82 FR 44792 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 185 (September 26, 2017)

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 HIV Outpatient Study (HOPS).

[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44792-44794]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-20511]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-1080; Docket No. CDC 2017-0078]


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 HIV Outpatient 
Study (HOPS).

DATES: Written comments must be received on or before November 27, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0078 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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 Leroy A. Richardson, 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

[[Page 44793]]

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 
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

    HIV Outpatient Study (HOPS) (OMB Control Number 0920-1080, 
Expiration, 8/31/2018)--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 CDC requests a three-year approval and a revision to the HIV 
Outpatient Study data collection activity. The HIV Outpatient Study 
(HOPS) is a prospective longitudinal cohort of HIV-infected outpatients 
at eight well-established private HIV care practices and university-
based U.S. clinics, in Tampa, Florida; Washington, DC; Stony Brook, New 
York; Chicago, Illinois; Denver, Colorado; and Philadelphia, 
Pennsylvania. Researchers abstract clinical data on an ongoing basis 
from the medical records of adult HIV-infected HOPS study participants, 
who also complete an optional telephone/Web-based behavioral assessment 
as part of their annual clinic visit, which on average takes about 
seven minutes. 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 revisions consist of adding 12 additional survey questions to 
assess additional risk behaviors that may affect the long-term care and 
treatment of HIV positive patients participating in the HIV Outpatient 
Study. Based on review of the current survey response items and the 
average completion time, these new questions will not pose additional 
burden on participants.
    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 
HIV related 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, to include: Rates of opportunistic illnesses, rates of 
comorbid conditions (e.g., hypertension, obesity, diabetes) and 
antiretroviral drug resistance.
    Researchers will collect data through medical record abstraction by 
trained abstractors and by telephone or Internet based, computer-
assisted interviews at eight 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. Researchers will acquire 
data on visit frequency, AIDS, and death from the clinic chart. Data 
collected using a brief Telephone Audio-Computer Assisted Self-
Interview (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 anticipate the annual recruitment of 450 new HOPS study 
participants into the HOPS from a pool of HIV-infected individuals 
currently in HIV-care at nine clinics (50 patients per site). 
Researchers will approach patients during one of the patients' routine 
clinic visits to participate in the HOPS. Researchers will give 
patients interested in participating in the HOPS detailed information 
about the nature of the study and provide them with a written informed 
consent form that the patient must complete prior to enrollment. 
Annually, the researchers will add the 450 newly enrolled participants 
to the database of existing participants. Researchers will conduct 
medical record abstractions and will not impose direct burden on HOPS 
study participants.
    Participation of respondents is voluntary. There is no cost to the 
respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
HOPS study Patients...........  Behavioral                 2,500               1            7/60             292
                                 survey.
HOPS Study Patients...........  Consent form....             450               1           15/60             113
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             405
----------------------------------------------------------------------------------------------------------------



[[Page 44794]]

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. 2017-20511 Filed 9-25-17; 8:45 am]
BILLING CODE 4163-18-P