Request for Comments on the Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events From Anticoagulants, Diabetes Agents, and Opioid Analgesics, 72594-72595 [2016-25424]

Download as PDF 72594 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents FDA center Annual frequency per response Total annual responses Hours per response Total hours CDRH ................................................................................... CBER ................................................................................... 2,465 79 1 1 2,465 79 137 137 337,705 10,823 Total .............................................................................. ........................ ........................ ........................ ........................ 348,528 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Respondents are medical device manufacturers subject to FDA’s laws and regulations. FDA’s annual estimate of 2,544 submissions is based on experienced trends over the past several years. FDA’s administrative and technical staffs, who are familiar with the requirements for current PreSubmissions, estimate that an average of 137 hours is required to prepare a PreSubmission. Dated: October 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25359 Filed 10–19–16; 8:45 am] BILLING CODE 4164–01–P DATES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on the Proposed Measures and 2020 Targets for the National Action Plan for Adverse Drug Event Prevention: Inpatient and Outpatient Measures for Reduction of Adverse Drug Events From Anticoagulants, Diabetes Agents, and Opioid Analgesics AGENCY: Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: The Office of Disease Prevention and Health Promotion (ODPHP), on behalf of the U.S. Department of Health and Human Services (HHS) Federal Interagency Steering Committee for Adverse Drug Events, proposes new measures and targets for adverse drug events (ADEs) from anticoagulants, diabetes agents, and opioid analgesics for the National Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based on input from the Federal Interagency Workgroups for Adverse Drug Events, six national measures and targets for the reduction of ADEs are being proposed. Each drug class highlighted in the ADE Action Plan (anticoagulants, diabetes agents, and opioid analgesics) includes VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 a proposed inpatient and outpatient measure to track national progress in reduction of ADEs from these drug classes. The proposed targets will reflect improvement efforts over a four to six year period since the release of the ADE Action Plan in August 2014. As such, HHS is proposing a baseline year of 2014 for five of the measures and 2016 for one measure. All targets are to be achieved by 2020. HHS invites interested public and private professionals, organizations, and consumer representatives to submit written comments on the proposed 2020 ADE targets, found at https://health.gov/ hcq/ade-measures.asp. Comments on the proposed ADE 2020 measures and targets must be received no later than 5 p.m. on November 21, 2016. ADDRESSES: Interested persons or organizations are invited to submit written comments by any of the following methods: • Email: OHQ@hhs.gov (please indicate in the subject line: Proposed ADE Measures and Targets) • Mail/Courier: Office of Disease Prevention and Health Promotion, Attn: Division of Health Care Quality, Department of Health and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Anna Gribble, Health Policy Fellow, Office of Disease Prevention and Health Promotion, via email at anna.gribble@ hhs.gov. SUPPLEMENTARY INFORMATION: In September 2012, in response to heightened awareness of the contribution of ADEs to the burden of health care-related harm and costs, the Office of the Assistant Secretary for Health (OASH) marshaled the wideranging and diverse resources of federal partners to form an extensive interagency partnership, the Federal Interagency Steering Committee and Workgroups for Adverse Drug Events, whose goals would be to develop the ADE Action Plan, as well as identify measures to track national progress in PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 reducing ADEs and targets to meet based on those measures. ODPHP, in conjunction with the Federal Interagency Steering Committee and three Federal Interagency Workgroups, developed and released the final ADE Action Plan in 2014. The ADE Action Plan seeks to engage all stakeholders in a coordinated, aligned, and multi-sector effort to reduce ADEs that are clinically significant, account for the greatest number of measurable harms as identified by existing surveillance systems, and are largely preventable; these were identified as ADEs resulting from inpatient and outpatient use of anticoagulants, diabetes agents, and opioid analgesics (with specific focus on ADEs from therapeutic use of opioids). The ADE Action Plan identifies the federal government’s highest priority strategies and opportunities for advancement, which will have the greatest impact on reducing ADEs. Implementation of these strategies is expected to result in safer and higher quality health care services, reduced health care costs, informed and engaged consumers and ultimately, improved health outcomes. The reduction of ADEs subsequent to implementation of these strategies will be tracked by the proposed measures and will aim to meet the targeted reduction rate by 2020. The six proposed measures use data from the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). The inpatient and outpatient measures for anticoagulants and diabetes agents and the outpatient measure for opioids will set baseline rates using data from 2014 and establish targets to be achieved by 2020. The inpatient opioids measure will have a 2016 baseline and a 2020 target year. The inpatient opioids measure will use data from AHRQ’s Quality Safety Review System (QSRS) which will begin collecting data in 2016. The inpatient measures for anticoagulants and diabetes agents will use AHRQ’s Medicare Patient Monitoring System (MPSMS) for 2015 E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices and QSRS for 2016–2020 and data will be adjusted accordingly. MPSMS did not include an opioids specific measure and QSRS now allows AHRQ to now track inpatient opioids adverse drug events. Descriptions of the surveillance systems, measures, and targets can be found here: https://health.gov/hcq/ademeasures.asp. Interested persons or organizations are invited to submit written comments in response to the proposed measures and targets. Written comments should not exceed more than two pages per ADE measure. The comments should reference the specific measure or target to which feedback refers. To be considered, the person or representative from an organization must self-identify and submit the written comments by close of business on November 21, 2016. Dated: September 30, 2016. Don Wright, Deputy Assistant Secretary for Health, Director, Office of Disease Prevention and Health Promotion Office of the Assistant Secretary for Health. [FR Doc. 2016–25424 Filed 10–19–16; 8:45 am] BILLING CODE 4150–32–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings mstockstill on DSK3G9T082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: Genetics and Genomics. Date: October 25, 2016. Time: 3:30 p.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Richard A. Currie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 Health, 6701 Rockledge Drive, Room 1108, MSC 7890, Bethesda, MD 20892, (301) 435– 1219, currieri@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Risk, Prevention, and Health Behavior. Date: October 31–November 1, 2016. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015. Contact Person: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 435– 3575, faradaym@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Brain injury. Date: November 7, 2016. Time: 11:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Samuel C. Edwards, Ph.D., IRG CHIEF, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435–1246, edwardss@ csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 14, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–25336 Filed 10–19–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 72595 amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel Rapid Assessment of Zika Virus (ZIKV) Complications (R21). Date: November 14, 2016 Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call). Contact Person: Travis J. Taylor, Ph.D., Scientific Review Officer Scientific, Review Program, Division of Extramural Activities, Room 3G62B, 5601 Fishers Lane, MSC 9823, Bethesda, MD 20892–9823, (240) 669–5082, Travis.Taylor@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Dated: October 14, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–25339 Filed 10–19–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Invention; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. SUMMARY: The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72594-72595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on the Proposed Measures and 2020 Targets 
for the National Action Plan for Adverse Drug Event Prevention: 
Inpatient and Outpatient Measures for Reduction of Adverse Drug Events 
From Anticoagulants, Diabetes Agents, and Opioid Analgesics

AGENCY: Office of Disease Prevention and Health Promotion, Office of 
the Assistant Secretary for Health, Office of the Secretary, Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The Office of Disease Prevention and Health Promotion (ODPHP), 
on behalf of the U.S. Department of Health and Human Services (HHS) 
Federal Interagency Steering Committee for Adverse Drug Events, 
proposes new measures and targets for adverse drug events (ADEs) from 
anticoagulants, diabetes agents, and opioid analgesics for the National 
Action Plan for Adverse Drug Event Prevention (ADE Action Plan). Based 
on input from the Federal Interagency Workgroups for Adverse Drug 
Events, six national measures and targets for the reduction of ADEs are 
being proposed. Each drug class highlighted in the ADE Action Plan 
(anticoagulants, diabetes agents, and opioid analgesics) includes a 
proposed inpatient and outpatient measure to track national progress in 
reduction of ADEs from these drug classes. The proposed targets will 
reflect improvement efforts over a four to six year period since the 
release of the ADE Action Plan in August 2014. As such, HHS is 
proposing a baseline year of 2014 for five of the measures and 2016 for 
one measure. All targets are to be achieved by 2020. HHS invites 
interested public and private professionals, organizations, and 
consumer representatives to submit written comments on the proposed 
2020 ADE targets, found at https://health.gov/hcq/ade-measures.asp.

