United States: New OMB Review Process Could Impede FDA Issuance Of Guidance Documents

Last Updated: May 10 2019
Article by David Horowitz and Randy J. Prebula

 Starting on May 11, 2019, there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents. On April 11, 2019, the Office of Management and Budget (OMB) issued a Memorandum for the Heads of Executive Departments and Agencies (Memo) that establishes new procedures for federal agencies that issue guidance documents, including FDA.

Enhancing OIRA's centralized review of policymaking

Although the subject of the Memo is identified as "Guidance on Compliance with the Congressional Review Act," arguably the most significant implications of the Memo relate not to review of guidance documents by Congress but by OMB's Office of Information and Regulatory Affairs (OIRA). This new directive expands OIRA's role in reviewing and assessing guidance documents, which will enhance OIRA's centralized control of policymaking. It may also have the effect of discouraging agencies from providing transparency through guidance about their enforcement policies and interpretations of statutes and regulations they administer.

In the past, FDA rarely submitted guidance documents for review by OIRA because Executive Order 12866, regarding centralized review of regulatory actions, has been interpreted by FDA and most agencies to cover regulations, not guidance documents. The Memo acknowledges that "OIRA does not consistently receive" guidance documents from agencies through the centralized review process under this executive order. However, the Memo states that the Congressional Review Act (CRA) provides for OIRA review of all "rules" to determine whether they are "major" in terms of their importance and economic impact.

Among other things, a determination that a rule is major triggers a Government Accountability Office (GAO) report and a delayed effective date, during which Congress may consider whether it will rescind the rule through a resolution of disapproval passed by both houses of Congress and signed by the president. During the Trump administration, the CRA was used to invalidate 14 Obama-era regulations, although the 1996 law had only been used one time before that.

Expanding OIRA and CRA review to cover guidance documents

Significantly, the Memo advances a literal interpretation of the scope of the CRA, broadly interpreting "rule," consistent with the Administrative Procedure Act, to include, with few exceptions, guidance documents, policy statements, and interpretive rules. Agencies will need to submit guidance for a CRA determination by OIRA at least 30 days before public issuance, and if OIRA designates the guidance as major, agencies are to delay the effective date by 60 days. In addition, agencies will need to start submitting guidance documents to Congress along with a report identifying whether OIRA determined that the guidance is major.

The Memo summarizes the CRA definition of a "major" rule, which is based on a finding by OIRA that the rule "has resulted in or is likely to result" in the following:

  • An annual effect on the economy of US$100 million or more.
  • A major increase in costs or prices for consumers; individual industries; federal, state, or local government agencies; or geographic regions.
  • Significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic and export markets.

The Memo asserts that the CRA definition of "major" sweeps very broadly in that "a rule may qualify as major...if it imposes disproportionate costs on a particular group in comparison to the burdens experienced by other groups or the benefits experienced by the burdened group."

Requiring economic analyses of guidance documents

Agencies will need to submit to OIRA an economic analysis of the guidance documents submitted for CRA review. The Memo states: "Insufficient or inadequate analysis may delay OIRA's determination and an agency's ability to public a rule and to make the rule effective." This signals that agencies will need to devote additional resources to conduct these newly required economic analyses.

The economic analyses of guidance documents will be uniquely challenging for agencies because guidance documents are, by definition, nonbinding, and the economic effects, if any, may be more indirect and thus harder to quantify. The Memo recognizes the quantification challenge in assessing whether a rule is major and suggests that a "qualitative analysis" will be acceptable when a quantitative analysis is not "reasonably possible."

In the past, OMB has recognized in the Final Bulletin for Agency Good Guidance Practices that the costs associated with guidance documents are "dependent on third party decisions and conduct." 72 FR 3432, 3435 (Jan. 25, 2007). Similarly, OMB stated that "guidance documents often will not be amenable to formal economic analysis of the kind that is prepared for an economically significant regulatory action." Id. (emphasis added).

Yet, the Memo indicates that OIRA will "designate certain categories of rules as presumptively not major in order to prioritize the evaluation of rules more likely to be major." In light of the fact that FDA issues thousands of guidance documents each year, the burden to review all federal agency guidance documents and economic analyses would be substantial for OIRA. How this provision – establishing presumptively nonmajor categories of guidance – is implemented will be critical to assess the impact of the Memo on agency guidance documents. We will continue to monitor this issue and report on how this OMB Memorandum may affect FDA guidance development.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions