Proposed Information Collection Activity: Comment Request, 17655-17656 [2011-7340]
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17655
Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Annual
number of
respondents
Number of
responses
Average
burden per
hours
response
Total annual
burden hours
First Follow-up Instrument ...............................................................................
Estimated Total Annual Burden Hours: ...........................................................
3,060
........................
1
........................
0.5
........................
1,530.
1,530.
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:
OMB 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: March 24, 2011.
Seth F. Chamberlain,
OPRE Reports Clearance Officer.
[FR Doc. 2011–7337 Filed 3–29–11; 8:45 am]
BILLING CODE 4184–07–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity: Comment Request
Title: Personal Responsibility
Education Program (PREP) Multi
Component Evaluation—Design Survey.
OMB No.: New Collection.
Description: The Family and Youth
Services Bureau (HHS/ACF/ACYF/
FYSB) and the Office of Planning,
Research, and Evaluation (HHS/ACF/
OPRE) in the Administration for
Children and Families (ACF) propose a
data collection activity as part of the
Personal Responsibility Education
Program (PREP) Multi Component
Evaluation.
In addition to other activities, the
PREP Evaluation will document the
design of the PREP State grant programs
via data gathered from States and
selected sub-awardees funded by PREP.
The findings will be of interest to the
general public, federal and state policymakers, PREP sub-awardees,
community-based organizations, and
other organizations interested in teen
pregnancy prevention.
The proposed activity involves the
collection of information through
telephone conversations or in-person
interviews held with administrators and
program staff at the State and sub
awardee level. The data collection
instrument will focus on information
related to program context,
administration, and design. This
includes, but is not limited to: Program
goals and strategy/approach, program
setting, population characteristics, statelevel requirements and processes,
program monitoring, and training and
technical assistance.
Respondents: State Level
Coordinators; Program Directors;
Program Staff; General Staff; Schools
and Organizations; and CommunityBased Organizations.
ANNUAL BURDEN ESTIMATES DESIGN SURVEY
Annual number of
respondents
Instrument
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Discussion Guide for use with State Level Coordinators and
State-Level Staff ...................................................................
Discussion Guide for use with Program Staff; Schools and
Organizations; and Community-Based Organizations .........
Estimated Annual Burden Sub-total
for Field Clearance: 240.
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
VerDate Mar<15>2010
14:59 Mar 29, 2011
Jkt 223001
Number of
responses per
respondent
Frm 00039
Total burden
hours
120
1
1
120
120
1
1
120
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)
PO 00000
Average burden
hours per
response
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\30MRN1.SGM
30MRN1
17656
Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices
Dated: March 23, 2011.
Seth F. Chamberlain,
Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–7340 Filed 3–29–11; 8:45 am]
Food and Drug Administration
BILLING CODE 4184–37–M
[Docket No. FDA–2010–N–0606]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Additional Listing
Information for Medical Device
Registration and Listing
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0492]
AGENCY:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Devices: Recommended
Glossary and Educational Outreach To
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Devices: Recommended
Glossary and Educational Outreach to
Support Use of Symbols on Labels and
in Labeling of In Vitro Diagnostic
Devices Intended for Professional Use’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of January 7, 2011 (76
FR 1169), the Agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0553. The
approval expires on March 31, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
Dated: March 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7387 Filed 3–29–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
14:59 Mar 29, 2011
Jkt 223001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 29,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0387. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, e-mail:
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Additional Listing Information for
Medical Device Registration and
Listing—(OMB Control Number 0910–
0387)—Extension
The Food and Drug Administration
Amendments Act of 2007 (FDAAA),
enacted September 27, 2007, requires
that device establishment registrations
and listings under 21 U.S.C. 360(p)
(including the submission of updated
information) be submitted to the
Secretary of Health and Human Services
(the Secretary) by electronic means,
unless the Secretary grants a request for
waiver of the requirement, because the
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
use of electronic means is not
reasonable for the person requesting the
waiver. The collections of information
under sections 222, 223, and 224 of
FDAAA have been approved under
OMB control number 0910–0625.
