95798 Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4821] 

Food and Drug Administration’s Best 

Practices for Food and Drug 

Administration Communication With 

Interested Parties: Draft Report for 

Public Comment; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

document entitled ‘‘Best Practices for 

FDA Communication with Interested 

Parties: Draft Report for Public 

Comment.’’ This draft report and 

implementation plan respond to the 

Consolidated Appropriations Act of 

2023, which directs FDA to issue a 

report on FDA’s practices for broadly 

communicating with external interested 

parties and a plan for implementation of 

such best practices. In addition, FDA is 

to conduct a review of the types and 

methods of public communication that 

FDA uses to communicate and interact 

with medical product sponsors and 

other external interested parties; 

identify best practices for the efficient 

development, issuance, and use of such 

communications; and develop a plan for 

implementation of best practices for 

these communications. As directed, 

FDA is publishing and soliciting 

feedback on this draft report and 

implementation plan. 

DATES: Submit either electronic or 

written comments on the draft report 

and implementation plan by February 3, 

2025. 

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– 

2024–N–4821 for ‘‘Best Practices for 

FDA Communication with Interested 

Parties.’’ 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: Will 

Bet-Sayad, Office of External Affairs, 

Food and Drug Administration, will.betsayad@fda.hhs.gov, 301–796–4523. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Clear, concise, and timely 

communication with medical product 

sponsors and other interested parties, 

including the public, using Agency 

regulatory documents as well as a 

variety of other communication 

methods, is essential to the public 

health mission of FDA. FDA currently 

uses a wide range of communication 

methods (e.g., website posting, online 

resource libraries, webinars and town 

halls, email, press releases and press 

conferences, social media, blogs, 

podcasts, guidance snapshots, graphics 

and short videos, conferences, meetings, 

workshops, focus groups, and public 

speeches) to reach external parties and 

the public. During the COVID–19 Public 

Health Emergency (PHE), FDA 

considered innovative approaches and 

novel communication methods to reach 

a broad audience in an expedited 

manner. Now that the PHE determined 

under section 319 of the Public Health 

Service Act (42 U.S.C. 247d) is over, 

FDA is internally discussing the lessons 

learned from that experience and 

reassessing our current best practices for 

communication to look for additional 

areas for improvement consistent with 

our statutory and regulatory framework. 

In accordance with section 2505(b) of 

the Consolidated Appropriations Act 

(Pub. L. 117–328) of 2023, FDA’s draft 

report and plan on ‘‘Best Practices for 

FDA Communication with Interested 

Parties’’ reviews the types and methods 

of public communication outside of 

guidance that FDA uses to communicate 

and interact with medical product 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 232 / Tuesday, December 3, 2024 / Notices 95799 

1FDA, ‘‘Food and Drug Administration Report on 

Good Guidance Practices: Improving Efficiency and 

Transparency,’’ available at https://www.fda.gov/ 

media/82644/download. 

2See https://www.fda.gov/about-fda/reports/fdareports-good-guidance-practices. As explained in 

the Draft Report and Plan, FDA will issue a separate 

Report and Plan in accordance with Section 2505(b) 

of the Consolidated Appropriations Act, 2023. 

sponsors and other external parties and 

identifies our current best practices for 

the efficient development, issuance, and 

use of such communications. As a part 

of this draft report and plan, FDA is also 

considering opportunities to advance 

the use of innovative forms of 

communication, to streamline the 

processes for regulatory submissions, 

and to implement innovative 

communication development processes 

and to transition or update 

communication practices used during 

the COVID–19 PHE. 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 ‘‘Best 

Practices for FDA Communication with 

Interested Parties: Draft Report for 

Public Comment.’’ 

II. Request for Comments 

FDA is soliciting comments on its 

‘‘Best Practices for FDA Communication 

with Interested Parties: Draft Report for 

Public Comment’’ from interested 

parties. Specifically, we request 

feedback on the following areas of 

communication: 

Communications Questions 

1. Are there communication practices 

that other Federal agencies use to 

communicate with interested parties, 

such as regulated industry, that would 

be consistent with FDA’s statutory and 

regulatory requirements and helpful for 

FDA to consider implementing? 

2. Recognizing that FDA used many 

innovative communications processes 

and practices during the COVID–19 

public health emergency, what types of 

communications were most beneficial/ 

useful during the COVID–19 pandemic 

and why? 

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: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28229 Filed 12–2–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5653] 

Food and Drug Administration Report 

and Plan on Best Practices for 

Guidance; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

document entitled ‘‘Food and Drug 

Administration Report and Plan on Best 

Practices for Guidance’’ (Report and 

Plan). FDA is publishing this Report and 

Plan in response to the Consolidated 

Appropriations Act, 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. 

DATES: The announcement of the report 

and plan is published in the Federal 

Register on December 3, 2024. 

ADDRESSES: 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 

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. 

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 FDA staff, 

industry, and the public to describe the 

Agency’s interpretation of, or policy on, 

a regulatory issue. (21 CFR 10.115(b)). 

Specifically, FDA uses guidance 

documents to assist regulated industry, 

FDA staff, and the public in 

understanding the Agency’s current 

thinking on policy, scientific, medical, 

and regulatory issues, such as: the 

design, manufacturing, and testing of 

regulated products; content and 

evaluation of applications for product 

approvals; and inspection and 

enforcement policies. Timely 

publication of guidance documents 

significantly benefits public health by 

providing transparency and valuable 

insight into approaches that may assist 

industry and other interested parties in 

complying with applicable statutes and 

regulations, ensuring consumer and 

patient safety, and developing new and 

innovative products to improve public 

health. 

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).1 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 made significant 

strides to implement the 

recommendations in the 2011 GGP 

Report and to modernize and enhance 

our best practices for the efficient 

initiation, prioritization, development, 

review, clearance, and issuance of our 

guidance documents. As a result of 

these and other Agency improvement 

efforts, and as explained in the Report 

and Plan, FDA has significantly 

increased the number of guidance 

documents it publishes annually. 

As part of FDA’s reassessment of its 

best practices for guidance and in 

accordance with section 2505(a) of the 

Consolidated Appropriations Act, 2023, 

FDA published a ‘‘Draft Report and Plan 

on Best Practices for Guidance’’ (Draft 

Report and Plan) on our website on 

December 28, 2023.2 Pursuant to section 

2505(c) of the Consolidated 

Appropriations Act, 2023 in a Federal 

Register notice announcing the 

availability of the Draft Report and Plan, 

FDA solicited public comment from a 

broad range of interested parties, 

including researchers; academic 

organizations; pharmaceutical, 

biotechnology, and medical device 

developers; clinical research 


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