Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 7547 

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 http://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 March 24, 2016. 

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 March 

16, 2016. 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 March 17, 2016. 

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 Cindy Hong 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 

http://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: February 8, 2016. 

Jill Hartzler Warner, 

Associate Commissioner for Special Medical 

Programs. 

[FR Doc. 2016–02857 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–2009–D–0268] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Labeling of Certain Beers Subject to 

the Labeling Jurisdiction of the Food 

and Drug Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Labeling of Certain Beers Subject to the 

Labeling Jurisdiction of the Food and 

Drug Administration’’ 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 

December 9, 2015, the Agency 

submitted a proposed collection of 

information entitled ‘‘Labeling of 

Certain Beers Subject to the Labeling 

Jurisdiction of the Food and Drug 

Administration’’ 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 0910–0728. The 

approval expires on January 31, 2019. 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. 2016–02880 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–0148] 

Government-Owned Inventions; 

Availability for Licensing; Influenza 

Virus Neuramindase 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed in this 

document is owned by an Agency of the 

U.S. Government and is available for 

licensing in accordance with Federal 

regulations to achieve expeditious 

commercialization of results of 

Federally funded research and 

development. 

FOR FURTHER INFORMATION CONTACT: 

For licensing information and copies 

of the patent applications: Alice Welch, 

Technology Transfer Program Office, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4226, Silver Spring, MD 20993, 240– 

402–2561, FAX: 301–847–3539. A 

signed Confidential Disclosure 

Agreement will be required to receive 

copies of the patent applications. 

For parties interested in licensing or 

collaborative research activities: 

William Ronnenberg, Technology 

Transfer Program Office, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4214, Silver Spring, 

MD 20993, 240–402–4561, 

William.ronnenberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Technology description. 

Title of Abstract: Therapeutic and 

prophylactic anti-Influenza virus 

neuraminidase 1 (N1) antibody (CD6) 

with a novel epitope that spans 

neuramindase (NA) dimers. 

Description of Technology: Influenza 

virus neuramindase (NA) protein is a 

surface protein that plays an essential 

role in virus replication. Drugs and 

antibodies that block NA function can 

reduce both the symptoms and the 

length of illness; however, variants of 

influenza virus are resistant to NA 

inhibitors. The neuramindase 1 (N1) 

subtype of NA is important because it is 

found in the two pandemic H1N1 

influenza virus strains (1918 Spanish flu 

and 2009 swine flu) and the H5N1 avian 

influenza virus. Anti-neuramindase 

antibody CD6 is a novel antibody that 

spans a conserved 30 amino acid 

epitope across the lateral face of a 

neuramindase (NA) dimer. 

The subject technology may offer an 

alternative to therapeutic NA inhibitors 


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