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)

Page Range		44792-44794
FR Document		2017-20511

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 Issue 185 (Tuesday, September 26, 2017)

[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]


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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

44792 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices

updated estimate (based on historical 2. Title: Covered Financial Company a Covered Financial Company (‘‘CFC’’);
information) of state nonmember banks Asset Purchaser Eligibility Certification. or (2) a bridge financial company
and state savings associations engaged OMB Number: 3064–0194. (‘‘BFC’’) which requires the approval of
in consumer leasing. In particular, the Form Number: Covered Financial the FDIC, as receiver for the predecessor
number of respondents has decreased Company Asset Sales Purchaser CFC and as the sole shareholder of the
while the hours per response remain the Eligibility Certification—7300/10. BFC (e.g., the BFC’s sale of a significant
Affected Public: Any individual or
same. business line).
entity that is a potential purchaser of
assets from (1) the FDIC as receiver for Burden Estimate:

Estimated time Total annual
Estimated Estimated per Frequency of estimated
Type of burden number of number of response response burden
respondents responses (minutes) (hours)

Covered Financial Company Reporting ............................. 10 1 30 Annual ......... 5
Asset Sales Purchaser Eli-
gibility Certification.

Total Hourly Burden ...... .............................................. ........................ ........................ ........................ ..................... 5

General Description of Collection: technology. All comments will become • Federal eRulemaking Portal:
Assets held by the FDIC in the course a matter of public record. Regulations.gov. Follow the instructions
of liquidating any covered financial Dated at Washington, DC, this 20th day of for submitting comments.
company must not be sold to persons September 2017. • Mail: Leroy A. Richardson,
who contributed to the demise of a Federal Deposit Insurance Corporation. Information Collection Review Office,
covered financial company in specified Valerie J. Best,
Centers for Disease Control and
ways (e.g., individuals who profited or Prevention, 1600 Clifton Road NE., MS–
Assistant Executive Secretary.
engaged in wrongdoing at the expense D74, Atlanta, Georgia 30329.
[FR Doc. 2017–20593 Filed 9–25–17; 8:45 am] Instructions: All submissions received
of the failed institution, or seriously
mismanaged the failed institution). 12 BILLING CODE 6714–01–P must include the agency name and
CFR part 380 requires prospective Docket Number. All relevant comments
purchasers to complete and submit a received will be posted without change
Purchaser Eligibility Certification DEPARTMENT OF HEALTH AND to Regulations.gov, including any
(‘‘PEC’’) to the FDIC. The PEC is a self- HUMAN SERVICES personal information provided. For
certification by a prospective purchaser access to the docket to read background
that it does not fall into any of the Centers for Disease Control and documents or comments received, go to
categories of individuals or entities that Prevention Regulations.gov.
are prohibited by statute or regulation [60Day–17–1080; Docket No. CDC 2017– Please note: All public comment should be
from purchasing the assets of covered 0078] submitted through the Federal eRulemaking
financial companies. The PEC will be portal (Regulations.gov) or by U.S. mail to the
required in connection with the sale of Proposed Data Collection Submitted address listed above.
assets by the FDIC, as receiver for a CFC, for Public Comment and
or the sale of assets by a BFC which Recommendations FOR FURTHER INFORMATION CONTACT: To
requires the approval of the FDIC, as request more information on the
AGENCY: Centers for Disease Control and proposed project or to obtain a copy of
receiver for the predecessor CFC and as Prevention (CDC), Department of Health
the sole shareholder of the BFC. the information collection plan and
and Human Services (HHS). instruments, contact Leroy A.
There is no change in the method or
ACTION: Notice with comment period. Richardson, Information Collection
substance of the collection. The number
of respondents and the hours per Review Office, Centers for Disease
SUMMARY: The Centers for Disease
response remain the same. Control and Prevention, 1600 Clifton
Control and Prevention (CDC), as part of
Road NE., MS–D74, Atlanta, Georgia
Request for Comment its continuing efforts to reduce public
30329; phone: 404–639–7570; Email:
burden and maximize the utility of
Comments are invited on: (a) Whether omb@cdc.gov.
government information, invites the
the collections of information are general public and other Federal SUPPLEMENTARY INFORMATION: Under the
necessary for the proper performance of agencies to take this opportunity to Paperwork Reduction Act of 1995 (PRA)
the FDIC’s functions, including whether comment on proposed and/or (44 U.S.C. 3501–3520), Federal agencies
the information has practical utility; (b) continuing information collections, as must obtain approval from the Office of
the accuracy of the estimates of the required by the Paperwork Reduction Management and Budget (OMB) for each
burden of the information collections, Act of 1995. This notice invites collection of information they conduct
including the validity of the comment on HIV Outpatient Study or sponsor. In addition, the PRA also
methodology and assumptions used; (c) (HOPS). requires Federal agencies to provide a
ways to enhance the quality, utility, and 60-day notice in the Federal Register
clarity of the information to be DATES: Written comments must be concerning each proposed collection of
collected; and (d) ways to minimize the received on or before November 27, information, including each new
burden of the collections of information 2017. proposed collection, each proposed
on respondents, including through the ADDRESSES: You may submit comments, extension of existing collection of
use of automated collection techniques identified by Docket No. CDC–2017– information, and each reinstatement of
or other forms of information 0078 by any of the following methods: previously approved information

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44794 Federal Register / Vol. 82, No. 185 / Tuesday, September 26, 2017 / Notices

