Agency Information Collection Activities: Proposed Collection; Comment Request, 6081-6082 [E6-1561]
Download as PDF
<![CDATA[
6081
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
respondents
Type of survey
Internet survey
Annual frequency
per response
3,240
Total annual
responses
1
Hours per
response
3,240
Total hours
.25
Total
810
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed in this document.
Dated: January 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1522 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0032]
Referral of ZINECARD (dexrazoxane)
and RELPAX (eletriptan) Written
Requests for the Conduct of Pediatric
Studies
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
referral of ZINECARD (dexrazoxane)
and RELPAX (eletriptan) Written
Requests for the conduct of pediatric
studies to the Foundation for the
National Institutes of Health (the
Foundation). FDA referred the
ZINECARD (dexrazoxane) and RELPAX
(eletriptan) Written Requests to the
Foundation on August 29, 2005, and is
publishing this notice of the referrals in
accordance with the Best
Pharmaceuticals for Children Act
(BPCA).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, rm. 1613,
Silver Spring, MD 20993–0002, 301–
796–2200, e-mail:
carmouzeg@cder.fda.gov.
In
accordance with section 4 of the BPCA
(Public Law 107–109), FDA is
announcing the referral to the
Foundation of the written requests for
the conduct of pediatric studies for
ZINECARD (dexrazoxane) and RELPAX
(eletriptan). Enacted on January 4, 2002,
SUPPLEMENTARY INFORMATION:
rmajette on PROD1PC67 with NOTICES1
810
VerDate Aug<31>2005
16:32 Feb 03, 2006
Jkt 205001
the BPCA reauthorizes, with certain
important changes, the exclusivity
incentive program described in section
505A of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 355a).
Section 505A of the act permits certain
applications to obtain 6 months of
exclusivity if, in accordance with the
requirements of the statute, the sponsor
submits requested information relating
to the use of the drug in the pediatric
population.
The BPCA established additional
mechanisms for obtaining information
on the safe and effective use of drugs in
pediatric patients. Specifically, section
4 of the BPCA amends section 505A(d)
of the act to create a referral process to
obtain studies for drugs that have patent
or exclusivity protection, but for which
the sponsor has declined to conduct the
pediatric studies in response to a
written request by FDA. Under section
4 of the BPCA, if the Secretary of Health
and Human Services (the Secretary)
determines that there is a continuing
need for the pediatric studies described
in the written request and the sponsors
of the products with patent or
exclusivity protection have declined to
conduct the studies, the Secretary shall
refer the drug to the Foundation,
established under section 499 of the
Public Health Service Act (42 U.S.C.
290(b)), for the conduct of the pediatric
studies described in the written request
(21 U.S.C. 355a(d)(4)(B)(i)). In addition,
the BPCA requires public notice of the
name of the drug, name of the
manufacturer, and indications to be
studied under the referrals (21 U.S.C.
355a(d)(4)(B)(ii)).
In accordance with section 4 of the
BPCA, FDA is announcing that on
August 29, 2005, it referred to the
Foundation the written requests for
pediatric studies for ZINECARD
(dexrazoxane) and RELPAX (eletriptan).
On July 14, 2004, FDA issued a written
request for pediatric studies to Pfizer,
Inc., the holder of approved
applications for RELPAX (eletriptan)
that have market exclusivity. The
studies described in the written request
were for the acute treatment of
migraines in adolescents. Pfizer, Inc.,
declined to conduct the requested
studies. FDA has determined that there
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
is a continuing need for information
relating to the use of RELPAX
(eletriptan) in the pediatric population.
On June 17, 2004, FDA issued a
written request for pediatric studies to
Pfizer, Inc., the holder of approved
applications for ZINECARD
(dexrazoxane) that have market
exclusivity. The studies described in the
written request were for
cardioprotection in children receiving
doxorubicin therapy. Pfizer, Inc.,
declined to conduct the requested
studies. FDA has determined that there
is a continuing need for information
relating to the use of ZINECARD
(dexrazoxane) in the pediatric
population.
Dated: January 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1520 Filed 2–3–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are 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) ways to enhance the
E:\FR\FM\06FEN1.SGM
06FEN1
6082
Federal Register / Vol. 71, No. 24 / Monday, February 6, 2006 / Notices
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.
Proposed Project: Social Network
Analysis of a Service System for
Transition Aged Youth—New
SAMHSA’s, Center for Mental Health
Services will seek information about the
change in the network of social services
in one community, Clark County
Washington, as a result of a Center for
Mental Health Services funded grant
initiative, the Options Program. The
Options program was one of 5 funded
sites across the country. Each site
received four years of funding to build
comprehensive supports that help
adolescents with serious emotional
disturbance and their families make the
difficult transition from adolescent to
adult functioning through the age of 25.
This grant program, called the
Partnerships for Youth Transition, aims
to remediate some of the most difficult
system barriers that interfere with
transition system building by providing
community leaders and advocates
funding for direct services and
infrastructure building, technical
assistance to help shape the vision, and
time to establish programs and
interagency relationships. Since no
single site in the country has ever
successfully built a transition support
system we do not know whether
combining the resources of this grant,
with the resources of the community are
sufficient to make significant strides in
transition system building. It is
imperative to answer this question
systematically and rigorously in order to
guide future efforts.
