24750 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 

renewal request to OMB also cover the 

fully automated version of the OGE 

Form 201, available only through the 

OGE Web site at www.oge.gov. Initially 

launched in March 2012, this automated 

version of the access form enables a 

requestor to obtain immediately upon 

Web site submission of the completed 

form, those financial disclosure reports 

of individuals who have been 

nominated by the President to executive 

branch positions requiring Senate 

confirmation. In addition, OGE reviews 

the public financial disclosure report of 

individuals who have declared their 

candidacy for the Office of the President 

of the United States. Those certified 

reports may also be requested by 

submitting a completed automated OGE 

Form 201. 

Request for Comments: OGE is 

publishing this first round notice of its 

intent to request paperwork clearance 

for a proposed modified OGE Form 201 

Ethics Act Access Form. Agency and 

public comment is invited specifically 

on the need for and practical utility of 

this information collection, the accuracy 

of OGE’s burden estimate, the 

enhancement of quality, utility and 

clarity of the information collected, and 

the minimization of burden (including 

the use of information technology). 

Comments received in response to this 

notice will be summarized for, and may 

be included with, the OGE request for 

extension of OMB paperwork approval. 

The comments will also become a 

matter of public record. 

Approved: April 22, 2013. 

Walter M. Shaub, Jr., 

Director, U.S. Office of Government Ethics. 

[FR Doc. 2013–09932 Filed 4–25–13; 8:45 am] 

BILLING CODE 6345–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request 

Therapies for Clinically Localized 

Prostate 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 from 

medical device manufacturers with 

products falling within the following 

UMDNS product codes: Brachytherapy 

Systems [20–352]; Cyclotrons [15–818]; 

Radiotherapy Systems, Linear 

Accelerator [12–364]; Radiotherapy 

Systems, and Proton Beam [20–546]. 

Scientific information is being solicited 

to inform the update of our Comparative 

Effectiveness Review of Therapies for 

Clinically Localized Prostate Cancer 

which is currently being conducted by 

one of the Evidence-based Practice 

Centers for the AHRQ Effective Health 

Care Program. Access to published and 

unpublished pertinent scientific 

information on this device 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. 

DATES: Submission-Deadline-on orbefore May 28, 2013. 

ADDRESSES: 

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 US Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Scientific Information 

Packet Coordinator, Telephone: 503– 

220–8262 x58652 or Email: sips@epcsrc.org. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned one of the Effective 

Health Care (EHC) Program Evidencebased Practice Centers to complete a 

comparative effectiveness review of the 

evidence for Therapies for Clinically 

Localized Prostate Cancer: An Update of 

a 2008 Comparative Effectiveness 

Review. 

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 

(e.g., details of studies conducted) 

through public information requests, 

including via the Federal Register and 

direct postal and/or online solicitations. 

We are looking for studies that report on 

Therapies for Clinically Localized 

Prostate Cancer, 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-reviewsand-reports/?pageaction=display

product&productID=1434#7270. 

This notice is a request for 

information about the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. AHRQ is interested 

in receiving both citations and reprints. 

Information identifying unpublished 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. If possible, please 

provide a summary that includes 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 withdrawn/follow-up/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this-program. This is a-voluntaryrequest for information, and all costs for 

complying with this request must be 

borne by the submitter. You may wish 

to indicate whether or not the 

submission comprises all of the 

complete information available. 

Please Note: The contents of all 

submissions, regardless of format, will 

be available to the public upon request 

unless prohibited by law. 

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/. 

Scope and Key Questions 

This update examines the same four 

key questions as in the original 2008 

report on the comparative effectiveness 

of treatments for clinically localized 

prostate cancer. Although these key 

questions were reviewed and approved 

by AHRQ and discussed with Technical 

Expert Panel (TEP) members for the 


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Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 24751 

original report, we presented them for 

discussion with a newly convened TEP 

for this update and made changes as 

necessary. This update will summarize 

the more recent evidence comparing the 

relative effectiveness and safety of 

treatment options for clinically 

localized prostate cancer. The key 

questions we will address are as 

follows: 

Key Question 1 

What are the comparative risks and 

benefits of the following therapies for 

clinically localized prostate cancer? 

