81_FR_72259 81 FR 72057 - Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions

81 FR 72057 - Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Administration on Aging

Federal Register Volume 81, Issue 202 (October 19, 2016)

Page Range72057-72058
FR Document2016-25118

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 202 (Wednesday, October 19, 2016)
[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72057-72058]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25118]



[[Page 72057]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living

Administration on Aging


Agency Information Collection Activities; Public Comment Request; 
State Annual Long-Term Care Ombudsman Report and Instructions

AGENCY: Administration for Community Living/Administration on Aging, 
HHS.

ACTION: Notice.

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

SUMMARY: The Administration on Aging (AoA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 18, 2016.

ADDRESSES: Submit written comments on the collection of information by 
fax 202.395.5806 or by email to [email protected], Attn: OMB 
Desk Officer for ACL.

FOR FURTHER INFORMATION CONTACT: Louise Ryan, telephone: (206) 615-
2514; email: [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, AoA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    States provide the following data and narrative information in the 
report:
    1. Numbers and descriptions of cases filed and complaints made on 
behalf of long-term care facility residents to the statewide ombudsman 
program;
    2. Major issues identified that impact the quality of care and life 
of long-term care facility residents;
    3. Statewide program operations; and
    4. Ombudsman activities in addition to complaint investigation.
    5. A new requirement to include organizational conflict of interest 
reporting as required by the reauthorized Older Americans Act and the 
LTC Ombudsman program rule at 45 CFR 1324.21.
    The report form and instructions have been in continuous use, with 
minor modifications, since they were first approved by OMB for the FY 
1995 reporting period. This current request is for a Revision of a 
Currently Approved Collection (ICR Rev), which will provide approval 
for FFY 2016-2018 with modifications to include organizational conflict 
of interest reporting as required by the reauthorized Older Americans 
Act, Section 712(f) and the LTC Ombudsman program rule at 45 CFR 
1324.21.
    The data collected on complaints filed with ombudsman programs and 
narrative on long-term care issues provide information to Centers for 
Medicare and Medicaid Services and others on patterns of concerns and 
major long-term care issues affecting residents of long-term care 
facilities. Both the complaint and program data collected assist the 
states and local ombudsman programs in planning strategies and 
activities, providing training and technical assistance and developing 
performance measures.

Comments in Response to the 60 Day Federal Register Notice

    A notice was published in the Federal Register/Vol. 81, No. 126/
Thursday, June 30, 2016 Notices, Pages 42712-42713, announcing that AoA 
was requesting modification of the current form and instructions to 
incorporate conflict of interest reporting requirements, directing 
readers to the AoA Web site where these documents are posted and 
providing an opportunity for public comment. One comment was received 
from the National Association of Ombudsman Programs (NASOP).
    NASOP members disagreed with the burden estimate developed by AoA, 
stating: Because an overwhelming majority of state long-term care 
ombudsman programs designate local ombudsman entities, those 
circumstances lead to a greater likelihood of organizational conflicts 
of interest. The burden is compounded by the number of local ombudsman 
entities within a state and will have multiple sources of reporting 
organizational conflicts at local or regional levels up to the states 
before states can report via NORS. Further, because approximately half 
of state long-term care ombudsman programs are housed within an 
umbrella agency, this also increases the likelihood that state programs 
have multiple organizational conflicts that must be identified, 
remedied or removed, and reported via NORS.
    In response to NASOP's concerns about burden estimates, we made a 
change in our estimated burden hours from one-half hour per state to 
one hour per state.
    NASOP requested additions to the instructions and report form such 
as the ability to certify that there was no change in conflicts/
remedies from the previous reporting year; and to allow for the ability 
to report a conflict and remedy that applies to many entities as a 
reporting entry. These suggestions were helpful and were incorporated 
into the instructions and form. They did not affect the estimated 
burden.
    NASOP also recommended that AoA/ACL add a reporting option in a 
check box to indicate a state has identified a conflict, but the 
conflict has not been remedied. We do not intend to take this 
recommendation because it would be contrary to the rule and law which 
require states to identify, remove or remedy conflicts and to report on 
such remedies. ACL is providing on-going technical assistance to states 
on the implementation of the Ombudsman program rule, including 
technical assistance on conflicts of interest and steps to remedy any 
identified conflicts.
    A reporting form and instructions may be viewed in the ombudsman 
section of the AoA Web site: http://www.aoa.acl.gov/AoA_Programs/Elder_Rights/Ombudsman/index.aspx. AoA estimates the burden of this 
collection and entering the additional report information as follows: 
Approximately 10 to 60 minutes per respondent, depending on the number 
of conflicts to report, with 52 state Ombudsman programs responding 
annually. This brings the total burden hours to approximately 7,753 
hours, (149 hours on average per program) with 52 Offices of Long-Term 
Care Ombudsman programs responding annually.

