39454 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list PROLIXIN 

(fluphenazine hydrochloride) tablets, 1 

mg, 2.5 mg, 5 mg, and 10 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to PROLIXIN (fluphenazine 

hydrochloride) tablets, 1 mg, 2.5 mg, 5 

mg, and 10 mg, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: August 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17026 Filed 8–8–18; 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 invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing 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: 

Amy F. Petrik, Ph.D., 240–627–3721, 

amy.petrik@nih.gov. Licensing 

information and copies of the U.S. 

patent application listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Stabilized Group 2 Influenza 

Hemagglutinin Stem Region Trimers 

and Uses Thereof 

Description of Technology: 

Researchers at the Vaccine Research 

Center of the National Institute of 

Allergy and Infectious Diseases (NIAID) 

have designed influenza vaccine 

candidates based on group 2 influenza 

hemagglutinin (HA) proteins. These 

group 2 HA proteins were engineered to 

remove the highly variable head region 

and stabilize the remaining stem region. 

The researchers then fused the 

engineered group 2 HA stabilized stem 

with a ferritin subunit. The resulting 

fusion protein can self-assemble into 

nanoparticles which display group 2 HA 

stem domain trimers on their surface. 

These immunogens elicit crossreactive antibodies to group 2 influenza 

viruses and could be used in 

combination with group 1 HA stemferritin immunogens as a universal 

influenza vaccine. Interestingly, a recent 

study by Andrews et al., Sci. Immunol. 

2, eaan2676 (2017), suggests that crossreactive group 1/group 2 HA stem 

antibodies may be more likely to be 

elicited in humans by a group 2 HA 

immunogen. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404. 

Potential Commercial Applications: 

• Use as a broadly protective influenza 

vaccine 

Competitive Advantages: 

• Elicits antibodies to both group 1 and 

group 2 influenza A viruses 

• Nucleic acid or recombinant proteinbased vaccine 

• Increased ease of production 

compared to current seasonal 

influenza vaccines 

Development Stage: 

• In vivo (animal studies) 

Inventors: Jeffrey C. Boyington, 

Barney S. Graham, John R. Mascola, 

Hadi M. Yassine, Syed M. Moin, 

Lingshu Wang, Kizzmekia S. Corbett, 

Masaru Kanekiyo (all from NIAID). 

Intellectual Property: HHS Reference 

Number E–228–2016 includes U.S. 

Provisional 62/383,267 filed 2 

September 2016 and PCT Patent 

Application No. PCT/US2017/049894 

filed 1 September 2017 (pending). 

Related Intellectual Property: HHS 

Reference Number E–293–2011. 

Licensing Contact: Dr. Amy Petrik, 

240–627–3721; amy.petrik@nih.gov. 

Dated: July 25, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–17036 Filed 8–8–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

[1651–0138] 

Agency Information Collection 

Activities: Biometric Identity 

AGENCY: U.S. Customs and Border 

Protection (CBP), Department of 

Homeland Security. 

ACTION: 30-Day notice and request for 

comments; revision and extension of an 

existing collection of information. 

SUMMARY: The Department of Homeland 

Security, U.S. Customs and Border 

Protection will be submitting the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995 (PRA). The 

information collection is published in 

the Federal Register to obtain comments 

from the public and affected agencies. 

DATES: Comments are encouraged and 

will be accepted (no later than 

September 10, 2018]) to be assured of 

consideration. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to dhsdeskofficer@

omb.eop.gov. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional PRA information 

should be directed to Seth Renkema, 

Chief, Economic Impact Analysis 

Branch, U.S. Customs and Border 

Protection, Office of Trade, Regulations 

and Rulings, 90 K Street NE, 10th Floor, 

Washington, DC 20229–1177, 

Telephone number (202) 325–0056 or 

via email CBP_PRA@cbp.dhs.gov. Please 

note that the contact information 

provided here is solely for questions 

regarding this notice. Individuals 

seeking information about other CBP 

programs should contact the CBP 

National Customer Service Center at 

877–227–5511, (TTY) 1–800–877–8339, 


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