83 FR 45241 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 83, Issue 173 (September 6, 2018)

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 ``Prenatal Assessment of Environmental Risk (PAER)''. This web-based data collection will provide information on behavioral risks for environmental exposures for patients seeking preconception and prenatal care, and for their reproductive health care clinicians (RHCCs).

[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45241-45243]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-19295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-18-18ARO; Docket No. ATSDR-2018-0007]


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 ``Prenatal Assessment of 
Environmental Risk (PAER)''. This web-based data collection will 
provide information on behavioral risks for environmental exposures for 
patients seeking preconception and prenatal care, and for their 
reproductive health care clinicians (RHCCs).

DATES: ATSDR must receive written comments on or before November 5, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2018-0007 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.
    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 Jeffery M. Zirger, Information Collection 
Review Office, Centers for Disease Control and

[[Page 45242]]

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;
    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

Prenatal Assessment of Environmental Risk (PAER)--NEW--Agency for Toxic 
Substances and Disease Registry (ATSDR)

Background and Brief Description
    Many environmental chemicals absorbed or ingested by pregnant women 
can cross the placenta to the fetus. The scientific evidence over the 
last 10 to 15 years has shown that exposure to toxic environmental 
agents before conception and during pregnancy can have significant and 
long-lasting adverse effects on the reproductive health of mothers, and 
on the long-term health of mothers and babies. Reducing exposure to 
toxic environmental agents is a critical area of intervention for 
reproductive health care professionals in the United States and 
worldwide. In 2013, the American College of Obstetricians and 
Gynecologists (ACOG) and other obstetrician-gynecologist professional 
societies called for timely action to identify and reduce exposure to 
toxic environmental agents while addressing the consequences of such 
exposure (ACOG, 2013; FIGO, 2105).
    In support of this call to action, the Agency for Toxic Substances 
and Disease Registry (ATSDR) is requesting a three-year Paperwork 
Reduction Act (PRA) clearance for a new information collection request 
(ICR) entitled ``Prenatal Assessment of Environmental Risk (PAER)''.
    The long-term goal is for the PAER web-based information collection 
system to be widely adopted by obstetricians, gynecologists, and other 
reproductive health care professionals. Through PAER, practicing 
clinicians will have readily accessible and reliable information, and 
educational resources to counsel mothers-to-be on their potential 
environmental exposures and associated risks. This will facilitate 
reduction in harm to mothers-to-be and their babies. PAER environmental 
exposure assessment results will be suitable for incorporation into 
patients' electronic health records and maintenance within health care 
provider organizations.
    Data collected will also establish an ongoing public health 
surveillance system that will provide an improved understanding of 
behaviors in daily life that put women of reproductive age and their 
babies at higher risk of exposure to environmental hazards. ATSDR will 
maintain only anonymous patient PAER survey responses and registration 
variables, including the PAER unique survey ID number, age, and zip 
code. Age and zip code will serve as the two variables for data 
analysis. Reported risk-based aggregate data will be at the zip code or 
higher geographic level, excluding zip code tabulation areas (ZTCAs) 
with 20,000 or fewer persons.
    ATSDR plans to analyze the exposure risk data by geographic regions 
and over time. This data analysis will allow clinician and patient 
education on the most prevalent region-specific environmental 
exposures. ATSDR and partner organizations can use this information to 
shape educational initiatives and counseling guidance on ways women can 
lower environmental exposure risk.
    The PAER survey is web-based, and includes 17 multiple-choice 
questions and one open-ended question. These questions are divided into 
five topic areas: Lifestyle; home; food and water; cans, bottles, and 
containers; and getting ready for the baby. The PAER survey focuses on 
11 common types of environmental exposures: Air pollution, benzene, 
bisphenol A (BPA), flame retardants, lead, mercury, polychlorinated 
biphenyls (PCBs), pesticides, phthalates, smoking, and volatile organic 
compounds (VOCs).
    There are two types of respondents who will participate in the PAER 
data collection, reproductive health care clinicians (RHCCs), and women 
of reproductive age who are seeking preconception or prenatal care. 
RHCCs will include obstetricians/gynecologists, family medicine 
physicians, nurse practitioners and physician assistants, and nurse 
midwives who are involved in the care of these women.
    RHCCs (the first type of respondent) who choose to participate in 
the PAER process will be required to register with ATSDR, and gain 
approval to participate and establish credentials through CDC's Secure 
Access Management Services (SAMS). ATSDR will provide online training 
resources to instruct RHCCs how to register themselves and their clinic 
for PAER, to recruit patients, to utilize environmental histories and 
PAER resources for patient counseling, and to link PAER results to 
their patient health records. Online registration and training module 
components are estimated to take 30 minutes per RHCC.
    Each RHCC who participates in PAER will also invite their patients 
to complete the environmental exposure survey by email or text, link 
their patients' survey response data with the invitations sent and 
health records, and provide counseling to individual patients to aid in 
modifying behavior to lower environmental exposure risks. These 
components are estimated to take RHCCs 30 minutes per patient.
    Of note, ATSDR will not receive any information from the patients' 
electronic health records. RHCCs will invite their patients to 
participate outside of the PAER application, and will be responsible 
for protecting the patient information provided to them within PAER in 
accordance with the 1996 Health Insurance Portability and 
Accountability (HIPAA) guidelines.
    Based on ACOG estimates, the number of practicing RHCCs in the U.S. 
is approximately 35,586. On average over the next three years, ATSDR 
estimates that up to 15 percent (n = 5,338) of these clinicians will 
participate in the PAER process each year through online registration 
and training. For purposes of estimation, ATSDR assumes the RHCCs 
represent the full effort of clinic staff. The

[[Page 45243]]

annualized frequency of response (12 per RHCC) is based on ATSDR 
assumptions about the number of patients who will take part in the PAER 
survey as described below.
    Women who receive preconception or prenatal care (the second type 
of respondents) may respond to the PAER environmental exposure history 
by accessing the online PAER survey through the application internet 
home page or through their RHCC's email/text invitation. ATSDR assumes 
that 5 percent of these women will participate in PAER over the next 
three years (or 1.67 percent per year). Using the 3,978,497 births 
reported in the 2015 U.S. Vital Statistics to represent the number 
women who receive preconception or prenatal care, 1.67 percent equals 
to 66,441 women who will take part in the PAER survey each year. Thus, 
each RHCCH is assumed to interact with 12 such patients per year 
(66,441/5,338 = 12). The time for women to respond to the survey is 
estimated at 10 minutes per patient.
    Participation in the PAER process and survey is voluntary. There is 
no cost to respondents other than their time. The total annualized time 
burden requested is 45,772 hours. A summary of the estimated annualized 
burden hours is shown in the table that follows.

                                        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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Reproductive Health Care        PAER Online                5,338               1           15/60           1,335
 Clinicians (RHCCs).             Registration
                                 for RHCCs.
                                PAER Training              5,338               1           15/60           1,335
                                 Materials for
                                 RHCCs.
                                PAER Email/Text            5,338              12           30/60          32,028
                                 Invitation,
                                 Data Linkage,
                                 and Counseling.
Women who Receive               Access and                66,441               1           10/60          11,074
 Preconception or Prenatal       Respond to PAER
 Care.                           Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          45,772
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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. 2018-19295 Filed 9-5-18; 8:45 am]
BILLING CODE 4163-18-P