National Heart, Lung, and Blood Institute; Notice of Meeting, 17970-17971 [E9-8903]
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17970
Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices
rmajette on PRODPC74 with NOTICES
products. Such systems have been put
in place for drugs that are or are
suspected to be teratogenic, and the
programs are designed to ensure
patients are not pregnant and will not
become pregnant while taking the drug.
Such systems create burdens on patients
and the health care system. Is such a
system necessary for opioids? How
would such a program be implemented
given the number of patients,
prescribers, and other health care
providers involved in their use?
2. Should the REMS include controls
on distributors who distribute products
to pharmacies and other health care
providers? What controls are necessary,
and how can they be efficiently
provided without being unduly
burdensome on the health care system?
3. What existing systems (for example,
in pharmacies) already exist that could
be used to implement a REMS? For
example, could patient information be
provided through existing pharmacy
systems to patients? Are there systems
for providing education to prescribers
that could be used to provide the
educational component of a REMS?
4. FDAAA requires that innovator and
generic application holders use a single,
shared system to provide a REMS with
elements to assure safe use. What
obstacles need to be addressed before
such a system could be developed?
5. What metrics should be used to
assess the success of the REMS? Please
comment on the metrics that should be
applied to measure the success of each
of the components of the REMS (e.g.,
educational requirements) as well as
metrics to assess the impact of the
overall REMS on decreasing abuse and
misuse of long acting opioids and
extended release opioids while seeking
to ensure that they remain available for
patients who suffer daily from chronic
pain.
III. Attendance and Registration
Register via email to
OpioidREMS@fda.hhs.gov by providing
complete contact information for each
attendee (including name, title,
affiliation, address, email address, and
phone number(s)) by May 15, 2009.
Registration is free and will be on a firstcome, first-served basis. Early
registration is recommended because
seating is limited. Please send no more
than two individuals from your
organization. Registration on the first
day of the meeting will be provided on
a space available basis beginning at 8
a.m.
If you wish to make an oral
presentation at the meeting, you must
indicate this at the time of registration.
FDA has included questions for
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comment in section II of this document.
You should also identify by number
each question you wish to address in
your presentation. FDA will do its best
to accommodate requests to speak.
Individuals and organizations with
common interests are urged to
consolidate or coordinate their
presentations, and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin. If you need special
accommodations because of disability,
please e-mail OpioidREMS@fda.hhs.gov
at least 7 days before the meeting.
IV. Comments
Regardless of attendance at the public
meeting, interested persons may submit
written or electronic comments to the
Division of Dockets Management (see
ADDRESSES). Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. To ensure consideration,
submit comments by June 30, 2009.
Received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
V. Transcripts
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the
meeting. A transcript will also be made
available in either hard copy or on CD–
ROM, upon submission of a Freedom of
Information request. Written requests
are to be sent to Division of Freedom of
Information (HFI–35), Office of
Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: April 14, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8992 Filed 4–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Amended Notice
The purpose of this notice is to inform
the public that the National Institutes of
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Health (NIH) is cancelling the May 5,
2009 meeting of the NIH Blue Ribbon
Panel to Advise on the Risk Assessment
of the National Emerging Infectious
Diseases Laboratories at Boston
University Medical Center. The
announcement for the May 5, 2009
meeting was previously published in
the Federal Register on April 3, 2009
(74 FR 15296).
The meeting will be rescheduled and
the new date for the meeting will be
announced and published in the
Federal Register.
Dated: April 14, 2009.
Kelly Fennington,
Special Assistant to the Acting Director,
Office of Science Policy, National Institutes
of Health.
[FR Doc. E9–9037 Filed 4–17–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Heart, Lung, and Blood
Advisory Council.
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 Heart, Lung,
and Blood Advisory Council.
Date: June 10, 2009.
Open: 8 a.m. to 12 p.m.
Agenda: To discuss program policies and
issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C–Wing, Room
10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
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Federal Register / Vol. 74, No. 74 / Monday, April 20, 2009 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, C–Wing, Room
10, Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, Phd,
Director, Division of Extramural Research
Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701
Rockledge Drive, Room 7100, Bethesda, MD
20892, (301) 435–0260,
mockrins@nhlbi.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the 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.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, drivers license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institutes/Center’s home page:
www.nhlbi.nih.gov/meetings/index.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Agreement Revisions, and FEMA Form
089–14, Self Evaluations, and FEMA
Form 089–15, Task Force Deployment
Data.
