83_FR_7073 83 FR 7040 - Agency Information Collection Activities: Proposed Collection; Comment Request

83 FR 7040 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 83, Issue 33 (February 16, 2018)

Page Range7040-7042
FR Document2018-03243

Through this Request for Information (RFI), the Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public, hospitals and other health care organizations, clinicians, quality improvement experts, researchers, and quality measure developers about current use of the AHRQ Quality Indicators (AHRQ QIs) for quality improvement efforts. AHRQ recognizes that the AHRQ QIs have been adopted for other uses, but for the purpose of this RFI, the Agency is specifically seeking information about quality improvement initiatives such as those that seek to: Improve clinical practice (e.g., adherence to guidelines, coordination of care); improve patient safety or reduce harm; address disparities in health or care; improve prevention practices; and collaborate with community groups to improve health or care. AHRQ is also seeking information about the ways in which the Agency can increase use of the AHRQ QI measures for quality improvement, for example by refining measures, summarizing best practices, creating training materials, developing standardized metrics, and/or convening learning networks. To learn more about the AHRQ QIs, visit https://www.qualityindicators.ahrq.gov/.

Federal Register, Volume 83 Issue 33 (Friday, February 16, 2018)
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7040-7042]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: Through this Request for Information (RFI), the Agency for 
Healthcare Research and Quality (AHRQ) is seeking information from the 
public, hospitals and other health care organizations, clinicians, 
quality improvement experts, researchers, and quality measure 
developers about current use of the AHRQ Quality Indicators (AHRQ QIs) 
for quality improvement efforts. AHRQ recognizes that the AHRQ QIs have 
been adopted for other uses, but for the purpose of this RFI, the 
Agency is specifically seeking information about quality improvement 
initiatives such as those that seek to: Improve clinical practice 
(e.g., adherence to guidelines, coordination of care); improve patient 
safety or reduce harm; address disparities in health or care; improve 
prevention practices; and collaborate with community groups to improve 
health or care. AHRQ is also seeking information about the ways in 
which the Agency can increase use of the AHRQ QI measures for quality 
improvement, for example by refining measures, summarizing best 
practices, creating training materials, developing standardized 
metrics, and/or convening learning networks. To learn more about the 
AHRQ QIs, visit https://www.qualityindicators.ahrq.gov/.

DATES: Comments on this notice must be received by the deadline on or 
before March 8, 2018.

ADDRESSES: Written comments should be submitted to: Maushami DeSoto, 
Ph.D., MHA, Health Scientist Administrator, Center for Delivery 
Organization and Markets, Agency for Healthcare Research and Quality, 
5600 Fishers Lane, Rockville, MD 20857, or by email at 
[email protected].

[[Page 7041]]


FOR FURTHER INFORMATION CONTACT: Maushami DeSoto, Ph.D. MHA, Health 
Scientist Administrator, (301) 427-1546, or by emails at 
[email protected].

SUPPLEMENTARY INFORMATION: The mission of AHRQ is to produce evidence 
to make health care safer; higher quality; and more accessible, 
equitable, and affordable. AHRQ works within the U.S. Department of 
Health and Human Services and with other public and private partners to 
make sure that the evidence is understood and used. The Agency fulfills 
this mission by supporting and conducting research; generating needed 
evidence; disseminating proven practices; creating and distributing 
training materials for health care systems and professionals; and 
developing measures and data used to track and improve performance. To 
learn more about the Agency, visit https://www.ahrq.gov/.

