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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2023-N-5653]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability, request for comments.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance.” This draft report responds to the Consolidated Appropriations Act of 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices. It also directs FDA to publish a draft report and plan no later than 1 year after enactment of the Consolidated Appropriations Act and to consult with stakeholders in developing the report and implementation plan.

# DATES:

Submit either electronic or written comments on the draft report and plan by March 4, 2024.

# ADDRESSES:

You may submit comments as follows:

### Electronic Submissions

Submit electronic comments in the following way:
      -  Federal eRulemaking Portal: https://www.regulations.gov.                      Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to                      https://www.regulations.gov                      will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on                      https://www.regulations.gov. 
      - If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

### Written/Paper Submissions

Submit written/paper submissions as follows:
      -  Mail/Hand Delivery/Courier (for written/paper submissions):                      Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.                
      - For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

*Instructions:*                     All submissions received must include the Docket No. FDA-2023-N-5653 for “Draft Report and Plan on Best Practices for Guidance.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at                     *https://www.regulations.gov*                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.                
      - Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov.                      Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with  21 CFR 10.20  and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see  80 FR 56469 , September 18, 2015, or access the information at:                      https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf. 

*Docket:*                     For access to the docket to read background documents or the electronic and written/paper comments received, go to                     *https://www.regulations.gov*                     and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.                

                    See the                     **SUPPLEMENTARY INFORMATION**                     section for electronic access to the draft report and plan.                

# FOR FURTHER INFORMATION CONTACT:

Julie Finegan, Office of Policy, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4252, Silver Spring, MD 20993-0002, 301-827-4830.

      ( print page 381)    

# SUPPLEMENTARY INFORMATION:

## I. Background

                    Clear, concise, and timely communication through guidance documents is essential to the public health mission of FDA. FDA guidance documents are prepared for regulated industry, FDA staff, and the public to describe the Agency's interpretation of, or policy on, a regulatory issue. (§ 10.115(b) (21 CFR 10.115(b))). Unlike statutes and regulations, guidance documents generally do not establish legally enforceable rights or responsibilities (§ 10.115(d)), and are thus exempt from notice and comment requirements applicable to most rulemaking under the Administrative Procedure Act. (5 U.S.C. 553(b)(A); (d)(2)). However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA's Good Guidance Practices (GGP) regulation (§ 10.115) require FDA to provide an opportunity for public comment prior to implementation for all Level 1 guidance documents (                    *i.e.,*                     guidance documents that include initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues), unless FDA determines that prior public participation is not feasible or appropriate. (21 U.S.C.371(h)(1)(C)(i); 10.115(g)). If FDA decides that public participation is not feasible or appropriate prior to implementation of a guidance document, FDA must provide for public comment upon publication and take such comment into consideration. (21 U.S.C. 371(h)(1)(C)(i); 10.115(g)(3)). For Level 2 guidance documents (                    *i.e.,*                     guidance documents that set forth existing practices or minor changes in policy), the FD&C Act and FDA's GGP regulation require that FDA provide for public comment upon implementation. (21 U.S.C. 371(h)(1)(D); 10.115(g)(4)).                

                    As part of FDA's Transparency Initiative, in 2011, FDA publicly released a comprehensive report entitled “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (2011 GGP Report, available at                     *https://www.fda.gov/​about-fda/​transparency/​transparency-initiative*). The 2011 GGP Report identified “best practices” and made recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and improve access to guidance documents on FDA's website. Since 2011, FDA has continued to make significant strides to modernize and improve our best practices for the efficient prioritization, development, review, clearance, and issuance of our guidance documents.                

The Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) pushed us to consider innovative approaches to streamline guidance issuance and regulatory submissions to reach a broad audience in an expedited manner. The facts and circumstances surrounding COVID-19 and the COVID-19 PHE enabled FDA to rapidly disseminate Agency recommendations and policies related to COVID-19 to industry and other interested parties, FDA staff, and the public, including patients and consumers. The Agency used Paperwork Reduction Act waivers, issuance of Level 1 guidance documents without prior public participation, and expedited external review of guidance documents, which translated into significant time savings. These tools were critical to the significant work FDA accomplished during the COVID-19 pandemic. Now that the PHE determined under section 319 of the Public Health Service Act is over, FDA is considering the lessons learned from that experience and reassessing our current best practices for guidance to look for additional areas for improvement consistent with our statutory and regulatory framework.

                    In accordance with section 2505(a) of the Consolidated Appropriations Act of 2023 (Pub. L. 117-328), FDA's “Draft Report and Plan on Best Practices for Guidance” identifies our current best practices for the efficient prioritization, development, issuance, and use of guidance documents. As a part of this draft report and plan, FDA is also considering opportunities to streamline processes for regulatory submissions through the revision and issuance of guidance documents and to implement innovative guidance development processes and practices. Pursuant to section 2505(c) of the Consolidated Appropriations Act, in this                     **Federal Register**                     notice announcing the availability of this document, FDA is seeking public comment on this “Draft Report and Plan on Best Practices for Guidance.”                

