Submission for OMB Review; Comment Request, 9418-9419 [2010-4209]
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9418
Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices
also conserve agency resources by
reducing the current volume of inquiries
individual FDA offices and employees
must handle concerning advisory
committee schedules and procedures.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 24, 2010.
Joanne Less,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–4258 Filed 3–1–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Submission for OMB Review;
Comment Request; Reinstatement of
OMB No. 0925–0601/exp. 02/28/2010,
Request for Human Embryonic Stem
Cell Line To Be Approved for Use in
NIH Funded Research
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a reinstatement of approval of
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on September 25, 2009, page
48973 and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
unless it displays a currently valid OMB
control number.
Proposed Collection: Title: Request for
Human Embryonic Stem Cell Line to be
Approved for Use in NIH Funded
Research. Type of Information
Collection Request: Revision, OMB
0925–0601, Expiration Date 02/28/2010,
Form Number: NIH 2890. Need and Use
of Information Collection: The form is
used by applicants to request that
human embryonic stem cell lines be
approved for use in NIH funded
research. Frequency of response:
Applicants may submit applications at
any time; this request is a one-time
submission. Affected Public: Business or
other for-profit; Not-for-profit
institutions; Federal Government; and
State, Local or Tribal Government. Type
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of Respondents: Adult scientific
professionals. The annual reporting
burden is as follows: Estimated Number
of Respondents: 160,135; Estimated
Number of Responses per Respondent:
1; Average Burden Hours per Response:
14; and Estimated Total Annual Burden
Hours Requested: 2,251,500. The
estimated annualized cost to
respondents is $78,802,500.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Ms.
Mikia Currie, Division of Grants Policy,
Office of Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number (301) 435–
0941, or E-mail your request, including
your address to: curriem@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: February 25, 2010.
Mikia Currie,
Office of Policy for Extramural Research
Administration, OD, NIH.
[FR Doc. 2010–4301 Filed 3–1–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Evaluation of Adolescent
Pregnancy Prevention Approaches—
Baseline Data Collection.
OMB No.: ICRAS: 0970–0360.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing a data
collection activity as part of the
Evaluation of Adolescent Pregnancy
Prevention Approaches (PPA). PPA is
being undertaken to expand available
evidence on effective ways to reduce
teen pregnancy. The evaluation will
document and test a range of pregnancy
prevention approaches in up to eight
program sites. Program impacts will be
estimated using a random assignment
design, involving random assignment at
the school, individual, or other level,
depending on the program setting. The
findings of the evaluation will be of
interest to the general public, to policymakers, and to organizations interested
in teen pregnancy prevention.
This proposed information collection
activity focuses on collecting baseline
data from a self-administered
questionnaire which will be used to
perform meaningful analysis to
determine significant program effects.
Through a survey instrument,
respondents will be asked to answer
carefully selected questions about
demographics and risk and protective
factors related to teen pregnancy. As
appropriate to each program being
evaluated, youth records, performance,
and program participation data will also
be collected.
Respondents: The data will be
collected through private, selfadministered questionnaires completed
by study participants, i.e. adolescents
assigned to a select school or
community teen pregnancy prevention
program or a control group. Surveys will
be distributed and collected by trained
professional staff. Youth school records,
performance, and program participation
data will also be collected from
participating schools and organizations,
as appropriate to the site.
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Federal Register / Vol. 75, No. 40 / Tuesday, March 2, 2010 / Notices
ANNUAL BURDEN ESTIMATES
Annual number of respondents
Instrument
Baseline Instrument .........................................................................................
School Records, Performance, and Program Participation Data Collection ...
Estimated Total Annual Burden
Hours: 1,864.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment
ONE is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 23, 2010.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2010–4209 Filed 3–1–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: During the morning session
of March 22, 2010, the committee will
discuss new drug application (NDA)
022–481, proposed trade name PIXUVRI
(pixantrone dimaleate) injection, by Cell
Therapeutics, Inc. The proposed
indication (use) for this product is as a
single agent treatment for patients with
recurring or refractory (difficult to treat),
aggressive Non-Hodgkin’s Lymphoma
who have received two or more prior
lines of therapy.
