Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety Institute, 40146-40147 [2013-15732]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES 40146 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices However, the total annual reporting hour burden on filers themselves is zero and not the 563 hours estimated above because OGE’s estimating methodology reflects the fact that all respondents hire private trust administrators or other private representatives to set up and maintain the qualified blind and diversified trusts. Respondents themselves, typically incoming private citizen Presidential nominees, therefore incur no hour burden. The estimated total annual cost burden to respondents resulting from the collection of information is $1,000,000. Those who use the model documents for guidance are private trust administrators or other private representatives hired to set up and maintain the qualified blind and diversified trusts of executive branch officials who seek to establish such qualified trusts. The cost burden figure is based primarily on OGE’s knowledge of the typical trust administrator fee structure (an average of 1 percent of total assets) and OGE’s experience with administration of the qualified trust program. The $1,000,000 annual cost figure is based on OGE’s estimate of an average of five possible active trusts anticipated to be under administration for each of the next three years with combined total assets of $100,000,000. However, OGE notes that the $1,000,000 figure is a cost estimate for the overall administration of the trusts, only a portion of which relates to information collection and reporting. For want of a precise way to break out the costs directly associated with information collection, OGE is continuing to report to OMB the full $1,000,000 estimate for paperwork clearance purposes. On December 27, 2012, OGE published a first round notice of its intent to request paperwork clearance for the proposed unmodified qualified trust certificates and modified model trust documents. See 77 FR 76293– 76294. OGE did not receive any responses to that notice. In this second notice, public comment is again invited on each aspect of the model qualified trust certificates and model trust documents, and underlying regulatory provisions, as set forth in this notice, including specific views on the need for and practical utility of this set of collections of information, the accuracy of OGE’s burden estimate, the potential for enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 Approved: June 27, 2013. Walter M. Shaub, Jr., Director, Office of Government Ethics. [FR Doc. 2013–15888 Filed 7–2–13; 8:45 am] BILLING CODE 6345–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice of Meeting Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of one AHRQ Subcommittee Meetings by Virtual Review. AGENCY: The subcommittee listed below is part of AHRQ’s Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at this meeting. This meeting will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6). Name of Subcommittee: Health Care Research Training Virtual Review. Date: July 11, 2013 (Open from 9:00 a.m. to 9:30 a.m. on July 11 and closed for remainder of the meeting). Place: Agency for Healthcare Research and Quality, John Eisenberg Building, 540 Gaither Road, OEREP Conference Room, Rockville, MD 20850. FOR FURTHER INFORMATION CONTACT: (To obtain a roster of members, agenda or minutes of the non-confidential portions of this meeting.) Mrs. Bonnie Campbell, Committee Management Officer, Office of Extramural Research Education and Priority Populations, AHRQ, 540 Gaither Road, Suite 2000, Rockville, Maryland 20850, Telephone (301) 427– 1554. SUPPLEMENTARY INFORMATION: In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), AHRQ announces meetings of the scientific peer review groups listed above, which are subcommittees of AHRQ’s Health Services Research Initial Review Group Committee. The subcommittee meetings will be closed to the public in accordance with the provisions set forth in 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6). The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Agenda items for these meeting are subject to change as priorities dictate. Dated: June 20, 2013. Carolyn M. Clancy, Director. [FR Doc. 2013–15733 Filed 7–2–13; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety Institute Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. AGENCY: The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Pubic Law 109–41, 42 U.S.C. 299b–21—b–26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Northern Metropolitan Patient Safety Institute of its status as a PSO, and has delisted the PSO accordingly. DATES: The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on May 29, 2013. ADDRESSES: Both directories can be accessed electronically at the following HHS Web site: http:// www.pso.AHRQ.gov/index.html. FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403–3697; SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices Telephone (local): (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@AHRQ.hhs.gov. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES Background The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity is to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule (PDF file, 450 KB. PDF Help) relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. AHRQ has accepted a notification from the Northern Metropolitan Patient Safety Institute, PSO number P0021, which is a component entity of Northern Metropolitan Hospital Association, to voluntarily relinquish its status as a PSO. Accordingly, the Northern Metropolitan Patient Safety Institute was delisted effective at 12:00 Midnight ET (2400) on May 29, 2013. Northern Metropolitan Patient Safety Institute has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification of providers that have reported to the PSO. In addition, according to section 3.108(c)(2)(ii) of the Patient Safety Rule regarding disposition of PSWP, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO’s possession. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.AHRQ.gov/ index.html. Dated: June 21, 2013. Carolyn M. Clancy, Director. [FR Doc. 2013–15732 Filed 7–2–13; 8:45 am] BILLING CODE 4160–90–M VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Scientific Information Request on Vitamin D and Calcium Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on Vitamin D and Calcium. Scientific information is being solicited to inform the Vitamin D and Calcium: A Systematic Review of Health Outcomes project, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on vitamin D and calcium will improve the quality of this systematic review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108–173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). SUMMARY: Submission Deadline on or before August 2, 2013. ADDRESSES: Online submissions: http:// effectivehealthcare.AHRO.gov/ index.cfm/submitscientific-informationpackets/. Please select the study for which you are submitting information from the list to upload your documents. Email submissions: SIPS@epc-src.org. Print submissions: Mailing Address: Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, PO Box 69539, Portland, OR 97239. Shipping Address (FedEx, UPS, etc.): Portland VA Research Foundation, Scientific Resource Center, ATTN: Scientific Information Packet Coordinator, 3710 SW U.S. Veterans HospitaL Road, Mail Code: R&D 71, Portland, OR 97239. FOR FURTHER INFORMATION CONTACT: Robin Paynter, Research Librarian, Telephone: 503–220–8262 ext. 58652 or Email: SIPS@epc-src.org. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Effective Health Care (EHC) Program Evidencebased Practice Centers to complete a DATES: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 40147 review of the evidence for Vitamin D and Calcium: A Systematic Review of Health Outcomes. The EHC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on vitamin D and calcium, including those that describe adverse events, as specified in the key questions detailed below. The entire research protocol, including the key questions, is also available online at: http:// effectivehealthcare.AHRQ.gov/searchforquides-reviews-and-reports/ ?pageaction=displayproduct& productID=1529 This notice is to notify the public that the EHC program would find the following information on Vitamin D and Calcium helpful: • A list of completed studies your company has sponsored for this indication. In the list, indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. • For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. • A list of ongoing studies your company has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. • A description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your company for this indication and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. 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. Materials that are considered confidential; marketing materials; pharmacoeconomic, E:\FR\FM\03JYN1.SGM 03JYN1

