Government-Owned Inventions; Availability for Licensing, 10776-10777 [2017-03015]
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Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices
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identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2007–D–0369 for ‘‘Draft Guidance on
Difluprednate.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ will be publicly viewable
at https://www.regulations.gov or at the
Division of Dockets Management
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• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
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will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
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18:44 Feb 14, 2017
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information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730,
Silver Spring, MD 20993–0002, 301–
796–5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE guidances available to the
public on FDA’s Web site at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm.
As described in that guidance, FDA
adopted this process to develop and
disseminate product-specific BE
guidances and to provide a meaningful
opportunity for the public to consider
and comment on the guidance. This
notice announces the availability of
revised draft BE recommendations for
generic difluprednate emulsion.
FDA initially approved new drug
application 022212 for DUREZOL
(difluprednate emulsion) in June 2008.
In January 2016, FDA issued a draft
guidance for industry on BE
recommendations for generic
difluprednate emulsion. We are now
issuing a revised draft guidance for
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industry on BE recommendations for
difluprednate emulsion (‘‘Draft
Guidance on Difluprednate’’).
In September 2016, Alcon
Pharmaceuticals, Ltd. and its affiliated
company, Novartis Pharmaceuticals
Corporation, submitted a citizen
petition requesting that FDA take
several actions with respect to ANDAs
for difluprednate emulsion, including
regarding the demonstration of BE for
any ANDA referencing DUREZOL. FDA
has reviewed the issues raised in this
citizen petition and is responding to the
citizen petition separately in the docket
for that citizen petition (Docket No.
FDA–2016–P–2781, available at https://
www.regulations.gov).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the design of BE studies to support
ANDAs for difluprednate emulsion. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–02972 Filed 2–14–17; 8:45 am]
BILLING CODE 4164–01–P
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.
SUMMARY:
E:\FR\FM\15FEN1.SGM
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Federal Register / Vol. 82, No. 30 / Wednesday, February 15, 2017 / Notices
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK3G9T082PROD with NOTICES
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.
Single-Chain Antibodies Directed to
Norovirus GI.1 and GII.4 and Their Use
Description of Technology: Vaccines
and therapies to prevent and treat
Norovirus infections are not available,
despite the worldwide prevalence of
Norovirus infections. Outbreaks of
human gastroenteritis attributable to
Norovirus commonly occur in group
settings, such as hospitals, nursing
homes, schools, dormitories, cruise
ships and military barracks. This
application claims isolated VHH
monoclonal antibodies that specifically
bind to a Norovirus polypeptide. Llamaderived single chain antibody fragments
(also called VHH) are small,
recombinant monoclonal antibodies of
15 kDa (‘‘nanobodies’’) with several
advantages over conventional
antibodies. The antibodies that were
derived from llamas showed strong
neutralizing activity against Norovirus
in in vitro assays. These nanobodies
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, and may be potentially
utilized in vaccine research.
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
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Therapeutics
• Diagnostics
• Vaccine research
Competitive Advantages:
• Ease of manufacture
• Potent neutralizing activity
• Potential cross-reactivity
• Low-cost therapeutics/
immunoprophylaxis
Development Stage:
• In vivo data assessment (animal)
Inventors: Lisbeth Kim Green (NIAID),
Karin Bok (NIAID), Stanislav
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18:44 Feb 14, 2017
Jkt 241001
Sosnovtsev (NIAID), Marina Bok (EM),
Pamela Aguilar (EM), Lorena
Garaicoechea (EM), and Viviana Parreno
(EM).
Publications: Garaicoechea L. et al.,
‘‘Llama nanoantibodies with therapeutic
potential against human norovirus
diarrhea,’’ PLoS One. 2015 Aug
12;10(8):e0133665. doi:10.1371/
journal.pone.0133665. eCollection 2015.
[PMID 26267898].
Intellectual Property: HHS Reference
No. E–136–2013/0—U.S. Provisional
Application No. 61/821,354, filed May
9, 2013; PCT Application No. PCT/
US2014/037520, filed May 9, 2014;
European Application No. 14727696.8,
filed May 9, 2014 (pending); U.S.
Application No. 14/889,774, filed
November 6, 2015 (pending); and
Argentine Application No.
20140101882, filed May 9, 2014
(pending).
Licensing Contact: Peter Soukas, J.D.,
301–594–8730; peter.soukas@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, diagnostic or vaccine for
Norovirus infections. For collaboration
opportunities, please contact Peter
Soukas, J.D., 301–594–8730;
peter.soukas@nih.gov.
Dated: February 8, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2017–03015 Filed 2–14–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke, Muscular
Dystrophy Coordinating Committee
Call for Committee Membership
Nominations
The Office of the Secretary of
the Department of Health and Human
Services (HHS) is seeking nominations
for an individual to serve as a
nonfederal public member on the
Muscular Dystrophy Coordinating
Committee.
DATES: Nominations are due by 5 p.m.
EST on March 17, 2017.