Background

    Over the years, use of the AHRQ QIs has evolved. Originally 
developed to support quality improvement at the hospital and community 
levels, the AHRQ QIs now serve several additional purposes including: 
(1) Research; (2) needs assessments for planning at the local, state, 
and national levels; and (3) performance assessment by private and 
public value-based payment and consumer choice programs. In the current 
context, in which the purposes and methods of measurement continue to 
change rapidly, AHRQ is seeking updated information to inform its own 
planning and priority setting for future work in the area of measures 
for quality improvement. To do so, AHRQ must define evidence criteria 
that are specific to quality improvement and use those criteria to 
determine which AHRQ QIs work best for quality improvement and how they 
can be improved for that purpose.
    As part of this effort, AHRQ is conducting a literature review and 
environmental scan to: (1) Document knowledge and evidence on the 
scientific acceptability of the AHRQ QIs for quality improvement; (2) 
document and synthesize information about the strengths and limitations 
of the AHRQ QIs; (3) identify areas of disagreement, if any, in the 
evidence; and (4) develop suggestions for refinement or improvement in 
the indicators, particularly those that make the AHRQ QIs more useful 
for quality improvement. As part of the environmental scan, AHRQ is 
issuing this RFI to obtain information from stakeholders who have not 
published their experiences using the AHRQ QIs or who wish to provide 
additional information beyond what they have published. AHRQ will 
review results from the literature review and environmental scan and 
release a summary report in December 2018.
    Specific questions of interest to the Agency include, but are not 
limited to:

For Hospitals or Other Health Care Entities That CURRENTLY USE AHRQ QIs 
for Quality Improvement:

    1. What type of organization do you represent?
    2. How does your organization define quality improvement?
    3. How does your organization use the AHRQ QIs for quality 
improvement? For example, do you use them for identifying patient 
safety problems, identifying quality improvement opportunities, and/or 
tracking performance over time?
    4. Which specific AHRQ QIs does your organization use for quality 
improvement? Please include the number of each QI, for example, PQI 05, 
which can be found at the AHRQ QI website.
    5. Have you stopped using an AHRQ QI for quality improvement? If 
yes, please identify it and explain why you stopped.
    6. Of the AHRQ QIs you use now or used previously, which ones have 
been most valuable in improving quality?
    a. What are the strengths of each measure you have used?
    b. What are the weaknesses of each measure you have used?
    7. What other methodological and/or data quality issues have you 
encountered when using AHRQ QIs for quality improvement that you 
haven't already mentioned?
    8. Does your organization use measures other than the AHRQ QIs for 
quality improvement? If yes, which ones and what types of quality 
improvement initiatives does your organization use them for? How do 
they compare to the AHRQ QIs in terms of ease of use and impact on 
quality?
    9. What changes and refinements to the AHRQ QIs would make them 
easier to use for quality improvement?
    10. What changes and refinements to the AHRQ QIs would make them 
more effective for improving quality?
    11. What resources would aid the uptake of the AHRQ QIs for quality 
improvement?
    12. What improvements are needed to current AHRQ QI resources? 
These include resources available through the QI website such as tool 
kits, case studies, webinars, presentations, publication lists, video 
tutorials (WinQI and SASQI), measure technical specifications (IQI, 
PQI, PSI, PDI), TA support, FAQs, and software.
    13. If you operate a community health center, which AHRQ QIs do you 
use for quality improvement in the community health center? Which other 
measures do you use for quality improvement in the community health 
center?
    14. If you operate a hospital emergency department (ED), which AHRQ 
QIs do you use for quality improvement in the ED? Which other measures 
do you use for quality improvement in the ED?

For Hospitals or Other Health Care Entities That Are NOT CURRENTLY 
USING Any AHRQ QIs for Quality Improvement:

