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unpublished randomized controlled 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

10750 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

Background and Brief Description 

The compilation of national vital 

statistics dates back to the beginning of 

the 20th century and has been 

conducted since 1960 by the Division of 

Vital Statistics of the National Center for 

Health Statistics, CDC. The collection of 

the data is authorized by 42 U.S.C. 242k. 

This submission requests approval to 

collect the monthly and annually 

summary statistics for three years. 

The Monthly Vital Statistics Report 

forms provide counts of monthly 

occurrences of births, deaths, infant 

deaths, marriages, and divorces. Similar 

data have been published since 1937 

and are the sole source of these data at 

the National level. The data are used by 

the Department of Health and Human 

Services and by other government, 

academic, and private research and 

commercial organizations in tracking 

changes in trends of vital events. The 

respondents are the registration officials 

in the 50 States, the District of 

Columbia, New York City, Puerto Rico, 

Virgin Islands, Guam, American Samoa, 

and the Commonwealth of the Northern 

Mariana Islands. In addition, 33 local 

(county) officials in New Mexico who 

record marriages occurring and divorces 

and annulments granted in each county 

of New Mexico will use this form. This 

form, which takes about 10 minutes to 

complete, is designed to collect counts 

of monthly occurrences of births, 

deaths, infant deaths, marriages, and 

divorces immediately following the 

month of occurrence. 

The Annual Vital Statistics 

Occurrence Report Form collects final 

annual counts of marriages and divorces 

by month for the United States and for 

each State. The statistical counts 

requested on this form differ from 

provisional estimates obtained on the 

Monthly Vital Statistics Report Form in 

that they represent complete counts of 

marriages, divorces, and annulments 

occurring during the months of the prior 

year. These final counts are usually 

available from State or county officials 

about eight months after the end of the 

data year. The data are widely used by 

government, academic, private research, 

and commercial organizations in 

tracking changes in trends of family 

formation and dissolution. The 58 

Respondents for the Annual Vital 

Statistics Occurrence Report Form, 

which takes about 30 minutes to 

complete, are registration officials in 

each State and Territory, the District of 

Columbia, and New York City. 

There are no costs to respondents 

other than their time to participate; the 

data are routinely available in each 

reporting office as a by-product of 

ongoing activities. The total estimated 

annualized burden hours are 211. 

TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondent 

Number of 

responses per 

respondents 

Average 

burden per 

response 

(in hours) 

State, Territory and New Mexico County officials.Monthly Vital Statistics Report ....................... 91 12 10/60 

State, Territory and Other officials .................. Annual Vital Statistics Occurrence Report ..... 58 1 30/60 

Kimberly S. Lane, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–4173 Filed 2–22–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day-12–0010] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–7570 and 

send comments to Kimberly Lane, CDC 

Reports Clearance Officer, 1600 Clifton 

Road, MS–D74, Atlanta, GA 30333 or 

send an email to omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection 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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

The National Birth Defects Prevention 

Study (NBDPS), (OMB 0920–0010)— 

Reinstatement Without Change— 

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. 

The National Birth Defects Prevention 

Study (NBDPS) formerly the Birth 

Defects Risk Factor Surveillance Study 

(BDRFS) began in 1997. 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. NBDPS 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 to 

complete. A maximum of four hundred 

interviews are planned per year per 

center, 300 cases and 100 controls 

resulting in a maximum interview 

burden of 400 hours for each of the 

centers each year. 

mstockstill on DSK4VPTVN1PROD with NOTICES