Proposed Data Collection Submitted for Public Comment and Recommendations
| Citation | 86 FR 36550 |
| Record Number | 2021-14752 |
| Published date | 12 July 2021 |
| Section | Notices |
| Court | Centers For Disease Control And Prevention,Health And Human Services Department |
36550
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
and other STDs; and (6) advance the
education of health professionals and
the public from HIV, viral hepatitis, and
other STDs.
The CDC/HRSA Advisory Committee
on HIV and STD Prevention and
Treatment meets at least two times each
calendar year, or at the discretion of the
Designated Federal Officer in
consultation with the CHACHSPT co-
chairs.
The CDC/HRSA Advisory Committee
on HIV and STD Prevention and
Treatment shall advise the Director,
CDC, and the Administrator, HRSA,
regarding objectives, strategies, policies,
and priorities for HIV, viral hepatitis,
and other STD prevention and treatment
efforts, including surveillance of HIV
infection, Acquired Immunodeficiency
Syndrome (AIDS), viral hepatitis, other
STDs, and related behaviors;
epidemiologic, behavioral, health
services, and laboratory research on
HIV, viral hepatitis, and other STDs;
identification of policy issues related to
HIV/viral hepatitis/STD professional
education, patient healthcare delivery,
and prevention services; agency policies
about prevention of HIV, viral hepatitis
and other STDs, treatment, healthcare
delivery, and research and training;
strategic issues influencing the ability of
CDC and HRSA to fulfill their missions
of providing prevention and treatment
services; programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to the
agencies in their development of
responses to emerging health needs
related to HIV, viral hepatitis and other
STDs.
Nominations are being sought for
individuals who have expertise and
qualifications necessary to contribute to
the accomplishments of the committee’s
objectives. Nominees will be selected
based on expertise in the fields of public
health; epidemiology; laboratory
practice; immunology; infectious
diseases; drug abuse; behavioral science;
health education; healthcare delivery;
state health programs; clinical care;
preventive health; medical education;
health services and clinical research;
and healthcare financing. The
Committee shall also include
representation of persons with HIV and
other affected populations; state and
local health and education agencies;
HIV/viral hepatitis/STD community-
based organizations; and the ethics or
faith-based community. Federal
employees will not be considered for
membership. Members may be invited
to serve for up to four-year terms.
Selection of members is based on
candidates’ qualifications to contribute
to the accomplishment of CHACHSPT
objectives. The U.S. Department of
Health and Human Services policy
stipulates that committee membership
be balanced in terms of points of view
represented, and the committee’s
function. Appointments shall be made
without discrimination on the basis of
age, race, ethnicity, gender, sexual
orientation, gender identity, HIV status,
disability, and cultural, religious, or
socioeconomic status. Nominees must
be U.S. citizens, and cannot be full-time
employees of the U.S. Government.
Current participation on federal
workgroups or prior experience serving
on a federal advisory committee does
not disqualify a candidate; however,
HHS policy is to avoid excessive
individual service on advisory
committees and multiple committee
memberships. Committee members are
Special Government Employees (SGEs),
requiring the filing of financial
disclosure reports at the beginning and
annually during their terms. Individuals
who are selected for appointment will
be required to provide detailed
information regarding their financial
interests and, for example, any work
they do for the federal government
through research grants or contracts.
Disclosure of this information is
required in order for CDC ethics officials
to determine whether there is a conflict
between the SGE’s public duties as
members of CHACHSPT and their
private interests, including an
appearance of a loss of impartiality as
defined by federal laws and regulations,
and to identify any required remedial
action needed to address the potential
conflict. CDC reviews potential
candidates for CHACHSPT membership
when a vacancy arises and provides a
slate of nominees for consideration to
the Secretary of HHS for final selection.
HHS notifies selected candidates of
their appointment near the start of the
term in December 1, 2021, or as soon as
the HHS selection process has been
completed. Note that the need for
different expertise varies from year to
year and a candidate who is not selected
for an open position may be
reconsidered for a subsequent open
position. SGE nominees must be U.S.
citizens, and cannot be full-time
employees of the U.S. Government.
