81 FR 8728 - Prospective Grant of Exclusive License: Production of Attenuated Respiratory Syncytial Virus Vaccines
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 34 (February 22, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 34 (February 22, 2016)
| Page Range | 8728-8729 | |
| FR Document | 2016-03486 |
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)] [Notices] [Pages 8728-8729] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03486] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Production of Attenuated Respiratory Syncytial Virus Vaccines AGENCY: National Institutes of Health. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-194-1999/0, Collins et al., ``Production of Attenuated Respiratory Syncytial Virus Vaccines Involving Modification of M2 ORF2'', U.S. Provisional Patent Application Number 60/143,097, filed July 9, 1999, PCT Patent Application Number PCT/US2000/18534, filed July 7, 2000, U.S. Patent Application Number 09/611,829 (now U.S. Patent Number 6,713,066), and U.S. Patent Application Number 11/011,502 (now U.S. Patent Number 7,485,440), (2) E-135-2010/0, Collins et al., ``Genetically Stable Live Attenuated Vaccine for Respiratory Syncytial Virus (RSV) with an Attenuation and Temperature Sensitive Phenotype Conferred by an Amino Acid Deletion'', U.S. Provisional Patent Application Number 61/624,010, filed April 13, 2012, PCT Patent Application Number PCT/US2013/030836, filed March 13, 2013, United States Patent Application Number 14/ 394,226, filed October 13, 2014, European Patent Application Number 13712641.3, filed March 13, 2013, (3) E-216-2014/0, Collins et al., ``Versions of Respiratory Syncytial Virus (RSV) Vaccine Candidate LID Delta M2-2 with Increased Attenuation'', U.S. Provisional Patent Application Number 62/266,199, filed December 11, 2015, (4) E-241-2014/ 0, Collins et al., ``Improved RSV F Protein for Expression from a Heterologous Vector'', U.S. Provisional Patent Application Number 62/ 105,667, filed January 20, 2015, PCT Patent Application Number PCT/ US2016/014154, filed January 20, 2016, and (5) E-037-2016/0, Collins et al., ``Attenuated RSV Vaccine Strains in which the NS1 and/or NS2 Genes have been Shifted to Promoter-Distal Positions'', U.S. Provisional Patent Application Number 62/266,206, filed December 11, 2015, to Sanofi Pasteur, Inc., having a place of business in Swiftwater, Pennsylvania, U.S.A. The patent rights in this invention have been assigned to the United States of America. DATES: Only written comments and/or application for a license which are received by the National Institute of Allergy and Infectious Diseases, Technology Transfer and Intellectual Property Office on or before March 8, 2016. will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Peter Soukas, Senior Technology Licensing Specialist, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite 6D, Rockville, MD 20852-9804, Tel: (301) 594-8730 or email: [email protected]. SUPPLEMENTARY INFORMATION: Respiratory syncytial virus (RSV) is the most important cause of viral acute lower respiratory infection (ALRI) in infants and children worldwide and is responsible for over 30 million new ALRI episodes worldwide and up to 199,000 deaths in children under five (5) years old. In the United States, the virus infects nearly all children at least once by the age of two (2) and is the most common cause of bronchiolitis and infant pneumonia, causing up to 125,000 hospitalizations of children each year. RSV disease burden is less understood in the developing world, but available data indicates that the virus causes a significant proportion of childhood ALRI in these parts of the world, particularly in the first months of life. The drug palivizumab (Synagis) can help prevent RSV disease in high risk infants, but it cannot treat or cure already-serious RSV infection. No vaccine exists today to prevent RSV due to an incomplete understanding of the body's immune response to the virus, which has challenged and delayed RSV vaccine development efforts. The methods and compositions of this invention provide a means for [[Page 8729]] prevention of RSV and/or parainfluenza virus (PIV) infection by immunization with live attenuated, immunogenic viral vaccines against RSV and/or PIV. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published Notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. The field of use may be limited to live attenuated vaccines against respiratory syncytial virus (RSV) and/or parainfluenza virus (PIV) infections in humans. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: February 16, 2016. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, NIAID. [FR Doc. 2016-03486 Filed 2-19-16; 8:45 am] BILLING CODE 4140-01-P
![8728 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
substantial revision to the ADVERSE comprehensive cardiovascular risk based on 5 CFR 1320.3(c)(2), which
REACTIONS or other labeling sections. management, including, as appropriate, states that the public disclosure of
3. Section VI.C of the guidance states lipid control, diabetes management, information originally supplied by the
that applicants are encouraged to antithrombotic therapy, smoking Federal government to the recipient for
include the following statement in cessation, exercise, and limited sodium the purpose of disclosure to the public
promotional materials for the drug. intake. Many patients will require more is not included within the definition of
‘‘[DRUGNAME] reduces blood than one drug to achieve blood pressure collection of information.