----------------------------------------------------------------------------------------------------------------
                                              Local Ombudsman  Office of state    Total burden     52 Programs
                   Summary                        programs        Ombudsman          hours           (hours)
----------------------------------------------------------------------------------------------------------------
Hours.......................................           132.1               17            149.1            7,753
----------------------------------------------------------------------------------------------------------------



[[Page 72058]]

    Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2016-25118 Filed 10-18-16; 8:45 am]
BILLING CODE 4154-01-P



                                                                                    Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices                                                                72057

                                                DEPARTMENT OF HEALTH AND                                                      The report form and instructions have                       the states before states can report via
                                                HUMAN SERVICES                                                             been in continuous use, with minor                             NORS. Further, because approximately
                                                                                                                           modifications, since they were first                           half of state long-term care ombudsman
                                                Administration for Community Living                                        approved by OMB for the FY 1995                                programs are housed within an
                                                                                                                           reporting period. This current request is                      umbrella agency, this also increases the
                                                Administration on Aging                                                    for a Revision of a Currently Approved                         likelihood that state programs have
                                                                                                                           Collection (ICR Rev), which will                               multiple organizational conflicts that
                                                Agency Information Collection                                              provide approval for FFY 2016–2018                             must be identified, remedied or
                                                Activities; Public Comment Request;                                        with modifications to include                                  removed, and reported via NORS.
                                                State Annual Long-Term Care                                                organizational conflict of interest                               In response to NASOP’s concerns
                                                Ombudsman Report and Instructions                                          reporting as required by the                                   about burden estimates, we made a
                                                AGENCY: Administration for Community                                       reauthorized Older Americans Act,                              change in our estimated burden hours
                                                Living/Administration on Aging, HHS.                                       Section 712(f) and the LTC Ombudsman                           from one-half hour per state to one hour
                                                                                                                           program rule at 45 CFR 1324.21.                                per state.
                                                ACTION: Notice.
                                                                                                                              The data collected on complaints filed                         NASOP requested additions to the
                                                SUMMARY:    The Administration on Aging                                    with ombudsman programs and                                    instructions and report form such as the
                                                (AoA) is announcing that the proposed                                      narrative on long-term care issues                             ability to certify that there was no
                                                collection of information listed below                                     provide information to Centers for                             change in conflicts/remedies from the
                                                has been submitted to the Office of                                        Medicare and Medicaid Services and                             previous reporting year; and to allow for
                                                Management and Budget (OMB) for                                            others on patterns of concerns and                             the ability to report a conflict and
                                                review and clearance under the                                             major long-term care issues affecting                          remedy that applies to many entities as
                                                Paperwork Reduction Act of 1995.                                           residents of long-term care facilities.                        a reporting entry. These suggestions
                                                DATES: Submit written comments on the
                                                                                                                           Both the complaint and program data                            were helpful and were incorporated into
                                                collection of information by November                                      collected assist the states and local                          the instructions and form. They did not
                                                18, 2016.                                                                  ombudsman programs in planning                                 affect the estimated burden.
                                                                                                                           strategies and activities, providing                              NASOP also recommended that AoA/
                                                ADDRESSES: Submit written comments
