Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Notices 52929 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of respondents 

Number of responses per 

respondent 

Hours per response Total burden 

hours 

Semi-structured interview ................................................................................ 9 9 60/60 81 

Training participant questionnaire ................................................................... 240 10 20/60 800 

Total .......................................................................................................... 249 NA NA 881 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of respondents 

Total burden 

hours 

Average hourly wage rate * Total cost burden 

Semi-structured interview ................................................................................ 9 81 $44.18 $3,579 

Training participant questionnaire ................................................................... 240 800 44.18 35,344 

Total .......................................................................................................... 249 881 NA 38,923 

* Based upon the mean of the average wages for all health professionals (29–000) for the training participant questionnaire and for executives, 

administrators, and managers for the organizational leader questionnaire presented in the National Compensation Survey: Occupational Wages 

in the United States, May, 2012, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#37-0000. 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) of 

information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: August 16, 2013. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2013–20826 Filed 8–26–13; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Imaging Tests for the Diagnosis and 

Staging of Pancreatic Adenocarcinoma 

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 imaging tests for the 

diagnosis and staging of pancreatic 

adenocarcinoma. Scientific information 

is being solicited to inform our review 

of Imaging Tests for the Diagnosis and 

Staging of Pancreatic Adenocarcinoma, 

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 imaging tests for the 

diagnosis and staging of pancreatic 

adenocarcinoma 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 September 26, 2013. 

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 a 

review of the evidence for Imaging Tests 

for the Diagnosis and Staging of 

Pancreatic Adenocarcinoma. 

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 Imaging Tests for the 

Diagnosis and Staging of Pancreatic 

Adenocarcinoma, including those that 

describe adverse events. The entire 

research protocol, including the key 

questions, is also available online at: 


tkelley on DSK3SPTVN1PROD with NOTICES
52930 Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Notices 

http://www.effective

healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?page

action=displayproduct

&productID=1620. 

This notice is to notify the public that 

the EHC program would find the 

following information on imaging tests 

for the diagnosis and staging of 

pancreatic adenocarcinoma helpful: 

D 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. 

D 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. 

D 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. 

D 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://www.effective

healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?page

action=displayproduct&product

ID=1620. 

The Key Questions 

Question 1 

What is the comparative effectiveness 

of imaging techniques (e.g., MDCT 

angiography ± 3D reconstruction, other 

MDCT, EUS–FNA, PET–CT, MRI) for 

diagnosis of pancreatic adenocarcinoma 

in adults with suspicious symptoms? 

a. What is the accuracy of each 

imaging technique for diagnosis and 

assessment of resectability? 

b. What is the comparative accuracy 

of the different imaging techniques for 

diagnosis and assessment of 

resectability? 

c. What is the comparative diagnostic 

accuracy of using a single imaging 

technique versus using multiple 

imaging techniques? 

d. How is test experience (e.g., 

operative experience, assessor 

experience, center’s annual volume) 

related to comparative diagnostic 

accuracy of the different imaging 

strategies? 

e. How are patient factors and tumor 

characteristics related to the 

comparative diagnostic accuracy of the 

different imaging strategies? 

f. What is the comparative clinical 

management after the different imaging 

strategies when used for diagnosis? 

What is the comparative impact of the 

different imaging strategies on long-term 

survival and quality of life when used 

for diagnosis? 

Question 2 

What is the comparative effectiveness 

of imaging techniques (e.g., MDCT 

angiography ± 3D reconstruction, other 

MDCT, EUS–FNA, PET–CT, MRI) for 

staging of pancreatic adenocarcinoma 

among adults with a diagnosis of 

pancreatic adenocarcinoma? 

a. What is the staging accuracy of each 

imaging technique (for tumor size, 

lymph node status, vessel involvement, 

metastases, stage [I–IV], and 

resectability)? 

b. What is the comparative staging 

accuracy among the different imaging 

techniques? 

c. What is the comparative staging 

accuracy of using a single imaging 

technique versus using multiple 

imaging techniques? 

d. How is test experience (e.g., 

operative experience, assessor 

experience, center’s annual volume) 

related to comparative staging accuracy 

of the different imaging strategies? 

e. How are patient factors and tumor 

characteristics related to the 

comparative staging accuracy of the 

different imaging strategies? 

f. What is the comparative clinical 

management of the different imaging 

strategies when used for staging? 

What is the comparative impact of the 

different imaging strategies on long-term 

survival and quality of life when used 

for staging? 

Question 3 

What are the rates of harms of imaging 

techniques (e.g., MDCT angiography ± 

3D reconstruction, other MDCT, EUS– 

FNA, PET–CT, MRI) when used to 

diagnose and/or stage pancreatic 

adenocarcinoma? 

a. How are patient factors related to 

the harms of different imaging 

techniques? 

What are patient perspectives on the 

tolerance of different imaging 

techniques and the balance of benefits 

and harms of different imaging 

techniques? 

Question 4 

What is the comparative screening 

accuracy of imaging techniques (e.g., 

MDCT angiography ± 3D reconstruction, 

other MDCT, EUS–FNA, PET–CT, MRI) 

in high-risk asymptomatic adults (i.e., 

those at genetic or familial risk of 

pancreatic adenocarcinoma)? 

Dated: August 19, 2013. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2013–20849 Filed 8–26–13; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0520] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed; Animal Proteins Prohibited in 

Ruminant Feed; Extension 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 


tkelley on DSK3SPTVN1PROD with NOTICES