Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices 52339 

• For adverse events: immediate 

Settings 

• Primary care (outpatient) or acute care 

setting, preferentially 

• Outpatient rheumatology practices/

academic medical centers 

Dated: August 26, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–20689 Filed 9–2–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Emerging Approaches To Diagnosis 

and Treatment of Non-Muscle-Invasive 

Bladder 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 

the public. Scientific information is 

being solicited to inform our review of 

Emerging Approaches to Diagnosis and 

Treatment of Non-Muscle-Invasive 

Bladder Cancer, 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published and unpublished pertinent 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 will improve the 

quality of this 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 October 3, 2014. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.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: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.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 Emerging 

Approaches to Diagnosis and Treatment 

of Non-Muscle-Invasive Bladder Cancer. 

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 Emerging Approaches to 

Diagnosis and Treatment of NonMuscle-Invasive Bladder Cancer, 

including those that describe adverse 

events. The entire research protocol, 

including the key questions, is also 

available online at: http://

effectivehealthcare.AHRQ.gov/searchfor-guides-reviews-and-reports/

?pageaction=displayproduct&product

ID=1941. 

This notice is to notify the public that 

the EHC Program would find the 

following information on Emerging 

Approaches to Diagnosis and Treatment 

of Non-Muscle-Invasive Bladder Cancer 

helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicafTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide 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 that your 

organization 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 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EHC 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; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EHC 

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.AHRO.gov/

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

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is also available 

online at: http://effectivehealth

care.AHRO.gov/search-for-guidesreviews-and-reports/

?pageaction=displayproduct&productID

=1941. 

The Key Questions 

Key Question 1 

What is the diagnostic accuracy of 

various urinary biomarkers compared 

with other urinary biomarkers or 

standard diagnostic methods 

(cystoscopy, cytology, and imaging) in 

(1) persons with signs or symptoms 

warranting evaluation for possible 

bladder cancer or (2) persons 

undergoing surveillance for previously 

treated bladder cancer? 

• Does the diagnostic accuracy differ 

according to patient characteristics (e.g., 

age, sex, ethnicity), or according to the 

nature of the presenting signs or 

symptoms? 

Key Question 2 

For patients with non-muscleinvasive bladder cancer, does the use of 

a formal risk-adapted assessment 

approach to treatment decisions (e.g., 

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52340 Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices 

aRestricted to tests that are approved for 

diagnosis of bladder cancer by the U.S. Food and 

Drug Administration (BTAstat® [BTA], Alere 

NMP228, BladderChek® [NMP22], UroVysion®

[FISH] and ImmunoCytrm [immunocytology]) or 

available in the U.S. and classified as a Laboratory 

Developed Test by the FDA (CxBladderrm). 

bChemotherapeutic and immunotherapeutic 

agents of interest include: mitomycin; apaziquone; 

paclitaxel; gemcitabine; thiotepa; valrubicin; 

doxorubicin; bacillus Calnnette-Guerin (BCG); and 

interferon. 

Guidelines of the European Association 

of Urology or based on urinary 

biomarker tests) decrease mortality or 

improve other outcomes (e.g., 

recurrence, progression, need for 

cystectomy, quality of life) compared 

with treatment not guided by an 

assessed risk-adapted approach? 

Key Question 3 

For patients with non-muscleinvasive bladder cancer treated with 

transurethral resection of bladder tumor 

(TURBT), what is the effectiveness of 

various intravesical chemotherapeutic 

or immunotherapeutic agents for 

decreasing mortality or improving other 

outcomes (e.g., recurrence, progression, 

need for cystectomy, quality of life) 

compared with other agents, TURBT 

alone, or cystectomy? 

• What is the comparative 

effectiveness of various 

chemotherapeutic or 

imnnunotherapeutic agents, as 

monotherapy or in combination? 

• Does the comparative effectiveness 

differ according to tumor characteristics, 

such as histology, stage, grade, size, or 

molecular/genetic markers? 

• Does the comparative effectiveness 

of various chemotherapeutic or 

immunotherapeutic agents differ 

according to dosing frequency, duration 

of treatment, and/or the timing of 

administration relative to TURBT? 

• Does the comparative effectiveness 

differ according to patient 

characteristics, such as age, sex, 

ethnicity, performance status, or 

medical comorbidities? 

Key Question 4 

For patients with high risk nonmuscle-invasive bladder cancer treated 

with TURBT, what is the effectiveness 

of external beam radiation therapy 

(either alone or with systemic 

chernotherapy/immunotherapy) for 

decreasing mortality or improving other 

outcomes compared with intravesical 

chemotherapy/immunotherapy alone or 

cystectomy? 