    15. How does your organization define quality improvement?
    16. What types of quality improvement initiatives does your 
organization engage in?
    17. Have you heard of the AHRQ QIs? If yes, what do you know about 
them?
    18. What factors contribute to your organization's decision to not 
use the AHRQ QIs?
    19. Has your organization used the AHRQ QIs in the past? If so, why 
is your organization no longer using them?
    20. What measures does your organization use for quality 
improvement? What are some of the reasons/factors your organization 
uses these measures?
    21. If you operate a community health center, which measures do you 
use for quality improvement?
    22. If you operate a hospital emergency department (ED), which 
measures do you use for quality improvement?
    23. If your organization is a community health center, which 
metrics do you use for quality improvement?
    24. If your organization is an ED which metrics do you use for 
quality improvement and monitoring?
    AHRQ is interested in all the questions listed above, but 
respondents are welcome to address as many or as few as they choose and 
to address additional areas of interest not listed. AHRQ will use the 
information it receives to assist in developing future initiatives. 
These initiatives may include, but are not limited to, developing 
research grant and contracting opportunities, investing in the creation 
of tools and training materials for health professionals and health 
care delivery organizations, developing quality improvement measures, 
and/or convening learning collaboratives.

[[Page 7042]]

    Health care professionals and organizations are encouraged to 
respond to this RFI by submitting a written statement and supporting 
explanatory materials to the email or mailing address listed above by 
February 28, 2018. Supporting materials might include charters for 
quality and safety improvement committees, data use agreements for 
learning collaboratives, population health metrics and reports, or 
guidelines for the use of evidence-based practices. When responding to 
questions listed above, please clearly indicate the number of the 
question that is being addressed. AHRQ encourages respondents to 
include a description of their health care delivery organization at the 
beginning of their response to provide context for the information they 
provide.

Request for Comments

    This RFI is for planning purposes only and should not be construed 
as a policy, solicitation for applications, or as an obligation on the 
part of the Government to provide support for any ideas identified in 
response to it. AHRQ will use the information submitted in response to 
this RFI at its discretion and will not provide comments to any 
responder's submission. However, responses to the RFI may be reflected 
in future solicitation(s) or policies. The information provided will be 
analyzed and may appear in reports. Respondents will not be identified 
in any published reports. Respondents are advised that the Government 
is under no obligation to acknowledge receipt of the information 
received or provide feedback to respondents with respect to any 
information submitted. No proprietary, classified, confidential, or 
sensitive information should be included in your response. The 
Government reserves the right to use any non-proprietary technical 
information in any resultant solicitation(s). The contents of all 
submissions will be made available to the public upon request. 
Materials submitted must be publicly available or can be made public.

Gopal Khanna,
Director.
[FR Doc. 2018-03243 Filed 2-15-18; 8:45 am]
BILLING CODE 4160-90-P



                                               7040                          Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices

                                               Request for Comment                                     commercial or financial information                   can also be sent by email to wliberante@
                                                  You can file a comment online or on                  which * * * is privileged or                          omb.eop.gov.
                                               paper. For the FTC to consider your                     confidential’’—as provided by Section
                                                                                                                                                             David C. Shonka,
                                               comment, we must receive it on or                       6(f) of the FTC Act, 15 U.S.C. 46(f), and
                                                                                                       FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—               Acting General Counsel.
                                               before March 19, 2018. Write ‘‘FPLA                                                                           [FR Doc. 2018–03289 Filed 2–15–18; 8:45 am]
                                               Rules, PRA Comment, P074200’’ on                        including in particular competitively
                                               your comment. Your comment—                             sensitive information such as costs,                  BILLING CODE 6750–01–P

