National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting, 22502-22503 [2019-10219]
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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Type of respondent
Cohort 2—Youth Aged
11 to 18.
Totals .......................
1 There
Cohort 2—Youth Baseline Questionnaire.
Cohort 2—Youth 1st,
2nd, 3rd Followup
Questionnaire.
.........................................
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
2,667
1
2,667
0.75 (45 minutes) ...
2,000
6,270
1
6,270
0.75 (45 minutes) ..
4,703
........................
........................
........................
................................
16,525
are no capital costs or operating and maintenance costs associated with this collection of information.
To accommodate the additional data
collection for media tracking, FDA
requests approval to increase the
number of burden hours under the
existing control number. The previous
number of approved screener responses
for media tracking was 60,000 and the
associated burden was 1,800 hours. The
previous burden for the media tracking
questionnaires was 6,000 and the
associated burden was 3,000 hours. We
are requesting an additional 20,000
screener responses and 2,000
questionnaire completions, which adds
600 burden hours and 1,000 burden
hours respectively. Deducting the
responses and burden for the completed
evaluation components associated with
Cohort 1 (general population screening
(13,413 responses, 2,281 hours), parent
interviews (3,342 responses, 569 hours),
youth questionnaires (8,954 responses,
6,144 hours)) and for the rural
smokeless evaluation (2,610 responses,
1,794 hours) results in a decrease of
6,319 annual responses and 9,187 hours.
Dated: May 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10320 Filed 5–16–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Amended
Notice of Meeting
jbell on DSK3GLQ082PROD with NOTICES
Number of
respondents
Activity
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Council of Research Advocates,
May 20, 2019, 9:30 a.m. to 4:00 p.m.,
National Institutes of Health, Building
40, Room 1201/1203, 40 Convent Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
April 11, 2019, 84 FR 14662.
This meeting notice is amended to
change the meeting start time from 9:00
a.m. to 9:30 a.m. on May 20, 2019 at the
National Institutes of Health, Building
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20:15 May 16, 2019
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40, Room 1201/1203, 40 Convent Drive,
Bethesda, MD 20892. This meeting is
open to the public.
Dated: May 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10217 Filed 5–16–19; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health, Two Democracy
Boulevard, Suite 920, 6707 Democracy Blvd.,
Bethesda, MD 20892, 301–451–4794,
dennis.hlasta@nih.gov.
Dated: May 13, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10235 Filed 5–16–19; 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 Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
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.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
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 Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Resources for
Technology Dissemination (U24) Review
Meeting (2019/08).
Date: June 27, 2019.
Time: 9:00 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Dennis Hlasta, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging, and Bioengineering,
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: June 6, 2019.
Time: 1:30 p.m. to 2:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive, Room
1206, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Abraham P. Bautista,
Ph.D., Executive Secretary, National
Advisory Council, Director, Office of
Extramural Activities, National Institute On
Alcohol Abuse And Alcoholism, 6700 B
PO 00000
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Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices
Rockledge Drive, Room 1458, MSC 6902,
National Institutes Of Health, Bethesda, MD
20892, 301–443–9737, bautista@
mail.nih.gov.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/about-niaaa/our-work/
advisory-council where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards., National
Institutes of Health, HHS)
Dated: May 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10219 Filed 5–16–19; 8:45 am]
BILLING CODE 4140–01–P
(Catalogue of Federal Domestic Assistance
Program Nos. 93.271, Alcohol Research
Career Development Awards for Scientists
and Clinicians; 93.272, Alcohol National
Research Service Awards for Research
Training; 93.273, Alcohol Research Programs;
93.891, Alcohol Research Center Grants;
93.701, ARRA Related Biomedical Research
and Research Support Awards, National
Institutes of Health, HHS)
Dated: May 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–10218 Filed 5–16–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Patent License: RP2 AAV Vectors for
Treating X-Linked Retinitis Pigmentosa
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
National Institutes of Health
jbell on DSK3GLQ082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
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 Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; RFA AA19–004 Specialized
Alcohol Research Centers.
Date: August 13–14, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700 B Rockledge Drive,
Conference Rooms B & C, Bethesda, MD
20817.
