Special Temporary Authority application - Applicant Name
Name of Applicant:
Teva Branded Pharmaceutical Products R&D, Inc.
Special Temporary Authority application - Best Contact
First Name:
Samir
Last Name:
Shah
Phone Number:
610-727-6706
Title:
Senior Manager
Special Temporary Authority application - Certification
Applicant certification
Neither the applicant nor any other party to the application is subject to a denial of Federal benefits that includes FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. Section 862, because of a conviction for possession or distribution of a controlled substance. The applicant hereby waives any claim to the use of any particular frequency or electromagnetic spectrum as against the regulatory power of the United States because of the prvious use of the same, whether by license or otherwise, and requests authorization in accordance with this application. (See Section 304 of the Communications Act of 1934, as amended.) The applicant acknowledges that all statements made in this application and attached exhibits are considered material representations, and that all the exhibits part hereof and are incorporated herein as if set out in full in this application; undersigned certifies that all statements in this application are true, complete and correct to the best of his/her knowledge and belief and are made in good faith. Applicant certifies that construction of the station would NOT be an action which is likely to have a significant environmental effect. See the Commission's Rules, 47 CFR1.1301-1.1319.
Date:
2017-01-02 00:00:00.0
Signature of Applicant (Authorized person filing form):
Samir A. Shah, PhD
Title of Applicant (if any):
Senior Manager, Regulatory Affairs
Special Temporary Authority application - Explanation
Please explain in the area below why an STA is necessary:
Bluetooth transmitter within inhaler to transfer usage information to mobile app for clinical study More inhalers (2,200) are needed for this clinical study. Certification is being applied for. However, certification would require FCC labeling. In order to maintain the same appearance for this clinical study, these inhalers cannot be labeled differently from the previous units, which were also imported under an STA and therefore not labeled. It is for this reason, to avoid having inconsistent labeling for units used in the clinical study, that an STA is being requested.
Special Temporary Authority application - Information
Callsign:
WK9XLC
Class of Station:
MO
Nature of Service:
Experimental
Special Temporary Authority application - Manufacturer
Equipment 1 Experimental
Yes
Equipment 1 Manufacturer
Teva Pharmaceutical Industries LTD
Equipment 1 Model Number
N/A
Equipment 1 No. Of Units
4000
Special Temporary Authority application - Purpose of Operation
Please explain the purpose of operation:
Electronics are being used to capture inhaler usage information for use in the clinical study. The study is being conducted under Food and Drug Administration Investigational New Drug Application 104532.
Special Temporary Authority application - Requested Period of Operation