Notice of Secretary's Advisory Committee Meeting, 54387-54388 [05-18257]
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54387
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
Board of Governors of the Federal Reserve
System, September 9, 2005.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 05–18303 Filed 9–9–05; 4:11 pm]
BILLING CODE 6210–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Performance Measurement Online Tool (PMOTOOL).
OMB No.: New Collection.
Description: The Performance
Measurement On-line Tool was
designed by the Children’s Bureau to
collect data, in an automated format,
from specified discretionary grants
funded by the Children’s Bureau. The
data collected by this instrument will be
submitted by individual discretionary
grantees funded under the following
programs: Abandoned Infants
Assistance Program, Infant Adoption
Awareness Training Program, Adoption
Opportunities Program, Child Abuse
and Neglect Program and the Child
Welfare Training Program. Grantees will
submit this information on a semiannual basis in conjunction with their
semi-annual program progress report.
The purpose of this data collection is
to assist the Children’s Bureau in
responding to the Program Assessment
Rating Tool (PART), an OMB-mandated
reporting system that focuses on
quantifiable outcome measures, directly
related to the expected social impact or
public benefit of each federal program.
The Children’s Bureau will use the
aggregated data collected under each
federal program. These measurable
outcomes will serve as evidence that the
federally funded programs are making
progress toward achieving broad,
legislated program goals.
Respondents: All competitive
discretionary grant programs funded by
the Children’s Bureau.
ANNUAL BURDEN ESTIMATES
Number of responses per
respondent
(per fiscal
year)
Instrument
Number of respondents
Performance Measurement On-line Tool .......
Abandoned Infants Assistance Program—
Range 30–36.
Infant Adoption Awareness Program—Range
4–6.
Adoption Opportunities Program—Range
45–55.
Child Abuse and Neglect Program—Range
25–32.
Child Welfare Training Program—Range 45–
55.
Range 149–184 ..............................................
Performance Measurement On-line Tool .......
Performance Measurement On-line Tool .......
Performance Measurement On-line Tool .......
Performance Measurement On-line Tool .......
Total .........................................................
In compliance with the requirement
of Section 3506(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 Information Services,
370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. The e-mail
address is: grjohnson@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comment on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
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16:17 Sep 13, 2005
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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
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 publication.
Dated: September 8, 2005.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 05–18258 Filed 9–13–05; 8:45 am]
BILLING CODE 4184–01–M
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Average
burden hours
per response
Total burden
hours
(range)
2
1
60–72
2
1
8–12
2
1
90–110
2
1
50–64
2
1
90–110
........................
........................
298–368
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Notice of Secretary’s Advisory
Committee Meeting
Office of Planning, Research
and Evaluation, ACF, HHS.
ACTION: Notice of meeting; Advisory
Committee on Head Start Research and
Evaluation.
AGENCY:
SUMMARY: The 1998 Head Start
Reauthorization (42 U.S.C. 9844(g);
section 649(g)(1) of the Head Start Act,
as amended) called on the Secretary of
Health and Human Services to form an
independent panel of experts (i.e., an
Advisory Committee) to offer advice
concerning research designs that would
provide a national analysis of the
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14SEN1
54388
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
impact of Head Start Programs. The
September 28–29, 2005 meeting
provides an opportunity for the
Advisory Committee to provide advice
on the analysis plans for the study
following the June 2005 release on the
first impact findings.
DATES: September 28 (9 a.m.–4 p.m.)
and 29 (9 a.m.–12:30 p.m.), 2005.
Place: Bethesda Park Clarion Hotel,
8400 Wisconsin Avenue, Bethesda, MD
20814; Phone: (301) 654–1000; Fax:
(301) 654–0751.
SUPPLEMENTARY INFORMATION: This
meeting is open to the public and is
barrier free. Meeting records will also be
open to the public and will be kept at
the Aerospace Building, 370 L’Enfant
Promenade, SW., Washington, DC
20447. The Administration for Children
and Families also intends to make
material related to this meeting
available on the Office of Planning,
Research and Evaluation Web site
(https://www.acf.hhs.gov/programs/opre/
index.html). An interpreter for the deaf
and hearing impaired will be available
upon advance request by calling Xtria at
703–821–6182.
FOR FURTHER INFORMATION CONTACT:
Maria Woolverton at 202–205–4039 for
substantive information. Contact ACF
Office of Public Affairs at 202–401–9215
for press inquiries. Contact Xtria at 703–
821–6182 for logistical information.
Dated: September 7, 2005.
Naomi Goldstein,
Director, Office of Planning, Research and
Evaluation, ACF.
