Notification of the Establishment of the National Commission on Children and Disasters, 51489-51490 [E8-20378]
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sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices
the data are released in the public
domain, so such requests will receive a
lower priority for the specimens.
Restricting a research proposal to
demographic categories that are design
variables for the survey is encouraged if
laboratory testing must be restricted.
(4) Clinical Significance or results:
Since the consent document for
specimen storage and continuing
studies states that individual results
will not be provided, the clinical
significance of the proposed laboratory
test should be addressed.
The proposal should include a
discussion of the potential clinical
significance of the results and whether
there is definitive evidence that results
of the test would provide grounds for
medical intervention even if many years
have passed since the examination of
the participant and collection of the
sample. Any test with results that
should be reported to a participant
should be considered for inclusion in
the concurrent survey, and is not
appropriate for testing on the stored
samples.
(5) Qualification: Provide a brief
description of the Principal
Investigator’s expertise in the proposed
area should be provided, including
publications in this area within the last
three years. A representative sample of
earlier publications may be listed as
long as this section does not exceed two
pages.
(6) Period of performance: Specify the
project period. Substantial progress
must be made in the first year, and the
project should be completed in two
years. If additional time is needed for
the research project a detailed
justification with a timeline should be
included. The investigator should
address his/her ability to comply with
this timeline or request and justify
additional time for the project. Return of
the specimens will be requested if
progress is not made in the project at the
end of the second year. Refund of
payment for the specimens will not be
returned in this situation. At the end of
the project period, any unused samples
must be returned to the NHANES
Specimen Bank or discarded. The NCHS
Project Officer must be consulted about
the disposition of the samples.
(7) Funding: Include the source and
status of the funding to perform the
requested laboratory analysis should be
included. Investigators will be
responsible for the cost of processing
and shipping the samples. The cost per
specimen is $6.50. The basis for the cost
structure is in the last section of this
document. Reimbursement for the
samples will be collected before the
samples are released.
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Submission of Proposals
Proposals can be submitted in MS
Word format by E-mail to: Dr. Geraldine
McQuillan, Division of Health and
Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782, Phone:
301–458–4371 Fax: 301–458–4028, Email gmm2@cdc.gov.
Approved Proposals
Approved projects will be provided
specimens on receipt of a signed
Materials Transfer Agreement (MTA)
and a check (written to The Centers for
Disease Control and Prevention) for the
cost of the specimens. All laboratory
results obtained from the samples will
be sent back to NCHS to be linked to the
sequence number that is the linking
identifier on the public use files. All
files will undergo disclosure review at
NCHS. Within 90 days of the return of
the data to NCHS these data may be
released to the public.
Agency Agreement
A formal signed agreement in the
form of a Materials Transfer Agreement
(MTA) with individuals who have
projects approved will be completed
before the release of the samples. This
agreement will contain the conditions
for use of the samples as stated in this
document and as agreed upon by the
investigators and CDC.
Progress Reports
Brief progress report will be
submitted annually. This will be the
basis for the NHANES ERB continuation
reports that are required annually.
Disposition of Results and Samples
No samples provided can be used for
any purpose other than those
specifically requested in the proposal
and approved by the Technical Panel
and the NHANES ERB. No sample can
be shared with others, including other
investigators, unless specified in the
proposal and so approved. Any unused
samples must be returned to the
NHANES Specimen Bank or disposed of
upon completion of the approved
project. These results, once returned to
NCHS, will be part of the public
domain. The proposer will have 90 days
for quality control review of the data
before public release.
Proposed Cost Schedule for Providing
NHANES Specimens:
A nominal processing fee of $6.50 is
proposed for each sample received from
the NHANES Specimen Bank. The costs
include both the collection, storage and
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51489
processing of the specimens along with
the review of proposals and the
preparation of the data files. These costs
were based on an assumption that
NCHS will receive and process eight
proposals in a year, each requesting
5,000 samples as shown in the table
below.
