Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53267 

The inventors have discovered that 

Zinc finger protein 36 like type-2 

(ZFP36L2) plays an essential role in 

hematopoiesis, possibly by affecting the 

stability of mRNAs involved in this 

process. ZFP36L2 is a member of the 

tristetraprolin (TTP) family, which are 

mRNA-binding proteins involved in 

mRNA processing and degradation. The 

invention discloses methods of 

detecting abnormal hematopoiesis by 

detecting abnormal ZFP36L2 expression 

or a mutation in the ZFP36L2 gene, and 

methods of controlling abnormal 

hematopoiesis by modulating levels of 

ZFP36L2 protein. 

Applications: 

• Diagnostic test to detect abnormal 

hematopoiesis. 

• Therapy for abnormal 

hematopoiesis. 

Development Status: Discovery stage. 

Market: 

• Over 3.5 million people in the 

United States suffer from anemia, 

according to NHLBI, and more than half 

of all chemotherapy treatment for cancer 

results in anemia. 

• The American Cancer Society 

estimates that approximately 4300 cases 

of chronic myelogenous leukemia are 

diagnosed in the United States every 

year. 

Inventors: Perry J. Blackshear and 

Deborah J. Stumpo (NIEHS). 

Related Publication: DJ Stumpo, HE 

Broxmeyer, T Ward, S Cooper, G 

Hangoc, YJ Chung, WC Shelley, EK 

Richfield, MK Ray, MC Yoder, PD 

Aplan, PJ Blackshear. Targeted 

disruption of Zfp36l2, encoding a CCCH 

tandem zinc finger RNA-binding 

protein, results in defective 

hematopoiesis. Blood 2009 Sep 

17;114(12):2401–2410. 

Patent Status: PCT Application Serial 

No. PCT/US08/68900 filed on 01 Jul 

2008 (HHS Reference No. E–255–2007/ 

0–PCT–02). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Tara Kirby, Ph.D.; 

301–435–4426; tarak@mail.nih.gov. 

Collaborative Research Opportunity: 

The NIEHS Laboratory of Signal 

Transduction, Polypeptide Hormone 

Action Group, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize this technology. Please 

contact Elizabeth M. Denholm, Ph.D., 

Director, Office of Technology Transfer, 

NIEHS, at denholme@niehs.nih.gov for 

more information. 

Susceptibility-Matched Multiwell Plates 

for High-Throughput Screening by 

Magnetic Resonance Imaging and 

Nuclear Magnetic Resonance 

Spectroscopy 

Description of Technology: Available 

for licensing and commercial 

development is a patent estate that 

covers multi-well assay plates for highthroughput screening by magnetic 

resonance imaging (MRI) and nuclear 

magnetic resonance (NMR) 

spectroscopy. Multi-well plates are used 

in a wide variety of high-throughput 

measurements in clinical chemistry and 

immunology, as well as in drug 

discovery and other research 

applications. Magnetic resonance 

imaging (MRI) of multi-well plates offers 

the possibility of performing new kinds 

of high-throughput assays, including the 

detection of magnetic nanoparticles 

attached to or within cells. Moreover, 

MRI-guided localized nuclear magnetic 

resonance (NMR) spectroscopy could be 

used to perform detailed chemical 

analysis of complex mixtures of 

metabolites not possible by any other 

common analytical technique. Best of 

all, conventional MRI techniques exist 

which would permit all samples in one 

or more multi-well plate(s) to be 

analyzed simultaneously. 

Unfortunately, conventional multi-well 

plates typically give poor performance 

for MRI-based assays since they provide 

inadequate matching of magnetic 

susceptibility between the plate, the 

sample and their surroundings. This 

results in distortion of the magnetic 

field within the scanner and thus 

reduces the sensitivity for detecting 

magnetic particles and the resolution of 

NMR spectra. 

This invention relates to a new multiwell plate design incorporating onepiece polyetherimide plastic 

construction for improved magnetic 

susceptibility matching for aqueous 

samples. This design can easily be 

extended to non-aqueous samples by the 

selection of an appropriate, 

commercially available plastic resin or 

resin blend. Further enhancement in 

susceptibility matching can be 

accomplished by combining the new 

plate design with plugs for each well 

constructed from the same plastic as the 

plate. These plugs would allow the 

entire thickness of each sample to be 

scanned in chemical analyses, 

improving signal-to-noise ratio and 

sensitivity. These plugs can optionally 

be integrated into a single ‘‘cap mat’’ so 

that the entire assembly can be filled 

and manipulated by standard robotic 

laboratory equipment already in wide 

use in the pharmaceutical industry. 

