Instructions For Completing Form Fda 3674 (Page 2 of 2) in pdf

Instructions For Completing Form Fda 3674 Page 2

10. National Clinical Trial (NCT) Numbers – If you have checked Box C in number 9 (Certification), provide

the NCT Number obtained from for each clinical trial that is an “applicable clinical trial”

and that is included, relied upon, or otherwise referred to, in the application/submission which the certification

accompanies. Type only the number, as the term “NCT” will be added automatically before number. Include

any and all NCT numbers that, as of the date the certification is signed, have been assigned to the clinical

trials included, relied upon, or otherwise referred to, in the application/submission which this certification

accompanies. Multiple NCT numbers may be required for a particular certification, depending on the number

of “applicable clinical trials” included, relied upon, or otherwise referred to, in the application/submission

which the certification accompanies. Leave this field blank if you have checked Box 9.C but, at the time the

certification is completed, you have not yet received any NCT number(s) for the “applicable clinical trial(s)”

included, relied upon, or otherwise referred to in the application/ submission. Use a continuation page only if

you have filled in all available spaces.

11. Name and Title of Person Who Signed in number 11 – Include the name and title of the person who

is signing the certification. If the person signing the certification is not the sponsor/applicant/submitter of the

application/submission, he or she must be an authorized representative of the sponsor/applicant/submitter.

12 & 13. Provide the full address, telephone and fax numbers of the person who is identified in number 11 and

signs the certification in number 15.

14. Provide the date the certification is signed. This date may be different from the date provided in number 2.

15. Signature of Sponsor/Applicant/Submitter or an Authorized Representative – The person signing the

certification must sign in this field.

FORM FDA 3674 SUPPLEMENT (2/13) – FORM INSTRUCTIONS

Page 2 of 2

Instructions For Completing Form Fda 3674 Page 2