                                               including your name and your state—                     sales statistics, inventories, formulas,
                                               will be placed on the public record of                  patterns, devices, manufacturing
                                                                                                       processes, or customer names.                         DEPARTMENT OF HEALTH AND
                                               this proceeding, including, to the extent
                                                                                                          Comments containing material for                   HUMAN SERVICES
                                               practicable, on the public Commission
                                               website, at http://www.ftc.gov/os/                      which confidential treatment is
                                                                                                       requested must be filed in paper form,                Agency for Healthcare Research and
                                               publiccomments.shtm.                                                                                          Quality
                                                  Postal mail addressed to the                         must be clearly labeled ‘‘Confidential,’’
                                               Commission is subject to delay due to                   and must comply with FTC Rule 4.9(c).                 Agency Information Collection
                                               heightened security screening. As a                     In particular, the written request for                Activities: Proposed Collection;
                                               result, we encourage you to submit your                 confidential treatment that accompanies               Comment Request
                                               comments online, or to send them to the                 the comment must include the factual
                                               Commission by courier or overnight                      and legal basis for the request, and must             AGENCY: Agency for Healthcare Research
                                               service. To make sure that the                          identify the specific portions of the                 and Quality, HHS.
                                               Commission considers your online                        comment to be withheld from the public                ACTION: Notice.
                                               comment, you must file it at https://                   record. See FTC Rule 4.9(c). Your
                                               ftcpublic.commentworks.com/ftc/                         comment will be kept confidential only                SUMMARY:   Through this Request for
                                               fplaregspra2, by following the                          if the General Counsel grants your                    Information (RFI), the Agency for
                                               instructions on the web-based form.                     request in accordance with the law and                Healthcare Research and Quality
                                               When this Notice appears at http://                     the public interest. Once your comment                (AHRQ) is seeking information from the
                                               www.regulations.gov/#!home, you also                    has been posted on the public FTC                     public, hospitals and other health care
                                               may file a comment through that                         website—as legally required by FTC                    organizations, clinicians, quality
                                               website.                                                Rule 4.9(b)—we cannot redact or                       improvement experts, researchers, and
                                                  If you file your comment on paper,                   remove your comment from the FTC                      quality measure developers about
                                               write ‘‘FPLA Rules, PRA Comment,                        website, unless you submit a                          current use of the AHRQ Quality
                                               P074200’’ on your comment and on the                    confidentiality request that meets the                Indicators (AHRQ QIs) for quality
                                               envelope, and mail it to the following                  requirements for such treatment under                 improvement efforts. AHRQ recognizes
                                               address: Federal Trade Commission,                      FTC Rule 4.9(c), and the General                      that the AHRQ QIs have been adopted
                                               Office of the Secretary, 600                            Counsel grants that request.                          for other uses, but for the purpose of
                                               Pennsylvania Avenue NW, Suite CC–                          The FTC Act and other laws that the                this RFI, the Agency is specifically
                                               5610 (Annex J), Washington, DC 20580,                   Commission administers permit the                     seeking information about quality
                                               or deliver your comment to the                          collection of public comments to                      improvement initiatives such as those
                                               following address: Federal Trade                        consider and use in this proceeding as                that seek to: Improve clinical practice
                                               Commission, Office of the Secretary,                    appropriate. The Commission will                      (e.g., adherence to guidelines,
                                               Constitution Center, 400 7th Street SW,                 consider all timely and responsive                    coordination of care); improve patient
                                               5th Floor, Suite 5610 (Annex J),                        public comments that it receives on or                safety or reduce harm; address
                                               Washington, DC 20024. If possible,                      before March 19, 2018. For information                disparities in health or care; improve
                                               submit your paper comment to the                        on the Commission’s privacy policy,                   prevention practices; and collaborate
                                               Commission by courier or overnight                      including routine uses permitted by the               with community groups to improve
                                               service.                                                Privacy Act, see https://www.ftc.gov/                 health or care. AHRQ is also seeking
                                                  Because your comment will be placed                  site-information/privacy-policy. For                  information about the ways in which
                                               on the publicly accessible FTC website                  supporting documentation and other                    the Agency can increase use of the
                                               at https://www.ftc.gov/, you are solely                 information underlying the PRA                        AHRQ QI measures for quality
                                               responsible for making sure that your                   discussion in this Notice, see http://                improvement, for example by refining
                                               comment does not include any sensitive                  www.reginfo.gov/public/jsp/PRA/                       measures, summarizing best practices,
                                               or confidential information. In                         praDashboard.jsp.                                     creating training materials, developing
                                               particular, your comment should not                        Comments on the information                        standardized metrics, and/or convening
                                               include any sensitive personal                          collection requirements subject to                    learning networks. To learn more about
                                               information, such as your or anyone                     review under the PRA should                           the AHRQ QIs, visit https://
                                               else’s Social Security number; date of                  additionally be submitted to OMB. If                  www.qualityindicators.ahrq.gov/.
                                               birth; driver’s license number or other                 sent by U.S. mail, they should be                     DATES: Comments on this notice must be
                                               state identification number, or foreign                 addressed to Office of Information and                received by the deadline on or before
                                               country equivalent; passport number;                    Regulatory Affairs, Office of                         March 8, 2018.
                                               financial account number; or credit or                  Management and Budget, Attention:                     ADDRESSES: Written comments should
                                               debit card number. You are also solely                  Desk Officer for the Federal Trade                    be submitted to: Maushami DeSoto,
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                                               responsible for making sure that your                   Commission, New Executive Office                      Ph.D., MHA, Health Scientist
                                               comment does not include any sensitive                  Building, Docket Library, Room 10102,                 Administrator, Center for Delivery
                                               health information, such as medical                     725 17th Street NW, Washington, DC                    Organization and Markets, Agency for
                                               records or other individually                           20503. Comments sent to OMB by U.S.                   Healthcare Research and Quality, 5600
                                               identifiable health information. In                     postal mail, however, are subject to                  Fishers Lane, Rockville, MD 20857, or
                                               addition, your comment should not                       delays due to heightened security                     by email at Maushami.Desoto@
                                               include any ‘‘trade secret or any                       precautions. Thus, comments instead                   ahrq.hhs.gov.