The materials listed are for the
recurring laboratory costs to dispense
and prepare the samples during
collection and for shipping; the
computer software needed for the
preparation of the data files and for the
release of the data along with
documentation on the NHANES Web
page. Labor costs are based on a
proposal administrator and computer
programmers at NCHS to prepare the
data files. The storage and pulling fees
include the costs for the NHANES
repository.
Total costs
Cost
Labor .............................................
Collection Storage ........................
Pulling specimens .........................
Shipping ........................................
Subtotal .........................................
CDC/FMO support (10%) .............
Subtotal .........................................
NCHS support (18%) ....................
$0.70
2.96
1.04
0.31
5.01
0.50
5.51
0.99
Total .......................................
6.50
Comments are solicited on the
proposed cost schedule. Comments are
due by: October 3, 2008.
Send Comments and Requests for
Information to: Dr. Geraldine
McQuillan, Division of Health and
Nutrition Examination Surveys,
National Center for Health Statistics,
Centers for Disease Control and
Prevention, 3311 Toledo Road, Room
4204, Hyattsville, MD 20782, Phone:
301–458–4371; Fax: 301–458–4028,
e-mail gmm2@cdc.gov.
Dated: August 26, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–20335 Filed 9–2–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notification of the Establishment of the
National Commission on Children and
Disasters
Administration for Children
and Families, Department of Health and
Human Services.
AGENCY:
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51490
Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices
Notification of the
establishment of the National
Commission on Children and Disasters.
ACTION:
SUMMARY: This notice announces the
establishment of the National
Commission on Children and Disasters,
a Secretary’s Advisory Committee. The
Consolidated Appropriations Act, 2008
(Pub. L. 110–161), Division G, Title VI,
directs the establishment of the National
Commission on Children and Disasters.
The Commission shall conduct a
comprehensive study to examine and
assess the needs of children as they
relate to preparation for, response to,
and recovery from all hazards, building
upon the evaluation of other entities
and avoiding unnecessary duplication
by reviewing the findings, conclusions,
and recommendations of these entities,
and shall then submit a report to the
President and Congress on the
Commission’s specific findings,
conclusions, and recommendations to
address the needs of children as they
relate to major disasters and
emergencies.
• At least one member appointed to
the Commission must be a
representative from a private nonprofit
entity with demonstrated experience in
addressing the needs of children as they
relate to preparation for, response to,
and recovery from all hazards, including
major disasters and emergencies; and
• At least one member appointed to
the Commission must be a State
emergency manager or local emergency
manager.
III. Copies of the Charter
To obtain a copy of the Commission’s
Charter, submit a written request to the
above contact.
Dated: August 27, 2008.
Daniel C. Schneider,
Acting Assistant Secretary for Children and
Families.
[FR Doc. E8–20378 Filed 9–2–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
Roberta Lavin, Office of Human Services
Emergency Preparedness and Response,
e-mail Roberta.lavin@acf.hhs.gov or
202–401–9306.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2008–F–0462]
I. Background
HHS.
The Commission and its staff are
governed by the provisions of the
Federal Advisory Committee Act (5
U.S.C. Appendix 2), which sets forth the
standards for the formation and use of
advisory committees. The Secretary’s
establishment of this Commission is
authorized pursuant to Section 1114 of
the Social Security Act (42 U.S.C. 1314).
The Commission shall determine a
schedule of meetings following an
election of a Chairperson and Vice
Chairperson from among its members.
An initial meeting of the Commission
shall take place not later than 120 days
after all members of the Commission
have been appointed.
ACTION:
sroberts on PROD1PC70 with NOTICES
II. Criteria for Members
The Commission shall be composed
of ten members, of whom one shall be
the Chairperson and one shall be the
Vice Chairperson, as determined by an
election among the total membership,
and shall be appointed by the Secretary
in a manner designed to assure
bipartisan representation on the
Commission, in accordance with the
intent of Congress as follows:
• No members of the Commission
may be officials or employees of the
Federal Government;
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Zentox Corp.; Filing of Food Additive
Petition
AGENCY:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that Zentox Corp. has filed a petition
proposing that the food additive
regulations be amended to provide for
the safe use of monochloramine as an
antimicrobial agent in poultry process
chiller water.
