82 FR 15059 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 82, Issue 56 (March 24, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 56 (March 24, 2017)
| Page Range | 15059-15061 | |
| FR Document | 2017-05839 |
[Federal Register Volume 82, Number 56 (Friday, March 24, 2017)] [Notices] [Pages 15059-15061] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05839] ----------------------------------------------------------------------- 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 ``Generic Clearance for the Collection of Data Through ACTION III Field-Based Investigations to Improve Health Care Delivery.'' 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 December 20, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by April 24, 2017. 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 Generic Clearance for the Collection of Data Through ACTION III Field- Based Investigations To Improve Health Care Delivery The Agency for Healthcare Research and Quality (AHRQ) is requesting OMB approval of a generic clearance for purposes of conducting field- based research to improve care delivery in diverse health care settings. More specifically, AHRQ seeks this clearance to support timely and meaningful answers to research questions investigated through AHRQ's ACTION Program. ACTION III research produces field- based, stakeholder-informed knowledge about ways to improve care delivery, and real-world-driven implementation and dissemination of evidence across diverse care settings. A generic clearance to support expedited performance of ACTION III research activities would enable AHRQ to more efficiently meet agency goals while fully meeting the intent and requirements of the Paperwork Reduction Act in a timely manner. Collection of the information described in this request is essential to supporting AHRQ's mission, which is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within HHS and with other partners to make sure that the evidence is understood and used. More specifically, in support of this mission, AHRQ initiates and oversees projects with the following overarching aims:Expand knowledge about how specific changes to processes or structures of care delivery might improve care quality; Develop and test interventions, strategies, tools, trainings and guidance for putting that knowledge into practice; Disseminate and implement evidence-based practices across diverse care settings. Method of Collection Information collections conducted under this clearance will be collected via the following methods: Interviews--Interviews (telephone or in-person) will be conducted with clinical or management staff from diverse health care settings, patients, or other providers or recipients of care with the purposes of expanding knowledge about how specific changes to processes or structures of care delivery might improve care quality; obtaining stakeholder-informed input about how and why an intervention or strategy will or won't work in a particular real world setting; identifying contextual factors that facilitate or impede implementation of complex system interventions or evidence-based practices; and identifying needs and challenges of intended users of tools and/or beneficiaries of trainings and other resources. Small discussion groups/focus groups--Small discussion groups/Focus [[Page 15060]] groups will be conducted with providers or recipients of care from diverse health care settings with the purposes of obtaining stakeholder-informed input about how and why an intervention or strategy is or is not working in a particular real world setting and identifying needs and gaining user/beneficiary feedback on value and limitations of prototype redesigned care processes, tools, resources or trainings. Implementation Logs will be used to track activities, time and resource use associated with use of tools, trainings or other resources and to monitor progress and identify needed revisions to implementation methods. Recruitment and Screening Calls will be used to identify and enroll individuals, groups, or organizations willing to participate in the broader research study. Questionnaires or brief surveys will be used to capture broad, high level staff or patient level feedback on experience with tools, redesigned care processes, trainings or other resources. Cognitive Testing of surveys, Web sites, or other resources will be used to support the development of materials that resonate and can be understood by intended users. Collection of published and internal documents, performance assessments, and other data or information that could provide important contextual information about the specific settings of care into which new tools, resources, training or redesigned care processes will be introduced. AHRQ will use the proposed generic clearance to obtain field-based, stakeholder-informed input and feedback about how and why interventions or strategies designed to improve care quality (i.e., safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity) do or do not work in the real world. Information collected under this clearance would be expected to increase understanding of how contextual factors and other key variables might affect the implementation and effectiveness of specific strategies, interventions or tools when utilized in particular settings. This knowledge would help health care providers and other decision-makers consider whether, when and how to use and adapt such strategies, interventions or tools to conform to their own needs and to the distinctive characteristics of the intended settings. Additionally, information collected under this clearance would be expected to increase AHRQ's understanding of contextual variables and other factors that facilitate or impede dissemination and implementation of clinical guidelines, evidence-based practices, and other research-based findings from the Patient-Centered Outcomes Research Institute (PCORI), National Institutes of Health (NIH), and other partners. Estimated Annual Respondent Burden As described above a variety of instruments and platforms will be used to collect information from respondents, though few, if any, single projects would be expected to use all the methods listed. The average number annual burden hours per year requested (2,189.5) are presented in Table 1 below, and is based on an assumed average of 5 projects per year (we rounded up the past average of 4.5 projects per year to 5). The maximum total burden across all three years is thus 6,568.5 hours. Table 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Data collection type Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Interviews...................................... 