[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 974-975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00101]


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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 www.reginfo.gov/public/do/PRAMain. 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
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                                                                                                      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
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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