80 FR 27311 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 92 (May 13, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 92 (May 13, 2015)
| Page Range | 27311-27313 | |
| FR Document | 2015-11511 |
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)] [Notices] [Pages 27311-27313] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11511] ======================================================================= ----------------------------------------------------------------------- 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 [[Page 27312]] 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 Self-Interview (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 socio-demographics, 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Avg. burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 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
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gsaadvantage.gov. The goal is to provide accessible/visible) within GSA’s personal information provided. For
customer agencies with quality, customer-facing eTools (GSA access to the docket to read background
meaningful, complete data to better Advantage!, eBuy, etc.). In addition, documents or comments received, go to
search and compare products, thereby GSA may consider noncompliance Regulations.gov.
enhancing competition and saving when determining whether to exercise Please note: All public comment should be
taxpayer dollars. This endeavor is a the next contract option period. GSA submitted through the Federal eRulemaking
critical piece of a larger effort to might choose not to exercise the next portal (Regulations.gov) or by U.S. mail to the
modernize the FSS program as a whole, option period, thereby allowing the address listed above.
under which FAS aims to increase contract to expire. FOR FURTHER INFORMATION CONTACT: To
efficiency and effectiveness, facilitate Dated: May 7, 2015. request more information on the
the purchase of total solutions,
Lisa P. Grant, proposed project or to obtain a copy of
maximize competition, and promote
Deputy Assistant Commissioner, Office of the information collection plan and
small business utilization across
Acquisition Management, Federal Acquisition instruments, contact the Information
Government.
The availability of MPN and UPC–A
Service. Collection Review Office, Centers for
data improves overall data integrity, [FR Doc. 2015–11534 Filed 5–12–15; 8:45 am] Disease Control and Prevention, 1600
encouraging additional business from BILLING CODE 6820–89–P Clifton Road NE., MS–D74, Atlanta,
customers looking for the ability to Georgia 30329; phone: 404–639–7570;
quickly and accurately compare Email: omb@cdc.gov.
identical products. The standardization DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
of part number data allows for greater HUMAN SERVICES Under the Paperwork Reduction Act
transparency and improved business of 1995 (PRA) (44 U.S.C. 3501–3520),
intelligence that will enable customers Centers for Disease Control and Federal agencies must obtain approval
to make smarter, data-driven buying Prevention from the Office of Management and
decisions. Collectively, these benefits Budget (OMB) for each collection of
[60Day–15–15AEZ; Docket No. CDC–2015–
will yield increased customer 0028]
information they conduct or sponsor. In
confidence as GSA works to make the addition, the PRA also requires Federal
FSS program the Government’s premier Proposed Data Collection Submitted agencies to provide a 60-day notice in
acquisition vehicle. for Public Comment and the Federal Register concerning each
Unaltered MPN data is required for all Recommendations proposed collection of information,
products, except where the including each new proposed
AGENCY: Centers for Disease Control and collection, each proposed extension of
manufacturer has not assigned a part
number to identify the item. UPC–A Prevention (CDC), Department of Health existing collection of information, and
data is required for all products for and Human Services (HHS). each reinstatement of previously
which this information is commercially ACTION: Notice with comment period. approved information collection before
available. The FAS performed market submitting the collection to OMB for
SUMMARY: The Centers for Disease approval. To comply with this
research to determine the Federal
Control and Prevention (CDC), as part of requirement, we are publishing this
Supply Schedules and Special Item
its continuing efforts to reduce public notice of a proposed data collection as
Numbers (SINs) under which UPC–A
burden and maximize the utility of described below.
data is commercially available—a
government information, invites the Comments are invited on: (a) Whether
complete listing can be viewed at
general public and other Federal the proposed collection of information
http://eoffer.gsa.gov.
