MicroArray Quality Control Project on the Evaluation of Analysis Protocols for Deoxyribonucleic Acid Microarray Data, 20707-20708 [E6-5995]
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Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices
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plans using the FY 2003 allotment’s
redistribution amounts.
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period. Any such adjustments resulting
from review and analysis of comments
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the comment period. (Section 1102 of
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1302).)
(Authority: Section 1102 of the Social
Security Act (42 U.S.C. 1302))
(Catalog of Federal Domestic Assistance
Program No. 93.767, State Children’s Health
Insurance Program)
Dated: March 17, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: April 6, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06–3833 Filed 4–19–06; 12 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
MicroArray Quality Control Project on
the Evaluation of Analysis Protocols
for Deoxyribonucleic Acid Microarray
Data
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice of solicitation.
Frm 00068
Fmt 4703
Sfmt 4703
20707
SUMMARY: The Food and Drug
Administration (FDA) is soliciting gene
expression datasets from
deoxyribonucleic acid (DNA)
microarray studies, as well as proposals
to analyze these datasets in order to
evaluate the impact of different analysis
protocols on the selection of genes and
their associated signatures for biomarker
pattern development. This project is
being coordinated by FDA as a followup
to the MicroArray Quality Control
(MAQC) Project. This evaluation
process is open to the public.
DATES: Datasets and proposals for
participation in the project must be
received by the National Center for
Toxicological Research on or before 4:30
p.m. c.s.t. on May 31, 2006, or be
postmarked on or before May 31, 2006.
ADDRESSES: Datasets and proposals
should be sent to Leming Shi, National
Center for Toxicological Research, Food
and Drug Administration, 3900 NCTR
Rd., Jefferson, AR 72079, 870–543–7387,
FAX: 870–543–7686; e-mail:
leming.shi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA’s
Critical Path Initiative (https://
www.fda.gov/oc/initiatives/criticalpath)
identifies pharmacogenomics as a key
opportunity in advancing medical
product development and personalized
medicine. FDA issued the ‘‘Guidance for
Industry: Pharmacogenomic Data
Submissions’’ (https://www.fda.gov/cder/
guidance/6400fnl.pdf) to facilitate
scientific progress in the field of
pharmacogenomic data integration in
drug development and medical
diagnostics.
A microarray is a tool for analyzing
gene expression. It consists of a small
membrane or glass slide containing
samples of many genes arranged in a
regular pattern. DNA is a nucleic acid—
usually in the form of a double helix—
that contains the genetic instructions
specifying the biological development of
all cellular forms of life and most
viruses. DNA microarray is a collection
of microscopic DNA spots attached to a
solid surface, such as glass, plastic or
silicon chip forming an array. DNA
microarrays represent a core technology
in pharmacogenomics and
toxicogenomics; however, before this
technology can be reliably applied in
clinical practice and regulatory
decisionmaking, further evaluation is
needed of the process for the analysis of
hybridization data that results in
predictive signatures.
The MAQC project involves six FDA
centers, major providers of microarray
platforms and ribonucleic acid (RNA)
samples, government agencies,
academic laboratories, and other
E:\FR\FM\21APN1.SGM
21APN1
20708
Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices
stakeholders. The MAQC project will
work with participating scientists to
develop baseline practices for the
analysis of hybridization data. Original
datasets, analyses, and conclusions from
this project will be made available to the
public throughout the project. For more
information about the MAQC project,
please visit https://www.fda.gov/nctr/
science/centers/toxicoinformatics/
maqc/.
Dated: April 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5995 Filed 4–20–06; 8:45 am]
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001N–0464 (formerly Docket
No. 01N–0464)]
Vaccine Adverse Event Reporting;
Revised Form VAERS–2; Withdrawal of
Proposed Revised Form
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal of a proposed revised form
that was issued in the Federal Register
on November 20, 2001.
DATES:
April 21, 2006.
FOR FURTHER INFORMATION CONTACT:
Joseph L. Okrasinski, Jr., Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
In a notice
published in the Federal Register of
November 20, 2001 (66 FR 58153), FDA
announced the availability of a
proposed revised form entitled ‘‘Vaccine
Adverse Event Reporting System’’ (Form
VAERS–2) dated July 2001. This
proposed revised form is being
withdrawn because FDA is no longer
pursuing changes to the form.
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: April 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–5970 Filed 4–20–06; 8:45 am]
BILLING CODE 4160–01–S
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United States Visitor and Immigrant
Status Indicator Technology (US-VISIT)
Program; Notice of Availability of a
Final Programmatic Environmental
Assessment (PEA) and a Finding of No
Significant Impact (FONSI) on the USVISIT Plan for Potential Changes to
Immigration and Border Management
Processes
US-VISIT, DHS.
Notice of availability.
AGENCY:
BILLING CODE 4160–01–S
AGENCY:
DEPARTMENT OF HOMELAND
SECURITY
SUMMARY: A Final Programmatic
Environmental Assessment (PEA) and
Finding of No Significant Impact
(FONSI) for the United States Visitor
and Immigrant Status Indicator
Technology (US-VISIT) program are
available to the public for electronic
download. The Final PEA examines the
potential environmental impacts of four
strategic approaches to enhance
immigration and border management
processes and addresses the substantive
comments received on the Draft PEA
during the public comment period.
These four approaches are aimed at
improving information available to
determine the identity and immigration
status of individuals traveling to and
from the United States. The Final PEA
resulted in a FONSI that selected the
proposed action, or Hybrid Alternative,
as the approach to enhance the
immigration and border management
enterprise. The Final PEA and FONSI
are made available to the public in
accordance with the National
Environmental Policy Act of 1969
(NEPA) and the Council on
Environmental Quality (CEQ)
regulations for implementing NEPA.
