80 FR 66014 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 208 (October 28, 2015)

Page Range		66014-66014
FR Document		2015-27427

Federal Register, Volume 80 Issue 208 (Wednesday, October 28, 2015)

[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Page 66014]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27427]


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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 (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, [email protected].

    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, [email protected].

    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, [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: 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

66014 Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices

Submit written requests for single be conducted under good laboratory Diseases Agents, Drug Resistance and Drug
copies of this guidance to the Division practices, clarification that Discovery.
of Drug Information, Center for Drug histopathology can be limited in some Date: November 16–17, 2015.
Evaluation and Research, Food and cases to locally exposed tissues, the Time: 9:00 a.m. to 6:00 p.m.
Drug Administration, 10001 New addition of a reference to the Agenda: To review and evaluate grant
Hampshire Ave., Hillandale Building, International Conference on applications.
4th Floor, Silver Spring, MD 20993– Harmonisation guidance for industry Place: National Institutes of Health, 6701
0002. Send one self-addressed adhesive entitled ‘‘S10 Photosafety Evaluation of Rockledge Drive, Bethesda, MD 20892
label to assist that office in processing Pharmaceuticals,’’ and other (Virtual Meeting).
your requests. See the SUPPLEMENTARY clarifications to the studies Contact Person: Tera Bounds, DVM, Ph.D.,
INFORMATION section for electronic recommended for specific routes such Scientific Review Officer, Center for
access to the guidance document. as dermal, ocular, and intranasal. Scientific Review, National Institutes of
This guidance is being issued Health, 6701 Rockledge Drive, Room 3214,
FOR FURTHER INFORMATION CONTACT: Paul
consistent with FDA’s good guidance MSC 7808, Bethesda, MD 20892, 301–435–
C. Brown, Center for Drug Evaluation 2306, boundst@csr.nih.gov.
and Research, Food and Drug practices regulation (21 CFR 10.115).
Administration, 10903 New Hampshire The guidance represents the current Name of Committee: Center for Scientific
thinking of FDA on nonclinical safety Review Special Emphasis Panel; Small
Ave., Bldg., 22, Rm. 6472, Silver Spring,
evaluation of reformulated drug Business: Skeletal Muscle.
MD 20993–0002, 301–796–0856.
products and products intended for Date: November 17, 2015.
SUPPLEMENTARY INFORMATION: Time: 4:00 p.m. to 5:00 p.m.
administration by an alternate route. It
I. Background does not establish any rights for any Agenda: To review and evaluate grant
person and is not binding on FDA or the applications.
FDA is announcing the availability of Place: National Institutes of Health, 6701
a guidance for industry and review staff public. You can use an alternative
approach if it satisfies the requirements Rockledge Drive, Bethesda, MD 20892,
entitled ‘‘Nonclinical Safety Evaluation (Telephone Conference Call).
of Reformulated Drug Products and of the applicable statutes and
regulations. Contact Person: Daniel F McDonald, Ph.D.,
Products Intended for Administration Scientific Review Officer, Center for
by an Alternate Route.’’ This guidance II. Electronic Access Scientific Review, National Institutes of
provides recommendations regarding Health, 6701 Rockledge Drive, Room 4110,
Persons with access to the Internet
the nonclinical evaluation of a new MSC 7814, Bethesda, MD 20892, (301) 435–
may obtain the document at either
formulation containing a previously 1215, mcdonald@csr.nih.gov.
http://www.fda.gov/Drugs/Guidance
approved drug substance and of a
ComplianceRegulatoryInformation/ Name of Committee: Center for Scientific
product proposed for use by an alternate
Guidances/default.htm or http:// Review Special Emphasis Panel;
route of administration for which the
www.regulations.gov. Pathophysiological Correlates of Visual
product was not previously approved. System Disorders and Mechanisms of
Generally, nonclinical data support Dated: October 21, 2015.
Intervention.
use of a drug product by a particular Leslie Kux,
Date: November 19, 2015.
route and also reflect the planned Associate Commissioner for Policy. Time: 9:00 a.m. to 6:00 p.m.
duration of use. Much of the available [FR Doc. 2015–27418 Filed 10–27–15; 8:45 am] Agenda: To review and evaluate grant
nonclinical information used to support BILLING CODE 4164–01–P applications.
approval of the initial formulation can Place: National Institutes of Health, 6701
be used to support the safety of Rockledge Drive, Bethesda, MD 20892.
additional formulations assuming all DEPARTMENT OF HEALTH AND Contact Person: Alessandra C Rovescalli,
legal rights to the information are met. HUMAN SERVICES Ph.D., Scientific Review Officer, National
Information used to support an initial Institutes of Health, Center for Scientific
formulation, however, may not always National Institutes of Health
Review, 6701 Rockledge Drive, Rm 5205
be sufficient to support such additional MSC7846, Bethesda, MD 20892, (301) 435–
Center for Scientific Review; Notice of
approvals because changes in the 1021, rovescaa@mail.nih.gov.
Closed Meetings
formulation could produce a new (Catalogue of Federal Domestic Assistance
toxicity. This is particularly true if the Pursuant to section 10(d) of the Program Nos. 93.306, Comparative Medicine;
drug product’s route of administration is Federal Advisory Committee Act, as 93.333, Clinical Research, 93.306, 93.333,
different or the duration of use changes amended (5 U.S.C. App.), notice is 93.337, 93.393–93.396, 93.837–93.844,
markedly. Therefore, additional hereby given of the following meetings. 93.846–93.878, 93.892, 93.893, National
nonclinical studies might be The meetings will be closed to the Institutes of Health, HHS)
recommended to ensure that the toxicity public in accordance with the
of a new formulation is fully provisions set forth in sections Dated: October 23, 2015.
characterized. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Carolyn Baum,
This guidance provides general as amended. The grant applications and Program Analyst, Office of Federal Advisory
nonclinical considerations for all the discussions could disclose Committee Policy.
reformulations or new routes of use and confidential trade secrets or commercial [FR Doc. 2015–27427 Filed 10–27–15; 8:45 am]
several route-specific considerations. property such as patentable material, BILLING CODE 4140–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES

The considerations in this guidance can and personal information concerning
also be applied to routes not specifically individuals associated with the grant
mentioned in the guidance. applications, the disclosure of which
This guidance finalizes the draft would constitute a clearly unwarranted
guidance of the same name published invasion of personal privacy.
on March 7, 2008. Changes to the Name of Committee: Center for Scientific
guidance include the addition of a Review Special Emphasis Panel; Member
recommendation that toxicology studies Conflict: Topics in Biology of Infectious

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Document Created: 2018-02-27 08:57:47
Document Modified: 2018-02-27 08:57:47

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		November 16-17, 2015.
FR Citation		80 FR 66014

80 FR 66014 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 208 (October 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health