14046 Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices 

comments, drafting final 

recommendation documents, and 

participating in workgroups on specific 

topics and methods. Members can 

expect to receive frequent emails, can 

expect to participate in multiple 

conference calls each month, and can 

expect to have periodic interaction with 

stakeholders. AHRQ estimates that 

members devote approximately 200 

hours a year outside of in-person 

meetings to their USPSTF duties. The 

members are all volunteers and do not 

receive any compensation beyond 

support for travel to in person meetings. 

Dated: February 26, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–05354 Filed 3–11–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Radiotherapy Treatments for Head and 

Neck 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 on 3-Dimensionsal Conformal 

Radiotherapy (3DRT), IntensityModulated Radiotherapy (IMRT), 

Stereotactic Body Radiotherapy (SBRT), 

and Proton Beam Radiotherapy (PBRT). 

Scientific information is being solicited 

to inform our update review of 

Radiotherapy Treatments for Head and 

Neck 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published and unpublished pertinent 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 on 3- 

Dimensionsal Conformal Radiotherapy 

(3DRT), Intensity-Modulated 

Radiotherapy (IMRT), Stereotactic Body 

Radiotherapy (SBRT), and Proton Beam 

Radiotherapy (PBRT) 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 April 11, 2014. 

ADDRESSES: 

Online submissions: http:// 

effectivehealthcare.AHRQ.gov/ 

index.cfm/submit-scientificinformation-packets/. 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 an 

updated review of the evidence for 

Radiotherapy Treatments for Head and 

Neck 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 Radiotherapy Treatments 

for Head and Neck Cancer, including 

those that describe adverse events. The 

entire research protocol, including the 

key questions, is also available online 

at: http://effectivehealthcare.AHRQ.gov/ 

ehc/products/569/1852/head-neckcancer-update-140204.pdf. 

This notice is to notify the public that 

the EHC program would find the 

following information on 3- 

Dimensionsal Conformal Radiotherapy 

(3DRT), Intensity-Modulated 

Radiotherapy (IMRT), Stereotactic Body 

Radiotherapy (SBRT), and Proton Beam 

Radiotherapy (PBRT) 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 

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 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/. 

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:// 

effectivehealthcare.AHRQ.gov/ehc/ 

products/569/1852/head-neck-cancerupdate-140204.pdf 

Key Questions (KQs) 

Key Question 1 

What is the comparative effectiveness 

of 3DRT, IMRT, SBRT, and PBRT 

regarding adverse events and quality of 

life (QoL)? 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 48 / Wednesday, March 12, 2014 / Notices 14047 

Key Question 2 

What is the comparative effectiveness 

of 3DRT, IMRT, SBRT, and PBRT 

regarding tumor control and patient 

survival? 

Key Question 3 

Are there differences in comparative 

effectiveness of 3DRT, IMRT, SBRT, and 

PBRT for specific patient and tumor 

characteristics? 

Key Question 4 

Is there variation in comparative 

effectiveness of 3DRT, IMRT, SBRT, and 

PBRT because of differences in user 

experience, treatment planning, 

treatment delivery, and target volume 

delineation? 

PICOTS (Population, Intervention, 

Comparator(s), Outcomes, Timing, 

Setting) 

Identify for each key question: 

Population(s) 

KQs 1–4: Populations of interest 

include patients with head and neck 

cancer. To define what constitutes head 

and neck cancer, we consulted clinical 

resources such as the National Cancer 

Institute’s Physician Data Query (PDQ) 

Cancer Information Summary and the 

National Comprehensive Cancer 

Network. The consensus definition of 

head and neck cancer includes tumors 

of: 

1. larynx 

2. pharynx (hypopharynx, oropharyx 

and nasopharynx) 

3. lip and oral cavity 

4. paranasal sinus and nasal cavity 

5. salivary gland 

6. occult primary of the head and neck 

The following tumors are excluded: 

1. brain tumors 

2. skull base tumors 

3. uveal/choroidal melanoma, other 

ocular and eyelid tumors 

4. otologic tumors 

5. cutaneous tumors of the head and 

neck (including melanoma) 

6. thyroid cancer 

7. parathyroid cancer 

8. esophageal cancer 

9. trachea tumors 

All therapeutic strategies will be 

included. Radiotherapy (RT) can be 

delivered as primary (curative) intent 

therapy or as an adjunct to surgery. 

