Att 2_60d FRN

Att 2 60 Day FRN.pdf

HIV Outpatient Study (HOPS)

Att 2_60d FRN

OMB: 0920-1080

Document [pdf]
Download: pdf | pdf
44792

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices

updated estimate (based on historical
information) of state nonmember banks
and state savings associations engaged
in consumer leasing. In particular, the
number of respondents has decreased
while the hours per response remain the
same.

2. Title: Covered Financial Company
Asset Purchaser Eligibility Certification.
OMB Number: 3064–0194.
Form Number: Covered Financial
Company Asset Sales Purchaser
Eligibility Certification—7300/10.
Affected Public: Any individual or
entity that is a potential purchaser of
assets from (1) the FDIC as receiver for

a Covered Financial Company (‘‘CFC’’);
or (2) a bridge financial company
(‘‘BFC’’) which requires the approval of
the FDIC, as receiver for the predecessor
CFC and as the sole shareholder of the
BFC (e.g., the BFC’s sale of a significant
business line).
Burden Estimate:

Type of burden

Estimated
number of
respondents

Estimated
number of
responses

Estimated time
per
response
(minutes)

Frequency of
response

Total annual
estimated
burden
(hours)

Covered Financial Company
Asset Sales Purchaser Eligibility Certification.

Reporting .............................

10

1

30

Annual .........

5

Total Hourly Burden ......

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

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

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

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

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

5

General Description of Collection:
Assets held by the FDIC in the course
of liquidating any covered financial
company must not be sold to persons
who contributed to the demise of a
covered financial company in specified
ways (e.g., individuals who profited or
engaged in wrongdoing at the expense
of the failed institution, or seriously
mismanaged the failed institution). 12
CFR part 380 requires prospective
purchasers to complete and submit a
Purchaser Eligibility Certification
(‘‘PEC’’) to the FDIC. The PEC is a selfcertification by a prospective purchaser
that it does not fall into any of the
categories of individuals or entities that
are prohibited by statute or regulation
from purchasing the assets of covered
financial companies. The PEC will be
required in connection with the sale of
assets by the FDIC, as receiver for a CFC,
or the sale of assets by a BFC which
requires the approval of the FDIC, as
receiver for the predecessor CFC and as
the sole shareholder of the BFC.
There is no change in the method or
substance of the collection. The number
of respondents and the hours per
response remain the same.
Request for Comment
Comments are invited on: (a) Whether
the collections of information are
necessary for the proper performance of
the FDIC’s functions, including whether
the information has practical utility; (b)
the accuracy of the estimates of the
burden of the information collections,
including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collections of information
on respondents, including through the
use of automated collection techniques
or other forms of information

VerDate Sep<11>2014

18:28 Sep 25, 2017

Jkt 241001

technology. All comments will become
a matter of public record.
Dated at Washington, DC, this 20th day of
September 2017.
Federal Deposit Insurance Corporation.
Valerie J. Best,
Assistant Executive Secretary.
[FR Doc. 2017–20593 Filed 9–25–17; 8:45 am]
BILLING CODE 6714–01–P

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
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 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:
SUMMARY:

PO 00000

Frm 00034

Fmt 4703

Sfmt 4703

• 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.

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:
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
FOR FURTHER INFORMATION CONTACT:

E:\FR\FM\26SEN1.SGM

26SEN1

44793

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices
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

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 SelfInterview (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 HIVinfected individuals currently in HIVcare 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.

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 multiyear 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,

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
burden
hours

Type of respondent

Form name

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

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

2,500
450

1
1

7/60
15/60

292
113

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

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

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

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

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

405

VerDate Sep<11>2014

18:28 Sep 25, 2017

Jkt 241001

PO 00000

Frm 00035

Fmt 4703

Sfmt 4703

E:\FR\FM\26SEN1.SGM

26SEN1

44794

Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / 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. 2017–20511 Filed 9–25–17; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–17NW]

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. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on April 27,
2017 to obtain comments from the
public and affected agencies. CDC
received one comment related to the
previous notice. The purpose of this
notice is to allow an additional 30 days
for public comments.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. The Office
of Management and Budget is
particularly interested in comments
that:
(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.

