83 FR 8086 - Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Community Living
Administration on Aging Federal Register Volume 83, Issue 37 (February 23, 2018)
Administration for Community Living
Administration on Aging
Federal Register Volume 83, Issue 37 (February 23, 2018)
| Page Range | 8086-8088 | |
| FR Document | 2018-03767 |
[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)] [Notices] [Pages 8086-8088] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03767] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Aging Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005) AGENCY: Administration for Community Living/Administration on Aging, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Administration for Community Living/Administration on Aging (ACL/AoA) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Long-Term Care Ombudsman Program (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)). DATES: Submit written comments on the collection of information by March 26, 2018. ADDRESSES: Submit written comments on the collection of information by fax to 202.395.5806, Attn: OMB Desk Officer for ACL; by email to [email protected], Attn: OMB Desk Officer for ACL; or by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC 20503, 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, ACL/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. [[Page 8087]] 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) to acquire new approval for a revised modification of instruction and data collection elements for FFY 2019-2021. The data collected on complaints filed with ombudsman programs and narrative on long-term care issues provide information to the 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. 152, Page 52438 on Monday, August 8, 2016 announcing that ACL/AoA was requesting comments on: (1) Whether the proposed collection of information is necessary for the proper performance of ACL/AoA's functions, including whether the information will have practical utility; (2) the accuracy of ACL/AoA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology. Readers were directed to the ACL/AoA website where the documents were posted and provided an opportunity to comment. ACL received comments from 18 individuals and groups. Comments were received by the following groups and individuals: National Association of State Ombudsman Programs (NASOP); National Association of Local LTC Ombudsman (NALLTCO); one software vendor; the California Association of Local LTC Ombudsmen; the Consumer Voice for Quality LTC Care. Individuals included one researcher with expertise in dementia, abuse and neglect and one local representative of the Office of State Ombudsman. The following State Ombudsman programs provided comment: California; Florida; Maryland; New York; Iowa; Pennsylvania; Arizona; New Hampshire; Texas; Alaska; Virginia. Many of the state Ombudsman comments were identical to NASOP's comments. In general, there were no significant comments on the proposed data elements. Instead, comments focused on ways to enhance the quality, utility, and clarity of the information to be collected. These comments were very helpful and many of the proposed edits and language suggestions were adopted. Concerns regarding burden included: Disagreement about the burden hours because of changes in data collection requirements and additional structured requirements of narrative complaint examples, systems issues and conflicts of interest reporting. The new reporting system will streamline these current reporting activities, allowing for flexibility and the ability to import data from the previous year for use in the next year, where appropriate, and will reduce overall reporting burden for State LTC Ombudsmen. Several commenters expressed concern about undue burden of a name change from ``board and care'' to ``residential care community'', but did not provide a specific estimate of burden hours. In response to their concerns the definition of residential care was revised to eliminate any confusion about the jurisdiction of the program with regards to the types of settings the program serves. ACL does not believe that a change in definition and title will cause confusion at the state and local level because there will not be a change in state level practice. These concerns are addressed in detail in the response to comments tables posted on the ACL website. Some responders expressed concern about burden with a data collection item to indicate if a complaint was a complaint on behalf of more than one complainant, i.e., a ``group complaint'' (Table 1, code C5 on the 60 day submission). ACL removed this data element. Some commenters expressed concerns about the cost to update and revise their reporting systems, but the estimates of impact on data collection burden varied. One State that has developed their own software utilizing in-house IT services, estimates a range from 9-52 days of work for software changes and 5-55 days to update training materials, update their in-house reference guide, provide training, etc. Another state estimates that the changes required will cost around $10,000. One vendor commented that they see ``no issue'' with the proposed changes and that they are committed to keeping all of their customers using their Ombudsman product up to date with any NORS reporting changes. Since the comments were not consistent in this area no changes have been made. Additional concerns about the wording in proposed definitions and requests to add additional data collection elements are addressed in the response to comments tables. Some commenters expressed concerns about training needs and time required to adapt their software. ACL is working with the contractor developing the reporting