Proposed Data Collection Submitted for Public Comment and Recommendations, 34135-34137 [2018-15437]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Agency for Toxic Substance and Disease Registry

[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]


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

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.

-----------------------------------------------------------------------

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

[[Page 34137]]

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)         hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             961
--------------------------------------------------------------------------------------------------------------------------------------------------------


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