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32632 Federal Register / Vol. 70, No.

106 / Friday, June 3, 2005 / Notices

0262. Attn: Melissa Musotto, CMS– safety and effectiveness summaries of believes that this procedure expedites
10156; approved PMAs through the Internet public notification of these actions
and, and FDA’s Division of Dockets because announcements can be placed
OMB Human Resources and Housing Management. on the Internet more quickly than they
Branch, Attention: Christopher can be published in the Federal
ADDRESSES: Submit written requests for
Martin, New Executive Office Register, and FDA believes that the
copies of summaries of safety and
Building, Room 10235, Washington, Internet is accessible to more people
effectiveness data to the Division of
DC 20503. than the Federal Register.
Dockets Management (HFA–305), Food
Dated: June 1, 2005. and Drug Administration, 5630 Fishers In accordance with section 515(d)(4)
Jimmy Wickliffe, Lane, rm. 1061, Rockville, MD 20852. and (e)(2) of the Federal Food, Drug, and
CMS Paperwork Reduction Act Reports Please include the appropriate docket Cosmetic Act (the act) (21 U.S.C.
Clearance Officer, Office of Strategic number as listed in table 1 of this 360e(d)(4) and (e)(2)), notification of an
Operations and Regulatory Affairs, document when submitting a written order approving, denying, or
Regulations Development Group. request. See the SUPPLEMENTARY withdrawing approval of a PMA will
[FR Doc. 05–11178 Filed 6–2–05; 8:45 am] INFORMATION section for electronic continue to include a notice of
BILLING CODE 4120–03–P access to the summaries of safety and opportunity to request review of the
effectiveness data. order under section 515(g) of the act.
FOR FURTHER INFORMATION CONTACT: The 30-day period for requesting
DEPARTMENT OF HEALTH AND Nathaniel L. Geary, Center for Biologics administrative reconsideration of an
HUMAN SERVICES Evaluation and Research (HFM–17), FDA action under § 10.33(b) (21 CFR
Food and Drug Administration, 1401 10.33(b)) for notices announcing
Food and Drug Administration approval of a PMA begins on the day the
Rockville Pike, suite 200N, Rockville,
[Docket No. 2005M–0005] MD 20852–1448, 301–827–6210. notice is placed on the Internet. Section
10.33(b) provides that FDA may, for
Medical Devices Regulated by the good cause, extend this 30-day period.
Center for Biologics Evaluation and I. Background Reconsideration of a denial or
Research; Availability of Safety and In the Federal Register of January 30, withdrawal of approval of a PMA may
Effectiveness Summaries for 1998 (63 FR 4571), FDA published a be sought only by the applicant; in these
Premarket Approval Applications final rule that revised 21 CFR 814.44(d) cases, the 30-day period will begin
AGENCY: Food and Drug Administration, and 814.45(d) to discontinue individual when the applicant is notified by FDA
HHS. publication of PMA approvals and in writing of its decision.
ACTION: Notice. denials in the Federal Register, The following is a list of PMAs
providing instead to post this approved by CBER for which summaries
SUMMARY: The Food and Drug information on the Internet at http:// of safety and effectiveness were placed
Administration (FDA) is publishing a In addition, the on the Internet from October 1, 2004,
list of premarket approval applications regulations provide that FDA publish a through December 31, 2004. There were
(PMAs) that have been approved by the quarterly list of available safety and no denial actions during the period. The
Center for Biologics Evaluation and effectiveness summaries of PMA list provides the manufacturer’s name,
Research (CBER). This list is intended to approvals and denials that were the product’s generic name or the trade
inform the public of the availability of announced during the quarter. FDA name, and the approval date.


PMA No./Docket No. Applicant Trade Name Approval Date

BP 040046/02005M–0005 Bio-Rad Laboratories Multispot HIV–1/HIV–2 Rapid Test November 12, 2004

II. Electronic Access DEPARTMENT OF HEALTH AND development. Foreign patent

HUMAN SERVICES applications are filed on selected
Persons with access to the Internet inventions to extend market coverage
may obtain the documents at http:// National Institutes of Health for companies and may also be available for licensing.
Government-Owned Inventions;
Dated: April 11, 2005.
Availability for Licensing ADDRESSES: Licensing information and
Jesse Goodman, copies of the U.S. patent applications
Director, Center for Biologics Evaluation and AGENCY: National Institutes of Health, listed below may be obtained by writing
Research. Public Health Service, DHHS. to the indicated licensing contact at the
[FR Doc. 05–11072 Filed 6–2–05; 8:45 am] ACTION: Notice. Office of Technology Transfer, National
BILLING CODE 4160–01–S Institutes of Health, 6011 Executive
SUMMARY: The inventions listed below Boulevard, Suite 325, Rockville,
are owned by an agency of the U.S. Maryland 20852–3804; telephone: (301)
Government and are available for 496–7057; fax: (301) 402–0220. A signed
licensing in the U.S. in accordance with Confidential Disclosure Agreement will
35 U.S.C. 207 to achieve expeditious be required to receive copies of the
commercialization of results of patent applications.
federally-funded research and

