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)
Agency for Toxic Substances and Disease Registry
Federal Register Volume 83, Issue 173 (September 6, 2018)
| Page Range | 45241-45243 | |
| FR Document | 2018-19295 |
[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] ======================================================================= ----------------------------------------------------------------------- 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
![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45241
reliable courier service will be costly projected time for signature and DEPARTMENT OF HEALTH AND
and requires a considerable amount of notarizing the letter internally is 0.5 HUMAN SERVICES
time to complete the registration hour.
process. Agency for Toxic Substances and
The other remaining 25,000 new and
Response: GSA has taken several Disease Registry
existing entities (re-registrants) per
actions to address alleged fraudulent [60Day–18–18ARO; Docket No. ATSDR–
activity in the System for Award month are estimated to be small entities
where the projected salary of the 2018–0007]
Management (SAM). The measures GSA
has put in place to help prevent executive or officer responsible signing
Proposed Data Collection Submitted
improper activity in SAM include the notarized letter is on average for Public Comment and
masking specific data elements in the approximately $100 per hour. These Recommendations
entity registration even for authorized entities will more than likely have to
entity users; requiring ‘‘parent’’ obtain notary services from an outside AGENCY: Agency for Toxic Substances
approval of new registrations for their source. The projected time for signature and Disease Registry (ATSDR),
‘‘child’’ entities; multi-factor and notarizing the letter externally is 1 Department of Health and Human
authentication using login.gov and hour. The estimate includes a nominal Services (HHS).
notifying Entity Administrators when fee ($5.00) usually charged by third- ACTION: Notice with comment period.
there is a change in the entity’s bank party notaries.
account information. Requiring the SUMMARY: The Agency for Toxic
formal appointment of the Entity D. Public Comments Substances and Disease Registry
Administrator by original, signed (ATSDR), as part of its continuing effort
Public comments are particularly to reduce public burden and maximize
notarized letter ensures that the invited on: Whether this collection of
individual(s) reporting for their entity the utility of government information,
information is necessary, whether it will invites the general public and other
are associated with the entity and have practical utility; whether our
provides a validation of the letter Federal agencies the opportunity to
estimate of the public burden of this comment on a proposed and/or
submitter’s identity by the notary. GSA
collection of information is accurate, continuing information collection, as
is actively pursuing technical
and based on valid assumptions and required by the Paperwork Reduction
alternatives to replace and/or
supplement the collection of notarized methodology; ways to enhance the Act of 1995. This notice invites
letters. quality, utility, and clarity of the comment on a proposed information
information to be collected; and ways in collection project titled ‘‘Prenatal
C. Annual Reporting Burden which we can minimize the burden of Assessment of Environmental Risk
Respondents: 686,400. the collection of information on those (PAER)’’. This web-based data collection
Responses per Respondent: 1. who are to respond, through the use of will provide information on behavioral
Total Annual Responses: 686,400. appropriate technological collection risks for environmental exposures for
Hours per Response: 2.25. techniques or other forms of information patients seeking preconception and
Total Burden Hours: 1,544,400. technology. prenatal care, and for their reproductive
The information collection allows health care clinicians (RHCCs).
GSA to request the notarized letter, and Obtaining Copies of Proposals:
DATES: ATSDR must receive written
apply this approach to new registrants Requesters may obtain a copy of the
comments on or before November 5,
(an average of 7,200 per month) and to information collection documents from
2018.
existing SAM registrants (an average of the General Services Administration,
50,000 re-register per month). Regulatory Secretariat Division (MVCB), ADDRESSES: You may submit comments,
Entities registered and registering in 1800 F Street NW, Washington, DC identified by Docket No. ATSDR–2018–
SAM are provided the template for the 20405. ATTN: Information Collection 0007 by any of the following methods:
requirements of the notarized letter. It is 3090–0317; Notarized Document • Federal eRulemaking Portal:
estimated that the Entity Administrator Submittal for System for Award Regulations.gov. Follow the instructions
will take on average 0.5 hour to create for submitting comments.
Management Registration. Please cite
the letter and 0.25 hour to mail the hard • Mail: Jeffrey M. Zirger, Information
OMB Control No. 3090–0317; Notarized
copy letter. GSA proposes that an Entity Collection Review Office, Centers for
Document Submittal for System for Disease Control and Prevention, 1600
Administrator equivalent to a GS–5, Award Management Registration, in all
Step 5 Administrative Support person Clifton Road NE, MS–D74, Atlanta,
correspondence. Georgia 30329.
within the Government would perform
these tasks. The estimated hourly rate of Dated: August 22, 2018. Instructions: All submissions received
$24.70 (Base + Locality + Fringe) was David A. Shive, must include the agency name and
used for the calculation. Chief Information Officer. Docket Number. ATSDR will post,
Based on historical data of the ratio of without change, all relevant comments
[FR Doc. 2018–19324 Filed 9–5–18; 8:45 am]
small entities to other than small to Regulations.gov.
