Agency Information Collection Activities; Proposed Collection; Comment Request, 25085-25088 [2013-09742]

Download as PDF Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Gene R. Giles, Alliance, Nebraska, Sally J. Giles, Denver, Colorado, Randall D. Giles, San Diego, California, Nicholas G. Giles, and Lucas G. Giles, both of Lincoln, Nebraska; all of the Giles family group; the Bradley S. Norden Irrevocable Trust, and the Brett A. Norden Irrevocable Trust, Brett A. Norden and Bradley S. Norden, as cotrustees of both trusts, all of Highlands Ranch, Colorado, and as members of the Norden family group; the Michael L. Ryan 2011 Irrevocable Trust and the Cheryl L. Ryan 2012 Irrevocable Trust, both of Minden, Nebraska, Jeffrey M. Ryan, Heartwell, Nebraska, and Jamie Johnson, Minden, Nebraska, as cotrustees of both trusts; and Walter D. Wood Revocable Trust, Walter D. Wood, trustee, both of Omaha, Nebraska, as part of the Ryan/Wood family group; to acquire voting shares of First Central Nebraska Co., and thereby indirectly acquire voting shares of Nebraska State Bank and Trust Company, both in Broken Bow, Nebraska. includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 24, 2013. A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309: 1. Oakworth Capital, Inc., Birmingham, Alabama; to become a bank holding company by acquiring 100 percent of the voting shares of Oakworth Capital Bank, Birmingham, Alabama. B. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105–1579: 1. TFB Bancorp, Inc., Yuma, Arizona; to become a bank holding company by acquiring 100 percent of the voting shares of The Foothills Bank, Yuma, Arizona. Board of Governors of the Federal Reserve System, April 24, 2013. Michael J. Lewandowski, Assistant Secretary of the Board. Board of Governors of the Federal Reserve System, April 24, 2013. Michael J. Lewandowski, Assistant Secretary of the Board. [FR Doc. 2013–10030 Filed 4–26–13; 8:45 am] [FR Doc. 2013–10029 Filed 4–26–13; 8:45 am] BILLING CODE 6210–01–P BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND HUMAN SERVICES emcdonald on DSK67QTVN1PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also VerDate Mar<15>2010 14:16 Apr 26, 2013 Jkt 229001 Agency for Healthcare Research and Quality Agency Information Collection Activities; Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. AGENCY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ‘‘Improving Sickle Cell Transitions of Care through Health Information Technology Phase 1.’’ In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on February 7th, 2013 and allowed 60 days for public comment. No SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 25085 comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by May 29, 2013. ADDRESSES: Written comments should be submitted to: AHRQ’s OMB Desk Officer by fax at (202) 395–6974 (attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov (attention: AHRQ’s desk officer). Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: Proposed Project Improving Sickle Cell Transitions of Care through Health Information Technology Phase I This project is the first phase in AHRQ’s effort toward the development of a health information technology (HIT) enabled tool designed to aid adolescents and young adults with sickle cell disease (SCD) during transitions of care. SCD is a serious, genetic blood disorder that affects approximately 70,000– 100,000 Americans, including one out of every 500 African American and one out of every 36,000 Hispanic American births. Persons with SCD produce abnormal, ‘‘sickle-shaped’’ red blood cells that obstruct blood vessels, leading to life-long anemia, organ damage, increased potential for infections, chronic episodes of pain, and substantially shortened life spans. SCD has been noted to be understudied relative to its prevalence resulting in a lack of knowledge about the important variables and domains that determine health outcomes for patients. Furthermore, patients with SCD, typically young, minority, and often of lower income status, have had few opportunities to voice their needs and concerns about their health and health care. As recently as 30 years ago, children with SCD usually did not survive into adulthood. Now, as a result of advances in screening and treatment, more than 90 percent of individuals with SCD reach adulthood, and life expectancy is typically into the fifth decade. Persons with SCD experience multiple transitions of care as a result of the chronicity of SCD, frequency of both acute and chronic-events requiring care, E:\FR\FM\29APN1.SGM 29APN1 emcdonald on DSK67QTVN1PROD with NOTICES 25086 Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices as well as the advancements in life expectancy. Transitions of care occur when either the setting of care changes (e.g., from home-based to hospital-based care) or the focus of care changes (e.g., from pediatric-focused to adult-focused care). When transitions of care occur, a need to share medical history and other types of health information arises. Transitions of care are more likely to be successful when this health information is accurate, tailored to the type of transition taking place, and communicated effectively. Times of care transitions are particularly fraught for patients with SCD and currently, few patients have access to effective transition programs for SCD. In a 2010 survey of pediatric SCD providers, the majority claimed to have transition programs in place but they were often newly formed and without the ability to transfer care to adult providers with specific expertise in SCD. Preliminary evidence suggests that HIT can be helpful for SCD and similar conditions. In particular, a