Agency Information Collection Activities; Proposed Collection; Comment Request, 9051-9054 [2013-02549]

Download as PDF Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices agree to submit to reasonable security measures. The meeting space is intended to accommodate public attendees. However, if the space will not accommodate all requests, the ASC may refuse attendance on that reasonable basis. The use of any video or audio tape recording device, photographing device, or any other electronic or mechanical device designed for similar purposes is prohibited at ASC meetings. Dated: February 1, 2013. James R. Park, Executive Director. [FR Doc. 2013–02732 Filed 2–6–13; 8:45 am] BILLING CODE P are found, the tariff of United Logistics (LAX) Inc. should be suspended pursuant to section 13 of the Shipping Act, 46 U.S.C. 41108(a); (5) whether the Ocean Transportation Intermediary license of United Logistics (LAX) Inc. should be suspended or revoked pursuant to section 19 of the Shipping Act, 46 U.S.C. 40903; and (6) whether, in the event violations are found, an appropriate cease and desist order should be issued as authorized by section 14 of the Shipping Act, 46 U.S.C. 41304. The Order may be viewed in its entirety at http://www.fmc.gov/13-01. Karen V. Gregory, Secretary. FEDERAL MARITIME COMMISSION [FR Doc. 2013–02819 Filed 2–6–13; 8:45 am] [Docket No. 13–01] BILLING CODE 6730–01–P Order of Investigation and Hearing: United Logistics (Lax) Inc.—Possible Violations of the Shipping Act of 1984 FEDERAL RESERVE SYSTEM Federal Maritime Commission. The Order of Investigation and Hearing was served January 25, 2013. ACTION: Notice of Order of Investigation and Hearing. AGENCY: DATES: Authority: 46 U.S.C. 41302. On January 25, 2013 the Federal Maritime Commission instituted an Order of Investigation and Hearing entitled United Logistics (LAX) Inc.—Possible Violations of Sections 10(a)(1) and 10(b)(2)(A) of the Shipping Act of 1984. Acting pursuant to Section 11 of the Shipping Act, 46 U.S.C. 41302, that investigation is instituted to determine: (1) Whether United Logistics (LAX) Inc. violated section 10(a)(1) of the Shipping Act, 46 U.S.C. 41102(a) by knowingly and willfully, directly or indirectly, obtaining transportation at less than the rates and charges otherwise applicable by the device or means of unlawfully accessing service contracts to which it was neither a signatory nor an affiliate; (2) whether United Logistics (LAX) Inc. violated section 10(b)(2)(A) of the Shipping Act, 46 U.S.C. 41104(2)(A), by providing transportation in the liner trade that was not in accordance with the rates, charges, classifications, rules, and practices contained in its published tariff; (3) whether, in the event violations of section 10 of the Shipping Act are found, civil penalties should be assessed against United Logistics (LAX) Inc. and, if so, the amount of the penalties to be assessed; (4) whether, in the event violations of section 10(b)(2)(A) of the Shipping Act mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:45 Feb 06, 2013 Jkt 229001 Fmt 4703 Board of Governors of the Federal Reserve System, February 4, 2013. Margaret McCloskey Shanks, Deputy Secretary of the Board. [FR Doc. 2013–02767 Filed 2–6–13; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities; Proposed Collection; Comment Request Agency for Healthcare Research and Quality, HHS. ACTION: Notice. The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 22, 2013. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Baylake Corporation, Sturgeon Bay, Wisconsin; to engage de novo through its subsidiary, Admiral Asset Management, LLC, Green Bay, Wisconsin, in conducting registered Frm 00025 investment advisory services, pursuant to section 225.28(b)(6). AGENCY: Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities PO 00000 9051 Sfmt 4703 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. DATES: Comments on this notice must be received by April 8, 2013. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz,AHRQ.hhs.gov. 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: SUMMARY: Proposed Project Improving Sickle Cell Transitions of Care Through Health Information Technology Phase 1 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 E:\FR\FM\07FEN1.SGM 07FEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 9052 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 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, 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 VerDate Mar<15>2010 17:45 Feb 06, 2013 Jkt 229001 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, pursuant to AHRQ’s 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 health care technologies. 42 U.S.C. 299a(a)(1), (2) and (5). 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 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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. Five of these stakeholders will be Federal government employees and therefore are excluded from the burden estimates in Exhibit 1 below. E:\FR\FM\07FEN1.SGM 07FEN1 9053 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 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. 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 236 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 $7,646 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 3 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 6 Total .......................................................................................................... 203 na na 236 * Five interview participants will be Federal government employees and therefore are excluded from the burden estimates. EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of respondents Form name Total burden hours Average hourly wage 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 3 10 40 60 40 20 20 20 20 6 a $26.89 f 52.72 $269 3,551 1,304 1,771 0 0 435 0 316 Total .......................................................................................................... 203 236 na 7,646 b 88.7 a 21.74 d 44.27 e0 e0 a 21.74 e0 mstockstill on DSK4VPTVN1PROD with NOTICES 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.’’ http://www.bls.gov/oes/current/oes_nat.htm#15-0000. 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) VerDate Mar<15>2010 18:18 Feb 06, 2013 Jkt 229001 Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 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 E:\FR\FM\07FEN1.SGM 07FEN1 9054 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices 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: January 23, 2013. Carolyn M. Clancy, Director. [FR Doc. 2013–02549 Filed 2–6–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH–144] Issuance of Final Guidance Publication National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). AGENCY: Notice of issuance of final guidance publication. ACTION: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: ‘‘NIOSH Criteria for a Recommended Standard: Occupational Exposure to Hexavalent Chromium’’ [2013–128]. SUMMARY: This document may be obtained at the following link: Web site: http://www.cdc.gov/niosh/docs/2013128/. ADDRESSES: mstockstill on DSK4VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Kathleen MacMahon, NIOSH, Robert A. Taft Laboratories, MS–C14, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone (513) 533–8547. Dated: January 28, 2013. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. BILLING CODE 4163–18–P VerDate Mar<15>2010 17:45 Feb 06, 2013 Jkt 229001 Centers for Disease Control and Prevention National Institute for Occupational Safety and Health Respiratory Protection for Healthcare Workers: Stakeholder Meeting The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ‘‘Stakeholder Meeting on Respiratory Protection for Healthcare Workers’’. Stakeholder Meeting Time and Date: 8 a.m.–5:15 p.m. EDT, June 18, 2013. Place: CDC Tom Harkin Global Communications Center located at 1600 Clifton Road, Building 19, Atlanta, Georgia 30333. This meeting will also be available by videoconference at select CDC locations. Purpose of the Meeting: This meeting is being held to exchange ideas and solutions to improve healthcare worker compliance with personal protective technologies (PPT), with a focus on respiratory protection. Stakeholder feedback is sought to (1) provide input to future updates of the NIOSH PPT program research agenda and (2) assess progress toward better respirators for healthcare workers. This meeting will include presentations and moderated roundtable discussions on ‘‘Improving the Evidence Base to Support Guidance on the Appropriate Level of Respiratory Protection’’, ‘‘Healthcare Worker Observational Studies of Respirator Use & New Educational Resources’’, ‘‘Considerations for Extending Respirator Supplies During an Outbreak or Pandemic’’, ‘‘Standards & Test Methods for Improved Respirators for Healthcare Workers’’, and ‘‘Advances toward Improved Respirators for Healthcare Workers’’. Status: The meeting is open to the public, limited only by the capacity (100) of the conference room. Registration will be accepted on a first come first served basis. Participants are encouraged to consider attending by video conference, which will be provided at select CDC locations (to be SUMMARY: BILLING CODE 4160–90–M [FR Doc. 2013–02743 Filed 2–6–13; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 announced). Registration for both in person and video conference attendance is available on the NIOSH NPPTL Web site, www.cdc.gov/niosh/npptl. Preregistration is required on or before May 31, 2013, even for remote attendees and US citizens. Non-US citizens need to register on or before May 18, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH and will include details needed to participate. A government issued photo ID will be required to obtain entrance to any of the CDC locations. Background: The NIOSH PPT program publishes and periodically updates its research agenda on personal protective equipment (PPE) for healthcare workers (http:// www.cdc.gov/niosh/docket/archive/ docket129.html). The research agenda, last updated in 2010, describes the near term and long term strategy for the PPT program’s influenza pandemic research, development, and investigative testing activities. Recently, the Institute of Medicine (IOM) published a report (http://www.iom.edu/Reports/2011/ Preventing-Transmission-of-PandemicInfluenza-and-Other-Viral-RespiratoryDiseases.aspx) that assessed the nation’s progress on improving PPE for healthcare personnel exposed to infectious respiratory diseases and made recommendations to address research gaps. Furthermore, a chapter in the recent HHS 2009 H1N1 Influenza Improvement Plan (http://www.phe.gov/ Preparedness/mcm/h1n1-retrospective/ Documents/2009-h1n1improvementplan.pdf) discusses research needs for respiratory protective devices as part of a broader non-vaccine medical countermeasures strategy. A key area of discussion at this stakeholder meeting will be progress on research gaps identified in the 2011 IOM and 2012 HHS reports and how NIOSH can use this information to update the 2010 PPT research agenda. The current version of PPT program research agenda for healthcare worker PPE focuses on conducting research to design and promote the appropriate use of PPE. Compliance with appropriate respirator use practices is important because healthcare workers often wear them incorrectly or fail to use them at all. Poor compliance has been linked to safety culture, workload issues, time constraints, risk perception, effectiveness concerns, availability, discomfort, interference with patient care, and communication difficulties. One strategy taken to improve healthcare worker compliance is to develop better respirators. In this E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9051-9054]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02549]