a. Radical prostatectomy, including 

open (retropubic and perineal) and 

laparoscopic (with or without robotic 

assistance) approaches. 

b. External Beam Radiotherapy, 

including standard therapy and 

therapies designed to decrease exposure 

to normal tissues such as 3D conformal 

radiation therapy, intensity-modulated 

radiation therapy, proton beam therapy, 

and stereotactic body radiation therapy. 

c. Interstitial brachytherapy. 

d. Cryosurgery. 

e. Watchful waiting. 

f. Active surveillance. 

g. Hormonal therapy as primary 

therapy, adjuvant, or neoadjuvant to 

other therapies. 

h. High-intensity focused ultrasound. 

Key Question 2 

How do specific patient 

characteristics (e.g., age, race/ethnicity, 

presence or absence of comorbid illness, 

preferences such as trade-off of 

treatment-related adverse effects vs. 

potential for disease progression) affect 

the outcomes of these therapies overall 

and differentially? 

Key Question 3 

How do provider/hospital 

characteristics affect outcomes of these 

therapies overall and differentially (e.g., 

geographic region, case volume, 

learning curve)? 

Key Question 4 

How do tumor characteristics (e.g., 

Gleason score, tumor volume, screendetected vs. clinically detected tumors, 

and PSA levels) affect the outcomes of 

these therapies overall and 

differentially? 

Population, Interventions, 

Comparators, Outcomes, Timing, 

Settings Criteria Population 

• Key Questions 1, 2, 3, and 4: Men 

considered to have clinically localized 

prostate cancer (T1 to T2, N0 to X, M0 

to X) regardless of age, histologic grade, 

or PSA level. Articles will be excluded 

if men with disease stage higher than T2 

were enrolled and outcomes were not 

stratified by stage. 

Interventions 

• For Key Questions 1, 2, 3, and 4, we 

will include treatment options for men 

with clinically localized prostate cancer: 

radical prostatectomy (including 

retropubic, perineal, laparoscopic, 

robotic-assisted), watchful waiting, 

active surveillance, External Beam 

Radiotherapy (including conventional 

radiation, Intensity Modulated 

Radiotherapy, 3D conformal radiation, 

proton beam, and stereotactic body 

radiation therapy), brachytherapy, 

androgen deprivation therapy, highintensity focused ultrasound, and 

cryotherapy. 

Comparators 

• Any of the interventions of interest 

above or watchful waiting. 

Outcomes 

• The primary outcome is overall 

mortality or survival. Additional 

outcomes include prostate-cancerspecific mortality or survival, 

biochemical (PSA) progression, 

metastatic and/or clinical progressionfree survival, health status, and quality 

of life. We will focus primarily on 

common and severe adverse events of 

treatment including bowel, bladder, and 

sexual dysfunction, as well as harms 

from biopsy such as bleeding and 

nosocomial infections. 

• For Key Question 3, we plan to 

examine outcomes after radical 

prostatectomy, the most common 

treatment for localized prostate cancer, 

in association with provider location, 

case volume, and affiliation with 

academic centers. 

Timing 

• Duration of follow-up will be 

appropriate for the outcome under 

consideration. 

Settings 

• No restrictions by setting. 

Dated: April 15, 2013. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2013–09739 Filed 4–25–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Continuing Prospective Birth 

Cohort Study Involving Environmental 

Uranium Exposure in the Navajo 

Nation, Funding Opportunity 

Announcement (FOA) TS13–001, Initial 

Review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned SEP: 

Time and Date: 12:00 p.m.–3:30 p.m., June 

13, 2013 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Continuing Prospective Birth 

Cohort Study Involving Environmental 

Uranium Exposure in the Navajo Nation, 

FOA TS13–001.’’ 

Contact Person for More Information: Jane 

Suen, Dr.P.H, M.S., M.P.H., Scientific Review 

Officer, CDC, 4770 Buford Highway NE., 

Mailstop F63, Atlanta, Georgia 30341, 

Telephone: (770) 488–4281. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2013–09874 Filed 4–25–13; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Safety and Occupational Health Study 

Section (SOHSS), National Institute for 

Occupational Safety and Health 

(NIOSH or Institute) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 


erowe on DSK2VPTVN1PROD with NOTICES