81 FR 72592 - 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 203 (October 20, 2016)

Page Range		72592-72593
FR Document		2016-25418

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 203 (Thursday, October 20, 2016)

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Notices]
[Pages 72592-72593]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25418]


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

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 21, 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 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 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

[[Page 72593]]

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
                    Summary                            programs            Ombudsman        Total burden hours                 52 Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Hours..........................................               132.1                   17                149.1   7,753 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: October 12, 2016.
Edwin L. Walker,
Acting Administrator and Assistant Secretary for Aging.
[FR Doc. 2016-25418 Filed 10-19-16; 8:45 am]
 BILLING CODE 4154-01-P

72592 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices

collection tool may be found on the ACL helping elderly people avoid 3. Statewide program operations; and
Web site: http://www.aoa.acl.gov/ institutionalization. The renewal is to 4. Ombudsman activities in addition
Program_Results/Program_survey.aspx. complete the data collection related to to complaint investigation.
The total burden estimate for the objective 3. 5. A new requirement to include
remaining data collection is: 482.67 In response to the 60-day Federal organizational conflict of interest
hours. Register notice related to this proposed reporting as required by the
data collection and published on July reauthorized Older Americans Act and
Dated: October 12, 2016.
19, 2016, no relevant comments were the LTC Ombudsman program rule CFR
Edwin L. Walker,
was received. The proposed data 1324.21.
Acting Assistant Secretary for Aging. The report form and instructions have
collection tool may be found on the ACL
[FR Doc. 2016–25416 Filed 10–19–16; 8:45 am]
Web site: http://www.aoa.acl.gov/ been in continuous use, with minor
BILLING CODE 4154–01–P
Program_Results/Program_survey.aspx. modifications, since they were first
The total burden estimate for the approved by OMB for the FY 1995
remaining data collection is: 192 hours. reporting period. This current request is
DEPARTMENT OF HEALTH AND for a Revision of a Currently Approved
HUMAN SERVICES Dated: October 14, 2016. Collection (ICR Rev), which will
Edwin L. Walker, provide approval for FFY 2016–2018
Administration for Community Living Acting Assistant Secretary for Aging. with modifications to include
[FR Doc. 2016–25414 Filed 10–19–16; 8:45 am] organizational conflict of interest
Agency Information Collection
BILLING CODE 4154–01–P reporting as required by the
Activities; Submission for OMB
reauthorized Older Americans Act,
Review; Comment Request; Evaluation
Section 712(f) and the LTC Ombudsman
of the Elderly Nutritional Services DEPARTMENT OF HEALTH AND program rule CFR 1324.21.
Program HUMAN SERVICES The data collected on complaints filed
AGENCY: Administration for Community with ombudsman programs and
Living, HHS. Administration for Community Living/ narrative on long-term care issues
Administration on Aging provide information to Centers for
ACTION: Notice.
Medicare and Medicaid Services and
Agency Information Collection
SUMMARY: The Administration for others on patterns of concerns and
Activities; Public Comment Request;
Community Living (formerly the major long-term care issues affecting
State Annual Long-Term Care
Administration on Aging (AoA)) is residents of long-term care facilities.
Ombudsman Report and Instructions
announcing that the continuation of Both the complaint and program data
collection of information listed below AGENCY: Administration for Community collected assist the states and local
has been submitted to the Office of Living/Administration on Aging, HHS. ombudsman programs in planning
Management and Budget (OMB) for ACTION: Notice. strategies and activities, providing
review and clearance under the training and technical assistance and
Paperwork Reduction Act of 1995. SUMMARY: The Administration on Aging developing performance measures.
DATES: Submit written comments on the (AoA) is announcing that the proposed
Comments in Response to the 60 Day
collection of information by November collection of information listed below
Federal Register Notice
21, 2016. has been submitted to the Office of
Management and Budget (OMB) for A notice was published in the Federal
ADDRESSES: Submit written comments
review and clearance under the Register/Vol. 81, No. 126/Thursday,
on the collection of information by fax
Paperwork Reduction Act of 1995. June 30, 2016 Notices, Pages 42712–
202.395.6974 to the OMB Desk Officer
DATES: Submit written comments on the 42713, announcing that AoA was
for ACL, Office of Information and
collection of information by November requesting modification of the current
Regulatory Affairs, OMB.
21, 2016. form and instructions to incorporate
FOR FURTHER INFORMATION CONTACT: conflict of interest reporting
Susan Jenkins, 202.795.7369. ADDRESSES: Submit written comments
requirements, directing readers to the
SUPPLEMENTARY INFORMATION: In on the collection of information by fax
AoA Web site where these documents
compliance with 44 U.S.C. 3507, the 202.395.5806 or by email to OIRA_
are posted and providing an opportunity
Administration for Community Living submission@omb.eop.gov, Attn: OMB
for public comment. One comment was
(Formerly the Administration for Aging) Desk Officer for ACL.
received from the National Association
has submitted the following proposed FOR FURTHER INFORMATION CONTACT: of Ombudsman Programs (NASOP).
collection of information to OMB for Louise Ryan, telephone: (206) 615–2514; NASOP members disagreed with the
review and clearance. The data email: louise.ryan@acl.hhs.gov burden estimate developed by AoA,
collection associated with the SUPPLEMENTARY INFORMATION: In stating:
Evaluation of the Elderly Nutrition compliance with 44 U.S.C. 3507, AoA Because an overwhelming majority of
Services Program (ENSP) is necessary to has submitted the following proposed state long-term care ombudsman
meet three broad objectives of ACL: (1) collection of information to OMB for programs designate local ombudsman
To provide information to support review and clearance. entities, those circumstances lead to a
program planning, including an analysis States provide the following data and greater likelihood of organizational
of program processes, (2) to develop narrative information in the report: conflicts of interest. The burden is
mstockstill on DSK3G9T082PROD with NOTICES