DATES: The Final PEA and FONSI will
be available to the public on April 17,
2006.
ADDRESSES: Copies of the Final PEA and
FONSI may be obtained by download
through the Internet at https://
www.dhs.gov/us-visit.
FOR FURTHER INFORMATION CONTACT: Lisa
Mahoney, US–VISIT Environmental
Program Manager, at (202) 298–5245,
Monday–Friday, 8 a.m.—5 p.m. EDT.
SUPPLEMENTARY INFORMATION: US-VISIT
published a Notice of Availability of a
Draft Programmatic Environmental
Assessment (PEA) on the US-VISIT Plan
for Potential Changes to Immigration
and Border Management Processes in
the Federal Register (71 FR 8602,
February 17, 2006). The Notice briefly
discussed four strategic approaches
analyzed in the Draft PEA, informed the
public on how to obtain a copy of the
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Draft PEA, requested comments from
the public on the Draft PEA during the
public commenting period, and
informed the public on the location and
time of public meetings in seven
locations in the United States during the
public comment period. The comment
period ended on March 18, 2006.
Thirty-two (32) comments were received
and considered by US-VISIT.
The proposed action, or Hybrid
Alternative, has been selected as the
approach by which enhancements will
be made to immigration and border
management processes. This approach
was selected after careful review of the
environmental assessment and
consideration of input received from the
public and other federal and state
agencies during the public comment
period. The Hybrid Alternative was
chosen because it provides the most
opportunity for the entities responsible
for immigration and border management
to incorporate and balance the most
useful components of the virtual and
physical border alternatives to achieve
security, facilitation, individual privacy,
and immigration system integrity goals.
A review of the relative impacts showed
that no alternative would result in a
significant impact and that the Hybrid
Alternative ranked second in terms of
environmental preference. As
warranted, tiered environmental
analyses for specific initiatives at the
land border ports of entry resulting from
selection of the Hybrid Alternative will
be conducted and these tiered analyses
will be made available to the public. A
collection or ‘‘toolbox’’ of strategies and
information for monitoring, mitigation,
and environmental stewardship will
also be developed to be used in
implementing the Hybrid Alternative.
Juan Reyes,
Director, Office of Safety and Environmental
Programs, Department of Homeland Security.
[FR Doc. E6–5971 Filed 4–20–06; 8:45 am]
BILLING CODE 4410–10–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[DHS–2005–0053]
Privacy Act of 1974; Systems of
Records
Department of Homeland
Security; United States Customs and
Border Protection.
ACTION: Notice of revision to and
expansion of Privacy Act system of
records.
AGENCY:
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]]>Agencies
[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Notices]
[Pages 20707-20708]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5995]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
MicroArray Quality Control Project on the Evaluation of Analysis
Protocols for Deoxyribonucleic Acid Microarray Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of solicitation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is soliciting gene
expression datasets from deoxyribonucleic acid (DNA) microarray
studies, as well as proposals to analyze these datasets in order to
evaluate the impact of different analysis protocols on the selection of
genes and their associated signatures for biomarker pattern
development. This project is being coordinated by FDA as a followup to
the MicroArray Quality Control (MAQC) Project. This evaluation process
is open to the public.
DATES: Datasets and proposals for participation in the project must be
received by the National Center for Toxicological Research on or before
4:30 p.m. c.s.t. on May 31, 2006, or be postmarked on or before May 31,
2006.
ADDRESSES: Datasets and proposals should be sent to Leming Shi,
National Center for Toxicological Research, Food and Drug
Administration, 3900 NCTR Rd., Jefferson, AR 72079, 870-543-7387, FAX:
870-543-7686; e-mail: leming.shi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA's Critical Path Initiative (https://
www.fda.gov/oc/initiatives/criticalpath) identifies pharmacogenomics as
a key opportunity in advancing medical product development and
personalized medicine. FDA issued the ``Guidance for Industry:
Pharmacogenomic Data Submissions'' (https://www.fda.gov/cder/guidance/
6400fnl.pdf) to facilitate scientific progress in the field of
pharmacogenomic data integration in drug development and medical
diagnostics.
A microarray is a tool for analyzing gene expression. It consists
of a small membrane or glass slide containing samples of many genes
arranged in a regular pattern. DNA is a nucleic acid--usually in the
form of a double helix--that contains the genetic instructions
specifying the biological development of all cellular forms of life and
most viruses. DNA microarray is a collection of microscopic DNA spots
attached to a solid surface, such as glass, plastic or silicon chip
forming an array. DNA microarrays represent a core technology in
pharmacogenomics and toxicogenomics; however, before this technology
can be reliably applied in clinical practice and regulatory
decisionmaking, further evaluation is needed of the process for the
analysis of hybridization data that results in predictive signatures.
The MAQC project involves six FDA centers, major providers of
microarray platforms and ribonucleic acid (RNA) samples, government
agencies, academic laboratories, and other
[[Page 20708]]
stakeholders. The MAQC project will work with participating scientists
to develop baseline practices for the analysis of hybridization data.
Original datasets, analyses, and conclusions from this project will be
made available to the public throughout the project. For more
information about the MAQC project, please visit https://www.fda.gov/
nctr/science/centers/toxicoinformatics/maqc/.
Dated: April 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5995 Filed 4-20-06; 8:45 am]
BILLING CODE 4160-01-S
