Research Determination

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Lindley, Megan C. (CDC/OID/NCIRD)
Hynes, Ansley (CDC/OID/NCIRD)
Khan, Munmun (CDC/OID/NCIRD)
RE: Review Required_0920-0004
Tuesday, April 25, 2017 12:44:34 PM
0920-0004_Supporting Statement A_Revision 2017_Under review_3272017_MCL.docx
0920-0004_Supporting Statement B_Revision 2017_Under review_03272017_MCL.docx

Hi Ansley –
Apologies for the delay; your e-mail this morning inspired me to finally review this. I read supporting
statements A and B and didn’t see any issues – none of the changes described would alter the
determination that activities under this package are public health surveillance and not research. Please let
me know if you think I also need to review the other attachments in the submission.
I did notice a few minor typos that I marked in the attached copies of the supporting statements in case
that is helpful.
Thanks,
-Megan
Megan C. Lindley, MPH
Human Subjects Advisor (Detailed 1/8-5/7/17)
Office of Science and Integrated Programs
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
cvx9@cdc.gov
404-639-8717

From: Hynes, Ansley (CDC/OID/NCIRD)
Sent: Monday, March 27, 2017 6:02 PM
To: Duff, Roderick W. (CDC/OID/NCIRD) ; Lindley, Megan C. (CDC/OID/NCIRD)

Cc: Posner, Sam (CDC/OID/NCIRD)
Subject: FW: Review Required_0920-0004
Megan and Roderick,
I am in the process of revising an approved OMB package. Attached are the supporting statements (
in particular A) that includes a human subjects and privacy act determination.
I have also attached a file that contains the collection instruments approved under this package.
Please let me know if you want to touch base briefly to review.
Thanks, Ansley
From: Hynes, Ansley (CDC/OID/NCIRD)
Sent: Monday, March 27, 2017 5:54 PM
To: Blanton, Lenee (CDC/OID/NCIRD) ; Prill, Mila M. (CDC/OID/NCIRD)
; Roberts, Virginia (CDC/OID/NCEZID) ; Kisselburgh, Hannah
(CDC/OID/NCEZID) (CTR) ; Binder, Alison (CDC/OID/NCIRD) (CTR)

; Chakravarthy, Sathya (CDC/OID/NCEZID) (CTR)
Cc: Tokars, Jerome (Jerry) (CDC/OID/NCIRD) ; Bell, David M. MD (CDC/OID/NCIRD)
; Payne, Daniel C. (CDC/OID/NCIRD)
Subject: Review Required_0920-0004

Dear All,
You have submitted changes to OMB 0920-0004 on behalf of your program.
Please review the submission in its entirety ( supporting statement A, B and the disease summary)
and make any corrections, updates, changes using tracked changes or please confirm that all
required information has been included and no further edits are required.
These are due by March 31st.

Please let me know if you have any questions or concerns.
Thanks, Ansley

Ansley Hynes
NCIRD, CDC
Office: 404.718.4520
Mobile: 404.360.5429