Proposed Information Collection Activity; Comment Request, 69861-69863 [2012-28321]
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69861
Federal Register / Vol. 77, No. 225 / Wednesday, November 21, 2012 / Notices
Dated: November 6, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Dated: November 15, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012–28274 Filed 11–16–12; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Parents and Children Together
(PACT) Evaluation.
OMB No.: 0970–0403.
Description: The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS), is
proposing data collection activity as
part of the Parents and Children
Together (PACT) Evaluation.
The PACT project is a formative
evaluation whose overall objective is to
document and provide initial
assessment of selected Responsible
Fatherhood and Healthy Marriage grant
programs that were authorized under
the 2010 Claims Resolution Act. This
information will be critical to informing
decisions related to future investments
in this kind of programming as well as
the design and operation of such
services.
To meet the objective of the study,
PACT is utilizing three major,
interrelated evaluation strategies:
(a) Impact evaluation;
(b) Implementation evaluation; and
(c) Qualitative evaluation.
Each of these strategies will be
employed separately with (1)
Responsible Fatherhood and (2) Healthy
Marriage grantees. Specifically, we
anticipate the following studies:
(a) Impact evaluation:
(1) Responsible Fatherhood grantee
evaluation; and (2) Healthy Marriage
grantee evaluation.
(b) Implementation evaluation:
(1) Responsible Fatherhood grantee
evaluation;
(1—additional substudy) Responsible
Fatherhood grantee evaluation with a
focus on Hispanic populations; and
(2) Healthy Marriage grantee
evaluation.
(c) Qualitative evaluation:
(1) Responsible Fatherhood grantee
evaluation.
The following instruments have been
approved for this study: Site selection:
a discussion guide to assist in selecting
sites was approved by OMB on April 20,
2012.
(a) Impact evaluation:
(1) Responsible Fatherhood grantee
evaluation:
• Introductory script, approved
October 31, 2012.
• Baseline survey, approved October
31, 2012.
(b) Implementation evaluation:
(1) Responsible Fatherhood grantee
evaluation:
• Responsible Fatherhood Study MIS,
approved October 31, 2012.
This 60-Day Federal Register Notice
requests clearance of new instruments:
(a) Impact evaluation:
(1) Healthy Marriage grantee
evaluation:
• Introductory script, which program
staff will use to introduce the study to
participants.
• Baseline survey, to capture
participant characteristics and
experiences prior to randomization.
(b) Implementation evaluation:
(1) and (2) Responsible Fatherhood
and Healthy Marriage grantee
evaluation:
• Semi-structured interview topic
guide, to gather information on program
implementation from program staff.
• On-line survey, to capture program
staff experiences.
• Telephone interviews (with staff at
referral organizations), to document
linkages between the program and
referral agencies.
Annual
number of
respondents
Instrument respondent
• Working Alliance Inventory, to
assess the strength of the participantprogram staff working relationship.
• Focus group guide, to elicit
participant experiences.
• Telephone interviews (with
program dropouts), to determine reasons
why those eligible for the program
choose not to participate.
(1—additional substudy) Responsible
Fatherhood grantee evaluation with a
focus on Hispanic populations:
• Semi-structured interview topic
guide, to examine how agencies adapt
programs to address the needs of
Hispanic populations.
• Focus group guide, to elicit
participant experiences.
• Participant questionnaire, to
capture participant characteristics and
experiences.
(2) Healthy Marriage grantee
evaluation:
• Study MIS (for use in HM
programs), to track participation in the
program.
(c) Qualitative evaluation:
(1) Responsible Fatherhood grantee
evaluation:
• Guide for in-person, in-depth
interviews, to understand the
experiences, both in and out of the
program, of a subset of men.
• Check-in call guide, to follow-up
from the in-person, in-depth interviews,
to ascertain new experiences by these
men since last discussion.
This 60-Day Federal Register Notice
also serves as a request for OMB to
waive subsequent 60-day Federal
Register notices pertaining to the PACT
Evaluation.
Respondents:
Respondents include program
applicants, program participants,
program staff, and staff at referral
agencies. Specific respondents per
instrument are noted in the burden
tables below.
Annual Burden Estimates
Some burden has already been
approved for this study, and the
following instruments are still in use.
Approved burden is provided below:
Number of
responses per
respondent
Average
burden per
response
(minutes)
Total annual
burden hours
srobinson on DSK4SPTVN1PROD with
Site Selection
Selecting Study Grantees:
Discussions/grantee and partner organization staff .................................