information about program efficiency 1. Numbers and descriptions of cases compounded by the number of local
and cost issues, and (3) to assess filed and complaints made on behalf of ombudsman entities within a state and
program effectiveness, as measured by long-term care facility residents to the will have multiple sources of reporting
the program’s effects on a variety of statewide ombudsman program; organizational conflicts at local or
important outcomes, including nutrient 2. Major issues identified that impact regional levels up to the states before
adequacy, socialization opportunities, the quality of care and life of long-term states can report via NORS. Further,
health outcomes, and, ultimately, care facility residents; because approximately half of state

VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Notices 72593

long-term care ombudsman programs a reporting entry. These suggestions A reporting form and instructions
are housed within an umbrella agency, were helpful and were incorporated into may be viewed in the ombudsman
this also increases the likelihood that the instructions and form. They did not section of the AoA Web site: http://
state programs have multiple affect the estimated burden. www.aoa.acl.gov/AoA_Programs/Elder_
organizational conflicts that must be NASOP also recommended that AoA/ Rights/Ombudsman/index.aspx. AoA
identified, remedied or removed, and ACL add a reporting option in a check estimates the burden of this collection
reported via NORS. box to indicate a state has identified a and entering the additional report
In response to NASOP’s concerns conflict, but the conflict has not been information as follows: Approximately
about burden estimates, we made a remedied. We do not intend to take this
10 to 60 minutes per respondent,
change in our estimated burden hours recommendation because it would be
depending on the number of conflicts to
from one-half hour per state to one hour contrary to the rule and law which
require states to identify, remove or report, with 52 state Ombudsman
per state.
NASOP requested additions to the remedy conflicts and to report on such programs responding annually. This
instructions and report form such as the remedies. ACL is providing on-going brings the total burden hours to
ability to certify that there was no technical assistance to states on the approximately 7,753 hours, (149 hours
change in conflicts/remedies from the implementation of the Ombudsman on average per program) with 52 Offices
previous reporting year; and to allow for program rule, including technical of Long-Term Care Ombudsman
the ability to report a conflict and assistance on conflicts of interest and programs responding annually.
remedy that applies to many entities as steps to remedy any identified conflicts.

