[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36502-36504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-22-0059]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry and the National Center for 
Environmental Health (ATSDR/NCEH) have submitted the information 
collection request titled ``Per- or Polyfluoroalkyl Substances Exposure 
Assessments (PFAS EAs)'' to the Office of Management and Budget (OMB) 
for review and approval. ATSDR/NCEH previously published a ``Proposed 
Data Collection Submitted for Public Comment and Recommendations'' 
notice on November 16, 2021, to obtain comments from the public and 
affected agencies. ATSDR/NCEH received one comment related to the 
previous notice. This notice serves to allow an additional 30 days for 
public and affected agency comments.
    ATSDR/NCEH 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

    Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs) 
(OMB Control No. 0923-0059, Exp. 06/30/2022)--Revision--Agency for 
Toxic Substances and Disease Registry (ATSDR) and the National Center 
for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).

[[Page 36503]]

Background and Brief Description

    Per- and polyfluoroalkyl substances (PFAS) are a large group of 
man-made chemicals that have been used in industry and consumer 
products worldwide since the 1950s. Although some PFAS are no longer 
produced in the United States, many remain in the environment and may 
impact people's health. Thus, PFAS are contaminants that have gained 
national prominence over the last decade.
    Under Section 8006 of the Consolidated Appropriations Act, 2018, 
the Agency for Toxic Substances and Disease Registry and CDC's National 
Center for Environmental Health (ATSDR/NCEH) obtained initial approval 
for a three-year Paperwork Reduction Act clearance for a new 
information collection request (ICR). During the initial approval 
period, ATSDR/NCEH conducted eight exposure assessments (EAs) at 
current or former domestic military installations known to have PFAS in 
drinking water, groundwater, or any other sources of water. The 
information collection allowed for ATSDR/NCEH to conduct the eight EAs, 
with the option for the completion of seven additional EAs at either 
Department of Defense (DoD) or non-DoD locations for a total of 15 EAs.
    Under this Revision ICR titled ``Per- or Polyfluoroalkyl Substances 
Exposure Assessments (PFAS EAs)'' (OMB Control No. 0923-0059, Exp. 06/
30/2022), ATSDR/NCEH now anticipates conducting up to three PFAS EAs 
each year for the next three years. This Revision will use lessons 
learned from the eight completed EAs to modify the methods used to 
conduct a maximum of nine additional EAs at either DoD or non-DoD 
locations. Briefly, protocol revisions include modifications to the 
protocol recruitment strategies (such as increasing in the number of 
letters of invitation per EA due to low response rates observed), 
allowing options to conduct door-to-door recruitment and telephone 
questionnaires when warranted, and modifying water intake questions to 
evaluate exposure that may have occurred when PFAS was present in the 
water.
    Community Event Evaluation Survey: ATSDR/NCEH will hold a public 
meeting prior to the start of the EA at each EA location. The EA team 
will use the community event evaluation survey to receive feedback from 
prospective EA participants about ATSDR/NCEH's PFAS public health 
messaging, the enrollment process, and local feelings toward the PFAS 
EA project. It is assumed that approximately 250 community members will 
attend the public meeting to inform the community about the EA effort. 
Using a response rate of 65 percent, ATSDR/NCEH assume that 163 
community members will fill out the community event evaluation survey 
at each EA location and the survey will take approximately five minutes 
(489 members for three EAs). The resultant time burden is 41 hours 
annually for three EAs.
    Biological Testing Tracking: All participants, adults (864) and 
children (273), will be provided a biological testing tracking form 
when they sign in for the testing event. The form will ensure that all 
appropriate forms are completed and all biological samples are 
collected. The time associated with filling out the form as the 
participant moves between the various stations and the time needed to 
collect the biological samples is approximately 20 minutes, resulting 
in a burden of 379 hours annually for three EAs.
    Household Eligibility Screener: ATSDR/NCEH will recruit a desired 
sample size of 379 respondents per EA (1,137 total per year for three 
EAs) using statistical household sampling methods. Eligibility criteria 
for individuals include specific age intervals (i.e., children older 
than three years given the lack of NHANES comparison data for younger 
children), lack of bleeding disorders that would prevent a blood draw, 
and time of residency (i.e., at least one year in the home prior to 
removal of PFAS from the drinking water).
    Applying an average U.S. household size of 2.5 members, per EA, 
ATSDR/NCEH will enroll respondents from 152 eligible households. ATSDR/
NCEH will use a response rate of 10% (65% was assumed in the original 
protocol) based on the response rate in the eight completed EAs. This 
will require administering a five-minute household eligibility phone 
script to 1,520 heads-of-households per EA, or to 4,560 heads-of-
households per year. The annual time burden requested for eligibility 
screening is 380 hours for three EAs.
    Consents: All eligible respondents will be consented before being 
included in each EA. The consent forms will include adult consent, and 
parental permission and child assent forms, as appropriate. Each 
consented respondent will provide a serum and a urine sample. In 
addition, heads of households from 10% of households using tap water 
for their drinking water will consent to provide tap water and indoor 
dust samples. The consent forms will include permission to store some 
biospecimens and environmental samples for future analysis and will 
include permission to recontact respondents for potential 
investigations or studies in the future. ATSDR/NCEH will also collect 
contact information to provide respondents with their individual 
sampling results. The time associated with administering the consent 
forms is approximately 10 minutes for 864 adults; 10 minutes for 273 
parents providing permission for their children aged 3-17 years old; 
and 10 minutes for 115 children aged 12-17 years old who assent for 
themselves.
    Exposure Assessment Questionnaires for Biological and Environmental 
Testing for Adults, Parents, or Children: ATSDR/NCEH will administer an 
exposure questionnaire to all consented respondents that includes 
questions associated with potential exposure to PFAS both inside and 
outside the home (e.g., work or school). The adult questionnaire also 
includes several questions associated with water use and flooring type 
while the child questionnaire includes questions regarding playing in 
soil; these questions are intended to evaluate potential exposure and 
to support the environmental testing. The time associated with 
administering the questionnaire and completing the biological sampling 
is approximately 30 minutes for 864 adults; 15 minutes for 158 parents 
responding for their children, 3-11 years old; and 15 minutes for 115 
children, 12-17 years old, who respond for themselves.
    Household Recruitment Script for Environmental Sampling: The 
households providing environmental samples (tap water and indoor dust) 
will be a random 10% subset of households that report using tap water 
for drinking water. Assuming a 65% response rate, ATSDR/NCEH will 
administer a 5-minute recruitment script to 23 heads-of households who 
are eligible to take part in each EA. This will result in annual 
recruitment of 70 heads-of-households and six hours for three EAs.
    Consent for Environmental Testing: ATSDR/NCEH will consent a 10% 
subset of households deemed eligible for the EA for testing of tap 
water and indoor dust samples; therefore, the desired number of 
households is 15 per EA, or 45 per year. The time associated with 
consenting to the environmental sampling is 10 minutes, resulting in a 
burden of eight hours annually for three EAs.
    Environmental Sample Collection Form: ATSDR/NCEH will collect 
samples from approximately 15 households per EA or 45 households 
annually. The average time burden is estimated as 15 minutes per 
response as documented in the sample collection form.