pressure, which reduces the risk of fatal
goals.’’ FDA requests public comments on the
and nonfatal cardiovascular events,
primarily strokes and myocardial The inclusion of this statement in the information collection provisions
infarctions. Control of high blood promotional materials for the drug described set forth in the following
pressure should be part of would be exempt from OMB review table:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Hours per
Activity responses per Total hours
respondents responses response
respondent
Submission to Docket No. FDA–2008–D–0150 .................. 1 1 1 10 10
Cardiovascular Outcome Claim Supplement Submission ... 1 1 1 20 20
Total .............................................................................. ........................ ........................ ........................ ........................ 30
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 16, 2016. (RSV) with an Attenuation and ADDRESSES: Requests for a copy of the
Leslie Kux, Temperature Sensitive Phenotype patent application, inquiries, comments
Associate Commissioner for Policy. Conferred by an Amino Acid Deletion’’, and other materials relating to the
[FR Doc. 2016–03543 Filed 2–19–16; 8:45 am] U.S. Provisional Patent Application contemplated license should be directed
BILLING CODE 4164–01–P
Number 61/624,010, filed April 13, to: Peter Soukas, Senior Technology
2012, PCT Patent Application Number Licensing Specialist, Technology
PCT/US2013/030836, filed March 13, Transfer and Intellectual Property
DEPARTMENT OF HEALTH AND 2013, United States Patent Application Office, National Institute of Allergy and
HUMAN SERVICES Number 14/394,226, filed October 13, Infectious Diseases, 5601 Fishers Lane,
2014, European Patent Application Suite 6D, Rockville, MD 20852–9804,
National Institutes of Health Number 13712641.3, filed March 13, Tel: (301) 594–8730 or email: ps193c@
2013, (3) E–216–2014/0, Collins et al., nih.gov.
Prospective Grant of Exclusive ‘‘Versions of Respiratory Syncytial Virus
License: Production of Attenuated SUPPLEMENTARY INFORMATION:
(RSV) Vaccine Candidate LID Delta M2– Respiratory syncytial virus (RSV) is the
Respiratory Syncytial Virus Vaccines 2 with Increased Attenuation’’, U.S. most important cause of viral acute
AGENCY: National Institutes of Health. Provisional Patent Application Number lower respiratory infection (ALRI) in
62/266,199, filed December 11, 2015, (4) infants and children worldwide and is
ACTION: Notice. E–241–2014/0, Collins et al., ‘‘Improved responsible for over 30 million new
RSV F Protein for Expression from a ALRI episodes worldwide and up to
SUMMARY: This is notice, in accordance
Heterologous Vector’’, U.S. Provisional 199,000 deaths in children under five
with 35 U.S.C. 209(c)(1) and 37 CFR
Patent Application Number 62/105,667, (5) years old. In the United States, the
404.7(a)(1)(i), that the National Institute
filed January 20, 2015, PCT Patent virus infects nearly all children at least
of Allergy and Infectious Diseases
Application Number PCT/US2016/ once by the age of two (2) and is the
(NIAID), National Institutes of Health
014154, filed January 20, 2016, and (5) most common cause of bronchiolitis and
(NIH), Department of Health and Human
E–037–2016/0, Collins et al., infant pneumonia, causing up to
Services (HHS), is contemplating the
‘‘Attenuated RSV Vaccine Strains in 125,000 hospitalizations of children
grant of a an exclusive license to
which the NS1 and/or NS2 Genes have each year. RSV disease burden is less
practice the following invention as
been Shifted to Promoter-Distal understood in the developing world, but
embodied in the following patent
Positions’’, U.S. Provisional Patent available data indicates that the virus
applications: (1) E–194–1999/0, Collins
Application Number 62/266,206, filed causes a significant proportion of
et al., ‘‘Production of Attenuated
December 11, 2015, to Sanofi Pasteur, childhood ALRI in these parts of the
Respiratory Syncytial Virus Vaccines
Inc., having a place of business in world, particularly in the first months of
Involving Modification of M2 ORF2’’,
Swiftwater, Pennsylvania, U.S.A. The life. The drug palivizumab (Synagis) can
U.S. Provisional Patent Application
patent rights in this invention have been help prevent RSV disease in high risk
Number 60/143,097, filed July 9, 1999,
assigned to the United States of infants, but it cannot treat or cure
PCT Patent Application Number PCT/
America. already-serious RSV infection. No
mstockstill on DSK4VPTVN1PROD with NOTICES
US2000/18534, filed July 7, 2000, U.S.
