National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations, 35666-35667 [2018-16112]
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Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: Intramural
Continuing Umbrella of Research
Experiences (iCURE) Application, 0925–
XXXX, Exp., Date XX/XXXX, EXISTING
COLLECTION IN USE WITHOUT OMB
APPROVAL, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The new Intramural
Continuing Umbrella of Research
Experiences (iCURE) program supports
mentored research experiences for
qualified post-baccalaureate (including
post masters) individuals, graduate
students, and postdoctoral fellows in
the multidisciplinary National Cancer
Institute (NCI) intramural research
environment. This information
collection request are applications and a
reference letter to help evaluate the
merits of the candidates and their
potential match for the iCURE program.
iCURE is an extension of the highly
successful NCI Center to Reduce Cancer
Health Disparities’ (CRCHD) Continuing
Umbrella of Research Experiences
(CURE) program which helps support
the career progress of its scholars
toward research independence, as well
as fosters and sustains diversity in the
biomedical research pipeline. Like the
CURE program, iCURE strongly
encourages the participation of
individuals from underrepresented
populations and is aligned with NCI’s
interest in diversity. The benefit of
collecting this information is to enable
the selection of the best matching
candidates for the iCURE program. The
iCURE program aims to, 1. Enhance the
diversity of the NCI Intramural Research
Program (IRP), and 2. Promote the career
progress of the iCURE scholars in cancer
research.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated burden hours are 305.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
time per
response
(in hours)
Total annual
burden hour
Form name
Type of respondent
Postbac Supplemental Application ...
50
1
30/60
25
Graduate Student Application ...........
Postdoctoral Fellowship Application
Reference Letter ...............................
Post-Baccalaureate (Including PostMaster’s) Individuals.
Graduate Students ...........................
Postdoctoral Candidates ..................
PIs, professors, supervisors .............
30
50
240
1
1
1
2
2
30/60
60
100
120
Total ...........................................
...........................................................
370
370
........................
305
Patricia M. Busche,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–16053 Filed 7–26–18; 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
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
Nominations are due by 5 p.m.
EDT on August 31, 2018.
DATES:
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
Nominations must be sent
to Glen Nuckolls, Ph.D., by email to
nuckollg@ninds.nih.gov.
FOR FURTHER INFORMATION CONTACT: Glen
Nuckolls, Ph.D., by email to nuckollg@
ninds.nih.gov. or (301) 496–5745.
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
Public Law 110–361, and again in 2014
by Public Law 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 two non-federal, public
members at this time, due to turnover of
committee membership. Nominations
will be accepted between July 31 and
August 31, 2018.
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. SelfADDRESSES:
PO 00000
Frm 00063
Fmt 4703
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nominations 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
E:\FR\FM\27JYN1.SGM
27JYN1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
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
Committee shall be made without
discrimination on the basis of age, race,
ethnicity, gender, sexual orientation,
disability, and cultural, religious, or
socioeconomic status. Requests for
reasonable accommodation to enable
participation on the Committee should
be indicated in the nomination
submission.
Member Terms: Non-Federal public
members of the Committee serve for a
term of 3 years, and may serve for an
unlimited number of terms if
reappointed. Members may serve after
the expiration of their terms, until their
successors have taken office.
Meetings and Travel: As specified by
Public Law 113–166, the MDCC ‘‘shall
meet no fewer than two times per
calendar year.’’ Travel expenses are
provided for non-federal public
Committee members to facilitate
attendance at in-person meetings.
Members are expected to make every
effort to attend all full committee
meetings, twice per year, either in
person or via remote access.
Participation in relevant subcommittee,
working and planning group meetings,
and workshops, is also encouraged.
Submission Instructions and
Deadline: Nominations are due by 5
p.m. EDT on August 31, 2018, and
should be sent to Glen Nuckolls, Ph.D.,
by email to nuckollg@ninds.nih.gov.
Nominations must include contact
information for the nominee, a current
curriculum vitae or resume of the
nominee and a paragraph describing the
qualifications of the person to represent
some portion(s) of the muscular
dystrophy research, advocacy and/or
patient care communities.
More information about the MDCC is
available at https://mdcc.nih.gov/.
Dated: July 24, 2018.
amozie on DSK3GDR082PROD with NOTICES1
Walter J. Koroshetz,
Director, National Institute of Neurological
Disorders and Stroke, National Institutes of
Health.
[FR Doc. 2018–16112 Filed 7–26–18; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent
License: Radiotherapy for Metastatic
Castration-Resistant Prostate Cancer
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Heart, Lung and
Blood Institute (NHLBI), National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant of an exclusive
commercialization patent license to
Sinotau Pharmaceutical Group,
headquartered in Beijing, China, to
practice the inventions embodied in the
patent application(s) listed in the
Supplementary Information section of
this notice.
DATES: Only written comments and/or
applications for a license which are
received by the NHLBI Office of
Technology Transfer and Development
August 27, 2018 will be considered.
