Change Request Justification Memo

0910-0815 change request justification memo Aug 2016.docx

National Panel of Tobacco Consumer Studies

Change Request Justification Memo

OMB: 0910-0815

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National Panel of Tobacco Consumer Studies (OMB Control Number 0910-0815)



Change Request (83-C)



January 22, 2021



The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-C) to incorporate several non-substantive changes to the questionnaires.



Overview of the Change Request for OMB Control No. 0910-0815

Based on final review, programming, and testing of the questionnaires, several non-substantive changes are needed in advance of the initial implementation phase of the panel. No changes to other study materials are requested. Additionally, there is no change in the burden estimate included in the original clearance request. All changes described in this memorandum and reflected in the attachments have been approved by the Institutional Review Board at RTI International (RTI).

Questionnaire Changes

Questionnaire changes are focused on assuring the correct question wording and routing for each item, ensuring consistency across panel questionnaires, and improving alignment with the National Health Interview Survey (NHIS). In addition, several typographical errors and fonts have also been corrected in the questionnaire specifications. Minor changes in several questionnaire instructions are designed to improve the readability of mail survey responses during optical scanning and simplify administration of the item by an interviewer.

Att #

Type

Attachment Title

Tracked Versions

1

Revised

Questionnaire English


2

Revised

Questionnaire Spanish


Table 1 provides a summary of the non-substantive changes that have been made to four panel questionnaires: Mail Screener (Attachments 1-1, 2-1), Field Screener (Attachments 1-2, 2-2), Enrollment Survey (Attachments 1-3, 2-3), and Baseline Survey (1-4, 2-4). This memo also includes tracked and clean versions of the English- and Spanish-language questionnaires that have been modified.



Table 1. Summary of Changes to Panel Questionnaires

Questionnaire

Item Number

Page Number*

Addition

Deletion

Edit

Change and Rationale

Prior Approval Given by OMB

Mail Screener

(Attachments 1-1, 2-1)

Start Here”

2



X

Inserted instruction to complete form using blue or black ink

RATIONALE: Improve scanning performance.

Base item approved by OMB on 6/8/16

Field Screening Instrument

(Attachments 1-2, 2-2)

SCD1

10



X

Inserted skip instruction for “no” response; underlined ”cigarettes” for emphasis

RATIONALE: Align with NHIS screening of cigarette users; ensure consistency with other items in screener.

Base item approved by OMB on 6/8/16

SCD3

10 (11)



X

Inserted “regular” in on-screen banner and question text

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

Enrollment Survey (Attachments 1-3, 2-3)

ESA3

16 (17)



X

Inserted skip instruction for “no” response; underlined “cigarettes” for emphasis

RATIONALE: Align with NHIS screening of cigarette users; ensure consistency with other items in questionnaire.

Base item approved by OMB on 6/8/16

ESA4

16 (17)



X

Underlined “cigarettes” for emphasis

RATIONALE: Ensure consistency with other items in questionnaire.

Base item approved by OMB on 6/8/16

ESB9

21 (23)



X

Revised wording of interviewer instruction; created separate interviewer instruction screen at ESB9CHK

RATIONALE: Improve item administration for interviewers.

Base item approved by OMB on 6/8/16

CHECK BOX 4

21 (23)



X

Updated skip logic

RATIONALE: Update programming instructions to improve exit script transition for potential tablet candidates

Base item approved by OMB on 6/8/16

Baseline Survey (Attachments 1-4, 2-4)

PBB1

39 (43)



X

Moved location of “a day” to end of question

RATIONALE: Align with wording of other items in baseline questionnaire and NHIS.

Base item approved by OMB on 6/8/16

PBB2

40 (43)



X

Removed date fill text, “that is, since [FILL DATE]”

RATIONALE: Align with NHIS.

Base item approved by OMB on 6/8/16

PBB3

40 (43)



X

Inserted “the” and moved location and underlined “cigarettes” in question text

RATIONALE: Align with parallel items on cigar and smokeless tobacco in baseline questionnaire.

Base item approved by OMB on 6/8/16

PBB7

42 (45)



X

Added “regular” to question wording and on-screen banner

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB8

42 (45)



X

Inserted “the” and moved location of “a day” to end of question; also added “regular” to question wording

RATIONALE: Align with wording of other items in baseline questionnaire and NHIS, and for consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB9

43 (45)



X

Added “regular” to question wording; also removed date fill text, “that is, since [FILL DATE]”

RATIONALE: Align with NHIS, and for consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB10

43 (46)



X

Added “the” and “regular” to question wording

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB10a

43 (46)



X

Added “regular” to question wording

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB11

43 (46)



X

Added “regular” to question wording; also included “cigarillos, or little filtered cigars” in question text

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires, and wording of other cigar items in baseline questionnaire.

Base item approved by OMB on 6/8/16

CHECK BOX 5

44 (47)



X

Updated skip pattern

RATIONALE: Ensure proper routing for new item PBB12a

Base item approved by OMB on 6/8/16

PBB12a

44 (47)

X



Inserted new item on number of times panel member now uses smokeless tobacco a day

RATIONALE: Consistency with parallel intensity question for cigarettes and cigars.

Item not previously approved

PBB13

44 (47)



X

Removed date fill text, “that is, since [FILL DATE]”

RATIONALE: Align with NHIS.

Base item approved by OMB on 6/8/16

PBB14

45 (47)



X

Inserted “the” and changed item from a categorical to open-ended response; also revised skip patterns to ensure item only asked of “some days” smokeless users

RATIONALE: Consistency with parallel cigarette and cigar items.

Base item approved by OMB on 6/8/16

PBB17

46 (48)


X


Deleted item on number of containers of smokeless tobacco used per week; replaced with PBB12a (number of times panel member now uses smokeless tobacco a day)

RATIONALE: Consistency with parallel intensity question for cigarettes and cigars.

Base item approved by OMB on 6/8/16

PBB20I2

47



X

Changed “some day” to “some days” in question text

RATIONALE: Correct typographical error in English questionnaire.

Base item approved by OMB on 6/8/16

PBB20I3

47 (50)



X

Removed date fill text, “that is, since [FILL DATE]”; also updated question wording to “did you use e-cigarettes”

RATIONALE: Align with NHIS; correct typographical error.

Base item approved by OMB on 6/8/16

PBB21

47 (50)



X

Added “regular” to question wording

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

PBB22

48 (50)



X

Added “regular” to question wording

RATIONALE: Consistency with cigar introduction, screener, and enrollment questionnaires.

Base item approved by OMB on 6/8/16

*Page numbers in parentheses show the location of the changes in the corresponding Spanish questionnaires.

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