Center for Scientific Review; Notice of Closed Meetings, 17415-17416 [2019-08313]
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Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Notices
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0002, or Office of Communication,
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Send one self-addressed adhesive label
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requests. See the SUPPLEMENTARY
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INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Scott N. Goldie, Center for Drug
Evaluation and Research, Office of
Biostatistics, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 3557, Silver Spring,
MD 20993–0002, 301–796–2055, or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Adjusting for Covariates in
Randomized Clinical Trials for Drugs
and Biologics with Continuous
Outcomes.’’ This guidance provides
recommendations for the use of analysis
of covariance (ANCOVA) in randomized
clinical trials.
The target population for a new drug
or biologic usually includes individuals
with diverse prognostic factors, and the
population studied in clinical trials
should reflect this diversity. However,
baseline differences in prognostic
factors impair the detection and
estimation of treatment effects.
Incorporating prognostic factors in the
statistical analysis of clinical trial data
can mitigate this impairment and can
result in a more efficient use of data to
demonstrate and quantify the effects of
treatment. The International Council for
Harmonisation guidance for industry
entitled ‘‘E9 Statistical Principles for
Clinical Trials’’ briefly addresses these
issues (https://www.fda.gov/downloads/
drugs/guidancecomplianceregulatory
information/guidances/ucm073137.pdf).
This guidance provides more detailed
recommendations for the use of
ANCOVA in randomized clinical trials.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Adjusting for Covariates in
Randomized Clinical Trials for Drugs
and Biologics with Continuous
Outcomes.’’ 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.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
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information found in FDA regulations.
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 21 CFR 312.23 for
investigational new drug application
content and format have been approved
under OMB control number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: April 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08353 Filed 4–24–19; 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: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Development of Appropriate Pediatric
Formulations and Pediatric Drug Delivery
Systems.
Date: May 31, 2019.
Time: 2:00 p.m. to 4:00 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: Paek-Gyu Lee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4201,
MSC 7812, Bethesda, MD 20892, (301) 613–
2064, leepg@csr.nih.gov.
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17416
Federal Register / Vol. 84, No. 80 / Thursday, April 25, 2019 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Basic Neurodevelopmental Biology of
Circuits and Behavior.
Date: June 3, 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: Alexei Kondratyev, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kondratyevad@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Emerging Imaging
Technologies in Neuroscience 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: Marriott Wardman Park Washington
DC Hotel, 2660 Woodley Road NW,
Washington, DC 20008.
Contact Person: Sharon S. Low, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5104,
MSC 7846, Bethesda, MD 20892, 301–237–
1487, lowss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuroengineering and Cognition
Special Emphasis Panel.
Date: June 7, 2019.
Time: 11:00 a.m. to 4:00 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: Mei Qin, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
Bethesda, MD 20892, 301–875–2215,
qinmei@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Community-Level Health Promotion Study
Section.
Date: June 10–11, 2019.
Time: 8:00 a.m. to 6:00 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: Ping Wu, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3166, Bethesda, MD 20892, 301–
451–8428, wup4@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Molecular
Neurogenetics Study Section.
Date: June 13–14, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: Wyndham Grand Chicago
Riverfront, 71 E Wacker Dr., Chicago, IL
60601.
Contact Person: Mary G. Schueler, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–915–
6301, marygs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–NS–
18–041: Discovery of Biomarkers, Biomarker
Signatures, and Endpoints for Pain.
Date: June 14, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Cristina Backman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7846, Bethesda, MD 20892, 301–480–
9069, cbackman@mail.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Bioengineering of
Neuroscience, Vision and Low Vision
Technologies Study Section.
Date: June 18–19, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Robert C. Elliott, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5190,
MSC 7846, Bethesda, MD 20892, 301–435–
3009, elliotro@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Aging Systems and Geriatrics Study
Section.
Date: June 19–20, 2019.
Time: 8:00 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: Inese Z. Beitins, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6152,
MSC 7892, Bethesda, MD 20892, 301–435–
1034, beitinsi@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: April 19, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–08313 Filed 4–24–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Sickle Cell Disease
Advisory Committee.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Sickle Cell Disease
Advisory Committee.
Date: May 31, 2019.
Time: 8:30 a.m. to 2:30 p.m.
Agenda: Discussion of Programs.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: W. Keith Hoots, MD,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Suite 9030, Bethesda, MD
20892, 301–435–0080, hootswk@
nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: April 19, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–08312 Filed 4–24–19; 8:45 am]
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DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7014–N–12]
60-Day Notice of Proposed Information
Collection: Pay for Success Pilot
Application Requirements
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Notice.
AGENCY:
HUD is seeking approval from
the Office of Management and Budget
(OMB) for the information collection
described below. In accordance with the
Paperwork Reduction Act, HUD is
requesting comment from all interested
parties on the proposed collection of
SUMMARY:
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[Federal Register Volume 84, Number 80 (Thursday, April 25, 2019)]
[Notices]
[Pages 17415-17416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08313]
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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: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Development of Appropriate Pediatric Formulations
and Pediatric Drug Delivery Systems.
Date: May 31, 2019.
Time: 2:00 p.m. to 4:00 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: Paek-Gyu Lee, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4201, MSC 7812, Bethesda, MD 20892, (301) 613-
2064, [email protected].
[[Page 17416]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR Panel: Basic Neurodevelopmental Biology of Circuits and
Behavior.
Date: June 3, 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: Alexei Kondratyev, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD
20892, 301-435-1785, [email protected].
Name of Committee: Emerging Technologies and Training
Neurosciences Integrated Review Group; Emerging Imaging Technologies
in Neuroscience 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: Marriott Wardman Park Washington DC Hotel, 2660 Woodley
Road NW, Washington, DC 20008.
Contact Person: Sharon S. Low, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5104, MSC 7846, Bethesda, MD 20892, 301-237-
1487, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neuroengineering and Cognition Special
Emphasis Panel.
Date: June 7, 2019.
Time: 11:00 a.m. to 4:00 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: Mei Qin, MD, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5213, Bethesda, MD 20892, 301-875-2215,
[email protected].
Name of Committee: Healthcare Delivery and Methodologies
Integrated Review Group; Community-Level Health Promotion Study
Section.
Date: June 10-11, 2019.
Time: 8:00 a.m. to 6:00 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: Ping Wu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3166, Bethesda, MD 20892, 301-451-8428,
[email protected].
Name of Committee: Emerging Technologies and Training
Neurosciences Integrated Review Group; Molecular Neurogenetics Study
Section.
Date: June 13-14, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Wyndham Grand Chicago Riverfront, 71 E Wacker Dr.,
Chicago, IL 60601.
Contact Person: Mary G. Schueler, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214, MSC 7846, Bethesda, MD
20892, 301-915-6301, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RFA-NS-18-041: Discovery of Biomarkers, Biomarker Signatures,
and Endpoints for Pain.
Date: June 14, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Cristina Backman, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211, MSC 7846, Bethesda, MD
20892, 301-480-9069, [email protected].
Name of Committee: Emerging Technologies and Training
Neurosciences Integrated Review Group; Bioengineering of
Neuroscience, Vision and Low Vision Technologies Study Section.
Date: June 18-19, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Robert C. Elliott, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5190, MSC 7846, Bethesda, MD
20892, 301-435-3009, [email protected].
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Aging Systems and Geriatrics Study Section.
Date: June 19-20, 2019.
Time: 8:00 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: Inese Z. Beitins, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6152, MSC 7892, Bethesda, MD 20892, 301-435-
1034, [email protected].
(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: April 19, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-08313 Filed 4-24-19; 8:45 am]
BILLING CODE 4140-01-P