[[Page 36504]]

    ATSDR/NCEH estimates the total annualized time burden is 1,535 
hours. This represents a decrease of 596 hours relative to the 
previously approved 2,131 hours. Participation is voluntary, and there 
are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
EA Community Members..................  Community Event                      489               1            5/60
                                         Evaluation Survey.
EA Participants (all ages)............  Biological Testing                 1,137               1           20/60
                                         Tracking.
EA Adults.............................  Household Eligibility              4,560               1            5/60
                                         Screener.
                                        Consent.................             864               1           10/60
                                        Exposure Questionnaire               864               1           30/60
                                         (Adult) for Biological
                                         and Environmental
                                         Testing.
EA Parents............................  Parental Permission.....             273               1           10/60
                                        Exposure Questionnaire               158               1           15/60
                                         (Child) for Biological
                                         Testing (Parent Proxy).
EA Children...........................  Assent..................             115               1           10/60
                                        Exposure Questionnaire               115               1           15/60
                                         (Child) for Biological
                                         Testing (Child
                                         completed).
EA Heads-of-Households................  Household Recruitment                 70               1            5/60
                                         Script for
                                         Environmental Sampling.
                                        Environmental Sampling                45               1           10/60
                                         Consent Form.
                                        Environmental Sample                  45               1           15/60
                                         Collection Form.
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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. 2022-13092 Filed 6-16-22; 8:45 am]
BILLING CODE 4163-18-P