Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice, 21632-21633 [E8-8683]
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21632
Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
CFR Sections
No. of
Respondents
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
821.2 and 821.30(e)
4
1
4
12
48
821.25(a)
1
1
1
76
76
821.25(d)
22
1
22
2
44
17,000
72
1,222,725
0.1666
203,706
1
1
1
28
28
17,000
15
259,186
0.1666
43,180
821.30(a) and (b)
821.30(c)(2)
821.30(d)
Total
1 There
247,082
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
CFR Sections
Annual Frequency
per
Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
821.25(b)
229
46,260
10,593,433
0.2899
3,071,036
821.25(c)
229
1
229
63.0
14,430
821.25(c)(3)
229
1,124
257,454
0.2899
74,636
TOTAL
sroberts on PROD1PC70 with NOTICES
1 There
3,160,102
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual hourly reporting burden
for respondents involved in medical
device tracking is estimated to be
247,082 hours, and the annual
recordkeeping burden for these
respondents is estimated to be 3,160,102
hours. These numbers have been
rounded up. The burden estimates cited
in tables 1 and 2 of this notice are based
primarily upon the data and methods
provided in FDA’s assessment for fiscal
year (FY) 1999 entitled ‘‘A Cost
Assessment of Medical Device
Tracking.’’ Using implantation
procedures from the National Center for
Health Statistics, FDA applied a 2percent annual growth rate to estimate
the number of procedures for tracked
implant devices for FY 1997 through FY
2006. This assessment also used unit
shipment data in combination with
various growth rates to estimate annual
sales distribution for the tracked l/s-l/s
devices over the same time period. In
addition, the assessment also estimated
the burden on industry for developing
and maintaining tracking systems for
these medical devices for FY 1997
through FY 2006.
For the annual recordkeeping burden,
the number of respondent medical
device manufacturers subject to device
tracking is estimated to be 229 and is
based on data from FDA’s
manufacturers database. FDA issued
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16:25 Apr 21, 2008
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tracking orders to 20 additional medical
device manufacturers during the time
period for FY 2002 through FY 2004.
Under § 821.25(c), the additional
medical device manufacturers
collectively bear a one-time
recordkeeping burden of 10,560 hours to
develop a medical device tracking
system. FDA’s estimate of 17,000
medical device distributor respondents
contained in this assessment, are
derived from Dun & Bradstreet sources
on medical equipment wholesalers,
retailers, home care dealers, and rental
companies. Health Forum, an American
Hospital Association Company,
provided statistics on hospitals.
Dated: April 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8682 Filed 4–21–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anesthetic and
Life Support Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Anesthetic
and Life Support Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. This
meeting was announced in the Federal
Register of March 27, 2008 (73 FR
16314). The amendment is being made
to reflect changes in the introductory
paragraph and to add a portion entitled
‘‘Closed Committee Deliberations.’’
There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Teresa Watkins, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, FAX: 301–827–
6776, e-mail:
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22APN1
Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices
Teresa.Watkins@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in
Washington, DC area), codes
3014512529 and 3014512535. Please
call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 27, 2008,
FDA announced that a meeting of the
Anesthetic and Life Support Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee would be held on May 5 and
6, 2008.
On page 16314, in the third column,
the introductory paragraph of the
document is amended to read as
follows:
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
On page 16315, the second column of
the document is amended to add a
portion entitled ‘‘Closed Committee
Deliberations’’ to read as follows:
Closed Committee Deliberations: On
May 5, 2008, from 8 a.m. to 9:15 a.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential commercial
information (5 U.S.C. 552b(c)(4)).
During this session, the committee will
discuss the details of a proprietary
research report and protocol addressing
characteristics of different formulations.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: April 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–8683 Filed 4–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
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16:25 Apr 21, 2008
Jkt 214001
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Platform for the High Throughput
Screening of Single Nucleotide
Polymorphisms and Small Insertions
and Deletions
Description of Technology: Available
for licensing and commercial
development is an oligoarray-based
process for gene-specific single
nucleotide polymorphism (SNP)
genotyping based on comparative
hybridization. This process can detect,
even in heterozygous conditions, known
and potentially flag unknown variants
(point mutations, base insertion or
deletion) along the complete sequence
of a given gene while drastically cutting
the time and costs compared to highthroughput direct sequencing without
affecting sensitivity and specificity. The
accuracy and efficiency of the invention
was validated based on the BRCA–1
breast and ovarian cancer predisposing
gene. This process can easily be custom
designed to include within the same
platform a relatively large number of
genes relevant to a specific clinical
condition and it is particularly useful
for the screening of long genomic region
with relatively infrequent but clinically
relevant variants.
