National Institute on Drug Abuse; Notice of Closed Meetings, 26125-26126 [2019-11667]
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26125
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR section and activity
Number of
responses per
respondent 2
Total annual
responses
Average
burden per
response
(in hours)
Total hours
§ 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial Equivalence Request
21 CFR 1107.1(c)—Preparation of additional information
for tobacco product exemption from substantial equivalence request ....................................................................
244
1
244
3
732
Total Hours (§ 1107.1(c)) ..............................................
........................
........................
........................
........................
732
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemptions granted by Secretary under section 905(j)(3)
Abbreviated report submitted to demonstrate tobacco
product is modified under section 905(j)(3), modifications are to a product that is commercially marketed and
compliant, and modifications covered by exemptions
granted by Secretary under section 905(j)(3) ..................
Total Hours (section 905(j)(1)(A)(ii)) of the FD&C Act
Total Hours Exemptions From Substantial
Equivalence Requirements ................................
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1 There
1217
1
1217
3
3,651
........................
........................
........................
........................
3,651
........................
........................
........................
........................
23,871
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that we will receive
812 exemption requests under
§ 1107.1(b) for 24 hours per response
including EA for a total of 19,488 hours.
Since an EA is required for each
§ 1107.1(b) (Optional Preparation of
Tobacco Product Exemption From
Substantial Equivalence Request), the
burden per response for EAs (12 hours)
has been combined with the 12 hours
for an SE request for a total of 24 hours
per response.
FDA further estimates that we will
receive 244 submissions requiring
additional information in support of the
initial exemption request, and it is
expected that it will take an average of
3 hours to prepare the additional
information for a total of 732 hours.
FDA estimates that 1,217 respondents
will prepare 1,217 responses and each
response will take approximately 3
hours to prepare, as required by section
905(j)(1)(A)(ii) of the FD&C Act, for a
total of 3,651 hours.
This collection of information
requires a manufacturer to submit a
report at least 90 days prior to making
an introduction or delivery for
introduction into interstate commerce
for commercial distribution of a tobacco
product. Section 905(j)(1)(A)(ii) of the
FD&C Act states that if an exemption
has been requested and granted, the
manufacturer must submit to FDA a
report that demonstrates that the
tobacco product is modified within the
meaning of section 905(j)(3), the
modifications are to a product that is
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commercially marketed and in
compliance with the requirements of the
FD&C Act, and all the modifications are
covered by exemptions granted by the
Secretary under section 905(j)(3). FDA
estimates the total hours for exemptions
from Substantial Equivalence
Requirements will be 23,871 hours.
FDA’s estimates are based on full
analysis of economic impacts and
information gathered from other FDAregulated products. Based on a review of
the currently approved information
collection, we have made no
adjustments to our burden estimate.
Dated: May 30, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11658 Filed 6–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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
PO 00000
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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
Drug Abuse Special Emphasis Panel; HEAL
Initiative: Preventing Opioid Use Disorder in
Older Adolescents and Young Adults (ages
16–30) (UG3/UH3 Clinical Trial Required).
Date: June 11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Hiromi Ono, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Boulevard,
Room 4238, MSC 9550, Bethesda, MD 20892,
301–827–5820, hiromi.ono@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; HEAL
Initiative: Coordinating Center to Support
NIDA Preventing Opioid Use Disorder in
Older Adolescents and Young Adults (ages
16–30) Initiative (U24 Clinical Trial Not
Allowed).
Date: June 12, 2019.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Hiromi Ono, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Boulevard,
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26126
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
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Room 4238, MSC 9550, Bethesda, MD 20892,
301–827–5820, hiromi.ono@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; R13
Conference Grant Review.
Date: June 26, 2019.
Time: 6:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852
(Virtual Meeting).
Contact Person: Susan O. McGuire, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, National Institutes
of Health, DHHS, 6001 Executive Blvd.,
Room 4245, Rockville, MD 20852, (301) 827–
5817, mcguireso@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Virtual
Reality Tools to Enhance Evidence Based
Treatment of Substance Use Disorders.
Date: July 10–11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, DHHS, 6001
Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892–9550, 301–827–5819,
gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; HEAL
Initiative: America’s Startups and Small
Businesses Build Technologies to Stop the
Opioid Epidemic (R41/R42/R43/R44—
Clinical Trial Optional).
