An Interactive Public Docket for the OTC Hearing Aid Rule
01/18/2022 Update

Public participation in the rulemaking process need not end with the close of the public comment period for a proposed rule. It is understood that any process must have a beginning and end date and consequently regulators will at a given date cease contact with the public.

However, this does not mean that the public must cease contact with regulators if such contact is done in a public matter. In recognition of this insight the Center for Regulatory Effectiveness championed the concept of an Interactive Public Docket as described on Wikipedia, which states:

“The Interactive Public Docket (IPD) is an eRulemaking tool created and managed by non governmental organizations that seek to provide the public with the capability to 1) publicly post data and other materials pertaining to federal proceedings on a continuous basis, including after the close of the Administrative Procedure Act comment period and 2) post comments on already submitted materials.

The IPD was first developed by the Center for Regulatory Effectiveness and its origins have been discussed on National Public Radio.”

The use of this IPD:

(1)  allows the public to offer comments on the comments submitted by other participants in this rulemaking  by posting them on this IPD and then submitting  the resultant link on the IPD to interested participants, including the media, Congressional staff and the regulators.

(2) provides a public forum for all participants to exchange views on key issues that they will discuss with OMB prior to the issuance of the final rule.

(3) allows stakeholders to alert the media and Congressional staff on a 24/7 time frame to the immediate and most significant activities associated with the launching of the OTC program for hearing aids.

(4) is easily accessible by regulators and provides them with a constant flow of information prepared by credentialed third parties all of which is presented in a public forum.

With respect to the FDA OTC Hearing Aid NPRM, we would appreciate responses to the following questions by posting them on this page using the “Submit a Post” mechanism to right of this post.

(1) Why did  the FDA  refuse to acknowledge receipt of the voluntary consensus standard developed by four hearing care professional associations in its Notice of Proposed Rulemaking, in that it was submitted to the FDA some three years ago?

(2) Since the FDA decided to base its recommended standard on a PSAP standard developed by a trade association why did it not base it on a PSAP standard developed by the United Nations?

(3) Another federal agency, the Department of Veterans Affairs, addressed the substance of the FDA rulemaking, and developed a standard with a different output level, why did the FDA refuse to address this standard in its NPRM?

(4) The Information Quality Act requires FDA to perform an accuracy check on the data it uses to develop a proposed rule, why did the FDA fail to comply with its own guidelines requiring compliance with the said Act?

(5) The National Technology Transfer  and Advancement Act requires the FDA to give deference to standards developed by non-federal entities. Why did the FDA refuse to allow the standard recommended by the Hearing Care Working Group to benefit from this Act.

[NB: Background information relevant to the five aforementioned questions  will be published in the forthcoming comments to be submitted to the FDA through Regulation.gov by the Center for Regulatory Effectiveness . The Center has made an informational filing applicable to all participants in this proceeding by identifying  influential studies which were not disclosed in the FDA NPRM.]

Interactive Public Dockets have been used for years in a number of rulemakings and the public is invited to participate subject to the understanding that comments  made on an IPD should go beyond a statement of an author’s preference and should be accompanied by analyses or analytical statements which substantiate the said statement. Consequently CRE reserves the right to transfer generic posts to a visible page elsewhere on this site.

You may review all comments submitted by clicking on “Home” in the left hand corner of this page. Populating the IPD is  a term applied to efforts to have substantive comments filed on the IPD; the greater the number of substantive comments  the greater the expected number of visits by federal regulators.

To submit a comment merely go to the “Submit a Post” section in the upper right hand side of this page.  No registration is required and comments may be made anonymously.


Background                                                                                                                                Center for Regulatory Effectiveness

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