                                                                                                                           training and technical assistance and                          ACL add a reporting option in a check
                                                on the collection of information by fax                                    developing performance measures.                               box to indicate a state has identified a
                                                202.395.5806 or by email to OIRA_                                                                                                         conflict, but the conflict has not been
                                                submission@omb.eop.gov, Attn: OMB                                          Comments in Response to the 60 Day
                                                                                                                                                                                          remedied. We do not intend to take this
                                                Desk Officer for ACL.                                                      Federal Register Notice
                                                                                                                                                                                          recommendation because it would be
                                                FOR FURTHER INFORMATION CONTACT:                                              A notice was published in the Federal                       contrary to the rule and law which
                                                Louise Ryan, telephone: (206) 615–2514;                                    Register/Vol. 81, No. 126/Thursday,                            require states to identify, remove or
                                                email: louise.ryan@acl.hhs.gov.                                            June 30, 2016 Notices, Pages 42712–                            remedy conflicts and to report on such
                                                SUPPLEMENTARY INFORMATION: In                                              42713, announcing that AoA was                                 remedies. ACL is providing on-going
                                                compliance with 44 U.S.C. 3507, AoA                                        requesting modification of the current                         technical assistance to states on the
                                                has submitted the following proposed                                       form and instructions to incorporate                           implementation of the Ombudsman
                                                collection of information to OMB for                                       conflict of interest reporting                                 program rule, including technical
                                                review and clearance.                                                      requirements, directing readers to the                         assistance on conflicts of interest and
                                                   States provide the following data and                                   AoA Web site where these documents                             steps to remedy any identified conflicts.
                                                narrative information in the report:                                       are posted and providing an opportunity                           A reporting form and instructions
                                                   1. Numbers and descriptions of cases                                    for public comment. One comment was                            may be viewed in the ombudsman
                                                filed and complaints made on behalf of                                     received from the National Association                         section of the AoA Web site: http://
                                                long-term care facility residents to the                                   of Ombudsman Programs (NASOP).                                 www.aoa.acl.gov/AoA_Programs/Elder_
                                                statewide ombudsman program;                                                  NASOP members disagreed with the                            Rights/Ombudsman/index.aspx. AoA
                                                   2. Major issues identified that impact                                  burden estimate developed by AoA,                              estimates the burden of this collection
                                                the quality of care and life of long-term                                  stating: Because an overwhelming                               and entering the additional report
                                                care facility residents;                                                   majority of state long-term care                               information as follows: Approximately
                                                   3. Statewide program operations; and                                    ombudsman programs designate local                             10 to 60 minutes per respondent,
                                                   4. Ombudsman activities in addition                                     ombudsman entities, those                                      depending on the number of conflicts to
                                                to complaint investigation.                                                circumstances lead to a greater                                report, with 52 state Ombudsman
                                                   5. A new requirement to include                                         likelihood of organizational conflicts of                      programs responding annually. This
                                                organizational conflict of interest                                        interest. The burden is compounded by                          brings the total burden hours to
                                                reporting as required by the                                               the number of local ombudsman entities                         approximately 7,753 hours, (149 hours
                                                reauthorized Older Americans Act and                                       within a state and will have multiple                          on average per program) with 52 Offices
                                                the LTC Ombudsman program rule at 45                                       sources of reporting organizational                            of Long-Term Care Ombudsman
                                                CFR 1324.21.                                                               conflicts at local or regional levels up to                    programs responding annually.

