42952 Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 

form as a common form, meaning HHS 

will only request approval for its own 

use of the form rather than aggregating 

the burden estimate across all Federal 

Agencies as was done for previous 

actions on this OMB control number. 

Comments submitted during the first 

public review of this ICR will be 

provided to OMB. OMB will accept 

further comments from the public on 

this ICR during the review and approval 

period. 

DATES: Comments on the ICR must be 

received on or before August 19, 2013. 

ADDRESSES: Submit your comments to 

OIRA_submission@omb.eop.gov or via 

facsimile to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Information Collection Clearance staff, 

Information.CollectionClearance@hhs.

gov or (202) 690–6162. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the OMB 

control number 4040–0004 and 

document identifier HHS–EGOV– 

16500–30D for reference. 

Information Collection Request Title: 

SF–424 Discretionary. 

OMB No.: 4040–0004. 

Abstract: The SF–424 Application for 

Federal Assistance is a common form 

used by all Federal grant-making 

agencies for applicants to apply for 

Federal financial assistance. Need and 

Proposed Use of the Information: The 

SF–424 Application for Federal 

Assistance is used by the public to 

apply for Federal financial assistance in 

the form of grants. These forms are 

submitted to the Federal grant-making 

agencies for evaluation and review. 

Likely Respondents: Organizations 

and institutions seeking grants. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose or provide the information 

requested. This includes the time 

needed to review instructions, to 

develop, acquire, install and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

HHS estimates that the SF–424 

Application for Federal Assistance will 

take 1 hour to complete. We expect that 

14,747 respondents will use this form. 

Once OMB approves the use of this 

common form, federal agencies may 

request OMB approval to use this 

common form without having to publish 

notices and request public comments for 

60 and 30 days. Each agency must 

account for the burden associated with 

their use of the common form. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden hours 

SF–424 Application for Federal Assistance .................................................... 14,747 1 1 14,747 

Total .......................................................................................................... 14,747 ........................ ........................ 14,747 

Keith A. Tucker, 

Information Collection Clearance Officer. 

[FR Doc. 2013–17221 Filed 7–17–13; 8:45 am] 

BILLING CODE 4151–AE–P 

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). 

AHRQ is republishing this document 

due to errors found on our first 

publication of July 3, 2013 (http://www.

gpo.gov/fdsys/pkg/FR-2013-07-03/pdf/

2013-5730.pdf). Please disregard the 

July 3 publication. 

DATES: Submission Deadline by 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, P.O. 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 


TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 42953 

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://effective

healthcare.AHRQ.gov/search-for-guidesreviews-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: 

D 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. 

D 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. 

D 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. 

D 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, 

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(OH)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) 


TKELLEY on DSK3SPTVN1PROD with NOTICES
42954 Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices 

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. 

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: July 11, 2013. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2013–17177 Filed 7–17–13; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Imaging Tests for the Staging of 

Colorectal Cancer 

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 on 

imaging tests for the staging of 

colorectal cancer (e.g., Chest x-ray, 

computed tomography, multidetector 

computed tomography (MD–CT), CT 

colonography, magnetic resonance 

imaging (MRI), transabdominal 

ultrasound (TUS), endoscopic 

ultrasound (EUS), transrectal ultrasound 

(TRUS), positron emission tomography 

(PET), positron emission tomography 

combined with computed tomography 

(PET/CT fusion), or positron emission 

tomography combined with magnetic 

resonance imaging (PET/MRI fusion)) 

from medical device manufacturers. 

Scientific information is being solicited 

to inform our Comparative Effectiveness 

Review of Imaging Tests for the Staging 

of Colorectal Cancer, which is currently 

being conducted by one of the Evidencebased Practice Centers for the AHRQ 

Effective Health Care Program. Access to 

published and unpublished pertinent 

scientific information on these devices 

will improve the quality of this 

comparative effectiveness review. 

AHRQ is requesting this scientific 

information and 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). 

AHRQ is republishing this document 

due to errors found on our first 

publication of June 27, 2013 (http://

www.gpo.gov/fdsys/pkg/FR-2013-06-27/

pdf/2013-15288.pdf). Please disregard 

the June 27 publication. 

DATES: Submission Deadline by July 29, 

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, P.O. 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 one of the 

Effective Health Care (EHC) Program 

Evidence-based Practice Centers to 

complete a comparative effectiveness 


TKELLEY on DSK3SPTVN1PROD with NOTICES