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Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices 32633

Method of Diagnosing Cancer Using methods may also be used in normal fecal antigen Ag1. The increased
beta-Catenin Splice Variants conjunction with the diagnostic/ specificity to CEA and reduced human
Mark J. Roth and Konrad Huppi (NCI); prognostic methods disclosed in related immunogenicity of these COL–1
U.S. Provisional Application No. 60/ provisional patent application 60/ humanized variants makes these
652,154 filed 10 Feb 2005 (DHHS 652,154 (NIH Ref: E–018–2005/0–US– antibodies attractive therapeutic and/or
Reference No. E–018–2005/0–US–01); 01). diagnostic compounds.
The methods are particularly useful The COL–1 antibody is described in
Licensing Contact: Susan S. Rucker;
with respect to adenocarcinomas and the following background publications:
(301) 435–4478;
squamous cell carcinomas. In particular, (i) Gonzales NR, Padlan EA, De
This application relates to methods
the methods described and claimed in Pascalis R, Schuck P, Schlom J, and
for early detection, diagnosis, and
the application are useful with respect Kashmiri SV. SDR grafting of a murine
prognosis of cancers and their
to preneoplasias and carcinomas antibody using multiple human
associated preneoplastic lesions. The involving the upper aerodigestive tract. germline templates to minmize its
methods are useful in evaluating the The methods employ small interfering immunogenicity. Mol. Immunol. 41(9):
status of preneoplastic lesions as well as RNA molecules (siRNAs) as a means to 863–872, 2004.
tumor tissue. Because of this, the alter the expression of one or more (ii) De Pascalis R, Iwahashi M,
methods can be used to track the particular CTNNB1 transcripts. In Tamura M, Padlan EA, Gonzales NR,
progression and therapeutic response of particular, preferred siRNA molecules Santos AD, Giuliano M, Schuck P,
disease in cell and tissue samples of alter the expression of the CTNNB1 Schlom J, and Kashmiri SV. Grafting of
normal, dysplasia or cancerous transcripts 16A and/or 16B. The siRNA ‘‘abbreviated’’ complementarity-
epithelium procured by routine molecules may be single-stranded (ss) or determining regions containing
cytology, i.e., exfoliated/brush or fine double-stranded (ds). The siRNA specificity-determining residues
needle aspiration, or surgical methods. molecules may be delivered using a essential for ligand contact to engineer
The methods are particularly useful construct, which is capable of a less immunogenic humanized
with respect to adenocarcinomas and expressing the siRNA molecule upon monoclonal antibody. J. Immunol. 169:
squamous cell carcinomas. In particular, delivery to the target cell. 3076–3084, 2002.
the methods described and claimed in In addition to licensing, the (iii) Gonzales NR, Padlan EA, De
the application are useful with respect technology is available for further Pascalis R, Schuck P, Schlom J,
to preneoplasias and carcinomas development through collaborative Kashmiri SV. Minimizing
involving the upper aerodigestive tract. research opportunities with the immunogenicity of the SDR-grafted
The methods involve the inventors. humanized antibody CC49 by genetic
measurement of levels of one or more manipulation of the framework
pairs of transcripts or the protein Framework Residue Substituted
Humanized COL–1 Antibodies and residues. Mol. Immunol. 40:337–349,
products of these pairs of transcripts or 2003.