BILLING CODE 6820–EP–P
entities registering in SAM, GSA Please note: Submit all comments
approximates 32,200 of the 57,200 new through the Federal eRulemaking portal
and existing entities (re-registrants) will (regulations.gov) or by U.S. mail to the
have in-house resources to notarize address listed above.
daltland on DSKBBV9HB2PROD with NOTICES
documents. GSA proposes that the FOR FURTHER INFORMATION CONTACT: To
entities with in-house notaries will request more information on the
typically be large businesses where the proposed project or to obtain a copy of
projected salary of the executive or the information collection plan and
officer responsible for signing the instruments, contact Jeffery M. Zirger,
notarized letter is on average Information Collection Review Office,
approximately $150 per hour. The Centers for Disease Control and
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![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45243
annualized frequency of response (12 invitation. ATSDR assumes that 5 (66,441/5,338 = 12). The time for
per RHCC) is based on ATSDR percent of these women will participate women to respond to the survey is
assumptions about the number of in PAER over the next three years (or estimated at 10 minutes per patient.
patients who will take part in the PAER 1.67 percent per year). Using the Participation in the PAER process and
survey as described below. 3,978,497 births reported in the 2015
survey is voluntary. There is no cost to
Women who receive preconception or U.S. Vital Statistics to represent the
prenatal care (the second type of respondents other than their time. The
number women who receive
respondents) may respond to the PAER preconception or prenatal care, 1.67 total annualized time burden requested
environmental exposure history by percent equals to 66,441 women who is 45,772 hours. A summary of the
accessing the online PAER survey will take part in the PAER survey each estimated annualized burden hours is
through the application internet home year. Thus, each RHCCH is assumed to shown in the table that follows.
page or through their RHCC’s email/text interact with 12 such patients per year
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden
Type of respondent Form name responses per burden
respondents per response
respondent hours
(in hours)
Reproductive Health Care Clinicians PAER Online Registration for 5,338 1 15/60 1,335
(RHCCs). RHCCs.
PAER Training Materials for RHCCs 5,338 1 15/60 1,335
PAER Email/Text Invitation, Data 5,338 12 30/60 32,028
Linkage, and Counseling.
Women who Receive Preconception Access and Respond to PAER Sur- 66,441 1 10/60 11,074
or Prenatal Care. vey.
Total ........................................... ........................................................... ........................ ........................ ........................ 45,772
Jeffrey M. Zirger, community health. The goal of the Call Atlanta, Georgia 30329. Telephone:
Acting Chief, Information Collection Review to Action is to: Clearly demonstrate that 404–639–1455, Email: CHP@cdc.gov.
Office, Office of Scientific Integrity, Office investments in community health have SUPPLEMENTARY INFORMATION:
of the Associate Director for Science, Office the potential to improve the health and
of the Director, Centers for Disease Control prosperity of communities and issue a Public Participation
and Prevention. call to action to the private sector and Interested persons or organizations
[FR Doc. 2018–19295 Filed 9–5–18; 8:45 am] local policy makers for investment in are invited to submit written views,
BILLING CODE 4163–18–P communities, unilaterally or as part of recommendations, and data about how
multi-sector or other consortium, to investing in communities can improve
improve community health. health and prosperity. Examples may
DEPARTMENT OF HEALTH AND include:
DATES: Written comments must be
HUMAN SERVICES (1) Available data, evidence and/or
received before November 5, 2018.
Centers for Disease Control and ADDRESSES: You may submit comments,
experience(s) (a) that suggest private
Prevention identified by Docket No. CDC–2018– sector investments in community health
0082 by any of the following methods: have (directly or indirectly) improved
[Docket No. CDC–2018–0082] health and prosperity of the workforce
• Federal eRulemaking Portal: http://
and communities; (b) that healthier
Surgeon General’s Call to Action: www.regulations.gov. Follow the
communities help private sector
‘‘Community Health and Prosperity’’ instructions for submitting comments.
businesses to be more efficient,
• Mail: Martin J. Vincent, Office of
AGENCY: Centers for Disease Control and profitable, successful, or competitive; (c)
the Associate Director for Policy,
Prevention (CDC), Department of Health description of data systems and
Centers for Disease Control and
and Human Services (HHS). evaluation frameworks that might
Prevention, 1600 Clifton Road NE, Mail
ACTION: Notice with comment period. contribute to supporting community
Stop D–28, Atlanta, Georgia 30329.
health investment decisions, evaluating
• Instructions: All submissions
SUMMARY: The Centers for Disease success and impact; and (d) case
received must include the agency name
Control and Prevention (CDC) in the studies, examples, reviews and meta-
and Docket Number. All relevant
Department of Health and Human analyses, data linkages, promising and
comments received will be posted
Services (HHS) announces the opening emerging ideas, and best practices;
without change to http://
of a docket to obtain comment on an (2) Types of investments the private
regulations.gov, including any personal
upcoming Surgeon General’s document/ sector and local policy makers can
information provided. For access to the
Call to Action with a working title consider to improve health and wellness
docket to read background documents
‘‘Community Health and Prosperity’’. of employees and families, and
daltland on DSKBBV9HB2PROD with NOTICES
CDC is the lead agency to support the or comments received, go to http://
community well-being and prosperity;
Office of the Surgeon General to publish www.regulations.gov. (3) Types of partners or coalitions that
a Call to Action that will be science- FOR FURTHER INFORMATION CONTACT: have invested in community health and
informed and actionable, outlining a Martin J. Vincent, Office of the the scope of their collaborations
conceptual framework with case Associate Director for Policy, Centers for contributions;
examples and available evidence on the Disease Control and Prevention, 1600 (4) Descriptions of important barriers
business case for investing in Clifton Road NE, Mail Stop D–28, to and facilitators of success;
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Document Created: 2018-09-05 23:55:44
Document Modified: 2018-09-05 23:55:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | ATSDR must receive written comments on or before November 5, 2018. | |
| 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 Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 45241 |
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