10748 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Review/update RoPR Record .......................................................................... 760 1 15/60 190 

Total .......................................................................................................... 2,280 na na 1,330 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate † 

Total cost 

burden 

New RoPR Record .......................................................................................... 1,520 1,140 $34.27 $39,068 

Review/update RoPR Record .......................................................................... 760 190 34.27 6,511 

Total .......................................................................................................... 2,280 1,330 na 45,579 

† Based upon the mean average wage for Healthcare Practitioners and Technical Occupations, May National Occupational Employment and 

Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics. Available at: http://www.bls.gov/oes/current/oes_nat.htm#29–0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the estimated total 

and annualized cost to the government 

to create and maintain the RoPR for 3 

years. The total cost is estimated to be 

$3,184,333. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost component Total cost Annualized 

cost 

Project Development ............................................................................................................................................... $2,318,509 $772,836 

Project Management ................................................................................................................................................ 409,149 136,383 

Overhead ................................................................................................................................................................. 456,675 152,225 

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: February 6, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–3911 Filed 2–22–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Mechanical Prophylaxis of Venous 

Thromboembolism (VTE) 

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 antithrombotic 

medical devices. Scientific information 

is being solicited to inform our 

Comparative Effectiveness of 

Pharmacologic and Mechanical 

Prophylaxis of Venous 

Thromboembolism Among Special 

Populations Review, 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 March 26, 2012. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/index.

cfm/submitscientific-informationpackets/. 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10749 

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@aohsu.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 

pharmacologic and mechanical 

prophylaxis of venous 

thromboembolism (VTE) among special 

populations. 

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 mechanical 

prophylaxis of venous 

thromboembolism among special 

populations, 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://effectivehealthcare.ahrq.gov/

index.cfm/search-for-guides-reviewsandreports/?pageaction=display

product&productid=928#4370. 

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. 

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 

and safety of Inferior Vena Cava filters 

to prevent Pulmonary Emboli in 

hospitalized patients with trauma? 

Question 2 

1. What is the comparative 

effectiveness and safety of 

pharmacologic and mechanical 

strategies to prevent VTE in hospitalized 

patients with traumatic brain injury? 

2. What is the optimal timing of 

initiation and duration of 

pharmacologic prophylaxis to prevent 

VTE in hospitalized patients with 

traumatic brain injury? 

Question 3 

What is the comparative effectiveness 

and safety of pharmacologic and 

mechanical strategies to prevent VTE in 

hospitalized patients with burns? 

Question 4 

What is the comparative effectiveness 

and safety of pharmacologic and 

mechanical strategies to prevent VTE in 

hospitalized patients with liver disease? 

Question 5 

What is the comparative effectiveness 

and safety of pharmacologic and 

mechanical strategies to prevent VIE in 

hospitalized patients receiving 

antiplatelet therapy? 

Question 6 

What is the comparative effectiveness 

and safety of pharmacologic and 

mechanical strategies to prevent VTE in 

patients having bariatric surgery? 

Question 7 

What is the comparative effectiveness 

and safety of pharmacologic prophylaxis 

for prevention of VTE during 

hospitalization of obese and 

underweight patients? 

Question 8 

What is the comparative effectiveness 

and safety of pharmacologic prophylaxis 

for prevention of VTE during 

hospitalization of patients with acute 

kidney injury, moderate renal 

impairment, or severe renal impairment 

not undergoing dialysis and patients 

receiving dialysis? 

Dated: February 7, 2012. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2012–3937 Filed 2–21–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30-Day—12–0213] 

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 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995. 

To request a copy of these requests, call 

the CDC Reports Clearance Officer at 

(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) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

National Vital Statistics Report Forms 

(0920–0213, Expiration 04/30/2012)— 

Extension—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC). 

mstockstill on DSK4VPTVN1PROD with NOTICES