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69862
Federal Register / Vol. 77, No. 225 / Wednesday, November 21, 2012 / Notices
Annual
number of
respondents
Instrument respondent
Average
burden per
response
(minutes)
Number of
responses per
respondent
Total annual
burden hours
Impact
Responsible Fatherhood Grantee Evaluation
Introductory Script:
Grantee staff .............................................................................................
Program applicants ...................................................................................
Baseline Survey:
Study participants .....................................................................................
30
2,105
70.2
1
10
10
351
351
2,000
1
30
1,000
Implementation
Responsible Fatherhood Grantee Evaluation
RF Study MIS:
Grantee staff .............................................................................................
30
2,533
2
2,533
Total ...................................................................................................
........................
........................
........................
4,285
Annual
number of
respondents
Number of
responses per
respondent
Average
burden per
response
(minutes)
This current 60-Day Federal Register
Notice covers many new instruments:
Instrument respondent
Total annual
burden hours
Impact
Healthy Marriage Grantee Evaluation
Introductory script:
Program staff ............................................................................................
Program applicants ...................................................................................
Baseline survey:
Study participants .....................................................................................
20
4,211
246
1
10
10
820
702
4,000
1
30
2,000
250
2
62
517
250
2
30
250
50
1
30
25
50
1,000
20
1
10
10
167
167
600
1
90
900
150
1
15
38
Implementation
Responsible Fatherhood and Healthy Marriage Grantee Evaluation
Semi-structured interview topic guide:
Program staff ............................................................................................
On-line survey:
Program staff ............................................................................................
Telephone interviews (with staff at referral organizations):
Program staff at referral organizations .....................................................
Working Alliance Inventory:
(1) Program staff ......................................................................................
(2) Participants .........................................................................................
Focus group guide:
Study participants .....................................................................................
Telephone interviews (with program dropouts):
Study participants (program dropouts) .....................................................
Additional Substudy: Responsible Fatherhood Grantee Evaluation With a Focus on Hispanic Populations
Semi-structured interview topic guide:
Program staff ............................................................................................
Focus group guide:
Study participants .....................................................................................
Participant questionnaire:
Study Participants .....................................................................................
42
1
65
45
25
1
90
38
25
1
30
13
3,400
2
3,400
srobinson on DSK4SPTVN1PROD with
Healthy Marriage Grantee Evaluation
HM Study MIS (for use in HM programs):
Program staff ............................................................................................
30
Qualitative
Responsible Fatherhood Grantee Evaluation
Guide for in-person, in-depth interviews:
VerDate Mar<15>2010
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69863
Federal Register / Vol. 77, No. 225 / Wednesday, November 21, 2012 / Notices
Annual
number of
respondents
Instrument respondent
Average
burden per
response
(minutes)
Number of
responses per
respondent
Total annual
burden hours
Study participants .....................................................................................
Check-in call guide:
Study participants .....................................................................................
95
3
120
570
63
4
10
42
Total ...................................................................................................
........................
........................
........................
9,694
Estimated Total Annual Burden
Hours (for instruments previously
approved and currently in use, as well
as those associated with this 60-Day
Notice): 13,969.
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.
Email 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.
Robert Sargis,
Administration for Children and Families,
Reports Clearance Officer.
[FR Doc. 2012–28321 Filed 11–20–12; 8:45 am]
srobinson on DSK4SPTVN1PROD with
BILLING CODE 4184–37–P
VerDate Mar<15>2010
18:13 Nov 20, 2012
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1040]
Antiseptic Patient Preoperative Skin
Preparation Products; Public Hearing;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public hearing to obtain
input on how to address microbial
contamination of patient preoperative
skin preparation drug products.
Currently, patient preoperative skin
preparations are not required to be
sterile. Bacteria can contaminate these
products at the time of manufacture or
during product use. Contaminated
patient preoperative skin preparations
have been associated with clinical
infections and adverse outcomes. At this
public hearing, FDA is interested in
obtaining public comment about certain
scientific and product use issues related
to patient preoperative skin
preparations.
Date and Time:The public hearing
will be held on December 12 and 13,
2012, from 9 a.m. to 4 p.m. The meeting
may be extended or may end early,
depending on the level of public
participation.
Location: The public hearing will be
held at the DoubleTree by Hilton Hotel
Washington, DC/Silver Spring, The
Ballrooms, 8727 Colesville Rd., Silver
Spring, MD 20910.
Contact Person: Lee Lemley, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20903, 301–796–3441, FAX: 301- 847–
8753, email: AntisepticPreOpPublic
Meeting@fda.hhs.gov.
