2110 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; The NIH/NCATS 

GRDRSM Program: Global Rare 

Diseases Patient Registry Data 

Repository (GRDR) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on July 17, 2014, 

page 44185 and allowed 60-days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. The National 

Center for Advancing Translational 

Sciences (NCATS), National Institutes of 

Health, may not conduct or sponsor, 

and the respondent is not required to 

respond to, an information collection 

that has been extended, revised, or 

implemented on or after October 1, 

1995, unless it displays a currently valid 

OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project 

contact: Dr. Yaffa Rubinstein, Director of 

Patient Resources for Clinical and 

Translational Research at the Office of 

Rare Diseases Research (ORDR), 

NCATS, NIH, Suite 1004, 6701 

Democracy Boulevard, Bethesda, MD 

20892–4874, or call non-toll-free 

number (301) 402–4338 or Email your 

request, including your address to: 

yaffa.rubinstein@nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

Proposed Collection: NIH/NCATS 

GRDRSM Program: Global Rare Diseases 

Patient Registry Data (GRDR), The 

National Center for Advancing 

Translational Sciences (NCATS), 

National Institutes of Health (NIH). 

Need and Use of Information 

Collection: The NIH created the GRDR 

program https://grdr.ncats.nih.gov an 

informatics system and central data 

repository, housed at the NCATS/NIH 

Center to support and accelerate 

research in the cause, diagnosis, and 

treatment of rare diseases. The GRDR 

program collects a wide range of data 

types, including phenotypic and clinical 

information, as well as medical images, 

derived from individuals who 

participate in rare disease patient 

registries, regardless of the source of 

funding. The GRDR program provides 

the infrastructure to store, search across, 

retrieve, and analyze these varied types 

of data. This valuable information will 

help NIH understand and evaluate the 

use of repositories/datasets in the 

research community. The GRDR 

program will support: (1) Mapping data 

to standards; (2) increased visibility for 

participating registries; (3) opportunity 

for cross-disease research; (4) better and 

faster rare disease clinical research. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

334. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hours) 

Total annual 

burden hours 

Request for Open access .................................. Individuals ........................ 2000 1 2/60 67 

Request for Controlled access .......................... Individuals ........................ 1000 1 15/60 250 

Request to Submit ............................................. Individuals ........................ 100 1 10/60 17 

Dated: January 9, 2015. 

Pamela McInnes, 

Deputy Director, NCATS, NIH. 

[FR Doc. 2015–00554 Filed 1–14–15; 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, 

HHS. 

ACTION: Notice. 

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. 209 and 37 CFR part 404 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. 

FOR FURTHER INFORMATION CONTACT: 

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. 

SUPPLEMENTARY INFORMATION: 

Technology descriptions follow. 

Highly Sensitive Tethered-Bead 

Immune Sandwich Assay 

Description of Technology: This 

technology is a highly sensitive 

tethered-bead immune sandwich assay. 

Analyte molecules are captured between 

two antibodies, a capture antibody and 

a detection antibody. The capture 

antibody on a micron-size bead binds 

analyte from a sample fluid. The beadcaptured analyte is then exposed to a 

‘‘detection’’ antibody that binds to the 

bead-captured analyte, forming a 

‘‘sandwich’’. The sandwiched analytebead complex then connects to a 

flexible polymer (such as DNA) 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices 2111 

anchored on a solid surface to form 

tethered particles. Binding the analytebead complex to a flexible polymer 

forms tethered particles and may be 

done, for example, by streptavidin 

biotin. Motion of the tethered beads 

easily identifies bound analyte. The 

tethered beads are quantified using lowmagnification light microscopy. Prior 

enhanced sensitivity tethered bead 

technologies require expensive and 

cumbersome detection equipment. This 

assay is inherently single molecule, low 

background, and works with simple 

inexpensive imaging formats, but is 

automatable and potentially adaptable 

to portable technologies. A prototype 

design using prostate specific antigen 

(PSA) shows detection sensitivity of 

∼.03ng/ml, compared with normal PSA 

sensitivity of ∼< 4ng/ml. Design 

refinements further improve 

sensitivities. 