Local Ombudsman Office of state Total burden
Summary 52 Programs
programs Ombudsman hours

Hours ................................................................................... 132.1 17 149.1 7,753 hours.

Dated: October 12, 2016. OMB, Attn: FDA Desk Officer, FAX: application sponsors. In addition to Pre-
Edwin L. Walker, 202–395–7285, or emailed to oira_ Submissions, the guidance addresses
Acting Administrator and Assistant Secretary submission@omb.eop.gov. All other feedback mechanisms including
for Aging. comments should be identified with the Informational Meetings, Study Risk
[FR Doc. 2016–25418 Filed 10–19–16; 8:45 am] OMB control number 0910–0756. Also Determinations, Formal Early
BILLING CODE 4154–01–P include the FDA docket number found Collaboration Meetings, and Submission
in brackets in the heading of this Issue Meetings and the procedures to
document. request feedback using these
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: FDA mechanisms.
HUMAN SERVICES PRA Staff, Office of Operations, Food A Pre-Submission is defined as a
and Drug Administration, Three White formal written request from an applicant
Food and Drug Administration for feedback from FDA to be provided
Flint North 10A63, 11601 Landsdown
[Docket No. FDA–2012–D–0530] St., North Bethesda, MD 20852, in the form of a formal written response
PRAStaff@fda.hhs.gov. or, if the manufacturer chooses, a
Agency Information Collection SUPPLEMENTARY INFORMATION: In meeting or teleconference in which the
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA feedback is documented in meeting
Management and Budget Review; has submitted the following proposed minutes. A Pre-Submission is
Comment Request; Pre-Submission collection of information to OMB for appropriate when FDA’s feedback on
Program for Medical Devices review and clearance. specific questions is necessary to guide
product development and/or
AGENCY: Food and Drug Administration, Pre-Submission Program for Medical application preparation. The proposed
HHS. Devices—OMB Control Number 0910– collections of information are necessary
ACTION: Notice. 0756—Extension to allow the Agency to receive Pre-
The guidance entitled ‘‘Requests for Submission packages in order to
SUMMARY: The Food and Drug implement this voluntary submission
Feedback on Medical Device
Administration (FDA) is announcing Submissions: The Pre-Submission program.
that a proposed collection of Program and Meetings with Food and For clarity, we are requesting that the
information has been submitted to the Drug Administration Staff’’ describes title of the information collection
Office of Management and Budget the Pre-Submission program for medical request, OMB control number 0910–
(OMB) for review and clearance under devices reviewed in the Center for 0756, be changed to ‘‘Pre-Submission
the Paperwork Reduction Act of 1995. Devices and Radiological Health (CDRH) Program for Medical Devices.’’
DATES: Fax written comments on the and the Center for Biologics Evaluation In the Federal Register of July 28,
collection of information by November and Research (CBER). The guidance 2016 (81 FR 49678), FDA published a
21, 2016. provides recommendations regarding 60-day notice requesting public
ADDRESSES: To ensure that comments on the information that should be comment on the proposed collection of
mstockstill on DSK3G9T082PROD with NOTICES

the information collection are received, submitted in a Pre-Submission package information. No comments were
OMB recommends that written and procedures that should be followed received.
comments be faxed to the Office of for meetings between CDRH and CBER FDA estimates the burden of this
Information and Regulatory Affairs, staff and industry representatives or collection of information as follows:

VerDate Sep<11>2014 16:40 Oct 19, 2016 Jkt 241001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

Document Created: 2016-10-21 09:59:16
Document Modified: 2016-10-21 09:59:16

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit written comments on the collection of information by November 21, 2016.
Contact		Louise Ryan, telephone: (206) 615- 2514; email: [email protected]
FR Citation		81 FR 72592

81 FR 72592 - Agency Information Collection Activities; Public Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Community Living/Administration on Aging

Federal Register Volume 81, Issue 203 (October 20, 2016)

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