Notice2022-13092
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
June 17, 2022
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Full Text
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<title>Federal Register, Volume 87 Issue 117 (Friday, June 17, 2022)</title>
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[Federal Register Volume 87, Number 117 (Friday, June 17, 2022)]
[Notices]
[Pages 36502-36504]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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
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
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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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
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