Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24959 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued 

Cost component Total cost Annualized 

cost 

Total .................................................................................................................................................................. 3,184,333 1,061,444 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, 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 healthcare 

research and healthcare 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: April 19, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–10009 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Local Therapies for Unresectable 

Primary Hepatocellular Carcinoma 

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 

manufacturers of local, minimally 

invasive, medical devices for 

unresectable primary hepatocellular 

carcinoma (e.g., ablation, radiotherapy, 

or embolization devices). Scientific 

information is being solicited to inform 

our Comparative Effectiveness Review 

of Local Therapies for Unresectable 

Primary Hepatocellular Carcinoma, 

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 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 29, 2012. 

ADDRESSES: 

Online submissions: http://effective

healthcare.AHRQ.gov/index.cfm/submit

scientific-information-packets/. Please 

select the study for which you are 

submitting information from the list of 

current studies and complete the form 

to upload your documents. 

Email submissions: ehcsrc@ohsu.edu 

(please do not send zipped files—they 

are automatically deleted for security 

reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or Email: 

ehcsrc@ohsu.edu. 

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 the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

local therapies for unresectable primary 

hepatocellular carcinoma. 

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 systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 

for studies that report on local therapies 

for unresectable primary hepatocellular 

carcinoma, 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.effective

healthcare.AHRQ.gov/index.cfm/

search-for-quides-reviews-and-reports/

?productid=1012&pageaction=display

product#5056. 

This notice is a request for industry 

stakeholders to submit 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. Please provide both a 

list of citations and reprints if possible. 

• 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. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

information please submit an index 

document outlining the relevant 

information in each file along with a 

statement regarding whether or not the 

submission comprises all of the 

complete information available. 


tkelley on DSK3SPTVN1PROD with NOTICES
24960 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

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/. 

The Key Questions 

Question 1 

What is the comparative effectiveness 

of the various liver-directed therapies in 

patients with hepatocellular carcinoma 

(HCC) who are not otherwise candidates 

for surgical resection or transplantation 

with no evidence of extrahepatic disease 

regarding survival and quality of life? 

Question 2 

What are the comparative harms of 

the various liver-directed therapies in 

patients with HCC who are not 

otherwise candidates for surgical 

resection or transplantation with no 

evidence of extrahepatic disease 

regarding adverse events? 

Question 3 

Are there differences in comparative 

effectiveness of various liver-directed 

therapies in patients with HCC who are 

not otherwise candidates for surgical 

resection or transplantation for specific 

patient and tumor characteristics, such 

as age, gender, disease etiology, and 

Child-Pugh score? 

Dated: April 19, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–10011 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-12–0010] 

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 or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

The National Birth Defects Prevention 

Study (NBDPS)–(0920–0010, Expiration 

06/30/2012)—Extension—National 

Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

CDC has been monitoring the 

occurrence of serious birth defects and 

genetic diseases in Atlanta since 1967 

through the Metropolitan Atlanta 

Congenital Defects Program (MACDP). 

The MACDP is a population-based 

surveillance system for birth defects in 

the 5 counties of Metropolitan Atlanta. 

Its primary purpose is to describe the 

spatial and temporal patterns of birth 

defects occurrence and serves as an 

early warning system for new 

teratogens. In 1997, the Birth Defects 

Risk Factor Surveillance (BDRFS) study, 

a case-control study of risk factors for 

selected birth defects, became the 

National Birth Defects Prevention Study 

(NBDPS). The major components of the 

study did not change. 

The NBDPS is a case-control study of 

major birth defects that includes cases 

identified from existing birth defect 

surveillance registries in nine states, 

including metropolitan Atlanta. Control 

infants are randomly selected from birth 

certificates or birth hospital records. 

Mothers of case and control infants are 

interviewed using a computer-assisted 

telephone interview. The interview 

takes approximately one hour. A 

maximum of thirty-six hundred 

interviews are planned, 2,700 cases and 

900 controls, resulting in a maximum 

interview burden of approximately 

3,600 hours for all Centers. 

Parents are also asked to collect cheek 

cells from themselves and their infants 

for DNA testing. The collection of cheek 

cells by the mother, father, and infant is 

estimated to take about 10 minutes per 

person. Each person will be asked to rub 

1 brush inside the left cheek and 1 

brush inside the right cheek for a total 

of 2 brushes per person. Collection of 

the cheek cells takes approximately 

1–2 minutes, but the estimate of burden 

is 10 minutes to account for reading and 

understanding the consent form and 

specimen collection instructions and 

mailing back the completed kits. The 

anticipated maximum burden for 

collection of the cheek cells is 1,800 

hours for all Centers. 

Information gathered from both the 

interviews and the DNA specimens will 

be used to study independent genetic 

and environmental factors as well as 

gene-environment interactions for a 

broad range of carefully classified birth 

defects. 

This request is submitted to obtain 

OMB clearance for three additional 

years. 

There are no costs to the respondents 

other than their time. The total 

estimated annualized burden is 5,400 

hours. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Mothers ................................................ NBDPS mother questionnaire ................................... 3,600 1 1 

Mothers, fathers, infants ...................... Cheek Cell Specimen Collection .............................. 10,800 1 10/60 


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