Notice2021-24992
Proposed Data Collection Submitted for Public Comment and Recommendations
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
November 16, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Toxic Substances and Disease Registry
Abstract
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 Act of 1995. This notice invites comment on a proposed information collection project titled Per-or-Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs). This Revision information collection request (ICR) will allow ATSDR/NCEH to continue to conduct additional Exposure Assessments (EAs) that may be requested at military or non- military installations.
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<title>Federal Register, Volume 86 Issue 218 (Tuesday, November 16, 2021)</title>
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[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63390-63392]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24992]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60 Day-2-0059; Docket No. ATSDR-2021-0008]
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 Act of 1995. This notice invites comment on a proposed
information collection project titled Per-or-Polyfluoroalkyl Substances
Exposure Assessments (PFAS EAs). This Revision information collection
request (ICR) will allow ATSDR/NCEH to continue to conduct additional
Exposure Assessments (EAs) that may be requested at military or non-
military installations.
DATES: ATSDR must receive written comments on or before January 18,
2022.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2021-0008 by any of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. ATSDR will post, without change, all relevant
comments to <a href="http://Regulations.gov">Regulations.gov</a>.
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,
[[Page 63391]]
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; Email: <a href="/cdn-cgi/l/email-protection#bed1d3dcfedddadd90d9d1c8"><span class="__cf_email__" data-cfemail="aac5c7c8eac9cec984cdc5dc">[email protected]</span></a>.
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
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).
Background and Brief Description
Per-or-polyfluoroalkyl substances (PFAS) are contaminants that have
gained national prominence over the last decade. 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.
The Agency for Toxic Substances and Disease Registry (ATSDR) and
the National Center for Environmental Health (NCEH) are requesting a
three-year revision information collection request (ICR) to continue to
conduct PFAS exposure assessments (EAs) at both military or non-
military locations known to have PFAS in drinking water, groundwater,
or any other sources of water. Previously, ATSDR was approved to
conduct up to five EAs per year, for which the agency completed a total
of eight. Currently, ATSDR is seeking approval to conduct up to three
EAs per year for a maximum of seven additional locations.
Originally authorized under the National Defense Authorization Act
(NDAA) of 2018, ATSDR is also mandated under the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA), commonly known as the ``Superfund'' Act, as amended by the
Superfund Amendments and Reauthorization Act (SARA) of 1986, to prevent
or mitigate adverse human health effects and diminished quality of life
resulting from the exposure to hazardous substances in the environment.
NCEH can conduct EAs under the authority of Section 301 of the Public
Health Service Act (42 U.S.C. 241).
The PFAS EAs are conducted using statistical sampling to produce
unbiased estimates of exposure to PFAS in communities living on or near
the chosen current or former military installations. The number of
respondents per EA will vary, but we expect the number to be
approximately 395, and to be determined by specific statistical
methods.
The time burden associated with the EAs include the following
collections:
<bullet> Community Event Evaluation Survey: ATSDR/NCEH will hold a
public meeting prior to the start of the EA and attendees will be asked
to complete a five minute Community Event Evaluation Survey. It is
assumed that 163 of the 250 attendees will complete the survey at each
EA site, resulting in a burden of 41 hours for three EAs.
<bullet> Household Eligibility Screener: ATSDR/NCEH anticipates
asking approximately 269 adults in each household at each EA site to
complete a five minute telephone script, resulting in a burden of 66
hours for three EAs.
<bullet> Estimation of Number of EA Respondents by Age Group: Based
on the criteria in the Household Recruitment Phone Script, 149
households are assumed to provide the target sample size of 395
respondents at each EA site, with a total of 1,185 respondents for
three EAs. Based on 2017 Census estimates of average household size
(2.5), and number of adults (1.9), and children under 18 years of age
(0.6) in the household, we are able to estimate the annual number of
respondents by age group as the following for three EAs: 900 adults
>=18 years and 284 children (165 aged 3-11 years and 119 aged 12-17
years).
<bullet> Biological Testing Tracking: All of the EAs use biological
sampling for PFAS (blood and urine). A biological testing tracking form
for the testing event will be provided to ensure that all appropriate
forms are completed and all biological samples are collected. The
testing will take 20 minutes, resulting in a burden of 395 hours
annually for three EAs.
<bullet> Adult Consent for Biological Testing: 300 adults at each
EA site will be administered a 10-minute consent form for testing of
blood and urine for PFAS, resulting in a burden of 150 hours annually
for three EAs.
<bullet> Parental Permission Form for Biological Testing: A
parental permission form will be administered to the parents of 284
children aged 3-17 years for testing of blood and urine. The parental
permission form will take 10 minutes resulting in a burden of 47 hours
annually for three EAs.
<bullet> Child Assent Form for Biological Testing: Children aged
12-17 years (119) will assent to the testing of blood and urine for
PFAS. The child assent form will take approximately 10 minutes,
resulting in a burden of 20 hours annually for three EAs.
<bullet> Adult Exposure Questionnaire for Biological and
Environmental Testing: 300 adults at each EA site will be administered
an exposure questionnaire. The time associated with administering the
questionnaire and completing the biological sampling is approximately
30 minutes, resulting in a burden of 450 hours annually for three EAs.
<bullet> Parent Proxy for Child Exposure Questionnaire for
Biological Testing: 165 parents will respond to the 15-minute
questionnaire for their children, 3-11 years, resulting in a burden of
41 hours annually for three EAs.
<bullet> Child Exposure Questionnaire for Biological Testing:
Annually, 119 children will respond to the 15-minute child
questionnaire for themselves (age 12-17 years), resulting in a burden
of 30 hours annually for three EAs.
<bullet> Household Recruitment Script for Environmental Testing:
ATSDR/NCEH will administer a five minute environmental recruitment
script to 69 heads of households, resulting in a burden of six hours
annually for three EAs.
[[Page 63392]]
<bullet> Consent for Environmental Testing: ATSDR/NCEH will obtain
consent to test 10% of EA households for tap water and indoor dust
samples using a 10-minute consent form for an annual total of 45
households, resulting in burden of eight hours annually for three EAs.
Environmental Sample Collection: ATSDR/NCEH will complete sampling
at 45 households for three EAs deemed eligible for the EA for testing
of tap water and indoor dust samples. The sampling will take 30
minutes, for an estimated burden of 23 hours annually for three EAs.
ATSDR estimates the annualized time burden is 1,277 hours.
Participation is voluntary, and there are no costs to participants
other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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EA Community Members.......... Community Event 489 1 5/60 41
Evaluation
Survey.
EA Participants (all ages).... Biological 1,185 1 20/60 395
Testing
Tracking.
EA Adults..................... Household 807 1 5/60 66
Eligibility
Screener.
Consent......... 900 1 10/60 150
Exposure 900 1 30/60 450
Questionnaire
(Adult) for
Biological and
Environmental
Testing.
EA Parents.................... Parental 284 1 10/60 47
Permission.
Exposure 165 1 15/60 41
Questionnaire
(Child) for
Biological
Testing (Parent
Proxy).
EA Children................... Assent.......... 119 1 10/60 20
Exposure 119 1 15/60 30
Questionnaire
(Child) for
Biological
Testing (Child
completed).
EA Heads-of-Households........ Household 69 1 5/60 6
Recruitment
Script for
Environmental
Sampling.
Environmental 45 1 10/60 8
Sampling
Consent Form.
Environmental 45 1 30/60 23
Sample
Collection Form.
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Total..................... ................ .............. .............. .............. 1,277
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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. 2021-24992 Filed 11-15-21; 8:45 am]
BILLING CODE 4163-70-P
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