Date: July 10–11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Gerald L. McLaughlin,
Ph.D., Scientific Review Officer, Office of
Extramural Policy and Review, National
Institute on Drug Abuse, NIH, DHHS, 6001
Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892–9550, 301–827–5819,
gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: May 30, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–11667 Filed 6–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
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.
Name of Committee: Cell Biology
Integrated Review Group; Membrane Biology
and Protein Processing Study Section.
Date: June 24, 2019.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Nikko San Francisco, 222
Mason Street, San Francisco, CA 94102.
Contact Person: Janet M. Larkin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142,
MSC 7840, Bethesda, MD 20892, 301–806–
2765, larkinja@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Opioids and HIV at the single cell, single
RNA level.
Date: June 27, 2019.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Nuria E. Assa-Munt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Health Informatics.
Date: July 1, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: AC Hotel by Marriott National
Harbor, 156 Waterfront Street, Oxon Hill, MD
20745.
Contact Person: Sheba King Dunston,
Ph.D., Scientific Review Officer, Center for
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Scientific of Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3150,
Bethesda, MD 20892, 301–402–4933,
dunstonsk@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Infectious
Diseases and Microbiology Research
Enhancement Review.
Date: July 1, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crown Plaza River Oaks, 2712
Southwest Freeway, Houston, TX 77098.
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
MSC 7808, Bethesda, MD 20892, 301–996–
5819, zhengli@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA
Topics in Infectious Disease.
Date: July 1, 2019.
Time: 12:00 p.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crown Plaza River Oaks, 2712
Southwest Freeway, Houston, TX 77098.
Contact Person: Susan Daum, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
Bethesda, MD 20892, 301–827–7233,
susan.boyle-vavra@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 30, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–11671 Filed 6–4–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the June 27, 2019 meeting of the
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
Special Emphasis Panel, which was
published in the Federal Register on
May 20, 2019, 84 FR 22870.
Date, Time and Place remain the
same. This notice is amended to update
contact information—Dr. Kathy Salaita,
Chief, Scientific Review Branch,
NIAMS/NIH/DHHS, 6701 Democracy
Blvd., Rm. 818, Bethesda, MD 20892,
Kathy.Salaita@nih.gov. The meeting is
closed to the public.
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]]>Agencies
[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26125-26126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11667]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
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.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; HEAL Initiative: Preventing Opioid Use Disorder in
Older Adolescents and Young Adults (ages 16-30) (UG3/UH3 Clinical
Trial Required).
Date: June 11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate cooperative agreement
applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer,
Office of Extramural Policy and Review, National Institute on Drug
Abuse, National Institutes of Health, DHHS, 6001 Executive
Boulevard, Room 4238, MSC 9550, Bethesda, MD 20892, 301-827-5820,
[email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; HEAL Initiative: Coordinating Center to Support NIDA
Preventing Opioid Use Disorder in Older Adolescents and Young Adults
(ages 16-30) Initiative (U24 Clinical Trial Not Allowed).
Date: June 12, 2019.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate cooperative agreement
applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Hiromi Ono, Ph.D., Scientific Review Officer,
Office of Extramural Policy and Review, National Institute on Drug
Abuse, National Institutes of Health, DHHS, 6001 Executive
Boulevard,
[[Page 26126]]
Room 4238, MSC 9550, Bethesda, MD 20892, 301-827-5820,
[email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; R13 Conference Grant Review.
Date: June 26, 2019.
Time: 6:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center
Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852
(Virtual Meeting).
Contact Person: Susan O. McGuire, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, National Institutes of Health, DHHS, 6001 Executive
Blvd., Room 4245, Rockville, MD 20852, (301) 827-5817,
[email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; Virtual Reality Tools to Enhance Evidence Based
Treatment of Substance Use Disorders.
Date: July 10-11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, Bethesda, MD 20852.
Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892-9550, 301-827-5819, [email protected].
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel; HEAL Initiative: America's Startups and Small
Businesses Build Technologies to Stop the Opioid Epidemic (R41/R42/
R43/R44--Clinical Trial Optional).
Date: July 10-11, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, Bethesda, MD 20852.
Contact Person: Gerald L. McLaughlin, Ph.D., Scientific Review
Officer, Office of Extramural Policy and Review, National Institute
on Drug Abuse, NIH, DHHS, 6001 Executive Blvd., Room 4238, MSC 9550,
Bethesda, MD 20892-9550, 301-827-5819, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: May 30, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-11667 Filed 6-4-19; 8:45 am]
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