89 FR 122 pgs. 53103-53105 - Proposed Data Collection Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 89Number: 122Pages: 53103 - 53105
Pages: 53103, 53104, 53105Docket number: [60Day-24-0051; Docket No. ATSDR-2024-0002]
FR document: [FR Doc. 2024-13904 Filed 6-24-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Agency for Toxic Substances and Disease Registry
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[60Day-24-0051; Docket No. ATSDR-2024-0002]
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection 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 environmental incidents].
DATES:
ATSDR must receive written comments on or before August 26, 2024.
ADDRESSES:
You may submit comments, identified by Docket No. ATSDR-2024-0002 by either of the following methods:
• Federal eRulemaking Portal: www.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 H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and Docket Number. ATSDR will post, without change, all relevant comments to www.regulations.gov.
Please note:
Submit all comments through the Federal eRulemaking portal ( www.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 Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 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
Assessment of Chemical Exposures (ACE) Investigations (OMB Control Number 0923-0051, Exp. 10/31/2024)-Revision-Agency for Toxic Substances and Disease Registry (ATSDR).
Background and Brief Description
[top] The Agency for Toxic Substances and Disease Registry (ATSDR) is requesting to revise the Assessment of Chemical Exposures (ACE) Investigations information collection project and seeks a three-year OMB approval to assist state and local health departments after toxic substance spills or other acute environmental incidents. ATSDR has successfully completed three
• During 2015, in U.S. Virgin Islands there was a methyl bromide exposure at a condominium resort. Under this ACE investigation, pest control companies were made aware that methyl bromide use is prohibited in homes and other residential settings. Additionally, clinicians were made aware of 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, the ACE team conducted a rash investigation in Flint, Michigan. Persons exposed to Flint municipal water who 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, the ACE team also conducted a follow-up investigation for people who were exposed to the Flint municipal water and sought care from dermatologists. The follow-up interviews resulted in improvement of the exam and referral processes that were still ongoing at the time.
ACE Investigations have focused on performing rapid epidemiological assessments to assist state, regional, local, or tribal health departments (requesting agencies) to respond to or prepare for acute environmental incidents. The main objectives for performing these rapid assessments are to:
• Characterize exposure and acute health effects of the affected community to inform health officials and the community;
• Identify needs ( i.e., medical, mental health, and basic) of those exposed during the incidents to aid in planning interventions in the community;
• Determine the sequence of events responsible for the incident so that actions can be taken to prevent future incidents;
• Assess the impact of the incidents on the emergency response and health services used and share lessons learned for use in hospital, local, and state planning for environmental incidents; and
• Identify cohorts that may be followed and assessed for persistent health effects resulting from environmental releases.
Because each incident is different, it is not possible to predict in advance exactly what type of, and how many respondents will 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, 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 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 Epidemiologic Contact Assessment Symptom Exposure (Epi CASE) Survey, 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 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 self-administered surveys can be collected. Medical charts may also be considered for review. In rare situations, an investigation might involve collection of clinical specimens.
ATSDR is proposing to increase the utility of this Generic ICR in response to stakeholder requests. We would also like to broaden who we may assist to include other federal public health agencies. ATSDR proposes revisions to select information collection forms, which will be deployed online or using handheld devices whenever possible to reduce burden, and to adjust the number of responses and time per response for several forms. Because of this addition of online self-administration we are expecting to be able to survey more respondents than previously done during large disasters. A brief Eligibility Screener will be conducted before the General or Epi CASE survey to make sure they were in the area at the time of the incident, before consenting them to be surveyed. The number of people to be screened will be increased to 2,500 responses per year. The shorter Epi CASE survey has been modified to incorporate the symptom checker showcard into the survey so that it can be easily self-administered online, and questions on functional disabilities were added as requested by stakeholders adding two minutes and 1,000 respondents. The General survey will also have an online option. For simplicity, adolescents will no longer be eligible to take the General Survey and the Child Survey will become a module of the General Survey for adults to answer for their minor children. At stakeholder direction, ATSDR has added modules to the General Survey for responder, pets, and livestock health, and a community resilience qualitative question bank. The General Survey has also added questions requested by stakeholders on functional disabilities and maternal and child health. The two existing long-term mental health screeners are replaced by three shorter versions and the race/ethnicity questions are now consistent with revised OMB Standards. Qualitative questions were added to several sections throughout the survey. These changes add to the time of the survey and the online self-administration option allows for an increase in respondents (60 minutes, 1000 responses annually). The Household Survey will be removed because of little use. The Hospital Survey for emergency department nurses and other health professionals on how they handled the response is unchanged (40 responses per year; 17 hours). We are modifying the Medical Chart Abstraction Form with slight question changes suggested by a medical toxicologist, and by adding functional disability questions and modifying the race/ethnicity questions to the OMB Standard. This results in no change to burden (250 responses per year; 125 hours).
[top] ATSDR anticipates one ACE investigation per year and is requesting OMB approval for 4,815 annual responses and for 1,508 annual burden hours. Participation in ACE investigations is voluntary and there are no anticipated costs to respondents other than their time.
| Type of respondents | Form name | Number of respondents | Number of Responses per respondent | Average Burden per response (in hours) | Total burden (in hours) |
|---|---|---|---|---|---|
| Residents, first responders, business owners, employees, customers | Eligibility Screener Epi CASE Survey | 2,500 1,000 | 1 1 | 2/60 17/60 | 83 283 |
| General survey | 1,000 | 1 | 60/60 | 1,000 | |
| Hospital staff | Hospital Survey | 40 | 1 | 25/60 | 17 |
| Staff from state, local, or tribal health agencies | Medical Chart Abstraction Form | 25 | 10 | 30/60 | 125 |
| Total | 4,565 | 1,508 |
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health Ethics and Regulations, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2024-13904 Filed 6-24-24; 8:45 am]
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