[Federal Register Volume 83, Number 139 (Thursday, July 19, 2018)]
[Notices]
[Pages 34135-34137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substance and Disease Registry
[60Day-18-18AJK Docket No. ATSDR-2018-0002]
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 (PFAS) Exposure Assessments.'' ATSDR and the CDC National
Center for Environmental Health (NCEH) will conduct a minimum of eight
exposure assessments (EAs) at current or former military installations
with known PFAS contamination in drinking water, groundwater, or
another water source.
DATES: ATSDR must receive written comments on or before September 17,
2018.
ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2018-0002 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.
[[Page 34136]]
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: 404-639-7570; 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; and
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.
5. Assess information collection costs.
Proposed Project
Per- or Polyfluoroalkyl Substances (PFAS) Exposure Assessments--
New--Agency for Toxic Substances and Disease Registry (ATSDR) and the
National Center for Environmental Health (NCEH), Centers for Disease
Control and Prevention (CDC).
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, they 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 National
Center for Environmental Health (ATSDR/NCEH) are requesting a three-
year Paperwork Reduction Act clearance for a new information collection
request (ICR). ATSDR/NCEH will conduct EAs at current or former
domestic military installations known to have PFAS in drinking water,
groundwater, or any other sources of water. The annualized number of
EAs assumes the following. ATSDR/NCEH will conduct a minimum of eight
EAs, but ATSDR/NCEH may complete an additional seven for a total of 15
EAs. Therefore, ATSDR/NCEH anticipates conducting five PFAS EAs each
year for three years.
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 ten percent 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 will also collect
contact information to provide respondents with their individual
sampling results.
Household Eligibility Screener: ATSDR/NCEH will conduct the PFAS
EAs in communities with populations living on or near current or former
military installations. ATSDR/NCEH will recruit a desired sample size
of 379 respondents per EA (1,895 total per year) 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).
Applying an average U.S. household size of 2.5 members, per EA,
ATSDR/NCEH will enroll respondents from 152 eligible households (379/
2.5). To identify the 152 eligible households, we further assume a 65
percent household eligibility rate. This will require administering a
5-minute eligibility screener to 234 heads-of-households per EA
(152*100/65), or to 1,170 heads-of-households per year (234 x 5). The
annual time burden requested for eligibility screening is 98 hours.
Exposure Assessment Questionnaire 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). In addition, 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 1,440 adults (720
hours). The time associated is 15 minutes for 264 parents responding
for their children, 3-11 years old (66 hours), and for 191 children,
12-17 years old, who respond for themselves (48 hours). ATSDR/NCEH will
use the questionnaire and laboratory results to identify likely
exposure scenarios.
Household Recruitment Script for Environmental Sampling: The
households providing environmental samples will be randomly selected
from households that report using tap water for drinking water. ATSDR/
NCEH will recruit 10 percent subset of these eligible households to
collect tap water and indoor dust samples. Assuming a 65 percent
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
(152/10*100/65). The time required to administer the recruitment script
is 5 minutes. This will result in annual recruitment from 117 heads-of-
households and 10 hours for five EAs.
Environmental Sample Collection Form: Again, assuming a 65 percent
response rate, to meet our sample size
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goal of 10 percent of eligible households, ATSDR/NCEH will consent and
collect samples from approximately 15 households per EA or households
annually (152*10/100*5). The average time burden is estimated as 15
minutes per response, or 19 hours annually.
ATSDR estimates the total annualized time burden is 961 hours.
Participation is voluntary, and there are no costs to respondents other
than their time.
Public health professionals, environmental risk managers, and other
decision makers can use EA results to make informed decisions about the
sources and impact of PFAS contamination in environmental media within
their own community and jurisdiction. The data will support their
recommendations for public health actions to reduce or eliminate
harmful levels of PFAS in the local environment. These EAs are not
intended to yield information about PFAS exposure that will be
generalized beyond the defined boundaries of each investigation;
however, ATSDR/NCEH will use these EA findings to inform a future
national PFAS health study.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
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Potential EA Heads-of-Households............... Household Eligibility Screener......... 1,170 1 5/60 98
EA Adults...................................... Exposure Questionnaire for Biological 1,440 1 30/60 720
and Environmental Testing (Adults).
EA Parents..................................... EA Questionnaire for Biological Testing 264 1 15/60 66
(Child).
EA Children.................................... EA Questionnaire for Biological Testing 191 1 15/60 48
(Child).
EA Heads-of-Households......................... Household Recruitment Script for 117 1 5/60 10
Environmental Sampling.
Environmental Sample Collection Form... 76 1 15/60 19
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Total...................................... ....................................... .............. .............. .............. 961
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of
Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-15437 Filed 7-18-18; 8:45 am]
BILLING CODE 4163-18-P