Registration by electronic means for
device establishments replaced FDA
Forms 2891 and 2891a, ‘‘Registration of
Device Establishment,’’ and FDA Form
2892, ‘‘Medical Device Listing,’’ with
FDA Form 3673, ‘‘Device Registration
and Listing Module.’’ The scope of this
information collection addresses only
the reporting and recordkeeping
requirements by non-electronic means
under § 807.31 (21 CFR 807.31).
Under § 807.31(a) through (d), each
owner or operator is required to
maintain an historical file containing
the labeling and advertisements in use
on the date of initial listing, and in use
after October 10, 1978, but not before
the date of initial listing. The owner or
operator must maintain in the historical
file any labeling or advertisements in
which a material change has been made
anytime after initial listing, but may
discard labeling and advertisements
from the file 3 years after the date of the
last shipment of a discontinued device
by an owner or operator. Section
807.31(e) requires that the owner or
operator be prepared to submit to FDA
copies of: (1) All device labeling, (2) all
device labeling and representative
advertising, or (3) only representative
package inserts, depending upon
whether the device is subject to the
regulatory controls under sections 514
and 515 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360d and 360e), or restrictions imposed
by 21 CFR 801.109 or otherwise by
section 520(e) of the FD&C Act (21
U.S.C. 360j(e)).
The information collected under these
provisions is used by FDA to identify:
(1) Firms subject to FDA’s regulations,
(2) geographic distribution of firms in
order to effectively allocate FDA’s field
resources for inspections, and (3) the
class of the device that determines the
frequency of inspection. As a result,
when complications occur with a
particular device or component, all
manufacturers of similar or related
devices can easily be identified.
The likely respondents to this
information collection are domestic and
foreign device establishments who must
register and submit a device list to FDA,
e.g., establishments engaged in the
manufacture, preparation, propagation,
compounding, assembly, or processing
of medical devices intended for human
use and commercial distribution.
The annual respondent reporting
burden for device establishment
E:\FR\FM\30MRN1.SGM
30MRN1
]]>Agencies
[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17655-17656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7340]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity: Comment Request
Title: Personal Responsibility Education Program (PREP) Multi
Component Evaluation--Design Survey.
OMB No.: New Collection.
Description: The Family and Youth Services Bureau (HHS/ACF/ACYF/
FYSB) and the Office of Planning, Research, and Evaluation (HHS/ACF/
OPRE) in the Administration for Children and Families (ACF) propose a
data collection activity as part of the Personal Responsibility
Education Program (PREP) Multi Component Evaluation.
In addition to other activities, the PREP Evaluation will document
the design of the PREP State grant programs via data gathered from
States and selected sub-awardees funded by PREP. The findings will be
of interest to the general public, federal and state policy-makers,
PREP sub-awardees, community-based organizations, and other
organizations interested in teen pregnancy prevention.
The proposed activity involves the collection of information
through telephone conversations or in-person interviews held with
administrators and program staff at the State and sub awardee level.
The data collection instrument will focus on information related to
program context, administration, and design. This includes, but is not
limited to: Program goals and strategy/approach, program setting,
population characteristics, state-level requirements and processes,
program monitoring, and training and technical assistance.
Respondents: State Level Coordinators; Program Directors; Program
Staff; General Staff; Schools and Organizations; and Community-Based
Organizations.
Annual Burden Estimates Design Survey
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Annual number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for use with State 120 1 1 120
Level Coordinators and State-Level
Staff..............................
Discussion Guide for use with 120 1 1 120
Program Staff; Schools and
Organizations; and Community-Based
Organizations......................
----------------------------------------------------------------------------------------------------------------
Estimated Annual Burden Sub-total for Field Clearance: 240.
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 other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
[[Page 17656]]
Dated: March 23, 2011.
Seth F. Chamberlain,
Reports Clearance Officer.
[FR Doc. 2011-7340 Filed 3-29-11; 8:45 am]
BILLING CODE 4184-37-M
