82_FR_13506 82 FR 13459 - Center for Scientific Review; Notice of Closed Meetings

82 FR 13459 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 47 (March 13, 2017)

Page Range13459-13460
FR Document2017-04807

Federal Register, Volume 82 Issue 47 (Monday, March 13, 2017) 
[Federal Register Volume 82, Number 47 (Monday, March 13, 2017)]
[Notices]
[Pages 13459-13460]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04807]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    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 
meetings.
    The meetings 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: Center for Scientific Review Special Emphasis 
Panel; AREA: Immunology.
    Date: March 9, 2017.
    Time: 12:00 p.m. to 4:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Alok Mulky, Ph.D., Scientific Review Officer, 
Center for Scientific Review (CSR), National Institutes of Health 
(NIH), 6701 Rockledge Dr, Room 4203, Bethesda, MD 20817, (301) 435-
3566, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Neuropharmacology.
    Date: March 28, 2017.
    Time: 2:00 p.m. to 5:30 p.m.

[[Page 13460]]

    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Telephone Conference Call).
    Contact Person: Mary Custer, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892, (301) 435-
1164, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR Panel: Neural Regulation of Cancer.
    Date: March 29, 2017.
    Time: 12:00 p.m. to 4:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301-495-
1718, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; PAR 16-218: Provocative Questions in Pediatric Cancer.
    Date: April 4, 2017.
    Time: 10:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 6701 Rockledge Drive, 
Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Charles Morrow, MD, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD 
20892, 301-451-4467, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: March 7, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-04807 Filed 3-10-17; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices 13459 submission. You should submit two members. More involvement from 1:30 p.m. and 2 p.m. Time allotted for copies total. One copy will include the regulators around the world is expected, oral presentations may be limited to 5 information you claim to be confidential as they will join their counterparts from minutes. Those desiring to make oral with a heading or cover note that states Europe, Japan, USA, Canada, and presentations should notify Amanda ‘‘THIS DOCUMENT CONTAINS Switzerland as ICH regulatory members. Roache (see FOR FURTHER INFORMATION CONFIDENTIAL INFORMATION.’’ The The reforms build on a 25-year track CONTACT) by April 19, 2017, and submit Agency will review this copy, including record of successful delivery of a brief statement of the general nature of the claimed confidential information, in harmonized guidelines for global the evidence or arguments they wish to its consideration of comments. The pharmaceutical development, and their present; the names and addresses, second copy, which will have the regulation. In recent years, many telephone number, fax, and email of claimed confidential information important initiatives have been proposed participants; and an redacted/blacked out, will be available undertaken by regulatory authorities indication of the approximate time for public viewing and posted on and industry associations to promote requested to make their presentation. https://www.regulations.gov. Submit international harmonization of The agenda for the public Webinar will both copies to the Division of Dockets regulatory requirements. FDA has be made available on the Internet at Management. If you do not wish your participated in many meetings designed http://www.fda.gov/Drugs/NewsEvents/ name and contact information to be to enhance harmonization and is ucm536015.htm. made publicly available, you can committed to seeking scientifically Dated: March 7, 2017. provide this information on the cover based harmonized technical procedures Leslie Kux, sheet and not in the body of your for pharmaceutical development. One of Associate Commissioner for Policy. comments and you must identify this the goals of harmonization is to identify [FR Doc. 2017–04839 Filed 3–10–17; 8:45 am] information as ‘‘confidential.’’ Any and then reduce differences in technical information marked as ‘‘confidential’’ requirements for medical product BILLING CODE 4164–01–P will not be disclosed except in development among regulatory accordance with 21 CFR 10.20 and other Agencies. ICH was organized to provide DEPARTMENT OF HEALTH AND applicable disclosure law. For more an opportunity for harmonization HUMAN SERVICES information about FDA’s posting of initiatives to be developed with input comments to public dockets, see 80 FR from both regulatory and industry National Institutes of Health 56469, September 18, 2015, or access representatives. The ICH process has the information at: https://www.gpo.gov/ achieved significant harmonization of Center for Scientific Review; Notice of fdsys/pkg/FR-2015-09-18/pdf/2015- the technical requirements for the Closed Meetings 23389.pdf. approval of pharmaceuticals for human Docket: For access to the docket to use in the ICH regions over the past two Pursuant to section 10(d) of the read background documents or the decades. The current ICH process and Federal Advisory Committee Act, as electronic and written/paper comments structure can be found at the following amended (5 U.S.C. App.), notice is received, go to https:// Web site: http://www.ich.org. (FDA has hereby given of the following meetings. www.regulations.gov and insert the verified the Web site addresses as of the The meetings will be closed to the docket number, found in brackets in the date this document publishes in the public in accordance with the heading of this document, into the Federal Register, but Web sites are provisions set forth in sections ‘‘Search’’ box and follow the prompts subject to change over time.) 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., and/or go to the Division of Dockets as amended. The grant applications and Management, 5630 Fishers Lane, Rm. II. Webinar Attendance and the discussions could disclose 1061, Rockville, MD 20852. Participation confidential trade secrets or commercial FOR FURTHER INFORMATION CONTACT: A. Registration property such as patentable material, Amanda Roache, Food and Drug and personal information concerning If you wish to attend the meeting, individuals associated with the grant Administration, Center for Drug please register at the following Web site: Evaluation and Research, Office of applications, the disclosure of which https://ich_regional_consultation. would constitute a clearly unwarranted Strategic Programs, 10903 New eventbrite.com. Registrations may be Hampshire Ave., Bldg. 51, Rm. 1176, invasion of personal privacy. limited, so early registration is Silver Spring MD, 20993, 301–796– recommended. Registration is free and Name of Committee: Center for Scientific 4548, email: Review Special Emphasis Panel; AREA: will be on a first-come, first-served Amanda.Roache@fda.hhs.gov. Immunology. basis. However, the number of Date: March 9, 2017. SUPPLEMENTARY INFORMATION: participants from each organization may Time: 12:00 p.m. to 4:00 p.m. be limited based on space limitations. Agenda: To review and evaluate grant I. Background Registrants will receive confirmation applications. The ICH, formerly known as the once they have been accepted. If you Place: National Institutes of Health, 6701 International Conference on need special accommodations because Rockledge Drive, Bethesda, MD 20892 Harmonisation, was established in 1990 of a disability, please contact Amanda (Telephone Conference Call). as a joint regulatory/industry project to Roache (see FOR FURTHER INFORMATION Contact Person: Alok Mulky, Ph.D., improve, through harmonization, the Scientific Review Officer, Center for CONTACT) at least 7 days before the efficiency of the process for developing Scientific Review (CSR), National Institutes mstockstill on DSK3G9T082PROD with NOTICES meeting. of Health (NIH), 6701 Rockledge Dr, Room and registering new medicinal products 4203, Bethesda, MD 20817, (301) 435–3566, in Europe, Japan, and the United States B. Requests for Oral Presentations alok.mulky@nih.gov. without compromising the regulatory Interested persons may present data, Name of Committee: Center for Scientific obligations of safety and effectiveness. information, or views orally or in Review Special Emphasis Panel; Member In 2015 the ICH was reformed to make writing on issues pending at the public Conflict: Neuropharmacology. the ICH a true global initiative that meeting. Public oral presentations will Date: March 28, 2017. expands beyond the previous ICH be scheduled between approximately Time: 2:00 p.m. to 5:30 p.m. VerDate Sep<11>2014 17:49 Mar 10, 2017 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1