technologybased tool has already been used successfully by patients with SCD to help with some aspects of disease management. In one study, a handheld wireless device was used to implement a pain management protocol and found to result in high rates of participation and satisfaction. Technology-based tools or applications—‘‘apps’’—have also been effective in improving care transitions for other chronic diseases such as diabetes and HIV, which can serve as models for this tool. Improving transitions of care is the focus of AHRQ’s plans to respond to the Department of Health and Human Services’ (HHS’) SCD Initiative announced in 2011. The overall HHS SCD initiative, which is aligned with AHRQ’s mission, aims to improve the health of persons with SCD through various activities, including developing and disseminating evidence-based guidelines, increasing the availability of medical homes that provide SCD care, and supporting research in areas such as pain and disease management, all of which could also be supported through the use of an effective HIT enabled tool. The goals of this project are to: (1) Gain the necessary background knowledge including qualitative information from key stakeholders, to establish a set of requirements that would guide the design and development of a HIT-enabled tool in future phases of work that meets patients’, families’, and providers’ needs to aid adolescents and young adults with sickle cell disease during transitions of care. VerDate Mar<15>2010 14:16 Apr 26, 2013 Jkt 229001 (2) Develop an understanding of the environmental context, current facilitators and barriers, health data use and needs of key stakeholders affected by sickle cell disease, including patients, families, and providers. This study is being conducted by AHRQ through its contractor, The Lewin Group in partnership with Children’s National Medical Center, Cincinnati Children’s Hospital Medical Center, Nemours Children’s ClinicJacksonville, and the National Initiative for Children’s Healthcare Quality, pursuant to AHRQ’s statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). Method of Collection To achieve the goals of this project, the following activities and data collections will be implemented: (1) Environmental Scan—AHRQ will execute a literature review to identify potentially relevant scientific literature and information from other literature and sources as well as complete a search for existing tools that aid transitions of care for persons with SCD or similar conditions. This will provide contextual background about the current state of the field with regards to tooldevelopment and use, identify keyissues of patients with SCD related to care transitions, and understand the context of care delivered and health data information needs to inform the content, design and functionality of a tool. This activity does not impose a burden on the public and is not included in the burden estimates in Exhibit 1. (2) Focus Groups—AHRQ will facilitate ten focus groups of key stakeholder groups including: parents/ caregivers of patients with SCD; health care providers (e.g. SCD specialists, primary care physicians (PCPs), hospitalists and emergency room (ER) physicians); IT developers; SCD patients ages 9–13; SCD patients ages 14–17; SCD patients 18 and older; and SCD patients of mixed ages; to gather qualitative information on stakeholder experiences with SCD and care transitions, barriers to quality care, and use of technology to inform tool design and functionality. Each group will consist of 10 participants and will be asked to describe their particular experiences with health care transitions, communication practices, information PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 needs and technology use in order to develop relevant ‘‘use cases’’ which will be used by investigators and tool developers for the later phases of the project. The in-person nature of focus groups allows for a more in-depth and targeted discussion, including participant experiences, impressions and priorities in a detailed fashion. (3) Demographic Questionnaire— AHRQ will implement a short demographic questionnaire at the start of each of the ten focus groups to collect basic demographic information to allow the team to contextualize findings from each focus group. Questionnaires are tailored to each focus group category: Parents/caregivers of patients with SCD; providers, hospitalists and ER physicians; IT developers; SCD patients ages 9–13; SCD patients ages 14–17; SCD patients 18 and older; and SCD patients of mixed ages. (4) Key Informant Interviews—AHRQ will conduct eight key informant interviews with stakeholders such as State Medicaid representatives, attorneys with expertise in privacy and security issues, representatives from the Office of the National Coordinator for Health Information Technology (ONC), Office of Chief Scientist, and other relevant policy makers. Qualitative information gained will contribute to tool development recommendations particularly in terms of cost issues related to reimbursement by payers, needs for proof of effectiveness, sustainability, and potential vehicles for facilitating and funding tool development and implementation. The information gained from the focus groups and key informant interviews will be used to understand if and how a patient-centered, HITenabled tool can improve the health of individuals with SCD during care transitions. Focus groups as a form of qualitative research are an important vehicle for gathering and explicating insight from the field, especially if, as in this case, the important domains are not yet understood, and need to be outlined by respondents, rather than suggested