Annual Computational Science Symposium; Conference, 7548-7549 [2016-02877]

Download as PDF 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. asabaliauskas on DSK9F6TC42PROD with NOTICES2 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 VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 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. 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. 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 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 https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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. 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: SUMMARY: 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 E:\FR\FM\12FEN1.SGM 12FEN1 7549 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 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 https://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–2016Registration.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: Fee ($) Attendee category Government/nonprofit/academia .......................................................................................................................................................... Industry Organizing Committee & PhUSE Board of Directors (password required) .......................................................................... Poster presenter (includes the printing of the poster by PhUSE, password required) ....................................................................... Industry ................................................................................................................................................................................................ Single-day ............................................................................................................................................................................................ Registering after the conference begins ............................................................................................................................................. 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES B. Accommodations 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 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: https://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. asabaliauskas on DSK9F6TC42PROD with NOTICES2 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 VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 Food and Drug Administration [Docket No. FDA–2012–N–0247] AGENCY: 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 Notice. 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. SUMMARY: 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 SUPPLEMENTARY INFORMATION: PO 00000 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 https:// www.reginfo.gov/public/do/PRAMain. Food and Drug Administration, HHS. ACTION: 300 350 375 750 650 1250 Frm 00053 Fmt 4703 Sfmt 4703 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. E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Pages 7548-7549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02877]


-----------------------------------------------------------------------

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

[[Page 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 https://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             350
 (password required)....................................
Poster presenter (includes the printing of the poster by             375
 PhUSE, password required)..............................
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: https://doubletree.hilton.com/en/dt/groups/personalized/D/DCASSDT-PHU-20160312/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
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