375 2 1 750 Focus Groups/Small Discussions.................. 420 1.5 1.5 945 Implementation Logs............................. 20 8 1 160 Recruitment and Screening....................... 139 1 0.5 69.5 Cognitive Testing............................... 40 1 1 40 Questionnaires/Brief Surveys.................... 1000 1 0.2 200 Collection of Internal Documents................ 25 1 1 25 --------------------------------------------------------------- Total....................................... 2189.5 ---------------------------------------------------------------------------------------------------------------- Table 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Total burden Average hourly Total cost Form name respondents hours wage rate * burden ---------------------------------------------------------------------------------------------------------------- Interviews...................................... 250 500 \a\ $95.05 $47,525.00 (Clinicians--line 1; Patients--line 2) 125 250 \b\ 27.12 6,780.00 Focus Groups/Small Discussions.................. 420 945 \c\ 27.12 25,628.40 Implementation Logs............................. 20 160 \c\ 27.12 4,339.20 Recruitment and Screening....................... 139 69.5 \a\ 95.05 6,605.98 Cognitive Testing............................... 40 40 \c\ 27.12 1,084.80 Questionnaires/Brief Surveys.................... 1000 200 \c\ 27.12 5,424.00 Collection of Internal Documents................ 25 25 \a\ 95.05 2,376.25 --------------------------------------------------------------- Total....................................... 99,763.63 ---------------------------------------------------------------------------------------------------------------- * National Compensation Survey: Occupational wages in the United States May 2015 ``U.S. Department of Labor, Bureau of Labor Statistics'': http://www.bls.gov/oes/current/oes_stru.htm. \a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other. \b\ Based on the mean wages for 00-0000 All Occupations. \c\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other. [[Page 15061]] Using average wage rates for relevant job categories from 2016 BLS data, the total annual costs associated with these data collections per year are $116,746.13 as shown in Table 2 above, for a total cost for all three years of $350,238.39. 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. [FR Doc. 2017-05839 Filed 3-23-17; 8:45 am] BILLING CODE 4160-90-P
![Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices 15059
or provide usual care (which could but will not be included in the research to improve care delivery in
include no access to specific services). systematic review. diverse health care settings. More
specifically, AHRQ seeks this clearance
Outcomes for Each Key Question Sharon B. Arnold,
to support timely and meaningful
Acting Director.
Key Question 1: Clinical and Economic answers to research questions
[FR Doc. 2017–05840 Filed 3–23–17; 8:45 am] investigated through AHRQ’s ACTION
Outcomes
BILLING CODE 4160–90–P Program. ACTION III research produces
• Clinical outcomes such as field-based, stakeholder-informed
mortality, morbidity, function, recovery, knowledge about ways to improve care
infection, and access to services. DEPARTMENT OF HEALTH AND
delivery, and real-world-driven
• Economic outcomes such as return HUMAN SERVICES
implementation and dissemination of
on investment, cost, volume of visits, Agency for Healthcare Research and evidence across diverse care settings. A
and resource use. Quality generic clearance to support expedited
Key Question 2: Intermediate Outcomes performance of ACTION III research
Agency Information Collection activities would enable AHRQ to more
• Patient satisfaction, behavior, and Activities: Proposed Collection; efficiently meet agency goals while fully
decisions such as completion of Comment Request meeting the intent and requirements of
treatment, or satisfaction with less travel the Paperwork Reduction Act in a
to access health care. AGENCY: Agency for Healthcare Research timely manner.
and Quality, HHS. Collection of the information
• Provider satisfaction, behavior, and
ACTION: Notice. described in this request is essential to
decisions such as choice of treatment or
antibiotic stewardship. SUMMARY: This notice announces the supporting AHRQ’s mission, which is to
produce evidence to make health care
• Time to diagnosis and time to intention of the Agency for Healthcare
Research and Quality (AHRQ) to request safer, higher quality, more accessible,
treatment.
that the Office of Management and equitable, and affordable, and to work
• Diagnostic concordance or other within HHS and with other partners to
measures of agreement between in- Budget (OMB) approve the proposed
information collection project ‘‘Generic make sure that the evidence is
person and telehealth consultations. understood and used. More specifically,
Clearance for the Collection of Data
Key Question 3: Adverse Effects or Through ACTION III Field-Based in support of this mission, AHRQ
Unintended Consequences Investigations to Improve Health Care initiates and oversees projects with the
Delivery.’’ In accordance with the following overarching aims:
• Loss of privacy or breach of data • Expand knowledge about how
Paperwork Reduction Act, 44 U.S.C.