Potential Commercial Applications: 

Diagnostics and research. 

Competitive Advantages: Highly 

sensitive single molecule adaptable 

format, specific, low background, 

inexpensive, simple to use, automatable 

for image analysis. 

Development Stage: 

• Early-stage 

• Prototype 

Inventors: Jonathan Silver (NHLBI), 

Zhenyu Li (George Washington Univ.), 

Keir Neuman (NHLBI). 

Publication: Silver J, et al. Tetheredbead, immune sandwich assay. Biosens 

Bioelectron. 2015 Jan 15;63:117–23. 

[PMID 25064819]. 

Intellectual Property: HHS Reference 

No. E–188–2014/0—U.S. Provisional 

Application No. 62/015,122 filed June 

20, 2014. 

Licensing Contact: Edward (Tedd) 

Fenn; 424–297–0336; Tedd.fenn@

nih.gov. 

Polyketal Nanoparticle Delivery of CpG 

Oligodeoxynucleotide for Treatment of 

Lung Cancer 

Description of Technology: This 

technology delivers 

oligodexoynucleotide locally to lung 

tumors using polyketal nanoparticles. 

CpG ODNs (oligonucleotides with CpG 

motifs) stimulate anti-tumor immune 

cells via Toll-like receptor 9 and show 

promise as cancer therapeutics in 

preclinical and clinical trials. However, 

previous systemic CpG ODN treatments 

of lung tumors progressed only to Phase 

3 trials. Local CpG ODN delivery 

appears to have superior antitumor 

effect compared to earlier systemic 

treatments. Adsorbing CpG ODNs onto 

biodegradable polyketal (CpG–NP) 

creates 1–3 micron nanoparticles that 

can reach distal alveoli by inhalation. 

This localized treatment improves 

uptake and persistence in the tumor 

microenvironment, resulting in 

decreased immunosuppressive T-Cells 

and increased macrophages. In vivo data 

indicate this therapy reduces tumor 

growth and enhances survival rate in 

lung cancer. Mice treated with CpG–NP 

had fewer and smaller tumor nodules 

(reduced by >90%). In Lewis lung 

carcinoma model, CpG–NP therapy 

significantly improved the survival; 

80% of CpG–NP-treated mice survived 

(some for >1 yr). CpG–NP represents a 

promising potential lung cancer 

therapy. 

Potential Commercial Applications: 

Therapeutic or combination therapy for 

lung cancer treatment. 

Competitive Advantages: 

• Superior therapeutic effect versus 

systemic administration. 

• CpG ODN treatments have well 

studied safety profile in phase 1–3 

clinical trials. 

Development Stage: In vivo data 

available (animal). 

Inventors: Dennis Klinman and 

Takashi Sato (NCI). 

Publication: Klinman D, et al. 

Synthetic oligonucleotides as 

modulators of inflammation. J Leukoc 

Biol. Oct 2008; 84(4): 958–64. [PMID 

18430787]. 

Intellectual Property: HHS Reference 

No. E–159–2014/0—U.S. Provisional 

Application No. 62/024,657 filed July 

15, 2014. 

Licensing Contact: Edward (Tedd) 

Fenn; 424–297–0336; Tedd.fenn@

nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute is seeking 

statements of capability or interest from 

parties interested in collaborative 

research to further develop, evaluate or 

commercialize optimizing delivery of 

immunostimulatory CpG 

oligonucleotides to patients with lung 

cancer. For collaboration opportunities, 

please contact John D. Hewes, Ph.D. at 

john.hewes@nih.gov. 

Aza-Englerin Analogues—Novel 

Natural Product-Based NitrogenContaining Anti-Cancer Agents 

Description of Technology: Available 

for licensing are synthetic compounds 

developed as novel cancer therapeutics. 

Scientists at the National Institutes of 

Health and University of Hawaii have 

designed and synthesized novel azaenglerin analogues that have shown 

great inhibitory effects on cancer cell 

growth. Englerin A is a natural 

compound from the African plant 

Phyllanthus engleri that displays potent 

and selective anti-cancer properties in 

several cancer types and has been found 

to be active in several mouse xenograft 

experiments with human tumor cells 

when injected intraperitoneally. The 

invention provides compositions, 

methods of synthesis and methods of 

using the aza-derivatives of englerin for 

cancer treatment. These englerin 

analogues show significant 

bioavailability after oral administration 

in mice, making them attractive as 

cancer therapeutics. 