by investigators. Thus active recruitment and qualitative techniques are a means to incorporate this necessary and important perspective into the derivation of effective interventions. The primary objective of the focus groups is to gather more richly nuanced information from sickle cell disease stakeholders. The in-person nature of focus groups allows for a more in-depth and targeted discussion, including participant experiences, impressions and priorities in a detailed fashion. E:\FR\FM\29APN1.SGM 29APN1 25087 Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents’ time to participate in this research. The demographic questionnaire will be completed by each focus group participant and takes 6 minutes to complete. All of the focus groups and key informant interviews will last 2 hours except for the IT developer focus group which will last 4 hours. Each focus group will consist of 10 persons. There will be two focus groups with providers, three with parents/caregivers, one group for IT developers, and one focus group with each of the four patient groups. Key informant interviews will be conducted with eight individuals. The total burden is estimated to be 246 hours annually. Exhibit 2 shows the estimated annualized cost burden associated with the respondents’ time to participate in this research. The total cost burden is estimated to be $8,174 annually. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Hours per response Total burden hours Demographic Questionnaire ............................................................................ Provider Focus Groups .................................................................................... Parent/Caregiver Focus Groups ...................................................................... IT Developer Focus Group .............................................................................. Patients 9–13 Focus Group ............................................................................. Patients 14–17 Focus Group ........................................................................... Patients 18 & older Focus Group .................................................................... Patients mixed ages Focus Group .................................................................. Key Informant Interviews ................................................................................. 100 20 30 10 10 10 10 10 8 1 1 1 1 1 1 1 1 1 6/60 2 2 4 2 2 2 2 2 10 40 60 40 20 20 20 20 16 Total .......................................................................................................... 208 na na 246 EXHIBIT 2—ESTIMATED ANNUALIZE COST BURDEN Number of respondents Form name Total burden hours Average hourly rate* Total cost burden Demographic Questionnaire ............................................................................ Provider Focus Groups .................................................................................... Parent/Caregiver Focus Groups ...................................................................... IT Developer Focus Group .............................................................................. Patients 9–13 Focus Group ............................................................................. Patients 14–17 Focus Group ........................................................................... Patients 18 & older Focus Group .................................................................... Patients mixed ages Focus Group .................................................................. Key Informant Interviews ................................................................................. 100 20 30 10 10 10 10 10 8 10 40 60 40 20 20 20 20 16 a $26.89 f 52.72 $269 3,551 1,304 1,771 0 0 435 0 844 Total .......................................................................................................... 208 246 na 8,174 b 88.78 c 21.74 d 44.27 e0 e0 c 21.74 e0 a Based on the mean wages for Physicians & Surgeons, All other (29–1069), All Occupations (00–0000), Software Developer (15–1132). Wages for children averaged in as $0. b Based on the mean wages for Physicians & Surgeons, All other (29–1069). c Based on the mean wages for All Occupations (00–0000). d Based on the mean wages for Software Developer (15–1132). e No wage data for children. f Based on the mean wages for Lawyers (23–1011), Social and Community Service Managers (11–9151), Medical and Health Services Managers (11–9111), and Computer and Information System Managers (11–3021). * National Compensation Survey: Occupational wages in the United States May 2011, ‘‘U.S. Department of_Labor, Bureau of Labor Statistics.’’https://www.bls.gov/oes/current/oes_nat.htm#15–0000. Estimated Annual Costs to the Federal Government emcdonald on DSK67QTVN1PROD with NOTICES Exhibit 3 shows the estimated total and annualized cost to the federal government over 18 months. The total cost to the federal government of this data collection effort is $264,043. This figure includes development of draft and final plans for conducting focus groups and interviews; development of materials including moderator guides for each stakeholders group (seven guides in total), recruitment materials for all four sites, consent forms; facilitating IRB approval processes at four sites; logistics coordination including securing facility space; recruitment of participants; incentives for participants (as described in section 9 above); and analyzing and summarizing findings as well as preparing final reports. EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST Cost component Total cost Project Development ................................................................................................................................... Data Collection Activities ............................................................................................................................. Data Processing and Analysis ..................................................................................................................... Publication of Results .................................................................................................................................. VerDate Mar<15>2010 16:51 Apr 26, 2013 Jkt 229001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\29APN1.SGM $23,689 169,586 16,000 33,472 29APN1 Annualized cost $15,793 113,057 10,667 22,315 25088 Federal Register / Vol. 78, No. 82 / Monday, April 29, 2013 / Notices EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued Cost component Total cost Annualized cost Project Management .................................................................................................................................... Overhead ..................................................................................................................................................... 18,319 2,977 12,213 1,985 Total ...................................................................................................................................................... 264,043 176,029 Request for Comments In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: April 15, 2013. Carolyn M Clancy, Director. [FR Doc. 2013–09742 Filed 4–26–13; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–13–13RE] emcdonald on DSK67QTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–7570 or send VerDate Mar<15>2010 14:16 Apr 26, 2013 Jkt 229001 comments to Ron Otten, at 1600 Clifton Road, MS D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments are invited 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) ways to enhance 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. Written comments should be received within 60 days of this notice. Proposed Project Public Health Systems, Mental Health and Community Recovery—New— Office of Public Health Preparedness and Response, Division of State and Local Readiness, Centers for Disease Control and Prevention (CDC). Background and Brief Description This project stems from, and aligns with, publication of the Office of Public Health Preparedness and Response’s (OPHPR) ‘‘National Strategic Plan for Public Health Preparedness and Response’’ which provides overall direction for Centers for Disease Control and Prevention’s (CDC) preparedness and response portfolio, including programmatic direction across OPHPR’s four divisions. The focus of this project is to generate findings useful for future preparedness planning and response in order to develop strategies and interventions aimed at mitigating the impact of adverse events. In April 2011, one of the largest tornado outbreaks ever recorded, a ‘‘Super Outbreak,’’ occurred in the southeastern United States, resulting in more than 300 deaths and an estimated $11 million in damages. This large-scale multistate tragedy offers a unique opportunity to study how communities with similar cultural and geographic features yet different public health and mental health emergency response systems could provide access to care around the same crisis. The PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 outcomes of these efforts can inform the field of what effect these differences had on the recovery patterns of each of these communities. By doing so, we can begin to elucidate best practices for robust community preparedness and recovery with attention to types of services that most effectively promote the natural resilience of survivors. Two primary research questions will guide the proposed study: 1. How did the Alabama and Mississippi State and local public health and mental health (PH/MH) systems prepare for, respond to, and support recovery after the April 2011 tornados? 2. To what extent have these communities recovered and what is the overall health and quality of life of individuals affected by these events? CDC requests Office of Management and Budget (OMB) approval to collect information for two years. To address these questions, CDC, in collaboration with ICF International, will conduct a mixed method evaluation utilizing key informant interviews of public health and mental health agency staff and other community representatives at the local, county and State levels and household survey data in each of the four regions in Mississippi and Alabama to assess community recovery and resilience. Specifically, the study design includes two main components (qualitative and quantitative) designed to comprehensively examine the PH/MH system response to and community recovery and resilience from disasters. The total estimated burden for the 98 one-time qualitative interviews for public health/mental health professionals and community leaders is 98 hours (98 respondents × 1 hour/ response). Interviews will be conducted during an in-person site-visit to the region to reduce travel and time burdens on the respondents. Respondents unable to participate during the site visit may participate via telephone. In addition, the total estimated burden for the quantitative computer-assisted interviews are based on 860 respondents in each of the four tornado effected regions; each survey will be approximately 25 minutes (4 counties × 860 respondents = 3,440 respondents; E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 78, Number 82 (Monday, April 29, 2013)]
[Notices]
[Pages 25085-25088]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09742]