                                                                                                                                                                           Local          Office of         Total burden   52 Programs
                                                                                                   Summary                                                              Ombudsman          state               hours          (hours)
                                                                                                                                                                         programs        Ombudsman
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                                                Hours ...............................................................................................................        132.1            17               149.1          7,753




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                                                72058                     Federal Register / Vol. 81, No. 202 / Wednesday, October 19, 2016 / Notices

                                                  Dated: October 12, 2016.                              detailed (see ‘‘Written/Paper                            Docket: For access to the docket to
                                                Edwin L. Walker,                                        Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                Acting Administrator and Assistant Secretary                                                                  electronic and written/paper comments
                                                                                                        Written/Paper Submissions
                                                for Aging.                                                                                                    received, go to http://
                                                [FR Doc. 2016–25118 Filed 10–18–16; 8:45 am]               Submit written/paper submissions as                www.regulations.gov and insert the
                                                BILLING CODE 4154–01–P                                  follows:                                              docket number, found in brackets in the
                                                                                                           • Mail/Hand delivery/Courier (for                  heading of this document, into the
                                                                                                        written/paper submissions): Division of               ‘‘Search’’ box and follow the prompts
                                                DEPARTMENT OF HEALTH AND                                Dockets Management (HFA–305), Food                    and/or go to the Division of Dockets
                                                HUMAN SERVICES                                          and Drug Administration, 5630 Fishers                 Management, 5630 Fishers Lane, Rm.
                                                                                                        Lane, Rm. 1061, Rockville, MD 20852.                  1061, Rockville, MD 20852.
                                                Food and Drug Administration                               • For written/paper comments                       FOR FURTHER INFORMATION CONTACT:
                                                [Docket No. FDA–2016–N–2406]                            submitted to the Division of Dockets                  Donna Mendrick, National Center for
                                                                                                        Management, FDA will post your                        Toxicological Research, Food and Drug
                                                Emerging Issues and Cross-Cutting                       comment, as well as any attachments,                  Administration, 10903 New Hampshire
                                                Scientific Advances; Establishment of                   except for information submitted,                     Ave., Silver Spring, MD 20993, 301–
                                                a Public Docket                                         marked and identified, as confidential,               796–8892, Donna.Mendrick@
                                                                                                        if submitted as detailed in                           fda.hhs.gov; or Michael Morgan, Office
                                                AGENCY:    Food and Drug Administration,
                                                                                                        ‘‘Instructions.’’                                     of Regulatory Science and Innovation,
                                                HHS.
                                                                                                           Instructions: All submissions received             Food and Drug Administration, 10903
                                                ACTION: Notice; establishment of docket;                                                                      New Hampshire Ave., Silver Spring, MD
                                                                                                        must include the Docket No. FDA–
                                                request for comments.                                                                                         20993, 240–402–3832,
                                                                                                        2016–N–2406 for ‘‘Emerging Issues and
                                                SUMMARY:    The Food and Drug                           Cross-Cutting Scientific Advances.’’                  Michael.Morgan@fda.hhs.gov.
                                                Administration (FDA) is establishing a                  Received comments will be placed in                   SUPPLEMENTARY INFORMATION: FDA is
                                                public docket to receive input on                       the docket and, except for those                      responsible for protecting the public
                                                emerging issues and cross-cutting                       submitted as ‘‘Confidential                           health by assuring the safety, efficacy,
                                                scientific advances that may impact                     Submissions,’’ publicly viewable at                   and security of human and veterinary
                                                FDA preparedness and inter-Agency                       http://www.regulations.gov or at the                  drugs, biological products, medical
                                                activities. Interested parties are invited              Division of Dockets Management                        devices, our Nation’s food supply,
                                                to submit comments regarding emerging                   between 9 a.m. and 4 p.m., Monday                     cosmetics, and products that emit
                                                technologies and cross-cutting scientific               through Friday.                                       radiation. FDA is tasked with advancing
                                                advances of importance to FDA. The                         • Confidential Submissions—To                      the public health by helping to speed