software to develop training modules on how to use the new software. ACL anticipates that states will not need to develop training materials or host training to meet the federal reporting requirements. Training will be offered as webinars and in person at national conferences, when possible. User support materials and recorded webinars will also be available on the submission website. The National Ombudsman Resource Center will develop modules on how to interpret the new definitions and codes similar to past training. This includes hosting webinars and providing in-person training at their annual spring training for state LTC Ombudsmen. In addition, they will host all tools and modules on their website. The contractor is holding meetings with vendors and state information technology staff on the technical requirements of the new system and will provide data templates in various formats; and detailed crosswalks of the current data collection to the new data collection. Despite the concerns addressed, there was an overall positive tone to the comments. State Ombudsman programs largely support the changes made by ACL to NORS. They indicated they appreciate ACL's efforts to incorporate many of the revisions previously recommended. Further, they indicated these changes will result in more accurate and consistent reporting as well as more precise identification of trends and the systems advocacy needed to address common complaints. Estimated Program Burden In consideration of the comments, additional burden time has been factored in to accommodate changes in data collection at the case level resulting in an average increase of 75.6 hours per state for a total 223.6 hours annually. Despite the decrease in the number of data elements we believe this more adequately reflects the overall burden. This increase in burden hours also recognizes that this revision is the most significant change to NORS data collection since its implementation in 1995. [[Page 8088]] The reporting form tables and a crosswalk from the old data collection to the new may be viewed at the ACL website: https://www.acl.gov/about-acl/public-input. AoA estimates the burden of this collection and entering the additional report information as follows: ---------------------------------------------------------------------------------------------------------------- Number Average burden Instrument Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- Annual State Ombudsman Report............... 52 1 223.6 11,628.6 ---------------------------------------------------------------------------------------------------------------- Dated: February 16, 2018. Mary Lazare, Administrator and Assistant Secretary for Aging. [FR Doc. 2018-03767 Filed 2-22-18; 8:45 am] BILLING CODE 4154-01-P
![8086 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
the General Services Administration, 299b–21 to b–26, (Patient Safety Act) DEPARTMENT OF HEALTH AND
Regulatory Secretariat Division (MVCB), and the related Patient Safety and HUMAN SERVICES
1800 F Street NW, Washington, DC Quality Improvement Final Rule, 42
20405. Please cite OMB Control No. CFR part 3 (Patient Safety Rule), Administration for Community Living
3090–0293, Reporting and Use of published in the Federal Register on
Information Concerning Integrity and November 21, 2008, 73 FR 70732– Administration on Aging
Performance of Recipients of Grants and 70814, establish a framework by which
Cooperative Agreements, in all Agency Information Collection
hospitals, doctors, and other health care Activities; Submission for OMB
correspondence. providers may voluntarily report Review; Public Comment Request;
Dated: February 20, 2018. information to Patient Safety State Annual Long-Term Care
David A. Shive, Organizations (PSOs), on a privileged Ombudsman Report Known as the
Chief Information Officer. and confidential basis, for the National Ombudsman Reporting
[FR Doc. 2018–03745 Filed 2–22–18; 8:45 am] aggregation and analysis of patient System (NORS) and Instructions (OMB
BILLING CODE 6820–WY–P safety events. No: 0985–0005)
The Patient Safety Act authorizes the AGENCY: Administration for Community
listing of PSOs, which are entities or Living/Administration on Aging, HHS.
DEPARTMENT OF HEALTH AND component organizations whose ACTION: Notice.
HUMAN SERVICES mission and primary activity are to
conduct activities to improve patient SUMMARY: The Administration for
Agency for Healthcare Research and Community Living/Administration on
safety and the quality of health care
Quality Aging (ACL/AoA) is announcing that
delivery. HHS issued the Patient Safety
Patient Safety Organizations: Expired Rule to implement the Patient Safety the proposed collection of information
Listing for Quality Solutions Act. AHRQ administers the provisions listed above has been submitted to the
of the Patient Safety Act and Patient Office of Management and Budget
AGENCY: Agency for Healthcare Research Safety Rule relating to the listing and (OMB) for review and clearance as
and Quality (AHRQ), Department of operation of PSOs. The Patient Safety required under the Paperwork
Health and Human Services (HHS). Rule authorizes AHRQ to list as a PSO Reduction Act of 1995. This 30-day
ACTION: Notice of delisting. an entity that attests that it meets the notice collects comments on the
statutory and regulatory requirements information collection requirements
SUMMARY: The Patient Safety Rule related to the Long-Term Care
authorizes AHRQ, on behalf of the for listing. A PSO can be ‘‘delisted’’ if
Ombudsman Program (Proposed
Secretary of HHS, to list as a PSO an it is found to no longer meet the
Extension with Changes of a Currently
entity that attests that it meets the requirements of the Patient Safety Act
Approved Collection (ICR Rev)).
