Notice of Partially Closed Meeting; National Commission on Children and Disasters, 66049-66050 [E8-26418]
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66049
Federal Register / Vol. 73, No. 216 / Thursday, November 6, 2008 / Notices
Number of respondents
Type of respondents
Number of responses per
respondent
68
1
NBCCEDP grantee ..........................................................................................
Dated: October 30, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–26429 Filed 11–5–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Objective Work Plan (OWP),
Objective Progress Report (OPR) and
Project Abstract.
OMB No.: 0980–0204.
Description: Content changes are
being made to the OPR ONLY. The
information in the OPR is being
collected on a quarterly basis to monitor
the performance of grantees and better
gauge grantee progress. The
standardized format will allow ANA to
report results across all its program
areas and flag grantees that may need
additional training and/or technical
assistance to successfully implement
their projects.
Following are content changes being
made within specific sections of the
OPR form:
OBJECTIVE WORK PLAN UPDATE
Section: Adding 1st through 4th Quarter
(Q1,Q2,Q3,Q4) results for Activities
within each Objective. The grantee can
continue to add to this form each
quarter (rather than on to a new form),
reflecting cumulative results throughout
the project period rather than just the
quarter.
FINANCIAL Section: Add 2
Questions: (1) Provide details on any
income generated as a result of ANA
project activities; (2) Provide details on
any changes made to the budget during
the reporting period.
NATIVE AMERICAN YOUTH AND
ELDER OPPORTUNITIES Section: Add
Question: (1) Request details on any
intergenerational activities between
grandparents and their grandchildren.
Number of
respondents
Instrument
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OWP ..............................................................................................................
OPR ...............................................................................................................
Project Abstract .............................................................................................
Estimated Total Annual Burden
Hours: 2,850.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
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Dated: November 3, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–26519 Filed 11–5–08; 8:45 am]
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Total
burden
(in hrs)
22
1,496
Finally, add a new section (last
section) to the form: PROJECT
SUSTAINABILITY: (1) Request details
on the grantee’s intention to continue
the project benefits and/or services after
the project period has ended.
End of Content Changes to the OPR.
No changes are being made to the
OWP or to the Project Abstract (below).
The information collected by the
OWP is needed to properly administer
and monitor the Administration for
Native Americans (ANA) programs
within the Administration for Children
and Families (ACF). The OWP assists
applicants in describing their projects’
objectives and activities, and also assists
independent panel reviewers, ANA staff
and the ANA Commissioner during the
review and funding decision process.
The Project Abstract provides crucial
information in a concise format that is
utilized by applicants, independent
reviewers, ANA staff and the ANA
Commissioner.
Respondents: Tribal Government,
Native non-profit organizations, Tribal
Colleges & Universities
Annual Burden Estimates.
Number of
responses per
respondent
Average burden
hours per
response
1
4
1
3
1
0.50
500
275
500
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Average burden
(in hrs)
Total burden
hours
1,500
1,100
250
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Partially Closed Meeting;
National Commission on Children and
Disasters
Administration for Children
and Families, Department of Health and
Human Services.
ACTION: Notice of meeting.
AGENCY:
The open session of the meeting
will be held on Thursday, November 20,
2008, from 10:45 a.m. to 5:30 p.m. and
Friday, November 21, 2008, from 8:30
a.m. to 1:30 p.m. The closed session of
the meeting will be held on Thursday,
November 20, 2008, from 8:30 a.m. to
10:30 a.m. The portion of the meeting
that will be closed to the public shall be
DATES:
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66050
Federal Register / Vol. 73, No. 216 / Thursday, November 6, 2008 / Notices
so in accordance with the provisions set
forth in sections 552b(c)(6), Title 5
U.S.C., as amended.
The meeting will be held at
the Administration for Children and
Families, 901 D Street, SW.,
Washington, DC 20447. Seating is
limited. To attend, please register by 5
p.m. EST, November 17, 2008. To
register, please e-mail
carol.apelt@acf.hhs.gov with ‘‘Meeting
Registration’’ in the subject line, or call
Carol Apelt at (202) 205–4618.
Registration must include your name,
affiliation, and phone number. If you
require a sign language interpreter or
other special assistance, please contact
Carol Apelt as soon as possible and no
later than 5 p.m. EST, November 14,
2008.
Agenda: As pertaining to man-made
and natural disaster situations, the
Commission will hear presentations on
and discuss: (1) Medical
countermeasures; (2) case management;
(3) shelter design and transition to
permanent housing; (4) acute medical
care; (5) other matters as may reasonably
come before the Commission and plans
for future work of the Commission.
Additional Information: Contact
Roberta Lavin, Office of Human Services
Emergency Preparedness and Response,
e-mail roberta.lavin@acf.hhs.gov or
(202) 401–9306.
ADDRESSES:
The
National Commission on Children and
Disasters is an independent Presidential
Commission that shall independently
conduct a comprehensive study to
examine and assess the needs of
children as they relate to preparation
for, response to, and recovery from all
hazards, building upon the evaluations
of other entities and avoiding
unnecessary duplication by reviewing
the findings, conclusions, and
recommendations of these entities. The
Commission shall then submit a report
to the President and the Congress on the
Commission’s independent and specific
findings, conclusions, and
recommendations to address the needs
of children as they relate to preparation
for, response to, and recovery from all
hazards, including major disasters and
emergencies.
sroberts on PROD1PC70 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: October 31, 2008.
Daniel C. Schneider,
Acting Assistant Secretary for Children and
Families.