Potential Commercial Applications: 

Potential therapeutics for cancer, 

particularly kidney cancer, Ewing’s 

sarcoma, and other cancers with a 

glycolytic phenotype. Potential in 

diabetes and HIV infection. 

Competitive Advantages: 

• Novel compounds with great 

inhibitory effect on select cancer cells, 

designed/synthesized as analogues to 

natural products that show striking anticancer properties. 

• Parent compounds are effective in 

in vivo cancer models. 

• Novel syntheses of the compounds 

of the invention are provided. 

• Bioavailability after oral 

administration in mouse model 

demonstrated, making it suitable for 

clinical usage. 

Development Stage: 

• Early-stage 

• In vitro data available 

• In vivo data available (animal) 

Inventors: John A Beutler (NCI), 

Douglas Figg (NCI), William Chain 

(Univ. of Hawaii-Manoa). 

Publications: 

1. Ratnayake R, et al. Englerin A, a 

selective inhibitor of renal cancer cell 

growth, from Phyllanthus engleri. Org 

Lett. 2009 Jan 1;11(1):57–60. [PMID 

19061394]. 

2. Li Z, et al. A brief synthesis of 

(-)-englerin A. J Am Chem Soc. 2011 

May 4;133(17):6553–6. [PMID 

21476574]. 

3. Akee R, et al. Chlorinated englerins 

with selective inhibition of renal cancer 

cell growth. J Nat Prod. 2012 Mar 

23;75(3):459–63. [PMID 22280462]. 

4. Sourbier C, et al. Englerin A 

stimulates PKC theta to inhibit insulin 

signaling while simultaneously 

activating HSF1: A case of 

pharmacologically induced synthetic 

lethality. Cancer Cell 23 (2):228–237, 

2013. [PMID 23352416]. 

Intellectual Property: 

• HHS Reference No. E–090–2014/

0—U.S. Provisional Patent Application 

No. 61/936,285 filed February 5, 2014. 

• HHS Reference No. E–090–2014/

1—U.S. Provisional Patent Application 

No. 62/018,381 filed June 27, 2014. 

Related Technologies: 

• HHS Reference No. E–064–2008/2– 

US–06—U.S. Patent No. 8,410,292 

issued April 2, 2013. 


rljohnson on DSK3VPTVN1PROD with NOTICES
2112 Federal Register / Vol. 80, No. 10 / Thursday, January 15, 2015 / Notices 

• HHS Reference No. E–042–2012/0– 

US–06—U.S. Patent Application No. 14/ 

370,140 filed July 1, 2014. 

• HHS Reference No. E–201–2012/0– 

PCT–02—PCT Application No. PCT/

US2013/069796 filed November 13, 

2013, which published as WO 2014/

078350 on May 22, 2014. 

Licensing Contact: Surekha Vathyam, 

Ph.D.; 301–435–4076; vathyams@

mail.nih.gov. 

Collaborative Research Opportunity: 

The National Cancer Institute, 

Molecular Targets Development 

Program, is seeking statements of 

capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize aza-englerin analogues as 

cancer inhibitors. For collaboration 

opportunities, please contact John D. 

Hewes, Ph.D. at john.hewes@nih.gov. 

Nicotine Conjugate Treatment for 

Parkinson’s Disease 

Description of Technology: It has been 

known since 1959 that tobacco use has 

protective effects against Parkinson’s 

disease. However, efforts to turn that 

knowledge into a safe and effective 

treatment, divorced from tobacco use, 

have had little success. An inventor at 

FDA now has in vitro evidence that 

nicotine promotes a protein clearance 

system, thereby halting Parkinson’s 

disease progression. In addition to using 

nicotine as the treatment, the inventor 

has created a coated conjugate of 

nicotine and nanoceria. This conjugate 

not only harnesses the power of nicotine 

but also takes advantage of the antioxidant effect of the nanoceria to reduce 

the oxidant environment, which is also 

a major mechanism of neuronal damage 

in Parkinson’s disease. 