=======================================================================
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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Agency for Healthcare Research and Quality


Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``Improving Sickle Cell Transitions of Care through Health 
Information Technology Phase 1.'' In accordance with the Paperwork 
Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment 
on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on February 7th, 2013 and allowed 60 days for 
public comment. No comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by May 29, 2013.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at OIRA_submission@omb.eop.gov (attention: AHRQ's desk officer).
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Improving Sickle Cell Transitions of Care through Health Information 
Technology Phase I

    This project is the first phase in AHRQ's effort toward the 
development of a health information technology (HIT) enabled tool 
designed to aid adolescents and young adults with sickle cell disease 
(SCD) during transitions of care. SCD is a serious, genetic blood 
disorder that affects approximately 70,000-100,000 Americans, including 
one out of every 500 African American and one out of every 36,000 
Hispanic American births. Persons with SCD produce abnormal, ``sickle-
shaped'' red blood cells that obstruct blood vessels, leading to life-
long anemia, organ damage, increased potential for infections, chronic 
episodes of pain, and substantially shortened life spans. SCD has been 
noted to be understudied relative to its prevalence resulting in a lack 
of knowledge about the important variables and domains that determine 
health outcomes for patients. Furthermore, patients with SCD, typically 
young, minority, and often of lower income status, have had few 
opportunities to voice their needs and concerns about their health and 
health care.
    As recently as 30 years ago, children with SCD usually did not 
survive into adulthood. Now, as a result of advances in screening and 
treatment, more than 90 percent of individuals with SCD reach 
adulthood, and life expectancy is typically into the fifth decade. 
Persons with SCD experience multiple transitions of care as a result of 
the chronicity of SCD, frequency of both acute and chronic-events 
requiring care,

[[Page 25086]]

as well as the advancements in life expectancy. Transitions of care 
occur when either the setting of care changes (e.g., from home-based to 
hospital-based care) or the focus of care changes (e.g., from 
pediatric-focused to adult-focused care). When transitions of care 
occur, a need to share medical history and other types of health 
information arises. Transitions of care are more likely to be 
successful when this health information is accurate, tailored to the 
type of transition taking place, and communicated effectively.
    Times of care transitions are particularly fraught for patients 
with SCD and currently, few patients have access to effective 
transition programs for SCD. In a 2010 survey of pediatric SCD 
providers, the majority claimed to have transition programs in place 
but they were often newly formed and without the ability to transfer 
care to adult providers with specific expertise in SCD.
    Preliminary evidence suggests that HIT can be helpful for SCD and 
similar conditions. In particular, a technology-based tool has already 
been used successfully by patients with SCD to help with some aspects 
of disease management. In one study, a handheld wireless device was 
used to implement a pain management protocol and found to result in 
high rates of participation and satisfaction. Technology-based tools or 
applications--``apps''--have also been effective in improving care 
transitions for other chronic diseases such as diabetes and HIV, which 
can serve as models for this tool.
    Improving transitions of care is the focus of AHRQ's plans to 
respond to the Department of Health and Human Services' (HHS') SCD 
Initiative announced in 2011. The overall HHS SCD initiative, which is 
aligned with AHRQ's mission, aims to improve the health of persons with 
SCD through various activities, including developing and disseminating 
evidence-based guidelines, increasing the availability of medical homes 
that provide SCD care, and supporting research in areas such as pain 
and disease management, all of which could also be supported through 
the use of an effective HIT enabled tool.
    The goals of this project are to:
    (1) Gain the necessary background knowledge including qualitative 
information from key stakeholders, to establish a set of requirements 
that would guide the design and development of a HIT-enabled tool in 
future phases of work that meets patients', families', and providers' 
needs to aid adolescents and young adults with sickle cell disease 
during transitions of care.
    (2) Develop an understanding of the environmental context, current 
facilitators and barriers, health data use and needs of key 
stakeholders affected by sickle cell disease, including patients, 
families, and providers.
    This study is being conducted by AHRQ through its contractor, The 
Lewin Group in partnership with Children's National Medical Center, 
Cincinnati Children's Hospital Medical Center, Nemours Children's 
Clinic-Jacksonville, and the National Initiative for Children's 
Healthcare Quality, pursuant to AHRQ's statutory authority to conduct 
and support research on healthcare and on systems for the delivery of 
such care, including activities with respect to the quality, 
effectiveness, efficiency, appropriateness and value of healthcare 
services and with respect to quality measurement and improvement. 42 
U.S.C. 299a(a)(1) and (2).

