Statement of Organization, Functions, and Delegations of Authority, 46495 [E6-13305]
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Federal Register / Vol. 71, No. 156 / Monday, August 14, 2006 / Notices
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: August 7, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–6877 Filed 8–11–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on PROD1PC65 with NOTICES
Statement of Organization, Functions,
and Delegations of Authority
Part N, National Institutes of Health,
of the Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (HHS) (40 FR 22859,
May 27, 1975, as amended most recently
at 70 FR 61146, October 20, 2005, and
redesignated from Part HN as Part N at
60 FR 56606, November 9, 1995), is
amended as set forth below to reflect the
reorganization of the NIH Ethics Office.
Section N–B, Organization and
Functions, is amended by replacing the
current section NAT (formerly HNAT)
with the following:
NIH Ethics Office (NAT, formerly
HNAT). (1) Provides oversight and
strategic direction of NIH activities
relating to ethics policy, oversight, and
operational activities; (2) develops and
administers the NIH policies and
procedures for implementing the
Government-wide conflict of interest
statutes and regulations, the HHS
supplemental conflict of interest
regulations, and HHS policies; (3)
implements a program for trans-NIH
ethics oversight that includes
information technology (IT) support
systems, periodic reviews, audits,
delegations of authority, training, and
records management; and (4) determines
real or potential conflicts of interest and
assesses ethical considerations in
scientific reporting, clinical trials, and
scientific conferences and workshops.
Division of IC Operations and Liaison
(NAT2, formerly HNAT2). (1) Provides
centralized operational services to ICs in
the review and processing of: (a)
Individual ethics actions and (b) ethics
actions having IC-wide impact such as
preapproval of awards, and blanket
approval of widely attended gatherings
(WAGs); (2) provides advisory services
in the management of IC ethics reviews;
and (3) provides ethics services for the
Office of the Director, NIH.
Division of Policy and Management
Review (NAT3, formerly HNAT3). (1)
VerDate Aug<31>2005
19:25 Aug 11, 2006
Jkt 208001
Provides technical review of NIH and IC
Ethics Programs and conducts risk
assessment; (2) develops NIH-wide
policies and procedures to ensure a
rigorous NIH Ethics Program; (3)
manages ethics delegations of authority;
(4) develops and manages content for
the NIH Ethics Web site; and (5)
provides NIH-wide ethics training to
staff.
Delegations of Authority: All delegations
and redelegations of authority to officers and
employees of NIH that were in effect
immediately prior to the effective date of this
amendment and are consistent with this
amendment shall continue in effect, pending
further redelegation.
Dated: August 4, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6–13305 Filed 8–11–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Recombinant Antibodies and
Immunoconjugates Targeted to CD–22
Bearing Cells and Tumors
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
Part 404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Patent Application
No. 09/381,497, filed September 20,
1999, entitled ‘‘Recombinant Antibodies
and Immunoconjugates Targeted to CD–
22 Bearing Cells and Tumors’’ [E–059–
1997/0–US–07]; European Patent
Application No. 98912977.0, filed
October 13, 1999, entitled
‘‘Recombinant Antibodies and
Immunoconjugates Targeted to CD–22
Bearing Cells and Tumors’’ [E–059–
1997/0–EP–05]; Japanese Patent
Application No. 10–540812, filed March
19, 1998, entitled ‘‘Recombinant
Antibodies and Immunoconjugates
Targeted to CD–22 Bearing Cells and
Tumors’’ [E–059–1997/0–JP–06];
Australian Patent No. 740904, issued on
February 28, 2002, entitled
‘‘Recombinant Antibodies and
Immunoconjugates Targeted to CD–22
Bearing Cells and Tumors’’ [E–059–
1997/0–AU–03]; and Canadian Patent
Application No. 2284665, filed March
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
46495
19, 1998, entitled ‘‘Recombinant
Antibodies and Immunoconjugates
Targeted to CD–22 Bearing Cells and
Tumors’’ [E–059–1997/0–CA–04]; to
Cambridge Antibody Technology, Ltd.,
which has offices in Cambridge, United
Kingdom. The patent rights in these
inventions have been assigned to the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the use
of the BL22 and HA22 and variants
thereof as claimed in the licensed patent
rights for the treatment of hematologic
malignancies.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before
October 13, 2006 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Jesse S. Kindra, J.D.,
M.S., Technology Licensing Specialist,
Office of Technology Transfer, National
Institutes of health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone (301) 435–5559;
Facsimile: (301) 402–0220; E-mail:
kindraj@mail.nih.gov.
This
technology is a family of two (2)
immunoconjugates, each consisting of
an anti-CD–22 antibody coupled to a
killing moiety, specifically
pseudomonas exotoxin (PE38). The
immunotoxins are both targeted towards
CD–22, and may be useful as
therapeutic agents for the treatment of
leukemias, lymphomas and
autoimmune diseases. Further, BL22 has
shown success in early clinical trials.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless
within sixty (60) days from the date of
this published notice, the NIH receives
written evidence and argument that
establishes that the grant of the license
would not be consistent with the
requirements of 35 U.S.C. 209 and 37
CFR 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14AUN1.SGM
14AUN1
]]>Agencies
[Federal Register Volume 71, Number 156 (Monday, August 14, 2006)]
[Notices]
[Page 46495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Statement of Organization, Functions, and Delegations of
Authority
Part N, National Institutes of Health, of the Statement of
Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services (HHS) (40 FR 22859, May 27,
1975, as amended most recently at 70 FR 61146, October 20, 2005, and
redesignated from Part HN as Part N at 60 FR 56606, November 9, 1995),
is amended as set forth below to reflect the reorganization of the NIH
Ethics Office.
Section N-B, Organization and Functions, is amended by replacing
the current section NAT (formerly HNAT) with the following:
NIH Ethics Office (NAT, formerly HNAT). (1) Provides oversight and
strategic direction of NIH activities relating to ethics policy,
oversight, and operational activities; (2) develops and administers the
NIH policies and procedures for implementing the Government-wide
conflict of interest statutes and regulations, the HHS supplemental
conflict of interest regulations, and HHS policies; (3) implements a
program for trans-NIH ethics oversight that includes information
technology (IT) support systems, periodic reviews, audits, delegations
of authority, training, and records management; and (4) determines real
or potential conflicts of interest and assesses ethical considerations
in scientific reporting, clinical trials, and scientific conferences
and workshops.
Division of IC Operations and Liaison (NAT2, formerly HNAT2). (1)
Provides centralized operational services to ICs in the review and
processing of: (a) Individual ethics actions and (b) ethics actions
having IC-wide impact such as preapproval of awards, and blanket
approval of widely attended gatherings (WAGs); (2) provides advisory
services in the management of IC ethics reviews; and (3) provides
ethics services for the Office of the Director, NIH.
Division of Policy and Management Review (NAT3, formerly HNAT3).
(1) Provides technical review of NIH and IC Ethics Programs and
conducts risk assessment; (2) develops NIH-wide policies and procedures
to ensure a rigorous NIH Ethics Program; (3) manages ethics delegations
of authority; (4) develops and manages content for the NIH Ethics Web
site; and (5) provides NIH-wide ethics training to staff.
Delegations of Authority: All delegations and redelegations of
authority to officers and employees of NIH that were in effect
immediately prior to the effective date of this amendment and are
consistent with this amendment shall continue in effect, pending
further redelegation.
Dated: August 4, 2006.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. E6-13305 Filed 8-11-06; 8:45 am]
BILLING CODE 4140-01-P
