Proposed Information Collection Activity; Comment Request, 2641-2642 [05-826]
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Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Notices
Maryland 21244–1850, Telephone
Number: (410) 786–9493.
SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS
OF THE ACT:
NOTIFICATION PROCEDURE:
[FR Doc. 05–836 Filed 1–13–05; 8:45 am]
For purpose of access, the subject
individual should write to the system
manager, who will require the system
name, the subject individual’s name
(woman’s maiden name, if applicable),
address, date of correspondence and
control number.
BILLING CODE 4120–03–P
RECORD ACCESS PROCEDURE:
Proposed Information Collection
Activity; Comment Request
None.
For purpose of access, use the same
procedures outlined in Notification
Procedures above. Requestors should
also reasonably specify the record
contents being sought. (These
procedures are in accordance with
Department regulation 45 CFR 5b.5 (a)
(2).)
CONTESTING RECORD PROCEDURES:
The subject individual should contact
the system manager named above, and
reasonably identify the record and
specify the information to be contested.
State the corrective action sought and
the reasons for the correction with
supporting justification. (These
procedures are in accordance with
Department regulation 45 CFR 5b.7.)
RECORD SOURCE CATEGORIES:
CMS will receive CYPERS data
periodically from CMS-approved
cytology proficiency testing programs
only. This System of Records protects
the data transmitted by CMS-approved
cytology proficiency testing programs at
all stages of collection, manipulation,
transmissions, storage, and
maintenance, at the PT program and at
CMS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Projects
Title: Follow-up to the National
Survey of Child and Adolescent WellBeing.
OMB No.: 0970–0202.
Description: The Department of
Health and Human Services intends to
collect data on a subset of children and
families who have participated in the
National Survey of Child and
Adolescent Well-Being (NSCAW). The
NSCAW was authorized under Section
427 of the Personal Responsibility and
Work Opportunity Reconciliation Act of
1996. The Survey began in November
1999 with a national Sample of 5,501
children ages 0–14 who had been the
subject of investigation by Child
Protective Services (CPS) during the
baseline data collection period, which
extended from November 1999 through
April 2000. Direct assessments and
interviews were conducted with the
children themselves, their primary
caregivers, their caseworkers, and, for
school-aged children, their teachers.
Follow-up data collections were
conducted 12 months, 18 months and
36 months post-baseline. The current
data collection plan involves only a
subset of 1,497 children from the
original sample, that is, children who
were ages 0–12 months during the
baseline period. The original sample
design for NSCAW was stratified to
include an over-sample or infants; thus,
the subset that is the subject of this data
collection is a representative sample of
infants who were the targets of CPS
investigations during the survey’s
baseline data collection period. This
group will be at the beginning of their
formal schooling as the next data
collection begins, and will allow for the
identification of early risk and
protective factors, as well as the
influence of services and service
systems, on their functioning as they
enter this critical transition period.
The NSCAW is unique in that it is the
only source of nationally representative,
firsthand information about the
functioning and well-being, service
needs and service utilization of children
and families who come to the attention
of the child welfare system. Information
is collected about children’s cognitive,
social, emotional, behavioral and
adaptive functioning, as well as family
and community factors that are likely to
influence their functioning. Family
service needs and service utilization
also are addressed in the data collection.
The data collection for the follow-up
will follow the same format as that used
in previous rounds of data collection,
and will employ the instruments that
have been used with 5- to 7-year-olds in
previous rounds. Data from NSCAW are
made available to the research
community through licensing
arrangements from the National Data
Archive on Child Abuse and Neglect,
housed at Cornell University.
Respondents: Children, who are
clients of the child welfare system, their
primary caregivers, caseworkers, and
teachers.
ANNUAL BURDEN ESTIMATES
No. of
respondents
Instrument
Child Interview .................................................................................................
Permanent Caregiver Interview .......................................................................
Foster Caregiver Interview ..............................................................................
Caseworker Interview ......................................................................................
Teacher Questionnaire ....................................................................................
No. of
responses per
respondent
1,497
1,122
375
375
1,497
1
1
1
1
1
Estimated Total Annual Burden Hours: ....................................................