Dated: April 13, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–8903 Filed 4–17–09; 8:45 am]
SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
DATES: Comments must be submitted on
or before May 20, 2009.
ADDRESSES: Submit written comments
on the proposed information collection
to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to the Desk Officer
for the Department of Homeland
Security, Federal Emergency
Management Agency, and sent via
electronic mail to
oira.submission@omb.eop.gov or faxed
to (202) 395–6974.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
should be made to Director, Records
Management Division, 1800 South Bell
Street, Arlington, VA 20598–3005,
facsimile number (202) 646–3347, or
e-mail address FEMA–InformationCollections@dhs.gov.
BILLING CODE 4140–01–M
SUPPLEMENTARY INFORMATION:
Collection of Information
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]
rmajette on PRODPC74 with NOTICES
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0073; FEMA
Form 089–10, Narrative Statement, and
FEMA Form 089–11, Performance
Reports, and FEMA Form 089–12,
Extensions/Budget Changes, and FEMA
Form 089–13, Memorandum of
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Title: National Urban Search and
Rescue Grant Program.
Type of information collection:
Revision of a currently approved
information collection.
OMB Number: 1660–0073.
Form Titles and Numbers: FEMA
Form 089–10, Narrative Statement, and
FEMA Form 089–11, Performance
Reports, and FEMA Form 089–12,
Extensions/Budget Changes, and FEMA
Form 089–13, Memorandum of
Agreement Revisions, and FEMA Form
089–14, Self Evaluations, and FEMA
Form 089–15, Task Force Deployment
Data.
Abstract: The information collection
activity is the collection of financial,
program and administrative information
for US&R Sponsoring Organizations
relating to preparedness and response
Cooperative Agreement awards. This
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17971
information includes a narrative
statement that FEMA uses to evaluate a
grantee’s proposed use of funds,
progress reports to monitor overall
progress on managing FEMA grant
program, extension or change requests
used to consider changing or extending
the time or the performance period of
the preparedness or response
cooperative agreement, evaluation and
information to assess and ensure
operational readiness and a
memorandum of agreement between
DHS/FEMA and the Sponsoring
Organizations of US&R task forces.
Affected Public: State, Local or Tribal
Government.
Estimated Number of Respondents:
28.
Frequency of Response: Semiannually.
Estimated Average Hour Burden per
Respondent: 17 Hours.
Estimated Total Annual Burden
Hours: 476 hours.
Estimated Cost: There are no start-up,
operational or other costs associated
with this information collection.
Larry Gray,
Director, Records Management Division,
Office of Management, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. E9–9008 Filed 4–17–09; 8:45 am]
BILLING CODE 9110–69–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0083; FEMA
Form 116–0–1, Promissory Note, FEMA
Form 085–0–1, Local Government
Resolution Collateral Security, FEMA
Form 090–0–1, Certification of
Eligibility for Community Disaster
Loans, and FEMA Form 090–0–2,
Application for Community Disaster
Loan.
SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the information collection
abstracted below to the Office of
Management and Budget for review and
clearance in accordance with the
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]]>Agencies
[Federal Register Volume 74, Number 74 (Monday, April 20, 2009)]
[Notices]
[Pages 17970-17971]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8903]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the
National Heart, Lung, and Blood Advisory Council.
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 Heart, Lung, and Blood Advisory
Council.
Date: June 10, 2009.
Open: 8 a.m. to 12 p.m.
Agenda: To discuss program policies and issues.
Place: National Institutes of Health, Building 31, 31 Center
Drive, C-Wing, Room 10, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
[[Page 17971]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 31 Center
Drive, C-Wing, Room 10, Bethesda, MD 20892.
Contact Person: Stephen C. Mockrin, Phd, Director, Division of
Extramural Research Activities, National Heart, Lung, and Blood
Institute, National Institutes of Health, 6701 Rockledge Drive, Room
7100, Bethesda, MD 20892, (301) 435-0260, mockrins@nhlbi.nih.gov.
Any interested person may file written comments with the
committee by forwarding the 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.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
drivers license, or passport) and to state the purpose of their
visit.
Information is also available on the Institutes/Center's home
page: www.nhlbi.nih.gov/meetings/index.htm, where an agenda and any
additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: April 13, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-8903 Filed 4-17-09; 8:45 am]
BILLING CODE 4140-01-M
