81 FR 22605 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 74 (April 18, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 74 (April 18, 2016)
| Page Range | 22605-22606 | |
| FR Document | 2016-08856 |
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)] [Notices] [Pages 22605-22606] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08856] ======================================================================= ----------------------------------------------------------------------- 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: ``Making It Easier for Patients to Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures.'' 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 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments of the public. 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 18, 2016. 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 [email protected] (attention: AHRQ's desk officer). FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]. SUPPLEMENTARY INFORMATION: Proposed Project Making It Easier for Patients To Understand Health Information and Navigate Health Care Systems: Developing Quality Improvement Measures A goal of Healthy People 2020 is to increase Americans' health literacy, defined as ``the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.'' \1\ The effects of limited health literacy are numerous and serious, including medication non-adherence resulting from patients' inability to read and comprehend medication labels; underuse of preventive measures, such as vaccines; poor self-management of conditions such as asthma and diabetes; and higher utilization of inpatient and emergency department care. According to the 2003 National Assessment of Adult Literacy, 88% of US adults have significant difficulties understanding widely used health information. By adopting ``health literacy universal precautions,'' health care providers and organizations can create an environment in which all patients--regardless of health literacy level--can successfully (1) understand health information, (2) navigate the health care system, (3) engage in medical decision-making, and (4) manage their health. Numerous resources have been developed to support health care organizations in their attempts to address limitations in patient health literacy. However, little work has been done to establish valid quality improvement measures that organizations can use to monitor the impact of initiatives aimed at improving patient understanding, navigation, engagement, and self-management. Absent such measures, organizations may be unable to accurately assess whether their initiatives are effective. This research has the following goals: 1. Identify existing quality improvement measures and gather proposals for additional measures (not generated from patient survey data) that organizations may use to monitor progress related to enhancing patient understanding, navigation, engagement, and self- management; and 2. Identify a set of quality improvement measures that reflects patient priorities, has expert support, and can be recommended for more formal measure development and testing. This project is being conducted by AHRQ through its contractor, Board of Regents of the University of Colorado, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). Method of Collection Environmental Scan Interviews: Representatives from 25 health care organizations engaged in relevant quality improvement efforts will be interviewed to obtain information about the quality improvement measures they [[Page 22606]] use in assessing their work to improve patient understanding, navigation, engagement, and self care. The planned environmental scan interviews will provide the information needed to:Identify and document the characteristics of relevant quality improvement measures that are already in use; and identify additional measures that would be useful to stakeholders in the field. The findings from these interviews will be used, along with the results from other activities (i.e., input from a Technical Expert Panel, literature review, a Request for Information published in the Federal Register, and focus groups with patients), to identify and document a set of quality improvement measures that can be recommended for rigorous testing and validation. Measures that are assessed to be valid and reliable will be eligible to be disseminated by AHRQ to support health care organizations in their efforts to improve patient understanding of health information, navigation of the health care system, engagement in medical decision making, and management of their health. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in Environmental Scan Interviews. The Environmental Scan Interviews will be completed by 50 respondents (2 representatives from each of the 25 organizations targeted for participation). Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Form name Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Environmental Scan Interviews................... 50 1 2 100 --------------------------------------------------------------- Total....................................... 50 1 2 100 ---------------------------------------------------------------------------------------------------------------- Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection. The annual cost burden for the Environmental Scan Interviews is estimated to be $4,984. Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average hourly Total cost Form name respondents hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- Environmental Scan Interviews................... 50 100 \a\ $49.84 $4,984 --------------------------------------------------------------- Total....................................... 50 100 \a\ 49.84 4,984 ---------------------------------------------------------------------------------------------------------------- * National Compensation Survey: Occupational wages in the United States May 2014, ``U.S. Department of Labor, Bureau of Labor Statistics.'' \a\ Based on the mean wages for Medical and Health Services Managers 11-9111. 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. Sharon B. Arnold, Acting Director. 1. U.S. Department of Health and Human Services. Healthy people 2010: Understanding and Improving Health. 2nd ed: U.S. Government Printing Office; 2000. [FR Doc. 2016-08856 Filed 4-15-16; 8:45 am] BILLING CODE 4160-90-P
![Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices 22605
in support of agency acquisition DEPARTMENT OF HEALTH AND comprehend medication labels;
missions. HUMAN SERVICES underuse of preventive measures, such
Both current and potential Federal as vaccines; poor self-management of
Government vendors are required to Agency for Healthcare Research and conditions such as asthma and diabetes;
register in CCR in order to be awarded Quality and higher utilization of inpatient and
contracts by the Federal Government. emergency department care. According
Vendors are required to complete a one- Agency Information Collection to the 2003 National Assessment of
time registration to provide basic Activities: Proposed Collection; Adult Literacy, 88% of US adults have
information relevant to procurement Comment Request significant difficulties understanding
and financial transactions. Vendors AGENCY: Agency for Healthcare Research widely used health information. By
must update or renew their registration and Quality, HHS. adopting ‘‘health literacy universal
at least once per year to maintain an precautions,’’ health care providers and
ACTION: Notice.
