Agency Information Collection Activities: Proposed Collection; Comment Request, 12254-12256 [2019-06192]

Download as PDF 12254 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name Average hourly wage rate * 167 337 67 7,583 a 98.83 83 4,167 4,167 4,167 83 4,167 4,167 4,167 b 27.87 30 60 334 167 60 120 4,008 2,505 14,022 27,064 b. Structural Assessments—Cohort 4 (baseline and endline) ................. 2. Team Antibiotic Review Form (Cohorts 1, 2, and 3) .................................. 3. AHRQ Patient Safety Culture Surveys: a. HSOPS, NHSOPS, MOSOPS (Cohort 1) ............................................ b. HSOPS (Cohort 2) ................................................................................ c. NHSOPS (Cohort 3) ............................................................................. d. MOSOPS (Cohort 4) ............................................................................ 4. Semi-structured qualitative interviews (Cohort 1): a. Physicians ............................................................................................ b. Other Health Practitioners .................................................................... 5. EHR data (Cohorts 1, 2, and 3) .................................................................. 6. EHR data (Cohort 4) ................................................................................... Total ................................................................................................... Total burden hours a 98.83 b 27.87 b 27.87 b 27.87 a 98.83 Total cost burden 6,622 749,428 2,313 116,134 116,134 116,134 b 27.87 5,930 3,344 111,703 69,814 ........................ 1,311,096 b 27.87 b 27.87 * National Compensation Survey: Occupational wages in the United States May 2016 ‘‘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 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other. 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’s 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. Gopal Khanna, Director. [FR Doc. 2019–06193 Filed 3–29–19; 8:45 am] BILLING CODE 4160–90–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. AGENCY: ACTION: Notice. 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 ‘‘Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.’’ SUMMARY: Comments on this notice must be received by May 31, 2019. DATES: 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. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by email at doris.lefkowitz@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:22 Mar 29, 2019 Jkt 247001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Proposed Project Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the EvidenceBased Practice Center Program In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, AHRQ invites the public to comment on this proposed information collection. The AHRQ Evidence-based Practice Center (EPC) Program develops evidence reports and technology assessments that summarize evidence for federal and other partners on topics relevant to clinical and other health care organization and delivery issues— specifically those that are common, expensive, and/or significant for the Medicare and Medicaid populations. Better understanding and use of evidence in practice, policy, and delivery of care improves the quality of health care. These reports, reviews, and technology assessments are based on rigorous, comprehensive syntheses and analyses of the scientific literature on topics. EPC reports and assessments emphasize explicit and detailed documentation of methods, rationale, and assumptions. EPC reports are conducted in accordance with an established policy on financial and nonfinancial interests. This research has the following goals: Æ Use research methods to gather knowledge on the effectiveness or comparative effectiveness of treatments, screening, diagnostic, management or health care delivery strategies for specific medical conditions, both published and unpublished, to evaluate the quality of research studies and the evidence from these studies. E:\FR\FM\01APN1.SGM 01APN1 12255 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices Æ Promote the use of evidence in health care decision making to improve health care and health Æ Identify research gaps to inform future research investments The 2011 Institute of Medicine report ‘‘Finding What Works in Health Care: Standards for Systematic Review’’ includes an assessment of publication bias through the identification of unpublished studies. This is an important source for bias which could affect the nature and direction of research findings. Identifying and including the results of these additional unpublished studies may provide a more complete and accurate assessment of an intervention’s effect on outcomes. An important way to identify unpublished studies is through requests to medical device manufacturers, pharmaceutical companies, and other intervention developers. The proposed project involves sending a notification via an email listserv and via Federal Register notice as needed of the opportunity to submit information on unpublished studies or other scientific information to the EPC Program website, with one request per systematic review topic. Because research on each topic must be completed in a timely manner in order for it to be useful, the collections are never ongoing—there is one request and collection per topic. Investigators in the EPC Program will review the information and assess potential risk of bias from both published and unpublished studies and its impact on the EPC Program’s findings. This study is being conducted by AHRQ, 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. 42 U.S.C 299a(a)(1). Method of Collection To achieve the goals of this project the following data collections will be implemented: • Online Submission Form Instrument. This information is collected for the purposes of providing supplemental evidence and data for systematic reviews (SEADS). The purpose of SEADS requests is not to collect generalizable data, but to supplement the published and grey literature searches EPC investigators are conducting. The online submission form (OSF) collects data from respondents on their name and the information packet. This happens following notification of opportunity to submit via email listserv and/or Federal Register notice as needed, with one request per topic. For the purposes of meta-analyses, trial summary data from missing and unidentified studies are sought. For the purposes of constructing evidence tables and quality ratings (e.g., on public reporting of cost measures or health information exchange), data can vary (e.g., URLs, study designs, and consumer-mediated exchange forms). Submitters are informed of the types of information that would be most helpful to include in the information packet, which includes a list of all sponsored but unpublished studies (both completed and ongoing), as well as comment on