[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Notices]
[Pages 60867-60868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25626]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-19-18AJK]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry (ATSDR) has 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 previously 
published a ``Proposed Data Collection Submitted for Public Comment and 
Recommendations'' notice on July 19, 2018 to obtain comments from the 
public and affected agencies. ATSDR received eight comments related to 
the previous notice. This notice serves to allow an additional 30 days 
for public and affected agency comments.
    ATSDR 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 or send an email to [email protected]. 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)--New--Agency for Toxic Substances and Disease Registry and the 
National Center for Environmental Health (ATSDR/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 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 
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.
    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 also use these EA findings to inform a future 
national PFAS health study.
    Community Event Evaluation Survey: ATSDR/NCEH will hold a public 
meeting prior to the start of the EA at each EA location. A Community 
Event Evaluation Survey will be used as a way for the EA team to 
receive feedback from prospective EA participants about ATSDR's PFAS 
public health messaging, the enrollment process and to gauge local 
feelings toward the ATSDR PFAS EA project. It is assumed that 
approximately 250 community members will attend the public meeting that 
will be held to inform the community about the EA effort. Using a 
response rate of 65 percent, it is assumed that 163 community members 
will fill out the community event evaluation survey at each EA location 
and the survey will take approximately 5 minutes (815 members for 5 
EAs). The resultant time burden is 68 hours annually for 5 EAs.
    Household Eligibility Screener: 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 household eligibility phone script 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.
    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 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. The time associated with administering the consent 
forms is approximately 10 minutes for 1,440 adults (240 hours); 10 
minutes for 455 parents providing permission for their children aged 3-
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years old (76 hours); and 10 minutes for 191 children aged 12-17 years 
old who assent for themselves (32 hours).
    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 1,440 adults (720 hours); 15 minutes 
for 264 parents responding for their children, 3-11 years old (66 
hours); and 15 minutes for 191 children, 12-17 years old, who respond 
for themselves (48 hours).
    Household Recruitment Script for Environmental Sampling: The 
households providing environmental samples (tap water and indoor dust) 
will be a random 10 percent subset of households that report using tap 
water for drinking water. Assuming a 65 percent response rate, ATSDR/
NCEH will administer a five-minute recruitment script to 23 heads-of 
households who are eligible to take part in each EA (152/10 * 100/65). 
This will result in annual recruitment from 117 heads-of-households and 
10 hours for five EAs.
    Consent for Environmental Testing: ATSDR/NCEH will consent a 10 
percent 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 76 per year (152 * 10/100 * 5). The time 
associated with consenting to the environmental sampling is 10 minutes, 
resulting in a burden of 13 hours annually for five EAs.
    Environmental Sample Collection Form: ATSDR will collect samples 
from approximately 15 households per EA or 76 households annually 
(152*10/100*5) and fill out a sample collection form. The average time 
burden is estimated as 15 minutes per response for the sample 
collection forms (19 hours annually).
    ATSDR estimates the total annualized time burden is 1,390 hours. 
Participation is voluntary, and there are no costs to respondents other 
than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
EA Community Members..................  Community Event                      815               1            5/60
                                         Evaluation Survey.
EA Adults.............................  Household Eligibility              1,170               1            5/60
                                         Screener.
                                        Consent.................           1,440               1           10/60
                                        Exposure Questionnaire             1,440               1           30/60
                                         (Adult)for Biological
                                         and Environmental
                                         Testing.
EA Parents............................  Parental Permission.....             455               1           10/60
                                        Exposure Questionnaire               264               1           15/60
                                         (Child)for Biological
                                         Testing (Parent Proxy).
EA Children...........................  Assent..................             191               1           10/60
                                        Exposure Questionnaire               191               1           15/60
                                         (Child)for Biological
                                         Testing (Child
                                         completed).
EA Heads-of-Households................  Household Recruitment                117               1            5/60
                                         Script for
                                         Environmental Sampling.
                                        Environmental Sampling                76               1           10/60
                                         Consent Form.
                                        Environmental Sample                  76               1           15/60
                                         Collection Form.
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Jeffrey M. Zirger,
Acting Team Lead, Information Collection Review Office, Office of 
Scientific Integrity, Office of Science, Centers for Disease Control 
and Prevention.
[FR Doc. 2018-25626 Filed 11-26-18; 8:45 am]
 BILLING CODE 4163-18-P