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NIEHS under NICEATM. NICEATM authority to sign Federal Register notices Dated: May 10, 2007.
administers ICCVAM and provides pertaining to announcements of meetings and Elaine L. Baker,
scientific and operational support for other committee management activities, for
both CDC and the Agency for Toxic Acting Director, Management Analysis and
ICCVAM-related activities. NICEATM Substances and Disease Registry. Services Office, Centers for Disease Control
and ICCVAM work collaboratively to and Prevention.
evaluate new and improved test Dated: May 10, 2007.
[FR Doc. E7–9479 Filed 5–16–07; 8:45 am]
methods applicable to the needs of Elaine L. Baker,
BILLING CODE 4163–18–P
federal agencies. Additional information Acting Director, Management Analysis and
about ICCVAM and NICEATM is Services Office, Centers for Disease Control
available on the following Web site: and Prevention.
[FR Doc. E7–9498 Filed 5–16–07; 8:45 am]
DEPARTMENT OF HEALTH AND
http://iccvam.niehs.nih.gov. HUMAN SERVICES
BILLING CODE 4163–18–P
Dated: May 8, 2007.
David A. Schwartz, National Institutes of Health
Director, National Institute of Environmental DEPARTMENT OF HEALTH AND
Health Sciences and National Toxicology Proposed Collection; Comment
HUMAN SERVICES
Program. Request; Physicians’ Experience of
[FR Doc. E7–9544 Filed 5–16–07; 8:45 am] Centers for Disease Control and Ethical Dilemmas and Resource
BILLING CODE 4140–01–P Prevention Allocation
For Further Information Contact: Trudy authority to sign Federal Register notices Frequency of Response: Once.
Messmer, Ph.D., Designated Federal Official, pertaining to announcements of meetings and Affected Public: Individuals or
1600 Clifton Road, Mailstop C–19, Atlanta, other committee management activities, for households; Businesses or other for-
GA 30333, telephone (404) 639–3770. both the Centers for Disease Control and
The Director, Management Analysis and Prevention and the Agency for Toxic
profit; Not-for-profit institutions.
Services Office, has been delegated the Substances and Disease Registry. Type of Respondents: Physicians.
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27818 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Notices
The annual reporting burden is as Average Burden Hours Per Response: Capital Costs, Operating Costs and/or
follows: .0.3674; and Maintenance Costs to report.
Estimated Number of Respondents: Estimated Total Annual Burden
250; Hours Requested: 91.85.
Estimated Number of Responses per The annualized cost to respondents is
Respondent: 1; estimated at: $5,218. There are no
Request for Comments: Written DEPARTMENT OF HEALTH AND human antibody framework.
comments and/or suggestions from the HUMAN SERVICES Additionally, the method identifies
public and affected agencies are invited Specificity Determining Residues
on one or more of the following points: National Institutes of Health (SDRs), the amino acid residues in the
(1) Whether the proposed collection of hypervariable regions of an antibody
information is necessary for the proper Government-Owned Inventions; that are most critical for antigen binding
performance of the function of the Availability for Licensing activity and of rendering any antibody
agency, including whether the AGENCY: National Institutes of Health, minimally immunogenic in humans by
information will have practical utility; Public Health Service, HHS. transferring the SDRs of the antibody to
(2) The accuracy of the agency’s a human antibody framework. The
ACTION: Notice.
estimate of the burden of the proposed resulting humanized antibodies,
collection of information, including the SUMMARY: The inventions listed below including CDR variants thereof
validity of the methodology and are owned by an agency of the U.S. (including a CH2 deleted version), are
assumptions used; (3) Ways to enhance Government and are available for also embodied in the invention, as are
the quality, utility, and clarity of the licensing in the U.S. in accordance with methods of using the antibodies for
information to be collected; and (4) 35 U.S.C. 207 to achieve expeditious therapeutic and diagnostic purposes.
Ways to minimize the burden of the commercialization of results of Furthermore, these antibodies are
collection of information on those who federally-funded research and suitable for radiolabeling for the
are to respond, including the use of development. Foreign patent application in radioimmunotherapy
appropriate automated, electronic, applications are filed on selected (RIT) based treatment of several cancers.
mechanical, or other technological inventions to extend market coverage Phase I results of radioimmunotherapy
collection techniques or other forms of for companies and may also be available for ovarian cancer using 90Yttrium-CC49
information technology. for licensing. murine monoclonal antibodies have
shown promising results and confirms
FOR FURTHER INFORMATION CONTACT: To ADDRESSES: Licensing information and
feasibility of the use of these antibodies
request more information on the copies of the U.S. patent applications
for RIT. Promising pharmacokinetic data
proposed project or to obtain a copy of listed below may be obtained by writing
for the radiolabeled humanized
the data collection plans and to the indicated licensing contact at the
antibodies in colon carcinoma xenograft
instruments, contact Dr. Marion Danis, Office of Technology Transfer, National
models were recently published.
Department of Clinical Bioethics, Institutes of Health, 6011 Executive
Building 10, room 1C118, National Boulevard, Suite 325, Rockville, Applications and Modality
Institutes of Health, Bethesda, MD Maryland 20852–3804; telephone: 301/ 1. A humanized anti-cancer CC49
20892, or call non-toll-free number 301– 496–7057; fax: 301/402–0220. A signed monoclonal antibody has been
435–8727 or e-mail your request, Confidential Disclosure Agreement will developed.
including your address to: be required to receive copies of the 2. New methods of humanization of
mdanis@cc.nih.gov. patent applications. rodent antibodies have been identified.
Humanized Anti-Carcinoma CC49 3. The antibody(s) has been shown to
Comments Due Date: Comments react with Tumor Associated
regarding this information collection are Monoclonal Antibodies
Glycoprotein 72 (TAG–72), an antigen
best assured of having their full effect if Description of Technology: The which is expressed on human breast,
received within 60-days of the date of technology describes the humanization ovarian, colorectal, and other
this publication. of a murine anti-carcinoma antibody carcinomas.
CC49 which has been shown to react 4. These antibodies are suitable for
David K. Henderson,
with Tumor Associated Glycoprotein 72 radiolabeling for the application in
Deputy Director, Warren G. Magnuson (TAG–72), an antigen which is
Clinical Center, National Institutes of Health.
radioimmunotherapy (RIT) based
expressed on human breast, ovarian, treatment of several cancers.
Ezekiel J. Emanuel, colorectal, and other carcinomas. 5. These antibodies can be useful in
pwalker on PROD1PC71 with NOTICES
Director, Department of Clinical Bioethics, The invention includes a new method diagnosis and treatment of several
Warren G. Magnuson Clinical Center, of humanization of a rodent antibody cancers.
National Institutes of Health. which is based on grafting all the Development Status: The technology
[FR Doc. E7–9543 Filed 5–16–07; 8:45 am] Complementarity Determining Residues is currently in the pre-clinical stage of
BILLING CODE 4140–01–P (CDRs) of a rodent antibody onto a development. Phase I results of
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