Alternatively, spherical wells, accessed 

by narrow fill holes, may be molded 

into a solid plate, eliminating the need 

for individual plugs to seal each well. 

The new multi-well plate/plug design 

reduces magnetic field distortions and 

should dramatically improve spectral 

resolution and sensitivity for NMR and 

MRI-based high-throughput screening. 

Applications: 

• NMR Spectroscopy, 

• MRI Imaging of magnetic 

nanoparticles, 

• Clinical Chemistry, 

• Immunology, 

• Drug Discovery, 

• Combinatorial Chemistry, and 

• Quality Control in the 

pharmaceutical, chemical and 

agricultural industries. 

Advantages: 

• Increased signal-to-noise ratio and 

sensitivity relative to conventional 

multi- well plates 

• Portability 

• Compatible with existing highthroughput robots. 

Development Status: Used actively in 

inventor’s lab. 

Inventor: Kenneth W Fishbein (NIA). 

Patent Status: U.S. Patent Application 

No. 12/083,501 filed 30 Dec 2008 (HHS 

Reference No. E–243–2005/0–US–03). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Michael 

Shmilovich, Esq.; 301–435–5019; 

shmilovm@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Magnetic Resonance Imaging & 

Spectroscopy Section, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Nicole Darack, Ph.D. at 301– 

435–3101 or darackn@mail.nih.gov for 

more information. 

Dated: October 5, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–24871 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 


jlentini on DSKJ8SOYB1PROD with NOTICES
53268 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Engineered Biological Pacemakers 

Description of Invention: A common 

symptom of many heart diseases is an 

abnormal heart rhythm or arrhythmia. 

While effectively improving the lives of 

many patients, implantable pacemakers 

have significant limitations such as 

limited power sources, risk of 

infections, potential for interference 

from other devices, and absence of 

autonomic rate modulation. 

The technology consists of biological 

pacemakers engineered to generate 

normal heart rhythm. The biological 

pacemakers include cardiac cells or 

cardiac-like cells derived from 

embryonic stem cells or mesenchymal 

stem cells. The biological pacemakers 

naturally integrate into the heart. Their 

generation of rhythmic electric impulses 

involves coupling factors, such as 

cAMP-dependent PKA and Ca2+- 

dependent CaMK II, which are 

regulatory proteins capable of 

modulating/enhancing interactions (i.e. 

coupling) of the sarcoplasmic reticulumbased, intracellular Ca2+ clock and the 

surface membrane voltage clock, thereby 

converting irregularly or rarely 

spontaneously active cells into 

pacemakers generating rhythmic 

excitations. 

Applications: This technology can be 

utilized in heart disease characterized 

by arrhythmia or situations requiring an 

implantable cardiac pacemaker. 

Advantages: In contrast to current 

implantable cardiac pacemaker 

technology, this technology is not 

externally powered, has a lower risk of 

infection, has decreased potential for 

interference from other devices, and has 

full autonomic rate modulation. 

Development Status: Early stage. 

Inventors: Victor A. Maltsev et al. 

(NIA). 

Publications: 

1. VA Maltsev and EG Lakatta. 

Synergism of coupled 

subsarcolemmal Ca2+ clocks and 

sarcolemmal voltage clocks confers 

robust and flexible pacemaker 

function in a novel pacemaker cell 

model. Am J Physiol Heart Circ 

Physiol. 2009 Mar;296(3):H594– 

H615. 

2. VA Maltsev and EG Lakatta. Dynamic 

interactions of an intracellular Ca2+

clock and membrane ion channel 

clock underlie robust initiation and 

regulation of cardiac pacemaker 

function. Cardiovasc Res. 2008 Jan 

15;77(2):274–284. 

Patent Status: U.S. Provisional 

Application No. 61/180,491 filed 22 

May 2009 (HHS Reference No. E–134– 

2009/0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Fatima Sayyid, 

M.H.P.M.; 301–435–4521; 

sayyidf@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Institute on Aging, 

Cellular Biophysics Section, is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate, or 

commercialize this technology. Please 

contact Vio Conley at 301–496–0477 or 

conleyv@mail.nih.gov for more 

information. 

Sensitizing Cancer Cells to DNA 

Targeted Therapies 

Description of Invention: Chk2 is a 

protein kinase activated in response to 

DNA double strand breaks. In normal 

tissues, Chk2 phosphorylates and 

thereby activates substrates that induce 

programmed cell death, or apoptosis, 

via interactions with p53, E2F1, PML 

proteins. In cancer tissues, where 

apoptosis is suppressed, Chk2 

phosphorylates and inactivates cell 

cycle checkpoints (via interactions with 

Cdc25, phosphatases and Brca1 

proteins), which allows cancer cells to 

repair and tolerate DNA damage. Hence, 

Chk2 inhibitors would be expected to 

protect normal tissues by reducing 

apoptosis, and to sensitize cancer cells 

to DNA-targeted agents. 

