41970 Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–4866 for the ‘‘Pediatric PostMarketing Pharmacovigilance and Drug 

Utilization Reviews’’ that have been 

posted on FDA’s Web site between 

March 11, 2017, and September 12, 

2017, but not presented at the 

September 12, 2017, PAC meeting. 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff office 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth Quinto, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5145, Silver Spring, 

MD 20993, 240–402–2221, email: 

kenneth.quinto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

responsible for protecting the public 

health by assuring the safety, efficacy, 

and security of human and veterinary 

drugs, biological products, medical 

devices, our Nation’s food supply, 

cosmetics, and products that emit 

radiation. 

FDA is establishing a public docket, 

Docket No. FDA–2017–N–4866, to 

receive input on pediatric postmarketing pharmacovigilance and drug 

utilization reviews posted between 

March 11, 2017, and September 12, 

2017, available on FDA’s Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

PediatricAdvisoryCommittee/ 

ucm510701.htm, but not presented at 

the September 12, 2017, PAC meeting. 

FDA welcomes comments by members 

of the PAC, as mandated by the Best 

Pharmaceuticals for Children Act (Pub. 

L. 107–109) and the Pediatric Research 

Equity Act (Pub. L. 108–155), interested 

parties (such as academic researchers, 

regulated industries, consortia, and 

patient groups), and the general public. 

The docket number is FDA–2017–N– 

4866. The docket will open on October 

9, 2017, and remain open until October 

20, 2017. These pediatric postmarketing pharmacovigilance and drug 

utilization reviews are for the following 

products from the following centers at 

FDA: 

Center for Biologics Evaluation and 

Research 

1. GRASTEK (Timothy Grass Pollen 

Allergen Extract) Tablet for 

Sublingual Use 

2. ORALAIR (Sweet Vernal, Orchard, 

Perennial Rye, Timothy, and 

Kentucky Blue Grass Mixed Pollens 

Allergen Extract) Tablet for 

Sublingual Use 

Center for Drug Evaluation and 

Research 

1. ALOXI (palonosetron hydrochloride) 

2. ARNUITY ELLIPTA (fluticasone 

furoate) 

3. ASMANEX HFA and ASMANEX 

TWISTHALER (mometasone furoate 

inhalation) 

4. CYMBALTA (duloxetine) 

5. EMSAM (selegiline transdermal 

system) 

6. LATISSE (bimatoprost ophthalmic 

solution) 0.03% 

7. NAMENDA (memantine 

hydrochloride) and NAMENDA XR 

(memantine hydrochloride) 

extended-release 

8. PRIFTIN (rifapentine) 

9. REYATAZ (atazanavir) 

10. TACLONEX (betamethasone 

dipropionate/calcipotriene hydrate) 

Topical Suspension 0.064%/ 

0.005% and TACLONEX 

(betamethasone dipropionate/ 

calcipotriene hydrate) Topical 

Ointment 0.064%/0.005% 

11. ZETONNA (ciclesonide) 

Dated: August 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18690 Filed 9–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Apparatus for 

Microarray Binding Sensors Having 

Biological Probe Materials Using 

Carbon Nanotube Transistors 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Commercialization 

Patent License to practice the inventions 

embodied in the Patents and Patent 

Applications listed in the 

SUPPLEMENTARY INFORMATION section of 

this notice to Nanobernetics, LLC 

(‘‘Nanobernetics’’) located in Maryland. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before September 20, 2017 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

Exclusive Commercialization Patent 

License should be directed to: Jaime M. 

Greene, Senior Licensing and Patenting 

Manager, NCI Technology Transfer 

Center, 9609 Medical Center Drive, Rm. 

1E530 MSC 9702, Bethesda, MD 20892– 

9702 (for business mail), Rockville, MD 

20850–9702 Telephone: (240)-276–5530; 

mstockstill on DSK30JT082PROD with NOTICES

Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices 41971 

Facsimile: (240)-276–5504 Email: 

greenejaime@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

EP Patent 1999277 (Application No. 

07753436.0) filed 19 March 2007, titled 

‘‘Apparatus for biosensor microarrays based 

on carbon nanotube transistors having 

biological probe materials, method for its 

production and method of electronically 

detecting a biological target material’’, 

validated in FR, DE, IE, and GB, HHS 

Reference No.: E–056–2007/0–EP–04; 

Australia Patent 2007227415 (Application 

No. 2007227415) filed 10/16/08, titled 

‘‘Apparatus for microarray binding sensors 

having biological probe materials using 

carbon nanotube transistors’’, HHS Reference 

No.: E–056–2007/0–AU–05; 

Canada Patent 2646465 (Application No. 

2646465) filed 03/19/07, titled ‘‘Apparatus 

for microarray binding sensors having 

biological probe materials using carbon 

nanotube transistors’’, HHS Reference No.: E– 

056–2007/0–CA–06; 

Japan Patent 5048752 (Application No. 

