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
40148 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

pharmacokinetic or pharmacodynamic 

studies; study types not included in the 

review; or information on indications 

not included in the review cannot be 

used by the Effective Health Care 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

Key Question 1 

What is the effect of vitamin D intake 

or combined vitamin D plus calcium 

intake (but not calcium intake alone) on 

clinical outcomes, including 

cardiovascular diseases, cancer, 

immune function, pregnancy or birth 

outcomes, mortality, fracture, renal 

outcomes, and soft tissue calcification 

(the current report excludes two 

outcomes included in the original 2009 

report: growth and weight management). 

Population(s) 

• The primary population of interest 

is generally healthy people with no 

known disorders, with the following 

exceptions. Studies that include broad 

populations might include some 

individuals with diseases or who are at 

risk for diseases. 

• Studies of individuals with 

previous cancer, previous fractures, or 

precancerous conditions will be 

included. 

• With the exception of studies of 

older adults, studies in which more than 

20 percent of the participants have been 

diagnosed with a disease will be 

excluded. 

• For clinical outcomes of 

cardiovascular disease (CVD), only 

studies of adults will be included (≥18 

years of age). 

Interventions 

• For observational studies 

(exposures): 

• Serum concentration of 25- 

hydroxyvitamin D [25(OH)D] or 

1,25- dihydroxyvitamin D 

[1,25(0i1)2D] and method used 

• Dietary intake of calcium from food 

and supplements 

• Calcium balance 

• For interventional studies: 

• Vitamin D supplements with 

known doses 

• Calcium supplements if coadministered with vitamin D 

• Food-based interventions in which 

the doses of vitamin D and calcium 

were quantified and in which the 

doses differ between comparison 

groups 

Comparators 

• For observational studies: 

• Lower serum concentrations of 

vitamin D 

• For interventional studies: 

• Placebo, non-fortified/ 

supplemented food 

Outcomes 

• CVD clinical outcomes 

• Cardiac events or symptoms 

• Cerebrovascular events 

• Peripheral vascular events or 

symptoms 

• Cardiovascular death 

• Study-specific combinations of 

cardiovascular events 

• Total cancer 

• Prostate cancer 

• Colorectal cancer 

• Breast cancer 

• Pancreatic cancer 

• Cancer-specific mortality 

• Immune function clinical outcomes 

• Infectious disease 

• Autoimmune diseases 

• Infectious disease-specific mortality 

• Pregnancy-related outcomes 

• Preterm birth or low birth weight 

• Infant mortality 

• Mortality, all cause 

• Bone health, clinical outcomes 

• Rickets 

• Fracture 

• Falls or muscle strength 

• Adverse effects of intervention(s) 

• All-cause mortality 

• Cancer incidence and cancer-specific 

mortality 

• Renal outcomes 

• Soft tissue calcification 

• (Other) adverse events from vitamin D 

or vitamin D plus calcium 

supplements 

Timing 

• Timing of interventions or 

exposures will not be pre-specified, 

with the exception that cross-sectional 

and retrospective case-control studies 

will not be included (nested case 

controls within prospective cohort 

studies will be included). 

• For studies with multiple follow-up 

periods, the longest follow-up times will 

be preferentially considered. 

Settings 

• Settings will not be pre-specified. 

Key Question 2 

What is the effect of vitamin D or 

combined vitamin D and calcium intake 

on-surrogate or intermediate outcomes 

such as hypertension, blood pressure, 

and bone mineral density? 

Populations 

• As described for KQ 1, with the 

exception that for blood pressure and 

other CVD intermediate outcomes, only 

studies of adults 18 years of age or older 

will be included. 

Interventions 

• As described for KQ 1, with the 

following exceptions: 

• For CVD outcomes, only 

randomized controlled trials (RCTs) will 

be included 

• For bone health outcomes, only 

RCTs of greater than 1 year in duration 

will be included 

Comparators 

• As described for KQ 1. 

Outcomes 

• As specified in the original 2009 

report, unless otherwise noted: 

• CVD intermediate outcomes 

• Cancer intermediate outcomes 

(colorectal adenoma, aberrant crypt 

cells, and mammographic breast 

density) 

• Bone health intermediate outcomes 

(only bone mineral density/content) 

• Pregnancy-related intermediate 

outcomes 

• Pre-eclampsia 

• High blood pressure with or 

without proteinuria 

Timing 

• As described for KQ 1, except for 

intermediate bone health for which 

studies of less than 1 year in duration 

will be excluded. 

Settings 

• As described for KQ 1. 

Key Question 3 

What is the association between 

serum 25(OH)D concentrations and 

clinical outcomes?* 

Populations 

• As described for KQ 1. 

Interventions 

• Serum concentration of 25(OH)D or 

1,25 (OH)2D and the method used. 

Comparators 

• The serum concentration of 

25(OH)D or 1,25 (OH)2D and the 

method used for the placebo or other 

comparison group. 

Outcomes 

• As described for KQ 1. 

Timing 

• As described for KQ 1. 


emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 40149 

Settings 

• As described for KQ 1. 

Key Question 4 

What is the effect of vitamin D or 

combined vitamin D and calcium intake 

on serum 25(OH)D concentrations? 

Populations 

• As described for KQ 1. 

Interventions 

• Randomized controlled trials 

(RCTs) identified to answer all other 

KQs. 

Comparators 

• Placebo or lower dose supplement. 

Outcomes 

• Dose-response relationship between 

intake levels and indices of exposure. 

Timing 

• As described for KQs 1 and 2. 

Settings 

• As described for KQs 1 and 2. 

Key Question 5 

What is the association between 

serum 25(OH)D concentration and 

surrogate or intermediate outcomes? 

Populations 

• As described for KQ 2. 

Interventions 

• As described for KQ 2. 

Comparators 

• As described for KQ 2. 

Outcomes 

• As described for KQ 2. 

Timing 

• As described for KQ 2. 

Settings 

• As described for KQ 2. 

Dated: June 21, 2013. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2013–15730 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 

Chronic Urinary Retention (CUR) 

Treatment 

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 medical devices to treat 

chronic urinary retention. Scientific 

information is being solicited to inform 

our review of chronic urinary retention 

(CUR) treatment, 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 medical 

devices to treat chronic urinary 

retention will improve the quality of 

this review. AHRQ is conducting this 

comparative effectiveness 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.AHRQ.gov/index.

cfm/submit-scientific-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 chronic 

urinary retention (CUR) treatment. 

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 chronic urinary retention 

treatment, 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://www.effectivehealthcare.AHRQ.

gov/search-for-guides-reviews-andreports/?pageaction=displayproduct&

productID=1539. 

This notice is to notify the public that 

the EHC program would find the 

following information on medical 

devices to treat chronic urinary 

retention 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. 

• 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 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; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the 

Effective Health Care Program. This is a 

voluntary request for information, and 

all costs for complying with this request 

must be borne by the submitter. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 


emcdonald on DSK67QTVN1PROD with NOTICES