[Federal Register Volume 84, Number 246 (Monday, December 23, 2019)]
[Notices]
[Pages 70544-70547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27550]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-20-19ACF]


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 ``Human Health Effects of 
Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): 
A Multi-site Cross-sectional Study (The Multi-site Study)'' 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 April 23, 2019 to obtain 
comments from the public and affected agencies. ATSDR received two 
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

    Human Health Effects of Drinking Water Exposures to Per- and 
Polyfluoroalkyl Substances (PFAS): A Multi-site Cross-sectional Study 
(The Multi-site Study)--NEW--Agency for

[[Page 70545]]

Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    Per- and polyfluoroalkyl substances (PFAS) are a family of 
chemicals used in industrial applications and consumer products. PFAS 
contamination of drinking water is widespread in the U.S. Some 
estimates indicate that at least sixty million residents were served by 
66 public water supplies that had at least one sample at or above the 
US Environmental Protection Agency (EPA) Lifetime Health Advisory for 
perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) 
(individually or combined), which is 70 nanograms per liter (ng/L) of 
water. Industrial facilities that manufacture or use PFAS have 
contaminated drinking water in surrounding communities in several 
states. In addition, PFOS, PFOA, perfluorohexane sulfonic acid (PFHxS) 
and other PFAS chemicals are constituents in aqueous film-forming foam 
(AFFF), used to extinguish flammable liquid fires. The use of AFFF at 
military bases and other sites may have resulted in the migration of 
PFAS chemicals through soils to ground water and/or surface water 
sources of drinking water for the bases and/or surrounding communities 
around the country.
    In response to growing awareness of the extent of PFAS 
contamination across the U.S., the Section 316(a) of the 2018 National 
Defense Authorization Act (Pub. L. 115-91), as amended by Section 315 
of the John S. McCain National Defense Authorization Act for Fiscal 
Year 2019 (Pub. L. 115-232), authorized and appropriated funds for the 
Agency for Toxic Substances and Disease Registry (ATSDR) to conduct a 
study on the human health effects of PFAS contamination in drinking 
water. The existence of widespread contamination at many sites across 
the U.S. makes this a paramount effort in addressing the health effects 
of exposures to PFAS from contaminated drinking water. Consequently, 
ATSDR is requesting a three-year Paperwork Reduction Act (PRA) 
clearance for the Multi-site Study.
    The Multi-site Study builds on activities undertaken in preparing 
and conducting the data collection for the proof-of-concept study at 
the Pease International Tradeport in Portsmouth, New Hampshire (the 
Pease Study) (OMB Control No. 0923-0061; expiration date 08/31/2022). 
These activities included developing data management systems and 
community engagement materials, modifying the childhood neurobehavioral 
test battery, adjusting blood collection volume, and modifying data 
collection materials such as the childhood questionnaire and medical 
records abstraction forms. Based on peer reviewer and OMB comments on 
the Pease Study, the Multi-site Study protocol now includes additional 
data analyses to address potential biases such as selection bias and 
confounding.
    ATSDR will conduct this research using a cooperative agreement 
titled ``Multi-site Study of the Health Implications of Exposure to 
PFAS-Contaminated Drinking Water'' (Notice of Funding Opportunity 
[NOFO] No. CDC-RFA-TS-19-002). Seven research recipients have been 
selected: University of Colorado School of Public Health, Michigan 
State Department of Health and Human Services, Pennsylvania Department 
of Health and RTI International, Rutgers School of Public Health, 
Silent Spring Institute, SUNY at Albany and the New York State 
Department of Health, and the University of California at Irvine.