Method of Collection

    To achieve the goals of this project, the following activities and 
data collections will be implemented:
    (1) Environmental Scan--AHRQ will execute a literature review to 
identify potentially relevant scientific literature and information 
from other literature and sources as well as complete a search for 
existing tools that aid transitions of care for persons with SCD or 
similar conditions. This will provide contextual background about the 
current state of the field with regards to tool-development and use, 
identify key-issues of patients with SCD related to care transitions, 
and understand the context of care delivered and health data 
information needs to inform the content, design and functionality of a 
tool. This activity does not impose a burden on the public and is not 
included in the burden estimates in Exhibit 1.
    (2) Focus Groups--AHRQ will facilitate ten focus groups of key 
stakeholder groups including: parents/caregivers of patients with SCD; 
health care providers (e.g. SCD specialists, primary care physicians 
(PCPs), hospitalists and emergency room (ER) physicians); IT 
developers; SCD patients ages 9-13; SCD patients ages 14-17; SCD 
patients 18 and older; and SCD patients of mixed ages; to gather 
qualitative information on stakeholder experiences with SCD and care 
transitions, barriers to quality care, and use of technology to inform 
tool design and functionality. Each group will consist of 10 
participants and will be asked to describe their particular experiences 
with health care transitions, communication practices, information 
needs and technology use in order to develop relevant ``use cases'' 
which will be used by investigators and tool developers for the later 
phases of the project. The in-person nature of focus groups allows for 
a more in-depth and targeted discussion, including participant 
experiences, impressions and priorities in a detailed fashion.
    (3) Demographic Questionnaire--AHRQ will implement a short 
demographic questionnaire at the start of each of the ten focus groups 
to collect basic demographic information to allow the team to 
contextualize findings from each focus group. Questionnaires are 
tailored to each focus group category: Parents/caregivers of patients 
with SCD; providers, hospitalists and ER physicians; IT developers; SCD 
patients ages 9-13; SCD patients ages 14-17; SCD patients 18 and older; 
and SCD patients of mixed ages.
    (4) Key Informant Interviews--AHRQ will conduct eight key informant 
interviews with stakeholders such as State Medicaid representatives, 
attorneys with expertise in privacy and security issues, 
representatives from the Office of the National Coordinator for Health 
Information Technology (ONC), Office of Chief Scientist, and other 
relevant policy makers. Qualitative information gained will contribute 
to tool development recommendations particularly in terms of cost 
issues related to reimbursement by payers, needs for proof of 
effectiveness, sustainability, and potential vehicles for facilitating 
and funding tool development and implementation.
    The information gained from the focus groups and key informant 
interviews will be used to understand if and how a patient-centered, 
HIT-enabled tool can improve the health of individuals with SCD during 
care transitions.
    Focus groups as a form of qualitative research are an important 
vehicle for gathering and explicating insight from the field, 
especially if, as in this case, the important domains are not yet 
understood, and need to be outlined by respondents, rather than 
suggested by investigators. Thus active recruitment and qualitative 
techniques are a means to incorporate this necessary and important 
perspective into the derivation of effective interventions. The primary 
objective of the focus groups is to gather more richly nuanced 
information from sickle cell disease stakeholders. The in-person nature 
of focus groups allows for a more in-depth and targeted discussion, 
including participant experiences, impressions and priorities in a 
detailed fashion.

