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, 7547 [2016-02880]

Download as PDF asabaliauskas on DSK9F6TC42PROD with NOTICES2 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 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 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 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). VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 Dated: February 8, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2016–02857 Filed 2–11–16; 8:45 am] 7547 [Docket No. FDA–2016–N–0148] Food and Drug Administration BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Government-Owned Inventions; Availability for Licensing; Influenza Virus Neuramindase AGENCY: ACTION: [Docket No. FDA–2009–D–0268] Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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 https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Notice. 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. SUMMARY: 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. 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 E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02880]

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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 https://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

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