Contact Person: Beata Buzas, Ph.D.,
Scientific Review Officer, National Institute
on Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive,
Room 2116, Rockville, MD 20852, 301–443–
0800, bbuzas@mail.nih.gov.
17:05 May 16, 2019
Notice.
The National Eye Institute, an
institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. and foreign Patents and Patent
Applications listed in the
SUPPLEMENTARY INFORMATION section of
this notice to IVERIC bio, Inc. located in
New York, NY.
DATES: Only written comments and/or
applications for a license which are
received by the National Eye Institute
c/o National Cancer Institute’s
Technology Transfer Center on or before
June 3, 2019 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Alan Hubbs, Ph.D., Senior
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, Rm. 1E530 MSC
9702, Bethesda, MD 20892–9702 (for
business mail), Rockville, MD 20850–
9702, Telephone: (240)–276–5530,
Email: hubbsa@mail.nih.gov.
SUPPLEMENTARY INFORMATION: The
following represents the intellectual
property to be licensed under the
prospective agreement:
SUMMARY:
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
VerDate Sep<11>2014
National Institutes of Health,
HHS.
Jkt 247001
Intellectually Property
1. U.S. Provisional Patent Application
No. 62/131,661, filed March 11, 2015
[HHS Reference No. E–050–2015/0–US–
01];
PO 00000
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2. PCT Patent Application No. PCT/
US2016/022072 filed March 11, 2016
[HHS Reference No. E–050–2015–0–
PCT–03];
3. Australian Patent Application No.
AU2016228751A, filed on March 11,
2016 [HHS Reference No. E–050–2015–
0–AU–04];
4. Canadian Patent Application No.
CA2979229A, filed on March 11, 2016
[HHS Reference No. E–050–2015–0–
CA–05];
5. European Patent Application No.
EP16762623.3A, filed on March 11,
2016 [HHS Reference No. E–050–2015–
0–EP–06];
6. Japanese Patent Application No.
JP2017547425A, filed on March 11,
2016 [HHS Reference No. E–050–2015–
0–JP–07];
7. United States Patent Application
No. US15/556,746, filed on March 11,
2016 [HHS Reference No. E–050–2015–
0–US–08].
With respect to persons who have an
obligation to assign their right, title and
interest to the Government of the United
States of America, the patent rights in
these inventions have been assigned to
the Government of the United States of
America. The prospective exclusive
license territory may be world-wide,
and the field of use may be limited to
the use of Licensed Patent Rights for the
following: ‘‘Human therapeutics for
treating x-linked retinitis pigmentosa:
The license will also be limited by
licensed products covered by patent
rights that pertain to AAV-mediated
gene therapy delivering an RP2
transgene.’’
This technology discloses adenoassociated virus (AAV) vectors
comprising nucleotide sequences
encoding RPGR–ORF15 or RP2 and
related pharmaceutical compositions. It
also discloses methods of treating or
preventing x-linked retinitis
pigmentosa, increasing photoreceptor
number in the retina of a mammal, and
increasing visual acuity of a mammal
using the vectors and pharmaceutical
compositions.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National Eye
Institute 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.
In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
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Agencies
[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22502-22503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10219]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Council on Alcohol Abuse and Alcoholism.
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 Advisory Council on Alcohol Abuse
and Alcoholism.
Date: June 6, 2019.
Time: 1:30 p.m. to 2:15 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Room 1206,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Abraham P. Bautista, Ph.D., Executive Secretary,
National Advisory Council, Director, Office of Extramural
Activities, National Institute On Alcohol Abuse And Alcoholism, 6700
B
[[Page 22503]]
Rockledge Drive, Room 1458, MSC 6902, National Institutes Of Health,
Bethesda, MD 20892, 301-443-9737, [email protected].
Information is also available on the Institute's/Center's home
page: https://www.niaaa.nih.gov/about-niaaa/our-work/advisory-council where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.271,
Alcohol Research Career Development Awards for Scientists and
Clinicians; 93.272, Alcohol National Research Service Awards for
Research Training; 93.273, Alcohol Research Programs; 93.891,
Alcohol Research Center Grants; 93.701, ARRA Related Biomedical
Research and Research Support Awards., National Institutes of
Health, HHS)
Dated: May 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-10219 Filed 5-16-19; 8:45 am]
BILLING CODE 4140-01-P