    The Multi-site Study is designed to aggregate data across all 
recipient sites and is designed to compare data between sites. The main 
goal of this cross-sectional study is to evaluate associations between 
measured and reconstructed historic serum levels of PFAS including 
PFOA, PFOS, and PFHxS, and selected health outcomes. The health 
outcomes of interest include lipids, renal function and kidney disease, 
thyroid hormones and disease, liver function and disease, glycemic 
parameters and diabetes, as well as immune response and function in 
both children and adults. In addition, the study will investigate PFAS 
differences in sex hormones and sexual maturation, vaccine response, 
and neurobehavioral outcomes in children. In adults, additional 
outcomes of interest include cardiovascular disease, osteoarthritis and 
osteoporosis, endometriosis, and autoimmune disease.
    Under the cooperative agreement, each recipient proposed candidate 
study sites at communities whose drinking water was impacted by AFFF 
use or by industrial PFAS releases. Site selection considered the 
documented levels of PFAS drinking water concentrations. The aim was to 
include sites so that a wide range in PFAS exposures levels were 
included in the study. This will enable the evaluation of exposure-
response trends including effects at the lower range of exposures. 
Ground water contaminant fate and transport models and water 
distribution system models may be necessary to identify the areas with 
contaminated drinking water, to determine the period when the drinking 
water was contaminated, and to reconstruct historical PFAS contaminant 
concentrations.
    For exposure estimation, participants will be categorized based on 
their measured serum concentration of PFAS compounds or on modeled 
estimated historical serum levels (e.g., referent or low, medium, 
high). Measured and estimated PFAS serum levels will also be evaluated 
as continuous variables. At sites with prior PFAS biomonitoring data, 
the study will evaluate changes in PFAS concentration over time.
    Each recipient shall reconstruct historic serum PFAS 
concentrations. This may be done by estimating half-lives and 
elimination rates as well as by water contamination modeling to inform 
pharmacokinetic (PK) or physiologically based pharmacokinetic (PBPK) 
models. Historical serum PFAS reconstruction will enable the evaluation 
of exposure lags and vulnerable periods as well as statistical analyses 
that can control for confounding and reverse causation due to 
physiological factors.
    If feasible, each recipient shall identify and enumerate all 
households served by the contaminated drinking water supply in the 
selected community to recruit potential participants and to meet the 
sample size requirements for children and adults. If the selected 
community is served by a PFAS-contaminated public water system, then 
the recipient will obtain a list of households served by the water 
purveyor from its billing records. If the community is served by 
contaminated private wells, then the recipient will obtain a list of 
households with contaminated wells from the local and/or state health 
and environmental agencies.
    Statistical sampling methods (e.g., a two-stage cluster sample) may 
be used for recruitment of study participants if all the affected 
households can be enumerated. If the PFAS drinking water concentrations 
vary widely across the community, then the recipient should consider 
using targeted sampling approaches--including oversampling of areas 
with higher PFAS concentrations--to ensure a sufficiently wide 
distribution of exposure levels among study participants to evaluate 
exposure-response trends. If enumeration of all households is not 
feasible, or if participation rates are expected to be low, then the 
recipient can consider non-probabilistic sampling approaches such as 
``judgment'' and ``snowball'' sampling approaches.
    The recipients should consider requesting assistance from local and 
state health departments in their recruitment efforts. In addition, the 
recipients should engage community organizations to assist in 
conducting outreach about the study and