DATES: Submit written or electronic
comments on the petitioner’s
environmental assessment by October 3,
2008.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1071.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 8A4775) has been filed by
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Zentox Corp., c/o Burdock Group, 801
North Orange Ave., suite 710, Orlando,
FL 32801. The petition proposes to
amend the food additive regulations in
part 173—Secondary Direct Food
Additives Permitted in Food for Human
Consumption (21 CFR part 173) to
provide for the safe use of
monochloramine as an antimicrobial
agent in poultry process chiller water.
The potential environmental impact
of this petition is being reviewed. To
encourage public participation
consistent with regulation issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the agency finds
that an environmental impact statement
is not required, and this petition results
in a regulation, the notice of availability
of the agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: August 27, 2008.
Laura M. Tarantino,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. E8–20293 Filed 9–2–08; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 171 (Wednesday, September 3, 2008)]
[Notices]
[Pages 51489-51490]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20378]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Notification of the Establishment of the National Commission on
Children and Disasters
AGENCY: Administration for Children and Families, Department of Health
and Human Services.
[[Page 51490]]
ACTION: Notification of the establishment of the National Commission on
Children and Disasters.
-----------------------------------------------------------------------
SUMMARY: This notice announces the establishment of the National
Commission on Children and Disasters, a Secretary's Advisory Committee.
The Consolidated Appropriations Act, 2008 (Pub. L. 110-161), Division
G, Title VI, directs the establishment of the National Commission on
Children and Disasters. The Commission shall conduct a comprehensive
study to examine and assess the needs of children as they relate to
preparation for, response to, and recovery from all hazards, building
upon the evaluation of other entities and avoiding unnecessary
duplication by reviewing the findings, conclusions, and recommendations
of these entities, and shall then submit a report to the President and
Congress on the Commission's specific findings, conclusions, and
recommendations to address the needs of children as they relate to
major disasters and emergencies.
FOR FURTHER INFORMATION CONTACT: Roberta Lavin, Office of Human
Services Emergency Preparedness and Response, e-mail
Roberta.lavin@acf.hhs.gov or 202-401-9306.
SUPPLEMENTARY INFORMATION:
I. Background
The Commission and its staff are governed by the provisions of the
Federal Advisory Committee Act (5 U.S.C. Appendix 2), which sets forth
the standards for the formation and use of advisory committees. The
Secretary's establishment of this Commission is authorized pursuant to
Section 1114 of the Social Security Act (42 U.S.C. 1314).
The Commission shall determine a schedule of meetings following an
election of a Chairperson and Vice Chairperson from among its members.
An initial meeting of the Commission shall take place not later than
120 days after all members of the Commission have been appointed.
II. Criteria for Members
The Commission shall be composed of ten members, of whom one shall
be the Chairperson and one shall be the Vice Chairperson, as determined
by an election among the total membership, and shall be appointed by
the Secretary in a manner designed to assure bipartisan representation
on the Commission, in accordance with the intent of Congress as
follows:
No members of the Commission may be officials or employees
of the Federal Government;
At least one member appointed to the Commission must be a
representative from a private nonprofit entity with demonstrated
experience in addressing the needs of children as they relate to
preparation for, response to, and recovery from all hazards, including
major disasters and emergencies; and
At least one member appointed to the Commission must be a
State emergency manager or local emergency manager.
III. Copies of the Charter
To obtain a copy of the Commission's Charter, submit a written
request to the above contact.
Dated: August 27, 2008.
Daniel C. Schneider,
Acting Assistant Secretary for Children and Families.
[FR Doc. E8-20378 Filed 9-2-08; 8:45 am]
BILLING CODE 4184-01-P
