Post Your Views on the Substance of the NPRM

Traditionally with the close of the public comment period, regulators close the curtain, perform their analyses and announce their decision in a final rule with no input from the public. The aforementioned approach is understandable in that a rulemaking must have a definite beginning and end.

However the public need not be shut out of the process completely. It is for this reason that CRE has  developed the Interactive Public Docket. Wikipedia 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 Obama Administration‘s Transparency and Open Government initiative seeks to address some of the same issues public participation goals as the IPDs.”

The  use of an IPD:

(1)  allows the public to offer comments on the comments submitted by other participants in the rulemaking all of which are accessible by 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 credentialled third parties  in an extremely public forum.

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.

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 Veterans Administration, 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 Technology  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 is forthcoming and will be published in the forthcoming comments of 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.]

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.

Jim Tozzi with the Center for Regulatory Effectiveness is the Program Manager for this Interactive Public Docket.

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.

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