the completeness of information provided. The EPC Program currently uses a broad-based email announcement via email listserv and a Federal Register notice, as needed, to publicize the opportunity to submit scientific information about each topic. The proposed project does not duplicate other available sources of this information. Available study registries and databases may not sufficiently inform the Program’s research. The EPC Program does not anticipate more than 15 topics per year with SEADS requests. Estimated Annual Respondent Burden Exhibit 1 presents estimates of the reporting burden hours for the data collection efforts. Time estimates are based on pilot testing of materials and what can reasonably be requested of respondents. The number of respondents listed in ‘‘Number of respondents per SEADS request’’ of Exhibit 1 reflects a projected 33% response rate with approximately 1–2 responses per request and assumes about 15 SEADS requests per year. EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS Form name Number of SEADS requests Number of SEADS request that receive response Number of responses per SEADS request Annual number of SEADS responses Hours per response Total burden hours per annum Online Submission Form (OSF) .............. 15 5 1.5 7.5 15/60 1.87 Average hourly wage rate * Total cost burden EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of SEADS requests Form name OSF .................................................................................................................. Total burden hours per SEADS 15 1.87 $61.39 a $115.10 * Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000. a Based on the mean wages for Public Relations and Fundraising Managers, 11–2031, the occupational group most likely tasked with completing the OSF. 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 VerDate Sep<11>2014 17:22 Mar 29, 2019 Jkt 247001 performance of AHRQ’s 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 E:\FR\FM\01APN1.SGM 01APN1 12256 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Notices 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. Gopal Khanna, Director. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–1725–N] Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: [FR Doc. 2019–06192 Filed 3–29–19; 8:45 am] BILLING CODE 4160–90–P This notice announces the next public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, July 22, 2019 and Tuesday, July 23, 2019. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests. DATES: Meeting Dates: The meeting of the Panel is scheduled for Monday, July 22, 2019 from 8:00 a.m. to 4:30 p.m., Eastern Daylight Time (E.D.T.) and Tuesday, July 23, 2019, from 8:00 a.m. to 4:30 p.m., E.D.T. The Panel is also expected to participate in the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting for Calendar Year (CY) 2020 on June 24, 2019 in order to gather information and ask questions to presenters. Notice of the CLFS Annual Public Meeting for CY 2020 is published elsewhere in this issue of the Federal Register. Deadline for Registration: The public may attend the Panel meeting in person, view via webcast or listen via teleconference. Beginning Monday, April 8, 2019 and ending Monday, July 1, 2019 at 5:00 p.m. E.D.T., registration to attend the Panel meeting in person may be completed online at http:// cms.gov/Regulations-and-Guidance/ Guidance/FACA/AdvisoryPanelon ClinicalDiagnosticLaboratoryTests.html. On this web page, under ‘‘Panel Meetings,’’ click the ‘‘Register for July 22 through 23, 2019 Panel Meeting’’ link and enter the required information. We refer readers to Section IV. of this notice for additional details related to meeting registration. Webinar, Webcast, and Teleconference Information: Teleconference dial-in instructions, and related webcast and webinar details will be posted on the meeting agenda, which will be available on the CMS website approximately 2 weeks prior to the meeting at https://www.cms.gov/ SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—CE19–004, Etiologic and Effectiveness Research To Address Polysubstance Impaired Driving; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)–CE19– 004, Etiologic and Effectiveness Research to Address Polysubstance Impaired Driving; May 7–8, 2019; 8:30 a.m.–5:30 p.m., (EDT) which was published in the Federal Register on February 15, 2019, Volume 84, Number 32, page/s/4446–4447. The meeting is being amended to change the meeting location to The W Buckhead, 3377 Peachtree Road, NE, Atlanta, GA 30326]. The meeting is closed to the public. FOR FURTHER INFORMATION CONTACT: Mikel L. Walters, M.A., Ph.D., Scientific Review Official, NCIPC, CDC, 4770 Buford Highway NE, Mailstop F–63, Atlanta, Georgia 30341,(404) 639–0913; mwalters@cdc.gov. The Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2019–06146 Filed 3–29–19; 8:45 am] BILLING CODE 4163–18–P VerDate Sep<11>2014 17:22 Mar 29, 2019 Jkt 247001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Regulations-and-Guidance/Guidance/ FACA/AdvisoryPanelonClinical DiagnosticLaboratoryTests.html. A preliminary agenda is described in Section II. of this notice. ADDRESSES: The Panel meeting will be held in the auditorium of the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244– 1850. FOR FURTHER INFORMATION CONTACT: Rasheeda Arthur, Ph.D., (410) 786–3434, email CDLTPanel@cms.hhs.gov. Press inquiries are handled through the CMS Press Office at (202) 690–6145. For additional information on the Panel, refer to the CMS website at https:// www.cms.gov/Regulations-andGuidance/Guidance/FACA/Advisory PanelonClinicalDiagnosticLaboratory Tests.html. SUPPLEMENTARY INFORMATION: I. Background The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) is authorized by section 1834A(f)(1) of the Social Security Act (the Act) (42 U.S.C. 1395m–1), as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113–93), enacted on April 1, 2014. The Panel is subject to the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory panels. Section 1834A(f)(1) of the Act directs the Secretary of the Department of Health and Human Services (the Secretary) to consult with an expert outside advisory panel established by the Secretary, composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests, which may include the development, validation, performance, and application of such tests. Such individuals may include molecular pathologists, researchers, and individuals with expertise in laboratory science or health economics. The Panel will provide input and recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on the following: • The establishment of payment rates under section 1834A of the Act for new clinical diagnostic laboratory tests, including whether to use ‘‘crosswalking’’ or ‘‘gapfilling’’ processes to determine payment for a specific new test. E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12254-12256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06192]


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

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 ``Online Submission Form for Supplemental Evidence and Data for 
Systematic Reviews for the Evidence-based Practice Center Program.''

DATES: Comments on this notice must be received by May 31, 2019.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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 
[email protected].

SUPPLEMENTARY INFORMATION: 

Proposed Project

Online Submission Form for Supplemental Evidence and Data for 
Systematic Reviews for the Evidence-Based Practice Center Program

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. The AHRQ Evidence-based Practice Center (EPC) Program 
develops evidence reports and technology assessments that summarize 
evidence for federal and other partners on topics relevant to clinical 
and other health care organization and delivery issues--specifically 
those that are common, expensive, and/or significant for the Medicare 
and Medicaid populations. Better understanding and use of evidence in 
practice, policy, and delivery of care improves the quality of health 
care.
    These reports, reviews, and technology assessments are based on 
rigorous, comprehensive syntheses and analyses of the scientific 
literature on topics. EPC reports and assessments emphasize explicit 
and detailed documentation of methods, rationale, and assumptions. EPC 
reports are conducted in accordance with an established policy on 
financial and nonfinancial interests.
    This research has the following goals:
    [cir] Use research methods to gather knowledge on the effectiveness 
or comparative effectiveness of treatments, screening, diagnostic, 
management or health care delivery strategies for specific medical 
conditions, both published and unpublished, to evaluate the quality of 
research studies and the evidence from these studies.