[[Page 70546]]

recruitment of participants and consider establishing a community 
assistance panel (CAP). The CAP could provide comments on any 
additional investigator-initiated research questions and hypotheses and 
facilitate the involvement of the affected community in decisions 
related to outreach about the study, participant recruitment 
strategies, and study logistics. The CAP could also assist the 
recipient in the dissemination of study findings to the community.
    In total, ATSDR seeks to enroll approximately 9,100 participants 
(7,000 adults and 2,100 children and their parents) from communities 
exposed to PFAS-contaminated drinking water over the first three years 
of the five-year cooperative agreement program. In total, each 
recipient will attempt to meet a target recruitment of 1,000 adults and 
300 children. Annualized estimates are 3,033 participants (2,333 adults 
and 700 children).
    To restrict this study to drinking water exposures, adults 
occupationally exposed to PFAS will not be eligible for the study 
(e.g., ever firefighters or ever workers in an industry using PFAS 
chemicals in its manufacturing process). Likewise, children whose birth 
mothers were occupationally exposed will not be eligible.
    Assuming a 95 percent eligibility rate and a 40 percent response 
rate, ATSDR estimates that the recipients will screen 7,982 people 
(6,140 adults and 1,842 children) each year across all sites in order 
to recruit the target sample size of 3,033 participants (2,333 adults 
and 700 children), using an annual time burden of 1,330 hours. The 
recipients will provide appointment reminder calls for each eligible 
person who agrees to be enrolled (n=3,033 per year).
    At enrollment, each recipient will obtain adult consent, parental 
permission, and child assent before data collection begins. For each 
participant, the recipient will take body measures, collect blood 
samples to measure PFAS serum levels and several effect biomarkers such 
as lipids, and thyroid, kidney, immune and liver function. The 
recipient will also obtain urine samples from participants to measure 
PFAS levels and kidney function biomarkers. The study will archive 
leftover serum and urine samples for additional analyses of PFAS 
chemicals and specific effect biomarkers. The National Center for 
Environmental Health (NCEH) laboratory will perform blood and urine 
PFAS analyses for all Multi-site Study participants. Thus, issues of 
inter-laboratory variability for exposure measures will be eliminated.
    Adult participants and a parent of child participants will complete 
a questionnaire that includes residential history, medical history, 
occupational history, and water consumption habits (n=3,033 adults and 
700 children per year). Ideally, the parent will be the child's birth 
mother, as ATSDR will ask details about the child's exposure, 
pregnancy, and breastfeeding history. For purposes of time burden 
estimation, ATSDR assumes that 20 percent of parents (n=140 per year) 
will also enroll as adults and can take the child short form 
questionnaire; therefore, 560 parents will take the child long form 
questionnaire per year. Parents and children, with administration by 
trained professionals, will also complete neurobehavioral assessments 
of the child's attention and behaviors (n=700 per year). The time 
burden for responding to questionnaires is 1,482 hours, and for 
neurobehavioral assessments is 1,225, per year.
    To facilitate access to medical and school records, each recipient 
will reach out to local medical societies, public school systems, and 
private schools, to enlist their cooperation with the study. The 
recipient will ask for permission to abstract participants' medical 
records to confirm self-reported health outcomes. The recipient will 
also seek permission to abstract and compare children's school records 
to their behavioral assessment results. Based on ATSDR's experience 
from the Pease Study (OMB Control No. 0923-0061; expiration date 08/31/
2022), ATSDR estimates that it will take 30 school administrators, 48 
education specialists, 70 medical office administrators, and 150 adult 
and 50 pediatric medical record specialists to complete record 
abstractions across all study sites. The annual time burden for medical 
and educational record abstraction is estimated to be 2,490 hours.
    The total annualized time burden requested is 7,960 hours. There is 
no cost to the 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)
----------------------------------------------------------------------------------------------------------------
Multi-site Study Participants.........  Eligibility Screening              7,982               1           10/60
                                         Script.
                                        Appointment Reminder               3,033               1            5/60
                                         Telephone Script.
                                        Update Contact                     3,033               1            5/60
                                         Information Hardcopy
                                         Form.
                                        Medication List.........           3,033               1            3/60
                                        Body and Blood Pressure            3,033               1            5/60
                                         Measures Form.
                                        Blood Draw and Urine               3,033               1           10/60
                                         Collection Form.
                                        Adult Questionnaire.....           2,333               1           30/60
                                        Child Questionnaire--                560               1           30/60
                                         Long Form.
                                        Child Questionnaire--                140               1           15/60
                                         Short Form.
                                        Parent Neurobehavioral               700               1           15/60
                                         Test Battery.
                                        Child Neurobehavioral                700               1           90/60
                                         Test Battery.
Medical Office Administrators.........  Request for Medical                   70              43           20/60
                                         Record Abstraction.
Medical Record Specialists............  Medical Record                       150              16           20/60
                                         Abstraction Form--Adult.
                                        Medical Record                        50              14           20/60
                                         Abstraction Form--Child.
School Administrators.................  Request for Child School              30              23           20/60
                                         Record Abstraction.
Education Specialists.................  Child School Record                   48              15           20/60
                                         Abstraction Form.
----------------------------------------------------------------------------------------------------------------



[[Page 70547]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-27550 Filed 12-20-19; 8:45 am]
 BILLING CODE 4163-18-P