Federal Register - July 12, 2021

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Source: Federal Register

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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 Healths Advisory Committee to the Virginia Medication Assistance Program or by another HIV clinical expert. The
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 patientand 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.

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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Average burden per response in hours
Total burden hours
Form name
Participants
Provider participants

Verbal consentparticipants
Verbal consentprovider participants.
Verbal consentcontrol participants for participants of provider-level intervention.
Verbal consentcontrol participants PositiveLinks enrollment
Phase I interview
Phase II interview
Clinician consultation

460
40

1
1

15/60
15/60

115
10

40

1

15/60

10

500
100
460
100
10

1
1 1
1 4

15/60
60/60
30/60
30/60
30/60

125
100
230
50
20

Clinician consultation
Post-consultation questionnaire

40
10

1
4

30/60
10/60

20
7

687

Participants
Control participants
PositiveLinks participants
Participants
Participants
Advisory Committee to the Virginia Medication Assistance Program member and other HIV clinical expects.
Provider participants
Advisory Committee to the Virginia Medication Assistance Program member and other HIV clinical expects.
Total

Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
FR Doc. 202114752 Filed 7921; 8:45 am
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and Prevention
BILLING CODE 416318P

60 Day210530; Docket No. CDC2021
0064
khammond on DSKJM1Z7X2PROD with NOTICES

Number of responses per respondent
Type of respondent
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:

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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
SUMMARY:

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Federal Register - July 12, 2021

TitoloFederal Register

PaeseStati Uniti

Data12/07/2021

Conteggio pagine157

Numero di edizioni7802

Prima edizione14/03/1936

Ultima edizione25/06/2026

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