[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17600-17602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06882]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-21-21EB; Docket No. ATSDR-2021-0004]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
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

[[Page 17601]]

Act of 1995. This notice invites comment on a proposed information 
collection project titled ``Evaluating the Association between Serum 
Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and 
Symptoms and Diagnoses of Selected Acute Viral Illnesses.'' The 
proposed study will examine the relationship between PFAS serum levels 
and susceptibility to certain acute viral illnesses, including but not 
limited to COVID-19.

DATES: ATSDR must receive written comments on or before June 4, 2021.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2021-0004 by any of the following methods:
     Federal eRulemaking Portal: 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-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. ATSDR will post, without change, all relevant 
comments to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (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-D74, Atlanta, Georgia 30329; phone: 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 the 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 technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Evaluating the Impact of Per- and Polyfluoroalkyl Substances (PFAS) 
Exposure on Susceptibility to Viral Infection--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. They 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 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.
    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).
    This a new two-year ATSDR information collection request (ICR) for 
a collaborative study between the National Center for Environmental 
Health (NCEH) and ATSDR. This follow-up study will recruit participants 
who were participated in a previous ATSDR-funded study, who have 
existing PFAS serum measurements, and who have given prior consent for 
additional contact from NCEH/ATSDR. We anticipate that the total number 
of participants enrolled in the NCEH/ATSDR cohorts will be around 4,075 
individuals (3,300 adults and 775 children). This study will attempt to 
enroll the entire universe of eligible participants; therefore, our 
target sample size is 4,075. 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 PFAS concentrations in serum collected from existing ATSDR 
cohorts 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 PFAS 
concentrations in serum collected from existing ATSDR cohorts and self-
reported positive test results indicating specific viral infections.

[[Page 17602]]

    During the first three months of the two-year study period, NCEH/
ATSDR will invite and consent approximately 4,075 participants (3,300 
adults and 775 children) to complete a new series of questionnaires 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 questionnaire and a series of four additional questionnaires over 
a 12- to 14-month period. Follow-up questionnaires will be offered in 
two modes: Web-based and paper-based. It is estimated that 75 percent 
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 questionnaires.
    The total time burden requested is 12,724 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     Total annual
      Type of respondent            Form name       respondents    responses per   response  (in    burden  (in
                                                                    respondent          hr)             hr)
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Adults........................  Initial                    1,650               1           30/60             825
                                 Questionnaire--
                                 Adult (paper).
                                Follow up                    412               4           30/60             825
                                 Questionnaire--
                                 Adult (paper).
                                Follow up                  1,238               4           25/60           2,063
                                 Questionnaire--
                                 Adult (REDCap).
                                Symptom Diary...           1,650               1               4           6,600
Children (7-17 years).........  Initial                      290               1           30/60             145
                                 Questionnaire--
                                 Child (paper).
                                Follow up                     72               4           30/60             145
                                 Questionnaire--
                                 Child (paper).
                                Follow up                    218               4           25/60             363
                                 Questionnaire--
                                 Child (REDCap).
                                Symptom Diary...             290               1               4           1,160
Parents of Children (3-6        Initial                       75               1           30/60              38
 years).                         Questionnaire--
                                 Child (paper).
                                Follow up                     24               4           30/60              49
                                 Questionnaire--
                                 Child (paper).
                                Follow up                     74               4           25/60             123
                                 Questionnaire--
                                 Child (REDCap).
                                Symptom Diary...              98               1               4             390
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          12,724
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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. 2021-06882 Filed 4-2-21; 8:45 am]
BILLING CODE 4163-70-P