ADDRESSES: Nominations must be sent
to Glen Nuckolls, Ph.D., by email to
nuckollg@ninds.nih.gov.
SUMMARY:
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10777
Glen
Nuckolls, Ph.D., by email to nuckollg@
ninds.nih.gov.
SUPPLEMENTARY INFORMATION: The
Muscular Dystrophy Coordinating
Committee (MDCC) is a federal advisory
committee established in accordance
with the Muscular Dystrophy
Community Assistance, Research, and
Education Amendments of 2001 (MD–
CARE Act; Pub. L. 107–84). The MD–
CARE Act was reauthorized in 2008 by
Pub. L. 110–361, and again in 2014 by
Pub. L. 113–166. The MD–CARE Act
specifies that the committee
membership be composed of 2/3
governmental agency representatives
and 1/3 public members. We are seeking
nominations for four non-federal, public
members at this time, due to turnover of
committee membership. Nominations
will be accepted between February 17
and March 17, 2017.
Who is Eligible: Nominations are
encouraged for new or reappointment of
non-federal public members who can
provide the public and/or patient
perspectives to discussions of issues
considered by the Committee. Selfnominations and nominations of other
individuals are both permitted. Only
one nomination per individual is
required. Multiple nominations for the
same individual will not increase
likelihood of selection. Non-federal,
public members may be selected from
the pool of submitted nominations or
other sources as needed to meet
statutory requirements and to form a
balanced committee that represents the
diversity within the muscular dystrophy
communities. Nominations are
especially encouraged from leaders or
representatives of muscular dystrophy
research, advocacy, or service
organizations, individuals with
muscular dystrophy or their parents or
guardians. In accordance with White
House Office of Management and
Budget guidelines (FR Doc. 2014–
19140), federally-registered lobbyists are
not eligible.
Committee Composition: The
Department strives to ensure that the
membership of HHS Federal advisory
committees is fairly balanced in terms of
points of view represented and the
committee’s function. Every effort is
made to ensure that the views of all
genders, all ethnic and racial groups,
and people with disabilities are
represented on HHS Federal advisory
committees and, therefore, the
Department encourages nominations of
qualified candidates from these groups.
The Department also encourages
geographic diversity in the composition
of the Committee. Appointment to this
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 82, Number 30 (Wednesday, February 15, 2017)]
[Notices]
[Pages 10776-10777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03015]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
[[Page 10777]]
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.
Single-Chain Antibodies Directed to Norovirus GI.1 and GII.4 and Their
Use
Description of Technology: Vaccines and therapies to prevent and
treat Norovirus infections are not available, despite the worldwide
prevalence of Norovirus infections. Outbreaks of human gastroenteritis
attributable to Norovirus commonly occur in group settings, such as
hospitals, nursing homes, schools, dormitories, cruise ships and
military barracks. This application claims isolated VHH monoclonal
antibodies that specifically bind to a Norovirus polypeptide. Llama-
derived single chain antibody fragments (also called VHH) are small,
recombinant monoclonal antibodies of 15 kDa (``nanobodies'') with
several advantages over conventional antibodies. The antibodies that
were derived from llamas showed strong neutralizing activity against
Norovirus in in vitro assays. These nanobodies 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, and may be
potentially utilized in vaccine research.
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 development and evaluation under a research
collaboration.
Potential Commercial Applications:
Therapeutics
Diagnostics
Vaccine research
Competitive Advantages:
Ease of manufacture
Potent neutralizing activity
Potential cross-reactivity
Low-cost therapeutics/immunoprophylaxis
Development Stage:
In vivo data assessment (animal)
Inventors: Lisbeth Kim Green (NIAID), Karin Bok (NIAID), Stanislav
Sosnovtsev (NIAID), Marina Bok (EM), Pamela Aguilar (EM), Lorena
Garaicoechea (EM), and Viviana Parreno (EM).
Publications: Garaicoechea L. et al., ``Llama nanoantibodies with
therapeutic potential against human norovirus diarrhea,'' PLoS One.
2015 Aug 12;10(8):e0133665. doi:10.1371/journal.pone.0133665.
eCollection 2015. [PMID 26267898].
Intellectual Property: HHS Reference No. E-136-2013/0--U.S.
Provisional Application No. 61/821,354, filed May 9, 2013; PCT
Application No. PCT/US2014/037520, filed May 9, 2014; European
Application No. 14727696.8, filed May 9, 2014 (pending); U.S.
Application No. 14/889,774, filed November 6, 2015 (pending); and
Argentine Application No. 20140101882, filed May 9, 2014 (pending).
Licensing Contact: Peter Soukas, J.D., 301-594-8730;
peter.soukas@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,
diagnostic or vaccine for Norovirus infections. For collaboration
opportunities, please contact Peter Soukas, J.D., 301-594-8730;
peter.soukas@nih.gov.
Dated: February 8, 2017.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2017-03015 Filed 2-14-17; 8:45 am]
BILLING CODE 4140-01-P
