Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), 4365-4366 [2017-00766]

Download as PDF Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices and related dementias and recruitment challenges. Additional presentations in the afternoon will include updates on progress towards a Care and Services Summit, federal workgroup updates, and preparation for the Advisory Council’s 2017 Recommendations, due in April 2017. Procedure and Agenda: This meeting is open to the public. Please allow 45 minutes to go through security and walk to the meeting room. The meeting will also be webcast at www.hhs.gov/live. Authority: 42 U.S.C. 11225; Section 2(e)(3) of the National Alzheimer’s Project Act. The panel is governed by provisions of Public Law 92–463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. Dated: January 5, 2017. Kathryn E. Martin, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2017–00606 Filed 1–12–17; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK3SPTVN1PROD with NOTICES National Cancer Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (http:// videocast.nih.gov). 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: National Cancer Advisory Board. Date: February 15, 2017. VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 Open: 1:00 p.m. to 2:00 p.m. Agenda: Program reports and presentations; business of the Board. Closed: 2:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove 9609 Medical Center Drive, Room TE406 Rockville, MD 20850 (Virtual Meeting). Contact Person: Paulette S. Gray, Ph.D., Executive Secretary, Division of Extramural Activities, National Cancer Institute—Shady Grove National Institutes of Health, 9609 Medical Center Drive, Room 7W444, Bethesda, MD 20892, 240–276–6340, grayp@ mail.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: http:// deainfo.nci.nih.gov/advisory/ncab/ncab.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: January 9, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. 4365 Name of Committee: National Institute on Aging Special Emphasis Panel; Predictors and Determinants of Age-Related Resiliencies to Physical Stressors, RFA–AG–014 (UH2). Date: February 23, 2017. Time: 2:30 p.m. to 4:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Carmen Moten, Ph.D., MPH, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7703, cmoten@mail.nih.gov. Name of Committee: National Institute on Aging Special Emphasis Panel; Late Onset of Alzheimer’s Disease (LOAD), PAR–16–205 (U24). Date: March 7, 2017. Time: 10:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Carmen Moten, Ph.D., MPH, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–402–7703, cmoten@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: January 10, 2017. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2017–00733 Filed 1–12–17; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2017–00579 Filed 1–12–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 National Institutes of Health Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) National Institutes of Health (NIH), HHS. ACTION: Notice of action under the NIH Guidelines. AGENCY: The National Institutes of Health (NIH) considered a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (http:// www.osp.od.nih.gov/sites/default/files/ SUMMARY: E:\FR\FM\13JAN1.SGM 13JAN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES 4366 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal. FOR FURTHER INFORMATION CONTACT: If you have questions, or require additional background information about this action, please contact the NIH by email at SciencePolicy@od.nih.gov, or by telephone at 301–496–9838 and reference this notice. SUPPLEMENTARY INFORMATION: This final action does not allow an investigator at the University of Chicago to transfer chloramphenicol resistance to three different Rickettsia species: Rickettsia typhi, rickettsii, and felis. The investigator also proposed to transfer chloramphenicol resistance to a fourth Rickettsia species, R. conorii. Transfer of chloramphenicol resistance to R. conorii was previously approved by the NIH Director as a Major Action (see 73 FR 32719) and therefore did not need to be reviewed and approved under Section III–A–1–a of the NIH Guidelines. Thus, the University of Chicago investigator was allowed to proceed with the transfer of chloramphenicol resistance to R. conorii under Section III–B–2 of the NIH Guidelines. The proposal to transfer chloramphenicol resistance to R. typhi, rickettsii, and felis was discussed with a working group of the RAC via a teleconference call on October 22, 2015. The recommendations of this group were presented to and discussed with the RAC at its December 4, 2015, meeting. At the March 8, 2016, meeting, the RAC continued the discussion which included consideration of the one comment received to the December 29, 2015, notice and unanimously recommended (by a vote of 11 in favor, none opposed, and no abstentions) that the transfer of chloramphenicol resistance to R. typhi, rickettsii, and felis should not be allowed to proceed. On August 23, 2016, the NIH Director disapproved the proposal to transfer chloramphenicol resistance to R. typhi, rickettsii, and felis. Dated: January 6, 2017. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2017–00766 Filed 1–12–17; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:06 Jan 12, 2017 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the patent applications listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301–496–2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications. SUPPLEMENTARY INFORMATION: Technology description follows. SUMMARY: Monoclonal Antibodies That Neutralize Norovirus Description of Technology: Vaccines and therapies to prevent and treat Norovirus infections do not exist, despite the worldwide prevalence of Norovirus infections. Outbreaks of human gastroenteritis attributable to Norovirus commonly occur in group setting, such as hospitals, nursing homes, schools, dormitories, cruise ships and military barracks. This technology relates to chimpanzeehuman chimeric monoclonal antibodies, which specifically bind to Norovirus and have therapeutic potential. The antibodies that were tested in a primate model of infection have shown protection against Norovirus. These Norovirus antibodies may have application as immunoprophylaxis to protect individuals from infections or as a possible treatment for infected individuals, or can be used to develop a diagnostic for detection of norovirus infections. This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 development and evaluation under a research collaboration. Potential Commercial Applications: • Therapeutics • Diagnostics Competitive Advantages: • There are currently no vaccines or therapeutics available against Norovirus infections Development Stage: • In vivo data available (animal) Inventors: Zhaochun Chen, Robert H. Purcell, Lisbeth Kim Green, Stanislav Sosnovtsev, Karin Bok (all from NIAID). Publications: Chen Z, et al., Development of Norwalk virus-specific monoclonal antibodies with therapeutic potential for the treatment of Norwalk virus gastroenteritis, J Virol. 2013 Sep; 87(17):9547–57. [PMID 23785216]. Intellectual Property: HHS Reference No. E–226–2011/0—U.S. Provisional Application No. 61/763,879, filed February 12, 2013; PCT Application No. PCT/US2014/015809, filed February 11, 2014; European Application No. 14706239.2, filed August 5, 2015 (pending); U.S. Application No. 14/ 767,274, filed August 11, 2015 (allowed); and U.S. Application No. 15/ 359,438, filed November 22, 2016 (pending). Licensing Contact: Dr. Jenish Patel, 240–669–2894; Jenish.Patel@nih.gov. Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize for development of a therapeutic or a diagnostic for Norovirus infections. For collaboration opportunities, please contact Dr. Jenish Patel, 240–669–2894; Jenish.Patel@ nih.gov. Dated: January 9, 2017. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2017–00735 Filed 1–12–17; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; 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. E:\FR\FM\13JAN1.SGM 13JAN1