Leroy A. Richardson, To request additional information on targeted interviews will seek
Chief, Information Collection Review Office, the proposed project or to obtain a copy respondents in the following eight
Office of Scientific Integrity, Office of the of the information collection plan and sectors: Pharmaceutical/life sciences
Associate Director for Science, Office of the instruments, call (404) 639–7570 or (n=8), health IT/mobile (n=8), retailers/
Director, Centers for Disease Control and send an email to omb@cdc.gov. Direct distributors (n=6), academia/research
Prevention. written comments and/or suggestions organization (n=6), hospital/healthcare
[FR Doc. 2017–20511 Filed 9–25–17; 8:45 am] regarding the items contained in this provider (n=5), health insurance (n=4),
BILLING CODE 4163–18–P notice to the Attention: CDC Desk logistics/transportation (n=4), and
Officer, Office of Management and charitable organization/foundation
Budget, 725 17th Street NW., (n=4). The interview questions and the
DEPARTMENT OF HEALTH AND Washington, DC 20503 or by fax to (202) information collected will vary
HUMAN SERVICES 395–5806. Provide written comments significantly across the different sectors.
within 30 days of notice publication. The survey portion of the information
Centers for Disease Control and
Prevention Proposed Project collection consists of a larger survey
A Novel Framework for Structuring administered to 200 individuals to reach
[30Day–17–17NW] a total sample population of 100
Industry-Tuned Public-Private
Agency Forms Undergoing Paperwork Partnerships and Economic Incentives (assuming a 50% response rate). CDC
Reduction Act Review for U.S. Health Emergency Preparedness will conduct the interviews and
and Response—New—Office of Public administer the survey only one time to
The Centers for Disease Control and Health Preparedness and Response each individual respondent. CDC plans
Prevention (CDC) has submitted the (OPHPR), Centers for Disease Control to conduct interviews and surveys
following information collection request and Prevention (CDC). within six months after OMB approval.
to the Office of Management and Budget Members of the research team will
(OMB) for review and approval in Background and Brief Description conduct the interviews. CDC will
accordance with the Paperwork Despite the important role of public- administer the surveys using the secure
Reduction Act of 1995. CDC previously private partnerships in supporting the online software Qualtrics, and
published a ‘‘Proposed Data Collection US’s public health preparedness and respondents will receive an email with
Submitted for Public Comment and response mission, many partnership a unique link that will direct them to
Recommendations’’ notice on April 27, efforts are not successful due to poorly the Qualtrics survey platform. The
2017 to obtain comments from the aligned incentives or lack of awareness research team will then transfer data to
public and affected agencies. CDC of external market factors. There is little CDC’s preferred Secure File Transfer
received one comment related to the research or information on private Protocol (SFTP) client for secure storage
previous notice. The purpose of this sector incentive structures and and access. After this transfer, CDC will
notice is to allow an additional 30 days partnership opportunities and barriers destroy all copies of the data that reside
for public comments. specific to public health preparedness outside of the SFTP. Only the research
Written comments and suggestions and response. This study will evaluate team will have access to the interview
from the public and affected agencies the effectiveness of public-private transcripts and survey responses that
concerning the proposed collection of partnership incentives from the will link responses to personally
information are encouraged. The Office perspective of private sector industries identifiable information. Researchers
of Management and Budget is within the public health preparedness will use locked file cabinets to store
particularly interested in comments and response space. securely, any printed or hand-written
that: Study activities include the following: documents containing personal
(a) Evaluate whether the proposed (1) Identification of public-private identifiable information. Once scanned
collection of information is necessary partnership incentives and target or otherwise transferred into electronic
for the proper performance of the industries for public health files (which will also be transferred to
functions of the agency, including preparedness and response; (2) the SFTP client), researchers will
whether the information will have interviews with industry leaders (in appropriately destroy the information.
practical utility; person or via telephone) to identify
(b) Evaluate the accuracy of the related public health emergency Only the research team will have
agencies estimate of the burden of the preparedness activities and partnership access to the SFTP, which will require
proposed collection of information, opportunities and barriers; (3) survey of the user to enter a host address,
including the validity of the private sector organization managers username, password and port number.
methodology and assumptions used; using on-line technology (Qualtrics) on Any information removed from the
(c) Enhance the quality, utility, and key issues and attractiveness of SFTP client to be shared with outside
clarity of the information to be partnership opportunities and parties will be presented in aggregated
collected; incentives; and (4) framework and de-identified form, unless otherwise
(d) Minimize the burden of the development to identify partnership compelled by law. CDC will retain and
collection of information on those who target organizations, opportunities, and destroy all records in accordance with
are to respond, including, through the incentives to promote public health the applicable CDC Records Control
use of appropriate automated, emergency preparedness capabilities. Schedule.
electronic, mechanical, or other CDC proposes to collect information OPHPR is requesting an approval
technological collection techniques or from the private industry leaders in the period of one year to collect this
other forms of information technology, public health preparedness and information. There is no cost to
e.g., permitting electronic submission of response space to accomplish this goal. respondents other than the time to
responses; and The information collection project is participate. The total estimated annual
(e) Assess information collection composed of two parts: (1) Interviews burden hours is 70 hours. A summary
costs. and (2) an on-line general survey. The of annualized burden hours is below.

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Document Created: 2017-09-26 02:48:19
Document Modified: 2017-09-26 02:48:19

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 November 27, 2017.
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]
FR Citation		82 FR 44792

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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