82 FR 4365 - Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 9 (January 13, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 9 (January 13, 2017)
| Page Range | 4365-4366 | |
| FR Document | 2017-00766 |
[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)] [Notices] [Pages 4365-4366] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00766] ----------------------------------------------------------------------- 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 [email protected], 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
![Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices 4365
and related dementias and recruitment Open: 1:00 p.m. to 2:00 p.m. Name of Committee: National Institute on
challenges. Additional presentations in Agenda: Program reports and Aging Special Emphasis Panel; Predictors
the afternoon will include updates on presentations; business of the Board. and Determinants of Age-Related Resiliencies
Closed: 2:00 p.m. to 3:00 p.m. to Physical Stressors, RFA–AG–014 (UH2).
progress towards a Care and Services Agenda: To review and evaluate grant Date: February 23, 2017.
Summit, federal workgroup updates, applications. Time: 2:30 p.m. to 4:30 p.m.
and preparation for the Advisory Place: National Cancer Institute Shady Agenda: To review and evaluate grant
Council’s 2017 Recommendations, due Grove 9609 Medical Center Drive, Room applications.
in April 2017. TE406 Rockville, MD 20850 (Virtual Place: National Institute on Aging,
Procedure and Agenda: This meeting Meeting). Gateway Building, Suite 2W200, 7201
is open to the public. Please allow 45 Contact Person: Paulette S. Gray, Ph.D., Wisconsin Avenue, Bethesda, MD 20892
minutes to go through security and walk Executive Secretary, Division of Extramural (Telephone Conference Call).
Activities, National Cancer Institute—Shady Contact Person: Carmen Moten, Ph.D.,
to the meeting room. The meeting will Grove National Institutes of Health, 9609
also be webcast at www.hhs.gov/live. MPH, National Institute on Aging, Gateway
Medical Center Drive, Room 7W444, Building, 7201 Wisconsin Avenue, Suite
Authority: 42 U.S.C. 11225; Section 2(e)(3) Bethesda, MD 20892, 240–276–6340, grayp@ 2C212, Bethesda, MD 20892, 301–402–7703,
of the National Alzheimer’s Project Act. The mail.nih.gov. cmoten@mail.nih.gov.
panel is governed by provisions of Public Any interested person may file written Name of Committee: National Institute on
Law 92–463, as amended (5 U.S.C. Appendix comments with the committee by forwarding Aging Special Emphasis Panel; Late Onset of
2), which sets forth standards for the the statement to the Contact Person listed on Alzheimer’s Disease (LOAD), PAR–16–205
formation and use of advisory committees. this notice. The statement should include the
(U24).
name, address, telephone number and when
Dated: January 5, 2017. Date: March 7, 2017.
applicable, the business or professional
Kathryn E. Martin, Time: 10:00 a.m. to 12:00 p.m.
affiliation of the interested person.
Agenda: To review and evaluate grant
Acting Assistant Secretary for Planning and Information is also available on the
applications.
Evaluation. Institute’s/Center’s home page: http://
Place: National Institute on Aging,
[FR Doc. 2017–00606 Filed 1–12–17; 8:45 am] deainfo.nci.nih.gov/advisory/ncab/ncab.htm,
Gateway Building, Suite 2W200, 7201
where an agenda and any additional
BILLING CODE P Wisconsin Avenue, Bethesda, MD 20892
information for the meeting will be posted
when available. (Telephone Conference Call).
Contact Person: Carmen Moten, Ph.D.,
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance MPH, National Institute on Aging, Gateway
Program Nos. 93.392, Cancer Construction; Building, 7201 Wisconsin Avenue, Suite
HUMAN SERVICES 93.393, Cancer Cause and Prevention 2C212, Bethesda, MD 20892, 301–402–7703,
Research; 93.394, Cancer Detection and cmoten@mail.nih.gov.
National Institutes of Health Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology (Catalogue of Federal Domestic Assistance
National Cancer Institute; Notice of Research; 93.397, Cancer Centers Support; Program Nos. 93.866, Aging Research,
Meeting 93.398, Cancer Research Manpower; 93.399, National Institutes of Health, HHS)
Pursuant to section 10(d) of the Cancer Control, National Institutes of Health, Dated: January 10, 2017.
HHS) Melanie J. Pantoja,
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is Dated: January 9, 2017. Program Analyst, Office of Federal Advisory
hereby given of a meeting of the Melanie J. Pantoja, Committee Policy.
