Change Request Memo_18OCT2024

Request for Non-substantive Change

Information Collection Request, Respiratory Protective Devices--42 CFR 84--Regulation

#0920-0109– Expiration date: 1/31/2027

Justification for Non-substantive change:

NIOSH is requesting a non-substantive change request for 0920-0109. The PRA package was previously approved with our test participants being compensated through Gift Cards or volunteers. NIOSH awarded a contract to a vendor (Napakiak Ventures, LLC) to manage various tasks such as recruiting, prescreening, selecting, scheduling in coordination with NPPTL, and compensating human participants for expenses they may incur due to their participation in respirator evaluations for the NIOSH respirator approval program and other PPE evaluation activities.

Existing documents being updated:

Information Collection Request, Respiratory Protective Devices – 42 CFR 84—Regulation has been updated to reflect the changes described below. The burden hours and costs will not be affected by these proposed changes.

Changes to Supporting Statement A:

1. Section 9, Explanation of Any Payment or Gift to Respondents – We removed the reference to gift cards and added the contractor information and duties.

2. Section 10, Assurance of Confidentiality Provided to Respondents – Added the contractors data collection responsibilities along with how in information would be transmitted via a CDC approved mechanism.

Change to the Test Participant Information Sheet:

1. Fields necessary for electronic payment were added to the Test Participant Information Sheet.

Change to the Informed Consent Form:

1. Bullet 10 was updated to reflect that participants will be compensated.

Attachments:

1. Approved 0920-0109 PRA Package Statement A (File name: SupportingStatement_A_23October)

2. Modified 0920-0109 Statement A Tracked (File name: SupportingStatement_A_24September_17_Tracked)

3. Modified 0920-0109 Statement A Clean (File name: SupportingStatement_A_24September_17_Clean-2(1))

4. Modified Attachment 8 Test Participant Information Sheet Tracked (File name: Atch_8_InformationSheet(Tracked))

5. Modified Attachment 8 Test Participant Information Sheet Clean (File name: Atch_8_InformationSheet(Clean))

6. Modified Attachment 9 Test Participant Informed Consent Form Tracked (File name: Atch_9_InformedConsentForm (Tracked))

7. Modified Attachment 9 Test Participant Informed Consent Form Clean (File name: Atch_9_InformedConsentForm (Clean))