Registration: The public hearing is
free, and seating will be on a first-come,
first-served basis. Attendees who do not
wish to make an oral presentation do
not need to register. If you need special
accommodations due to disability,
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
please contact Lee Lemley (see Contact
Person) at least 7 days in advance.
Requests for Oral Presentations: If you
wish to make an oral presentation
during the hearing, you must register by
submitting a written or electronic
request by close of business on
November 27, 2012, to Lee Lemley (see
Contact Person). Provide your name,
title, business affiliation (if applicable),
address, telephone and fax numbers,
email address, and type of organization
you represent (e.g., pharmaceutical
company or consumer organization).
You also should submit a brief summary
of the presentation, including the
discussion topic(s) that will be
addressed and the approximate time
requested for your presentation. We
encourage individuals and organizations
with common interests to consolidate or
coordinate their presentations to allow
adequate time for each request for
presentation. Persons registered to make
an oral presentation should check in
before the hearing.
Participants should submit a copy of
each presentation to Lee Lemley (see
Contact Person) no later than December
7, 2012. We will file the hearing
schedule, indicating the order of
presentation and the time allotted to
each person, with the Division of
Dockets Management (see Comments).
We will mail, email, or telephone the
schedule to each participant before the
hearing. In anticipation of the hearing
presentations moving ahead of
schedule, participants are encouraged to
arrive early to ensure their designated
order of presentation. Participants who
are not present when called risk
forfeiting their scheduled time.
Comments: Interested persons may
submit either written comments
regarding this document to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852 or electronic comments to https://
www.regulations.gov. Comments will be
accepted after the hearing until
February 12, 2013. Persons who wish to
provide additional materials for
consideration should file these materials
with the Division of Dockets
Management. You should annotate and
E:\FR\FM\21NON1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Notices]
[Pages 69861-69863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28321]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Parents and Children Together (PACT) Evaluation.
OMB No.: 0970-0403.
Description: The Office of Planning, Research, and Evaluation
(OPRE), Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS), is proposing data collection
activity as part of the Parents and Children Together (PACT)
Evaluation.
The PACT project is a formative evaluation whose overall objective
is to document and provide initial assessment of selected Responsible
Fatherhood and Healthy Marriage grant programs that were authorized
under the 2010 Claims Resolution Act. This information will be critical
to informing decisions related to future investments in this kind of
programming as well as the design and operation of such services.
To meet the objective of the study, PACT is utilizing three major,
interrelated evaluation strategies:
(a) Impact evaluation;
(b) Implementation evaluation; and
(c) Qualitative evaluation.
Each of these strategies will be employed separately with (1)
Responsible Fatherhood and (2) Healthy Marriage grantees. Specifically,
we anticipate the following studies:
(a) Impact evaluation:
(1) Responsible Fatherhood grantee evaluation; and (2) Healthy
Marriage grantee evaluation.
(b) Implementation evaluation:
(1) Responsible Fatherhood grantee evaluation;
(1--additional substudy) Responsible Fatherhood grantee evaluation
with a focus on Hispanic populations; and
(2) Healthy Marriage grantee evaluation.
(c) Qualitative evaluation:
(1) Responsible Fatherhood grantee evaluation.
The following instruments have been approved for this study: Site
selection: a discussion guide to assist in selecting sites was approved
by OMB on April 20, 2012.
(a) Impact evaluation:
(1) Responsible Fatherhood grantee evaluation:
Introductory script, approved October 31, 2012.
Baseline survey, approved October 31, 2012.
(b) Implementation evaluation:
(1) Responsible Fatherhood grantee evaluation:
Responsible Fatherhood Study MIS, approved October 31,
2012.
This 60-Day Federal Register Notice requests clearance of new
instruments:
(a) Impact evaluation:
(1) Healthy Marriage grantee evaluation:
Introductory script, which program staff will use to
introduce the study to participants.
Baseline survey, to capture participant characteristics
and experiences prior to randomization.
(b) Implementation evaluation:
(1) and (2) Responsible Fatherhood and Healthy Marriage grantee
evaluation:
Semi-structured interview topic guide, to gather
information on program implementation from program staff.
On-line survey, to capture program staff experiences.
Telephone interviews (with staff at referral
organizations), to document linkages between the program and referral
agencies.
Working Alliance Inventory, to assess the strength of the
participant-program staff working relationship.
Focus group guide, to elicit participant experiences.
Telephone interviews (with program dropouts), to determine
reasons why those eligible for the program choose not to participate.
