10746 Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 

discretion, the Commission tries to 

remove individuals’ home contact 

information from comments before 

placing them on the Commission Web 

site. 

Because your comment will be made 

public, you are solely responsible for 

making sure that your comment doesn’t 

include any sensitive personal 

information, like anyone’s Social 

Security number, date of birth, driver’s 

license number or other state 

identification number or foreign country 

equivalent, passport number, financial 

account number, or credit or debit card 

number. You are also solely responsible 

for making sure that your comment 

doesn’t include any sensitive health 

information, like medical records or 

other individually identifiable health 

information. In addition, don’t include 

any ‘‘[t]rade secret or any commercial or 

financial information which is obtained 

from any person and which is privileged 

or confidential * * *,’’ as provided in 

Section 6(f) of the FTC Act, 15 U.S.C. 

46(f), and FTC Rule 4.10(a)(2), 16 CFR 

4.10(a)(2). In particular, don’t include 

competitively sensitive information 

such as costs, sales statistics, 

inventories, formulas, patterns, devices, 

manufacturing processes, or customer 

names. 

If you want the Commission to give 

your comment confidential treatment, 

you must file it in paper form, with a 

request for confidential treatment, and 

you have to follow the procedure 

explained in FTC Rule 4.9(c), 16 CFR 

4.9(c). Your comment will be kept 

confidential only if the FTC General 

Counsel, in his or her sole discretion, 

grants your request in accordance with 

the law and the public interest. 

Postal mail addressed to the 

Commission is subject to delay due to 

heightened security screening. As a 

result, we encourage you to submit your 

comments online, or to send them to the 

Commission by courier or overnight 

service. To make sure that the 

Commission considers your online 

comment, you must file it at https:// 

ftcpublic.commentworks.com/ftc/ 

apparelrulespra2, by following the 

instructions on the web based form. If 

this Notice appears at http:// 

www.regulations.gov, you also may file 

a comment through that Web site. 

If you file your comment on paper, 

write ‘‘Apparel Rules: FTC File No. 

P074201’’ on your comment and on the 

envelope, and mail or deliver it to the 

following address: Federal Trade 

Commission, Office of the Secretary, 

Room H–113 (Annex J), 600 

Pennsylvania Avenue NW., Washington, 

DC 20580. If possible, submit your 

paper comment to the Commission by 

courier or overnight service. 

Visit the Commission Web site at 

http://www.ftc.gov to read this Notice. 

The FTC Act and other laws that the 

Commission administers permit the 

collection of public comments to 

consider and use in this proceeding as 

appropriate. The Commission will 

consider all timely and responsive 

public comments that it receives on or 

before March 26, 2012. You can find 

more information, including routine 

uses permitted by the Privacy Act, in 

the Commission’s privacy policy, at 

http://www.ftc.gov/ftc/privacy.shtm. 

Comments on the information 

collection requirements subject to 

review under the PRA should also be 

submitted to OMB. If sent by U.S. mail, 

address comments to: Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

Attention: Desk Officer for the Federal 

Trade Commission, New Executive 

Office Building, Docket Library, Room 

10102, 725 17th Street, NW., 

Washington, DC 20503. Comments sent 

to OMB by U.S. postal mail, however, 

are subject to delays due to heightened 

security precautions. Thus, comments 

instead should be sent by facsimile to 

(202) 395–5167. 

Willard K. Tom, 

General Counsel. 

[FR Doc. 2012–4141 Filed 2–22–12; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting 

Pursuant to the Federal Advisory 

Committee Act, the Department of 

Health and Human Services (HHS) 

announces the following advisory 

committee meeting. 

Name: National Committee on Vital and 

Health Statistics (NCVHS), Subcommittee on 

Population Health Meeting. 

Time and Date: 

March 8, 2012: 9 a.m.–5:30 p.m. EST; 

March 9, 2012: 9 a.m.–3 p.m. EST. 

Place: National Center for Health Statistics, 

3311 Toledo Road, Auditorium, Hyattsville, 

MD 20782, Tel: 301–458–4200. 

Status: Open. 

Purpose: The purpose of this meeting is to 

gain input about the collection of 

socioeconomic (SES) data in federal surveys, 

including innovative uses of information. 

The intention is to describe SES measures, 

review SES data collection in federal surveys 

and provide recommendations for SES data 

collection within HHS. 

Contact Person for More Information: 

Substantive program information as well as 

summaries of meetings and a roster of 

committee members may be obtained from 

Marjorie S. Greenberg, Executive Secretary, 

NCVHS, National Center for Health Statistics, 

Centers for Disease Control and Prevention, 

3311 Toledo Road, Room 2402, Hyattsville, 

Maryland 20782, telephone (301) 458–4245. 

Information also is available on the NCVHS 

home page of the HHS Web site: http:// 

www.ncvhs.hhs.gov/, where further 

information including an agenda will be 

posted when available. 

Should you require reasonable 

accommodation, please contact the CDC 

Office of Equal Employment Opportunity on 

(301) 458–4EEO (4336) as soon as possible. 

Dated: February 14, 2012. 

James Scanlon, 

Deputy Assistant Secretary for Planning and 

Evaluation, Office of the Assistant Secretary 

for Planning and Evaluation. 

[FR Doc. 2012–4118 Filed 2–22–12; 8:45 am] 

BILLING CODE 4151–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: 

‘‘American Recovery and Reinvestment 

Act ‘Developing a Registry of 

Registries’.’’ In accordance with the 

Paperwork Reduction Act, 44 U.S.C. 

3501–3521, AHRQ invites the public to 

comment on this proposed information 

collection. 