DATES: Comments on the proposed ADE 2020 measures and targets must be 
received no later than 5 p.m. on November 21, 2016.

ADDRESSES: Interested persons or organizations are invited to submit 
written comments by any of the following methods:
     Email: OHQ@hhs.gov (please indicate in the subject line: 
Proposed ADE Measures and Targets)
     Mail/Courier: Office of Disease Prevention and Health 
Promotion, Attn: Division of Health Care Quality, Department of Health 
and Human Services, 1101 Wootton Parkway, Suite LL100, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Anna Gribble, Health Policy Fellow, 
Office of Disease Prevention and Health Promotion, via email at 
anna.gribble@hhs.gov.

SUPPLEMENTARY INFORMATION: In September 2012, in response to heightened 
awareness of the contribution of ADEs to the burden of health care-
related harm and costs, the Office of the Assistant Secretary for 
Health (OASH) marshaled the wide-ranging and diverse resources of 
federal partners to form an extensive interagency partnership, the 
Federal Interagency Steering Committee and Workgroups for Adverse Drug 
Events, whose goals would be to develop the ADE Action Plan, as well as 
identify measures to track national progress in reducing ADEs and 
targets to meet based on those measures.
    ODPHP, in conjunction with the Federal Interagency Steering 
Committee and three Federal Interagency Workgroups, developed and 
released the final ADE Action Plan in 2014. The ADE Action Plan seeks 
to engage all stakeholders in a coordinated, aligned, and multi-sector 
effort to reduce ADEs that are clinically significant, account for the 
greatest number of measurable harms as identified by existing 
surveillance systems, and are largely preventable; these were 
identified as ADEs resulting from inpatient and outpatient use of 
anticoagulants, diabetes agents, and opioid analgesics (with specific 
focus on ADEs from therapeutic use of opioids). The ADE Action Plan 
identifies the federal government's highest priority strategies and 
opportunities for advancement, which will have the greatest impact on 
reducing ADEs. Implementation of these strategies is expected to result 
in safer and higher quality health care services, reduced health care 
costs, informed and engaged consumers and ultimately, improved health 
outcomes. The reduction of ADEs subsequent to implementation of these 
strategies will be tracked by the proposed measures and will aim to 
meet the targeted reduction rate by 2020.
    The six proposed measures use data from the Agency for Healthcare 
Research and Quality (AHRQ), the Centers for Disease Control and 
Prevention (CDC), and the Food and Drug Administration (FDA). The 
inpatient and outpatient measures for anticoagulants and diabetes 
agents and the outpatient measure for opioids will set baseline rates 
using data from 2014 and establish targets to be achieved by 2020. The 
inpatient opioids measure will have a 2016 baseline and a 2020 target 
year. The inpatient opioids measure will use data from AHRQ's Quality 
Safety Review System (QSRS) which will begin collecting data in 2016. 
The inpatient measures for anticoagulants and diabetes agents will use 
AHRQ's Medicare Patient Monitoring System (MPSMS) for 2015

[[Page 72595]]

and QSRS for 2016-2020 and data will be adjusted accordingly. MPSMS did 
not include an opioids specific measure and QSRS now allows AHRQ to now 
track inpatient opioids adverse drug events.
    Descriptions of the surveillance systems, measures, and targets can 
be found here: https://health.gov/hcq/ade-measures.asp.
    Interested persons or organizations are invited to submit written 
comments in response to the proposed measures and targets. Written 
comments should not exceed more than two pages per ADE measure. The 
comments should reference the specific measure or target to which 
feedback refers. To be considered, the person or representative from an 
organization must self-identify and submit the written comments by 
close of business on November 21, 2016.

    Dated: September 30, 2016.
Don Wright,
Deputy Assistant Secretary for Health, Director, Office of Disease 
Prevention and Health Promotion Office of the Assistant Secretary for 
Health.
[FR Doc. 2016-25424 Filed 10-19-16; 8:45 am]
 BILLING CODE 4150-32-P