Proposed Data Collection Submitted for Public Comment and Recommendations, 45241-45243 [2018-19295]
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Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
reliable courier service will be costly
and requires a considerable amount of
time to complete the registration
process.
Response: GSA has taken several
actions to address alleged fraudulent
activity in the System for Award
Management (SAM). The measures GSA
has put in place to help prevent
improper activity in SAM include
masking specific data elements in the
entity registration even for authorized
entity users; requiring ‘‘parent’’
approval of new registrations for their
‘‘child’’ entities; multi-factor
authentication using login.gov and
notifying Entity Administrators when
there is a change in the entity’s bank
account information. Requiring the
formal appointment of the Entity
Administrator by original, signed
notarized letter ensures that the
individual(s) reporting for their entity
are associated with the entity and
provides a validation of the letter
submitter’s identity by the notary. GSA
is actively pursuing technical
alternatives to replace and/or
supplement the collection of notarized
letters.
C. Annual Reporting Burden
Respondents: 686,400.
Responses per Respondent: 1.
Total Annual Responses: 686,400.
Hours per Response: 2.25.
Total Burden Hours: 1,544,400.
The information collection allows
GSA to request the notarized letter, and
apply this approach to new registrants
(an average of 7,200 per month) and to
existing SAM registrants (an average of
50,000 re-register per month).
Entities registered and registering in
SAM are provided the template for the
requirements of the notarized letter. It is
estimated that the Entity Administrator
will take on average 0.5 hour to create
the letter and 0.25 hour to mail the hard
copy letter. GSA proposes that an Entity
Administrator equivalent to a GS–5,
Step 5 Administrative Support person
within the Government would perform
these tasks. The estimated hourly rate of
$24.70 (Base + Locality + Fringe) was
used for the calculation.
Based on historical data of the ratio of
small entities to other than small
entities registering in SAM, GSA
approximates 32,200 of the 57,200 new
and existing entities (re-registrants) will
have in-house resources to notarize
documents. GSA proposes that the
entities with in-house notaries will
typically be large businesses where the
projected salary of the executive or
officer responsible for signing the
notarized letter is on average
approximately $150 per hour. The
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16:56 Sep 05, 2018
Jkt 244001
projected time for signature and
notarizing the letter internally is 0.5
hour.
The other remaining 25,000 new and
existing entities (re-registrants) per
month are estimated to be small entities
where the projected salary of the
executive or officer responsible signing
the notarized letter is on average
approximately $100 per hour. These
entities will more than likely have to
obtain notary services from an outside
source. The projected time for signature
and notarizing the letter externally is 1
hour. The estimate includes a nominal
fee ($5.00) usually charged by thirdparty notaries.
D. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary, whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected; and ways in
which we can minimize the burden of
the collection of information on those
who are to respond, through the use of
appropriate technological collection
techniques or other forms of information
technology.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW, Washington, DC
20405. ATTN: Information Collection
3090–0317; Notarized Document
Submittal for System for Award
Management Registration. Please cite
OMB Control No. 3090–0317; Notarized
Document Submittal for System for
Award Management Registration, in all
correspondence.
Dated: August 22, 2018.
David A. Shive,
Chief Information Officer.
[FR Doc. 2018–19324 Filed 9–5–18; 8:45 am]
BILLING CODE 6820–EP–P
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45241
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 for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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.
SUMMARY:
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
ADDRESSES:
E:\FR\FM\06SEN1.SGM
06SEN1
45242
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
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
daltland on DSKBBV9HB2PROD with NOTICES
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
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16:56 Sep 05, 2018
Jkt 244001
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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
E:\FR\FM\06SEN1.SGM
06SEN1
45243
Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
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
Form name
Reproductive Health Care Clinicians
(RHCCs).
Women who Receive Preconception
or Prenatal Care.
PAER Online Registration for
RHCCs.
PAER Training Materials for RHCCs
PAER Email/Text Invitation, Data
Linkage, and Counseling.
Access and Respond to PAER Survey.
Total ...........................................
...........................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2018–0082]
Surgeon General’s Call to Action:
‘‘Community Health and Prosperity’’
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the opening
of a docket to obtain comment on an
upcoming Surgeon General’s document/
Call to Action with a working title
‘‘Community Health and Prosperity’’.
CDC is the lead agency to support the
Office of the Surgeon General to publish
a Call to Action that will be scienceinformed and actionable, outlining a
conceptual framework with case
examples and available evidence on the
business case for investing in
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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16:56 Sep 05, 2018
Jkt 244001
Number of
responses per
respondent
Number of
respondents
Type of respondent
1
15/60
1,335
5,338
5,338
1
12
15/60
30/60
1,335
32,028
66,441
1
10/60
11,074
........................
........................
........................
45,772
FOR FURTHER INFORMATION CONTACT:
Martin J. Vincent, Office of the
Associate Director for Policy, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mail Stop D–28,
Frm 00038
Fmt 4703
Total
burden
hours
5,338
community health. The goal of the Call
to Action is to: Clearly demonstrate that
investments in community health have
the potential to improve the health and
prosperity of communities and issue a
call to action to the private sector and
local policy makers for investment in
communities, unilaterally or as part of
multi-sector or other consortium, to
improve community health.
DATES: Written comments must be
received before November 5, 2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2018–
0082 by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Martin J. Vincent, Office of
the Associate Director for Policy,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, Mail
Stop D–28, Atlanta, Georgia 30329.
• Instructions: All submissions
received must include the agency name
and Docket Number. All relevant
comments received will be posted
without change to https://
regulations.gov, including any personal
information provided. For access to the
docket to read background documents
or comments received, go to https://
www.regulations.gov.
PO 00000
Average
burden
per response
(in hours)
Sfmt 4703
Atlanta, Georgia 30329. Telephone:
404–639–1455, Email: CHP@cdc.gov.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations
are invited to submit written views,
recommendations, and data about how
investing in communities can improve
health and prosperity. Examples may
include:
(1) Available data, evidence and/or
experience(s) (a) that suggest private
sector investments in community health
have (directly or indirectly) improved
health and prosperity of the workforce
and communities; (b) that healthier
communities help private sector
businesses to be more efficient,
profitable, successful, or competitive; (c)
description of data systems and
evaluation frameworks that might
contribute to supporting community
health investment decisions, evaluating
success and impact; and (d) case
studies, examples, reviews and metaanalyses, data linkages, promising and
emerging ideas, and best practices;
(2) Types of investments the private
sector and local policy makers can
consider to improve health and wellness
of employees and families, and
community well-being and prosperity;
(3) Types of partners or coalitions that
have invested in community health and
the scope of their collaborations
contributions;
(4) Descriptions of important barriers
to and facilitators of success;
E:\FR\FM\06SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45241-45243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19295]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