[FR Doc. E8–26418 Filed 11–5–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0567]
Designating Additions to the Current
List of Tropical Diseases in the Food
and Drug Administration Amendments
Act; Public Hearing
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public hearing to obtain input on adding
additional diseases to the list of tropical
diseases recognized under the Food and
Drug Administration Amendments Act
(FDAAA), which adds a new section to
the Federal Food, Drug, and Cosmetic
Act (the act). The new section
authorizes FDA to award priority review
vouchers to sponsors of certain tropical
disease product applications that meet
the criteria specified by the act. The
new section lists diseases considered to
be ‘‘tropical diseases’’ for the purposes
of this legislation, and provides for
expansion of the list to include diseases
meeting certain criteria. This public
meeting is being held to obtain
comments from the public on the
criteria that should be used to determine
whether an infectious disease should be
added to the list, and to elicit
suggestions for adding specific diseases.
DATES: The public hearing will be held
on December 12, 2008, from 9 a.m. to 5
p.m. However, depending on the level
of public participation, the meeting may
be extended or may end early. Submit
written or electronic requests for oral
presentations and comments by
November 17, 2008. Written or
electronic comments will be accepted
after the hearing until February 6, 2009.
ADDRESSES: The public hearing will be
held at the National Transportation
Safety Board Boardroom and Conference
Center at 429 L’Enfant Plaza, SW,
Washington, DC 20594. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. All comments
should be identified with the docket
number found in brackets in the
heading of this document. Transcripts of
the hearing 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 hearing.
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Jeff
O’Neill, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20903, 301–
796–0777, FAX: 301–847–8753, e-mail:
jeff.o’neill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
The new section, section 524 of the
act (21 U.S.C. 360n), is designed to
encourage development of new drug or
biological products for prevention and
treatment of certain tropical diseases
affecting millions of people throughout
the world. Section 524 provides a means
by which the holder of an application
for a tropical disease product may be
eligible to receive a priority review
voucher upon approval of that
application. This voucher entitles the
sponsor to be granted a priority review
for a subsequent application of a drug or
biologic, submitted under section
505(b)(1) of the act (21 U.S.C. 355(b)(1))
or section 351 of the Public Health
Service Act (42 U.S.C. 262), of the
sponsor’s choosing that would not
otherwise be eligible for a priority
review. FDA is committed to a goal of
reviewing and taking an action within 6
months of receipt on 90% of
applications that have been granted a
priority review (see https://www.fda.gov/
oc/pdufa4/pdufa4goals.html).
To be granted a priority review
voucher, the tropical disease application
must meet all of the following criteria:
• The application must be a human
drug application as defined in section
735(1) of the act (21 U.S.C. 379g(1)).
• The application must be for the
prevention or treatment of a tropical
disease.
• The tropical disease application
must be eligible for priority review.
• The tropical disease application
must be for ‘‘a human drug, no active
ingredient (including any ester or salt of
the active ingredient) of which has been
approved in any other application under
section 505(b)(1) or section 351 of the
Public Health service Act.’’
After being granted a priority review
voucher, the owner of the voucher may
transfer it to another sponsor. The
sponsor intending to redeem a priority
review voucher must notify the agency
at least 365 days prior to submission of
the application for which the voucher is
to be redeemed. This notification
constitutes a legally binding agreement
to pay a supplemental user fee that is
mandated by the act to be applied to an
application using a priority review
voucher.
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]]>Agencies
[Federal Register Volume 73, Number 216 (Thursday, November 6, 2008)]
[Notices]
[Pages 66049-66050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26418]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Notice of Partially Closed Meeting; National Commission on
Children and Disasters
AGENCY: Administration for Children and Families, Department of Health
and Human Services.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
DATES: The open session of the meeting will be held on Thursday,
November 20, 2008, from 10:45 a.m. to 5:30 p.m. and Friday, November
21, 2008, from 8:30 a.m. to 1:30 p.m. The closed session of the meeting
will be held on Thursday, November 20, 2008, from 8:30 a.m. to 10:30
a.m. The portion of the meeting that will be closed to the public shall
be
[[Page 66050]]
so in accordance with the provisions set forth in sections 552b(c)(6),
Title 5 U.S.C., as amended.
ADDRESSES: The meeting will be held at the Administration for Children
and Families, 901 D Street, SW., Washington, DC 20447. Seating is
limited. To attend, please register by 5 p.m. EST, November 17, 2008.
To register, please e-mail carol.apelt@acf.hhs.gov with ``Meeting
Registration'' in the subject line, or call Carol Apelt at (202) 205-
4618. Registration must include your name, affiliation, and phone
number. If you require a sign language interpreter or other special
assistance, please contact Carol Apelt as soon as possible and no later
than 5 p.m. EST, November 14, 2008.
Agenda: As pertaining to man-made and natural disaster situations,
the Commission will hear presentations on and discuss: (1) Medical
countermeasures; (2) case management; (3) shelter design and transition
to permanent housing; (4) acute medical care; (5) other matters as may
reasonably come before the Commission and plans for future work of the
Commission.
Additional Information: Contact Roberta Lavin, Office of Human
Services Emergency Preparedness and Response, e-mail
roberta.lavin@acf.hhs.gov or (202) 401-9306.
SUPPLEMENTARY INFORMATION: The National Commission on Children and
Disasters is an independent Presidential Commission that shall
independently conduct a comprehensive study to examine and assess the
needs of children as they relate to preparation for, response to, and
recovery from all hazards, building upon the evaluations of other
entities and avoiding unnecessary duplication by reviewing the
findings, conclusions, and recommendations of these entities. The
Commission shall then submit a report to the President and the Congress
on the Commission's independent and specific findings, conclusions, and
recommendations to address the needs of children as they relate to
preparation for, response to, and recovery from all hazards, including
major disasters and emergencies.
Dated: October 31, 2008.
Daniel C. Schneider,
Acting Assistant Secretary for Children and Families.
[FR Doc. E8-26418 Filed 11-5-08; 8:45 am]
BILLING CODE 4184-01-P