MPN and UPC–A data is widely agencies to take this opportunity to is necessary for the proper performance
utilized throughout the commercial comment on proposed and/or of the functions of the agency, including
marketplace. FSS contractors are simply continuing information collections, as whether the information shall have
providing the existing MPN and UPC– required by the Paperwork Reduction practical utility; (b) the accuracy of the
A data that is used to classify their Act of 1995. This notice invites agency’s estimate of the burden of the
awarded FSS products. Many FSS comment on the proposed information proposed collection of information; (c)
contractors have already provided this collection entitled Identification of ways to enhance the quality, utility, and
data in their price lists. In fact, Behavioral and Clinical Predictors of clarity of the information to be
approximately 8 million MPNs and 1.3 Early HIV Infection (Project DETECT). collected; (d) ways to minimize the
million unique UPC–A codes are DATES: Written comments must be burden of the collection of information
currently listed in FSS contractor price received on or before July 13, 2015. on respondents, including through the
lists published on gsaadvantage.gov. ADDRESSES: You may submit comments, use of automated collection techniques
Obtaining MPN and UPC–A data from identified by Docket No. CDC–2015– or other forms of information
existing FSS contractors will allow GSA 0028 by any of the following methods: technology; and (e) estimates of capital
to acquire baseline information across • Federal eRulemaking Portal: or start-up costs and costs of operation,
the contracts already awarded under the Regulation.gov. Follow the instructions maintenance, and purchase of services
FSS program. A bilateral ‘‘mass for submitting comments. to provide information. Burden means
modification’’ will be distributed by • Mail: Leroy A. Richardson, the total time, effort, or financial
GSA to all contractors with FSS Information Collection Review Office, resources expended by persons to
asabaliauskas on DSK5VPTVN1PROD with NOTICES
contracts that include products. FSS Centers for Disease Control and generate, maintain, retain, disclose or
contractors will be required to sign the Prevention, 1600 Clifton Road, NE., provide information to or for a Federal
modification and provide this data in MS–D74, Atlanta, Georgia 30329. agency. This includes the time needed
their price lists within 60 days of Instructions: All submissions received to review instructions; to develop,
distribution. must include the agency name and acquire, install and utilize technology
FSS contractors that do not provide Docket Number. All relevant comments and systems for the purpose of
this data will have noncompliant received will be posted without change collecting, validating and verifying
products ‘‘grayed-out’’ (i.e., no longer to Regulations.gov, including any information, processing and
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Leroy A. Richardson, instruments, call (404) 639–7570 or for prevention, including:
Chief, Information Collection Review Office, send an email to omb@cdc.gov. Written cardiovascular disease, fragility
Office of Scientific Integrity, Office of the comments and/or suggestions regarding fractures, renal and hepatic disease, and
Associate Director for Science, Office of the the items contained in this notice cancers. The HOPS remains an
Director, Centers for Disease Control and should be directed to the Attention: important source for multi-year trend
Prevention.
CDC Desk Officer, Office of Management data concerning conditions and
[FR Doc. 2015–11511 Filed 5–12–15; 8:45 am]
and Budget, Washington, DC 20503 or behaviors for which data are not readily
BILLING CODE 4163–18–P by fax to (202) 395–5806. Written available elsewhere, including: rates of
comments should be received within 30 opportunistic illnesses, rates of
days of this notice. comorbid conditions (e.g., hypertension,
DEPARTMENT OF HEALTH AND
obesity, diabetes) and antiretroviral drug
HUMAN SERVICES Proposed Project
resistance.
Centers for Disease Control and HIV Outpatient Study (HOPS)— Data will be collected through
Prevention New—National Center for HIV/AIDS, medical record abstraction by trained
Viral Hepatitis, STD, and TB Prevention abstractors and by telephone or internet-
[30Day–15–15JX] (NCHHSTP), Centers for Disease Control based, computer-assisted interviews at
and Prevention (CDC). nine funded study sites in six U.S.
Agency Forms Undergoing Paperwork
Reduction Act Review Background and Brief Description cities.