More specifically, the invention is
made reliable by the development of
two tailored algorithms: the first
automatically designs the complete data
set of gene-specific probes starting from
the genomic sequence according to the
user specification (size of the probes,
relative position, etc.); and the other is
based on an algorithm that flags gene
variants in the test sample. This allows
detecting unknown variants in the
region in which only the reference
hybridizes to the probes. These features
drastically reduce the amount of
sequencing (the gold standard for SNP
detection) to small regions in which a
discrepancy between test signal and
reference signal is found. Moreover,
there is no limit, other than the physical
area of the slide, to the number of
probes that can be added to the array
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21633
and the number of genes that can be
queried simultaneously. Thus, a
repertoire of considerable size can be
scanned in a single test for each sample
with sensitivity and specificity
comparable to direct sequencing.
Applications: The immediate clinical
applications of this platform is a
remarkable improvement of genetic
testing by increasing the number of
target genes that can be screened in a
short time, at a minimal cost using an
automated simplified analysis, such as
the sequencing-grade screening for
BRCA–1 variants and the detection of
mutations in cancerous tissues. The
method can be also applied to other
human genes (coding and non-coding
sequences), and other sequences from
animals, bacterial and viruses.
Development Status: Method fully
developed and validated.
Inventors: Ena Wang (CC), Alessandro
Monaco (CC), Francesco M Marincola
(CC), et al.
Patent Status: U.S. Provisional
Application No. 61/068,182 filed 05 Mar
2008 (HHS Reference No. E–082–2008/
0–US–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Cristina
Thalhammer-Reyero, Ph.D., M.B.A.;
301–435–4507; thalhamc@mail.nih.gov.
Generation of Wild-Type Dengue
Viruses for Use in Rhesus Monkey
Infection Studies
Description of Technology: Dengue
virus is a positive-sense RNA virus
belonging to the Flavivirus genus of the
family Flaviviridae. Dengue virus is
widely distributed throughout the
tropical and semitropical regions of the
world and is transmitted to humans by
mosquito vectors. Dengue virus is a
leading cause of hospitalization and
death in children in at least eight
tropical Asian countries. There are four
serotypes of dengue virus (DEN–1,
DEN–2, DEN–3, and DEN–4) that
annually cause an estimated 50–100
million cases of dengue fever and
500,000 cases of the more severe form
of dengue virus infection known as
dengue hemorrhagic fever/dengue shock
syndrome (DHF/DSS). This latter
disease is seen predominately in
children and adults experiencing a
second dengue virus infection with a
serotype different than that of their first
dengue virus infection and in primary
infection of infants who still have
circulating dengue-specific maternal
antibody. A vaccine is needed to lessen
the disease burden caused by dengue
virus, but none is licensed.
Because of the association of more
severe disease with secondary dengue
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]]>Agencies
[Federal Register Volume 73, Number 78 (Tuesday, April 22, 2008)]
[Notices]
[Pages 21632-21633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8683]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anesthetic and Life Support Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee;
Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Anesthetic and Life Support Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee. This meeting was announced in the Federal Register of March
27, 2008 (73 FR 16314). The amendment is being made to reflect changes
in the introductory paragraph and to add a portion entitled ``Closed
Committee Deliberations.'' There are no other changes.
FOR FURTHER INFORMATION CONTACT: Teresa Watkins, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
[[Page 21633]]
Teresa.Watkins@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572) in Washington, DC area), codes 3014512529
and 3014512535. Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 27, 2008,
FDA announced that a meeting of the Anesthetic and Life Support Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee would be held on May 5 and 6, 2008.
On page 16314, in the third column, the introductory paragraph of
the document is amended to read as follows:
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
On page 16315, the second column of the document is amended to add
a portion entitled ``Closed Committee Deliberations'' to read as
follows:
Closed Committee Deliberations: On May 5, 2008, from 8 a.m. to 9:15
a.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential commercial information (5 U.S.C.
552b(c)(4)). During this session, the committee will discuss the
details of a proprietary research report and protocol addressing
characteristics of different formulations.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: April 16, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-8683 Filed 4-21-08; 8:45 am]
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