Change Request Memo

Change Request Memo.docx

Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

Change Request Memo

OMB: 0910-0753

Document [docx]
Download: docx | pdf

U.S Food and Drug Administration

Evaluation of the FDA's General Market Youth Tobacco Prevention Campaigns

(OMB Control No. 0910-0753)


The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to update materials related to the Public Education on Teen Tobacco (ExPECTT) due to changes requested by FDA’s IRB. The FDA IRB will no longer provide IRB oversight for research in which FDA staff are not directly engaged. FDA has updated the following language to clarify that the FDA will not have direct involvement with human subjects to adhere to the new FDA IRB policy.

Track Changed Documents


2

ExPECTT II Youth Instrument_2nd follow-up

  • Remove the RIHSC number

  • Updated OMB expiration date

6_E2a

Routing for Consent ExPECTT

  • Updated OMB expiration date

6_E2b3

Parent Permission ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

6_E2c2

Youth Assent under 18 ExPECTT II

  • Remove the RIHSC number

  • Updated OMB expiration date

6_E2d

Youth Consent 18 and up ExPECTT II

  • Remove the RIHSC number

  • Updated OMB expiration date

08_E2b

Study Description ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

10_E2d

Lead Letter ExPECTT II 1st and 2nd FU

  • Remove the RIHSC number

  • Updated OMB expiration date

11_E2b

Q&A about ExPECTT II FU 1-3

  • Remove the RIHSC number

  • Updated OMB expiration date

12_E2b

Telephone Verification Survey ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

13_E2a

Notifications ExPECTT

  • Remove the RIHSC number

  • Updated OMB expiration date

15_E1

Panel Maintenance ExPECTT

  • Updated OMB expiration date

18_E2d

Survey Invitation Email ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

19_E2e

Email Reminder 1 ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

20_E2d

Email Reminder 2 ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

21_E2d

Email Reminder 3 ExPECTT II FU 2-3

  • Remove the RIHSC number

  • Updated OMB expiration date

22

Reminder Letter ExPECTT II FU 1-3

  • Remove the RIHSC number

  • Updated OMB expiration date




File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorLacorte, Lester (Jao)
File Modified0000-00-00
File Created2022-04-08

© 2024 OMB.report | Privacy Policy