13460 Federal Register / Vol. 82, No. 47 / Monday, March 13, 2017 / Notices Agenda: To review and evaluate grant commercialization of results of Inventors: Mark Connors, Jinghe applications. federally-funded research and Huang, Byong Ha Kang, John Mascola, Place: National Institutes of Health, 6701 development. Foreign patent Elise Ishida, Tongqing Zhou, Peter Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). applications are filed on selected Kwong, Anqi Zheng, all of NIAID. Contact Person: Mary Custer, Ph.D., inventions to extend market coverage Publications: Huang, Jinghe, et al. Scientific Review Officer, Center for for companies and may also be available ‘‘Identification of a CD4-binding-site Scientific Review, National Institutes of for licensing. antibody to HIV that evolved near-pan Health, 6701 Rockledge Drive, Room 4148, FOR FURTHER INFORMATION CONTACT: neutralization breadth.’’ Immunity 45.5 MSC 7850, Bethesda, MD 20892, (301) 435– Licensing information and copies of the (2016): 1108–1121. 1164, custerm@csr.nih.gov. patent applications listed below may be Intellectual Property: HHS Reference Name of Committee: Center for Scientific obtained by communicating with the Review Special Emphasis Panel; PAR Panel: No. E–131–2015 et seq.—US provisional Neural Regulation of Cancer. indicated licensing contact at the application 62/136,228, US provisional Date: March 29, 2017. Technology Transfer and Intellectual application 62/250,378, and PCT Time: 12:00 p.m. to 4:30 p.m. Property Office, National Institute of application PCT/US2016/023145. Agenda: To review and evaluate grant Allergy and Infectious Diseases, 5601 Licensing Contact: Chris Kornak, 240– applications. Fishers Lane, Rockville, MD 20852; tel. 627–3705, chris.kornak@nih.gov. Place: National Institutes of Health, 6701 301–496–2644. A signed Confidential Rockledge Drive, Bethesda, MD 20892 Disclosure Agreement will be required Collaborative Research Opportunity: (Virtual Meeting). to receive copies of unpublished patent The Technology Transfer and Contact Person: Rolf Jakobi, Ph.D., Intellectual Property Office (TTIPO) is Scientific Review Officer, Center for applications. seeking parties interested in Scientific Review, National Institutes of SUPPLEMENTARY INFORMATION: collaborative research to further co- Health, 6701 Rockledge Drive, Room 6187, Technology description follows. develop this technology. For MSC 7806, Bethesda, MD 20892, 301–495– 1718, jakobir@mail.nih.gov. N6, A Novel, Broad, Highly Potent HIV- collaboration opportunities, please Specific Antibody contact Chris Kornak, 240–627–3705, Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 16– chris.kornak@nih.gov. Description of Technology 218: Provocative Questions in Pediatric Dated: March 3, 2017. Cancer. The N6 antibody has evolved a Suzanne Frisbie, Date: April 4, 2017. unique mode of binding that depends Deputy Director, Technology Transfer and Time: 10:00 a.m. to 5:00 p.m. less on a variable area of the HIV Agenda: To review and evaluate grant Intellectual Property Office, National Institute envelope known as the V5 region and of Allergy and Infectious Diseases. applications. focuses more on conserved regions, Place: National Institutes of Health, 6701 [FR Doc. 2017–04834 Filed 3–10–17; 8:45 am] which change relatively little among Rockledge Drive, Bethesda, MD 20892 BILLING CODE 4140–01–P (Virtual Meeting). HIV strains. This allows N6 to tolerate Contact Person: Charles Morrow, MD, changes in the HIV envelope, including Ph.D., Scientific Review Officer, Center for the attachment of sugars in the V5 DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of region, a major mechanism by which HUMAN SERVICES Health, 6701 Rockledge Drive, Room 6202, HIV develops resistance to other VRC01- MSC 7804, Bethesda, MD 20892, 301–451– class antibodies. N6 was shown in pre- National Institutes of Health 4467, morrowcs@csr.nih.gov. clinical studies to neutralize (Catalogue of Federal Domestic Assistance approximately 98 percent of HIV National Institute of Allergy and Program Nos. 93.306, Comparative Medicine; isolates tested. The studies also Infectious Diseases; Notice of Closed 93.333, Clinical Research, 93.306, 93.333, demonstrate that N6 neutralizes Meeting 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National approximately 80 percent of HIV isolates which were resistant to other Pursuant to section 10(d) of the Institutes of Health, HHS) antibodies of the same class, and does Federal Advisory Committee Act, as Dated: March 7, 2017. amended (5 U.S.C. App.), notice is so very potently. Its breadth and Natasha M. Copeland, potency makes N6 a highly desirable hereby given of the following meeting. Program Analyst, Office of Federal Advisory candidate for development in The meeting will be closed to the Committee Policy. therapeutic or prophylactic strategies. public in accordance with the [FR Doc. 2017–04807 Filed 3–10–17; 8:45 am] This technology is available for provisions set forth in sections BILLING CODE 4140–01–P licensing for commercial development 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., in accordance with 35 U.S.C. 209 and 37 as amended. The grant applications and CFR part 404, as well as for further the discussions could disclose DEPARTMENT OF HEALTH AND development and evaluation under a confidential trade secrets or commercial HUMAN SERVICES research collaboration. property such as patentable material, and personal information concerning National Institutes of Health Potential Commercial Applications individuals associated with the grant • HIV therapeutic applications, the disclosure of which Government-Owned Inventions; • HIV prophylactic would constitute a clearly unwarranted Availability for Licensing Competitive Advantages invasion of personal privacy. mstockstill on DSK3G9T082PROD with NOTICES AGENCY: National Institutes of Health, • Neutralized 98 percent of HIV Name of Committee: National Institute of HHS. Allergy and Infectious Diseases Special ACTION: Notice. isolates tested. Emphasis Panel NIAID; Investigator Initiated • Neutralized 80 percent of HIV Program Project Applications (P01). SUMMARY: The invention listed below is isolates which were resistant to other Date: March 29, 2017. owned by an agency of the U.S. antibodies of the same class, and does Time: 11:00 a.m. to 3:30 p.m. Government and is available for so very potently. Agenda: To review and evaluate grant licensing to achieve expeditious Development Stage: Pre-Clinical. applications. VerDate Sep<11>2014 17:49 Mar 10, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\13MRN1.SGM 13MRN1


Document Created: 2018-02-01 14:57:45
Document Modified: 2018-02-01 14:57:45
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesMarch 9, 2017.
FR Citation82 FR 13459 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR