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Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
gsaadvantage.gov. The goal is to provide
customer agencies with quality,
meaningful, complete data to better
search and compare products, thereby
enhancing competition and saving
taxpayer dollars. This endeavor is a
critical piece of a larger effort to
modernize the FSS program as a whole,
under which FAS aims to increase
efficiency and effectiveness, facilitate
the purchase of total solutions,
maximize competition, and promote
small business utilization across
Government.
The availability of MPN and UPC–A
data improves overall data integrity,
encouraging additional business from
customers looking for the ability to
quickly and accurately compare
identical products. The standardization
of part number data allows for greater
transparency and improved business
intelligence that will enable customers
to make smarter, data-driven buying
decisions. Collectively, these benefits
will yield increased customer
confidence as GSA works to make the
FSS program the Government’s premier
acquisition vehicle.
Unaltered MPN data is required for all
products, except where the
manufacturer has not assigned a part
number to identify the item. UPC–A
data is required for all products for
which this information is commercially
available. The FAS performed market
research to determine the Federal
Supply Schedules and Special Item
Numbers (SINs) under which UPC–A
data is commercially available—a
complete listing can be viewed at
http://eoffer.gsa.gov.
MPN and UPC–A data is widely
utilized throughout the commercial
marketplace. FSS contractors are simply
providing the existing MPN and UPC–
A data that is used to classify their
awarded FSS products. Many FSS
contractors have already provided this
data in their price lists. In fact,
approximately 8 million MPNs and 1.3
million unique UPC–A codes are
currently listed in FSS contractor price
lists published on gsaadvantage.gov.
Obtaining MPN and UPC–A data from
existing FSS contractors will allow GSA
to acquire baseline information across
the contracts already awarded under the
FSS program. A bilateral ‘‘mass
modification’’ will be distributed by
GSA to all contractors with FSS
contracts that include products. FSS
contractors will be required to sign the
modification and provide this data in
their price lists within 60 days of
distribution.
FSS contractors that do not provide
this data will have noncompliant
products ‘‘grayed-out’’ (i.e., no longer

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accessible/visible) within GSA’s
customer-facing eTools (GSA
Advantage!, eBuy, etc.). In addition,
GSA may consider noncompliance
when determining whether to exercise
the next contract option period. GSA
might choose not to exercise the next
option period, thereby allowing the
contract to expire.
Dated: May 7, 2015.
Lisa P. Grant,
Deputy Assistant Commissioner, Office of
Acquisition Management, Federal Acquisition
Service.
[FR Doc. 2015–11534 Filed 5–12–15; 8:45 am]
BILLING CODE 6820–89–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15AEZ; Docket No. CDC–2015–
0028]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the proposed information
collection entitled Identification of
Behavioral and Clinical Predictors of
Early HIV Infection (Project DETECT).
DATES: Written comments must be
received on or before July 13, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0028 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road, NE.,
MS–D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
SUMMARY:

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personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
Federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor. In
addition, the PRA also requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each new proposed
collection, each proposed extension of
existing collection of information, and
each reinstatement of previously
approved information collection before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing this
notice of a proposed data collection as
described below.
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; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
FOR FURTHER INFORMATION CONTACT:

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Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices

maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Identification of Behavioral and
Clinical Predictors of Early HIV
Infection (Project DETECT)—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Division of
HIV/AIDS Prevention (DHAP) requests a
3-year approval for a new data
collection called ‘‘Identification of
Behavioral and Clinical Predictors of
Early HIV Infection (Project DETECT).’’
CDC provides guidelines for HIV
testing and diagnosis for the United
States, as well as technical guidance for
its grantees. CDC will use the HIV
testing data collected for this project to
update these guidance documents to
reflect the latest available testing
technologies, their performance
characteristics, and considerations
regarding their use. Specifically, CDC
will describe the information on
behavioral and clinical characteristics of
persons with early infection to help HIV
test providers (including CDC grantees)
choose which HIV tests to use, and
target tests appropriately to persons at
different levels of risk. This information
will be disseminated primarily through
guidance documents and articles in
peer-reviewed journals.
The primary study population will be
persons at high risk for or diagnosed
with HIV infection, many of whom will
be men who have sex with men (MSM)

storage and use in future HIV test
evaluations at CDC. Participants will be
followed up only to the point at which
all their test results become concordant.
At each time point, participants will be
asked to complete the Phase 2 HIV
Symptom and Care survey that collects
information on symptoms associated
with early HIV infection as well as
access to HIV care and treatment since
the last Phase 2 visit. When all tests
become concordant (i.e., at the last
Phase 2 visit) participants will complete
the Phase 2 behavioral survey to
identify any behavioral changes during
follow-up. Of the 50 Phase 2
participants; it is estimated that no more
than 26, annually, will have early HIV
infection.
All data for the proposed information
collection will be collected via an
electronic Computer Assisted SelfInterview (CASI) survey. Participants
will complete the surveys on an
encrypted computer, with the exception
of the Phase 2 Symptom and Care
survey, which will be administered by
a research assistant and then
electronically entered into the CASI
system. Data to be collected via CASI
include questions on sociodemographics, medical care, HIV
testing, pre-exposure prophylaxis,
antiretroviral treatment, sexually
transmitted diseases (STD) history,
symptoms of early HIV infection,
substance use and sexual behavior.
Data from the surveys will be merged
with HIV test results and relevant
clinical data using the unique
identification (ID) number. Data will be
stored on a secure server managed by
the University of Washington
Department of Medicine Information
Technology (IT) Services.
The participation of respondents is
voluntary. There is no cost to the
respondents other than their time. The
total estimated annual burden hours for
the proposed project are 2,111 hours.

because the majority of new HIV
infections occur each year among this
population. The goals of the project are
to: (1) characterize the performance of
new HIV tests for detecting established
and early HIV infection at the point of
care, relative to each other and to
currently used gold standard, non-POC
tests, and (2) identify behavioral and
clinical predictors of early HIV
infection.
Project DETECT will enroll 1,667
persons annually at the primary study
site clinic in Seattle, and an additional
200 persons will be enrolled from other
clinics in the greater Seattle area. The
study will be conducted in two phases.
Phase 1: After a clinic client consents
to participate, he/she will be assigned a
unique participant ID and will then
undergo testing with the seven new HIV
tests under study. While awaiting test
results, participants will undergo
additional specimen collections and
complete the Phase 1 Enrollment
Survey.
Phase 2: All Phase 1 participants
whose results on the seven tests under
investigation are not in agreement with
one another (‘‘discordant’’) will be
considered to have a potential early HIV
infection. Nucleic amplification testing
that detects viral nucleic acids will be
conducted to confirm an HIV diagnosis
and rule out false positives. Study
investigators expect that each year, 50
participants with discordant test results
will be invited to participate in serial
follow-up specimen collections to assess
the time point at which all HIV test
results resolve and become concordant
positive (indicating enrollment during
early infection) or concordant negative
(indicating one or more false-positive
test results in Phase 1).
The follow-up schedule will consist
of up to nine visits scheduled at regular
intervals over a 70-day period. At each
follow-up visit, participants will be
tested with the new HIV tests and
additional oral fluid and blood
specimens will also be collected for

ESTIMATED ANNUALIZED BURDEN HOURS

asabaliauskas on DSK5VPTVN1PROD with NOTICES

Type of respondents
Persons
Enrolled
Enrolled
Enrolled
Enrolled

Number of
respondents

Form name

eligible for study ..................
participants ..........................
participants ..........................
participants ..........................
participants ..........................

Number of
responses per
respondent

Avg. burden
per response
(in hours)

Total burden
hours

2,334
1,667
200
50
50

1
1
1
1
9

15/60
45/60
1
15/60
5/60

584
1,251
200
13
38

Enrolled participants ..........................