Collection of data abstracted from
The Centers for Disease Control and The Centers for Disease Control and
patient medical records provides data in
Prevention (CDC) has submitted the Prevention requests a three-year
five general categories: Demographics
following information collection request approval for the HIV Outpatient Study
and risk behaviors for HIV infection;
to the Office of Management and Budget data collection activity. The HIV
symptoms; diagnosed conditions
(OMB) for review and approval in Outpatient Study (HOPS) is a
(definitive and presumptive);
accordance with the Paperwork prospective longitudinal cohort of HIV-
medications prescribed (including dose,
Reduction Act of 1995. The notice for infected outpatients at nine well-
duration, and reasons for stopping); all
the proposed information collection is established private HIV care practices
laboratory values, including CD4+ T-
published to obtain comments from the and university-based U.S. clinics.
lymphocyte (CD4+) cell counts, plasma
public and affected agencies. Clinical data are abstracted on ongoing
HIV–RNA determinations, and
Written comments and suggestions basis from the medical records of adult
genotype, phenotype, and trophile
from the public and affected agencies HIV-infected HOPS study participants,
results. Data on visit frequency, AIDS,
concerning the proposed collection of who also complete an optional seven
and death are acquired from the clinic
information are encouraged. Your minute telephone/web-based behavioral
chart.
comments should address any of the assessment as part of their annual clinic
visit. Data collected using a brief Telephone
following: (a) Evaluate whether the
Before enrolling in this study, all Audio-Computer Assisted Self-
proposed collection of information is
potential study participants will Interview (T–ACASI) survey or an
necessary for the proper performance of
undergo an informed consent process identical web-based Audio-Computer
the functions of the agency, including
(including signing of a written informed Assisted Self-Interview (ACASI)
whether the information will have
consent) which is estimated to take 15 include: Age, sex at birth, use of alcohol
practical utility; (b) Evaluate the
minutes. and drugs, cigarette smoking, adherence
accuracy of the agencies estimate of the
The core areas of HOPS research to antiretroviral medications, types of
burden of the proposed collection of
extending through the present HIV sexual intercourse, condom use, and
information, including the validity of
treatment era include (i) monitoring disclosure of HIV status to partners.
the methodology and assumptions used;
(c) Enhance the quality, utility, and death rates and causes of death (ii) We estimate consenting 450 new
clarity of the information to be characterizing the optimal patient participants per year across all HOPS
collected; (d) Minimize the burden of management strategies to reduce HIV- study sites (50 participants at each of
the collection of information on those related morbidity and mortality (e.g., the 9 sites). The consent process takes
who are to respond, including through effectiveness of antiretroviral therapies approximately 15 minutes to complete.
the use of appropriate automated, and other clinical interventions (iii) Medical record abstractions will be
electronic, mechanical, or other monitoring of sexual and drug use completed on all eligible participants.
technological collection techniques or behaviors to inform Prevention with All eligible participants will be offered
other forms of information technology, Positives, and (iv) investigating the opportunity to participate in an
e.g., permitting electronic submission of disparities in the HIV care continuum optional short survey that will take
responses; and (e) Assess information by various demographic factors. In approximately seven minutes.
collection costs. recent years, the HOPS has been Participation of respondents is
To request additional information on instrumental in bringing attention to voluntary. There is no cost to the
the proposed project or to obtain a copy emerging issues in chronic HIV respondents other than their time. The
of the information collection plan and infection with actionable opportunities estimated annual burden hours are 405.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of
Type of respondents Form name responses per per response
respondents respondent (in hrs.)
HOPS study Patients ...................................... Behavioral survey .......................................... 2,500 1 7/60
HOPS Study Patients ...................................... Consent form ................................................. 450 1 15/60
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Document Created: 2015-12-16 07:46:58
Document Modified: 2015-12-16 07:46:58
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before July 13, 2015. | |
| 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: [email protected] | |
| FR Citation | 80 FR 27311 |
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