8119 Form

8119 Form: What You Should Know

FDA to require submission of electronic requests and comments in all of its regulatory activities; and 3. FDA may direct that other regulatory activities be conducted using the use of electronic submission of requests and comments.  (1) FDA may consider requests and comments regarding a regulatory action whether FDA actually took the regulatory action, with the understanding that responses to request and comments are confidential and FDA is not required to disclose them. (1) For purposes of this rule, FDA must accept requests and comments about regulatory actions within 20 business days of their receipt as submitted by the submitting party. (2) Information collected through electronic submission of requests and comments shall be used in accordance with the disclosure requirements set forth in Section 8.7(b)(2)(i)(A) of this chapter. (3) The agency's decision about whether to accept a request or comment is not dependent upon any review of the content of a request or comment by a Government employee or contractor. (4) An agency that believes that it is appropriate to require an additional step in obtaining regulatory approval to conduct a regulatory activity using an electronic form submitted by the submitting party may request that a Federal judge issue an injunction against the use of electronic form(s) for the regulatory activity. (5) A government employee or contractor who provides data from an electronic form or from a data retrieval system used to maintain this form in the agency should use caution in using that data to conduct any other activity. (6) An agency is not required to accept a request or comment from an interested party for a regulatory action or activity if such a submission would pose an unreasonable risk of disclosing its deliberations and decisions. FACT SHEET FOR FEDERAL EMPLOYEE REASONABLE RISK. The Agency has to make the case for reasonable risk of disclosure of its deliberations and decisions in response to every email or other communication in its electronic records relating to the Agency's regulation activity.  There is no such thing as unreasonable risk of disclosure.   It's a huge win for those that have been in contact with us over the years, but still a huge hit against me for submitting comments against FDA regulations to the EPA, USDA and EPA's proposed change to the Clean Air Act I had a good run in the EPA, but there are always ups and downs in your career I thought “I've got to quit” before.

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