Center for Scientific Review; Notice of Closed Meetings, 19925-19926 [2019-09345]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Notices
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program.’’ 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. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
copy of the document. Please use the
document number 1677 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR Part or guidance
Topic
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’.
‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’.
‘‘Medical Device Accessories—Describing Accessories and Classification
Pathways’’.
312 ..................................................................................................................
601 ..................................................................................................................
807, subpart E ................................................................................................
812 ..................................................................................................................
814, subparts A through E .............................................................................
814, subpart H ................................................................................................
Q-submissions ........................................................
0910–0756
De Novo Requests .................................................
0910–0844
CLIA Waivers .........................................................
0910–0598
Accessories ............................................................
0910–0823
Investigational New Drug Application ....................
Biologics License Application .................................
Premarket Notification ............................................
Investigational Device Exemption ..........................
Premarket Approval ...............................................
Humanitarian Use Device; Humanitarian Device
Exemption.
0910–0014
0910–0338
0910–0120
0910–0078
0910–0231
0910–0332
Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–09338 Filed 5–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
jbell on DSK3GLQ082PROD with NOTICES
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm. Persons
unable to download an electronic copy
of ‘‘Requests for Feedback and Meetings
for Medical Device Submissions: The QSubmission Program’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
19925
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.
VerDate Sep<11>2014
16:24 May 06, 2019
Jkt 247001
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Language and Communication Study
Section.
Date: June 3, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Canopy by Hilton, 940 Rose Avenue,
Rockville, MD 20852.
Contact Person: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
MSC 7770, Bethesda, MD 20892, (301) 455–
1761, kellya2@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Adult Psychopathology and Disorders
of Aging Study Section.
Date: June 3–4, 2019.
Time: 8:30 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marines’ Memorial Club & Hotel,
609 Sutter Street, San Francisco, CA 94102.
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, BBBP IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178,
MSC 7848, Bethesda, MD 20892, (301) 500–
5829, sechu@csr.nih.gov.
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Bacterial Pathogenesis Study Section.
Date: June 3–4, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Marci Scidmore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–435–
1149, marci.scidmore@nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group;
Integrative Physiology of Obesity and
Diabetes Study Section.
Date: June 4–5, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Warwick Denver, 1776 Grant Street,
Denver, CO 80203.
Contact Person: Raul Rojas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
Bethesda, MD 20892, (301) 451–6319, rojasr@
mail.nih.gov.
E:\FR\FM\07MYN1.SGM
07MYN1
19926
Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Notices
(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 2, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–09345 Filed 5–6–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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 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: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Pathophysiological Basis of Mental
Disorders and Addictions Study Section.
Date: May 29, 2019.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Biochemistry and Biophysics
of Membranes Study Section.
Date: May 29–30, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Spero, 405 Taylor Street, San
Francisco, CA 94102.
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.
VerDate Sep<11>2014
17:46 May 06, 2019
Jkt 247001
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Cancer Etiology Study Section.
Date: May 31, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Hotel-Seattle, 1113
6th Avenue, Seattle, WA 98101.
Contact Person: Ola Mae Zack Howard,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Dr., Room 4192, MSC
7806, Bethesda, MD 20892, 301–451–4467,
howardz@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Training in
Veterinary and Comparative Medicine.
Date: June 4, 2019.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lystranne Alysia Maynard
Smith, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–402–4809,
lystranne.maynard-smith@nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Clinical
and Integrative Diabetes and Obesity Study
Section.
Date: June 5–6, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Handlery Union Square Hotel, 351
Geary Street, San Francisco, CA 94102.
Contact Person: Hui Chen, MD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD 20892, 301–435–1044,
chenhui@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Neurobiology of
Motivated Behavior Study Section.
Date: June 6–7, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marines’ Memorial Club & Hotel,
609 Sutter Street, San Francisco, CA 94102.
Contact Person: Jasenka Borzan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892–7814, 301–
435–1260, borzanj@csr.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 2, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–09346 Filed 5–6–19; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; 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
Alcohol Abuse and Alcoholism Special
Emphasis Panel; RFA AA19–005 Medications
Development for the Treatment of Alcohol
Use Disorder.
Date: May 22, 2019.
Time: 2:00 p.m. to 3:30 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
2114, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Ranga Srinivas, Ph.D.,
Chief, Extramural Project Review Branch,
National Institute on Alcohol Abuse and
Alcoholism, National Institutes of Health,
6700 B Rockledge Drive, Room 2114,
Bethesda, MD 20892, (301) 451–2067,
srinivar@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Member Conflict Review.
Date: June 7, 2019.
Time: 1:00 p.m. to 3:00 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, Room
2116, Bethesda, MD 20817 (Telephone
Conference Call).
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, Bethesda, MD 20892, 301–443–
0800, bbuzas@mail.nih.gov.
(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
E:\FR\FM\07MYN1.SGM
07MYN1
]]>Agencies
[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Notices]
[Pages 19925-19926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09345]
-----------------------------------------------------------------------
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: Biobehavioral and Behavioral Processes
Integrated Review Group; Language and Communication Study Section.
Date: June 3, 2019.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Canopy by Hilton, 940 Rose Avenue, Rockville, MD 20852.
Contact Person: Andrea B. Kelly, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184, MSC 7770, Bethesda, MD
20892, (301) 455-1761, [email protected].
Name of Committee: Biobehavioral and Behavioral Processes
Integrated Review Group; Adult Psychopathology and Disorders of
Aging Study Section.
Date: June 3-4, 2019.
Time: 8:30 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Marines' Memorial Club & Hotel, 609 Sutter Street, San
Francisco, CA 94102.
Contact Person: Serena Chu, Ph.D., Scientific Review Officer,
BBBP IRG, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD
20892, (301) 500-5829, [email protected].
Name of Committee: Infectious Diseases and Microbiology
Integrated Review Group; Bacterial Pathogenesis Study Section.
Date: June 3-4, 2019.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road NW, Washington, DC 20015.
Contact Person: Marci Scidmore, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192, MSC 7808, Bethesda, MD
20892, 301-435-1149, [email protected].
Name of Committee: Endocrinology, Metabolism, Nutrition and
Reproductive Sciences Integrated Review Group; Integrative
Physiology of Obesity and Diabetes Study Section.
Date: June 4-5, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Warwick Denver, 1776 Grant Street, Denver, CO 80203.
Contact Person: Raul Rojas, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6185, Bethesda, MD 20892, (301) 451-6319,
[email protected].
[[Page 19926]]
(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 2, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-09345 Filed 5-6-19; 8:45 am]
BILLING CODE 4140-01-P