statutory and regulatory requirements and Patient Safety Rule, when a PSO
DATES: Submit written comments on the
for listing. A PSO can be ‘‘delisted’’ by chooses to voluntarily relinquish its
collection of information by March 26,
the Secretary if it is found to no longer status as a PSO for any reason, or when
2018.
meet the requirements of the Patient a PSO’s listing expires. Section 3.108(d)
ADDRESSES: Submit written comments
Safety Act and Patient Safety Rule, of the Patient Safety Rule requires
on the collection of information by fax
when a PSO chooses to voluntarily AHRQ to provide public notice when it
to 202.395.5806, Attn: OMB Desk
relinquish its status as a PSO for any removes an organization from the list of
Officer for ACL; by email to OIRA_
reason, or when a PSO’s listing expires. federally approved PSOs. submission@omb.eop.gov, Attn: OMB
The listing for Quality Solutions has Quality Solutions, PSO number Desk Officer for ACL; or by mail to the
expired and AHRQ has delisted the PSO
P0165, is a component entity of: Chest Office of Information and Regulatory
accordingly.
Medicine Associates, Coastal Women’s Affairs, OMB, New Executive Office
DATES: The directories for both listed
Healthcare, Eyecare Medical Group, Bldg., 725 17th St. NW, Rm. 10235,
and delisted PSOs are ongoing and Maine Nephrology Associates, New Washington, DC 20503, Attn: OMB Desk
reviewed weekly by AHRQ. The Officer for ACL.
England Cancer Specialists, Plastic &
delisting was effective at 12:00 Midnight
Hand Surgical Associates, Portland FOR FURTHER INFORMATION CONTACT:
ET (2400) on January 6, 2018.
Gastroenterology, and Spectrum Louise Ryan, telephone: (206) 615–2514;
ADDRESSES: Both directories can be email: louise.ryan@acl.hhs.gov.
Medical Group. The PSO chose to let its
accessed electronically at the following
listing expire by not seeking continued SUPPLEMENTARY INFORMATION: In
HHS website: http://www.pso.ahrq.gov/
listing. Accordingly, Quality Solutions compliance with 44 U.S.C. 3507, ACL/
listed.
was delisted effective at 12:00 Midnight AoA has submitted the following
FOR FURTHER INFORMATION CONTACT: proposed collection of information to
ET (2400) on January 6, 2018.
Eileen Hogan, Center for Quality OMB for review and clearance.
Improvement and Patient Safety, AHRQ, More information on PSOs can be
States provide the following data and
5600 Fishers Lane, Room 06N94B, obtained through AHRQ’s PSO website narrative information in the report:
Rockville, MD 20857; Telephone (toll at http://www.pso.ahrq.gov. 1. Numbers and descriptions of cases
free): (866) 403–3697; Telephone (local): Karen J. Migdail, filed and complaints made on behalf of
(301) 427–1111; TTY (toll free): (866) long-term care facility residents to the
daltland on DSKBBV9HB2PROD with NOTICES
438–7231; TTY (local): (301) 427–1130; Chief of Staff.
statewide ombudsman program;
Email: pso@ahrq.hhs.gov. [FR Doc. 2018–03744 Filed 2–22–18; 8:45 am]
2. Major issues identified that impact
SUPPLEMENTARY INFORMATION: BILLING CODE 4160–90–P the quality of care and life of long-term
care facility residents;
Background 3. Statewide program operations; and
The Patient Safety and Quality 4. Ombudsman activities in addition
Improvement Act of 2005, 42 U.S.C. to complaint investigation.
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![8088 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices
The reporting form tables and a website: https://www.acl.gov/about-acl/ AoA estimates the burden of this
crosswalk from the old data collection public-input. collection and entering the additional
to the new may be viewed at the ACL report information as follows:
Average
Number
Number of burden per Total burden
Instrument responses per
respondents response hours
respondent (in hours)
Annual State Ombudsman Report .................................................................. 52 1 223.6 11,628.6
Dated: February 16, 2018. 2018. The https://www.regulations.gov Instructions: All submissions received
Mary Lazare, electronic filing system will accept must include the Docket Nos. FDA–
Administrator and Assistant Secretary for comments until midnight Eastern Time 2015–E–2602 and FDA–2015–E–2615
Aging. at the end of April 24, 2018. Comments for ‘‘Determination of Regulatory
[FR Doc. 2018–03767 Filed 2–22–18; 8:45 am] received by mail/hand delivery/courier Review Period for Purposes of Patent
BILLING CODE 4154–01–P (for written/paper submissions) will be Extension; ZYDELIG–NDA 206545.’’
considered timely if they are Received comments, those filed in a
postmarked or the delivery service timely manner (see ADDRESSES), will be
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that placed in the dockets and, except for
HUMAN SERVICES date. those submitted as ‘‘Confidential
Electronic Submissions Submissions,’’ publicly viewable at
Food and Drug Administration https://www.regulations.gov or at the
Submit electronic comments in the Dockets Management Staff between 9
[Docket Nos. FDA–2015–E–2602; FDA–
following way: a.m. and 4 p.m., Monday through
2015–E–2615]
• Federal eRulemaking Portal: Friday.
