Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27311 

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 

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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: 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 

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. 

FOR FURTHER INFORMATION CONTACT: 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: omb@cdc.gov. 

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 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
27312 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) 

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 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hours) 

Total burden 

hours 

Persons eligible for study .................. Phase 1 Consent ............................. 2,334 1 15/60 584 

Enrolled participants .......................... Phase 1 Enrollment Survey A ......... 1,667 1 45/60 1,251 

Enrolled participants .......................... Phase 1 Enrollment Survey B ......... 200 1 1 200 

Enrolled participants .......................... Phase 2 Consent ............................. 50 1 15/60 13 

Enrolled participants .......................... Phase 2 HIV Symptom and Care 

Survey.

50 9 5/60 38 

Enrolled participants .......................... Phase 2 Behavioral Survey ............. 50 1 30/60 25 

Total ........................................... .......................................................... ........................ ........................ ........................ 2,111 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27313 

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 

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 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. 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. 

Proposed Project 

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

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Avg. burden 

per response 

(in hrs.) 

HOPS study Patients ...................................... Behavioral survey .......................................... 2,500 1 7/60 

HOPS Study Patients ...................................... Consent form ................................................. 450 1 15/60 


asabaliauskas on DSK5VPTVN1PROD with NOTICES