Proposed Information Collection Activity; Comment Request, 69861-69863 [2012-28321]

Download as PDF 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 ................................. VerDate Mar<15>2010 18:13 Nov 20, 2012 Jkt 229001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 50 E:\FR\FM\21NON1.SGM 1 21NON1 60 50 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 18:13 Nov 20, 2012 Jkt 229001 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 E:\FR\FM\21NON1.SGM 21NON1 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 http:// 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 21NON1

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