Determination of Regulatory Review https://www.regulations.gov. Follow the • Confidential Submissions—To
Period for Purposes of Patent instructions for submitting comments. submit a comment with confidential
Extension; ZYDELIG—New Drug Comments submitted electronically, information that you do not wish to be
Application 206545 including attachments, to https:// made publicly available, submit your
www.regulations.gov will be posted to comments only as a written/paper
AGENCY: Food and Drug Administration, the docket unchanged. Because your submission. You should submit two
HHS. comment will be made public, you are copies total. One copy will include the
ACTION: Notice. solely responsible for ensuring that your information you claim to be confidential
comment does not include any with a heading or cover note that states
SUMMARY: The Food and Drug confidential information that you or a
Administration (FDA or the Agency) has ‘‘THIS DOCUMENT CONTAINS
third party may not wish to be posted, CONFIDENTIAL INFORMATION.’’ The
determined the regulatory review period such as medical information, your or
for ZYDELIG based on new drug Agency will review this copy, including
anyone else’s Social Security number, or the claimed confidential information, in
application (NDA) 206545 and is confidential business information, such
publishing this notice of that its consideration of comments. The
as a manufacturing process. Please note
determination as required by law. FDA second copy, which will have the
that if you include your name, contact
has made the determination because of claimed confidential information
information, or other information that
the submission of applications to the redacted/blacked out, will be available
identifies you in the body of your
Director of the U.S. Patent and for public viewing and posted on
comments, that information will be
Trademark Office (USPTO), Department https://www.regulations.gov. Submit
posted on https://www.regulations.gov.
of Commerce, for the extension of a • If you want to submit a comment both copies to the Dockets Management
patent which claims that human drug with confidential information that you Staff. If you do not wish your name and
product. do not wish to be made available to the contact information to be made publicly
public, submit the comment as a available, you can provide this
DATES: Anyone with knowledge that any information on the cover sheet and not
of the dates as published (in the written/paper submission and in the
manner detailed (see ‘‘Written/Paper in the body of your comments and you
SUPPLEMENTARY INFORMATION section) are must identify this information as
incorrect may submit either electronic Submissions’’ and ‘‘Instructions’’).
‘‘confidential.’’ Any information marked
or written comments and ask for a Written/Paper Submissions as ‘‘confidential’’ will not be disclosed
redetermination by April 24, 2018. Submit written/paper submissions as except in accordance with § 10.20 (21
Furthermore, any interested person may follows: CFR 10.20) and other applicable
petition FDA for a determination • Mail/Hand delivery/Courier (for disclosure law. For more information
regarding whether the applicant for written/paper submissions): Dockets about FDA’s posting of comments to
extension acted with due diligence Management Staff (HFA–305), Food and public dockets, see 80 FR 56469,
during the regulatory review period by Drug Administration, 5630 Fishers September 18, 2015, or access the
August 22, 2018. See ‘‘Petitions’’ in the Lane, Rm. 1061, Rockville, MD 20852. information at: https://www.gpo.gov/
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION section for • For written/paper comments fdsys/pkg/FR-2015-09-18/pdf/2015-
more information. submitted to the Dockets Management 23389.pdf.
ADDRESSES: You may submit comments Staff, FDA will post your comment, as Docket: For access to the docket to
as follows. Please note that late, well as any attachments, except for read background documents or the
untimely filed comments will not be information submitted, marked and electronic and written/paper comments
considered. Electronic comments must identified, as confidential, if submitted received, go to https://
be submitted on or before April 24, as detailed in ‘‘Instructions.’’ www.regulations.gov and insert the
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Document Created: 2018-02-23 01:32:20
Document Modified: 2018-02-23 01:32:20
| 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 March 26, 2018. | |
| Contact | Louise Ryan, telephone: (206) 615- 2514; email: [email protected] | |
| FR Citation | 83 FR 8086 |
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