Candidates should submit the following
items:
DCurrent curriculum vitae or resume,
including complete contact information
(telephone numbers, mailing address,
email address).
DAt least one letter of
recommendation from person(s) not
employed by the U.S. Department of
Health and Human Services.
(Candidates may submit letters(s)
from current HHS employees if they
wish, but at least one letter must be
submitted by a person not employed by
an HHS agency (e.g., CDC, NIH, FDA,
etc.).
DA biographical sketch of the
nominee (500 words or fewer).
DA letter of interest or personal
statement from the nominee stating how
their expertise would inform the work
of CHACHSPT.
Nominations may be submitted
directly by the individual seeking
nomination or by the person/
organization recommending the
candidate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–14686 Filed 7–9–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–21–21GH; Docket No. CDC–2021–
0065]
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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Using Real-time Prescription and
Insurance Claims Data to Support the
HIV Care Continuum. This proposed
collection will collect data to evaluate
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36551
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
the efficacy of using administrative
insurance and prescription claims
(billing) data to identify and intervene
upon persons with HIV who fail to fill
antiretroviral (ARV) prescriptions.
DATES
: CDC must receive written
comments on or before September 10,
2021.
ADDRESSES
: You may submit comments,
identified by Docket No. CDC–2021–
0065 by any of the following methods:
•Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
•Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
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 Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7118; 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
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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 submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Using Real-time Prescription and
Insurance Claims Data to Support the
HIV Care Continuum—New—National
Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention (NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Use of HIV surveillance data to
identify out-of-care persons is one
strategy for identifying and re-engaging
out-of-care persons, and is called Data-
to-Care or ‘‘D2C.’’ Data-to-Care uses
laboratory reports (i.e., CD4 and HIV
viral load test results) received by a
health department’s HIV surveillance
program as markers of HIV care. In the
current D2C model, there is a delay in
the identification of out-of-care persons
due to the time interval between
recommended monitoring tests (i.e.,
every three to six months) and the
subsequent reporting of these tests to
surveillance.
Insurance and prescription
administrative claims (billing) data can
be used to identify persons who fail to
fill antiretroviral (ARV) prescriptions
and who are at risk for falling out of
care. Because most ARVs are prescribed
as a 30-day supply of medication,
prescription claims can be used to
identify persons who are not filling ARV
prescriptions on a monthly basis.
Tracking ARV refill data can, therefore,
be a more real-time indicator of poor
adherence and can act as a harbinger of
potential poor retention in care. Using
real time insurance and prescription
claims data to identify persons who fail
to fill ARV prescriptions, and to
intervene, could have a significant
impact on ARV therapy adherence, viral
suppression and potentially on
retention in care.
The purpose of the Antiretroviral
Improvement among Medicaid Enrollees
(AIMS) study is to develop, implement
and evaluate a D2C strategy that uses
Medicaid insurance and prescription
claims data to identify; (1) persons with
HIV who have never been prescribed
ARV therapy, and (2) persons with HIV
who fail to pick up prescribed ARV
medications in a timely manner, and to
target these individuals for adherence
interventions.
A validated HIV case identification
algorithm will be applied to the Virginia
Medicaid database to identify persons
with HIV who have either never filled
an ARV prescription or have not filled
an ARV prescription within >30 to <90
days of the expected fill date.
Deterministic and probabilistic methods
will be used to link this list to the
Virginia Department of Health’s (VDH)
Care Markers database (an extract of the
VDH HIV surveillance database).
Individuals that are matched across the
two databases (indicating that the
persons are both enrolled in Medicaid
and confirmed HIV positive) are eligible
for study participation. Additional
eligibility criteria include age 19–63
years and continuous enrollment in
Virginia Medicaid for the preceding 12
months.
Cluster randomization will occur at
the healthcare provider level and will be
conducted concurrently with the initial
potential participant screening.
Providers will be randomized to either
the intervention arm or to the usual care
arm (i.e., no intervention or control
arm). Study participants are the patients
of the randomized healthcare providers.