Potential Commercial Applications: 

Treatment for Parkinson’s disease. 

Competitive Advantages: Improved 

mechanism to use nicotine as a 

treatment. 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventor: Syed Z. Imam (FDA). 

Intellectual Property: HHS Reference 

No. E–016–2014/0—U.S. Provisional 

Application No. 62/010,033 filed June 

10, 2014. 

Licensing Contact: Jaime M. Greene, 

M.S.; 301–435–5559; greenejaime@

mail.nih.gov. 

Collaborative Research Opportunity: 

The FDA National Center for 

Toxicological Research, Division of 

Neurotoxicology, is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize A Nicotine-NanoCeria 

Conjugate named NIC–NANO for 

treatment of Parkinson’s disease. For 

collaboration opportunities, please 

contact Syed Z Imam at syed.imam@

fda.hhs.gov. 

cGAP–PNA Multivalent Ligand Display 

at the Nanoscale 

Description of Technology: Scientists 

at the NIH are developing new types of 

peptide nucleic acids (PNAs) that 

maintain aqueous solubility at longer 

lengths. This new type of PNA is called 

‘‘cGAP–PNA’’ because it contains a 

sequence complementary to the L–PNA 

sequence, which is a PNA with one or 

more gamma-sidechains that displays a 

ligand. The investigators have 

synthesized cGAP–PNAs that are 60 

nucleobases long that can support the 

assembly of 5 complementary L–PNAs 

(each with 12 nucleobases) that bear 

specific ligands. This platform can 

replace more traditional multivalent 

scaffolds, such as dendrimers and gold 

nanoparticles. 

Potential Commercial Applications: 

Multivalent ligand display. 

Competitive Advantages: 

• Decreased hydrophobicity 

• Increased water solubility 

• Can be used at very long lengths 

• More stable and resistant to 

degradation than existing PNAs 

Development Stage: 

• Early-stage 

• In vitro data available 

Inventors: Daniel H. Appella, Andrew 

V. Dix, Ethan A. Englund, Kara M. 

George Rosenker (all of NIDDK). 

Publication: Dix A, et al. 

Programmable nanoscaffolds that 

control ligand display to a G-proteincoupled receptor in membranes to allow 

dissection of multivalent effects. J Am 

Chem Soc. 2014 Sep 3;136(35):12296– 

303. [PMID 25116377]. 

Intellectual Property: HHS Reference 

No. E–761–2013/0—U.S. Provisional 

Application No. 61/929,893 filed 

January 21, 2014. 

Related Technologies: 

• HHS Reference No. E–308–2006/

3—U.S. Application No. 13/592,490 

filed August 23, 2012. 

• HHS Reference No. E–129–2010/

0—EP Application No. 11721899.0 filed 

May 11, 2011; U.S. Application No. 13/ 

697,123 filed November 9, 2012. 

Licensing Contact: Charlene S. 

Maddox, Ph.D.; 301–435–4689; 

charlene.maddox@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Diabetes and 

Digestive and Kidney Diseases is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize this 

technology. For collaboration 

opportunities, please contact Marguerite 

Miller at Marguerite.Miller@nih.gov or 

301–496–9003. 

Dated: January 9, 2015. 

Richard U. Rodriguez, 

Acting Director, Office of Technology 

Transfer, National Institutes of Health. 

[FR Doc. 2015–00535 Filed 1–14–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Closure Devices for Transcaval Access to the 

Abdominal Aorta. 

Date: February 6, 2015. 

Time: 11:00 a.m. to 1:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Room 7185, Bethesda, MD 

20892, (Telephone Conference Call). 

Contact Person: Kristen Page, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7185, Bethesda, MD 20892, 301–435–0725, 

kristen.page@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 8, 2015. 

Michelle Trout, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–00497 Filed 1–14–15; 8:45 am] 

BILLING CODE 4140–01–P 


rljohnson on DSK3VPTVN1PROD with NOTICES