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). 

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: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of one AHRQ 

Subcommittee Meetings by Virtual 

Review. 

SUMMARY: 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 

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: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of Delisting. 

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; 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Vitamin D and Calcium 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Scientific 

Information Submissions. 

SUMMARY: 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). 

DATES: 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 

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, 


emcdonald on DSK67QTVN1PROD with NOTICES