|February 18, 2014|
Previously published on February 14, 2014
The U.S. Food and Drug Administration (FDA) on February 10, 2014, published its Guidance for Industry on the receipt date for regulatory submissions. The Guidance applies to submissions that are in electronic or paper format, including submissions that are a hybrid of both.
The FDA states that the receipt date for a premarket application, such as an Abbreviated New Drug Application (ANDA), "is the date on which an application is deemed to have arrived at FDA." For electronic submissions that arrive via the electronic submission gateway (ESG) on a weekday, the submission "is deemed to have arrived at FDA on the date and time corresponding to the Official Center Acknowledgement (second acknowledgement)," while a submission that arrives on a weekend, federal holiday or another day on which the FDA is closed, "is deemed to have arrived at FDA on the next day when that office is open for business." For submissions of physical media, the submission "is deemed to have arrived at FDA on the date on which it arrived physically at the appropriate receiving unit, while open for business, for the FDA center that will review the submission." However, when submissions, such as reports of adverse drug experiences, are required within a certain number of calendar days, the information is "deemed to have arrived at FDA on the date and time corresponding to the Official Center Acknowledgment (second acknowledgement)" regardless of whether the date falls on a weekday, weekend or holiday.
An applicant should be aware, however, that the "FDA considers a technically deficient electronic submission to be not received (i.e., not present at FDA and not under review) until all technical deficiencies are resolved." As such, the receipt date of an electronic submission is not permanently established until the submission is deemed technically acceptable. The official receipt date becomes the date that a technically acceptable resubmission arrives at the designated receiving unit, not the date that the resubmission passes technical validation.
It is important to note the distinction between the receipt date and the submission date, which can affect the determination of whether an ANDA earns 180-day exclusivity over other ANDAs. The Generic Drug User Fee Amendments (GDUFA) state that submissions, such as ANDAs and their amendments and supplements, "are deemed to be submitted to FDA on the day when transmission to the ESG is completed." The Guidance notes that "there may be a short lag time between the completion of the submission of an ANDA to the ESG and completion of the transmission from the ESG to the appropriate Center and production of the corresponding Official Center Acknowledgment," which would make the receipt date different from the submission date. For instance, if an ANDA is transmitted to the ESG at 11:55 p.m. EST on April 20 but does not completely arrive at the Center for Drug Evaluation and Research until 12:01 a.m. EST the next day, the receipt date is April 21 but the submission date is April 20 (i.e., the date the transmission to the ESG was completed). Conversely, if transmission of an ANDA to ESG is not completed until 12:05 a.m. EST on April 21, then the receipt date and the submission date are both April 21. This, and other helpful examples, are provided in an Appendix to this Guidance.