DATES: Comments on this notice must be 

received by April 23, 2012. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 36 / Thursday, February 23, 2012 / Notices 10747 

Proposed Project 

American Recovery and Reinvestment 

Act ‘‘Developing a Registry of 

Registries’’ 

The Food and Drug Administration 

Modernization Act of 1997, Public Law 

105–115, provided for the creation of a 

Clinical Trials Data Bank, known as 

ClinicalTrials.gov. Since its launch in 

2000, the ClinicalTrials.gov system has 

registered over 90,500 trials. The large 

volume of studies currently listed in 

ClinicalTrials.gov and the high usage 

numbers suggest that the system has 

been successful at improving access to 

information about clinical studies. 

However, while ClinicalTrials.gov 

supports the listing of observational 

studies, such listing is not required. 

Patient registries are a distinct type of 

observational study. Patient registries 

may be designed for many purposes, 

such as to observe the natural history of 

disease, examine comparative 

effectiveness, or fulfill post-approval 

commitments. Patient registries have 

specific characteristics that are not 

currently captured on 

ClinicalTrials.gov. To date, some 

registry sponsors have attempted to 

leverage the observational study model 

to post patient registry-type records on 

ClinicalTrials.gov; however, 

stakeholders have noted that the system 

does not fully meet their needs. 

Patient registries have received 

significant attention and funding in 

recent years. Similar to controlled 

interventional studies, patient registries 

represent some burden to patients (e.g., 

time to complete patient reported 

outcome measures, risk of loss of 

privacy), who often participate 

voluntarily in hopes of improving 

knowledge about a disease or condition. 

Patient registries also represent a 

substantial investment of health 

research resources. Despite these 

factors, registration of patient registries 

in ClinicalTrials.gov is not currently 

required, presenting the potential for 

duplication of efforts and insufficient 

dissemination of findings that are not 

published in the peer-reviewed 

literature. To ensure that resources are 

used in the most efficient manner, 

registries need to be listed in a manner 

similar to that of trials in 

ClinicalTrials.gov. 

By creating a central point of 

collection for information about all 

patient registries in the United States, 

the Registry of Patient Registries (RoPR) 

helps to further AHRQ’s goals by 

making information regarding quality, 

appropriateness, and effectiveness of 

health services and patient registries in 

particular) more readily available and 

centralized. 

The primary goal of this project is to 

engage stakeholders in the design and 

development of a RoPR database system 

that is compatible with 

ClinicalTrials.gov and meets the 

following objectives: 

(1) Provides a searchable database of 

patient registries in the United States (to 

promote collaboration, reduce 

redundancy, and improve 

transparency); 

(2) Facilitates the use of common data 

fields and definitions in similar health 

conditions (to improve opportunities for 

sharing, comparing, and linkage); 

(3) Provides a public repository of 

searchable summary results (including 

results from registries that have not yet 

been published in the peer-reviewed 

literature); 

(4) Offers a search tool to locate 

existing data that researchers can 

request for use in new studies; and 

serves as a recruitment tool for 

researchers and patients interested in 

participating in patient registries. 

This study is being conducted by 

AHRQ through its contractor, the 

Outcome DEcIDE Center, pursuant to 

the American Recovery and 

Reinvestment Act, Public Law 111–5, 

and pursuant to AHRQ’s statutory 

authority to conduct and support 

research and disseminate information 

on health care and on systems for the 

delivery of such care, including 

activities with respect to the quality, 

effectiveness, efficiency, 

appropriateness and value of health care 

services and with respect to database 

development. 42 U.S.C. 299a(a)(1) and 

(8). 

Method of Collection 

To achieve the goals of this project the 

following data collections will be 

implemented: 

(1) Collect information from registry 

holders, defining a patient registry 

profile via a web-based interface, to 

populate the RoPR database system. 

The purpose of the RoPR is to create 

a readily available public resource in 

the model of ClinicalTrials.gov to share 

information on existing patient 

registries to promote collaboration, 

reduce redundancy, and improve 

transparency in registry research. 

Patient registry research has become 

more prevalent and, based on 

stakeholder feedback, is not adequately 

served by ClinicalTrials.gov at present. 

The information being collected in the 

RoPR record will be visible to the public 

visiting the RoPR Web site and will be 

available for public use in this capacity. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden for the respondents’ 

time to participate in the RoPR. Because 

the RoPR is a voluntary system available 

to any entity conducting a patient 

registry, it is not possible to determine 

the number of potential respondents. 

We do know that over 3,800 newly 

registered records designated as 

‘‘observational studies’’ were entered 

into ClinicalTrials.gov in 2010. Only a 

subset of this number (which we will 

estimate at a maximum of 40%) would 

qualify as patient registries and would 

likely be registered in the RoPR. 

Therefore, we use 1,520 (3,800*0.40) in 

Exhibits 1 and 2 below as a very rough, 

but high, estimation of the potential 

number of respondents who will enter 

registries into the RoPR annually. The 

actual number of respondents will 

depend on a variety of factors and could 

vary widely. It should be remembered 

that mandates could evolve making 

registration in the RoPR mandatory. Our 

estimates therefore attempt to factor an 

upper threshold for volume. 

Each respondent will enter a new 

RoPR record only once and is estimated 

to take 45 minutes. An estimated 50% 

(760 records) of RoPR records will be 

updated once a year and will take about 

15 minutes. This estimate is based on a 

query of ClinicalTrials.gov which 

showed that about 50% of observational 

studies registered in ClinicalTrials.gov 

had been updated in the past year. The 

total respondent burden is estimated to 

be 1,330 hours annually. 

Exhibit 2 shows the estimated cost 

burden associated with the respondent’s 

time to participate in the RoPR. The 

total cost burden is estimated to be 

$45,579 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

New RoPR Record .......................................................................................... 1,520 1 45/60 1,140 

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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 

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