the cellular localization of the Their Use
In addition to licensing, the
transcripts or proteins. The primary Syed Kashmiri (NCI), Eduardo Padlan technology is available for further
transcripts or protein products useful in (NIDDK), and Jeffrey Schlom (NCI); U.S. development through collaborative
this method are those of the beta- Provisional Application No. 60/640,672 research opportunities with the
Catenin gene (CTNNB1). In particular, filed 30 Dec 2004 (DHHS Reference No. inventors.
the levels of the 16A and 16B CTNNB1 E–339–2004/0–US–01); Licensing
transcripts or protein products are of Contact: Michelle A. Booden; (301) 451– Inhibiting IL–13 Receptor-Expressing
importance in carrying out the methods 7337; Cancer Cells With Anti-IL–13 Receptor
of this patent application. Other gene Carcinoembryonic antigen (CEA) has Immunotoxin and Alkylating Agents
transcripts or protein products that may been found to be an important marker Raj Puri and Syed Husain (FDA); U.S.
be used in conjunction with CTNNB1 of colorectal cancer. CEA is expressed in Provisional Application No. 60/621,035
16A and 16B to provide additional 85 percent of all gastric cancers and may filed 20 Oct 2004 (DHHS Reference No.
information are WAF1 (p21) and cMYC. function as a metastatic potentiator of E–302–2003/0–US–01); Licensing
The methods can be practiced using such cancers. In addition, it has been Contact: Brenda Hefti; (301) 435–4632;
fresh or frozen cell and/or tissue shown that CEA is up regulated when
specimens and techniques such as laser certain cancers are treated with standard The present invention relates to
capture microdissection (LCM) RT–PCR. chemotherapy drugs. A treatment methods of inhibiting the growth of
In addition to licensing, the modality that focuses specifically on cancer cells expressing the IL–13
technology is available for further CEA could be an effective way of receptor. Most generally, the patent
development through collaborative treating many carcinomas, including application claims immunotoxins
research opportunities with the colorectal, gastric, pancreatic, lung and consisting of anti-IL–13 antibodies
inventors. breast cancers. bound to toxins such as pseudomonas
The present invention relates to exotoxin or diphtheria toxin, or a
Method of Diagnosing and Treating
humanized monoclonal antibodies that cytotoxic fragment thereof, used in
Cancer Using beta-Catenin Splice
bind to CEA. Specifically, these combination with alkylating agents.
antibody variants have amino acid This combination appears to have
Mark J. Roth and Konrad Huppi (NCI); substitutions in the heavy chain significant advantages over use of either
U.S. Provisional Application No. 60/ framework that reduces the likelihood agent alone in the treatment of
667,084 filed 30 Mar 2005 (DHHS of human anti-mouse antibodies malignant gliomas, head and neck
Reference No. E–018–2005/1–US–01); (HAMA). cancers, adenocarcinomas of the colon,
Licensing Contact: Susan S. Rucker; The original murine COL–1 antibody stomach of skin, and Hodgkin’s disease.
(301) 435–4478; has been shown to be reactive to CEA
This application relates to methods without cross reactivity with other Regulation of RNA Stability
for treatment of cancers and potential antigens of the CEA family: Wi Lai et al. (NIEHS); U.S. Provisional
preneoplastic lesions. The treatment specifically Antigens NCA–1 and Application No. 60/451,976 filed 06 Mar