Phase 1 Consent .............................
Phase 1 Enrollment Survey A .........
Phase 1 Enrollment Survey B .........
Phase 2 Consent .............................
Phase 2 HIV Symptom and Care
Survey.
Phase 2 Behavioral Survey .............

50

1

30/60

25

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

..........................................................

........................

........................

........................

2,111

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Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–11511 Filed 5–12–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Project

Centers for Disease Control and
Prevention
[30Day–15–15JX]

Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
asabaliauskas on DSK5VPTVN1PROD with NOTICES

instruments, call (404) 639–7570 or
send an email to [email protected]. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
HIV Outpatient Study (HOPS)—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention requests a three-year
approval for the HIV Outpatient Study
data collection activity. The HIV
Outpatient Study (HOPS) is a
prospective longitudinal cohort of HIVinfected outpatients at nine wellestablished private HIV care practices
and university-based U.S. clinics.
Clinical data are abstracted on ongoing
basis from the medical records of adult
HIV-infected HOPS study participants,
who also complete an optional seven
minute telephone/web-based behavioral
assessment as part of their annual clinic
visit.
Before enrolling in this study, all
potential study participants will
undergo an informed consent process
(including signing of a written informed
consent) which is estimated to take 15
minutes.
The core areas of HOPS research
extending through the present HIV
treatment era include (i) monitoring
death rates and causes of death (ii)
characterizing the optimal patient
management strategies to reduce HIVrelated morbidity and mortality (e.g.,
effectiveness of antiretroviral therapies
and other clinical interventions (iii)
monitoring of sexual and drug use
behaviors to inform Prevention with
Positives, and (iv) investigating
disparities in the HIV care continuum
by various demographic factors. In
recent years, the HOPS has been
instrumental in bringing attention to
emerging issues in chronic HIV
infection with actionable opportunities

for prevention, including:
cardiovascular disease, fragility
fractures, renal and hepatic disease, and
cancers. The HOPS remains an
important source for multi-year trend
data concerning conditions and
behaviors for which data are not readily
available elsewhere, including: rates of
opportunistic illnesses, rates of
comorbid conditions (e.g., hypertension,
obesity, diabetes) and antiretroviral drug
resistance.
Data will be collected through
medical record abstraction by trained
abstractors and by telephone or internetbased, computer-assisted interviews at
nine funded study sites in six U.S.
cities.
Collection of data abstracted from
patient medical records provides data in
five general categories: Demographics
and risk behaviors for HIV infection;
symptoms; diagnosed conditions
(definitive and presumptive);
medications prescribed (including dose,
duration, and reasons for stopping); all
laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma
HIV–RNA determinations, and
genotype, phenotype, and trophile
results. Data on visit frequency, AIDS,
and death are acquired from the clinic
chart.
Data collected using a brief Telephone
Audio-Computer Assisted SelfInterview (T–ACASI) survey or an
identical web-based Audio-Computer
Assisted Self-Interview (ACASI)
include: Age, sex at birth, use of alcohol
and drugs, cigarette smoking, adherence
to antiretroviral medications, types of
sexual intercourse, condom use, and
disclosure of HIV status to partners.
We estimate consenting 450 new
participants per year across all HOPS
study sites (50 participants at each of
the 9 sites). The consent process takes
approximately 15 minutes to complete.
Medical record abstractions will be
completed on all eligible participants.
All eligible participants will be offered
the opportunity to participate in an
optional short survey that will take
approximately seven minutes.
Participation of respondents is
voluntary. There is no cost to the
respondents other than their time. The
estimated annual burden hours are 405.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

HOPS study Patients ......................................
HOPS Study Patients ......................................

Behavioral survey ..........................................
Consent form .................................................

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Number of
responses per
respondent

2,500
450

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1

Avg. burden
per response
(in hrs.)
7/60
15/60