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Federal Register / Vol. 73, No.

61 / Friday, March 28, 2008 / Notices 16691

a deeming organization for HHAs. In the ++ Obtain The Joint Commission’s the HHA will be required to submit a
proposed notice, we detailed our agreement to provide us with a copy of written plan of correction.
evaluation criteria. Under section the most current accreditation survey • To meet the requirements at
1865(b)(2) of the Act and our regulations together with any other information 488.8(a)(3), The Joint Commission has
at § 488.4 (Application and related to the survey as we may require, agreed to provide CMS with a copy of
reapplication procedures for including corrective action plans. its most current accreditation survey
accreditation organizations), we In accordance with section along with any other related information
conducted a review of The Joint 1865(b)(3)(A) of the Act, the October 26, that CMS requires, including corrected
Commission’s application in accordance 2007 proposed notice (72 FR 60855) also action plans, when requested.
with the criteria specified by our solicited public comments regarding
B. Term of Approval
regulation, which include, but are not whether The Joint Commission’s
limited to the following: requirements met or exceeded the Based on the review and observations
• An onsite administrative review of Medicare conditions of participation for described in section III of this final
The Joint Commission’s (1) Corporate HHAs. We received no public comments notice, we have determined that The
policies; (2) financial and human in response to our proposed notice. Joint Commission’s requirements for
resources available to accomplish the HHAs meet or exceed our requirements.
IV. Provisions of the Final Notice
proposed surveys; (3) procedures for Therefore, we approve The Joint
training, monitoring, and evaluation of A. Differences Between the Joint Commission as a national accreditation
its surveyors; (4) ability to investigate Commission’s Standards and organization for HHAs that request
and respond appropriately to Requirements for Accreditation and participation in the Medicare program,
complaints against accredited facilities; Medicare’s Conditions and Survey effective March 31, 2008 through March
and (5) survey review and decision- Requirements 31, 2014.
making process for accreditation. We compared the standards contained
• A comparison of The Joint V. Collection of Information
in The Joint Commission’s Requirements
Commission’s HHA accreditation
Comprehensive Accreditation Manual
standards to our current Medicare HHA This document does not impose
for Home Care and its survey process in
conditions for participation. information collection and
• A documentation review of The The Joint Commission’s Application for
recordkeeping requirements.
Joint Commission’s survey processes to: Continued Home Health Deeming
Consequently, it need not be reviewed
++ Determine the composition of the Authority with the Medicare HHA
by the Office of Management and
survey team, surveyor qualifications, conditions for participation and our
Budget under the authority of the
and the ability of The Joint Commission State Operations Manual (SOM). Our
Paperwork Reduction Act of 1995 (44
to provide continuing surveyor training. review and evaluation of The Joint
U.S.C. 35).
++ Compare The Joint Commission’s Commission’s deeming application,
which were conducted as described in (Catalog of Federal Domestic Assistance
processes to those of State survey Program No. 93.778, Medical Assistance
agencies, including survey frequency, section III of this final notice, yielded
the following: Program; No. 93.773 Medicare—Hospital
and the ability to investigate and Insurance Program; and No. 93.774,
respond appropriately to complaints • To meet the requirements for initial Medicare—Supplemental Medical Insurance
against accredited facilities. home health certification surveys listed Program)
++ Evaluate The Joint Commission’s in the SOM at 2200A5, The Joint
Commission revised its standards to Dated: January 25, 2008.
procedures for monitoring providers or
reflect the requirement that HHAs must Kerry Weems,
suppliers found to be out of compliance
have provided care to a minimum of ten Acting Administrator, Centers for Medicare
with The Joint Commission program
patients and at least seven of the ten & Medicaid Services.
requirements. The monitoring
patients are receiving care at the time of [FR Doc. E8–5074 Filed 3–27–08; 8:45 am]
procedures are used only when The
Joint Commission identifies the initial survey. BILLING CODE 4120–01–P