During the afternoon session, the
committee will discuss NDA 022–374,
proposed trade name OMAPRO
(omacetaxine mepesuccinate) for
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Average burden hours per
response
1
1
.5
8
3,600
8
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 22, 2010, from 8 a.m. to
5 p.m. This meeting is a reschedule of
a postponed meeting originally
announced in the Federal Register of
December 17, 2009 (74 FR 66986) to
take place on February 10, 2010.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
PO 00000
Number of responses per
respondent
Total annual
burden hours
1,800
64
injection, by ChemGenex
Pharmaceuticals. The proposed
indication (use) for this product is for
the treatment of adults with chronic
myeloid leukemia bearing a genetic
alteration known as the Bcr-Abl T315I
mutation, and who have failed prior
therapy with the drug imatinib.
Due to the postponement of the
February 10, 2010, Oncologic Drugs
Advisory Committee meeting because of
severe weather conditions and the
urgency to reschedule this meeting,
FDA regrets that it was unable to
publish this notice 15 days prior to the
March 22, 2010, Oncologic Drugs
Advisory Committee meeting. Because
the agency believes there is some
urgency to bring these issues to public
discussion and qualified members of the
Oncologic Drugs Advisory Committee
were available at this time, the
Commissioner of Food and Drugs
concluded that it was in the public
interest to hold this meeting even if
there was not sufficient time for the
customary 15-day public notice.
Background materials from the
originally scheduled February 10, 2010,
Oncologic Drugs Advisory Committee
meeting are currently available at https://
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
link. Should any additional background
materials become available, they will be
posted 2 days before the March 22,
2010, meeting at this same Web site.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 17, 2010.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m., and 3:30 p.m. to
4 p.m. Those desiring to make formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before March 12, 2010. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
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]]>Agencies
[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9418-9419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4209]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Evaluation of Adolescent Pregnancy Prevention Approaches--
Baseline Data Collection.
OMB No.: ICRAS: 0970-0360.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services (HHS), is proposing a data
collection activity as part of the Evaluation of Adolescent Pregnancy
Prevention Approaches (PPA). PPA is being undertaken to expand
available evidence on effective ways to reduce teen pregnancy. The
evaluation will document and test a range of pregnancy prevention
approaches in up to eight program sites. Program impacts will be
estimated using a random assignment design, involving random assignment
at the school, individual, or other level, depending on the program
setting. The findings of the evaluation will be of interest to the
general public, to policy-makers, and to organizations interested in
teen pregnancy prevention.
This proposed information collection activity focuses on collecting
baseline data from a self-administered questionnaire which will be used
to perform meaningful analysis to determine significant program
effects. Through a survey instrument, respondents will be asked to
answer carefully selected questions about demographics and risk and
protective factors related to teen pregnancy. As appropriate to each
program being evaluated, youth records, performance, and program
participation data will also be collected.
Respondents: The data will be collected through private, self-
administered questionnaires completed by study participants, i.e.
adolescents assigned to a select school or community teen pregnancy
prevention program or a control group. Surveys will be distributed and
collected by trained professional staff. Youth school records,
performance, and program participation data will also be collected from
participating schools and organizations, as appropriate to the site.
[[Page 9419]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Annual number responses per hours per Total annual
of respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Baseline Instrument............................. 3,600 1 .5 1,800
School Records, Performance, and Program 8 1 8 64
Participation Data Collection..................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,864.
Additional Information
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer. All requests should be identified
by the title of the information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment
ONE is required to make a decision concerning the collection of
information between 30 and 60 days after publication of this document
in the Federal Register. Therefore, a comment is best assured of having
its full effect if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974,
Attn: Desk Officer for the Administration for Children and Families.
Dated: February 23, 2010.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2010-4209 Filed 3-1-10; 8:45 am]
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