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                                                                             Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices                                          7041

                                               FOR FURTHER INFORMATION CONTACT:                        their experiences using the AHRQ QIs                  and SASQI), measure technical
                                               Maushami DeSoto, Ph.D. MHA, Health                      or who wish to provide additional                     specifications (IQI, PQI, PSI, PDI), TA
                                               Scientist Administrator, (301) 427–1546,                information beyond what they have                     support, FAQs, and software.
                                               or by emails at Maushami.Desoto@                        published. AHRQ will review results                     13. If you operate a community health
                                               ahrq.hhs.gov.                                           from the literature review and                        center, which AHRQ QIs do you use for
                                               SUPPLEMENTARY INFORMATION:     The                      environmental scan and release a                      quality improvement in the community
                                               mission of AHRQ is to produce                           summary report in December 2018.                      health center? Which other measures do
                                               evidence to make health care safer;                        Specific questions of interest to the              you use for quality improvement in the
                                               higher quality; and more accessible,                    Agency include, but are not limited to:               community health center?
                                               equitable, and affordable. AHRQ works                   For Hospitals or Other Health Care                      14. If you operate a hospital
                                               within the U.S. Department of Health                    Entities That CURRENTLY USE                           emergency department (ED), which
                                               and Human Services and with other                       AHRQ QIs for Quality Improvement:                     AHRQ QIs do you use for quality
                                               public and private partners to make sure                                                                      improvement in the ED? Which other
                                                                                                          1. What type of organization do you                measures do you use for quality
                                               that the evidence is understood and                     represent?
                                               used. The Agency fulfills this mission                                                                        improvement in the ED?
                                                                                                          2. How does your organization define
                                               by supporting and conducting research;                  quality improvement?                                  For Hospitals or Other Health Care
                                               generating needed evidence;                                3. How does your organization use the              Entities That Are NOT CURRENTLY
                                               disseminating proven practices; creating                AHRQ QIs for quality improvement? For                 USING Any AHRQ QIs for Quality
                                               and distributing training materials for                 example, do you use them for                          Improvement:
                                               health care systems and professionals;                  identifying patient safety problems,
                                               and developing measures and data used                                                                            15. How does your organization
                                                                                                       identifying quality improvement                       define quality improvement?
                                               to track and improve performance. To                    opportunities, and/or tracking
                                               learn more about the Agency, visit                                                                               16. What types of quality
                                                                                                       performance over time?                                improvement initiatives does your
                                               https://www.ahrq.gov/.                                     4. Which specific AHRQ QIs does                    organization engage in?
                                               Background                                              your organization use for quality                        17. Have you heard of the AHRQ QIs?
                                                                                                       improvement? Please include the                       If yes, what do you know about them?
                                                  Over the years, use of the AHRQ QIs                  number of each QI, for example, PQI 05,
                                               has evolved. Originally developed to                                                                             18. What factors contribute to your
                                                                                                       which can be found at the AHRQ QI                     organization’s decision to not use the
                                               support quality improvement at the                      website.
                                               hospital and community levels, the                                                                            AHRQ QIs?
                                                                                                          5. Have you stopped using an AHRQ
                                               AHRQ QIs now serve several additional                                                                            19. Has your organization used the
                                                                                                       QI for quality improvement? If yes,
                                               purposes including: (1) Research; (2)                                                                         AHRQ QIs in the past? If so, why is your
                                                                                                       please identify it and explain why you
