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21632 Federal Register / Vol. 73, No.

78 / Tuesday, April 22, 2008 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency per Total Annual Hours per
CFR Sections Total Hours
Respondents Response Responses Response

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

821.30(a) and (b) 17,000 72 1,222,725 0.1666 203,706

821.30(c)(2) 1 1 1 28 28

821.30(d) 17,000 15 259,186 0.1666 43,180

Total 247,082
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


Annual Frequency
No. of Total Annual Hours per
CFR Sections per Total Hours
Recordkeepers Records Record
Recordkeeping

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 3,160,102
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual hourly reporting burden tracking orders to 20 additional medical DEPARTMENT OF HEALTH AND
for respondents involved in medical device manufacturers during the time HUMAN SERVICES
device tracking is estimated to be period for FY 2002 through FY 2004.
247,082 hours, and the annual Under § 821.25(c), the additional Food and Drug Administration
recordkeeping burden for these medical device manufacturers
respondents is estimated to be 3,160,102 Joint Meeting of the Anesthetic and
collectively bear a one-time
hours. These numbers have been Life Support Drugs Advisory
recordkeeping burden of 10,560 hours to Committee and the Drug Safety and
rounded up. The burden estimates cited develop a medical device tracking
in tables 1 and 2 of this notice are based Risk Management Advisory
system. FDA’s estimate of 17,000 Committee; Amendment of Notice
primarily upon the data and methods medical device distributor respondents
provided in FDA’s assessment for fiscal contained in this assessment, are AGENCY: Food and Drug Administration,
year (FY) 1999 entitled ‘‘A Cost derived from Dun & Bradstreet sources HHS.
Assessment of Medical Device ACTION: Notice.
on medical equipment wholesalers,
Tracking.’’ Using implantation
retailers, home care dealers, and rental The Food and Drug Administration
procedures from the National Center for
Health Statistics, FDA applied a 2- companies. Health Forum, an American (FDA) is announcing an amendment to
percent annual growth rate to estimate Hospital Association Company, the notice of meeting of the Anesthetic
the number of procedures for tracked provided statistics on hospitals. and Life Support Drugs Advisory
implant devices for FY 1997 through FY Dated: April 15, 2008. Committee and the Drug Safety and Risk
2006. This assessment also used unit Jeffrey Shuren, Management Advisory Committee. This
shipment data in combination with Associate Commissioner for Policy and
meeting was announced in the Federal
various growth rates to estimate annual Planning. Register of March 27, 2008 (73 FR
sales distribution for the tracked l/s-l/s 16314). The amendment is being made
[FR Doc. E8–8682 Filed 4–21–08; 8:45 am]
devices over the same time period. In to reflect changes in the introductory
BILLING CODE 4160–01–S
addition, the assessment also estimated paragraph and to add a portion entitled
the burden on industry for developing ‘‘Closed Committee Deliberations.’’
and maintaining tracking systems for There are no other changes.
these medical devices for FY 1997 FOR FURTHER INFORMATION CONTACT:
through FY 2006. Teresa Watkins, Center for Drug
For the annual recordkeeping burden, Evaluation and Research (HFD–21),
sroberts on PROD1PC70 with NOTICES

the number of respondent medical Food and Drug Administration, 5600


device manufacturers subject to device Fishers Lane, (for express delivery, 5630
tracking is estimated to be 229 and is Fishers Lane, rm. 1093), Rockville, MD
based on data from FDA’s 20857, 301–827–7001, FAX: 301–827–
manufacturers database. FDA issued 6776, e-mail:

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Federal Register / Vol. 73, No. 78 / Tuesday, April 22, 2008 / Notices 21633