                                                focus is on areas that may impact FDA                   submit a comment with confidential                    innovations that protect the public
                                                in 5 or more years.                                     information that you do not wish to be                health. FDA also has responsibility for
                                                DATES: Submit either electronic or                      made publicly available submit your                   regulating the manufacturing,
                                                written comments by October 21, 2019.                   comments only as a written/paper                      marketing, and distribution of tobacco
                                                ADDRESSES: You may submit comments                      submission. You should submit two                     products, to protect the public health,
                                                as follows:                                             copies total. One copy will include the               and to reduce tobacco use by minors.
                                                                                                        information you claim to be confidential              Finally, FDA plays a significant role in
                                                Electronic Submissions                                  with a heading or cover note that states              the Nation’s counterterrorism capability.
                                                  Submit electronic comments in the                     ‘‘THIS DOCUMENT CONTAINS                              FDA fulfills this responsibility by
                                                following way:                                          CONFIDENTIAL INFORMATION.’’ The                       ensuring the security of the food supply,
                                                  • Federal eRulemaking Portal: http://                 Agency will review this copy, including               and by fostering development of
                                                www.regulations.gov. Follow the                         the claimed confidential information, in              medical products used to respond to
                                                instructions for submitting comments.                   its consideration of comments. The                    deliberate and naturally emerging
                                                Comments submitted electronically,                      second copy, which will have the                      public health threats.
                                                including attachments, to http://                       claimed confidential information                         FDA’s ability to achieve its mission
                                                www.regulations.gov will be posted to                   redacted/blacked out, will be available               relies on awareness of, and proactive
                                                the docket unchanged. Because your                      for public viewing and posted on http://              preparedness for, emerging issues and
                                                comment will be made public, you are                    www.regulations.gov. Submit both                      scientific advances, which will impact
                                                solely responsible for ensuring that your               copies to the Division of Dockets                     the development of regulated products
                                                comment does not include any                            Management. If you do not wish your                   well in advance of formal FDA
                                                confidential information that you or a                  name and contact information to be                    regulatory submissions (e.g., 5–10
                                                third party may not wish to be posted,                  made publicly available, you can                      years). To realize this goal requires long-
                                                such as medical information, your or                    provide this information on the cover                 range horizon scanning by a cadre of
                                                anyone else’s Social Security number, or                sheet and not in the body of your                     scientific leaders from FDA, other
                                                confidential business information, such                 comments and you must identify this                   government Agencies, interested
                                                as a manufacturing process. Please note                 information as ‘‘confidential.’’ Any                  stakeholders, and the public. Emerging
                                                that if you include your name, contact                  information marked as ‘‘confidential’’                sciences, such as synthetic biology, are
                                                information, or other information that                  will not be disclosed except in                       expected to impact FDA regulated
                                                                                                        accordance with 21 CFR 10.20 and other
sradovich on DSK3GMQ082PROD with NOTICES




                                                identifies you in the body of your                                                                            products in the relatively near term. The
                                                comments, that information will be                      applicable disclosure law. For more                   goal of this initiative is to identify issues
                                                posted on http://www.regulations.gov.                   information about FDA’s posting of                    and advances that will impact the
                                                  • If you want to submit a comment                     comments to public dockets, see 80 FR                 Agency in the longer term and thus may
                                                with confidential information that you                  56469, September 18, 2015, or access                  be in their infancy.
                                                do not wish to be made available to the                 the information at: http://www.fda.gov/                  FDA formed the Emerging Sciences
                                                public submit the comment as a written/                 regulatoryinformation/dockets/                        Working Group to provide an FDA-wide
                                                paper submission and in the manner                      default.htm.                                          science-based forum to identify and


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Document Created: 2016-10-19 02:11:55
Document Modified: 2016-10-19 02:11:55
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.
DatesSubmit written comments on the collection of information by November 18, 2016.
ContactLouise Ryan, telephone: (206) 615- 2514; email: [email protected]
FR Citation81 FR 72057 

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