83 FR 814 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 5 (January 8, 2018)

[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Notices]
[Pages 814-815]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-18-0051]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry (ATSDR) has submitted the 
information collection request titled Assessment of Chemical Exposures 
(ACE) Investigations to the Office of Management and Budget (OMB) for 
review and approval. ATSDR previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
August 30, 2017 to obtain comments from the public and affected 
agencies. ATSDR did not receive comments related to the previous 
notice. This notice serves to allow an additional 30 days for public 
and affected agency comments.
    ATSDR will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) 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;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) 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 submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to [email protected]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Assessment of Chemical Exposures (ACE) Investigations OMB Control 
No: 0923-0051 (Expiration Date: 03/31/2018)--Revision--Agency for Toxic 
Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Paperwork Reduction Act (PRA) revision of 
generic clearance information collection request 0923-0051 titled 
``Assessment of Chemical Exposures (ACE) Investigations'' to assist 
state and local health departments after toxic substance spills or 
chemical incidents. The PRA clearance for this information collection 
request expires 3/31/2018. In this revision, we are renaming the form 
previously titled the Rapid Response Registry Form as the ACE Short 
Form. This revision better describes the use of 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 they are 
not currently asked in the longer surveys. There are no changes to the 
requested burden hours.
    ATSDR has successfully completed three investigations to date using 
this PRA clearance and would like to continue this impactful 
information collection. Briefly summarized below are the 
accomplishments of this information collection:
     During 2015, in U.S. Virgin Islands there was a methyl 
bromide exposure at a condominium resort. Under this ACE investigation, 
awareness was raised among pest control companies that methyl bromide 
was prohibited for use in homes and other residential settings. 
Additionally, awareness was raised 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 who were exposed to Flint municipal water and 
had current or worsening rashes were surveyed and referred to 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 who were 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

[[Page 815]]

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.
    Because each chemical incident is different, it is not possible to 
predict in advance exactly what type of and how many respondents will 
need to be consented and interviewed to 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.
    Data will be collected by the multidisciplinary ACE team consisting 
of staff from ATSDR, the Centers for Disease Control and Prevention 
(CDC), and the requesting agencies. ATSDR has developed a series of 
draft survey forms that can be quickly tailored in the field to collect 
data that will meet the goals of the investigation. They 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 may be collected by face-to-face 
interviews, telephone interviews, written surveys, mailed surveys, or 
on-line surveys. Medical and veterinary charts may also be reviewed. 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Residents, first responders, business   General Survey..........             800               1           30/60
 owners, employees, customers.          ACE Short Form..........              50               1            7/60
Residents.............................  Household Survey........             120               1           15/60
Hospital staff........................  Hospital Survey.........              40               1           30/60
Staff from state, local, or tribal      Medical Chart                        250               1           30/60
 health agencies.                        Abstraction Form.                    30               1           20/60
                                        Veterinary Chart
                                         Abstraction Form.
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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. 2018-00141 Filed 1-5-18; 8:45 am]
 BILLING CODE 4163-18-P