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    Date: 2022-11-08 10:55:14.306659

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    Date: 2022-11-09 08:14:33.520562

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    Date: 2022-11-09 11:44:15.426970

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FDA: Regulation, Technical Specifications, and Registration of Alcohol Breath Analyzer (ABA)

Requested from DOH by J. Del Rosario at 10:55 AM on Nov 08, 2022.
Purpose: Second opinion and confirmation of initial opinion from the FDA.
Date of Coverage: 01/01/2013 - 11/08/2022
Tracking no: #DOH-832697333022

Del Rosario 10:55 AM, Nov 08, 2022 

Hi! I would like to request for information for the following:

1. Are Alcohol Breath Analyzers (ABA) currently regulated by the FDA?

2. Are there any issuances or circulars, by the DOH or FDA regarding the IRR of RA 10586 “An Act Penalizing Persons Driving Under The Influence Of Alcohol, Dangerous Drugs, And Similar Substances, And For Other Purposes”?

3. Are Alcohol Breath Analyzers (ABA) currently registrable under the FDA?

Upon consultation with the FDA, Alcohol Breath Analyzers are currently not regulated by the FDA and is not considered a medical device or In Vitro Diagnostic Device.

Receiving Officer 08:14 AM, Nov 09, 2022 

November 9, 2022

Dear Jullian Raphael,

Thank you for your request dated Nov 08, 2022 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for FDA: Regulation, Technical Specifications, and Registration of Alcohol Breath Analyzer (ABA).

We received your request on Nov 08, 2022 and will respond on or before Nov 29, 2022 10:55:14 AM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://foipmo07022020123059-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC04MzI2OTczMzMwMjIM, for request with ticket number #DOH-832697333022.

Thank you.

Respectfully,

FOI Receiving Officer
FOI Officer


Dear Jullian Raphael,

Greetings!


Thank you for your request dated {2} under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.


While our aim is to provide information whenever possible, in this instance this Office does not have the information you have requested. However, you may wish to contact LAND TRANSPORTATION OFFICE- LAW ENFORCEMENT SERVICE- Anti Drug and Drunk Enforcement Unit (ADDEU) at Tel. No. : (02) 8922-9061 Local 291 or resubmit your request addressed to the correct agency on the eFOI portal at : https://www.foi.gov.ph/requests?agency=LTO


Your right to request a review

If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to the Central Appeals and Review Committee, at foi@doh.gov.ph. Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request.


If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011).

Thank you.

Respectfully,
FOI Officer

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