[FR Doc. 05–18257 Filed 9–13–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0353]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pharmaceutical
Development Study
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
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16:17 Sep 13, 2005
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public comment in response to the
notice. This notice solicits comments on
a proposed Pharmaceutical
Development Study.
DATES: Submit written or electronic
comments on the collection of
information by November 14, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register before submitting
the collection to OMB for approval. To
comply with this requirement, FDA is
publishing notice of the proposed
collection of information set forth in
this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Pharmaceutical Development Study
FDA’s Office of Pharmaceutical
Science (OPS) of the Center for Drug
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Evaluation and Research is proposing
collaboration under a Cooperative
Research and Development Agreement
(CRADA) with Conformia Software, Inc.
of Redwood City, CA (hereafter referred
to as ‘‘CRADA Partner’’), to collect
information using focus group
discussions with firms to determine
what factors may influence
pharmaceutical development. These
factors include development
information bottlenecks, pilot plant
information management,
manufacturing science, information
retrieval, quality systems and preclinical development challenges.
The FDA has introduced three new
initiatives to help manufacturers
develop higher quality drugs faster and
cheaper. These initiatives include, but
are not limited to, the following:
• Challenge and Opportunity on the
Critical Path to New Medical Products
(commonly referred to as the ‘‘Critical
Path Initiative’’)
• Pharmaceutical cGMPs for the 21st
Century—A Risk Based Approach
• International Conference on
Harmonization (ICH) Steering
Committee Guidelines—Pharmaceutical
Development, ICH Q8 (Defining the
Design Space)
The proposed study is designed to
augment and support these initiatives
by providing practical industry
experiences and feedback to help FDA
refine these initiatives. The scope of the
proposed collaboration is aligned with
FDA’s ‘‘Critical Path’’ of development-specifically, the area between selection
of drug candidates and commercial
manufacturing.
Gathering information through this
collaboration represents an opportunity
for FDA to gain insights into current
industry practices and provide the
opportunity to better understand the
specific factors that contribute to drug
development difficulties. There is a
perceived reluctance by industry to
share information with regulatory
bodies (outside of the formal review
processes). Therefore, obtaining
necessary and timely information
through this collaboration will help the
Critical Path Initiative progress.
The information collected will be
used to create a clearer picture of
current development bottlenecks,
identify current state practices,
highlight potential improvements in
production, and provide feedback to
FDA on the impact of current regulatory
guidance.
Use of information: The three groups
who will be involved with the study
may benefit by the collection of this
information as follows:
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Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54387-54388]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18257]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Notice of Secretary's Advisory Committee Meeting
AGENCY: Office of Planning, Research and Evaluation, ACF, HHS.
ACTION: Notice of meeting; Advisory Committee on Head Start Research
and Evaluation.
-----------------------------------------------------------------------
SUMMARY: The 1998 Head Start Reauthorization (42 U.S.C. 9844(g);
section 649(g)(1) of the Head Start Act, as amended) called on the
Secretary of Health and Human Services to form an independent panel of
experts (i.e., an Advisory Committee) to offer advice concerning
research designs that would provide a national analysis of the
[[Page 54388]]
impact of Head Start Programs. The September 28-29, 2005 meeting
provides an opportunity for the Advisory Committee to provide advice on
the analysis plans for the study following the June 2005 release on the
first impact findings.
DATES: September 28 (9 a.m.-4 p.m.) and 29 (9 a.m.-12:30 p.m.), 2005.
Place: Bethesda Park Clarion Hotel, 8400 Wisconsin Avenue,
Bethesda, MD 20814; Phone: (301) 654-1000; Fax: (301) 654-0751.
SUPPLEMENTARY INFORMATION: This meeting is open to the public and is
barrier free. Meeting records will also be open to the public and will
be kept at the Aerospace Building, 370 L'Enfant Promenade, SW.,
Washington, DC 20447. The Administration for Children and Families also
intends to make material related to this meeting available on the
Office of Planning, Research and Evaluation Web site (https://
www.acf.hhs.gov/programs/opre/). An interpreter for the deaf
and hearing impaired will be available upon advance request by calling
Xtria at 703-821-6182.
FOR FURTHER INFORMATION CONTACT: Maria Woolverton at 202-205-4039 for
substantive information. Contact ACF Office of Public Affairs at 202-
401-9215 for press inquiries. Contact Xtria at 703-821-6182 for
logistical information.
Dated: September 7, 2005.
Naomi Goldstein,
Director, Office of Planning, Research and Evaluation, ACF.
[FR Doc. 05-18257 Filed 9-13-05; 8:45 am]
BILLING CODE 4184-01-M