Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 53509 

Dockets Management Staff, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

BRUDAC@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 02BC;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: The committee will discuss 

new drug application (NDA) 208088, 

oral testosterone undecanoate capsules, 

submitted by Lipocine Inc. for the 

proposed indication of testosterone 

replacement in males for conditions 

associated with a deficiency or absence 

of endogenous testosterone: primary 

hypogonadism (congenital or acquired) 

and hypogonadotropic hypogonadism 

(congenital or acquired). 

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 02BC;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. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section) on 

or before December 22, 2017, will be 

provided to the committee. 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 

December 14, 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 December 15, 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 special accommodations 

due to a disability, please contact 

Kalyani Bhatt 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/Advisory

Committees/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: November 13, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24832 Filed 11–15–17; 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 

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. 

Chimeric Antibodies Against Hepatitis 

B e-Antigen 

Description of Technology: The 

invention relates to recombinant 

chimeric rabbit/human monoclonal 

antibody fragments (Fabs) against 

hepatitis B Virus e-antigen (HBeAg). 

Viral hepatitis is the seventh leading 

cause of death worldwide. Hepatitis B 

core antigen (HBcAg) forms an 

icosahedral structure containing the 

viral genome. Both the HBcAg and the 

HBeAg of interest here are expressed by 

two different start codons of the viral C 

gene. Unlike the related HBcAg which 

activates type 1 T helper (Th1) cells 

leading to immune attack, the HBeAg 

activates Th2 cells which promote 

immune tolerance. The long-term 

persistence of HBeAg is associated with 

the development of hepatocellular 

carcinoma. Conversely, HBeAg 

seroconversion (from HBeAg carrier to 

anti-HBeAg carrier) is a marker for 

successful therapy of chronically 

infected patients. The presently phage 

display engineered antibody has 

potential for anti-hepatitis B virus 

therapeutic interventions. 

Potential Commercial Applications: 

• Hepatitis B therapy. 

• Hepatocellular carcinoma 

prophylaxis. 

Development Stage: 

• In vitro data available. 

Inventors: Paul Winfield, Norman 

Watts, Alasdair Steven (all of NIAMS). 

Intellectual Property: HHS Reference 

No. E–192–2017/0–US–01. 

• U.S. Provisional Patent Application 

62/534,603 filed July 19, 2017. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Environmental 

Health Sciences seeks statements of 

capability or nterest from parties 

interested in collaborative research to 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
53510 Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices 

further develop and evaluate, please 

contact Cecilia Pazman, Ph.D., 

Technology Development Specialist, 

Office of Technology Transfer, National 

Heart, Lung, and Blood Institute, Phone: 

(301) 594–4273; pazmance@

nhlbi.nih.gov . 

Dated: November 6, 2017. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2017–24773 Filed 11–15–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Dysregulation of Immune 

Cell Regulatory Pathways by MTB in the 

Context of HIV Infection (R61/R33). 

Date: December 11–12, 2017. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: J. Bruce Sundstrom, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

Room 3G11A, National Institutes of Health/ 

NIAID, 5601 Fishers Lane, MSC 9823, 

Bethesda, MD 20892–9823, 240–669–5045, 

sundstromj@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Global Infectious Disease 

Research Administration Development 

Award For Low-And Middle-Income Country 

Institutions (G11). 

Date: December 13, 2017. 

Time: 1:00 p.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Dharmendar Rathore, 

Ph.D., Senior Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3G30, National 

Institutes of Health/NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

240–669–5058, rathored@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: November 9, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–24762 Filed 11–15–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; NCI Cancer 

Genetics Services Directory WebBased Application and Update Mailer 

(National Cancer Institute) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with 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. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: 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: Desk 

Officer for NIH. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Margaret 

Beckwith, Office of Cancer Content, 

Office of Communications and Public 

Liaison (OCPL), 9609 Medical Center 

Drive, Rockville, MD 20892 or call nontoll-free number 240–276–6600 or email 

your request, including your address to: 

nciocpl@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on September 5, 2017 page 

41971 (82 FR 41971) 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 Cancer Institute (NCI), 

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. 

In compliance with 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. 

Proposed Collection: NCI Cancer 

Genetics Services Directory Web-Based 

Application and Update Mailer, 0925– 

0639, Exp., date 10/31/2017, 

Reinstatement without change, National 

Cancer Institute (NCI), National 

Institutes of Health (NIH). 

Need and Use of Information 

Collection: The Office of 

Communications and Public Liaison has 

created the NCI Cancer Genetics 

Services Directory on NCI’s Web site 

Cancer.gov. This directory is a 

searchable collection of information 

about professionals who provide 

services related to cancer genetics. 

These services include cancer risk 

assessment, genetic counseling, and 

genetic susceptibility testing. The 

professionals have applied to be in the 

directory using an online application 

form and have met basic criteria 

outlined on the form. 

There are currently 552 genetics 

professionals listed in the directory. 

Approximately 30–60 new professionals 

are added to the directory each year. 

The applicants are nurses, physicians, 

genetic counselors, and other 

professionals who provide services 

related to cancer genetics. The 

information collected on the application 

form includes name, professional 

qualifications, practice locations, and 

the area of specialization. The 

information is updated annually using a 

Web-based update mailer that mirrors 

the application form. 

The NCI Cancer Genetics Services 

Directory is a unique resource for cancer 

patients and their families who are 


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