80 FR 27313 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 92 (May 13, 2015)

Page Range		27313-27314
FR Document		2015-11510

Federal Register, Volume 80 Issue 92 (Wednesday, May 13, 2015)

[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27313-27314]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11510]


-----------------------------------------------------------------------

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 [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.

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 
HIV-infected outpatients at nine well-established 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 
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, 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 internet-based, 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+ T-
lymphocyte (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 
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 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      Avg. burden
         Type of respondents                   Form name             Number of     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
----------------------------------------------------------------------------------------------------------------



[[Page 27314]]

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. 2015-11510 Filed 5-12-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27313

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 07:47:20
Document Modified: 2015-12-16 07:47:20

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
FR Citation		80 FR 27313

80 FR 27313 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 92 (May 13, 2015)

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