active status. organizations can create an environment
The CCR validates the vendor SUMMARY: This notice announces the in which all patients—regardless of
information and electronically share the intention of the Agency for Healthcare health literacy level—can successfully
secure and encrypted data with Federal Research and Quality (AHRQ) to request (1) understand health information, (2)
agency finance offices to facilitate that the Office of Management and navigate the health care system, (3)
paperless payments through electronic Budget (OMB) approve the proposed engage in medical decision-making, and
funds transfer. Additionally, CCR shares information collection project: ‘‘Making (4) manage their health.
It Easier for Patients to Understand Numerous resources have been
the data with Federal Government
Health Information and Navigate Health developed to support health care
procurement and electronic business
Care Systems: Developing Quality organizations in their attempts to
systems.
Improvement Measures.’’ In accordance address limitations in patient health
B. Annual Reporting Burden with the Paperwork Reduction Act, 44 literacy. However, little work has been
U.S.C. 3501–3521, AHRQ invites the done to establish valid quality
Respondents: 110,350.
public to comment on this proposed improvement measures that
Responses per Respondent: 1. organizations can use to monitor the
Annual Responses: 110,350. information collection.
This proposed information collection impact of initiatives aimed at improving
Hours per Response: 1.7141. patient understanding, navigation,
was previously published in the Federal
Total Burden Hours: 189,151. Register on February 10, 2016 and engagement, and self-management.
allowed 60 days for public comment. Absent such measures, organizations
C. Public Comments
AHRQ received no substantive may be unable to accurately assess
Public comments are particularly comments of the public. The purpose of whether their initiatives are effective.
invited on: Whether this collection of this notice is to allow an additional 30 This research has the following goals:
information is necessary for the proper 1. Identify existing quality
days for public comment.
performance of functions of the Federal improvement measures and gather
DATES: Comments on this notice must be
Acquisition Regulation (FAR), and proposals for additional measures (not
received by May 18, 2016. generated from patient survey data) that
whether it will have practical utility;
whether our estimate of the public ADDRESSES: Written comments should organizations may use to monitor
burden of this collection of information be submitted to: AHRQ’s OMB Desk progress related to enhancing patient
is accurate, and based on valid Officer by fax at (202) 395–6974 understanding, navigation, engagement,
assumptions and methodology; ways to (attention: AHRQ’s desk officer) or by and self-management; and
enhance the quality, utility, and clarity email at OIRA_submission@ 2. Identify a set of quality
of the information to be collected; and omb.eop.gov (attention: AHRQ’s desk improvement measures that reflects
ways in which we can minimize the officer). patient priorities, has expert support,
burden of the collection of information FOR FURTHER INFORMATION CONTACT: and can be recommended for more
on those who are to respond, through Doris Lefkowitz, AHRQ Reports formal measure development and
the use of appropriate technological Clearance Officer, (301) 427–1477, or by testing.
collection techniques or other forms of email at doris.lefkowitz@AHRQ.hhs.gov. This project is being conducted by
information technology. SUPPLEMENTARY INFORMATION:
AHRQ through its contractor, Board of
Obtaining Copies of Proposals: Regents of the University of Colorado,
Proposed Project pursuant to AHRQ’s statutory authority
Requesters may obtain a copy of the
information collection documents from Making It Easier for Patients To to conduct and support research on
the General Services Administration, Understand Health Information and health care and on systems for the
Regulatory Secretariat Division (MVCB), Navigate Health Care Systems: delivery of such care, including
1800 F Street NW., Washington, DC Developing Quality Improvement activities with respect to the quality,
20405, telephone 202–501–4755. Please Measures effectiveness, efficiency,
cite OMB Control Number 9000–0159, appropriateness and value of health care
A goal of Healthy People 2020 is to services and with respect to quality
Central Contractor Registration, in all increase Americans’ health literacy,
correspondence. measurement and improvement. 42
defined as ‘‘the degree to which U.S.C. 299a(a)(1) and (2).
