OMB, through its Office of Information and Regulatory Affairs, is vested with the responsibility to review regulations before they are disseminated as a final rule. During its more than forty years of existence it has done an excellent job and is the pinnacle of “neutral competence”.
However, OMB is located within the Executive Office of the President and often its review is “assisted” by personnel less visible than the career officials of OMB(OIRA). A possible case in point is the recent handling of proposed rule dealing with Over- the- Counter Hearing Aids authored by the FDA.
CRE has been a constant and forceful reviewer of the proposed regulation and has written several papers describing its shortcomings [PDF], including its violation of a long list of statutes and Executive Orders.
CRE was scheduled to meet with OMB on Wednesday August 10. On the preceding Saturday, August 6, OIRA notified CRE that:
- It was cancelling the CRE meeting.
- It was cancelling the meetings of other parties which had been given a date to meet with OMB.
- and in addition OMB even eliminated from its website the copies of papers submitted by other parties who had already met with OIRA prior to August 6–undoubtedly a first in the history of OMB review.
Central to the CRE presentation was an in-depth review of the findings of three internationally credentialed experts which was included in the papers submitted to OMB. Two of the aforementioned parties had not filed comments in the proceeding. We know of no other instance in recent memory where OMB has muted the position of internationally recognized institutions as set forth in the aforementioned PDF.
As stated above this transaction is a possible example of “assists” from other parties which have been part of the review process for decades and which we fully support, including comments to OMB as part of its Executive Order 12866 review of regulations. We understand fully the plurality of the regulatory review process but to make the final decision on a rule without giving affected parties the opportunity to express their views pursuant to a previously agreed date and time is more than extraordinary.
It should be noted that OMB concluded its review of the proposed FDA rule in which it cleared the rule with the following phase: “consistent with change”. In theory substantive changes could be forthcoming which address the concerns of those members of the public denied access to OMB. Arguably OMB might have fully understood the significance of the three credentialled parties and decided that no further discussion was needed.
We expect the final rule to be issued shortly; in any event OMB’s actions as delineated above are rare indeed.
NB Had OMB continued its past record of complete transparency, the type of information set forth in the following link would be available for public review as a result of the disclosure of the comments submitted to OMB during its review of the OTC Hearing Aid rulemaking:
View Completed EO 12866 Meeting
We cannot conceive any argument in support of denying public access to such information.
The above post available on this link: https://www.thecre.com/forum8/?p=7274
