Attach_9

Early Hearing Detection and Intervention

Hearing Screening and Follow-up Survey

Reinstatement with Change

Marcus Gaffney

Project Officer

1600 Clifton Rd. MS E-88

Atlanta, GA 30333

(404) 498-3031

[email protected]

Attachment 9:

Research Determination

-----Original Message-----
From: Milton, Micah
Sent: Friday, March 10, 2006 4:17 PM
To: Gaffney, Marcus
Cc: NCBDDD Human Subjects Review; Campbell, Vince
Subject: Research Determination #9646 EARLY HEARING DETECTION AND INTERVENTION HEARING SCREENING AND FOLLOW-UP SURVEY

Dear Marcus:

The proposed project titled " EARLY HEARING DETECTION AND INTERVENTION HEARING SCREENING AND FOLLOW-UP SURVEY" was reviewed by the NCBDDD Human Subjects Contact and determined to be:

PUBLIC HEALTH PRACTICE

The scope of all activities should be limited to collection of aggregate data from states to improve the program's ability to provide estimates across the different states to interested parties and MUST NOT INVOLVE RESEARCH.

Since the project is not considered to be research, no further action is required by CDC for human subjects protections in accordance with federal regulation for the protection of human subjects in research.

If this project involves CDC funds, contact Sheryl Heard of NCBDDD RMO for further guidance.

RE-REVIEW REQUIRED: Upon completion of a detailed project plan by the awardee, submit that plan to the NCBDDD Human Subjects Contact for re-review to ensure the scope of the activities are still considered Public Health Practice.

Save this email as documentation of the original determination.

Signed,

Micah Milton

NCBDDD Human Subjects Contact

This 0.684 form was approved by Center(MICAH MILTON) and will be sent to CDC Human Research Protection Office (HRPO).

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