Human health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS) at Pease International Tradeport, Portsmouth, NH
(OMB Control No. 0923-0061, exp. date 08/31/2022)
Justification/Brief Explanation for Change Request
The Request: This is a non-material/non-substantive change request for “Human health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS) at Pease International Tradeport, Portsmouth, NH)“ (OMB Control No. 0923-0061; expiration date August 31, 2022). This change request reflects modifications to the currently approved information collection request (ICR) and incorporates the need to practice social distancing to the extent possible, such as changing from in-person contact to virtual meetings and telephone interviews. Where necessary, ATSDR has modified its scripts and forms to let the public know of the COVID-19 precautions that the agency is implementing.
The program is requesting an expedited review to restart the Pease study as soon as possible. The shutdown of the study over the last several months has likely impacted community interest in the study. The longer study recruitment is delayed, the harder it will be to achieve reasonable study participation by the community. Moreover, if the study restart is delayed much further, it will begin to interfere with the holiday season, adding to the difficulty of recruitment. Restarting the study by the end of September at the latest would be optimal for recruitment.
Background: ATSDR and contractors suspended the Pease Study activities when the COVID-19 pandemic began in the United States. Restarting Pease Study will require that precautions be put in place to ensure that staff, contractors, and members of the public are protected from COVID-19. This plan is based on interim CDC guidance for non-COVID-19 public health activities that require face-to-face interaction during the COVID-19 pandemic and will be used to outline practices for conducting PFAS EA activities https://www.cdc.gov/coronavirus/2019-ncov/hcp/non-covid-19-client-interaction.html.
Since that time, the program has developed the Pease restart plan in collaboration with and reviewed and approved by CDC Leadership and the CDC Emergency Operation Center (EOC) Joint Information Center (JIC).
Summary of the Restart Plan: Appendix G, the Pease Restart Plan, in Attachment 14, the Manual of Procedures, has been included and outlines the additional procedures that will be implemented during recruitment, field work, and community meetings to ensure that the Pease study activities are completed in compliance with state, local, and CDC requirements.
The activities that will be modified include:
Holding virtual community assistance panel (CAP) meetings on a quarterly basis. In addition, in order to improve study participation recruitment, meetings of small groups (e.g., “lunch and learn”) may be held at businesses and colleges/universities at the Pease Tradeport, and at community organizations in Portsmouth, as needed. Media and community outreach activities will be held online or structured to ensure less than 10 participants at a time in accordance with applicable local, state and CDC guidelines in place at the time of the events.
Asking participants about their and their family’s health/COVID-19-status during their appointment reminder phone call and prior to beginning the testing process.
Monitoring the temperature of Pease study contractor staff twice daily and taking participant’s temperatures prior to entering the Pease study office.
Administering the questionnaire over the phone instead of at the Pease study office to reduce the participant’s time in the Pease study office: consent form administration and collection of biological samples will occur at the Pease study office.
Ensure proper use of PPE when participants and examiners are not able to be socially distance when conducting neurobehavioral tests and body measurements
Below is the change request cross-walk table. Attached please find the revised protocol and modified forms and appendices. The overall number of respondents and requested burden hours remain the same.
Attachment |
Revisions |
Justification |
P_Att14 PeaseManualofProcedures_20200729 |
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P_Att09a_ApptReminderCard_20200729_trackchanges |
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Pease Study Protocol 20191122_clean_COVID insert 20200622 |
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P_Att11_ApptTrackingForm_20200729 |
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P_Att10_AppointmentReminderTelScript_20200729_trackchanges |
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P_Att07c WaveTwoorWaveThreeElgbltyScreeningScript_20200729 |
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P_Att06c WaveOneElgbltyScreeningScript_20200729_trackchanges |
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P_Att09c_StudyFactSheet_20200729_trackchanges |
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P_Att06_WaveOne_NHDHHSInvitationLttrsStudyRollout_20200729_trackchanges
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P_Att09b_InformedConsentPacket_20200729_trackchanges |
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Meredith Shoemaker |
| File Modified | 0000-00-00 |
| File Created | 2021-01-13 |