Agencies

[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4365-4366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00766]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Action Under the NIH Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

AGENCY: National Institutes of Health (NIH), HHS.

ACTION: Notice of action under the NIH Guidelines.

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

SUMMARY: The National Institutes of Health (NIH) considered a proposal 
to conduct research involving the deliberate transfer of a 
chloramphenicol resistance trait to Rickettsia typhi, conorii, 
rickettsii, and felis. The acquisition of this antibiotic resistance 
trait could possibly compromise the use of a class of antibiotics for 
the treatment of Rickettsia infections in humans. Under the NIH 
Guidelines (http://www.osp.od.nih.gov/sites/default/files/

[[Page 4366]]

NIH_Guidelines.html), these experiments can proceed only after they are 
reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and 
specifically approved by the NIH Director as Major Actions. This 
proposal was discussed at the December 4, 2015, RAC meeting. The 
proposal was published in the Federal Register on December 29, 2015, 
(80 FR 81346) with a request for public comment; one comment was 
received. This notice announces the final NIH action regarding this 
proposal.

FOR FURTHER INFORMATION CONTACT: If you have questions, or require 
additional background information about this action, please contact the 
NIH by email at SciencePolicy@od.nih.gov, or by telephone at 301-496-
9838 and reference this notice.

SUPPLEMENTARY INFORMATION: This final action does not allow an 
investigator at the University of Chicago to transfer chloramphenicol 
resistance to three different Rickettsia species: Rickettsia typhi, 
rickettsii, and felis. The investigator also proposed to transfer 
chloramphenicol resistance to a fourth Rickettsia species, R. conorii. 
Transfer of chloramphenicol resistance to R. conorii was previously 
approved by the NIH Director as a Major Action (see 73 FR 32719) and 
therefore did not need to be reviewed and approved under Section III-A-
1-a of the NIH Guidelines. Thus, the University of Chicago investigator 
was allowed to proceed with the transfer of chloramphenicol resistance 
to R. conorii under Section III-B-2 of the NIH Guidelines.
    The proposal to transfer chloramphenicol resistance to R. typhi, 
rickettsii, and felis was discussed with a working group of the RAC via 
a teleconference call on October 22, 2015. The recommendations of this 
group were presented to and discussed with the RAC at its December 4, 
2015, meeting. At the March 8, 2016, meeting, the RAC continued the 
discussion which included consideration of the one comment received to 
the December 29, 2015, notice and unanimously recommended (by a vote of 
11 in favor, none opposed, and no abstentions) that the transfer of 
chloramphenicol resistance to R. typhi, rickettsii, and felis should 
not be allowed to proceed. On August 23, 2016, the NIH Director 
disapproved the proposal to transfer chloramphenicol resistance to R. 
typhi, rickettsii, and felis.

    Dated: January 6, 2017.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2017-00766 Filed 1-12-17; 8:45 am]
BILLING CODE 4140-01-P