noncompliance. If noncompliance is • To meet the requirements for initial


identified through validation reviews, certification surveys listed in the SOM
at 2200A5, The Joint Commission DEPARTMENT OF HEALTH AND
the survey agency monitors corrections
revised it standards to reflect the HUMAN SERVICES
as specified at § 488.7(d).
++ Assess The Joint Commission’s requirement that HHAs must provide
nursing and at least one other National Institutes of Health
ability to report deficiencies to the
surveyed facilities and respond to the therapeutic service. Government-Owned Inventions;
facility’s plan of correction in a timely • To meet the requirements listed in Availability for Licensing
manner. the SOM at 2200C4, The Joint
++ Establish The Joint Commission’s Commission updated its home care AGENCY: National Institutes of Health,
ability to provide us with electronic surveyor activity guide to reflect that all Public Health Service, HHS.
data in ASCII-comparable code and patients (private pay and Medicare ACTION: Notice.
reports necessary for effective validation beneficiaries) are included in the
and assessment of The Joint clinical record review or selection of SUMMARY: The inventions listed below
Commission’s survey process. home visits for a Medicare certification are owned by an agency of the U.S.
++ Determine the adequacy of staff survey. Government and are available for
and other resources. • To meet the requirements of licensing in the U.S. in accordance with
++ Review The Joint Commission’s § 488.28(a), The Joint Commission will 35 U.S.C. 207 to achieve expeditious
sroberts on PROD1PC70 with NOTICES

ability to provide adequate funding for no longer issue supplemental findings commercialization of results of
performing required surveys. for HHAs seeking deemed status. All federally-funded research and
++ Confirm The Joint Commission’s deficiencies identified during a development. Foreign patent
policies with respect to whether surveys certification survey will be cited as applications are filed on selected
are announced or unannounced. requirements for improvement which inventions to extend market coverage

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16692 Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices

for companies and may also be available Patent Status: HHS Reference No. E– synthesis of sugar molecules known as
for licensing. 100–2008/0—Research Tool. Patent sialic acids which play an important
ADDRESSES: Licensing information and protection is not being sought for this role in specific biological processes
copies of the U.S. patent applications technology. such as cellular adhesion, cellular
listed below may be obtained by writing Availability: Available for non- communication and signal transduction.
to the indicated licensing contact at the exclusive licensing. Lack of sialic acids also play an
Office of Technology Transfer, National Licensing Contact: Adaku important role in disease processes such
Institutes of Health, 6011 Executive Nwachukwu, J.D.; 301–435–5560; as cancer, inflammation and immunity.
Boulevard, Suite 325, Rockville, madua@mail.nih.gov. This invention relates to methods of
Maryland 20852–3804; telephone: 301/ Mucin Binding Lectin Imaging Agents administering N–Acetyl Mannosamine
496–7057; fax: 301/402–0220. A signed for Colonic Polyp Imaging or its derivative (to produce sialic acid
Confidential Disclosure Agreement will in patients who are deficient in the
Description of Technology: Available sugar molecule) to treat muscular
be required to receive copies of the for licensing and commercial
patent applications. atrophy including hereditary inclusion
development is an imaging agent body myopathy (HIBM) and distal
Cell Line PE, Developed From Mouse specific for colonic polyps that myopathy with rimmed vacuoles
Skin Tumors, Demonstrates Unique overexpress glycoprotein a-L-fucose (Nonaka myopathy). Certain kidney
Qualities containing mucins. Colon cancer is the conditions such as those arising from
second leading cause of cancer related hyposialytion of kidney membranes
Description of Technology: Available deaths in the United States. The legume
for licensing is the mouse skin tumor may be treated by this method as well.
protein Ulex europaeus agglutinin I Applications: Treatment of rare
cell line PE. These skin tumor cells were (UEA–1) has shown high specificity to
isolated from papilloma cells induced diseases such as HIBM and Nonaka
a-L-fucose glycoproteins. Colonic myopathy.
by chemical carcinogens. The PE cell mucosal neoplasia and/or polyps with
lines differ from normal keratinocytes in Treatment of kidney conditions
high surface expression of a-L-fucosyl involving sialic acid deficiencies
their ability to maintain a proliferating terminal residues can be specifically
population under conditions favoring resulting in proteinuria and hematuria.
targeted with UEA–1 contrast agents. In May be useful in treating other
terminal differentiation, their consistent one example, a computer tomography
proliferative response to phorbol esters diseases involving sialic acid
(CT) agent made from Iodine-127 (127I) deficiencies.
under these same conditions, and their labeled UEA–1 (I–UEA–1) and Publication: B Galeano et al. Mutation
reduced sensitivity to phorbol ester- encapsulated into polymeric liposome in the key enzyme of sialic acid
induced terminal differentiation. All of nanoparticles was used to image murine biosynthesis causes severe glomerular
these properties should provide a colonic polyps. Ideally, the inventors proteinuria and is rescued by N–
growth advantage to these cells during envision a contrast agent that can be acetylmannosamine. J Clin Invest. 2007
tumor promotion. The PE cell line is administered orally (e.g., liquid or pill Jun;117(6):1585–1594.
one of the studied cell lines. form) and that would eliminate a Inventors: Marjan Huizing et al.
Applications: The PE cell lines could patient’s need to drink harsh enema/ (NHGRI).
be used for assays for cancer treatment contrast solutions prior to CT imaging. Patent Status: U.S. Provisional
and prevention or study of several Applications: Colon cancer; Cancer Application No. 60/932,451 filed 31
aspects of cutaneous biology. Imaging; Contrast Agents; CT May 2007 (HHS Reference No. E–217–
PE cells could be used in the cosmetic colonography 2007/0–US–01).
industry to study response to Inventors: Ronald M. Summers, Licensing Status: Available for
cosmaceuticals or fragrances. Jianwu Xie, Celeste Roney (CC). licensing.
PE cells also demonstrated robust Relevant Publications: Licensing Contact: Fatima Sayyid,
expression of phase 2 detoxification 1. J Xie et al. Oral contrast enhanced M.H.P.M.; 301–435–4521;
enzymes in response to a variety of MicroCT virtual colonoscopy of APC
Fatima.Sayyid@nih.hhs.gov.
inducing agents. knockout mouse colon polyp model. Collaborative Research Opportunity:
Advantage: The various properties of Gastroenterology. 2007 Apr;132(4), The National Human Genome Research
papilloma cells (PE cell line) differ from Suppl. 1, Abstract No. M1063, pp A- Institute, Medical Genetics Branch, Cell
keratinocytes which will provide a 353–A-354. Biology of Metabolic Disorders unit is
growth advantage to the PE cell lines 2. C Roney et al. Glycoprotein
seeking statements of capability or
during tumor promotion. expression by adenomatous polyps of
interest from parties interested in
Market: In the U.S., there was an the colon. SPIE 2008 (in press).
3. SD O’Connor et al. Oral contrast collaborative research to further
estimated 59,940 new cases of develop, evaluate, or commercialize N–
melanoma cancer in 2007 and an adherence to polyps on CT
colonography. J Comput Assist Tomogr. acetylmannosamine as a therapeutic
estimated 8,110 melanoma deaths in agent. Please contact Marjan Huizing at
2006 Jan–Feb;30(1):51–57.
2007. There were nearly one million 301–402–2797or
Patent Status: U.S. Provisional
cases of non-melanoma skin cancers mhuizing@mail.nih.gov for more
Application filed 15 Feb 2008 (HHS Ref.
diagnosed in the U.S. in 2007. No. E–254–2007/0–US–01). information.
Cosmetics industry is a $30 billion Licensing Status: Available for
industry with a 20% annual growth rate. Nitrite Adjunctive Therapy to Enhance
licensing. Efficacy of Reperfusion Therapy for
Inventors: Stuart H. Yuspa and Henry Licensing Contact: Michael A.
Hennings (NCI). Acute Myocardial Infarction
Shmilovich, Esq.; 301–435–5010;
Publication: SH Yuspa et al. Description of Technology: The
sroberts on PROD1PC70 with NOTICES

shmilovm@mail.nih.gov.
Cultivation and characterization of cells treatment of coronary heart disease is a
derived from mouse skin papillomas N–Acetyl Mannosamine as a multi-billion dollar market. In the case
induced by an initiation-promotion Therapeutic Agent of acute myocardial infarction (MI),
protocol. Carcinogenesis 1986 Description of Technology: N–Acetyl more commonly known as a heart
Jun;7(6):949–958. Mannosamine is a precursor for the attack, the patient receives a number of

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Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices 16693

diagnostic tests to determine the type Waclawiw, JH Shelhamer, MT Gladwin. as antibodies, cytokines, growth factors,
and location of the heart damage. Most Effects of inhaled nitric oxide on enzymes, immunomodulators,
patients with ST segment elevation are regional blood flow are consistent with thrombolytics, glycosylated proteins,
treated with percutaneous coronary intravascular nitric oxide delivery. J secreted proteins, and DNA sequences
intervention (PCI) or thrombolysis. Clin Invest. 2001 Jul;108(2):279–287. encoding such polypeptides and a
While current therapies, that attempt to Patent Status: U.S. Provisional reduction in the associated costs of such
reestablish the blood flow and limit Application No. 60/911,026 filed 10 Apr biological products.
ischemia, can be effective, practical 2007 (HHS Reference No. E–023–2007/ Advantages: This technology offers
delays between symptom presentation 0–US–01) the ability to improve yields and reduce
and intervention compromise the Licensing Status: Available for the cost associated with the production
amount of myocardial salvage. licensing. of recombinant protein products
Moreover, the elapsed time prior to PCI Licensing Contact: Fatima Sayyid, through the selection of cell lines
is closely related to the clinical M.H.P.M.; 301–435–4521; having: Altered growth characteristics;
outcome. This has resulted in a Fatima.Sayyid@nih.hhs.gov. altered adhesion characteristics; altered
mortality rate of 7% after MI and nearly Collaborative Research Opportunity: rate of proliferation; improvement in
all patients suffer from some degree of The NHLBI Pulmonary and Vascular cell density growth; improvement in
myocardial necrosis. However, the use Medicine Branch is seeking statements recombinant protein expression level.
of adjunctive pharmacological therapies of capability or interest from parties Market: Biopharmaceuticals,
can improve myocardial salvage interested in collaborative research to including recombinant therapeutic
following acute percutaneous further develop, evaluate, or proteins and monoclonal antibody-
reperfusion of an acute MI and commercialize nitrite adjunctive based products used for in vivo medical
substantially impact cardiac function. therapy to enhance efficacy of purposes and nucleic acid based
This technology is a method of using reperfusion therapy for acute medicinal products now represent
nitrite as an adjunctive therapy to myocardial infarction. Please contact Dr. approximately one in every four new
enhance efficacy of reperfusion therapy Mark Gladwin at 301–435–2310 for pharmaceuticals on the market. The
for acute MI. Evidence suggests that more information. market size has been estimated at $33
anion nitrite (NO2) is a physiological Compositions and Methods for billion in 2004 and is projected to reach
signaling molecule with roles in Increasing Recombinant Protein Yields $70 billion by the end of the decade.
intravascular endocrine nitric oxide Through the Modification of Cellular The list of approved biopharmaceuticals
(NO) transport, hypoxic vasodilation, Properties includes recombinant hormones and
signaling, and cytoprotection. In growth factors, mAB-based products
addition, nitrite has the characteristics Description of Technology: This and therapeutic enzymes as well as
of an ideal adjunctive therapy that now technology relates to compositions and recombinant vaccines and nucleic acid
appears ready for translation to human methods for improving the growth based products.
clinical trials. The benefits of nitrite characteristics of cells engineered to Mammalian cells are widely used
therapy include (1) Significant produce biologically active products expression systems for the production of
cardioprotection after prolonged such as antibodies or glycosylated biopharmaceuticals. Human embryo
ischemia, (2) simple administration, (3) proteins. Featured is a method that uses kidney (including HEK–293) and
low dose for pharmacological action, (4) gene candidates (e.g., cdkl3, siat7e, or Chinese hamster ovary (CHO) are host
short half-life (5) minimal side effects, lama4), or their expressed or inhibited cell of choice. The genes identified in
(6) low expense, (7) rapid onset of products in cell lines, such as Human this technology (e.g., cdkl3, sia7e, or
action. Additionally, the therapy Embryonic Kidney (including HEK– lama4) can be used to modify these
utilizes a cardioprotective mechanism 293), HeLa, or Chinese Hamster Ovary important cell based systems.
that is not dependent on vasodilation or (CHO). The gene expression modulates This technology is ready for use in
pressure rate changes. The use and growth characteristics, such as adhesion drug/vaccine discovery, production and
dosing protocols of nitrite, as described properties, of the cell lines thereby development. The technology provides
by this technology, could limit MI and increasing recombinant protein yields methods for identification of specific
apoptosis in the reperfusion phase of and reducing product production costs. gene targets useful for altering the
Applications: This technology may be production properties of either existing
injury and provide a remarkable degree
used to improve production of cell lines to improve yields or with new
of cardioprotection.
Applications: Treatment or therapeutic and/or diagnostic cell lines for the production of
amelioration of myocardial salvage compounds, including therapeutic therapeutic and or diagnostic
following acute percutaneous proteins or monoclonal antibodies from compounds from mammalian cells.
reperfusion of an acute MI. mammalian cells. Optimization of Companies that are actively seeking
Development Status: Clinical mammalian cells for use as expression production platforms based on
Development. systems in the production of mammalian cell lines that offer high
Inventors: Mark T. Gladwin et al. biologically active products is very efficiency, high throughput systems for
(NHLBI). difficult. For certain applications, protein production or analysis at lower
Relevant Publications: anchorage-independent cell lines may cost and ease of scale-up would be
1. MT Gladwin, JH Shelhamer, AN be preferred, whereas for other potential licensors of this technology.
Schechter, ME Pease-Fye, MA applications, a cell line that adheres to Development Status: Late Stage—
Waclawiw, JA Panza, FP Ognibene, RO a surface, e.g., is anchorage-dependent, Ready for Production.
Cannon 3rd. Role of circulating nitrite may be preferable. This technology Inventors: Joseph Shiloach (NIDDK),
and S–nitrosohemoglobin in the provides a method for identifying a gene Pratik Jaluria (NIDDK).
sroberts on PROD1PC70 with NOTICES

regulation of regional blood flow in whose expression modulates such Related Publication: P Jaluria et al.
humans. Proc Natl Acad Sci U S A. 2000 cellular adhesion characteristics. This Application of microarrays to identify
Oct 10;97(21):11482–11487. method thus leads to an increase in the and characterize genes involved in
2. RO Cannon 3rd, AN Schechter, JA expression or yield of polypeptides, attachment dependence in HeLa cells.
Panza, FP Ognibene, ME Pease-Fye, MA including therapeutic biologicals, such Metab Eng. 2007 May;9(3):241–251.

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16694 Federal Register / Vol. 73, No. 61 / Friday, March 28, 2008 / Notices

Patent Status: U.S. Provisional the discussions could disclose Name of Committee: Heart, Lung, and
Application No. 60/840,381 filed 24 confidential trade secrets or commercial Blood Initial Review Group; NHLBI
Aug 2006 (HHS Reference No. E–149– property such as patentable material, Institutional Training Mechanism
2006/0–US–01); PCT Application No. and personal information concerning Review Committee.
PCT/US2007/018699 filed 24 Aug 2007 individuals associated with the Date: June 19–20, 2008.
(HHS Reference No. E–149–2006/0– proposed research projects, the Time: 8 a.m. to 5 p.m.
PCT–02). disclosure of which would constitute a Agenda: To review and evaluate grant
Licensing Status: Available for clearly unwarranted invasion of applications.
exclusive or non-exclusive licensing. personal privacy. Place: Admiral Fell Inn, 888 South
Licensing Contact: Peter A. Soukas, Broadway, Baltimore, MD 21231.
Name of Committee: National Cancer Contact Person: Charles Joyce, PhD,
J.D.; 301–435–4646; Institute Special Emphasis Panel; Rapid
soukasp@mail.nih.gov. Access to Intervention Development.
Scientific Review Administrator,
Collaborative Research Opportunity: Date: May 2, 2008. Review Branch/DERA, National Heart,
The National Institute of Diabetes and Time: 8:30 a.m.–5 p.m. Lung, and Blood Institute, 6701
Digestive and Kidney Diseases, Agenda: To evaluate the Rapid Access to Rockledge Drive, Room 7196, Bethesda,
Biotechnology Core Laboratory, is Intervention Development Portfolio. MD 20892–7924, 301–435–0288,
seeking parties interested in Place: National Institutes of Health, cjoyce@nhlbi.nih.gov.
collaborative research projects directed Executive Plaza North, Conference Room G,
(Catalogue of Federal Domestic Assistance
toward the use of this technology with 6130 Executive Boulevard, Rockville, MD
Program Nos. 93.233, National Center for
20852.
cells for drug and vaccine production Contact Person: Phyllis G. Bryant,
Sleep Disorders Research; 93.837, Heart and
and development, including growth Vascular Diseases Research; 93.838, Lung
Executive Secretary, Program Analyst,
optimization, production and product Diseases Research; 93.839, Blood Diseases
Developmental Therapeutics Program,
recovery processes. For more and Resources Research, National Institutes
National Cancer Institute, NIH, 6130
information, please contact Dr. Joseph of Health, HHS)
Executive Boulevard, Rm. 8022, Bethesda,
Shiloach, josephs@intra.niddk.nih.gov, MD 20892, (301) 496–8720. Dated: March 20, 2008.
or Rochelle S. Blaustein at (Catalogue of Federal Domestic Assistance Anna Snouffer,
Rochelle.Blaustein@nih.gov. Program Nos. 93.392, Cancer Construction; Acting Director, Office of Federal Advisory
93.393, Cancer Cause and Prevention Committee Policy.
March 20, 2008.
Research; 93.394, Cancer Detection and [FR Doc. E8–6196 Filed 3–27–08; 8:45 am]
