Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting, 49744 [2019-20449]
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Federal Register / Vol. 84, No. 184 / Monday, September 23, 2019 / Notices
‘‘Search’’ box and follow the prompts
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development (OCOD), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
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0002 or the Office of Communications,
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your requests. The draft guidance may
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8010. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
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Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911; or
Scott Goldie, CDER, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 21, Rm. 3557, Silver Spring,
MD 20993–0002, 301–796–2055.
SUPPLEMENTARY INFORMATION:
jbell on DSK3GLQ082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Interacting with the FDA on Complex
Innovative Clinical Trial Designs for
Drugs and Biological Products.’’ The
draft guidance document provides
recommendations to sponsors and
applicants on interacting with the FDA
on CID proposals for drugs or biological
products. FDA is issuing this guidance
to satisfy, in part, a mandate under
section 3021 of the Cures Act. In
accordance with the Cures Act mandate,
the draft guidance discusses the use of
novel trial designs in the development
and regulatory review of drugs and
biological products, how sponsors may
obtain feedback on technical issues
related to modeling and simulation, and
the types of quantitative and qualitative
information that should be submitted
for review.
This draft guidance is being issued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The draft guidance, when finalized, will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
VerDate Sep<11>2014
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on ‘‘Interacting with the FDA on
Complex Innovative Clinical Trial
Designs for Drugs and Biological
Products.’’ 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
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 part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; and the collections
of information in the guidance for
industry entitled ‘‘Special Protocol
Assessment,’’ have been approved
under 0910–0470.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics,
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, or https://
www.regulations.gov.
Dated: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–20494 Filed 9–20–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
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
PO 00000
Frm 00040
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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
Child Health and Human Development
Special Emphasis Panel; Innovative
Epidemiologic approaches for understanding
long-term health outcomes of HIV-exposed
uninfected populations. (R61/R33)
Date: December 13, 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: Helen Huang, Scientific
Review Officer, Scientific Review Branch,
Eunice Kennedy Shriver National Institute of
Health and Human Development, NIH,
Bethesda, MD 20817, 301–435–8380,
helen.huang@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 17, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–20449 Filed 9–20–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
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: Heart, Lung and
Blood Initial Review Group Clinical Trials
Review Committee.
Date: October 24–25, 2019.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Page 49744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20449]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human
Development; Notice of Closed Meeting
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 of Child Health and Human
Development Special Emphasis Panel; Innovative Epidemiologic
approaches for understanding long-term health outcomes of HIV-
exposed uninfected populations. (R61/R33)
Date: December 13, 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: Helen Huang, Scientific Review Officer,
Scientific Review Branch, Eunice Kennedy Shriver National Institute
of Health and Human Development, NIH, Bethesda, MD 20817, 301-435-
8380, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.864,
Population Research; 93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation Research; 93.209,
Contraception and Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 17, 2019.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-20449 Filed 9-20-19; 8:45 am]
BILLING CODE 4140-01-P