Patent Application Number 09/611,829 DATES: Only written comments and/or vaccine exists today to prevent RSV due
(now U.S. Patent Number 6,713,066), application for a license which are to an incomplete understanding of the
and U.S. Patent Application Number 11/ received by the National Institute of body’s immune response to the virus,
011,502 (now U.S. Patent Number Allergy and Infectious Diseases, which has challenged and delayed RSV
7,485,440), (2) E–135–2010/0, Collins et Technology Transfer and Intellectual vaccine development efforts.
al., ‘‘Genetically Stable Live Attenuated Property Office on or before March 8, The methods and compositions of this
Vaccine for Respiratory Syncytial Virus 2016. will be considered. invention provide a means for
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![Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices 8729
prevention of RSV and/or parainfluenza Date: March 14–15, 2016 Contact Person: Maria E. Davila-Bloom,
virus (PIV) infection by immunization Time: 8:00 a.m. to 5:00 p.m. Ph.D., Scientific Review Officer, Review
with live attenuated, immunogenic viral Agenda: To review and evaluate grant Branch, DEA, NIDDK, National Institutes of
applications. Health, Room 758, 6707 Democracy
vaccines against RSV and/or PIV. Place: Courtyard by Marriott, 5520 Boulevard, Bethesda, MD 20892–5452, (301)
The prospective exclusive license will Wisconsin Avenue, Chevy Chase, MD 20815. 594–7637, davila-bloomm@
be royalty bearing and will comply with Contact Person: Carol J. Goter-Robinson, extra.niddk.nih.gov.
the terms and conditions of 35 U.S.C. Ph.D., Scientific Review Officer, Review Name of Committee: National Institute of
209 and 37 CFR part 404. The Branch, DEA, NIDDK, National Institutes of Diabetes and Digestive and Kidney Diseases
prospective exclusive license may be Health, Room 748, 6707 Democracy Special Emphasis Panel; R24 Review.
granted unless, within fifteen (15) days Boulevard, Bethesda, MD 20892–5452, (301) Date: April 8, 2016.
from the date of this published Notice, 594–7791, goterrobinsonc@ Time: 4:00 p.m. to 6:00 p.m.
extra.niddk.nih.gov. Agenda: To review and evaluate grant
NIH receives written evidence and
argument that establishes that the grant Name of Committee: National Institute of applications.
Diabetes and Digestive and Kidney Diseases Place: National Institutes of Health, Two
of the license would not be consistent Special Emphasis Panel; Mouse Metabolic Democracy Plaza, 6707 Democracy
with the requirements of 35 U.S.C. 209 Phenotyping Centers Consortium. Boulevard, Bethesda, MD 20892, (Telephone
and 37 CFR part 404. Date: March 14–15, 2016. Conference Call).
The field of use may be limited to live Time: 8:00 a.m. to 5:00 p.m. Contact Person: Barbara A. Woynarowska,
attenuated vaccines against respiratory Agenda: To review and evaluate grant Ph.D., Scientific Review Officer, Review
syncytial virus (RSV) and/or applications. Branch, DEA, NIDDK, National Institutes of
parainfluenza virus (PIV) infections in Place: Hilton Washington/Rockville, 1750 Health, Room 754, 6707, Democracy
humans. Rockville Pike, Rockville, MD 20852. Boulevard, Bethesda, MD 20892–5452, (301)
Contact Person: Jian Yang, Ph.D., Scientific 402–7172, woynarowskab@niddk.nih.gov.
Properly filed competing applications
Review Officer, Review Branch, DEA, (Catalogue of Federal Domestic Assistance
for a license filed in response to this NIDDK, National Institutes of Health, Room
notice will be treated as objections to Program Nos. 93.847, Diabetes,
755, 6707 Democracy Boulevard, Bethesda, Endocrinology and Metabolic Research;
the contemplated license. Comments MD 20892–5452, (301) 594–7799, yangj@ 93.848, Digestive Diseases and Nutrition
and objections submitted in response to extra.niddk.nih.gov. Research; 93.849, Kidney Diseases, Urology
this notice will not be made available Name of Committee: National Institute of and Hematology Research, National Institutes
for public inspection, and, to the extent Diabetes and Digestive and Kidney Diseases of Health, HHS)
permitted by law, will not be released Special Emphasis Panel; R24 Molecular Basis
of Diabetic Complications. Dated: February 16, 2016.
under the Freedom of Information Act,
Date: March 23, 2016. David Clary,
5 U.S.C. 552.
Time: 3:00 p.m. to 5:00 p.m. Program Analyst, Office of Federal Advisory
Dated: February 16, 2016. Agenda: To provide concept review of Committee Policy.