Applications: 

• Combination with DNA targeted 

chemotherapeutic agents for the 

treatment of cancers. 

• Single agents therapy for cancers 

with endogenously activated (‘‘addicted 

to’’) Chk2. 

• Antiviral agent against hepatitis, 

herpes viruses and retroviral infections 

(HIV). 

Advantages: Selective enhancement 

of the antiproliferative and proapoptotic 

activities of DNA targeted 

chemotherapeutic agents in tumors with 

inactivated p53, while protection of 

normal tissues by blocking p53- 

mediated apoptosis (‘‘side effects’’) 

induced by the DNA targeted agents. 

Development Status: Optimization of 

chemical structure for improving drug 

delivery and pharmacokinetics. 

Inventors: Yves G Pommier et al. 

(NCI). 

Related Publications: 

1. AG Jobson, JH Cardellina 2nd, D 

Scudiero, S Kondapaka, H Zhang, H 

Kim, R Shoemaker, Y Pommier. 

Identification of a Bisguanylhydrazone [4,4’- 

Diacetyldiphenylureabis(guanylhydrazone); NSC 109555] 

as a Novel Chemotype for Inhibition 

of Chk2 Kinase. Mol Pharmacol. 

2007 Oct;72(4):876–884. 

2. AG Jobson, GT Lountos, PL Lorenzi, 

J Llamas, J Connelly, D Cerna, JE 

Tropea, A Onda, G Zoppoli, S 

Kondapaka, G Zhang, NJ Caplen, JH 

Cardellina, SS Yoo, A Monks, C 

Self, DS Waugh, RH Shoemaker, Y 

Pommier. Cellular inhibition of 

Chk2 kinase and potentiation of 

camptothecins and radiation by the 

novel Chk2 inhibitor PV1019. J 

Pharmacol Exp Ther. 2009 Sep 9; In 

press (Epub ahead of print). 

3. GT Lountos, JE Tropea, D Zhang, AG 

Jobson, Y Pommier, RH Shoemaker, 

DS Waugh. Crystal structure of 

checkpoint kinase 2 in complex 

with NSC 109555, a potent and 

selective inhibitor. Protein Sci. 

2009 Jan;18(1):92–100. 

Patent Status: U.S. Patent Application 

No. 11/989,737 filed 29 Jan 2008 (HHS 

Reference No. E–211–2005/0–US–06); 

Related international patent application 

filings. 

Licensing Status: Available for 

licensing. 

Licensing Contact: Betty B. Tong, 

Ph.D.; 301–594–6565; 

tongb@mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Laboratory of Molecular Pharmacology, 

is seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Please contact John D. 

Hewes, Ph.D. at 301–435–3121 or 

hewesj@mail.nih.gov for more 

information. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53269 

Dated: October 5, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–24869 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0328] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Wound Dressing With Poly (Diallyl 

Dimethyl Ammonium Chloride) 

Additive; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Wound Dressing With Poly 

(Diallyl Dimethyl Ammonium Chloride) 

(pDADMAC) Additive.’’ This guidance 

document describes a means by which 

wound dressing with Poly (diallyl 

dimethyl ammonium chloride) 

(pDADMAC) additive may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule to classify wound 

dressing with pDADMAC additive into 

class II (special controls). This guidance 

document is being immediately 

implemented as the special control for 

wound dressing with pDADMAC 

additive, but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs). 

DATES: Submit written or electronic 

comments on the guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Wound Dressing 

With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8502. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: Sam 

Arepalli, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 3612, 

Silver Spring, MD 20993, 301–796– 

6434. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying into class II (special controls) 

under section 513(f)(2) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360c(f)(2)). This guidance 

document will serve as the special 

control for wound dressing with 

pDADMAC additive. Section 513(f)(2) of 

the act provides that any person who 

submits a premarket notification under 

section 510(k) of the act (21 U.S.C. 

360(k)) for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Thus, FDA is issuing this 

guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on wound 

dressings with pDADMAC additive. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Class II Special 

Controls Guidance Document: Wound 

Dressing With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive,’’ you may either send an email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 240– 

276–3151 to receive a hard copy. Please 

use the document number 1684 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 


jlentini on DSKJ8SOYB1PROD with NOTICES