ADDRESSES: Requests for copies of the
patent applications, inquiries, and
comments relating to the contemplated
exclusive patent license should be
directed to: Michael Shmilovich, Esq.,
Senior Licensing and Patent Manager,
31 Center Drive, Room 4A29, MSC2479,
Bethesda, MD 20892–2479, phone
number 301–435–5019, or shmilovm@
mail.nih.gov.
SUMMARY:
The
following and all continuing U.S. and
foreign patents/patent applications
thereof are the intellectual properties to
be licensed under the prospective
agreement to Sinotau Pharmaceutical
Group: U.S. Provisional Patent
Application 62/633,648, ‘‘Chemical
Conjugates Of Evans Blue Derivatives
And Their Use As Radiotherapy And
Imaging Agents For Targeting Prostate
Cancer,’’ filed February 22, 2018 (HHS
Ref. No. E–054–2018–0). The patent
rights in this invention have been
assigned to the Government of the
United States of America. The
perspective license would be granted
worldwide and in a field of use not
broader than radiotherapeutics for
metastatic castration-resistant prostate
cancer.
The invention covered by the patents
and patent applications pertaining to
HHS Ref. No. E–054–2018–0 pertain to
a therapeutic agent that includes a
SUPPLEMENTARY INFORMATION:
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35667
chemically conjugated residue derived
from (((R-)-1-carboxy-2mercaptoethyl)carbamoyl)-L-glutamic
acid that is further bound to an Evans
blue analog (EB). The EB analog
reversibly binds to circulating serum
albumin to provide a
radiopharmaceutical that retains affinity
and specificity to prostate specific
membrane antigen (PSMA; in this case
PSMA-617). PSMA is a surface molecule
shown to be specifically expressed by
prostate tumor cells. PSMA expression
levels correlate with disease stage and
with hormone refractory cancers.
Although most PSMA expression
appears to be restricted to the prostate
cancer, low levels of expression can also
be detected in the brain, kidneys,
salivary glands, and small intestine. The
antigen is also shown to be expressed by
neovascular tumor vessels of multiple
other cancers. Inclusion of the Evans
blue analog promotes high
internalization and retention rates of the
conjugated target ligand, and therefore,
higher accumulation in PSMA positive
tumors. Labeling EB-PSMA-617
derivatives with the therapeutic beta
emitters, e.g., 90Y, 86Y, and 177Lu gives
rise to improved tumor response and
survival rates.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent license
will be royalty bearing and may be
granted unless within fifteen (15) days
from the date of this published notice,
the NHLBI 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.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
license.
Comments and objections submitted
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: July 19, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2018–16066 Filed 7–26–18; 8:45 am]
BILLING CODE 4140–01–P
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27JYN1
]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35666-35667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16112]
-----------------------------------------------------------------------
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
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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. EDT on August 31, 2018.
ADDRESSES: Nominations must be sent to Glen Nuckolls, Ph.D., by email
to [email protected].
FOR FURTHER INFORMATION CONTACT: Glen Nuckolls, Ph.D., by email to
[email protected]. or (301) 496-5745.
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 Public Law 110-361, and again in
2014 by Public Law 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 two non-federal, public members at this time, due to turnover of
committee membership. Nominations will be accepted between July 31 and
August 31, 2018.
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. Self-nominations 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
[[Page 35667]]
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 Committee shall be
made without discrimination on the basis of age, race, ethnicity,
gender, sexual orientation, disability, and cultural, religious, or
socioeconomic status. Requests for reasonable accommodation to enable
participation on the Committee should be indicated in the nomination
submission.
Member Terms: Non-Federal public members of the Committee serve for
a term of 3 years, and may serve for an unlimited number of terms if
reappointed. Members may serve after the expiration of their terms,
until their successors have taken office.
Meetings and Travel: As specified by Public Law 113-166, the MDCC
``shall meet no fewer than two times per calendar year.'' Travel
expenses are provided for non-federal public Committee members to
facilitate attendance at in-person meetings. Members are expected to
make every effort to attend all full committee meetings, twice per
year, either in person or via remote access. Participation in relevant
subcommittee, working and planning group meetings, and workshops, is
also encouraged.
Submission Instructions and Deadline: Nominations are due by 5 p.m.
EDT on August 31, 2018, and should be sent to Glen Nuckolls, Ph.D., by
email to [email protected].
Nominations must include contact information for the nominee, a
current curriculum vitae or resume of the nominee and a paragraph
describing the qualifications of the person to represent some
portion(s) of the muscular dystrophy research, advocacy and/or patient
care communities.
More information about the MDCC is available at https://mdcc.nih.gov/.
Dated: July 24, 2018.
Walter J. Koroshetz,
Director, National Institute of Neurological Disorders and Stroke,
National Institutes of Health.
[FR Doc. 2018-16112 Filed 7-26-18; 8:45 am]
BILLING CODE 4140-01-P