Chemotherapy can also be given as an 

adjunct to radiation therapy, 

particularly in patients with more 

advanced cancer (i.e., stages III or IV). 

We will seek direct evidence for one 

intervention compared to another, with 

or without chemotherapy or surgery. 

Interventions 

The primary interventions of interest 

in all therapeutic settings are: 

1. 3 dimensional conformal 

radiotherapy (3DRT): Defined as 

any treatment plan where CT-based 

forward treatment planning is used 

to delineate radiation beams and 

target volumes in three dimensions 

2. intensity modulated radiotherapy 

(IMRT): Defined as any treatment 

plan where intensity-modulated 

radiation beams and computerized 

inverse treatment planning is used 

3. stereotactic body radiation therapy 

(SBRT): Defined as conformal RT 

(forward or reverse-planned) 

delivered in 3 to 5 relatively larger 

doses of ionizing radiation than 

typically delivered in a standard 

conformal schedule of 25–35 doses 

4. proton beam radiotherapy (PBRT): 

Defined as any treatment plan 

where proton beam radiation is 

used 

Interventions may occur as part of a 

multimodal treatment strategy if the 

comparisons only differ with respect to 

the radiation therapy given. 

Comparators 

All therapies will be compared to 

each other as part of a continuum of 

treatment for patients with head and 

neck cancer. Thus, we will include 

studies in which a RT method was 

compared to a different method, for 

example with or without chemotherapy 

or surgery. We will include all studies 

from which we can be reasonably 

certain additional treatments are 

contemporary and similar, leaving the 

major comparison that between RT 

modalities; those that we cannot 

ascertain from the publication will be 

excluded. To ensure chemotherapy or 

other treatments are similar and 

contemporary, we will consult accepted 

guidelines such as those from the 

National Comprehensive Cancer 

Network (NCCN) or National Cancer 

Institute (NCI). We will not extract 

details on chemotherapy dosages or 

schedules, but rather will ascertain their 

degree of general similarity and the 

proportions of patients who receive and 

complete such regimens. We will 

categorize and synthesize evidence 

according to overall treatment, for 

example concurrent chemoradiotherapy, 

or adjuvant radiotherapy, not mixing 

these in the strength of evidence 

synthesis. 

Outcomes 

KQ 1, 3 & 4: 

1. Final outcomes: quality of life 

(QoL) and adverse events including; 

radiation induced toxicities, xerostomia, 

mucositis, taste changes, dental 

problems, and dysphagia. 

2. Intermediate outcomes: Salivary 

flow, probability of completing 

treatment according to protocol. 

We will search for evidence related to 

user experience, treatment planning, 

and target volume delineation within 

the context of KQ4. In the absence of an 

evidence-base on these measures, these 

issues will be addressed as appropriate 

in both the future research needs and 

discussion sections of the report. 

Based on input received from the 

TEP, any outcomes not adequately 

addressed in the literature will be stated 

as evidence gaps for primary research in 

the future research needs section of the 

report. 

KQ 2, 3 & 4: 

1. Final outcomes: Overall survival 

and cancer specific survival. 

2. Intermediate outcomes: Local 

control, and time to recurrence. 

Timing 

All durations of follow-up will be 

considered. 

Settings 

Inpatient and outpatient. 

Dated: March 6, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–05389 Filed 3–11–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day 14–0787] 

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 

Personal Flotation Devices (PFDs) and 

Commercial Fishermen: Preconceptions 

and Evaluation in Actual Use— 

Reinstatement with Change (0920–0787, 


tkelley on DSK3SPTVN1PROD with NOTICES