National Cancer Advisory Board. Program Analyst, Office of Federal Advisory [FR Doc. 2017–00733 Filed 1–12–17; 8:45 am]
The meeting will be open to the Committee Policy. BILLING CODE 4140–01–P
public as indicated below, with [FR Doc. 2017–00579 Filed 1–12–17; 8:45 am]
attendance limited to space available. BILLING CODE 4140–01–P
Individuals who plan to attend and DEPARTMENT OF HEALTH AND
need special assistance, such as sign HUMAN SERVICES
language interpretation or other DEPARTMENT OF HEALTH AND
reasonable accommodations, should HUMAN SERVICES National Institutes of Health
notify the Contact Person listed below
in advance of the meeting. The open National Institutes of Health Action Under the NIH Guidelines for
session will be videocast and can be Research Involving Recombinant or
accessed from the NIH Videocasting and National Institute on Aging; Notice of Synthetic Nucleic Acid Molecules (NIH
Podcasting Web site (http:// Closed Meetings Guidelines)
videocast.nih.gov). Pursuant to section 10(d) of the AGENCY: National Institutes of Health
The meeting will be closed to the Federal Advisory Committee Act, as (NIH), HHS.
public in accordance with the amended (5 U.S.C. App.), notice is ACTION: Notice of action under the NIH
provisions set forth in sections hereby given of the following meetings. Guidelines.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meetings will be closed to the
as amended. The grant applications and public in accordance with the SUMMARY: The National Institutes of
the discussions could disclose provisions set forth in sections Health (NIH) considered a proposal to
confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., conduct research involving the
property such as patentable material, as amended. The grant applications and deliberate transfer of a chloramphenicol
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and personal information concerning the discussions could disclose resistance trait to Rickettsia typhi,
individuals associated with the grant confidential trade secrets or commercial conorii, rickettsii, and felis. The
applications, the disclosure of which property such as patentable material, acquisition of this antibiotic resistance
would constitute a clearly unwarranted and personal information concerning trait could possibly compromise the use
invasion of personal privacy. individuals associated with the grant of a class of antibiotics for the treatment
Name of Committee: National Cancer applications, the disclosure of which of Rickettsia infections in humans.
Advisory Board. would constitute a clearly unwarranted Under the NIH Guidelines (http://
Date: February 15, 2017. invasion of personal privacy. www.osp.od.nih.gov/sites/default/files/
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![4366 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
NIH_Guidelines.html), these DEPARTMENT OF HEALTH AND development and evaluation under a
experiments can proceed only after they HUMAN SERVICES research collaboration.
are reviewed by the NIH Recombinant Potential Commercial Applications:
DNA Advisory Committee (RAC) and National Institutes of Health • Therapeutics
specifically approved by the NIH • Diagnostics
Director as Major Actions. This proposal Government-Owned Inventions; Competitive Advantages:
was discussed at the December 4, 2015, Availability for Licensing
• There are currently no vaccines or
RAC meeting. The proposal was AGENCY: National Institutes of Health, therapeutics available against
published in the Federal Register on HHS. Norovirus infections
December 29, 2015, (80 FR 81346) with Development Stage:
ACTION: Notice.
a request for public comment; one
comment was received. This notice • In vivo data available (animal)
SUMMARY: The invention listed below is
announces the final NIH action Inventors: Zhaochun Chen, Robert H.
owned by an agency of the U.S.
regarding this proposal. Purcell, Lisbeth Kim Green, Stanislav
Government and is available for
FOR FURTHER INFORMATION CONTACT: If Sosnovtsev, Karin Bok (all from NIAID).
licensing to achieve expeditious
you have questions, or require Publications: Chen Z, et al.,
commercialization of results of
additional background information Development of Norwalk virus-specific
federally-funded research and
about this action, please contact the NIH monoclonal antibodies with therapeutic
development. Foreign patent
by email at SciencePolicy@od.nih.gov, potential for the treatment of Norwalk
applications are filed on selected
or by telephone at 301–496–9838 and virus gastroenteritis, J Virol. 2013 Sep;
inventions to extend market coverage
reference this notice. 87(17):9547–57. [PMID 23785216].
for companies and may also be available Intellectual Property: HHS Reference
SUPPLEMENTARY INFORMATION: This final for licensing. No. E–226–2011/0—U.S. Provisional
action does not allow an investigator at FOR FURTHER INFORMATION CONTACT: Application No. 61/763,879, filed
the University of Chicago to transfer Licensing information and copies of the February 12, 2013; PCT Application No.
chloramphenicol resistance to three patent applications listed below may be PCT/US2014/015809, filed February 11,
different Rickettsia species: Rickettsia obtained by communicating with the 2014; European Application No.