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32634 Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices

2003 (DHHS Reference No. E–314–2002/ hyperplasia. Almost all aspects of these Special Emphasis Panel, NCMHD
0–US–01); PCT Application No. PCT/ phenotypes can be prevented with Endowment.
US04/06703 filed 05 Mar 2004, which repeated injections of antibodies to Date: June 27–28, 2005.
published as WO 2004/081179 A2 on 10 TNF. Moreover, macrophages isolated Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
Feb 2005 (DHHS Reference No. E–314– from these mice exhibit increased applications.
2002/0–PCT–02); Licensing Contact: production of TNF-alpha and increased Place: Bethesda Marriott, 5151 Pooks Hill
Jesse S. Kindra; (301) 435–5559; amounts of TNF-alpha mRNA. Road, Bethesda, MD 20814. This transgenic mouse model will be Contact Person: Merlyn M. Rodrigues, PhD,
This invention relates to the discovery valuable in advancing our MD, Director, Office of Extramural Activities,
that tristetraprolin (TTP) can promote understanding of the mechanisms National Center On Minority Health and
the poly(A)RNase (PARN) mediated controlling mRNA turnover in immune Health Disparities, National Institutes of
deadenylation of polyadenylated homeostasis as well as autoimmune Health, 6707 Democracy Blvd. Suite 800,
substrates containing AU-rich elements diseases. This model will also permit Bethesda, MD 20894, (301) 402–1366,
(AREs). As one aspect of the invention,
the development of screening assays to
the inventors have developed a cell free elucidate the functions and binding Dated: May 25, 2005.
system that may be used for the partners for other members of the CCCH LaVerne Y. Stringfield,
purposes of assessing the effects of the zinc finger family as well as compounds Director, Office of Federal Advisory
various system components or their capable of inhibiting aberrant TNF- Committee Policy.
derivatives (i.e. AREs, PARN, or TTP) alpha and IL–2 biosynthesis. Lastly, this [FR Doc. 05–11095 Filed 6–2–05; 8:45 am]
on the deadenylation process or the model will advance understanding of BILLING CODE 4140–01–M
effects of various test agents on the the pathogenetic role for IL–2 and/or
deadenylation process. Aspects of this TNF in various autoimmune and
work have been published as follows: inflammatory diseases. The mice will be DEPARTMENT OF HEALTH AND
Lai et al., 2003, Tristetraprolin and Its made available on a non-exclusive basis HUMAN SERVICES
Family Members Can Promote the Cell- under a Biological Materials License
Free Deadenylation of AU-Rich Agreement. National Institutes of Health
Element-Containing mRNAs by Poly(A) Background scientific detail may be
Ribonuclease, MCB 23(11):3798–3812. found in Immunol. 2005 Jan 15; National Institute of Diabetes and
This technology is available for 174(2):953–61; Arthritis Res Ther. 2004; Digestive and Kidney Disorders;
licensing on an exclusive or a non- 6(6):248–64; and Science. 1998 Aug 14; Notice of Closed Meeting
exclusive basis. 281(5379):1001–5.
In addition to licensing, the Pursuant to section 10(d) of the
technology is available for further Dated: May 23, 2005. Federal Advisory Committee Act, as
development through collaborative Steven M. Ferguson, amended (5 U.S.C. Appendix 2) notice
research opportunities with the Director, Division of Technology Development is hereby given of the following
inventors. and Transfer, Office of Technology Transfer, meeting.
National Institutes of Health.
Tristetraprolin (TTP) Knockout Mice The meeting will be closed to the
[FR Doc. 05–11096 Filed 6–2–05; 8:45 am] public in accordance with the
Perry Blackshear et al (NIEHS). BILLING CODE 4140–01–P provisions set forth in sections
DHHS Reference No. B–015–1999/0— 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Research Material. as amended. The purpose of this
Licensing Contact: Michelle A. Booden; DEPARTMENT OF HEALTH AND meeting is to evaluate requests for
301/451–7337; HUMAN SERVICES preclinical development resources for potential new therapeutics for Type 1
National Institutes of Health National Institutes of Health
diabetes. The outcome of the evaluation
researchers have developed knockout will be a decision whether NIDDK
National Center on Minority Health and
mice that do not express Tristetraprolin should support the request and make
Health Disparities; Notice of Closed
(TTP). TTP is an AU-rich element (ARE) available contract resources for
binding protein and the prototype of a development of the potential
family of CCCH zinc finger proteins. Pursuant to section 10(d) of the therapeutic to improve the treatment or
AREs were identified as conserved Federal Advisory Committee Act, as prevent the development of Type 1
sequences found in the 3’ untranslated amended (5 U.S.C. Appendix 2), notice diabetes and its complications. The
region (3’ UTR) of a variety of is hereby given of the following research proposals and the discussions
transiently expressed genes including meeting. could disclose confidential trade secrets
early respsonse genes, proto-oncogenes, The meeting will be closed to the or commercial property such as
and other growth regulatory genes. public in accordance with the patentable material, and personal
AREs function as instability sequences provisions set forth in sections information concerning individuals
that target ARE-containing transcripts 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., associated with the proposed research
for rapid mRNA decay. TTP functions as amended. The grant applications and projects, the disclosure of which would
by binding directly to the ARE sequence the discussions could disclose constitute a clearly unwarranted
contained in the TNF-alpha mRNA, confidential trade secrets or commercial invasion of personal privacy.
which destabilizes and mediates rapid property such as patentable material,
decay of the TNF-alpha mRNA. More and personal information concerning Name of Committee: National Institute of
individuals associated with the grant Diabetes and Digestive and Kidney Disorders
recent studies demonstrate TTP’s ability Special Emphasis Panel; Type 1 Diabetes—
to downregulate IL–2 gene expression. applications, the disclosure of which Rapid Access to Intervention Development.
TTP knockout mice appear normal at would constitute a clearly unwarranted Date: June 21, 2005.
birth but soon develop inflammatory invasion of personal privacy. Time: 3 p.m.–4 p.m.
arthritis, dermatitis, cachexia, Name of Committee: National Center on Agenda: To evaluate requests for
autoimmunity, and myeloid Minority Health and Health Disparities preclinical development resources for

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