Notice2022-00101
Agency Forms Undergoing Paperwork Reduction Act Review
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
January 7, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 5 (Friday, January 7, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 974-975]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00101]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-22-22BJ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Agency
for Toxic Substances and Disease Registry (ATSDR) has submitted the
information collection request titled Evaluating the Association
between Serum Concentrations of Per- and Polyfluoroalkyl substances
(PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses to
the Office of Management and Budget (OMB) for review and approval.
ATSDR previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on April 5, 2021 to obtain
comments from the public and affected agencies. ATSDR did not receive
comments related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
ATSDR will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Evaluating the Association between Serum Concentrations of Per- and
Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of
Selected Acute Viral Illnesses--New--Agency for Toxic Substances and
Disease Registry (ATSDR).
Background and Brief Description
Per- and poly-fluoroalkyl substances (PFAS) are a large, diverse
group of thousands of chemicals that have been used extensively in a
wide range of industrial and consumer applications. Epidemiological
studies have evaluated the associations between PFAS exposure and
health effects in humans. Evidence from these studies in occupationally
exposed populations, residential populations exposed to higher levels
of PFAS in drinking water, and studies in the general population
suggest associations between PFAS and several health outcomes.
Exposure to PFAS is nearly ubiquitous in the United States.
Epidemiological studies suggest that PFAS exposure may impact the
immune system and susceptibility to viral infections. However, there is
little consistency in the results of studies on PFAS exposure and
infectious disease. The coronavirus disease 2019 (COVID-19) pandemic
presents a unique concern and opportunity to explore this association.
If PFAS affect the immune system, it is possible that they could affect
susceptibility to infection with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, or could
affect severity of COVID-19 symptoms.
In 2019 and 2020, the Agency for Toxic Substances and Disease
Registry (ATSDR) conducted statistically based biomonitoring PFAS
exposure assessments (EAs) in eight communities that had documented
exposures to PFAS in drinking water. ATSDR also supported two EAs that
were designed to test the PFAS Exposure Assessment Technical Tools
(PEATT). PFAS concentrations were measured in serum collected from EA
and PEATT assessment participants, and a questionnaire was administered
to gather information to characterize each individual's exposure. These
communities were investigated under ``Per- or Polyfluoroalkyl
Substances Exposure Assessments [PFAS EAs]'' (OMB Control No. 0923-
0059, expiration date 06/30/2022). During the same period, ATSDR
initiated a health study at the Pease International Tradeport that
included measurement of PFAS serum levels and collection of information
about individual exposures in participants under ``Human Health Effects
of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances
(PFAS) at Pease International Tradeport, Portsmouth, NH (The Pease
Study)'' (OMB Control No. 0923-0061, expiration date 08/31/2022).
[[Page 975]]
This a new two-year ATSDR information collection request (ICR) for
a collaborative study between the Centers for Disease Control and
Prevention's National Center for Environmental Health (CDC/NCEH) and
ATSDR. This follow-up study will recruit participants who; (1)
participated in a previous ATSDR-funded study, (2) have existing serum-
PFAS measurements, and (3) have given prior consent for additional
contact from NCEH/ATSDR. We anticipate that the total number of
participants enrolled in the CDC/ATSDR cohorts will be around 3,170
(2,800 adults and 370 children) individuals. This study will attempt to
enroll the entire universe of eligible participants; therefore, our
target sample size is 3,170. The cohorts have a substantial number of
participants with high PFAS exposure, as well as a sufficient range of
serum-PFAS concentrations to allow examination of associations between
the outcomes and across a wide range of PFAS exposures.
The objectives are the following: (1) To examine the association
between serum-PFAS collected through the EAs, PEATT assessments, and
Pease Study and the frequency of occurrence of selected syndromes
(combinations of self-reported symptoms), which will be used as a proxy
for viral infections; and, (2) to examine the association between
serum-PFAS collected through the EAs, PEATT assessments, and Pease
Study and self-reported positive test results indicating specific viral
infections.
During the first three months of the two-year study period, NCEH/
ATSDR will invite and consent approximately 3,170 participants (2,800
adults and 370 children) to complete a new series of surveys to
determine whether PFAS exposure increases susceptibility to viral
infections, including, but not limited to COVID-19. Data will be
collected from those who enroll in the study through an initial paper-
based survey and a series of four additional surveys over a 12- to 14-
month period. Follow-up surveys will be offered in two modes: Web-based
and paper-based. It is estimated that 75% of the participants will
choose the web-based mode. Participants will also be given symptom
diaries to improve recall after the initial and between each of the
follow-up surveys.
The total time burden requested is 19,816 hours (or 9,908 hours
annually). There are no costs to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Adults............................. Initial Questionnaire-- 700 1 30/60
Adult (paper).
Follow up Questionnaire-- 175 4 30/60
Adult (paper).
Follow up Questionnaire-- 525 4 25/60
Adult (REDCap).
Symptom Diary.............. 700 1 4
Children (7-17 years).............. Initial Questionnaire-- 70 1 30/60
Child (paper).
Follow up Questionnaire-- 18 4 30/60
Child (paper).
Follow up Questionnaire-- 52 4 25/60
Child (REDCap).
Symptom Diary.............. 70 1 4
Parents of Children (3-6 years).... Initial Questionnaire-- 12 1 30/60
Child (paper).
Follow up Questionnaire-- 6 4 30/60
Child (paper).
Follow up Questionnaire-- 18 4 25/60
Child (REDCap).
Symptom Diary.............. 23 1 4
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-00101 Filed 1-6-22; 8:45 am]
BILLING CODE 4163-70-P
</pre></body>
</html>Indexed from Federal Register on January 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.