typhi, rickettsii, and felis. The indicated licensing contact at the 14706239.2, filed August 5, 2015
investigator also proposed to transfer Technology Transfer and Intellectual (pending); U.S. Application No. 14/
chloramphenicol resistance to a fourth Property Office, National Institute of 767,274, filed August 11, 2015
Rickettsia species, R. conorii. Transfer of Allergy and Infectious Diseases, 5601 (allowed); and U.S. Application No. 15/
chloramphenicol resistance to R. conorii Fishers Lane, Rockville, MD 20852; tel. 359,438, filed November 22, 2016
was previously approved by the NIH 301–496–2644. A signed Confidential (pending).
Director as a Major Action (see 73 FR Disclosure Agreement will be required Licensing Contact: Dr. Jenish Patel,
32719) and therefore did not need to be to receive copies of unpublished patent 240–669–2894; Jenish.Patel@nih.gov.
reviewed and approved under Section applications. Collaborative Research Opportunity:
III–A–1–a of the NIH Guidelines. Thus, The National Institute of Allergy and
SUPPLEMENTARY INFORMATION:
the University of Chicago investigator Infectious Diseases is seeking statements
Technology description follows.
was allowed to proceed with the of capability or interest from parties
transfer of chloramphenicol resistance Monoclonal Antibodies That Neutralize
interested in collaborative research to
to R. conorii under Section III–B–2 of Norovirus
further develop, evaluate or
the NIH Guidelines. Description of Technology: Vaccines
The proposal to transfer commercialize for development of a
and therapies to prevent and treat therapeutic or a diagnostic for Norovirus
chloramphenicol resistance to R. typhi,
Norovirus infections do not exist, infections. For collaboration
rickettsii, and felis was discussed with
despite the worldwide prevalence of opportunities, please contact Dr. Jenish
a working group of the RAC via a
Norovirus infections. Outbreaks of Patel, 240–669–2894; Jenish.Patel@
teleconference call on October 22, 2015.
human gastroenteritis attributable to nih.gov.
The recommendations of this group
Norovirus commonly occur in group Dated: January 9, 2017.
were presented to and discussed with
setting, such as hospitals, nursing
the RAC at its December 4, 2015, Suzanne Frisbie,
homes, schools, dormitories, cruise
meeting. At the March 8, 2016, meeting, Deputy Director, Technology Transfer and
ships and military barracks. This
the RAC continued the discussion Intellectual Property Office, National Institute
which included consideration of the one technology relates to chimpanzee- of Allergy and Infectious Diseases.
comment received to the December 29, human chimeric monoclonal antibodies,
[FR Doc. 2017–00735 Filed 1–12–17; 8:45 am]
2015, notice and unanimously which specifically bind to Norovirus
BILLING CODE 4140–01–P
recommended (by a vote of 11 in favor, and have therapeutic potential. The
none opposed, and no abstentions) that antibodies that were tested in a primate
the transfer of chloramphenicol model of infection have shown DEPARTMENT OF HEALTH AND
resistance to R. typhi, rickettsii, and felis protection against Norovirus. These HUMAN SERVICES
should not be allowed to proceed. On Norovirus antibodies may have
August 23, 2016, the NIH Director application as immunoprophylaxis to National Institutes of Health
protect individuals from infections or as
asabaliauskas on DSK3SPTVN1PROD with NOTICES
disapproved the proposal to transfer
chloramphenicol resistance to R. typhi, a possible treatment for infected National Institute of Diabetes and
rickettsii, and felis. individuals, or can be used to develop Digestive and Kidney Diseases; Notice
a diagnostic for detection of norovirus of Closed Meetings
Dated: January 6, 2017. infections.
Francis S. Collins, This technology is available for Pursuant to section 10(d) of the
Director, National Institutes of Health. licensing for commercial development Federal Advisory Committee Act, as
[FR Doc. 2017–00766 Filed 1–12–17; 8:45 am] in accordance with 35 U.S.C. 209 and 37 amended (5 U.S.C. App.), notice is
BILLING CODE 4140–01–P CFR part 404, as well as for further hereby given of the following meetings.
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Document Created: 2017-01-13 02:45:29
Document Modified: 2017-01-13 02:45:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of action under the NIH Guidelines. | |
| Contact | If you have questions, or require additional background information about this action, please contact the NIH by email at [email protected], or by telephone at 301-496- 9838 and reference this notice. | |
| FR Citation | 82 FR 4365 |
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