                                               needs assessments for planning at the                                                                         organization no longer using them?
                                                                                                       stopped.
                                               local, state, and national levels; and (3)                                                                       20. What measures does your
                                                                                                          6. Of the AHRQ QIs you use now or
                                               performance assessment by private and                                                                         organization use for quality
                                                                                                       used previously, which ones have been
                                               public value-based payment and                                                                                improvement? What are some of the
                                                                                                       most valuable in improving quality?
                                               consumer choice programs. In the                           a. What are the strengths of each                  reasons/factors your organization uses
                                               current context, in which the purposes                  measure you have used?                                these measures?
                                               and methods of measurement continue                        b. What are the weaknesses of each                    21. If you operate a community health
                                               to change rapidly, AHRQ is seeking                      measure you have used?                                center, which measures do you use for
                                               updated information to inform its own                      7. What other methodological and/or                quality improvement?
                                               planning and priority setting for future                data quality issues have you                             22. If you operate a hospital
                                               work in the area of measures for quality                encountered when using AHRQ QIs for                   emergency department (ED), which
                                               improvement. To do so, AHRQ must                        quality improvement that you haven’t                  measures do you use for quality
                                               define evidence criteria that are specific              already mentioned?                                    improvement?
                                               to quality improvement and use those                       8. Does your organization use                         23. If your organization is a
                                               criteria to determine which AHRQ QIs                    measures other than the AHRQ QIs for                  community health center, which metrics
                                               work best for quality improvement and                   quality improvement? If yes, which ones               do you use for quality improvement?
                                               how they can be improved for that                       and what types of quality improvement                    24. If your organization is an ED
                                               purpose.                                                initiatives does your organization use                which metrics do you use for quality
                                                  As part of this effort, AHRQ is                      them for? How do they compare to the                  improvement and monitoring?
                                               conducting a literature review and                      AHRQ QIs in terms of ease of use and                     AHRQ is interested in all the
                                               environmental scan to: (1) Document                     impact on quality?                                    questions listed above, but respondents
                                               knowledge and evidence on the                              9. What changes and refinements to                 are welcome to address as many or as
                                               scientific acceptability of the AHRQ QIs                the AHRQ QIs would make them easier                   few as they choose and to address
                                               for quality improvement; (2) document                   to use for quality improvement?                       additional areas of interest not listed.
                                               and synthesize information about the                       10. What changes and refinements to                AHRQ will use the information it
                                               strengths and limitations of the AHRQ                   the AHRQ QIs would make them more                     receives to assist in developing future
                                               QIs; (3) identify areas of disagreement,                effective for improving quality?                      initiatives. These initiatives may
                                               if any, in the evidence; and (4) develop                   11. What resources would aid the                   include, but are not limited to,
                                               suggestions for refinement or                           uptake of the AHRQ QIs for quality                    developing research grant and
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                                               improvement in the indicators,                          improvement?                                          contracting opportunities, investing in
                                               particularly those that make the AHRQ                      12. What improvements are needed to                the creation of tools and training
                                               QIs more useful for quality                             current AHRQ QI resources? These                      materials for health professionals and
                                               improvement. As part of the                             include resources available through the               health care delivery organizations,
                                               environmental scan, AHRQ is issuing                     QI website such as tool kits, case                    developing quality improvement
                                               this RFI to obtain information from                     studies, webinars, presentations,                     measures, and/or convening learning
                                               stakeholders who have not published                     publication lists, video tutorials (WinQI             collaboratives.


