60d FRN - published

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Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices

Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–26570 Filed 11–2–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17CA]; Docket No. CDC–2016–
0105]

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 a proposed information
collection project entitled ‘‘Positive
Health Check Evaluation Trial.’’ CDC is
requesting a three-year approval for a
data collection effort designed to
evaluate effectiveness of the Positive
Health Check (PHC) online tool created
by RTI and CDC. This CDC and
Research Triangle Institute (RTI)
developed tool delivers tailored
evidence based prevention messages to
HIV positive patients, on improving
clinical outcomes and retention in care
of HIV positive patients with
unsuppressed viral loads. This data
collection is also designed to assess the
feasibility of implementing the
intervention in clinics and the cost of
the intervention.
DATES: Written comments must be
received on or before January 3, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0105 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

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SUMMARY:

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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: [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
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

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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
Positive Health Check Evaluation
Trial—New—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
HIV transmission continues to be an
urgent public health challenge in the
United States. According to CDC,
approximately 1.2 million people are
living with HIV, with close to 50,000
new cases each year. Antiretroviral
therapy (ART) suppresses the plasma
HIV viral load (VL) and people living
with HIV (PLWH) who are treated with
ART—compared with those who are
not—have a substantially reduced risk
of transmitting HIV sexually, through
drug sharing, or from mother to child.
However, it is estimated that only 19%
to 28% of people who are infected with
HIV in the United States have an
undetectable HIV VL. To enhance HIV
prevention efforts, implementable,
effective, scalable interventions are
needed that focus on enhancing
prevention and care to improve the
health of and reduce HIV transmission
risk among PLWH. The Positive Health
Check (PHC) intervention is based on
earlier computer-based interventions
that were proven efficacious for HIV
prevention.
The PHC intervention approach is
innovative in multiple ways. First, it
uses an interactive video doctor to
deliver tailored messages that meet
specific patient needs related to
adherence, sexual risk reduction,
engagement in care, mother-to-child
transmission, and drug use. Second, this
intervention is designed specifically to
support patient behavior change by
providing useful tips to practice
between visits. These tips are patient
driven and populated on a handout
while patients use the PHC intervention,
thereby increasing engagement and the
likelihood of success. Third, PHC
supports patient-provider
communication by also generating a set

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Federal Register / Vol. 81, No. 213 / Thursday, November 3, 2016 / Notices
of questions that patients would like to
ask their provider. These behavior
change tips and questions are also
populated on a Patient Handout that
patients may share with their provider.
As such, PHC supports patients and
providers during their clinical
encounter and promotes
communication. Finally, the PHC
intervention has been designed from the
onset for wide-scale dissemination. Its
flexible digital strategy provides access
on multiple devices and platforms. This
approach makes PHC an important
intervention strategy to improve public
health in communities that have a high
incidence of HIV infection.
This data collection has four primary
aims: (1) Implement a randomized trial
to test the efficacy of the PHC
intervention for improving clinical
health outcomes, specifically viral load
and retention in care; (2)conduct a
feasibility assessment to determine

strategies to facilitate implementation
and integration of PHC into HIV primary
care clinics; (3) collect and document
data on the cost of PHC intervention
implementation; and (4) document the
standard of care at each participating
clinic. The awardee of this cooperative
agreement is RTI. RTI has subcontracted
with four clinical sites to implement the
trial. The sub-contractors are the Atlanta
VA Medical Center (Atlanta, Georgia),
Hillsborough County Health Department
(Tampa, Florida), Rutgers Infectious
Disease Practice (Newark, New Jersey),
and Crescent Care (New Orleans,
Louisiana). The four clinical sites are
well suited for this work, given the high
rates of patients with elevated viral
loads.
During the 24-month implementation
period, 1,010 patients will be enrolled
into the trial (505 intervention arm and
505 control arm) across the four clinics
to evaluate the effectiveness of the PHC

intervention. To assess the effectiveness
of the PHC intervention, patients
randomized to the intervention arm will
provide their responses to the patient
tailoring questions embedded within the
intervention and all enrolled patients
will consent to have their de-identified
clinical values be made available via
passive data collection via the electronic
medical record. In addition to the main
trial, three to five key staff at each clinic
site will be selected to participate in the
PHC feasibility assessment which
includes an online survey and
qualitative interviews.
Finally, clinic staff who participate in
the implementation of the PHC
intervention will provide data on the
cost of implementing the PHC
intervention. It is estimated that the
total burden hours for all data collection
activities is 315.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average burden
per response
(in hours)

Total response
burden
(in hours)

Form name

Persons eligible for study .....

PHC intervention trial consent .............
Staff online survey consent ..................
PHC tailoring questions ........................
Online clinic staff survey ......................
Clinic staff qualitative interview ............
Non-research labor cost questionnaire
PHC labor cost questionnaire ..............

505
20
505
20
20
12
12

1
1
3
3
3
3
3

5/60
5/60
5/60
15/60
40/60
75/60
75/60

42
2
126
15
40
45
45

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

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

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

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

315

Enrolled participants .............

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

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. 2016–26501 Filed 11–2–16; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2013–0021; Docket Number NIOSH–
245, 245–A]

Issuance of Final Guidance Publication
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Number of
respondents

Type of respondent

National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of issuance of final
guidance publication.
AGENCY:

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NIOSH announces the
availability of the following final
publication: ‘‘Criteria for a
Recommended Standard: Occupational
Exposure to Diacetyl and 2,3pentanedione’’ [DHHS(NIOSH)
Publication Number 2016–111].
DATES: The final criteria document was
published October 31, 2016.
ADDRESSES: This document may be
obtained at the following link: http://
www.cdc.gov/niosh/docs/2016–111.
FOR FURTHER INFORMATION CONTACT:
Lauralynn McKernan, NIOSH/Division
of Surveillance, Hazard Evaluations and
Field Studies, 1090 Tusculum Avenue,
MS R–12, Cincinnati, OH 45226. 513–
533–8542 (not a toll free number).
SUPPLEMENTARY INFORMATION: On July
25, 2011, NIOSH published a notice of
public meeting and request for
comments on the draft ‘‘Criteria for a
Recommended Standard: Occupational
Exposure to Diacetyl and 2,3pentanedione.’’ in the Federal Register
(76 FR 44338). On October 18, 2011,
NIOSH published an extension of
SUMMARY:

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comment period (76 FR 64353). On
April 11, 2012, NIOSH published an
expanded charge for peer reviewers (77
FR 21777) and then on December 26,
2013, NIOSH published another notice
(78 FR 78363) for review of revised
Chapters 6 and 8 of the Criteria
document. All comments received were
reviewed and accepted where
appropriate. Comments for Docket 245
are available at: http://www.cdc.gov/
niosh/docket/archive/docket245.html.
Comments for Docket 245–A can be
found in the docket at:
www.regulations.gov, Docket No. CDC–
2013–0021.
Dated: October 28, 2016.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2016–26507 Filed 11–2–16; 8:45 am]
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