2009–501490) filed 03/19/07, titled 

‘‘Apparatus for microarray binding sensors 

having biological probe materials using 

carbon nanotube transistors’’, HHS Reference 

No.: E–056–2007/0–JP–07; 

EP Patent 2570490 (Application No. 

12160369.0) filed 03/19/07, titled ‘‘Apparatus 

for microarray binding sensors having 

biological probe materials using carbon 

nanotube transistors’’, validated in FR, DE, 

and GB. HHS Reference No.: E–056–2007/0– 

EP–08; 

U.S. Patent 8,017,938 (Application No. 11/ 

723,369), filed 19 March 2007, titled 

‘‘Apparatus for Microarray Binding Sensors 

Having Biological Probe Materials Using 

Carbon Nanotube Transistors’’, HHS Ref. No.: 

E–056–2007/0–US–03; and 

PCT Application No. PCT/US2007/06809, 

filed 19 March 2007, now abandoned, titled 

‘‘Apparatus for Microarray Binding Sensors 

Having Biological Probe Materials Using 

Carbon Nanotube Transistors’’, HHS Ref. No.: 

E–056–2007/0–PCT–02. 

U.S. Provisional Patent Application No. 

60/743,524, filed 17 March 2006, now 

abandoned, titled ‘‘Apparatus for Microarray 

DNA Binding Sensors Using Carbon 

Nanotube Transistors’’, HHS Ref. No.: E–056– 

2007/0–US–01. 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The prospective exclusive license 

territory may be worldwide and the 

field of use may be limited to: ‘‘The 

development of an FDA-approved or 

cleared in vitro diagnostic for the 

detection of hematological 

malignancies, wherein nucleic acids 

encoding one or more of the following 

genes are detected: (1) BCR–ABL, (2) 

FLT3, (3) Btk, (4) Alk, (5) Bcl–2, (6) Akt, 

and (7) PI3K.’’ 

This technology discloses a 

microarray apparatus that uses carbon 

nanotubes transistors and electronic 

circuitry to quantitatively measure 

changes in gene expression levels. 

Typically, microarrays are microscope 

glass slides spotted with thousands of 

different genes. The array does not have 

built-in reader, and the detection is 

performed using a fluorescence scanner 

after hybridization with fluorescenttagged target DNA. For simple nucleic 

acid detection, current methods rely 

upon various combinations of 

enzymatic amplification of nucleic acids 

and fluorescent labeling of targets, 

which entail enzymatic manipulation of 

the nucleic acid being tested and 

chemical labeling, respectively. These 

methods are both time consuming and 

afford limited sensitivity. In cases where 

microarray technology is used as a tool 

for monitoring gene expression patterns 

and profiling of micro RNA (miRNA) in 

normal and cancerous tissue, 

quantification of changes has typically 

been optically-based. While this 

technique is highly sensitive, use of 

optical methods impedes progress in 

both system miniaturization and in 

direct interfacing with data collection 

electronics. 

To overcome the limitation of current 

microarray technologies, the inventors 

have developed a highly sensitive 

microarray apparatus that uses carbon 

nanotube transistors for the electronic 

detection of biological probe-target 

binding. The present invention provides 

an apparatus for biological target 

material detection which uses an array 

of carbon nanotube transistors, with 

each being operated as a field effect 

transistor. A single carbon nanotube 

transistor is associated with a distinct 

biological probe material. The current 

versus voltage characteristics or 

transconductance between the source 

and drain electrodes is measured before 

and after a binding event between the 

biological probe and target materials. By 

using a mathematical relationship, the 

exact amount of target binding can be 

extracted. Importantly, the present 

apparatus offers a significant advantage 

in simplicity of protocol as the method 

used therewith does not require 

chemical or enzymatic manipulation of 

the target being detected. 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published notice, the National 

Cancer Institute receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404. 

Complete applications for a license in 

the prospective field of use that are filed 

in response to this notice will be treated 

as objections to the grant of the 

contemplated Exclusive 

Commercialization Patent License 

Agreement. Comments and objections 

submitted to this notice will not be 

made available for public inspection 

and, to the extent permitted by law, will 

not be released under the Freedom of 

Information Act, 5 U.S.C. 552. 

Dated: August 25, 2017. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2017–18668 Filed 9–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; NCI Cancer Genetics 

Services Directory Web-Based 

Application and Update Mailer 

(National Cancer Institute) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Cancer Institute (NCI) will 

publish periodic summaries of propose 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 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: Margaret Beckwith, Office of 

Cancer Content, Office of 

Communications and Public Liaison 

(OCPL), 9609 Medical Center Drive, 

Rockville, MD 20892 or call non-tollfree number 240–276–6600 or email 

your request, including your address to: 

nciocpl@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

SUPPLEMENTARY INFORMATION: Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires: Written 

mstockstill on DSK30JT082PROD with NOTICES