In compliance with the requirements
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
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14:36 Jan 13, 2005
Jkt 205001
Frm 00041
Fmt 4703
Sfmt 4703
1.2
2.0
1.5
1.0
.75
Total burden
hours
1,796
2,244
563
375
1,123
6,101
information collections 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,
PO 00000
Average
burden hours
per response
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
grjohnson@acf.hhs.gov. All requests
E:\FR\FM\14JAN1.SGM
14JAN1
2642
Federal Register / Vol. 70, No. 10 / Friday, January 14, 2005 / Notices
should be identified by the title of the
information collection.
The department specifically requests
comments on: (a) Whether the proposed
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.
Dated: January 10, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05–826 Filed 1–13–05; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Clinical Studies of Safety and
Effectiveness of Orphan Products;
Availability of Grants; Request for
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
I. Funding Opportunity Description
The Food and Drug Administration
(FDA) is announcing changes to its
Office of Orphan Products Development
(OPD) grant program for fiscal year (FY)
2006. This announcement supercedes
the previous announcement of this
program, which was published in the
Federal Register of August 8, 2003 (68
FR 47340). Please note that there are
new submission requests and
requirements for this grant program.
These include, but are not limited to, a
requested letter of intent, a change in
funding levels, a change in number of
receipt dates, and changes in review
criteria.
1. Background
The OPD was created to identify and
promote the development of orphan
products. Orphan products are drugs,
biologics, medical devices, and foods for
medical purposes that are indicated for
a rare disease or condition (that is, one
with a prevalence, not incidence, of
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Jkt 205001
fewer than 200,000 people in the United
States). Diagnostic tests and vaccines
will qualify only if the U.S. population
of intended use is fewer than 200,000
people a year.
2. Program Research Goals
The goal of FDA’s OPD grant program
is to support the clinical development of
products for use in rare diseases or
conditions where no current therapy
exists or where the product will
improve the existing therapy. FDA
provides grants for clinical studies on
safety and/or effectiveness that will
either result in, or substantially
contribute to, market approval of these
products. Applicants must include in
the application’s ‘‘Background and
Significance’’ section an explanation of
how the proposed study will either help
gain product approval or provide
essential data needed for product
development. All funded studies are
subject to the requirements of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 331 et seq.) and
regulations issued under it.
II. Award Information
Except for applications for studies of
medical foods that do not need
premarket approval, FDA will only
award grants to support premarket
clinical studies to determine safety and
effectiveness for approval under section
505, 512, or 515 of the act (21 U.S.C.
355, 360b, or 360eet seq.) or safety,
purity, and potency for licensing under
section 351 of the Public Health Service
Act (the PHS Act) (42 U.S.C. 262).
FDA will support the clinical studies
covered by this notice under the
authority of section 301 of the PHS Act
(42 U.S.C. 241). FDA’s research program
is described in the Catalog of Federal
Domestic Assistance, No. 93.103.
Applicants for Public Health Service
(PHS) clinical research grants are
encouraged to include minorities and
women in study populations so research
findings can be of benefit to all people
at risk of the disease or condition under
study. It is recommended that
applicants place special emphasis on
including minorities and women in
studies of diseases, disorders, and
conditions that disproportionately affect
them. This policy applies to research
subjects of all ages. If women or
minorities are excluded or poorly
represented in clinical research, the
applicant should provide a clear and
compelling rationale that shows
inclusion is inappropriate.
The PHS strongly encourages all grant
recipients to provide a smoke-free
workplace and to discourage the use of
all tobacco products. This is consistent
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
with the PHS mission to protect and
advance the physical and mental health
of the American people.
FDA is committed to achieving the
health promotion and disease
prevention objectives of ‘‘Healthy
People 2010,’’ a national effort designed
to reduce morbidity and mortality and
to improve quality of life. Applicants
may obtain a paper copy of the ‘‘Healthy
People 2010’’ objectives, vols. I and II,
for $70 ($87.50 foreign) S/N 017–000–
00550–9, by writing to the
Superintendent of Documents, P.O. Box
371954, Pittsburgh, PA 15250–7954.
Telephone orders can be placed to 202–
512–2250. The document is also
available in CD–ROM format, S/N 017–
001–00549–5 for $19 ($23.50 foreign) as
well as on the Internet at https://
www.healthypeople.gov/. (FDA has
verified the Web site address, but we are
not responsible for subsequent changes
to the Web site after this document
publishes in the Federal Register).
Internet viewers should proceed to
‘‘Publications.’’
1. Award Instrument
Support will be in the form of a grant.
All awards will be subject to all policies
and requirements that govern the
research grant programs of the PHS,
including the provisions of 42 CFR part
52 and 45 CFR parts 74 and 92. The
regulations issued under Executive
Order 12372 do not apply to this
program. The National Institutes of
Health (NIH) modular grant program
does not apply to this FDA grant
program. All grant awards are subject to
applicable requirements for clinical
investigations imposed by sections 505,
512, and 515 of the act, section 351 of
the PHS Act, and regulations issued
under any of these sections.
2. Award Amount
Of the estimated fiscal year (FY 2006)
funding ($13.2 million), approximately
$9.2 million will fund noncompeting
continuation awards, and approximately
$4 million will fund 10 to 12 new
awards subject to availability of funds.
The expected start date for the FY 2006
awards will be June 1, 2006.
Grants will be awarded up to
$200,000 or up to $350,000 in total
(direct plus indirect) costs per year for
up to 3 years. Please note that beginning
in FY 2006, the dollar limitation will be
total costs, not direct costs as in
previous years. Applications for the
smaller grants ($200,000) may be for
phase 1, 2, or 3 studies. Study proposals
for the larger grants ($350,000) must be
for studies continuing in phase 2 or 3
of investigation. Phase 1 studies include
the initial introduction of an
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14JAN1
]]>Agencies
[Federal Register Volume 70, Number 10 (Friday, January 14, 2005)]
[Notices]
[Pages 2641-2642]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-826]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Follow-up to the National Survey of Child and Adolescent
Well-Being.
OMB No.: 0970-0202.
Description: The Department of Health and Human Services intends to
collect data on a subset of children and families who have participated
in the National Survey of Child and Adolescent Well-Being (NSCAW). The
NSCAW was authorized under Section 427 of the Personal Responsibility
and Work Opportunity Reconciliation Act of 1996. The Survey began in
November 1999 with a national Sample of 5,501 children ages 0-14 who
had been the subject of investigation by Child Protective Services
(CPS) during the baseline data collection period, which extended from
November 1999 through April 2000. Direct assessments and interviews
were conducted with the children themselves, their primary caregivers,
their caseworkers, and, for school-aged children, their teachers.
Follow-up data collections were conducted 12 months, 18 months and
36 months post-baseline. The current data collection plan involves only
a subset of 1,497 children from the original sample, that is, children
who were ages 0-12 months during the baseline period. The original
sample design for NSCAW was stratified to include an over-sample or
infants; thus, the subset that is the subject of this data collection
is a representative sample of infants who were the targets of CPS
investigations during the survey's baseline data collection period.
This group will be at the beginning of their formal schooling as the
next data collection begins, and will allow for the identification of
early risk and protective factors, as well as the influence of services
and service systems, on their functioning as they enter this critical
transition period.
The NSCAW is unique in that it is the only source of nationally
representative, firsthand information about the functioning and well-
being, service needs and service utilization of children and families
who come to the attention of the child welfare system. Information is
collected about children's cognitive, social, emotional, behavioral and
adaptive functioning, as well as family and community factors that are
likely to influence their functioning. Family service needs and service
utilization also are addressed in the data collection. The data
collection for the follow-up will follow the same format as that used
in previous rounds of data collection, and will employ the instruments
that have been used with 5- to 7-year-olds in previous rounds. Data
from NSCAW are made available to the research community through
licensing arrangements from the National Data Archive on Child Abuse
and Neglect, housed at Cornell University.
Respondents: Children, who are clients of the child welfare system,
their primary caregivers, caseworkers, and teachers.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
No. of Average
Instrument No. of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Child Interview................................. 1,497 1 1.2 1,796
Permanent Caregiver Interview................... 1,122 1 2.0 2,244
Foster Caregiver Interview...................... 375 1 1.5 563
Caseworker Interview............................ 375 1 1.0 375
Teacher Questionnaire........................... 1,497 1 .75 1,123
-----------------
Estimated Total Annual Burden Hours:........ 6,101
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements 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 collections 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: grjohnson@acf.hhs.gov. All requests
[[Page 2642]]
should be identified by the title of the information collection.
The department specifically requests comments on: (a) Whether the
proposed 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.
Dated: January 10, 2005.
Robert Sargis,
Reports Clearance, Officer.
[FR Doc. 05-826 Filed 1-13-05; 8:45 am]
BILLING CODE 4184-01-M
