Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 47753 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. The meeting will be open to the 

public. 

DATES: The meeting will be held on 

December 12, 2017, from 8 a.m. to 6 

p.m. 

ADDRESSES: Hilton Washington DC 

North/Gaithersburg, salons A, B, C, and 

D, 620 Perry Pkwy., Gaithersburg, MD 

20877. The hotel’s telephone number is 

301–977–8900. 

FOR FURTHER INFORMATION CONTACT: Sara 

J. Anderson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G616, Silver Spring, 

MD 20993–0002, 301–796–7047, 

Sara.Anderson@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: On December 12, 2017, the 

committee will discuss, make 

recommendations, and vote on 

information regarding the premarket 

approval application (PMA) for the 

Barricaid Anular Closure Device by 

Intrinsic Therapeutics. The proposed 

Indication for Use, as stated in the PMA, 

is as follows: The Barricaid is intended 

to be implanted following a limited 

discectomy, to prevent reherniation and 

the recurrence of pain or dysfunction. 

The Barricaid is indicated for patients 

with radiculopathy (with or without 

back pain), a posterior or posterolateral 

herniation, characterized by 

radiographic confirmation of neural 

compression using magnetic resonance 

imaging, and a large anular defect (e.g., 

between 4–6 mm tall and between 6–12 

mm wide) post discectomy, at one level 

between L4 and S1. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before December 1, 2017. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before 

November 3, 2017. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by November 9, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22174 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–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. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 

Technology Transfer, 31 Center Drive 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: This 

notice is 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. A description of the 

technology follows. 

Derivatives of 

Docosahexaenoylethanolamide (DEA) 

for Neurogenesis 

The invention pertains to derivatives 

of docosahexaenoylethanolamide 

(synaptamide or DEA) and their use in 

inducing neurogenesis, neurite growth, 

and/or synaptogenesis. As such, these 

DEA derivatives can be used as 

therapeutics for neurodegenerative 

diseases such as traumatic brain injury, 

spinal cord injury, peripheral nerve 

injury, stroke, multiple sclerosis, 

autism, Alzheimer’s disease, 

Huntington’s disease, Parkinson’s 

disease, amyotrophic lateral sclerosis. 

The DEA derivatives of the invention 

have increased potency and hydrolysis 

resistance as compared to native DEA. 

Docosahexaenoic acid (DHA), an n-3 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
47754 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 

polyunsaturated fatty acid accumulates 

in the brain during development, and 

has been implicated in learning and 

memory development. DEA, a 

metabolite derived from DHA, also has 

been shown to accelerate neuronal 

growth and development. In vitro 

studies in which neural progenitor cells 

were treated with DEA derivatives 

showed an increase in the number of 

somatic neurons produced after 

differentiation. 

Potential Commercial Applications 

• Neurogenesis, 

• Neurite growth, 

• Synaptogenesis, 

• Therapeutics for traumatic brain 

injury, spinal cord injury, peripheral 

nerve injury, stroke, multiple sclerosis, 

autism, Alzheimer’s disease, 

Huntington’s disease, Parkinson’s 

disease, and amyotrophic lateral 

sclerosis. 

Inventors: Erika Englund (NCATS), 

Juan Marugan (NCATS), Samarjit 

Patnaik (NCATS), Hee-Yong Kim 

(NIAAA). 

Intellectual Property: HHS Reference 

No. E–070–2012/0, U.S. Provisional 

Patent Application 61/624,741 filed 

April 16, 2012 (expired), International 

Patent Application PCT/US2013/032333 

filed March 15, 2013 (expired), U.S. 

Patent 9,422,308; German Patent 

602013016154.2, French Patent 

2847178, and UK Patent 2847178. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@nih.gov. 

Dated: October 5, 2017. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development . 

[FR Doc. 2017–22146 Filed 10–12–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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 grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Immune 

System Plasticity in Dental, Oral, and 

Craniofacial Diseases. 

Date: November 1, 2017. 

Time: 2:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Yi-Hsin Liu, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4214, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1781, liuyh@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

263: Innovation for HIV Vaccine Discovery. 

Date: November 3, 2017. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Barna Dey, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3184, 

Bethesda, MD 20892, 301–451–2796, bdey@

mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Epidemiology, Ethical and 

Population Sciences. 

Date: November 3, 2017. 

Time: 2:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Gniesha Yvonne 

Dinwiddie, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 3137, Bethesda, MD 20892, 

dinwiddiegy@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Systems Science and Health in the 

Behavioral and Social Science. 

Date: November 7, 2017. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Ping Wu, Ph.D., Scientific 

Review Officer, HDM IRG, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3166, 

Bethesda, MD 20892, 301–451–8428, wup4@

csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Improving Smoking Cessation in 

Socioeconomically Disadvantaged 

Populations via Scalable Interventions. 

Date: November 7, 2017. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Kristen Prentice, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3112, 

MSC 7808, Bethesda, MD 20892, 301–496– 

0726, prenticekj@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Digestive Sciences. 

Date: November 8–9, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Martha Garcia, Ph.D., 

Scientific Reviewer Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2186, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1243, garciamc@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Computational, Modeling, and 

Biodata Management. 

Date: November 8, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW., 

Washington, DC 20015. 

Contact Person: Allen Richon, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

MSC 7892, Bethesda, MD 20892, 301–379– 

9351, allen.richon@nih.hhs.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Pathophysiology of 

Neurodevelopmental Disorders. 

Date: November 8, 2017. 

Time: 11:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Boris P Sokolov, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217A, 

MSC 7846, Bethesda, MD 20892, 301–408– 

9115, bsokolov@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–17– 

171: Cancer Tissue Engineering Collaborative 

Research. 

Date: November 8, 2017. 

Time: 12:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 


asabaliauskas on DSKBBXCHB2PROD with NOTICES