Suzanne Frisbie, proposed grant applications. [FR Doc. 2016–03509 Filed 2–19–16; 8:45 am]
Deputy Director, Technology Transfer and Place: National Institutes of Health,
BILLING CODE 4140–01–P
Intellectual Property Office, NIAID. Building 38, 8600 Rockville Pike, Bethesda,
MD 20892.
[FR Doc. 2016–03486 Filed 2–19–16; 8:45 am]
Contact Person: Robert Wellner, Ph.D.,
BILLING CODE 4140–01–P Scientific Review Officer, Review Branch, DEPARTMENT OF HEALTH AND
DEA, NIDDK, National Institutes of Health, HUMAN SERVICES
Room 706, 6707 Democracy Boulevard,
DEPARTMENT OF HEALTH AND Bethesda, MD 20892–5452, 301–594–4721, National Institutes of Health
HUMAN SERVICES rw175w@nih.gov.
Name of Committee: National Institute of National Institute of Diabetes and
National Institutes of Health Diabetes and Digestive and Kidney Diseases Digestive and Kidney Diseases; Notice
Special Emphasis Panel; NIDDK Ancillary of Meetings
National Institute of Diabetes and Studies (R01).
Digestive and Kidney Diseases; Notice Date: March 24, 2016. Pursuant to section 10(d) of the
of Closed Meetings Time: 11:00 a.m. to 12:30 p.m. Federal Advisory Committee Act, as
Agenda: To review and evaluate grant amended (5 U.S.C. App.), notice is
Pursuant to section 10(d) of the applications. hereby given of the following meetings.
Federal Advisory Committee Act, as Place: National Institutes of Health, Two The meetings will be open to the
amended (5 U.S.C. App.), notice is Democracy Plaza, 6707 Democracy public as indicated below, with
hereby given of the following meetings. Boulevard, Bethesda, MD 20892, (Telephone attendance limited to space available.
The meetings will be closed to the Conference Call). Individuals who plan to attend and
public in accordance with the Contact Person: Jian Yang, Ph.D., Scientific
need special assistance, such as sign
Review Officer, Review Branch, DEA,
provisions set forth in sections NIDDK, National Institutes of Health, Room language interpretation or other
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 755, 6707 Democracy Boulevard, Bethesda, reasonable accommodations, should
as amended. The grant applications and MD 20892–5452, (301) 594–7799, yangj@ notify the Contact Person listed below
the discussions could disclose extra.niddk.nih.gov. in advance of the meeting.
confidential trade secrets or commercial Name of Committee: National Institute of The meetings will be closed to the
property such as patentable material, Diabetes and Digestive and Kidney Diseases public in accordance with the
and personal information concerning Special Emphasis Panel; Ancillary Studies in provisions set forth in sections
Liver Diseases.
mstockstill on DSK4VPTVN1PROD with NOTICES
individuals associated with the grant 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
applications, the disclosure of which Date: April 4, 2016. as amended. The grant applications and
would constitute a clearly unwarranted Time: 4:00 p.m. to 5:30 p.m. the discussions could disclose
Agenda: To review and evaluate grant
invasion of personal privacy. applications.
confidential trade secrets or commercial
Name of Committee: National Institute of Place: National Institutes of Health, Two property such as patentable material,
Diabetes and Digestive and Kidney Diseases Democracy Plaza, 6707 Democracy and personal information concerning
Special Emphasis Panel; NIDDK Cooperative Boulevard, Bethesda, MD 20892, (Telephone individuals associated with the grant
Hematology Specialized Core Centers. Conference Call). applications, the disclosure of which
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Document Created: 2016-02-19 23:57:03
Document Modified: 2016-02-19 23:57:03
| 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. | |
| Dates | Only written comments and/or application for a license which are received by the National Institute of Allergy and Infectious Diseases, Technology Transfer and Intellectual Property Office on or before March 8, 2016. will be considered. | |
| FR Citation | 81 FR 8728 |
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