(1--additional substudy) Responsible Fatherhood grantee evaluation
with a focus on Hispanic populations:
Semi-structured interview topic guide, to examine how
agencies adapt programs to address the needs of Hispanic populations.
Focus group guide, to elicit participant experiences.
Participant questionnaire, to capture participant
characteristics and experiences.
(2) Healthy Marriage grantee evaluation:
Study MIS (for use in HM programs), to track participation
in the program.
(c) Qualitative evaluation:
(1) Responsible Fatherhood grantee evaluation:
Guide for in-person, in-depth interviews, to understand
the experiences, both in and out of the program, of a subset of men.
Check-in call guide, to follow-up from the in-person, in-
depth interviews, to ascertain new experiences by these men since last
discussion.
This 60-Day Federal Register Notice also serves as a request for
OMB to waive subsequent 60-day Federal Register notices pertaining to
the PACT Evaluation.
Respondents:
Respondents include program applicants, program participants,
program staff, and staff at referral agencies. Specific respondents per
instrument are noted in the burden tables below.
Annual Burden Estimates
Some burden has already been approved for this study, and the
following instruments are still in use. Approved burden is provided
below:
----------------------------------------------------------------------------------------------------------------
Average
Annual number Number of burden per Total annual
Instrument respondent of responses per response burden hours
respondents respondent (minutes)
----------------------------------------------------------------------------------------------------------------
Site Selection
----------------------------------------------------------------------------------------------------------------
Selecting Study Grantees:
Discussions/grantee and partner organization 50 1 60 50
staff......................................
----------------------------------------------------------------------------------------------------------------
[[Page 69862]]
Impact
Responsible Fatherhood Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
Introductory Script:
Grantee staff............................... 30 70.2 10 351
Program applicants.......................... 2,105 1 10 351
Baseline Survey:
Study participants.......................... 2,000 1 30 1,000
----------------------------------------------------------------------------------------------------------------
Implementation
Responsible Fatherhood Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
RF Study MIS:
Grantee staff............................... 30 2,533 2 2,533
---------------------------------------------------------------
Total................................... .............. .............. .............. 4,285
----------------------------------------------------------------------------------------------------------------
This current 60-Day Federal Register Notice covers many new
instruments:
----------------------------------------------------------------------------------------------------------------
Average
Annual number Number of burden per Total annual
Instrument respondent of responses per response burden hours
respondents respondent (minutes)
----------------------------------------------------------------------------------------------------------------
Impact
Healthy Marriage Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
Introductory script:
Program staff............................... 20 246 10 820
Program applicants.......................... 4,211 1 10 702
Baseline survey:
Study participants.......................... 4,000 1 30 2,000
----------------------------------------------------------------------------------------------------------------
Implementation
Responsible Fatherhood and Healthy Marriage Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
Semi-structured interview topic guide:
Program staff............................... 250 2 62 517
On-line survey:
Program staff............................... 250 2 30 250
Telephone interviews (with staff at referral
organizations):
Program staff at referral organizations..... 50 1 30 25
Working Alliance Inventory:
(1) Program staff........................... 50 20 10 167
(2) Participants............................ 1,000 1 10 167
Focus group guide:
Study participants.......................... 600 1 90 900
Telephone interviews (with program dropouts):
Study participants (program dropouts)....... 150 1 15 38
----------------------------------------------------------------------------------------------------------------
Additional Substudy: Responsible Fatherhood Grantee Evaluation With a Focus on Hispanic Populations
----------------------------------------------------------------------------------------------------------------
Semi-structured interview topic guide:
Program staff............................... 42 1 65 45
Focus group guide:
Study participants.......................... 25 1 90 38
Participant questionnaire:
Study Participants.......................... 25 1 30 13
----------------------------------------------------------------------------------------------------------------
Healthy Marriage Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
HM Study MIS (for use in HM programs):
Program staff............................... 30 3,400 2 3,400
----------------------------------------------------------------------------------------------------------------
Qualitative
Responsible Fatherhood Grantee Evaluation
----------------------------------------------------------------------------------------------------------------
Guide for in-person, in-depth interviews:
[[Page 69863]]
Study participants.......................... 95 3 120 570
Check-in call guide:
Study participants.......................... 63 4 10 42
---------------------------------------------------------------
Total................................... .............. .............. .............. 9,694
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours (for instruments previously
approved and currently in use, as well as those associated with this
60-Day Notice): 13,969.
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. Email
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.
Robert Sargis,
Administration for Children and Families, Reports Clearance Officer.
[FR Doc. 2012-28321 Filed 11-20-12; 8:45 am]
BILLING CODE 4184-37-P