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: April 13, 2016. individuals have the capacity to obtain,
Lorin S. Curit, process, and understand basic health Method of Collection
Director, Federal Acquisition Policy Division, information and services needed to Environmental Scan Interviews:
Office of Governmentwide Acquisition Policy, make appropriate health decisions.’’ 1 Representatives from 25 health care
Office of Acquisition Policy, Office of The effects of limited health literacy are organizations engaged in relevant
Governmentwide Policy. numerous and serious, including quality improvement efforts will be
[FR Doc. 2016–08872 Filed 4–15–16; 8:45 am] medication non-adherence resulting interviewed to obtain information about
BILLING CODE 6820–EP–P from patients’ inability to read and the quality improvement measures they
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![22606 Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
use in assessing their work to improve other activities (i.e., input from a health care system, engagement in
patient understanding, navigation, Technical Expert Panel, literature medical decision making, and
engagement, and self care. review, a Request for Information management of their health.
The planned environmental scan published in the Federal Register, and
interviews will provide the information Estimated Annual Respondent Burden
focus groups with patients), to identify
needed to: and document a set of quality
• Identify and document the Exhibit 1 shows the estimated
improvement measures that can be annualized burden hours for the
characteristics of relevant quality
recommended for rigorous testing and respondents’ time to participate in
improvement measures that are already
validation. Measures that are assessed to Environmental Scan Interviews. The
in use; and
• identify additional measures that be valid and reliable will be eligible to Environmental Scan Interviews will be
would be useful to stakeholders in the be disseminated by AHRQ to support completed by 50 respondents (2
field. health care organizations in their efforts representatives from each of the 25
The findings from these interviews to improve patient understanding of organizations targeted for participation).
will be used, along with the results from health information, navigation of the
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Hours per Total burden
Form name responses per
respondents response hours
respondent
Environmental Scan Interviews ....................................................................... 50 1 2 100
Total .......................................................................................................... 50 1 2 100
Exhibit 2 shows the estimated annual respondents’ time to participate in this burden for the Environmental Scan
cost burden associated with the information collection. The annual cost Interviews is estimated to be $4,984.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate *
Environmental Scan Interviews ....................................................................... 50 100 a $49.84 $4,984
Total .......................................................................................................... 50 100 a 49.84 4,984
* National Compensation Survey: Occupational wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean wages for Medical and Health Services Managers 11–9111.
Request for Comments comments will become a matter of ACTION: Notice of public meeting;
public record. request for comments.
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s Sharon B. Arnold, SUMMARY: The Food and Drug
information collection are requested Acting Director. Administration (FDA or Agency) is
with regard to any of the following: (a) announcing a public meeting and an
Whether the proposed collection of 1. U.S. Department of Health and opportunity for public comment on
information is necessary for the proper Human Services. Healthy people 2010: Patient-Focused Drug Development for
performance of AHRQ health care Understanding and Improving Health. neuropathic pain associated with
research and health care information 2nd ed: U.S. Government Printing peripheral neuropathies. Patient-
dissemination functions, including Office; 2000. Focused Drug Development is part of
whether the information will have [FR Doc. 2016–08856 Filed 4–15–16; 8:45 am] FDA’s performance commitments made
practical utility; (b) the accuracy of BILLING CODE 4160–90–P as part of the fifth authorization of the
AHRQ’s estimate of burden (including Prescription Drug User Fee Act (PDUFA
hours and costs) of the proposed V). The public meeting is intended to
collection(s) of information; (c) ways to DEPARTMENT OF HEALTH AND allow FDA to obtain patient
enhance the quality, utility, and clarity HUMAN SERVICES perspectives on the impact of
of the information to be collected; and Food and Drug Administration neuropathic pain associated with
(d) ways to minimize the burden of the peripheral neuropathies, patient views
collection of information upon the on treatment approaches, and decision
respondents, including the use of [Docket No. FDA–2016–N–1110] factors taken into account when
mstockstill on DSK4VPTVN1PROD with NOTICES
automated collection techniques or selecting a treatment.
Public Meeting on Patient-Focused
other forms of information technology. DATES: The public meeting will be held
Drug Development for Neuropathic
Comments submitted in response to Pain Associated With Peripheral on June 10, 2016, from 10 a.m. to 4 p.m.
this notice will be summarized and Neuropathy Registration to attend the meeting must
included in the Agency’s subsequent be received by June 3, 2016 (see
request for OMB approval of the AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION for
proposed information collection. All HHS. instructions). Submit electronic or
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Document Created: 2016-04-16 01:46:09
Document Modified: 2016-04-16 01:46:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by May 18, 2016. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 81 FR 22605 |
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