National Institute on Aging; Notice of Closed Meeting, 2747 [2020-00577]
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Federal Register / Vol. 85, No. 11 / Thursday, January 16, 2020 / Notices
New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD
20993–0002 or the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Gregory Reaman, Oncology Center of
Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2202, Silver Spring,
MD 20993–0002, 301–796–0785; 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:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pediatric Study Plans for Oncology
Drugs: Questions and Answers.’’ This
draft guidance provides information
regarding the submission of an iPSP, as
required by section 505B(e) of the FD&C
Act (21 U.S.C. 355c(e)), for oncology
drugs only. When finalized, this draft
guidance will provide FDA’s current
thinking regarding iPSPs for oncology
drugs in light of the amendments to
section 505B of the FD&C Act (also
referred to as the Pediatric Research
Equity Act, or PREA) made by section
504 of FDARA (Pub. L. 115–52). This
draft guidance does not contain a
complete discussion of general
requirements for development of drugs
for pediatric use under PREA or section
505A of the FD&C Act (21 U.S.C. 355a)
(also referred to as the Best
Pharmaceuticals for Children Act or
BPCA (Pub. L. 107–109)).
Section 504 of FDARA amended
section 505B of the FD&C Act to
require—for original applications
submitted on or after August 18, 2020—
pediatric investigations of certain
targeted cancer drugs with new active
ingredients, based on molecular
mechanism of action rather than clinical
indication. FDARA thus created a
mechanism to require evaluation of
certain novel medicines that may have
the potential to address an unmet
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medical need in the pediatric
population. Timely investigation in
children of the antitumor activity of
potentially effective targeted drugs
under development in adults and of
those drugs’ toxicities relative to the
unique growth and developmental
considerations of pediatric patients, is
intended to accelerate early pediatric
evaluation of these products and
ultimately facilitate development of
appropriate new therapies for pediatric
patients.
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 ‘‘Pediatric Study Plans for Oncology
Drugs: Questions and Answers.’’ 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.
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. 3501–3521). 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. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
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: January 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00592 Filed 1–15–20; 8:45 am]
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2747
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on
Aging Special Emphasis Panel; Early
Diagnosis and Prediction.
Date: February 13, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Nijaguna Prasad, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, 7201 Wisconsin Avenue,
Gateway Building, Suite 2W200, Bethesda,
MD 20892, (301) 496–9667,
nijaguna.prasad@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: January 10, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–00577 Filed 1–15–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Privacy Act of 1974; System of
Records Notice
National Institutes of Health
(NIH), Department of Health and Human
Services (HHS).
ACTION: Notice of a modified system of
records and rescindment of a system of
records notice.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
SUMMARY:
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[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Notices]
[Page 2747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Aging; 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 on Aging Special Emphasis
Panel; Early Diagnosis and Prediction.
Date: February 13, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute on Aging, Gateway Building, 7201
Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Nijaguna Prasad, Ph.D., Scientific Review
Officer, Scientific Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin Avenue, Gateway
Building, Suite 2W200, Bethesda, MD 20892, (301) 496-9667,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging
Research, National Institutes of Health, HHS)
Dated: January 10, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-00577 Filed 1-15-20; 8:45 am]
BILLING CODE 4140-01-P
