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published and unpublished pertinent 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
40150 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

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

Key Questions 

KQ 1: What is the effectiveness and 

comparative effectiveness of treatments 

for CUR in adults: 

• With male-specific etiologies? 

• With female-specific etiologies? 

• With non-sex-specific etiologies? 

KQ 1a: What patient or condition 

characteristics (e.g., age, severity, etc.) 

modify the effectiveness of treatment? 

KQ 2: What are the harms and 

comparative harms of treatments for 

CUR in adults: 

• With male-specific etiologies? 

• With female-specific etiologies? 

• With non-sex-specific etiologies? 

KQ 2a: What patient or condition 

characteristics (e.g., age, severity, etc.) 

modify the harms of treatment? 

Dated: June 21, 2013. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2013–15729 Filed 7–2–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day 13–0106] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC 20503 or by fax to (202) 395–5806. 

Written comments should be received 

within 30 days of this notice. 

Proposed Project 

Preventive Health and Health Services 

Block Grant (OMB No. 0920–0106, exp. 

7/31/2013)—Revision—National Center 

for Chronic Disease Prevention and 

Health Promotion (NCCDPHP), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

The Preventive Health and Health 

Services (PHHS) Block Grant program 

was established to provide awardees 

with a source of flexible funding for 

health promotion and disease 

prevention programs. Currently, 61 

awardees (50 states, the District of 

Columbia, two American Indian Tribes, 

and eight U.S. territories) receive Block 

Grants to address locally-defined public 

health needs in innovative ways. Block 

Grants allow awardees to prioritize the 

use of funds and to fill funding gaps in 

programs that deal with the leading 

causes of death and disability. Block 

Grant funding also provides awardees 

with the ability to respond rapidly to 

emerging health issues, including 

outbreaks of diseases or pathogens. The 

PHHS Block Grant program is 

authorized by sections 1901–1907 of the 

Public Health Service Act. 

CDC currently collects information 

from Block Grant awardees to monitor 

their objectives and activities 

(Preventive Health and Health Services 

Block Grant, OMB No. 0920–0106, exp. 

7/31/2013). Each awardee is required to 

submit an annual application for 

funding (Work Plan) that describes its 

objectives and the populations to be 

addressed, and an Annual Report that 

describes activities, progress toward 

objectives, and Success Stories which 

highlight the improvements Block Grant 

programs have made and the value of 

program activities. Information is 

submitted electronically through the 

Web-based Block Grant Information 

Management System (BGMIS). 

The Work Plan and Annual Report are 

designed to help Block Grant awardees 

attain their goals and to meet reporting 

requirements specified in the program’s 

authorizing legislation. Block Grant 

activities adhere to the Healthy People 

(HP) framework established by the 

Department of Health and Human 

Services (HHS). The current version of 

the BGMIS associates each awardeedefined activity with a specific HP 

National Objective, and identifies the 

location where funds are applied. CDC 

is updating the BGMIS by replacing 

Healthy People 2010 objectives with 

Healthy People 2020 objectives. 

CDC requests OMB approval to 

continue the Block Grant information 

collection for three years. CDC will 

continue to use the electronic BGMIS to 

monitor awardee progress, identify 

activities and personnel supported with 

Block Grant funding, conduct 

compliance reviews of Block Grant 

awardees, and promote the use of 

evidence-based guidelines and 

interventions. There are no changes to 

the number of respondents or the 

estimated annual burden per 

respondent. There are no changes to 

BGMIS data elements other than 

changes related to HP 2020 objectives 

and enhancements. The Work Plan and 

the Annual Report will be submitted 

annually. The estimated burden per 

response for the Work Plan is 20 hours 

and the estimated burden per response 

for the Annual Report is 15 hours. 

Participation in this information 

collection is required for Block Grant 

awardees. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 2,135. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Block Grant Awardees .................................... Work Plan ....................................................... 61 1 20

Annual Report ................................................ 61 1 15 


emcdonald on DSK67QTVN1PROD with NOTICES