[[Page 25087]]

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this research. The demographic 
questionnaire will be completed by each focus group participant and 
takes 6 minutes to complete. All of the focus groups and key informant 
interviews will last 2 hours except for the IT developer focus group 
which will last 4 hours. Each focus group will consist of 10 persons. 
There will be two focus groups with providers, three with parents/
caregivers, one group for IT developers, and one focus group with each 
of the four patient groups. Key informant interviews will be conducted 
with eight individuals. The total burden is estimated to be 246 hours 
annually.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
cost burden is estimated to be $8,174 annually.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire.......................             100               1            6/60              10
Provider Focus Groups...........................              20               1               2              40
Parent/Caregiver Focus Groups...................              30               1               2              60
IT Developer Focus Group........................              10               1               4              40
Patients 9-13 Focus Group.......................              10               1               2              20
Patients 14-17 Focus Group......................              10               1               2              20
Patients 18 & older Focus Group.................              10               1               2              20
Patients mixed ages Focus Group.................              10               1               2              20
Key Informant Interviews........................               8               1               2              16
                                                 ---------------------------------------------------------------
    Total.......................................             208              na              na             246
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated annualize cost burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden       Average       Total cost
                    Form name                       respondents        hours       hourly rate*       burden
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire.......................             100              10      \a\ $26.89            $269
Provider Focus Groups...........................              20              40       \b\ 88.78           3,551
Parent/Caregiver Focus Groups...................              30              60       \c\ 21.74           1,304
IT Developer Focus Group........................              10              40       \d\ 44.27           1,771
Patients 9-13 Focus Group.......................              10              20           \e\ 0               0
Patients 14-17 Focus Group......................              10              20           \e\ 0               0
Patients 18 & older Focus Group.................              10              20       \c\ 21.74             435
Patients mixed ages Focus Group.................              10              20           \e\ 0               0
Key Informant Interviews........................               8              16       \f\ 52.72             844
                                                 ---------------------------------------------------------------
    Total.......................................             208             246              na           8,174
----------------------------------------------------------------------------------------------------------------
\a\ Based on the mean wages for Physicians & Surgeons, All other (29-1069), All Occupations (00-0000), Software
  Developer (15-1132). Wages for children averaged in as $0.
\b\ Based on the mean wages for Physicians & Surgeons, All other (29-1069).
\c\ Based on the mean wages for All Occupations (00-0000).
\d\ Based on the mean wages for Software Developer (15-1132).
\e\ No wage data for children.
\f\ Based on the mean wages for Lawyers (23-1011), Social and Community Service Managers (11-9151), Medical and
  Health Services Managers (11-9111), and Computer and Information System Managers (11-3021).
* National Compensation Survey: Occupational wages in the United States May 2011, ``U.S. Department of--Labor,
  Bureau of Labor Statistics.''https://www.bls.gov/oes/current/oes_nat.htm#15-0000.

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annualized cost to the 
federal government over 18 months. The total cost to the federal 
government of this data collection effort is $264,043. This figure 
includes development of draft and final plans for conducting focus 
groups and interviews; development of materials including moderator 
guides for each stakeholders group (seven guides in total), recruitment 
materials for all four sites, consent forms; facilitating IRB approval 
processes at four sites; logistics coordination including securing 
facility space; recruitment of participants; incentives for 
participants (as described in section 9 above); and analyzing and 
summarizing findings as well as preparing final reports.

             Exhibit 3--Estimated Total and Annualized Cost
------------------------------------------------------------------------
          Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
Project Development...............            $23,689            $15,793
Data Collection Activities........            169,586            113,057
Data Processing and Analysis......             16,000             10,667
Publication of Results............             33,472             22,315

[[Page 25088]]

 
Project Management................             18,319             12,213
Overhead..........................              2,977              1,985
                                   -------------------------------------
    Total.........................            264,043            176,029
------------------------------------------------------------------------

Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's 
information collection are requested with regard to any of the 
following: (a) Whether the proposed collection of information is 
necessary for the proper performance of AHRQ health care research and 
health care information dissemination functions, including whether the 
information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility, 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology. Comments submitted in response 
to this notice will be summarized and included in the Agency's 
subsequent request for OMB approval of the proposed information 
collection. All comments will become a matter of public record.

    Dated: April 15, 2013.
Carolyn M Clancy,
Director.
[FR Doc. 2013-09742 Filed 4-26-13; 8:45 am]
BILLING CODE 4160-90-M
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