SSB_EI Extension 0923-0048 20151118 final

SSB_EI Extension 0923-0048 20151118 final.docx

ATSDR Exposure Investigations (EIs)

OMB: 0923-0048

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ATSDR Exposure Investigations (EIs)

OMB Control No. 0923-0048 (Expiration Date: 05/31/2016)

Extension



Supporting Statement Part B –

Collections of Information Employing Statistical Methods











Program Official:

Peter J. Kowalski, MPH, CIH

Lead, Exposure Investigations Team

Science Support Branch

Division of Community Health Investigations

Agency for Toxic Substances and Disease Registry

4770 Buford Hwy NE, MS F59
Atlanta, GA 30341

Phone: 770-488-0776

Fax: 770-488-1542

Email: PKowalski@cdc.gov


Date: November 18, 2015





Part B. Collections of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods



The respondent universe and statistical methods for determining sample size are not a factor since the Agency for Toxic Substances and Disease Registry (ATSDR) does not use the results from exposure investigations (EIs), typically based on convenience sampling, to generalize or estimate the total exposed population. ATSDR does, however, need to know the potential size of the population to be sampled and since many EIs are location-based, we estimate the potential respondent universe based on street maps and census information.

B.2. Procedures for the Collection of Information



A survey of questions (based on the list in Attachment 4) is administered either in-person or over the phone. Several procedures may be used to sign up participants for convenience sampling, such as newsletters or recruitment posters. The principal investigator, or team, is identified by name along with qualifications or experience in conducting similar EIs. The questions listed in Attachment 4 are not required to be used, but are used as the basis for building an appropriate list of questions for the EI.

The EI team may also recruit participants at public availability meetings. Based on ATSDR’s experience recruiting and interviewing subjects for investigations, the response rate is close to 100%.

Quality Control Procedures

Prior to the interviews, the EI team is trained on the site-specific questions to be asked (e.g., the purpose of each question, how to capture answers, place for comments, etc.). Once developed, the list of questions is not changed unless the team discovers the need for an important addition. If additional questions are considered to be needed, the questions will be submitted to OMB for approval prior to administration and the participants will be re-interviewed. The list of questions and individual’s answers are stored in a secure database or locked filing cabinet.

Each participant is given information regarding the name of the EI, a telephone number to answer questions, and the address of the ATSDR website where they can find more information about the EI, if applicable. Each participant receives a copy of their personal results

B.3. Methods to Maximize Response Rates and Deal with No Response



An EI is usually requested by officials of a state health agency, a county health department, the Environmental Protection Agency (EPA), the general public and ATSDR staff in order to address community health concerns. To evaluate potential exposure, ATSDR is generally looking for participants that are the most highly exposed. We identify them through a location or an activity that they engage in. If activity-based (e.g., fishing, working, etc.) we may need to contact people to encourage their participation.

Ours is not a response rate as the term is typically used in research or evaluation to show the legitimacy of a study. We invite people to participate in our sampling based on who would likely be most exposed. Generally, we look for 10-100 participants in the most exposed category. Getting participants using convenience sampling has not been a problem since communities have been requesting the sampling before we arrive. Since our goal for participation is a wide range and participants usually request the sampling, we usually have a response rate of more than 70 percent. However, because we are interpreting each individual’s response to his or her specific exposure and not attempting to determine population level exposures, we can interpret results without 100% participation.

B.4. Test of Procedures or Methods to be Undertaken



The EI team will use questions consistent with or similar to those in Attachment 4 to generate EI-specific lists of questions when conducting EIs. The questions will be submitted to OMB for review in each EI Generic Information Collection (GenIC) submission.

ATSDR has completed over 190 EIs over approximately 10 years. Therefore, the procedures and methods are well-tested and based on the Agency’s long experience working in communities with environmental contamination.



B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data



Statistical calculations are not used to determine participation in EIs using convenience sampling. Rather, all the community residents with the greatest likelihood of exposure are asked to participate.



List of Attachments



Attachment 1. Authorizing Legislation -CERCLA

Attachment 2. 60-day Federal Register Notice

Attachment 3: Map of EPA and ATSDR Regions

Attachment 4: Chemical Exposure Question Bank

Attachment 5: Example Consent Form

Attachment 6. Program Research Determination





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