Center for Scientific Review; Notice of Closed Meetings, 66014 [2015-27427]
Download as PDF
<![CDATA[
66014
Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Paul
C. Brown, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 22, Rm. 6472, Silver Spring,
MD 20993–0002, 301–796–0856.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance for industry and review staff
entitled ‘‘Nonclinical Safety Evaluation
of Reformulated Drug Products and
Products Intended for Administration
by an Alternate Route.’’ This guidance
provides recommendations regarding
the nonclinical evaluation of a new
formulation containing a previously
approved drug substance and of a
product proposed for use by an alternate
route of administration for which the
product was not previously approved.
Generally, nonclinical data support
use of a drug product by a particular
route and also reflect the planned
duration of use. Much of the available
nonclinical information used to support
approval of the initial formulation can
be used to support the safety of
additional formulations assuming all
legal rights to the information are met.
Information used to support an initial
formulation, however, may not always
be sufficient to support such additional
approvals because changes in the
formulation could produce a new
toxicity. This is particularly true if the
drug product’s route of administration is
different or the duration of use changes
markedly. Therefore, additional
nonclinical studies might be
recommended to ensure that the toxicity
of a new formulation is fully
characterized.
This guidance provides general
nonclinical considerations for all
reformulations or new routes of use and
several route-specific considerations.
The considerations in this guidance can
also be applied to routes not specifically
mentioned in the guidance.
This guidance finalizes the draft
guidance of the same name published
on March 7, 2008. Changes to the
guidance include the addition of a
recommendation that toxicology studies
VerDate Sep<11>2014
19:16 Oct 27, 2015
Jkt 238001
be conducted under good laboratory
practices, clarification that
histopathology can be limited in some
cases to locally exposed tissues, the
addition of a reference to the
International Conference on
Harmonisation guidance for industry
entitled ‘‘S10 Photosafety Evaluation of
Pharmaceuticals,’’ and other
clarifications to the studies
recommended for specific routes such
as dermal, ocular, and intranasal.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on nonclinical safety
evaluation of reformulated drug
products and products intended for
administration by an alternate route. 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. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27418 Filed 10–27–15; 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
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
Diseases Agents, Drug Resistance and Drug
Discovery.
Date: November 16–17, 2015.
Time: 9:00 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
(Virtual Meeting).
Contact Person: Tera Bounds, DVM, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892, 301–435–
2306, boundst@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Skeletal Muscle.
Date: November 17, 2015.
Time: 4:00 p.m. to 5:00 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: Daniel F McDonald, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110,
MSC 7814, Bethesda, MD 20892, (301) 435–
1215, mcdonald@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Pathophysiological Correlates of Visual
System Disorders and Mechanisms of
Intervention.
Date: November 19, 2015.
Time: 9:00 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.
Contact Person: Alessandra C Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205
MSC7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.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: October 23, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–27427 Filed 10–27–15; 8:45 am]
BILLING CODE 4140–01–P
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Biology of Infectious
PO 00000
Frm 00032
Fmt 4703
Sfmt 9990
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Page 66014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27427]
-----------------------------------------------------------------------
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 (5 U.S.C. App.), 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; Member Conflict: Topics in Biology of Infectious Diseases
Agents, Drug Resistance and Drug Discovery.
Date: November 16-17, 2015.
Time: 9:00 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 (Virtual Meeting).
Contact Person: Tera Bounds, DVM, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD
20892, 301-435-2306, boundst@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Skeletal Muscle.
Date: November 17, 2015.
Time: 4:00 p.m. to 5:00 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: Daniel F McDonald, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110, MSC 7814, Bethesda, MD
20892, (301) 435-1215, mcdonald@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Pathophysiological Correlates of Visual System Disorders and
Mechanisms of Intervention.
Date: November 19, 2015.
Time: 9:00 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.
Contact Person: Alessandra C Rovescalli, Ph.D., Scientific
Review Officer, National Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205 MSC7846, Bethesda, MD 20892,
(301) 435-1021, rovescaa@mail.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: October 23, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-27427 Filed 10-27-15; 8:45 am]
BILLING CODE 4140-01-P