[[Page 12255]]

    [cir] Promote the use of evidence in health care decision making to 
improve health care and health
    [cir] Identify research gaps to inform future research investments
    The 2011 Institute of Medicine report ``Finding What Works in 
Health Care: Standards for Systematic Review'' includes an assessment 
of publication bias through the identification of unpublished studies. 
This is an important source for bias which could affect the nature and 
direction of research findings. Identifying and including the results 
of these additional unpublished studies may provide a more complete and 
accurate assessment of an intervention's effect on outcomes. An 
important way to identify unpublished studies is through requests to 
medical device manufacturers, pharmaceutical companies, and other 
intervention developers.
    The proposed project involves sending a notification via an email 
listserv and via Federal Register notice as needed of the opportunity 
to submit information on unpublished studies or other scientific 
information to the EPC Program website, with one request per systematic 
review topic. Because research on each topic must be completed in a 
timely manner in order for it to be useful, the collections are never 
ongoing--there is one request and collection per topic. Investigators 
in the EPC Program will review the information and assess potential 
risk of bias from both published and unpublished studies and its impact 
on the EPC Program's findings.
    This study is being conducted by AHRQ, 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. 42 U.S.C 299a(a)(1).

Method of Collection

    To achieve the goals of this project the following data collections 
will be implemented:
     Online Submission Form Instrument. This information is 
collected for the purposes of providing supplemental evidence and data 
for systematic reviews (SEADS). The purpose of SEADS requests is not to 
collect generalizable data, but to supplement the published and grey 
literature searches EPC investigators are conducting. The online 
submission form (OSF) collects data from respondents on their name and 
the information packet. This happens following notification of 
opportunity to submit via email listserv and/or Federal Register notice 
as needed, with one request per topic. For the purposes of meta-
analyses, trial summary data from missing and unidentified studies are 
sought. For the purposes of constructing evidence tables and quality 
ratings (e.g., on public reporting of cost measures or health 
information exchange), data can vary (e.g., URLs, study designs, and 
consumer-mediated exchange forms). Submitters are informed of the types 
of information that would be most helpful to include in the information 
packet, which includes a list of all sponsored but unpublished studies 
(both completed and ongoing), as well as comment on the completeness of 
information provided.
    The EPC Program currently uses a broad-based email announcement via 
email listserv and a Federal Register notice, as needed, to publicize 
the opportunity to submit scientific information about each topic. The 
proposed project does not duplicate other available sources of this 
information. Available study registries and databases may not 
sufficiently inform the Program's research. The EPC Program does not 
anticipate more than 15 topics per year with SEADS requests.

Estimated Annual Respondent Burden

    Exhibit 1 presents estimates of the reporting burden hours for the 
data collection efforts. Time estimates are based on pilot testing of 
materials and what can reasonably be requested of respondents. The 
number of respondents listed in ``Number of respondents per SEADS 
request'' of Exhibit 1 reflects a projected 33% response rate with 
approximately 1-2 responses per request and assumes about 15 SEADS 
requests per year.

                                                      Exhibit 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of SEADS
                                                    Number of SEADS    request that      Number of      Annual number      Hours per       Total burden
                     Form name                          requests         receive       responses per       of SEADS         response     hours per annum
                                                                         response      SEADS request      responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Online Submission Form (OSF)......................              15                5              1.5              7.5            15/60             1.87
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                   Total burden
                    Form name                        Number of       hours per    Average hourly    Total cost
                                                  SEADS requests       SEADS        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
OSF.............................................              15            1.87      $61.39 \a\         $115.10
----------------------------------------------------------------------------------------------------------------
* Occupational Employment Statistics, May 2017 National Occupational Employment and Wage Estimates United
  States, U.S. Department of Labor, Bureau of Labor Statistics. https://www.bls.gov/oes/current/oes_nat.htm#11-0000 0000.
\a\ Based on the mean wages for Public Relations and Fundraising Managers, 11-2031, the occupational group most
  likely tasked with completing the OSF.

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's 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

[[Page 12256]]

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.

Gopal Khanna,
Director.
[FR Doc. 2019-06192 Filed 3-29-19; 8:45 am]
 BILLING CODE 4160-90-P