Attachment B -- Federal Register Notice

srobinson on DSK4SPTVN1PROD with NOTICES

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

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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 for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

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:
SUMMARY:

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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

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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
Number of
responses per
respondent

Number of
respondents

Form name

Hours per
response

Total burden
hours

New RoPR Record ..........................................................................
Review/update RoPR Record ..........................................................

1,520
760

1
1

45/60
15/60

1,140
190

Total ..........................................................................................

2,280

na

na

1,330

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average hourly
wage rate*

Total cost burden

New RoPR Record ..........................................................................
Review/update RoPR Record ..........................................................

1,520
760

1,140
190

$34.27
34.27

$39,068
6,511

Total ..........................................................................................

2,280

1,330

na

45,579

srobinson on DSK4SPTVN1PROD with NOTICES

* 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.

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Federal Register / Vol. 77, No. 133 / Wednesday, July 11, 2012 / Notices
Estimated Annual Costs to the Federal
Government

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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.

Centers for Disease Control and
Prevention
[30Day–12–0842]

Agency Forms Undergoing Paperwork
Reduction Act Review

EXHIBIT 3—ESTIMATED TOTAL AND
ANNUALIZED COST

srobinson on DSK4SPTVN1PROD with NOTICES

The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
Cost
Annualized
Total cost
review by the Office of Management and
component
cost
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Project Development ......
$2,318,509
$772,836 Chapter 35). To request a copy, call the
CDC Reports Clearance Officer at (404)
Project Management ....
409,149
136,383 639–7570 or send an email to
Overhead ......
456,675
152,225 omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of
Total ..........
3,184,333
1,061,444 Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
Request for Comments
comments should be received within 30
days of this notice.
In accordance with the Paperwork
Proposed Project
Reduction Act, comments on AHRQ’s
information collection are requested
STD Surveillance Network (SSuN)with regard to any of the following:
(OMB 0920–0842 Exp: 1/31/2013)—
Revision—National Center for HIV/
(a) Whether the proposed collection of
AIDS, Viral Hepatitis, STD, and TB
information is necessary for the proper
Prevention (NCHHSTP), Centers for
performance of AHRQ healthcare
Disease Control and Prevention (CDC).
research and healthcare information
dissemination functions, including
Background and Brief Description
whether the information will have
The purpose of the STD Surveillance
practical utility; (b) the accuracy of
Network (SSuN) project is to improve
AHRQ’s estimate of burden (including
the capacity of national, state, and local
hours and costs) of the proposed
STD programs to detect, monitor, and
collection(s) of information; (c) ways to
respond rapidly to trends in STDs
enhance the quality, utility, and clarity
through enhanced collection, reporting,
of the information to be collected; and
analysis, visualization and
(d) ways to minimize the burden of the
interpretation of disease information.
collection of information upon the
The objectives of the SSuN Project are
respondents, including the use of
(1) To establish an integrated network of
automated collection techniques or
sentinel STD clinics and health
departments to inform and guide
other forms of information technology.
national programs and policies for STD
Comments submitted in response to
control in the U.S.; (2) to improve the
this notice will be summarized and
capacity of national, state and local STD
included in the Agency’s subsequent
programs to detect, monitor and
request for OMB approval of the
respond to established and emerging
proposed information collection. All
trends in STDs, HIV, and viral hepatitis;
comments will become a matter of
and (3) to identify and evaluate the
public record.
effectiveness of public health
interventions to reduce STD morbidity.
Dated: July 5, 2012.
The SSuN Project is an active STD
Carolyn M. Clancy,
sentinel surveillance network
Director.
comprised of 12 surveillance sites
[FR Doc. 2012–16849 Filed 7–10–12; 8:45 am]
around the United States. SSuN uses
BILLING CODE 4160–90–M
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
Number of
respondents

Types of respondent

SSuN site .....................................................................................................................................

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12

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Number of
responses per
respondent
4

Average
burden per
response
(in hours)
2