Scientific Information Request Therapies for Clinically Localized Prostate Cancer, 24750-24751 [2013-09739]

Download as PDF 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 for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for Scientific Information Submissions. AGENCY: 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 erowe on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:39 Apr 25, 2013 Jkt 229001 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 E:\FR\FM\26APN1.SGM 26APN1 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices 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 erowe on DSK2VPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 14:46 Apr 25, 2013 Jkt 229001 were enrolled and outcomes were not stratified by stage. DEPARTMENT OF HEALTH AND HUMAN SERVICES Interventions Centers for Disease Control and Prevention • 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. • No restrictions by setting. 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] DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: April 15, 2013. Carolyn M. Clancy, AHRQ, Director. BILLING CODE 4160–90–M PO 00000 Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review BILLING CODE 4163–18–P Settings [FR Doc. 2013–09739 Filed 4–25–13; 8:45 am] • 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 24751 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 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\26APN1.SGM 26APN1

Agencies

[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24750-24751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09739]


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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 or-before May 28, 2013.

ADDRESSES:
    Email submissions: src.org">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: src.org">sips@epc-src.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 Evidence-
based 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-reviews-and-reports/?pageaction=displayproduct&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-
voluntary-request 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

[[Page 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, 
screen-detected 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, 
high-intensity 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-cancer-specific mortality or 
survival, biochemical (PSA) progression, metastatic and/or clinical 
progression-free 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