National Institute of Mental Health; Notice of Closed Meetings, 45646 [2010-19012]
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45646
Federal Register / Vol. 75, No. 148 / Tuesday, August 3, 2010 / Notices
you have any problems with this
process, e-mail: reglist@cdrh.fda.gov or
call 301–796–7400 for assistance. (Note:
this e-mail address and this telephone
number are for assistance with
establishment registration only, and not
for any other aspects of medical device
user fees.) Problems with BER should be
directed to bloodregis@fda.hhs.gov or
call 301–827–3546.
D. Step Four—Enter Your DFUF Order
PIN and PCN
After completing your annual or
initial registration and device listing,
you will be prompted to enter your
DFUF order PIN and PCN, when
applicable. This process does not apply
to licensed biologic devices. CBER will
send invoices for payment of the
establishment registration fee to
companies who only manufacture
licensed biologics devices. Fees are only
required for those establishments
defined in section I of this document.
Dated: July 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19038 Filed 8–2–10; 8:45 am]
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; SBIR
Phase II Topic 59.
Date: August 20, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: July 28, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–19012 Filed 8–2–10; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
erowe on DSK5CLS3C1PROD with NOTICES
National Institute of Mental Health;
Notice of Closed Meetings
Food and Drug Administration
Name of Committee: National Institute of
Mental Health Special Emphasis Panel; SBIR
Phase II Topic 60.
Date: August 18, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
VerDate Mar<15>2010
14:41 Aug 02, 2010
Jkt 220001
[Docket No. FDA–2010–N–0001]
Design of Clinical Trials of Aerosolized
Antimicrobials for the Treatment of
Cystic Fibrosis; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop regarding scientific
issues in clinical development of
aerosolized antimicrobials for the
management and/or treatment of
patients with cystic fibrosis.
Aerosolized antimicrobials are used to
treat chronic bacterial infection in the
lungs and thus improve the respiratory
symptoms in patients with cystic
fibrosis. This public workshop is
intended to provide information for and
gain perspective from health care
providers, patients and patient advocacy
organizations, academia, and industry
on various aspects of the design of
clinical trials of aerosolized
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
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antimicrobials in patients with cystic
fibrosis. The input from this public
workshop will help in developing topics
for further discussion.
Dates and Times: The public
workshop will be held on September 23,
2010, from 8:30 a.m. to 5:30 p.m. and on
September 24, 2010, from 8 a.m. to 4
p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel,8777
Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on
a first-come, first-served basis.
Contact Persons: Chris Moser or Lori
Benner, Center for Drug Evaluation and
Research,Food and Drug
Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave.,
Bldg. 22, rm. 6209, Silver Spring, MD
20993–0002, 301–796–1300.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, e-mail
registration information (including
name, title, firm name, address,
telephone, and fax number) to
CFWORKSHOP@fda.hhs.gov Persons
without access to the Internet can call
301–796–1300 to register. Persons
needing a sign language interpreter or
other special accommodations should
notify Christine Moser or Lori Benner
(see Contact Persons) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding scientific considerations in
the design of clinical trials of
aerosolized antimicrobials to treat
chronic bacterial infection in the lungs
and thus improve the respiratory
symptoms in patients with cystic
fibrosis. The development of clinical
trial endpoints to establish efficacy is a
major challenge in the design of
informative clinical trials of aerosolized
antimicrobials for the management and/
or treatment of patients with cystic
fibrosis. The workshop will include
discussion of clinical trial endpoints to
establish efficacy, such as timing and
definitions of pulmonary exacerbations,
changes in the results of pulmonary
function testing, and changes on patient
reported outcome measures. An
important consideration will be the
evaluation of new aerosolized
antimicrobials in the context of
approved aerosolized antimicrobials on
the basis of these or other efficacy
endpoints. Other issues in the design of
clinical trials of aerosolized
antimicrobials include: The
development of drug resistance and
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 75, Number 148 (Tuesday, August 3, 2010)]
[Notices]
[Page 45646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19012]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; SBIR Phase II Topic 60.
Date: August 18, 2010.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Marina Broitman, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153,
MSC 9608, Bethesda, MD 20892-9608, 301-402-8152,
mbroitma@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; SBIR Phase II Topic 59.
Date: August 20, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852 (Telephone Conference
Call).
Contact Person: Marina Broitman, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153,
MSC 9608, Bethesda, MD 20892-9608, 301-402-8152,
mbroitma@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.242,
Mental Health Research Grants; 93.281, Scientist Development Award,
Scientist Development Award for Clinicians, and Research Scientist
Award; 93.282, Mental Health National Research Service Awards for
Research Training, National Institutes of Health, HHS)
Dated: July 28, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-19012 Filed 8-2-10; 8:45 am]
BILLING CODE 4140-01-P