Agencies

[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40146-40147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15732]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment From 
Northern Metropolitan Patient Safety Institute

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice of Delisting.

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SUMMARY: The Patient Safety and Quality Improvement Act of 2005 
(Patient Safety Act), Pubic Law 109-41, 42 U.S.C. 299b-21--b-26, 
provides for the formation of Patient Safety Organizations (PSOs), 
which collect, aggregate, and analyze confidential information 
regarding the quality and safety of health care delivery. The Patient 
Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR 
Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as 
a PSO an entity that attests that it meets the statutory and regulatory 
requirements for listing. A PSO can be ``delisted'' by the Secretary if 
it is found no longer to meet the requirements of the Patient Safety 
Act and Patient Safety Rule, or when a PSO chooses to voluntarily 
relinquish its status as a PSO for any reason. AHRQ has accepted a 
notification of voluntary relinquishment from the Northern Metropolitan 
Patient Safety Institute of its status as a PSO, and has delisted the 
PSO accordingly.

DATES: The directories for both listed and delisted PSOs are ongoing 
and reviewed weekly by AHRQ. The delisting was effective at 12:00 
Midnight ET (2400) on May 29, 2013.

ADDRESSES: Both directories can be accessed electronically at the 
following HHS Web site: http://www.pso.AHRQ.gov/index.html.

FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality 
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 
20850; Telephone (toll free): (866) 403-3697;

[[Page 40147]]

Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY 
(local): (301) 427-1130; Email: pso@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Background

    The Patient Safety Act authorizes the listing of PSOs, which are 
entities or component organizations whose mission and primary activity 
is to conduct activities to improve patient safety and the quality of 
health care delivery.
    HHS issued the Patient Safety Rule to implement the Patient Safety 
Act. AHRQ administers the provisions of the Patient Safety Act and 
Patient Safety Rule (PDF file, 450 KB. PDF Help) relating to the 
listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ 
to list as a PSO an entity that attests that it meets the statutory and 
regulatory requirements for listing. A PSO can be ``delisted'' if it is 
found no longer to meet the requirements of the Patient Safety Act and 
Patient Safety Rule, or when a PSO chooses to voluntarily relinquish 
its status as a PSO for any reason. Section 3.108(d) of the Patient 
Safety Rule requires AHRQ to provide public notice when it removes an 
organization from the list of federally approved PSOs.
    AHRQ has accepted a notification from the Northern Metropolitan 
Patient Safety Institute, PSO number P0021, which is a component entity 
of Northern Metropolitan Hospital Association, to voluntarily 
relinquish its status as a PSO. Accordingly, the Northern Metropolitan 
Patient Safety Institute was delisted effective at 12:00 Midnight ET 
(2400) on May 29, 2013. Northern Metropolitan Patient Safety Institute 
has patient safety work product (PSWP) in its possession. The PSO will 
meet the requirements of section 3.108(c)(2)(i) of the Patient Safety 
Rule regarding notification of providers that have reported to the PSO. 
In addition, according to section 3.108(c)(2)(ii) of the Patient Safety 
Rule regarding disposition of PSWP, the PSO has 90 days from the 
effective date of delisting and revocation to complete the disposition 
of PSWP that is currently in the PSO's possession.
    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.gov/index.html.

    Dated: June 21, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-15732 Filed 7-2-13; 8:45 am]
BILLING CODE 4160-90-M