[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63390-63392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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 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 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,

[[Page 63391]]

Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS 
H21-8, Atlanta, Georgia 30329; phone: 404-639-7118; 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;
    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:
     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.
     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.
     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).
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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]]

     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
----------------------------------------------------------------------------------------------------------------
                                                                     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.
                                                 ---------------------------------------------------------------
    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