Notice2022-20602
Proposed Data Collections Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 23, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 184 (Friday, September 23, 2022)</title>
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[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58092-58094]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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: <a href="/cdn-cgi/l/email-protection#610e0c03210205024f060e17"><span class="__cf_email__" data-cfemail="b2dddfd0f2d1d6d19cd5ddc4">[email protected]</span></a>.
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.
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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
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