security. specific changes to processes or
3501–3521, AHRQ invites the public to
• Misdiagnosis or delayed diagnosis. comment on this proposed information structures of care delivery might
• Inappropriate treatment. collection. improve care quality;
• Increase in resource costs, negative This proposed information collection • Develop and test interventions,
return on investment. was previously published in the Federal strategies, tools, trainings and guidance
Register on December 20, 2016 and for putting that knowledge into practice;
Key Question 4: Not Applicable (This is allowed 60 days for public comment. • Disseminate and implement
a Descriptive Question) AHRQ did not receive any substantive evidence-based practices across diverse
Key Question 5: Clinical and Economic comments during this period. The care settings.
Outcomes (see Key Question 1), purpose of this notice is to allow an
Method of Collection
Intermediate Outcomes (see Key additional 30 days for public comment.
Question 2), and Adverse Effects or DATES: Comments on this notice must be Information collections conducted
Unintended Consequences (see Key received by April 24, 2017. under this clearance will be collected
Question 3). ADDRESSES: Written comments should
via the following methods:
be submitted to: AHRQ’s OMB Desk • Interviews—Interviews (telephone
Timing or in-person) will be conducted with
Officer by fax at (202) 395–6974
• Telehealth consultations can be (attention: AHRQ’s desk officer) or by clinical or management staff from
used at any point in the diagnosis, email at OIRA_submission@ diverse health care settings, patients, or
treatment, or management of a patient. omb.eop.gov (attention: AHRQ’s desk other providers or recipients of care
officer). with the purposes of expanding
• Outcome measurement needs to
knowledge about how specific changes
occur after the telehealth consultation. FOR FURTHER INFORMATION CONTACT:
to processes or structures of care
Setting Doris Lefkowitz, AHRQ Reports delivery might improve care quality;
Clearance Officer, (301) 427–1477, or by obtaining stakeholder-informed input
The consultation can involve email at doris.lefkowitz@AHRQ.hhs.gov about how and why an intervention or
providers and patients in any location. SUPPLEMENTARY INFORMATION: strategy will or won’t work in a
These could include inpatient, particular real world setting; identifying
Proposed Project
outpatient, or long-term care, and could contextual factors that facilitate or
be in civilian, Veterans Administration, Generic Clearance for the Collection of impede implementation of complex
jstallworth on DSK7TPTVN1PROD with NOTICES
or military facilities. Data Through ACTION III Field-Based system interventions or evidence-based
Investigations To Improve Health Care practices; and identifying needs and
Study Designs
Delivery challenges of intended users of tools
• Comparative studies, including The Agency for Healthcare Research and/or beneficiaries of trainings and
trials and observational studies. and Quality (AHRQ) is requesting OMB other resources.
• Descriptive studies may be used to approval of a generic clearance for • Small discussion groups/focus
inform the decision model as needed purposes of conducting field-based groups—Small discussion groups/Focus
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![Federal Register / Vol. 82, No. 56 / Friday, March 24, 2017 / Notices 15061
Using average wage rates for relevant that stockpile N95 respirators and high- by respirators and surgical gowns.
job categories from 2016 BLS data, the level protective surgical gowns. NIOSH seeks to sample N95 respirators
total annual costs associated with these DATES: Electronic or written and high-protection level surgical
data collections per year are submissions must be received by [30 gowns from a variety of stockpiles
$116,746.13 as shown in Table 2 above, days from FRN posting]. representing contemporary storage
for a total cost for all three years of ADDRESSES: You may submit responses, conditions from across the nation. To
$350,238.39. identified by CDC–2017–0024 and that end, the information sought in this
docket number NIOSH–297, by any of Notice is aimed at ensuring that study
Request for Comments
the following methods: findings are broadly applicable to U.S.
In accordance with the Paperwork • Federal eRulemaking Portal: stockpiles.