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                                               7042                          Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices

                                                  Health care professionals and                        DEPARTMENT OF HEALTH AND                              including attachments, to https://
                                               organizations are encouraged to respond                 HUMAN SERVICES                                        www.regulations.gov will be posted to
                                               to this RFI by submitting a written                                                                           the docket unchanged. Because your
                                               statement and supporting explanatory                    Food and Drug Administration                          comment will be made public, you are
                                               materials to the email or mailing                       [Docket Nos. FDA–2015–E–3856; FDA–                    solely responsible for ensuring that your
                                               address listed above by February 28,                    2015–E–3857]                                          comment does not include any
                                               2018. Supporting materials might                                                                              confidential information that you or a
                                               include charters for quality and safety                 Determination of Regulatory Review                    third party may not wish to be posted,
                                               improvement committees, data use                        Period for Purposes of Patent                         such as medical information, your or
                                                                                                       Extension; MOVANTIK                                   anyone else’s Social Security number, or
                                               agreements for learning collaboratives,
                                                                                                                                                             confidential business information, such
                                               population health metrics and reports,                  AGENCY:    Food and Drug Administration,              as a manufacturing process. Please note
                                               or guidelines for the use of evidence-                  HHS.                                                  that if you include your name, contact
                                               based practices. When responding to                     ACTION:   Notice.                                     information, or other information that
                                               questions listed above, please clearly                                                                        identifies you in the body of your
                                               indicate the number of the question that                SUMMARY:   The Food and Drug                          comments, that information will be
                                               is being addressed. AHRQ encourages                     Administration (FDA or the Agency) has                posted on https://www.regulations.gov.
                                               respondents to include a description of                 determined the regulatory review period                 • If you want to submit a comment
                                               their health care delivery organization at              for MOVANTIK and is publishing this                   with confidential information that you
                                               the beginning of their response to                      notice of that determination as required              do not wish to be made available to the
                                               provide context for the information they                by law. FDA has made the                              public, submit the comment as a
                                               provide.                                                determination because of the                          written/paper submission and in the
                                                                                                       submission of applications to the                     manner detailed (see ‘‘Written/Paper
                                               Request for Comments                                    Director of the U.S. Patent and                       Submissions’’ and ‘‘Instructions’’).
                                                                                                       Trademark Office (USPTO), Department
                                                 This RFI is for planning purposes                     of Commerce, for the extension of a                   Written/Paper Submissions
                                               only and should not be construed as a                   patent which claims that human drug                      Submit written/paper submissions as
                                               policy, solicitation for applications, or               product.                                              follows:
                                               as an obligation on the part of the                                                                              • Mail/Hand delivery/Courier (for
                                               Government to provide support for any                   DATES:   Anyone with knowledge that any
                                                                                                                                                             written/paper submissions): Dockets
                                               ideas identified in response to it. AHRQ                of the dates as published (in the
                                                                                                                                                             Management Staff (HFA–305), Food and
                                                                                                       SUPPLEMENTARY INFORMATION section) are
                                               will use the information submitted in                                                                         Drug Administration, 5630 Fishers
                                                                                                       incorrect may submit either electronic
                                               response to this RFI at its discretion and                                                                    Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                       or written comments and ask for a                        • For written/paper comments
                                               will not provide comments to any
                                                                                                       redetermination by April 17, 2018. See                submitted to the Dockets Management
                                               responder’s submission. However,
