47752 Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices 

for FDA’s Agricultural Biotechnology 

Education and Outreach Initiative. 

III. Participating in the Public Meeting 

Registration: To register for a public 

meeting, please include your name, 

title, firm name, address, and phone and 

fax numbers in your registration 

information and send to: Simone Katz, 

Strategic Results, 101 Lakeforest Blvd., 

Suite 390, Gaithersburg, MD 20877, 

240–449–8427, Fax: 240–641–9042, 

email: simone.katz@

strategicresults.com. You can register for 

one or both meetings. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by October 30, 2017, for the 

Charlotte, NC, meeting and must register 

by November 6, 2017, for the San 

Francisco, CA, meeting. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. Registrants will 

receive confirmation when they have 

been accepted. 

If you need special accommodations 

due to a disability, please contact 

Simone Katz, Strategic Results, 101 

Lakeforest Blvd., Suite 390, 

Gaithersburg, MD 20877, 240–449–8427, 

Fax: 240–641–9042, email: 

simone.katz@strategicresults.com no 

later than October 20, 2017, for the 

Charlotte, NC, meeting and no later than 

October 27, 2017, for the San Francisco, 

CA, meeting. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session or participate 

in a specific session, and which topic(s) 

you wish to address. We will do our 

best to accommodate requests to make 

public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

October 24, 2017, for the meeting in 

Charlotte, NC, and by November 1, 

2017, for the meeting in San Francisco, 

CA. All requests to make oral 

presentations must be received by 

October 20, 2017, for the meeting in 

Charlotte, NC, and by October 27, 2017, 

for the meeting in San Francisco, CA. 

Streaming Webcast of the Public 

Meeting: Each public meeting will also 

be webcast. Individuals who wish to 

participate by webcast are asked to 

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

Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of each public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. 

Other Issues for Consideration: A 

summary of key information on 

participating in a meeting follows: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING

Date Address Preregister Electronic address 

Request to 

make an oral 

presentation 

Special 

accommodations 

Submit either electronic or 

written comments 

November 7, 

2017, from 8:30 

a.m. to 1 p.m. 

EST.

Omni Charlotte 

Hotel, 132 E 

Trade St., 

Charlotte, NC 

28202.

October 30, 

2017: Closing 

date for registration.

Please preregister at https://

www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/default.htm.

October 20, 

2017.

October 20, 

2017: Closing 

date to request special 

accommodations due to a 

disability.

Submit Comments by November 

17, 2017, to: https://

www.regulations.gov, or Dockets Management Staff (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 

20852. 

November 14, 

2017, from 8:30 

a.m. to 1 p.m. 

PST.

San Francisco 

Marriott Marquis, 780 Mission St., San 

Francisco, CA 

94103.

November 6, 

2017: Closing 

date for registration.

Please preregister at https://

www.fda.gov/Food/ 

NewsEvents/ 

WorkshopsMeetingsConferences/default.htm.

October 27, 

2017.

October 27, 

2017: closing 

date to request special 

accommodations due to a 

disability.

Same as above. 

You may also register via email, mail, 

or fax. Please include your name, title, 

firm name, address, and phone and Fax 

numbers in your registration 

information and send to: Simone Katz, 

Strategic Results, 101 Lakeforest Blvd., 

Suite 390, Gaithersburg, MD 20877, 

240–449–8427, Fax: 240–641–9042, 

email: simone.katz@

strategicresults.com. 

Individuals who wish to participate 

by webcast are asked to preregister at: 

https://www.fda.gov/Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. 

Dated: October 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–22172 Filed 10–12–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5953] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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