[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41263-41265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-17-0051; Docket No. ATSDR-2017-0004]


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).

[[Page 41264]]


ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing efforts to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies to take this opportunity to comment on proposed 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the proposed 
request to extend the information collect project titled ``Assessment 
of Chemical Exposures (ACE) Investigations.'' The purpose of ACE 
Investigations is to focus on performing rapid epidemiological 
assessments to assist state, regional, local, or tribal health 
departments (the requesting agencies) to respond to or prepare for 
acute chemical releases.

DATES: Written comments must be received on or before October 30, 2017.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2017-0004 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. CDC will post all relevant comments, without change, 
to Regulations.gov, to include any personal information provided. For 
access to the docket to read background documents or comments received, 
go to Regulations.gov.
    Please note: All public comment should be submitted 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 Leroy A. Richardson, 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Assessment of Chemical Exposures (ACE) Investigations (OMB Control 
Number 0923-0051; expiration 3/31/2018)--Revision--Agency for Toxic 
Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting to revise ``Assessment of Chemical Exposures (ACE) 
Investigations'' information collection project and seek a three-year 
OMB approval to assist state and local health departments after toxic 
substance spills or chemical incidents. The OMB Control number for this 
information collection expires 3/31/2018. We are renaming the form 
previously titled the Rapid Response Registry Form as the ACE Short 
Form. This revision better describes that we use the ACE Short Form in 
time-limited investigations where longer surveys are not possible. We 
do not use the form to establish registries. In addition, we are 
removing two insurance questions from the ACE Short Form, as we do not 
ask in the longer surveys and have never been asked as part of an ACE 
Investigation. There are no changes to the requested burden hours.
    ATSDR has successfully completed three investigations to date. With 
the uses of this valuable mechanism, ATSDR would like to continue this 
impactful information collection. See below a brief summary of 
information collections approved under this tool:
     During 2015, in U.S. Virgin Islands there was a methyl 
bromide exposure at a condominium resort. Under this ACE investigation, 
awareness among pest control companies that methyl bromide currently 
prohibited in the homes and other residential settings. Additionally, 
awareness for clinicians about the toxicologic syndrome caused by 
exposure to methyl bromide and the importance of notifying first 
responders immediately when they have encountered contaminated 
patients.
     During 2016, ACE team conducted a rash investigation in 
Flint, Michigan. Persons exposed to Flint municipal water and had 
current or worsening rashes surveyed and referred too free 
dermatologist screening if desired. Findings revealed that when the 
city was using water from the Flint River, there were large swings in 
chorine, pH, and hardness, which could be one possible explanation for 
the eczema-related rashes.
     During 2016, ACE team also conducted a follow-up 
investigation for people whom been exposed to the Flint municipal water 
and sought care from the free dermatologists. Data analysis for this 
project is in process and results are pending. However, the follow-up 
interviews resulted in improving the exam and referral processes that 
were still on going at the time.
    The ACE investigations focus on performing rapid epidemiological 
assessments to assist state, regional, local, or tribal health 
departments (the requesting agencies) to respond to or prepare for 
acute chemical releases.
    The main objectives for performing these rapid assessments are to:
    1. Characterize exposure and acute health effects of respondents 
exposed to toxic substances from discrete, chemical

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releases and determine their health statuses;
    2. Identify needs (i.e., medical and basic) of those exposed during 
the releases to aid in planning interventions in the community;
    3. Assess the impact of the incidents on health services use and 
share lessons learned for use in hospital, local, and state planning 
for chemical incidents; and
    4. Identify cohorts may be followed and assessed for persistent 
health effects resulting from acute releases.
    Because each chemical incident is different, it is not possible to 
predict in advance exactly what type of and how many respondents will 
be consented and interviewed too effectively evaluate the incident. 
Respondents typically include, but are not limited to emergency 
responders such as police, fire, hazardous material technicians, 
emergency medical services, and personnel at hospitals where patients 
from the incident were treated. Incidents may occur at businesses or in 
the community setting; therefore, respondents may also include business 
owners, managers, workers, customers, community residents, pet owners, 
and those passing through the affected area.
    The multidisciplinary ACE team consisting of staff from ATSDR, the 
Centers for Disease Control and Prevention (CDC), and the requesting 
agencies that will be collecting data. ATSDR has developed a quickly 
tailored series of draft survey forms used in the field to collect data 
that will meet the goals of the investigation. ATSDR collections will 
be administered based on time permitted and urgency. For example, it is 
preferable to administer the general survey to as many respondents as 
possible. However, if there are time constraints, the shorter household 
survey or the ACE Short Form may be administered instead. The 
individual surveys collect information about exposure, acute health 
effects, health services use, medical history, needs resulting from the 
incident, communication during the release, health impact on children 
and pets, and demographic data. Hospital personnel are asked about the 
surge, response and communication, decontamination, and lessons 
learned.
    Depending on the situation, data collected by face-to-face 
interviews, telephone interviews, written surveys, mailed surveys, or 
on-line surveys can be consider collected. Medical and veterinary 
charts may also be consider for review. In rare situations, an 
investigation might involve collection of clinical specimens.
    ATSDR anticipates up to four ACE investigations per year. The 
number of participants has ranged from 30-715, averaging about 300 per 
year. Therefore, the total annualized estimated burden will be 591 
hours per year. Participation in ACE investigations is voluntary and 
there are no anticipated costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Residents, first responders,    General Survey..             800               1           30/60             400
 business owners, employees,    ACE Short Form..              50               1            7/60               6
 customers.
Residents.....................  Household Survey             120               1           15/60              30
Hospital staff................  Hospital Survey.              40               1           30/60              20
Staff from state, local, or     Medical Chart                250               1           30/60             125
 tribal health agencies.         Abstraction
                                 Form.
                                Veterinary Chart              30               1           20/60              10
                                 Abstraction
                                 Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             591
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Leroy A. Richardson,
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. 2017-18404 Filed 8-29-17; 8:45 am]
 BILLING CODE 4163-18-P