Key Question 5 

In surveillance of patients treated for 

non-muscle-invasive bladder cancer, 

what is the effectiveness of various 

urinary biomarkers to decrease mortality 

or improve other outcomes compared 

with other urinary biomarkers or 

standard diagnostic methods 

(cystoscopy, cytology, and imaging)? 

• Does the comparative effectiveness 

differ according to tumor characteristics, 

such as histology, stage, grade, size, or 

molecular/genetic markers? 

• Does the comparative effectiveness 

differ according to the treatment used 

(i.e., specific chemotherapeutic or 

immunotherapeutic agents and/or 

TURBT)? 

• Does the comparative effectiveness 

differ according to the length of 

surveillance intervals? 

• Does the comparative effectiveness 

differ according to patient 

characteristics, such as age, sex, or 

ethnicity? 

Key Question 6 

For initial diagnosis or surveillance of 

patients treated for non-muscle-invasive 

bladder cancer, what is the effectiveness 

of blue light or other methods of 

augmented cystoscopy compared with 

standard cystoscopy for recurrence 

rates, progression of bladder cancer, 

mortality, or other clinical outcomes? 

Key Question 7 

What are the comparative adverse 

effects of various tests for diagnosis and 

post-treatment surveillance of bladder 

cancer, including urinary biomarkers, 

cytology, and cystoscopy? 

Key Question 8 

What are the comparative adverse 

effects of various treatments for nonmuscle-invasive bladder cancer, 

including intravesical chemotherapeutic 

or immunotherapeutic agents and 

TURBT? 

• How do adverse effects of treatment 

vary by patient characteristics, such as 

age, sex, ethnicity, performance status, 

or medical connorbidities such as 

chronic kidney disease? 

PICOTS (Population, Intervention, 

Comparator, Outcome, Timing, Setting) 

Population(s) 

• For KQ 1, 6, and 7: Adults with signs 

or symptoms of possible bladder 

cancer (e.g., gross or microscopic 

hematurla, irritative voiding 

symptoms) 

• For KQ 2: Adults with non-muscleinvasive bladder cancer (stages Ta, 

Tis, or Ti) 

• For KQ 3 and 8: Adults with nonmuscle invasive bladder cancer 

treated with TURBT 

• For KQ 4 and 8: Adults with high-risk 

non-muscle invasive bladder cancer 

treated with TURBT 

• For KQs 1 and 5 through 7: Adults 

undergoing surveillance following 

treatment for non-muscle invasive 

bladder cancer 

Interventions 

• For KQ 1, 5, and 7: Urinary 

biomarkers a

• For KQ 2: Risk-adapted treatment 

approaches 

• For KQ 3a, 3b, 3c, 3d, and 8: 

Intravesical chemotherapeutic or 

immunotherapeutic agents b

• For KQ 4: External beam radiation 

therapy, with or without systemic 

chemotherapy or immunotherapy 

• For KQ 6: Blue light or other methods 

of augmented cystoscopy 

Comparators 

• For KQ 1, 5, and 7: Other urinary 

biomarkers or standard diagnostic 

methods (cystoscopy, cytology, and 

imaging) 

• For KQ 2: Treatment not guided by 

risk-adapted approach 

• For KQ 3a, 3b, 3c, 3d, and 8: Other 

intravesical chemotherapeutic or 

innmunotherapeutic agent, different 

dose or duration of intravesical 

chemotherapy or immunotherapy, or 

transurethral resection of bladder 

tumor (TURBT) alone 

• For KQ 4: Intravesical 

chemotherapeutic or 

immunotherapeutic agents or 

cystectomy 

Outcomes 

• For KQ 1 and 5: Diagnostic accuracy, 

using cystoscopy with biopsy as the 

reference standard 

• For KQ 2, KQ 3, KQ 4, KQ 5: 

Mortality, disease-specific and allcause 

• For KQ 2, KQ 3, KQ 4, KQ 5: Need 

for cystectomy 

• For KQ 2, KQ 3, KQ 4, KQ 5, KQ 6: 

Recurrence of cancer 

• For KQ 2, KQ 3, KQ 4, KQ 5: 

Progression of cancer 

• For KQ 2, KQ 3, KQ 4, KQ 5: Quality 

of life 

• For KQ 7: Adverse effects of 

diagnostic testing (e.g., false-positives, 

labeling, anxiety, complications of 

cystoscopy) 

