[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58092-58094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22IX; Docket No. CDC-2022-0113]


Proposed Data Collections 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.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden, invites the general 
public and other federal agencies to take this opportunity to comment 
on proposed information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Study of PrEPline reported PrEP-
adherent patients with HIV acquisition. The purpose of this project is 
to understand preferences for long-acting pre-exposure prophylaxis (LA-
PrEP) products for HIV prevention among potential users and providers.

DATES: CDC must receive written comments on or before November 22, 
2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0113 by either of the following methods:
     Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to www.regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (www.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 H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; 
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.
    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

[[Page 58093]]

technological collection techniques or other forms of information 
technology, e.g., permitting electronic submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Study of PrEPline Reported PrEP-Adherent Patients with HIV 
Acquisition--New--National Center for HIV, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    As the use of antiretroviral preexposure prophylaxis (PrEP) 
continues to grow in the United States, despite the high effectiveness 
of PrEP (>95%) when taken as prescribed, sporadic case reports are 
appearing that document HIV acquisition among patients apparently 
adherent to the prescribed PrEP dosing schedule. Because PrEP 
medications can alter the immune responses on which HIV testing relies, 
ambiguous test results also occur and present diagnostic challenges to 
clinicians. Careful selection of tests, and the timing and sequence in 
which they are done to confirm whether HIV infection has occurred, and 
resistance characteristics of the virus, if present, are increasingly 
necessary. In addition, objective measures of the amount of PrEP drug 
in patients around the time of potential HIV acquisition is important 
to assess medication adherence and further characterize PrEP 
effectiveness in ``real world'' settings. A system of active case 
detection and confirmation of HIV acquisition in PrEP-adherent patients 
was successfully piloted and can now be continuously implemented by 
leveraging clinician contacts to the National Clinician Consultation 
Center's (NCCC) PrEPline, PEPline, and HIV Warmline; and by obtaining 
consent for specimens to be shipped to the University of California San 
Francisco (UCSF) or the Centers for Disease Control and Prevention 
(CDC) for research assays. Monitoring and improving our understanding 
of the occurrence of ambiguous test results, HIV acquisition among PrEP 
patients, and their relationship to medication adherence is necessary 
to inform clinician management of these patients and to ensure clear 
messaging about PrEP ``failures'' (most of which are a result of non-
adherence) and HIV testing in PrEP patients.
    The PrEPline (and other ``warmlines'' operated by NCCC) and health 
department HIV case reporting are complementary sources of case 
identification. Clinicians call the PrEPline with testing and 
management questions soon after receiving test results for patients 
continuing or re-initiating PrEP, or transitioning from PEP to PrEP, 
and have direct access to clinical records and patients. In addition, 
clinicians call the HIV Warmline with questions about HIV screening/
testing results and best practices in evaluation and management of 
patients who acquire HIV while on PrEP. Health departments typically 
identify such patients later (especially if by periodic review of 
National HIV Surveillance System data) and then must reach out to 
clinicians for clinical records, and sometimes for patient consents for 
research specimens, to confirm HIV status.
    The goals are to conduct a study that obtains consent and case 
report information from clinicians calling the NCCC's PrEPline and HIV 
Warmline to help identify, assess, and discuss clinical management of: 
(1) PrEP patients with ambiguous HIV test results; and (2) patients who 
acquire HIV infection while being prescribed PrEP. This information 
will allow CDC to: (a) assess the proportion of clinicians with 
eligible patients who provide case information from medical records; 
(b) measure the completeness and utility of data collection forms to be 
sent to CDC; (c) assess the proportion of clinicians with eligible 
patients who refer patients to participate in a UCSF National 
Institutes of Health-funded study called SeroPrEP that involves 
specimen testing to be performed at designated specialty reference/
research labs; and (d) assess the proportion of eligible patients who 
consent to enroll in the SeroPrEP study and provide specimens to 
reference/research labs to confirm HIV status and measure PrEP drug 
levels.
    The study's target population includes clinicians calling to NCCC 
within 90 days of a reactive/detectable HIV test (in cases of oral PrEP 
use) or 180 days of a reactive/detectable HIV test (in cases of long-
acting injectable cabotegravir use) about case-patients who reported:
    [cir] Regularly taking prescribed oral PrEP medication 
(emtricitabine or lamivudine co-formulated with either tenofovir 
disoproxil fumarate or tenofovir alafenamide, or oral cabotegravir) 
either:
    [ssquf] Throughout the interval from the last negative HIV test to 
the date of first reactive or detectable HIV test results; or
    [ssquf] During the interval from the last negative HIV test to 
stopping injections, within 18 months before the date of first reactive 
or detectable HIV test results.
    and for whom either:
    [cir] Laboratory tests confirm acquisition of HIV infection while 
reportedly medication-adherent; or
    [cir] Laboratory tests are ambiguous (do not clearly confirm HIV 
status).
    The study data will be collected via phone interviews with 
clinicians calling the NCCC PrEPline (or other warmlines) for clinical 
advice about diagnostic testing and clinical management of patients 
with ambiguous HIV test results or diagnosed HIV infection while taking 
PrEP medications. Data collection will last approximately five years.
    Participation is voluntary. An estimated one-time reporting burden 
for this collection will be approximately 62 hours. This includes the 
time burden associated with the Provider Verbal Consent and completing 
the Patient Data Collection Form. CDC will enroll approximately 125 
providers, at 10 minutes per Provider Verbal Consent and 20 minutes per 
Patient Data Collection Form, to provide patient information over five 
years. There are no costs to respondents other than time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Clinician.....................  Provider Consent             125               1           10/60              21
                                 Form.
Clinician report of patient     Patient Data                 125               1           20/60              42
 information.                    Collection Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............              63
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[[Page 58094]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-20602 Filed 9-22-22; 8:45 am]
BILLING CODE 4163-18-P