=======================================================================
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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.

DATES: Comments on this notice must be received by April 8, 2013.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
doris.lefkowitz,AHRQ.hhs.gov.
    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 
AHRQ.hhs.gov">doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Improving Sickle Cell Transitions of Care Through Health Information 
Technology Phase 1

    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

[[Page 9052]]

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, 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, pursuant to AHRQ's 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 health 
care technologies. 42 U.S.C. 299a(a)(1), (2) and (5).

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. Five of these 
stakeholders will be Federal government employees and therefore are 
excluded from the burden estimates in Exhibit 1 below.

[[Page 9053]]

    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.

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 236 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 $7,646 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........................               3               1               2               6
                                                 ---------------------------------------------------------------
    Total.......................................             203              na              na            236
----------------------------------------------------------------------------------------------------------------
* Five interview participants will be Federal government employees and therefore are excluded from the burden
  estimates.


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
Demographic Questionnaire.......................             100              10      \a\ $26.89            $269
Provider Focus Groups...........................              20              40        \b\ 88.7           3,551
Parent/Caregiver Focus Groups...................              30              60       \a\ 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       \a\ 21.74             435
Patients mixed ages Focus Group.................              10              20           \e\ 0               0
Key Informant Interviews........................               3               6       \f\ 52.72             316
                                                 ---------------------------------------------------------------
    Total.......................................             203             236              na          7,646
----------------------------------------------------------------------------------------------------------------
\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.'' http://www.bls.gov/oes/current/oes_nat.htm#15-0000.

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

[[Page 9054]]

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: January 23, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-02549 Filed 2-6-13; 8:45 am]
BILLING CODE 4160-90-M