Federal Register Says FDA, Others Need to Include More Information on Outside Standards

Posted 15 October 2013 By Alexander Gaffney, RF News Editor

If you're in the regulated healthcare products space-and in particular are involved with medical devices-you already know a thing or two about standards. There are of course ones that the US Food and Drug Administration (FDA) creates itself, and there are also those created and maintained by outside organizations such as the International Standards Organization (ISO) and the American National Standards Institute (ANSI).

A Matter of Access

But with this use of outside standards-also known as Incorporation by Reference-comes a notable problem, explains Jessica Bassett of the University of Pennsylvania's Program on Regulation: The public can often times only access these rules for a fee.

And while this may not be of major consequence for industry types, who can see the relatively minor costs as just the cost of doing business, it makes it difficult for the public at large, government watchdogs and academic groups to keep abreast of what is required of companies. Others argue it shifts agency accountability to outside organizations, allowing them to be less accountable to the public.

"What if the public cannot access or consult a particular law?" asked Bassett, writing on UPenn's RegBlog website. Noting that these rules are most often copyrighted by their respective organizations, Bassett said a citizen's lowest-cost option would be to visit the National Archives and Records Administration (NARA) to obtain free access. "In many cases, members of the public can be required to pay to access the incorporated content found in government regulations," she added.

Reasonable Availability

The public, however, does have one recourse: The Office of the Federal Register (OFR) requires all documents incorporated by reference to be made "reasonably available." What that means hasn't been defined, though, and a petition filed in 2012 sought to have the office clarify its practical implications for access.

Should, as the petitioners argue, "reasonably available" mean "free" and "available online?" Or should federal regulators develop an alternate approach?

In a response to that petition, OFR takes the latter approach: Reasonably available does not need to be free or digitally available, but information about the standard needs to be more available.

In its 2 October 2013 Federal Register notice, OFR said it lacked the statutory authority to make the changes called for in the petition, namely that standards should be free and available online. But it agreed that more information is a normatively good thing, and proposed a new regulation that would direct agencies to "add more information regarding materials incorporated by reference to the preambles of their rulemaking documents."

"We propose that they set out in the preambles a discussion of the actions they took to ensure the materials are reasonably available to interested parties or summarize the contents of the materials they wish to incorporate by reference," OFR wrote. Alternately, agencies may still attempt to make the materials "reasonably available" to the public.

"The OFR has no authority to create agencies, change how standards development organizations (SDOs) operate, or amend existing statutes," it explained. "Regulated entities … and their trade associations should work directly with the agencies issuing regulations to ensure that all regulated entities and their representatives have access to the content of materials Incorporated by Reference."

New Requirements

Under the new language, an agency must:

(1) Discuss the ways in which it worked to make the materials it proposes to incorporate by reference reasonably available to interested parties in the preamble of the proposed rule, or

(2) Summarize the material it proposes to incorporate by reference in the preamble of the proposed rule.

(b) In a final rule, the agency must request formal approval by:

(1) Making a written request for approval at least 20 working days before the agency intends to submit the final rule document for publication;

(2) Discussing, in the preamble, the ways in which it worked to make the materials it incorporates by reference reasonably available to interested parties and how interested parties can obtain the materials;

(3) Sending a copy of the final rule document that uses the proper language of incorporation with the written request (See § 51.9); and

(4) Ensuring that a copy of the publication is on file at the Office of the Federal Register.

(c) Agencies may consult with the Office of the Federal Register at any time with respect to the requirements of this part.


Comments on the proposed rule are due to OFR by 31 December 2013.


OFR: Incorporation By Reference

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