There have been 110 agencies
identified in Clark County that could
potentially serve youth or young adults
with serious mental, emotional and
behavioral disorders. This study will
Number of
respondents
Respondent
Key informants from social services in Clark County ..........
Responses/
respondent
110
Total
responses
1
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 7–1044, One Choke Cherry Road,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning the
National Urban Search and Rescue
(US&R) grant program.
Dated: January 27, 2006.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. E6–1561 Filed 2–3–06; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4162–20–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice and request for
comments.
rmajette on PROD1PC67 with NOTICES1
AGENCY:
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a proposed revision of a
VerDate Aug<31>2005
14:55 Feb 03, 2006
Jkt 208001
Section
303 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act
(Stafford Act), 42 U.S.C. 5144,
authorizes the President of the United
States to form emergency Support teams
of Federal personnel to be deployed in
an area affected by a major disaster or
emergency. Under Section 403(a)(3)(B)
of the Stafford Act provides that the
President may authorize Federal
agencies to perform work on public or
private lands essential to save lives and
protect property, including search and
rescue and emergency medical care, and
other essential needs. FEMA established
the National Urban Search and Rescue
Response System (US&R) under these
authorities. The President amended E.O.
121448 to transfer the FEMA Director’s
delegated authority to the Secretary of
Homeland Security.
Collection of Information
Title: National Urban Search and
Rescue Program Agreement,
Application, Reporting, and Audit
Requirement.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
conduct network analysis by
interviewing one key informant from
each of these programs about their
organization’s professional relationship
with other social services. The Social
Network Questionnaire was previously
developed for use in several studies in
mental health and homeless services.
Questions focus on aspects of
professional relationship such as how
often clients are referred to another
agency and how often staff meet for
client planning purposes with staff from
another agency, as well as some
background information about the
agency and the quality of services
offered. An additional 10 items focus on
whether the program is following
guidelines for exemplary practice with
transition aged youth. Findings will be
compared to data collected prior to
program initiation.
The following table summarizes the
estimated response burden for this
project.
110
Hours per
response
1.25
Total hour
burden
137.5
Type of Information Collection:
Revision of a currently approved
collection.
OMB Number: 1660–0073.
Form Numbers: None.
Abstract: The information collection
activity is the collection of financial,
program and administrative information
for US&R Sponsoring Organizations
relating to preparedness and response
grant awards. This 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 and a
memorandum of agreement between
DHS/FEMA and the Sponsoring
Organizations of US&R task forces as
described below.
Narrative Statement: FEMA uses
narrative statements to evaluate a
grantee’s proposed use of funds.
Examples of information a grantee needs
to provide FEMA for preparedness and
response cooperative agreements are a
description of the types of eligible
activities the grantee will undertake, a
plan for expending and monitoring
funds, and an estimate of the percentage
or amount of funds the grantee will pass
through to sub-grantees. Sponsoring
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6081-6082]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are 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) ways to enhance the
[[Page 6082]]
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.
Proposed Project: Social Network Analysis of a Service System for
Transition Aged Youth--New
SAMHSA's, Center for Mental Health Services will seek information
about the change in the network of social services in one community,
Clark County Washington, as a result of a Center for Mental Health
Services funded grant initiative, the Options Program. The Options
program was one of 5 funded sites across the country. Each site
received four years of funding to build comprehensive supports that
help adolescents with serious emotional disturbance and their families
make the difficult transition from adolescent to adult functioning
through the age of 25. This grant program, called the Partnerships for
Youth Transition, aims to remediate some of the most difficult system
barriers that interfere with transition system building by providing
community leaders and advocates funding for direct services and
infrastructure building, technical assistance to help shape the vision,
and time to establish programs and interagency relationships. Since no
single site in the country has ever successfully built a transition
support system we do not know whether combining the resources of this
grant, with the resources of the community are sufficient to make
significant strides in transition system building. It is imperative to
answer this question systematically and rigorously in order to guide
future efforts.
There have been 110 agencies identified in Clark County that could
potentially serve youth or young adults with serious mental, emotional
and behavioral disorders. This study will conduct network analysis by
interviewing one key informant from each of these programs about their
organization's professional relationship with other social services.
The Social Network Questionnaire was previously developed for use in
several studies in mental health and homeless services. Questions focus
on aspects of professional relationship such as how often clients are
referred to another agency and how often staff meet for client planning
purposes with staff from another agency, as well as some background
information about the agency and the quality of services offered. An
additional 10 items focus on whether the program is following
guidelines for exemplary practice with transition aged youth. Findings
will be compared to data collected prior to program initiation.
The following table summarizes the estimated response burden for
this project.
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours per Total hour
Respondent respondents respondent responses response burden
----------------------------------------------------------------------------------------------------------------
Key informants from social 110 1 110 1.25 137.5
services in Clark County.......
----------------------------------------------------------------------------------------------------------------
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written
comments should be received within 60 days of this notice.
Dated: January 27, 2006.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. E6-1561 Filed 2-3-06; 8:45 am]
BILLING CODE 4162-20-P