Steven M. Ferguson, Diagnosis Research; 93.395, Cancer
BILLING CODE 4140–01–M
Director, Division of Technology Development Treatment Research; 93.396, Cancer Biology
and Transfer, Office of Technology Transfer, Research; 93.397, Cancer Centers Support;
National Institutes of Health. 93.398, Cancer Research Manpower; 93.399,
[FR Doc. E8–6316 Filed 3–27–08; 8:45 am] Cancer Control, National Institutes of Health, DEPARTMENT OF HEALTH AND
HHS) HUMAN SERVICES
BILLING CODE 4140–01–P
Dated: March 20, 2008. National Institutes of Health
Anna Snouffer,
DEPARTMENT OF HEALTH AND Acting Director, Office of Federal Advisory National Institute of Allergy and
HUMAN SERVICES Committee Policy. Infectious Diseases; Notice of Closed
[FR Doc. E8–6198 Filed 3–27–08; 8:45 am] Meeting
National Institutes of Health
BILLING CODE 4140–01–M
Pursuant to section 10(d) of the
National Cancer Institute; Notice of Federal Advisory Committee Act, as
Closed Meeting amended (5 U.S.C. Appendix 2), notice
DEPARTMENT OF HEALTH AND
Pursuant to section 10(d) of the HUMAN SERVICES is hereby given of the following
Federal Advisory Committee Act, as meeting.
amended (5 U.S.C. Appendix 2) notice National Institutes of Health The meeting will be closed to the
is hereby given of the following public in accordance with the
meeting. National Heart, Lung, and Blood provisions set forth in sections
The meeting will be closed to the Institute; Notice of Closed Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
public in accordance with the as amended. The contract proposals and
provisions set forth in sections Pursuant to section 10(d) of the the discussions could disclose
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Federal Advisory Committee Act, as confidential trade secrets or commercial
as amended. The purpose of this amended (5 U.S.C. Appendix 2), notice property such as patentable material,
meeting is to evaluate proposals for is hereby given of the following and personal information concerning
support through the RAID program by meeting. individuals associated with the contract
making available to the research The meeting will be closed to the proposals, the disclosure of which
community, on a competitive basis, NCI public in accordance with the would constitute a clearly unwarranted
new agent development contract provisions set forth in sections invasion of personal privacy.
resources for the preclinical 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Institute of
development of drugs and biologics. as amended. The grant applications and Allergy and Infectious Diseases Special
The outcome of the evaluation will be the discussions could disclose Emphasis Panel To Review Contract
a decision whether NCI should support confidential trade secrets or commercial Proposals.
the request and make available contract property such as patentable material, Date: April 16–17, 2008.
sroberts on PROD1PC70 with NOTICES

Time: 7:30 a.m. to 7 p.m.


resources for support through the RAID and personal information concerning Agenda: To review and evaluate contract
program to the research community and individuals associated with the grant proposals.
NCI new agent development for the applications, the disclosure of which Place: Hilton Washington DC/Silver
preclinical development of drugs and would constitute a clearly unwarranted Spring; 8727 Colesville Road, Silver Spring,
biologics. The research proposals and invasion of personal privacy. MD 20910.

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