National Institute on Drug Abuse; Notice of Meeting, 53235 [05-17682]
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53235
Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN—Continued
PREA Provision
Number of Respondents
Number of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
505B(a)(3) Deferrals
54
3.0
160
24
3,840
505B(a)(4) Full and partial
waivers
80
1.4
110
8
880
505B(e) Meetings
95
1.7
160
16
2,560
Total
12,580
In addition, the draft guidance
discusses when sponsors may need to
report on the status of postmarketing
study commitments as part of annual
reports submitted under 21 CFR
314.81(b) and 21 CFR 601.70. The
burdens associated with the annual
reporting requirements were previously
accounted for under OMB number
0910–0001 (expires 5/31/08) (for 21 CFR
314.81(b) and OMB number 0910–0433
(expires 3/31/07) (for 21 CFR 601.70).
Furthermore, although labeling
submissions are required under certain
PREA provisions (e.g., section
505B(a)(4)(D) of the act), the draft
guidance does not provide
recommendations on these requirements
and therefore FDA has not estimated
associated burdens.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: August 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17694 Filed 9–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
National Advisory Council on Drug
Abuse.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
VerDate Aug<18>2005
15:05 Sep 06, 2005
Jkt 205001
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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.
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s Home page: https://
www.drugabuse.gov/NACDA/
NACDAHome.html, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse Research
Programs, National Institutes of Health, HHS)
Name of Committee: National Advisory
Council on Drug Abuse.
Date: September 21, 2005.
Closed: 9 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Open: 1 p.m. to 4 p.m.
Agenda: This portion of the meeting will
be open to the public for announcements and
reports of administrative, legislative and
program developments in the drug abuse
field.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Teresa Levitin, PhD,
Director, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 220, MSC 8401, 6101 Executive
Boulevard, Bethesda, MD 20892–8401, (301)
433–2755.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
Dated: August 29, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–17682 Filed 9–6–05; 8:45 am]
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BILLING CODE 4140–01–M
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 (5 U.S.C. Appendix 2), 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 Heart,
Lung, and Blood Institute Special
Emphasis Panel, Review of Heart Study
Applications (UO1s).
Date: September 13, 2005.
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Notices]
[Page 53235]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17682]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of
the National Advisory Council on Drug Abuse.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the 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 Advisory Council on Drug Abuse.
Date: September 21, 2005.
Closed: 9 a.m. to 11:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Open: 1 p.m. to 4 p.m.
Agenda: This portion of the meeting will be open to the public
for announcements and reports of administrative, legislative and
program developments in the drug abuse field.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852.
Contact Person: Teresa Levitin, PhD, Director, Office of
Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS,
Room 220, MSC 8401, 6101 Executive Boulevard, Bethesda, MD 20892-
8401, (301) 433-2755.
Any member of the public interested in presenting oral comments
to the committee may notify the Contact Person listed on this notice
at least 10 days in advance of the meeting. Interested individuals
and representatives of organizations may submit a letter of intent,
a brief description of the organization represented, and a short
description of the oral presentation. Only one representative of an
organization may be allowed to present oral comments and if accepted
by the committee, presentations may be limited to five minutes. Both
printed and electronic copies are requested for the record. In
addition, any interested person may file written comments with the
committee by forwarding their statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
Information is also available on the Institute's/Center's Home
page: https://www.drugabuse.gov/NACDA/NACDAHome.html, where an agenda
and any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.277, Drug
Abuse Scientist Development Award for Clinicians, Scientist
Development Awards, and Research Scientist Awards; 93.278, Drug
Abuse National Research Service Awards for Research Training;
93.279, Drug Abuse Research Programs, National Institutes of Health,
HHS)
Dated: August 29, 2005.
Anthony M. Coelho, Jr.,
Acting Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-17682 Filed 9-6-05; 8:45 am]
BILLING CODE 4140-01-M