Reduction Act, comments on AHRQ’s www.regulations.gov. Follow the Background: Various entities
information collection are requested instructions for submitting comments. stockpile personal protective equipment
with regard to any of the following: (a) • Mail: National Institute for (PPE) in preparation for public health
Whether the proposed collection of Occupational Safety and Health, NIOSH responses to outbreaks of high
information is necessary for the proper Docket Office, 1090 Tusculum Avenue, consequence infectious diseases such as
performance of AHRQ health care MS C–34, Cincinnati, Ohio 45226–1998. SARS, influenza, and Ebola, where PPE
research and health care information Instructions: All information received demand may outpace supply.
dissemination functions, including in response to this notice must include Stockpiling PPE is a costly endeavor
whether the information will have the agency name and docket number that includes PPE purchase, storage
practical utility; (b) the accuracy of [CDC–2017–0024; NIOSH–297]. All space, product rotation over time, and
AHRQ’s estimate of burden (including relevant responses received will be environmental controls for heat,
hours and costs) of the proposed posted without change to humidity, dust, and sunlight. Resource
collection(s) of information; (c) ways to www.regulations.gov, including any limitations may lead facilities to
enhance the quality, utility and clarity personal information provided. For stockpile PPE in environments that do
of the information to be collected; and access to the docket to read background not meet manufacturer storage
(d) ways to minimize the burden of the documents or information received, go recommendations or exceed shelf life,
collection of information upon the to www.regulations.gov. All information increasing the potential for PPE
respondents, including the use of received in response to this notice will degradation. Even when resources exist
automated collection techniques or also be available for public examination to store PPE per manufacturer’s
other forms of information technology. and copying at the NIOSH Docket environmental recommendations, the
Comments submitted in response to influence of long-term storage time
Office, 1150 Tusculum Avenue, Room
this notice will be summarized and alone on PPE performance has been
155, Cincinnati, OH 45226–1998.
included in the Agency’s subsequent questioned. Additionally, large
FOR FURTHER INFORMATION CONTACT:
request for OMB approval of the quantities of stockpiled PPE obtained
proposed information collection. All Kerri Wizner, NIOSH, National Personal
during previous nationwide responses
comments will become a matter of Protective Technology Laboratory,
may now be exceeding its shelf life and
public record. Research Branch, 626 Cochrans Mill
expected replacement costs will likely
Road, Building 19A, Pittsburgh, PA
Sharon B. Arnold,
far exceed available budgets. Data is
15236, (412) 386–5225, (not a toll free
needed to better understand the
Acting Director. number).
potential impact upon worker health
[FR Doc. 2017–05839 Filed 3–23–17; 8:45 am] SUPPLEMENTARY INFORMATION: NIOSH and safety.
BILLING CODE 4160–90–P seeks information about personal Information Needs: Information is
protective equipment (PPE) needed to assist NIOSH in identifying
environmental storage conditions and important factors to focus the research
DEPARTMENT OF HEALTH AND inventory for federal, state, municipal, study design. Information is needed
HUMAN SERVICES county, and hospital system stockpiles. from facilities that stockpile N95
Maintaining PPE stockpiles for public respirators and high-level protective
Centers for Disease Control and health emergencies is a significant cost
Prevention surgical gowns for use during public
and time investment for these various health emergencies. Please ensure the
[Docket Number CDC–2017–0024, NIOSH– entities, which may include purchasing type of stockpile you are affiliated with
297] new products, maintaining inventory is included in the responses to any of
records, and lease or purchase of the below questions.
Effect of Stockpiling Conditions on the environmentally controlled storage 1. Please describe the type of
Performance of Medical N95 space away from contaminated areas, stockpile with which you are affiliated
Respirators and High-Level Protective dust, sun light, extreme temperatures, (e.g., federal, state, county). Please
Surgical Gowns excessive moisture, and damaging describe the end users of the stockpiled
AGENCY: National Institute for chemicals. The information provided by products (e.g., healthcare workers,
Occupational Safety and Health respondents to this Notice will be used public).
(NIOSH) of the Centers for Disease to inform a research study design where 2. Please describe the extent to which
Control and Prevention (CDC), N95 respirators and high-protection environmental controls are
Department of Health and Human level surgical gowns are sampled from implemented and maintained. For
stockpiles and tested against established example, does the stockpile employ
jstallworth on DSK7TPTVN1PROD with NOTICES
Services (HHS).
ACTION: Request for information. performance standards. The research controls against humidity, temperature,
study will be designed to obtain sunlight, dust, or chemical exposure?
SUMMARY: The National Institute for scientific data to assess (1) the potential Please describe how these controls are
Occupational Safety and Health to extend manufacturer-recommended implemented, monitored, regularity of
(NIOSH) of the Centers for Disease shelf life and (2) the effect of common, monitoring, and what optimal
Control and Prevention announces the albeit sometimes non-ideal, stockpile conditions are. Available guidance
request for information about facilities conditions on the protections provided documents used for the stockpile would
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Document Created: 2018-02-01 15:11:02
Document Modified: 2018-02-01 15:11:02
| 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 April 24, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 15059 |
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