## II. Request for Comments

FDA is soliciting comments on its “Draft Report and Plan on Best Practices for Guidance” from a broad range of commenters, including regulated industry; researchers; academic organizations; pharmaceutical, biotechnology, and medical device developers; clinical research organizations; clinical laboratories; healthcare providers; food manufacturers; and consumer and patient groups. We are particularly interested in feedback on the following areas:

1. FDA regularly considers its processes for the development, clearance, and issuance of guidance documents, with a goal of streamlining these processes and making the best use of Agency resources. The draft report summarizes FDA's current best practices for the initiation, prioritization, development, review, clearance, and issuance of guidance documents that FDA has implemented in response to the 2011 report and other continual improvement efforts not described in the 2011 report. The draft report also proposes additional initiatives that FDA could consider to further improve its processes for the issuance of guidance documents. FDA solicits input on whether there are additional or revised practices, consistent with our statutory and regulatory framework, for the Agency to consider.

                    2. Level 1 guidance documents are guidance documents that include initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues. Level 2 guidance documents describe existing practices or minor changes in interpretation or policy. Pursuant to FDA's statutory and regulatory requirements, while the public may comment on a guidance document at any time, public participation is directly solicited prior to the implementation of Level 1 guidance documents unless we determine that such prior public participation is not feasible or appropriate. In the preamble to the final GGP rule, we noted that we anticipated that this exception would generally be applicable when there are public health reasons for the immediate implementation of the guidance document; there is a statutory requirement, executive order, or court order that requires immediate implementation; or the guidance document presents a less burdensome policy that is consistent with public health.[1]                                          Issuing more guidance documents either as Level 1 guidance documents for immediate implementation, as FDA did during the COVID-19 PHE, or as Level 2 guidance documents would allow FDA to allocate its limited resources more efficiently, which would help FDA keep pace with rapid scientific developments and better serve the public health. In addition,                           ( print page 382)                        FDA's GGP regulation provides that the public may comment on any guidance at any time, including Level 1 guidance documents for immediate implementation and Level 2 guidance documents, and FDA may delay implementation of any guidance document.                

a. In light of the above, we seek input on whether there are any additional circumstances, categories of guidance documents, or topics for guidance for which it may be appropriate and consistent with the FD&C Act and FDA's GGP regulation for FDA to consider issuance as a Level 1 guidance document for immediate implementation without prior public comment.

b. We also seek comment on whether there are additional categories or types of guidance documents that FDA should consider issuing as Level 2 guidance documents to streamline the guidance process and allow the Agency to better leverage its resources for the timely development of more guidance documents.

3. FDA requests comment on any novel guidance document formats that would be of particular utility, such as use of templates to accompany a guidance document, Q&A formats, flowcharts, etc., that are used in FDA guidance documents or that were used in guidance documents issued in response to the COVID-19 PHE.

4. FDA makes robust use of guidance documents to assist industry in making regulatory submissions. As described in the report, examples of such guidances include device-specific guidance documents, disease or indication specific guidance documents that include recommendations on developing drugs intended to treat a specific disease or for a specific indication to support submissions of New Drug Applications (NDAs) or Supplemental NDAs, product specific guidances for generic drug development to support submission of Abbreviated New Drug Applications (ANDAs), Data Technical Conformance Guides to accompany guidance documents, and guidance documents that provide assistance with registration and listing requirements. FDA requests comment on the utility of guidances in streamlining regulatory submissions and whether there are additional categories or types of guidance that would be helpful to streamline processes for regulatory submissions to the Agency.

5. Currently, FDA's GGP regulation (§ 10.115) provides that interested persons can suggest areas for guidance document development and that such suggestions should address why a guidance document is necessary. (§ 10.115(f)(2)). In addition, proposed guidance documents can be submitted to a specified docket for FDA consideration. (§ 10.115(f)(3)). FDA requests comments on whether the currently available mechanisms for submitting suggested areas for guidance development and proposed guidance documents are useful and sufficient or whether additional mechanisms, for example, a Center-specific or Office-specific mailbox for such suggestions would ease the process for such submissions.

6. FDA Centers publish guidance agendas on their web pages to give interested parties and the public notice of the areas in which FDA is considering upcoming guidance. We request comment on the utility of these guidance agendas and what, if any, modifications to these agendas would be helpful for the Agency to consider.

## III. Electronic Access

                    Persons with access to the internet may obtain the draft report and plan at                     *https://www.fda.gov/​about-fda/​reports/​reports-agency-policies-and-initiatives*                     or                     *https://www.regulations.gov.*

Dated: December 22, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

# Footnotes

1.                             65 FR 56468 at 56472 (September 19, 2000).                    
        Back to Citation      

[FR Doc. 2023-28872 Filed 1-2-24; 8:45 am]

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