Proposed Information Collection Activity; Comment Request, 34078-34079 [2011-14106]
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34078
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Survey development field tests, respondent debriefing questionnaires, cognitive interviews and focus groups ...............................................................
Estimated Total Annual Burden
Hours: 2,500
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 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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. E-mail address:
OPREinfocollection@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
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
Number of
responses
per
respondent
5,000
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: May 31, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–14107 Filed 6–9–11; 8:45 am]
BILLING CODE M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Formative Data Collections for
Informing Policy Research.
OMB No.: 0970–0356.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS),
intends to request approval from the
Office of Management and Budget
(OMB) for a generic clearance that will
allow OPRE to conduct a variety of
qualitative data collections. Over the
next three years, OPRE anticipates
undertaking a variety of new research
Average
burden hours
per response
1
0.5
Total annual
burden hours
2,500
projects in the fields of cash welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, and child
welfare. In order to inform the
development of OPRE research, to
maintain a research agenda that is
rigorous and relevant, and to ensure that
research products are as current as
possible, OPRE will engage in a variety
of qualitative data collections in concert
with researchers and practitioners
throughout the field. OPRE envisions
using a variety of techniques including
semi-structured discussions, focus
groups, telephone interviews, and inperson observations and site visits, in
order to integrate the perspectives of
program operators, policy officials and
members of the research community.
Following standard Office of
Management and Budget (OMB)
requirements, OPRE will submit a
change request to OMB individually for
every group of data collection activities
undertaken under this generic
clearance. OPRE will provide OMB with
a copy of the individual instruments or
questionnaires (if one is used), as well
as other materials describing the project.
Respondents: Administrators or staff
of State and local agencies or programs
in the relevant fields; academic
researchers; and policymakers at various
levels of government.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total annul
burden hours
Semi-Structured Discussion and Information-Gathering Protocol ...................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Instrument
2,000
1
0.5
1,000
Estimated Total Annual Burden
Hours: 1,000
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 collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
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. E-mail address:
OPREinfocollection@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
collection of information is necessary
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
E:\FR\FM\10JNN1.SGM
10JNN1
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: May 31, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–14106 Filed 6–9–11; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0405]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection for in vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by August 9, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
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 concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
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.
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR Part
315 (OMB Control Number 0910–
0409)—Extension
FDA is requesting OMB approval of
the information collection requirements
contained in 21 CFR 315.4, 315.5, and
315.6. These regulations require
manufacturers of diagnostic
radiopharmaceuticals to submit
information that demonstrates the safety
and effectiveness of a new diagnostic
radiopharmaceutical or of a new
indication for use of an approved
diagnostic radiopharmaceutical.
In response to the requirements of
section 122 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115), FDA published
a final rule in the Federal Register of
May 17, 1999 (64 FR 26657), amending
its regulations by adding provisions that
clarify the Agency’s evaluation and
approval of in vivo
radiopharmaceuticals used in the
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Fmt 4703
Sfmt 4703
34079
diagnosis or monitoring of diseases. The
regulation describes the kinds of
indications of diagnostic
radiopharmaceuticals and some of the
criteria that the Agency would use to
evaluate the safety and effectiveness of
a diagnostic radiopharmaceutical under
section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355) and section 351 of the
Public Health Service Act (the PHS Act)
(42 U.S.C. 262). Information about the
safety or effectiveness of a diagnostic
radiopharmaceutical enables FDA to
properly evaluate the safety and
effectiveness profiles of a new
diagnostic radiopharmaceutical or a
new indication for use of an approved
diagnostic radiopharmaceutical.
The rule clarifies existing FDA
requirements for approval and
evaluation of drug and biological
products already in place under the
authorities of the FD&C Act and the PHS
Act. The information, which is usually
submitted as part of a new drug
application or biologics license
application or as a supplement to an
approved application, typically
includes, but is not limited to,
nonclinical and clinical data on the
pharmacology, toxicology, adverse
events, radiation safety assessments,
and chemistry, manufacturing, and
controls. The content and format of an
application for approval of a new drug
are set forth in § 314.50 (21 CFR 314.50).
Under 21 CFR part 315, information
required under the FD&C Act and
needed by FDA to evaluate the safety
and effectiveness of in vivo
radiopharmaceuticals still needs to be
reported.
Based on the number of submissions
(that is, human drug applications and/
or new indication supplements for
diagnostic radiopharmaceuticals) that
FDA receives, the Agency estimates that
it will receive approximately two
submissions annually from two
applicants. The hours per response
refers to the estimated number of hours
that an applicant would spend
preparing the information required by
the regulations. Based on FDA’s
experience, the Agency estimates the
time needed to prepare a complete
application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth, or 2,000 hours, of which is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulation does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34078-34079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Formative Data Collections for Informing Policy Research.
OMB No.: 0970-0356.
Description: The Office of Planning, Research and Evaluation
(OPRE), Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS), intends to request approval from
the Office of Management and Budget (OMB) for a generic clearance that
will allow OPRE to conduct a variety of qualitative data collections.
Over the next three years, OPRE anticipates undertaking a variety of
new research projects in the fields of cash welfare, employment and
self-sufficiency, Head Start, child care, healthy marriage and
responsible fatherhood, and child welfare. In order to inform the
development of OPRE research, to maintain a research agenda that is
rigorous and relevant, and to ensure that research products are as
current as possible, OPRE will engage in a variety of qualitative data
collections in concert with researchers and practitioners throughout
the field. OPRE envisions using a variety of techniques including semi-
structured discussions, focus groups, telephone interviews, and in-
person observations and site visits, in order to integrate the
perspectives of program operators, policy officials and members of the
research community.
Following standard Office of Management and Budget (OMB)
requirements, OPRE will submit a change request to OMB individually for
every group of data collection activities undertaken under this generic
clearance. OPRE will provide OMB with a copy of the individual
instruments or questionnaires (if one is used), as well as other
materials describing the project.
Respondents: Administrators or staff of State and local agencies or
programs in the relevant fields; academic researchers; and policymakers
at various levels of government.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total annul
respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Semi-Structured Discussion and Information- 2,000 1 0.5 1,000
Gathering Protocol.........................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,000
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 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
Planning, Research and Evaluation, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: OPRE Reports Clearance Officer. E-mail
address: OPREinfocollection@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 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
[[Page 34079]]
other forms of information technology. Consideration will be given to
comments and suggestions submitted within 60 days of this publication.
Dated: May 31, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011-14106 Filed 6-9-11; 8:45 am]
BILLING CODE 4184-22-M