                                                                                                       ‘‘Petitions’’ in the SUPPLEMENTARY                    Staff, FDA will post your comment, as
                                               responses to the RFI may be reflected in                INFORMATION section for more
                                               future solicitation(s) or policies. The                                                                       well as any attachments, except for
                                                                                                       information.                                          information submitted, marked and
                                               information provided will be analyzed
                                               and may appear in reports. Respondents                  ADDRESSES:    You may submit comments                 identified, as confidential, if submitted
                                               will not be identified in any published                 as follows. Please note that late,                    as detailed in ‘‘Instructions.’’
                                               reports. Respondents are advised that                   untimely filed comments will not be                      Instructions: All submissions received
                                                                                                       considered. Electronic comments must                  must include the Docket Nos. FDA
                                               the Government is under no obligation
                                                                                                       be submitted on or before April 17,                   2015–E–3856 and FDA 2015–E–3857 for
                                               to acknowledge receipt of the
                                                                                                       2018. The https://www.regulations.gov                 ‘‘Determination of Regulatory Review
                                               information received or provide                                                                               Period for Purposes of Patent Extension;
                                                                                                       electronic filing system will accept
                                               feedback to respondents with respect to                 comments until midnight Eastern Time                  MOVANTIK.’’ Received comments,
                                               any information submitted. No                           at the end of April 17, 2018. Comments                those filed in a timely manner (see
                                               proprietary, classified, confidential, or               received by mail/hand delivery/courier                ADDRESSES), will be placed in the docket
                                               sensitive information should be                         (for written/paper submissions) will be               and, except for those submitted as
                                               included in your response. The                          considered timely if they are                         ‘‘Confidential Submissions,’’ publicly
                                               Government reserves the right to use                    postmarked or the delivery service                    viewable at https://www.regulations.gov
                                               any non-proprietary technical                           acceptance receipt is on or before that               or at the Dockets Management Staff
                                               information in any resultant                            date. Furthermore, any interested                     between 9 a.m. and 4 p.m., Monday
                                               solicitation(s). The contents of all                    person may petition FDA for a                         through Friday.
                                               submissions will be made available to                   determination regarding whether the                      • Confidential Submissions—To
                                               the public upon request. Materials                      applicant for extension acted with due                submit a comment with confidential
                                               submitted must be publicly available or                 diligence during the regulatory review                information that you do not wish to be
                                               can be made public.                                     period by August 15, 2018. See                        made publicly available, submit your
                                                                                                       ‘‘Petitions’’ in the SUPPLEMENTARY                    comments only as a written/paper
                                               Gopal Khanna,                                                                                                 submission. You should submit two
                                                                                                       INFORMATION section for more
                                               Director.                                               information.                                          copies total. One copy will include the
                                               [FR Doc. 2018–03243 Filed 2–15–18; 8:45 am]                                                                   information you claim to be confidential
daltland on DSKBBV9HB2PROD with NOTICES




                                                                                                       Electronic Submissions                                with a heading or cover note that states
                                               BILLING CODE 4160–90–P
                                                                                                         Submit electronic comments in the                   ‘‘THIS DOCUMENT CONTAINS
                                                                                                       following way:                                        CONFIDENTIAL INFORMATION.’’ The
                                                                                                         • Federal eRulemaking Portal:                       Agency will review this copy, including
                                                                                                       https://www.regulations.gov. Follow the               the claimed confidential information, in
                                                                                                       instructions for submitting comments.                 its consideration of comments. The
                                                                                                       Comments submitted electronically,                    second copy, which will have the


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Document Created: 2018-02-16 00:55:47
Document Modified: 2018-02-16 00:55:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this notice must be received by the deadline on or before March 8, 2018.
ContactMaushami DeSoto, Ph.D. MHA, Health Scientist Administrator, (301) 427-1546, or by emails at [email protected]
FR Citation83 FR 7040 

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