7548 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 

currently available. CD6 is a potent 

monoclonal antibody against N1 

subtypes of NA that inhibits the 

enzymatic activity of the NA protein, 

including NA variants resistant to NA 

inhibitors. In a murine model of 

infection, a single dose of antibody was 

protective against lethal challenge with 

H1N1 influenza virus. The CD6 

antibody can potentially be used in 

combination with other antibodies in an 

antibody ‘‘cocktail’’ or in conjunction 

with other therapeutic agents. 

Additionally, this unique anti-NA 

antibody may be useful in combination 

with known neutralizing antihemagglutinin (HA) antibodies. 

Potential Commercial Applications 

• Prophylactic and therapeutic 

against influenza virus infections; 

• Diagnostic tests for influenza virus 

infections; and 

• Reagent to measure the potency of 

H1N1 NA in influenza virus vaccines. 

Competitive Advantages 

• Monoclonal antibody demonstrated 

to be effective against circulating H1N1 

influenza viruses; 

• Monoclonal antibody binds a novel, 

conserved epitope spanning NA dimers; 

and 

• Monoclonal antibody is well-suited 

for an antibody cocktail that includes 

anti-HA antibodies. 

Development Stage: Early state; In 

vitro data available; In vivo data 

available (animal). 

Inventors: Hongquan Wan (FDA); 

Maryna Eichelberger (FDA); Hua Yang 

(CDC); James Stevens (CDC); David 

Shore (CDC); and Rebecca Garten (CDC). 

Publication: Wan, H., H. Yang, D. A. 

Shore, R. J. Garten, L. Couzens, J. Gao, 

L. Jiang, P. J. Carney, J. Villanueva, J. 

Stevens, and M. C. Eichelberger. 

‘‘Structural Characterization of a 

Protective Epitope Spanning 

A(H1N1)pdm09 Influenza Virus 

Neuraminidase Monomers.’’ 6:6114, 

Nature Communications, 2015. 

Intellectual Property: HHS Reference 

No. E–005–2015/0—U.S. Provisional 

Patent Application No. 62/088,388 filed 

December 5, 2014. 

Licensing and Collaborative Research 

Opportunity: The invention is owned by 

an Agency of the U.S. Government and 

is available for licensing in accordance 

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

The Food and Drug Administration is 

seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate, or commercialize this 

technology. Parties interested in 

licensing or collaborative research 

activities for this technology should 

contact William Ronnenberg (see FOR

FURTHER INFORMATION CONTACT). 

Dated: February 4, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02887 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0742] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Registration of Producers of Drugs 

and Listing of Drugs in Commercial 

Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On July 8, 

2015, the Agency submitted a proposed 

collection of information entitled 

‘‘Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution’’ to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0045. The 

approval expires on December 31, 2018. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02881 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–N–0001] 

Annual Computational Science 

Symposium; Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration, in cosponsorship with 

the Pharmaceutical Users Software 

Exchange (PhUSE) is announcing a 

public conference entitled ‘‘The FDA/

PhUSE Annual Computational Science 

Symposium.’’ The purpose of the 

conference is to help the broader 

community align and share experiences 

to advance computational science. At 

the conference, which will bring 

together FDA, industry, and academia, 

FDA will update participants on current 

initiatives, and collaborative project 

groups will address specific challenges 

in accessing and reviewing data to 

support product development. These 

project groups will focus on solutions 

and practical ways to implement them. 

DATES: The meeting will be held on 

March 13, 2016, from 3 p.m. to 7 p.m., 

and March 14 to 15, 2016, from 9 a.m. 

to 5:30 p.m. 

ADDRESSES: The meeting will be held at 

the Silver Spring Civic Building at 

Veterans Plaza, One Veterans Pl., Silver 

Spring, MD 20910, 1–240–777–5300. 