• For KQ 8: Adverse effects of treatment 

(e.g., cystitis, urinary urgency, urinary 

frequency, incontinence, hematuria, 

pain, urosepsis, myelosuppression 

Timing 

Any duration of follow-up 

Settings 

• Inpatient settings 

• Outpatient settings 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 170 / Wednesday, September 3, 2014 / Notices 52341 

Dated: August 26, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–20690 Filed 9–2–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–14–14AAO] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act of 1995. The notice for 

the proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information are encouraged. Your 

comments should address any of the 

following: (a) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (b) Evaluate the 

accuracy of the agencies estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; (d) Minimize the burden of 

the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and (e) Assess information 

collection costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Written 

comments and/or suggestions regarding 

the items contained in this notice 

should be directed to the Attention: 

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 

Testing Act Early Messages and 

Materials for ‘‘Learn the Signs. Act 

Early.’’—Phase II,—New—National 

Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

The CDC initiated the ‘‘Learn the 

Signs. Act Early.’’ (LTSAE) campaign in 

2004 in an effort to improve the 

likelihood that children with 

developmental disabilities are identified 

and connected with appropriate services 

at the earliest age possible. To this end, 

the campaign’s overall goal has been to 

empower parents to ‘‘Act Early’’ if they 

have concerns about their child’s 

development. Children from families 

insured by Medicaid and those from 

families with low incomes are at higher 

risk for developmental delays and 

disabilities, and thus are the target 

audience for the campaign. 

The study described in this 

information collection request seeks to 

assess the impact of ‘‘Act Early’’ 

messages embedded within LTSAE 

campaign materials. To achieve this 

goal, we will work with our contractor, 

Westat, to test revised draft messages 

and materials with low-income parents 

through focus groups and intercept 

interviews administered via the web on 

a tablet device. Parents/guardians who 

are age 18–55 and who have children 

age 5 or younger will recruited from six 

primary care practices (3 in the 

Baltimore, Maryland metropolitan area 

and 3 in the Atlanta, Georgia 

metropolitan area) to participate in 

focus groups followed by an intercept 

interview. 

Selected primary care practices will 

see children as part of their patient 

population and consist of a substantial 

number of low income families. Each of 

the six selected practices will receive 

study promotional materials, including 

a poster to hang in the office and 

waiting room as well as handouts to 

leave at the front desk. These materials 

will advertise the focus groups and 

outline eligibility criteria. 

Parents interested in participating 

will be advised to call an 800 number 

to be screened and scheduled for a 

group discussion (if eligible). The 800 

number will be staffed by the Westat 

study team who will be responsible for 

screening and scheduling. 

Representatives from each of the 

practices will be provided with brief 

‘‘talking points’’ and study FAQs to 

refer to if interested parents have any 

basic questions about the study. It is 

estimated that 80 respondents will have 

to be screened in order to recruit 40 

participants for the focus groups. 

The focus groups will have 10 

participants each. Four focus groups 

will be conducted in two locations (the 

metropolitan areas of Atlanta, Georgia 

and Baltimore, Maryland) with a total of 

40 participants. Parents/guardians will 

be asked to complete an informed 

consent, which will take approximately 

15 minutes to review and the focus 

group discussion using the moderator’s 

guide will take 60 minutes to complete. 

Both of these focus group activities will 

have a total burden of 50 hours. 

We plan to conduct a total of 40 

intercept interviews. The intercept 

interviews will take place in the waiting 

rooms or right outside the waiting 

rooms. Parents will be recruited as they 

are waiting for their appointment. It is 

estimated that 80 respondents will have 

to be screened in order to recruit 40 

participants. Twenty interviews will be 

conducted in each of two locations 

(Atlanta, Georgia and Baltimore, 

Maryland). The intercept interview will 

be conducted as a computer-assisted 

personal interviewing (CAPI) and will 

take each respondent approximately 15 

minutes to complete, for an estimated 

total burden of 10 hours. 

The total estimated burden for this 

data collection is 74 hours. There is no 

cost to respondents other than their 

time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

in hours) 

Parents/Guardians ........................... Focus Group Screener ................................................. 80 1 5/60 

Parents/Guardians ........................... Focus Group Informed Consent ................................... 40 1 15/60 

Parents/Guardians ........................... Focus Group Moderator’s Guide .................................. 40 1 1 

Parents/Guardians ........................... Intercept Interview Screener ......................................... 80 1 5/60 

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