Participants in the intervention arm will
be delegated to either a patient-level or
provider-level intervention, depending
on need; participants who are >30 to
<90 days late filling their ARV
prescription(s) will receive the patient-
level intervention, and participants who
have never filled an ARV prescription
will be delegated to the provider-level
intervention. Participants of the
provider-level intervention will not
receive direct intervention. Instead, the
healthcare providers of these patients
(‘‘provider participants’’) will receive
the provider-level intervention.
Potential participants will be contacted
by a study Linkage Coordinator to
explain the study and obtain consent for
participation.
The patient-level intervention has two
phases. Phase I is intended for patients
who are >30 to <60 days late filling their
ARV prescription(s). In Phase I, a
Linkage Coordinator will contact
participants to discuss the participants’
adherence barriers. Once the
participant’s adherence barriers are
identified, the participant will be
referred to appropriate resources to
assist them in overcoming their
adherence barrier(s). Phase II is
intended for patients who were enrolled
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36552
Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices
in Phase I but who failed to fill their
ARV prescriptions in the subsequent 30
days of the Phase I consultation, and for
participants who are >60 to <90 days
late at the time the participant was
determined to be study eligible. In
Phase II, the Linkage Coordinator will
lead a similar consultation as in Phase
I, but will probe for more complex
adherence barriers (e.g., mental health
concerns) and referrals will be made
accordingly. The participant will also be
offered an evidence-informed mobile
application (‘‘app’’) which is designed
to support ART adherence and retention
in care.
The provider-level intervention will
consist of a peer-to-peer clinician
consultation delivered by clinicians
from the Virginia Department of
Health’s Advisory Committee to the
Virginia Medication Assistance Program
or by another HIV clinical expert. The
peer-to-peer clinician consultations will
involve introduction or reinforcement of
HIV clinical guidelines for ART
initiation, strategies to optimize ART
adherence, and resources for supporting
adherence for people with HIV. The
consultation will be tailored to the
needs of the provider participant.
All analyses will be conducted at the
patient level. Persons within the
intervention arm will be followed
prospectively for 12 months. At the end
of the intervention arm follow-up
period, persons within the usual care
arm will be followed retrospectively for
12 months. The primary study outcome
of HIV viral suppression (HIV RNA
<200 copies/mL) will be compared
between study arms.
CDC requests OMB approval to collect
standardized information from 500
AIMS study participants (460
participants of the patient-level
intervention and 40 participants of the
provider-level intervention) and 500
controls over the three-year project
period. Secondary data will be
abstracted from the Virginia Medicaid
and Virginia Care Markers databases to
determine study eligibility, to conduct
the patient- and provider-level
interventions, and to determine study
outcomes. During the patient-level
intervention, data will be collected on
participants’ adherence barriers; this
information will be used to refer
participants to appropriate resources to
assist their adherence to ART. During
the provider-level intervention data will
be collected to inform the peer-to-peer
clinician consultation.
CDC requests OMB approval for an
estimated 687 burden hours annually.
There are no costs to respondents other
than their time to participate.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondent Form name Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
Participants ....................................... Verbal consent—participants ........... 460 1 15/60 115
Provider participants ......................... Verbal consent—provider partici-
pants. 40 1 15/60 10
Participants ....................................... Verbal consent—control participants
(for participants of provider-level
intervention).
40 1 15/60 10
Control participants ........................... Verbal consent—control participants 500 1 15/60 125
PositiveLinks participants .................. PositiveLinks enrollment .................. 100 1 60/60 100
Participants ....................................... Phase I interview .............................. 460 1 30/60 230
Participants ....................................... Phase II interview ............................. 100 1 30/60 50
Advisory Committee to the Virginia
Medication Assistance Program
member and other HIV clinical ex-
pects.
Clinician consultation ....................... 10 4 30/60 20
Provider participants ......................... Clinician consultation ....................... 40 1 30/60 20
Advisory Committee to the Virginia
Medication Assistance Program
member and other HIV clinical ex-
pects.
Post-consultation questionnaire ....... 10 4 10/60 7
Total ........................................... ........................................................... ........................ ........................ ........................ 687
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–14752 Filed 7–9–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–21–0530; Docket No. CDC–2021–
0064]
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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Energy Employees Occupational
Illness Compensation Program Act
(EEOICPA) Dose Reconstruction
Interviews and Forms. This data
collection permits claimants under
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