VerDate Sep<11>2014

18:28 Sep 25, 2017

Jkt 241001

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. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW.,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
A Novel Framework for Structuring
Industry-Tuned Public-Private
Partnerships and Economic Incentives
for U.S. Health Emergency Preparedness
and Response—New—Office of Public
Health Preparedness and Response
(OPHPR), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Despite the important role of publicprivate partnerships in supporting the
US’s public health preparedness and
response mission, many partnership
efforts are not successful due to poorly
aligned incentives or lack of awareness
of external market factors. There is little
research or information on private
sector incentive structures and
partnership opportunities and barriers
specific to public health preparedness
and response. This study will evaluate
the effectiveness of public-private
partnership incentives from the
perspective of private sector industries
within the public health preparedness
and response space.
Study activities include the following:
(1) Identification of public-private
partnership incentives and target
industries for public health
preparedness and response; (2)
interviews with industry leaders (in
person or via telephone) to identify
related public health emergency
preparedness activities and partnership
opportunities and barriers; (3) survey of
private sector organization managers
using on-line technology (Qualtrics) on
key issues and attractiveness of
partnership opportunities and
incentives; and (4) framework
development to identify partnership
target organizations, opportunities, and
incentives to promote public health
emergency preparedness capabilities.
CDC proposes to collect information
from the private industry leaders in the
public health preparedness and
response space to accomplish this goal.
The information collection project is
composed of two parts: (1) Interviews
and (2) an on-line general survey. The

PO 00000

Frm 00036

Fmt 4703

Sfmt 4703

targeted interviews will seek
respondents in the following eight
sectors: Pharmaceutical/life sciences
(n=8), health IT/mobile (n=8), retailers/
distributors (n=6), academia/research
organization (n=6), hospital/healthcare
provider (n=5), health insurance (n=4),
logistics/transportation (n=4), and
charitable organization/foundation
(n=4). The interview questions and the
information collected will vary
significantly across the different sectors.
The survey portion of the information
collection consists of a larger survey
administered to 200 individuals to reach
a total sample population of 100
(assuming a 50% response rate). CDC
will conduct the interviews and
administer the survey only one time to
each individual respondent. CDC plans
to conduct interviews and surveys
within six months after OMB approval.
Members of the research team will
conduct the interviews. CDC will
administer the surveys using the secure
online software Qualtrics, and
respondents will receive an email with
a unique link that will direct them to
the Qualtrics survey platform. The
research team will then transfer data to
CDC’s preferred Secure File Transfer
Protocol (SFTP) client for secure storage
and access. After this transfer, CDC will
destroy all copies of the data that reside
outside of the SFTP. Only the research
team will have access to the interview
transcripts and survey responses that
will link responses to personally
identifiable information. Researchers
will use locked file cabinets to store
securely, any printed or hand-written
documents containing personal
identifiable information. Once scanned
or otherwise transferred into electronic
files (which will also be transferred to
the SFTP client), researchers will
appropriately destroy the information.
Only the research team will have
access to the SFTP, which will require
the user to enter a host address,
username, password and port number.
Any information removed from the
SFTP client to be shared with outside
parties will be presented in aggregated
and de-identified form, unless otherwise
compelled by law. CDC will retain and
destroy all records in accordance with
the applicable CDC Records Control
Schedule.
OPHPR is requesting an approval
period of one year to collect this
information. There is no cost to
respondents other than the time to
participate. The total estimated annual
burden hours is 70 hours. A summary
of annualized burden hours is below.

E:\FR\FM\26SEN1.SGM

26SEN1


File Typeapplication/pdf
File Modified2017-09-26
File Created2017-09-26

© 2024 OMB.report | Privacy Policy