2023-15558. Public Meeting and Listening Session for Developing the Food and Drug Administration's Center for Tobacco Products' Strategic Plan; Request for Comments

AGENCY:

Food and Drug Administration, Department of Health and Human Services (HHS).

ACTION:

Notification of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual listening session entitled “Public Meeting and Listening Session for Developing FDA's Center for Tobacco Products' Strategic Plan.” The purpose of the listening session is to obtain feedback on the proposed strategic goals that are being used to develop FDA's Center for Tobacco Products' (CTP) comprehensive Strategic Plan. FDA will provide information on the proposed goals and provide the public an opportunity to provide open public comment.

DATES:

The virtual listening session will be held on August 22, 2023, beginning at 10 a.m. Eastern Time. Additional details, such as the time of the listening session and registration information, is available at: https://www.fda.gov/​tobacco-products/​ctp-newsroom/​listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023. All requests to make open public comment must be received by August 14, 2023, at 11:59 p.m. Eastern Time. Either electronic or written comments on this listening session must be submitted to the docket by August 29, 2023. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The listening session will be held virtually and more information will be posted here: https://www.fda.gov/​tobacco-products/​ctp-newsroom/​listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023.

You may submit written comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 29, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

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–2873. Received comments, those filed in a timely manner (see ADDRESSES ), 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 dockets 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.

FOR FURTHER INFORMATION CONTACT:

May Nelson, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 877–287–1373, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In September 2022, per the request of the FDA Commissioner, Dr. Robert Califf, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of CTP. The evaluation's goal was to help ensure that CTP has the tools to address today's challenges as it works to prevent tobacco use among youth and to reduce tobacco-attributable death and disease. The final report was issued on December 19, 2022, and included 15 recommendations across a number of areas.

One recommendation stated: “To address today's challenges and position itself for the future, CTP must pivot from a reactive mode to a proactive mode. CTP must invest the time, now, with staff and public input, to create and implement a strategic plan that identifies CTP's strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.”

In response, CTP has initiated the development of a 5-year Strategic Plan to advance its mission. As part of an iterative, Center-wide process, CTP has developed five proposed goal areas that have been shaped by staff and leaders across the Center. These goal areas are intended to be interconnected with four proposed cross-cutting themes: health equity, science, transparency, and stakeholder engagement. The Center intends to publish its Strategic Plan by the end of 2023.

To gain additional perspectives as CTP develops its Strategic Plan, the Center seeks public comments on these proposed goal areas or on any other areas that CTP should consider that might not be encapsulated by these proposed goal areas. CTP asks that comments be forward-looking, constructive, and concise in addressing the following questions:

1. What key features, activities, or initiatives would you like CTP to consider as related to any of these proposed goal areas? For example, in the area of regulations and guidance documents, we would be interested in your feedback on specific regulations and guidance documents FDA should pursue and how they should be prioritized.

2. What are measurable short- and long-term outcomes for the proposed goal areas over the next 2 to 5 years?

3. What are three specific actions CTP could take in the next 5 years that would have the most impact in significantly reducing tobacco-related death and disease?

4. Are there any important features, activities, or initiatives not encapsulated by these proposed goal areas that you believe CTP should consider as part of its Strategic Plan?

Proposed goal areas are as follows:

1. Develop, Advance, and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance. This goal includes activities related to the development and implementation of CTP's regulatory and policy agenda; the articulation and publication of clear and comprehensive public policy statements; and efforts to advance health equity.

2. Ensure Timely, Clear, and Consistent Product Application Review to Protect Public Health. This goal includes activities related to work processes such as optimizing the efficiency, consistency, and effectiveness of the product application review process; enhancing public understanding of regulatory requirements through transparency and stakeholder engagement efforts; and ensuring that the review process is supported by a strong regulatory science program.

3. Ensure Compliance of Regulated Industry and Tobacco Products Utilizing All Available Tools, Including Robust Enforcement Actions. This goal includes pursuing enforcement actions to reduce violations; enhancing collaborations with federal and state agencies on tobacco enforcement efforts; and prioritizing agile market intelligence and surveillance to facilitate awareness of and effective responses to the evolving tobacco landscape.

4. Improve Public Health by Enhancing Knowledge and Understanding of CTP Tobacco Product Regulation and the Risks Associated with Tobacco Product Use. This goal includes timely, clear, and accessible health communications and education to diverse public audiences, including those to discourage youth initiation, encourage cessation, and to inform adults who smoke about the relative risks of tobacco products.

5. Advance Operational Excellence. This goal includes prioritization of workforce growth, engagement, and retention and CTP's commitment to diversity, equity, inclusion, and accessibility; modernizing business processes to enhance information management and programmatic efficacy; and seeking and applying needed resources to support CTP's full portfolio of regulatory activities.

II. Topics for Discussion at the Listening Session

The listening session will provide the public an opportunity to provide open public comment on the proposed goal areas and help inform development of the final Strategic Plan. After introductions, FDA will begin the listening session with an overview of the development of CTP's Strategic Plan and subsequent proposed goal areas. Then, the registered speakers will have approximately 4 minutes each to share their comments on any topics related to the proposed goal areas.

III. Participating in the Listening Session

Registration: To register to attend the free listening session, please visit the following website: https://www.fda.gov/​tobacco-products/​ctp-newsroom/​listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023. Registration information will be posted soon.

Live closed captioning will be provided during the listening session. Additional information on requests for special accommodations due to a disability will be provided during registration.

Requests to Provide Open Public Comment: During online registration you may indicate if you wish to make open public comments during the listening session. All requests to make open public comment must be received by August 14, 2023, at 11:59 p.m. Eastern Time. We will do our best to accommodate requests to make public comments. We are seeking to have a broad representation of ideas and perspectives presented at the meeting. During the listening session, FDA is especially interested to hear from those individuals or communities who may be less likely or less able to provide written comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time for a joint presentation. FDA will allow registered speakers 4 minutes to provide their open public comments and will notify all registrants of their approximate time ahead of the listening session if they are selected to make public comment. FDA will not accept presentation materials for the listening session. Instead, any materials can be submitted to the respective docket noted in the “Docket” section of this document before the end of the comment period.

Transcript: Please be advised that as soon as the transcript of the listening session is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript and recording will also be available on the internet at https://www.fda.gov/​tobacco-products/​ctp-newsroom/​listening-session-developing-fdas-center-tobacco-products-strategic-plan-08222023.

Dated: July 18, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.