregate. Although 10 states
participate in Flu Hosp, because New
York includes two functionally and
geographically different catchment
areas, those two areas will submit
individual discharge audit data, to make
a total of 11 respondents.
The respondents for the data
collections are the Flu Hosp
participating sites. There are no costs to
respondents other than their time for
participating.

forms that will assess the completeness
of the surveillance system’s cases. These
forms make up an Adult discharge
audit, which will reveal any limitations
in the prospective case identification
that will have occurred prior to the
discharge audit.
Flu Hosp uses standardized data
collection instruments that collect
demographic and clinical information
from laboratory-confirmed influenza
hospitalized adults and children who
reside in a geographic- and populationdefined area of the United States. The
data collection network is an
established CDC-state-academic
institution collaborative network, the
Emerging Infections Program (EIP)
which includes the states of California,
Colorado, Connecticut, Georgia,
Maryland, Minnesota, New Mexico,
New York, Oregon, and Tennessee.
From October 1 of this year through
April 30 of the following year (the
current flu season), Flu Hosp collects
data and transmits it to CDC. Case
reports are submitted as soon as
possible after the investigation of a case.
Prompt notification to CDC allows for
identification of epidemics and

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Total burden
(in hours)

Type of respondent

Pediatric Influenza Hospitalization Surveillance
Project Case Report Form.
Adult Influenza Hospitalization Surveillance Project
Case Report Form.
Adult Discharge Audit Case Report Form ...............
Adult Discharge Audit Form A: Description of
Matching Method.
Adult Discharge Audit Form B: Sampling Strategy
Adult Discharge Audit Form C: Summary ...............
Adult Discharge Audit Form D: Future ....................

Health Department ....

10

75

15/60

188

Health Department ....

10

120

15/60

300

Health Department ....
Health Department ....

11
11

3
1

15/60
15/60

8
3

Health Department ....
Health Department ....
Health Department ....

11
11
11

1
1
1

15/60
15/60
15/60

3
3
3

Total ..................................................................

....................................

........................

........................

........................

508

Dated: November 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22919 Filed 11–23–07; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 4163–18–P

[60Day–08–0692]

Centers for Disease Control and
Prevention

Proposed Data Collections Submitted
for Public Comment and
Recommendations
mstockstill on PROD1PC66 with NOTICES

Average
burden per
response
(in hours)

Number of
responses per
respondent

Form name

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

VerDate Aug<31>2005

22:03 Nov 23, 2007

Jkt 214001

PO 00000

Frm 00030

Fmt 4703

Sfmt 4703

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 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
[email protected].
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)

E:\FR\FM\26NON1.SGM

26NON1