Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Notices 40885 

on HIV/AIDS (PACHA) will hold a 

meeting. The meeting will be open to 

the public. 

DATES: The meeting will be held July 25, 

2012 from 3:00 p.m. to approximately 

5:00 p.m. (EDT). 

ADDRESSES: 801 K Street NW., 

Washington, DC, 20001. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Melvin Joppy, Committee Manager, 

Presidential Advisory Council on HIV/ 

AIDS, Department of Health and Human 

Services, 200 Independence Avenue 

SW., Room 443H, Hubert H. Humphrey 

Building, Washington, DC 20201; (202) 

690–5560. More detailed information 

about PACHA can be obtained by 

accessing the Council’s Web site 

www.aids.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995 as amended 

by Executive Order 13009, dated June 

14, 1996. The Council was established 

to provide advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective 

prevention of HIV disease and AIDS. 

The functions of the Council are solely 

advisory in nature. 

The Council consists of not more than 

25 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

philanthropy, marketing or business, as 

well as other national leaders held in 

high esteem from other sectors of 

society. Council members are appointed 

by the Secretary or designee, in 

consultation with the White House 

Office on National AIDS Policy. The 

agenda for the upcoming meeting will 

be posted on the Council’s Web site at 

www.aids.gov/pacha. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated contact person. Preregistration for public attendance is 

advisable and can be accomplished by 

contacting the PACHA Committee 

Manager at melvin.joppy@hhs.gov. 

Members of the public will have the 

opportunity to provide comments at the 

meeting. Any individual who wishes to 

participate in the public comment 

session must register with Melvin Joppy 

at melvin.joppy@hhs.gov; registration 

for public comment will not be accepted 

by telephone. Public comment will be 

limited to two minutes per speaker. Any 

members of the public who wish to have 

printed material distributed to PACHA 

members at the meeting should submit, 

at a minimum, 1 copy of the materials 

to the Committee Manager, PACHA, no 

later than close of business Wednesday, 

July 18, 2012. Contact information for 

the PACHA Committee Manager is 

listed above. 

Dated: July 5, 2012. 

B. Kaye Hayes, 

Executive Director, Presidential Advisory 

Council on HIV/AIDS. 

[FR Doc. 2012–16907 Filed 7–10–12; 8:45 am] 

BILLING CODE 4150–43–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. 

This proposed information collection 

was previously published in the Federal 

Register on February 23rd, 2012 and 

allowed 60 days for public comment. 

Several comments were received. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

DATES: Comments on this notice must be 

received by August 10, 2012. 

ADDRESSES: Written comments should 

be submitted to: AHRQ’s OMB Desk 

Officer by fax at (202) 395–6974 

(attention: AHRQ’s desk officer) or by 

email at 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

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: 

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 


srobinson on DSK4SPTVN1PROD with NOTICES
40886 Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Notices 

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, Pub. L. 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 

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 2010 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. 


srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Notices 40887 

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: July 5, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–16849 Filed 7–10–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–12–0842] 

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, 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 

STD Surveillance Network (SSuN)- 

(OMB 0920–0842 Exp: 1/31/2013)— 

Revision—National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The purpose of the STD Surveillance 

Network (SSuN) project is to improve 

the capacity of national, state, and local 

STD programs to detect, monitor, and 

respond rapidly to trends in STDs 

through enhanced collection, reporting, 

analysis, visualization and 

interpretation of disease information. 

The objectives of the SSuN Project are 

(1) To establish an integrated network of 

sentinel STD clinics and health 

departments to inform and guide 

national programs and policies for STD 

control in the U.S.; (2) to improve the 

capacity of national, state and local STD 

programs to detect, monitor and 

respond to established and emerging 

trends in STDs, HIV, and viral hepatitis; 

and (3) to identify and evaluate the 

effectiveness of public health 

interventions to reduce STD morbidity. 

The SSuN Project is an active STD 

sentinel surveillance network 

comprised of 12 surveillance sites 

around the United States. SSuN uses 

two surveillance strategies to collect 

information. The first is a STD clinicbased surveillance which extracts data 

from existing electronic medical records 

for all patient visits at participating STD 

clinics. The second is a populationbased surveillance in which a sample of 

individuals reported with gonorrhea to 

the 12 SSuN state or city health 

departments are interviewed using 

locally-designed interview templates. 

For the clinic-based surveillance, the 

specified data elements are abstracted 

on a quarterly basis from existing 

electronic medical records for all patient 

visits to participating clinics. Data in the 

electronic medical record may be 

collected at time of registration, during 

the clinic encounter, or through 

laboratory testing. For the populationbased STD surveillance, the results of 

interviews will be entered into a 

developed Microsoft Access database 

that will be adapted locally for each 

clinic. High quality, informative, and 

timely surveillance data are necessary to 

guide STD programs so interventions 

are designed and implemented 

appropriately. Furthermore, 

surveillance data are necessary for 

understanding the impact of STD 

interventions based on the 

epidemiology of each STD. 

This information is collected to 

establish an integrated network of 

sentinel STD clinics and health 

departments to inform and guide 

national programs and policies for STD 

control in the U.S. It will improve the 

capacity of national, state, and local 

STD programs to detect, monitor, and 

respond to established and emerging 

trends in STDs, HIV, and viral hepatitis. 

SSuN will help identify and evaluate 

the effectiveness of public health 

interventions to reduce STD morbidity. 

The SSuN surveillance platform 

allows CDC to establish and maintain 

common standards for data collection, 

transmission, and analysis, and to build 

and maintain STD surveillance 

expertise in 12 surveillance areas. Such 

common systems, established 

mechanisms of communication, and inplace expertise are all critical 

components for timely, flexible, and 

high quality surveillance. 

There is no cost to respondents other 

than their time. The total estimated 

annual burden hours are 480. 

ESTIMATED ANNUALIZED BURDEN HOURS

Types of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

SSuN site ..................................................................................................................................... 12 4 2 


srobinson on DSK4SPTVN1PROD with NOTICES