Can the OMB send the deeming regulations back to the FDA for clarification without a public notice it is doing so ?
No....or they aren't supposed to.....
Office of Information and Regulatory Affairs (OIRA) Q&A’s
What is a "prompt" letter?
Answer: "Prompt" letters are a mechanism created in 2001 that OIRA uses to pro-actively suggest issues that agencies might address. Prompt letters may suggest areas where further regulation may be needed to fill gaps in current environmental, health or safety protections; or they could be used to suggest areas where a current regulation is no longer needed and should be modified or rescinded. To date, OIRA has issued 12 prompt letters on subjects ranging from the transfat content of foods to pollution from diesel engines. You can find the various prompt letters issued from OIRA at:
http://www.reginfo.gov/public/jsp/EO/promptLetters.jsp.
(for example of prompts - click on that link above - reginfo..... )
What are OIRA’s disclosure procedures?
Answer: Consistent with E.O. 12866, OIRA provides extensive information about its work related to regulatory review in OIRA’s public docket room and on its website,
http://edit.whitehouse.gov/omb/inforeg_regmatters/.
The information includes reports, "return" and "prompt" letters, speeches and testimony by the OIRA Administrator, and lists and statistics regarding regulatory review. For example, OIRA makes publicly available all substantive communications with any party outside the Executive Branch concerning regulations under review. If the OIRA Administrator or his designee meets with outside parties regarding a rule under review, the subject, date, and participants of the meeting are disclosed on the OIRA website. Any material received from outside parties on rules under review is placed in the public docket and noted on the OIRA website. Finally, after a rule is published, OIRA will make publicly available certain documents exchanged between OIRA and the rulemaking agency during the review period.