Teresa.Watkins@fda.hhs.gov, or FDA applications are filed on selected and the number of genes that can be
Advisory Committee Information Line, inventions to extend market coverage queried simultaneously. Thus, a
1–800–741–8138 (301–443–0572) in for companies and may also be available repertoire of considerable size can be
Washington, DC area), codes for licensing. scanned in a single test for each sample
3014512529 and 3014512535. Please ADDRESSES: Licensing information and with sensitivity and specificity
call the Information Line for up-to-date copies of the U.S. patent applications comparable to direct sequencing.
information on this meeting. listed below may be obtained by writing Applications: The immediate clinical
SUPPLEMENTARY INFORMATION: In the to the indicated licensing contact at the applications of this platform is a
Federal Register of March 27, 2008, Office of Technology Transfer, National remarkable improvement of genetic
FDA announced that a meeting of the Institutes of Health, 6011 Executive testing by increasing the number of
Anesthetic and Life Support Drugs Boulevard, Suite 325, Rockville, target genes that can be screened in a
Advisory Committee and the Drug Maryland 20852–3804; telephone: 301/ short time, at a minimal cost using an
Safety and Risk Management Advisory 496–7057; fax: 301/402–0220. A signed automated simplified analysis, such as
Committee would be held on May 5 and Confidential Disclosure Agreement will the sequencing-grade screening for
6, 2008. be required to receive copies of the BRCA–1 variants and the detection of
On page 16314, in the third column, patent applications. mutations in cancerous tissues. The
the introductory paragraph of the method can be also applied to other
document is amended to read as Platform for the High Throughput human genes (coding and non-coding
follows: Screening of Single Nucleotide sequences), and other sequences from
This notice announces a forthcoming Polymorphisms and Small Insertions animals, bacterial and viruses.
meeting of a public advisory committee and Deletions Development Status: Method fully
of the Food and Drug Administration Description of Technology: Available developed and validated.
(FDA). At least one portion of the Inventors: Ena Wang (CC), Alessandro
for licensing and commercial
meeting will be closed to the public. Monaco (CC), Francesco M Marincola
development is an oligoarray-based
On page 16315, the second column of (CC), et al.
process for gene-specific single
the document is amended to add a Patent Status: U.S. Provisional
nucleotide polymorphism (SNP)
portion entitled ‘‘Closed Committee Application No. 61/068,182 filed 05 Mar
genotyping based on comparative
Deliberations’’ to read as follows: 2008 (HHS Reference No. E–082–2008/
hybridization. This process can detect,
Closed Committee Deliberations: On 0–US–01).
even in heterozygous conditions, known Licensing Status: Available for non-
May 5, 2008, from 8 a.m. to 9:15 a.m., and potentially flag unknown variants
the meeting will be closed to permit exclusive or exclusive licensing.
(point mutations, base insertion or Licensing Contact: Cristina
discussion and review of trade secret deletion) along the complete sequence
and/or confidential commercial Thalhammer-Reyero, Ph.D., M.B.A.;
of a given gene while drastically cutting 301–435–4507; thalhamc@mail.nih.gov.
information (5 U.S.C. 552b(c)(4)). the time and costs compared to high-
During this session, the committee will throughput direct sequencing without Generation of Wild-Type Dengue
discuss the details of a proprietary affecting sensitivity and specificity. The Viruses for Use in Rhesus Monkey
research report and protocol addressing accuracy and efficiency of the invention Infection Studies
characteristics of different formulations. was validated based on the BRCA–1 Description of Technology: Dengue
This notice is issued under the breast and ovarian cancer predisposing virus is a positive-sense RNA virus
Federal Advisory Committee Act (5 gene. This process can easily be custom belonging to the Flavivirus genus of the
U.S.C. app. 2) and 21 CFR part 14, designed to include within the same family Flaviviridae. Dengue virus is
relating to the advisory committees. platform a relatively large number of widely distributed throughout the
Dated: April 16, 2008. genes relevant to a specific clinical tropical and semitropical regions of the
Randall W. Lutter, condition and it is particularly useful world and is transmitted to humans by
Deputy Commissioner for Policy. for the screening of long genomic region mosquito vectors. Dengue virus is a
[FR Doc. E8–8683 Filed 4–21–08; 8:45 am] with relatively infrequent but clinically leading cause of hospitalization and
BILLING CODE 4160–01–S relevant variants. death in children in at least eight
More specifically, the invention is tropical Asian countries. There are four
made reliable by the development of serotypes of dengue virus (DEN–1,
DEPARTMENT OF HEALTH AND two tailored algorithms: the first DEN–2, DEN–3, and DEN–4) that
HUMAN SERVICES automatically designs the complete data annually cause an estimated 50–100
set of gene-specific probes starting from million cases of dengue fever and
National Institutes of Health the genomic sequence according to the 500,000 cases of the more severe form
user specification (size of the probes, of dengue virus infection known as
Government-Owned Inventions; relative position, etc.); and the other is dengue hemorrhagic fever/dengue shock
Availability for Licensing based on an algorithm that flags gene syndrome (DHF/DSS). This latter
AGENCY: National Institutes of Health, variants in the test sample. This allows disease is seen predominately in
Public Health Service, HHS. detecting unknown variants in the children and adults experiencing a
ACTION: Notice. region in which only the reference second dengue virus infection with a
hybridizes to the probes. These features serotype different than that of their first
SUMMARY: The inventions listed below drastically reduce the amount of dengue virus infection and in primary
are owned by an agency of the U.S. sequencing (the gold standard for SNP infection of infants who still have
Government and are available for detection) to small regions in which a circulating dengue-specific maternal
sroberts on PROD1PC70 with NOTICES

licensing in the U.S. in accordance with discrepancy between test signal and antibody. A vaccine is needed to lessen
35 U.S.C. 207 to achieve expeditious reference signal is found. Moreover, the disease burden caused by dengue
commercialization of results of there is no limit, other than the physical virus, but none is licensed.
federally-funded research and area of the slide, to the number of Because of the association of more
development. Foreign patent probes that can be added to the array severe disease with secondary dengue

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