FOR FURTHER INFORMATION CONTACT: 

Chris Decker, PhUSE FDA Liaison 

Director, Pharmaceutical Users Software 

Exchange (PhUSE), Kent Innovation 

Centre, Broadstairs, Kent CT10 2QQ, 

United Kingdom; 1–609–514–5105 (US), 

css@phuse.eu. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Since 2008, the Office of 

Computational Science (formerly the 

Computational Science Center) of FDA’s 

Center for Drug Evaluation and Research 

(CDER) has supported CDER’s scientific 

community by offering innovative 

solutions that improve the scientific 

drug review process by integrating data, 

tools, services, and training. Since the 

first Computational Science Symposium 

four years ago, FDA has played an 

important part in the development and 

ongoing support of the conference and 

the associated PhUSE Computational 

Science Working Groups. The PhUSE 

Collaboration was formed to bring 

together experts from industry, FDA and 

other regulatory agencies, academia, and 


asabaliauskas on DSK9F6TC42PROD with NOTICES2
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 7549 

technology providers in specific areas to 

collaborate on computational science, 

describe best practices in challenging 

areas, and propose methods for 

addressing knowledge gaps. A 

description of the project groups and 

planned activities can be found at 

http://www.phuse.eu/css.aspx. 

II. Registration and Accommodations 

A. Registration 

All registrants (with the exception of 

a limited number of speakers and/or 

organizers who will have a 

complimentary registration) will pay a 

fee for this meeting to help defray the 

costs of facilities, materials, and food. 

Seats are limited, and registration will 

be on a first-come, first-served basis. 

To register, please complete the 

registration form online at (https://

www.phuse.eu/PhUSE–CSS–2016- 

Registration.aspx. (FDA has verified the 

Web site address, but is not responsible 

for subsequent changes to the Web site 

after this document publishes in the 

Federal Register). The costs of 

registration for the different categories 

of attendees are as follows: 

Attendee category Fee 

($) 

Government/nonprofit/academia .......................................................................................................................................................... 300 

Industry Organizing Committee & PhUSE Board of Directors (password required) .......................................................................... 350 

Poster presenter (includes the printing of the poster by PhUSE, password required) ....................................................................... 375 

Industry ................................................................................................................................................................................................ 750 

Single-day ............................................................................................................................................................................................ 650 

Registering after the conference begins ............................................................................................................................................. 1250 

Government and nonprofit attendees 

and exhibitors will need an invitation 

code to register at the discounted rate. 

An invitation code can be obtained by 

sending an email to: office@phuse.eu. 

B. Accommodations 

Attendees are responsible for their 

own hotel accommodations. Attendees 

making reservations at the DoubleTree 

by Hilton Silver Spring Hotel are 

eligible for a reduced rate of $189 not 

including applicable taxes. Those 

making reservations online should use 

the following link to receive the reduced 

rate: http://doubletree.hilton.com/en/dt/ 

groups/personalized/D/DCASSDT-PHU20160312/index.jhtml?WT.mc_id=POG. 

If you need special accommodations 

because of disability, please contact 

Chris Decker (see FOR FURTHER

INFORMATION CONTACT) at least 14 days in 

advance. 

III. Transcripts 

We expect that transcripts will be 

available approximately 30 days after 

the meeting. A transcript can be 

obtained either in hard copy or on CD– 

ROM, after submission of a Freedom of 

Information request. Send written 

requests to the Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857. Send faxed requests to 301–827– 

9267. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02877 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0247] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on Formal 

Meetings With Sponsors and 

Applicants for Prescription Drug User 

Fee Act Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on Formal 

Meetings With Sponsors and Applicants 

for Prescription Drug User Fee Act 

Products’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

October 21, 2015, the Agency submitted 

a proposed collection of information 

entitled ‘‘Guidance for Industry on 

Formal Meetings With Sponsors and 

Applicants for Prescription Drug User 

Fee Act Products’’ to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0429. The 

approval expires on December 31, 2018. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://

www.reginfo.gov/public/do/PRAMain. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02889 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting 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: NIGMS Initial Review 

Group, Training and Workforce Development 

Subcommittee—D. 

Date: March 11, 2016. 

Time: 8:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


asabaliauskas on DSK9F6TC42PROD with NOTICES2