2024-08956. Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; establishment of a public docket; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is establishing a public docket entitled “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology.” The purpose of this docket is to solicit input from interested parties on specific and actionable policy topics that could be prioritized, developed, and implemented by the staff of the Center for Drug Evaluation and Research's (CDER's) Office of Clinical Pharmacology (OCP) to support effective drug development programs.

DATES:

Although you can comment at any time, to ensure that the Agency considers your comment, submit either electronic or written comments by June 25, 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-2024-N-1592 for “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration's Office of Clinical Pharmacology.” 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.

• 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.

FOR FURTHER INFORMATION CONTACT:

Anuradha Ramamoorthy, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1688, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

Clinical pharmacology impacts many important aspects of drug development including, but not limited to, dose selection and optimization, clinical trial inclusion and exclusion criteria, and evidence generation for safety and effectiveness determinations. Clinical pharmacology derived recommendations are also critical for optimizing pharmacotherapy in clinical practice ( e.g., by informing patient-specific treatment strategies).

Within CDER, OCP leverages clinical pharmacology information on drug disposition, disease biology, pharmacology, and determinants of response variability to support risk/benefit determinations and therapeutic individualization recommendations for patients and practitioners. OCP's mission is to advance the development of innovative new medicines by applying state-of-the-art scientific principles and promoting therapeutic optimization and individualization. OCP fulfills this mission through its core functions of regulatory review, regulatory research, and development and implementation of scientific guidances and policies.

To facilitate effective and efficient drug development, FDA is engaged in multiple, high-priority policy initiatives. Consistent with FDA's broader initiatives and modernization efforts, OCP works collaboratively with stakeholders to develop and implement contemporary guidance and policy in the multidisciplinary field of clinical pharmacology to share the current regulatory thinking on a topic and promote effective drug development programs. FDA is establishing a public docket to solicit input from interested parties on specific and actionable clinical pharmacology-relevant policy topics that could be prioritized, developed, and implemented by OCP staff.

II. Request for Comments

FDA is soliciting specific, actionable policy suggestions that could be prioritized, developed, and implemented in the near-term by OCP staff to promote effective drug development programs. We emphasize that the focus of this request is to seek input in the multidisciplinary field of clinical pharmacology. The Agency welcomes any relevant information that interested parties wish to share in a submission to the docket. We are particularly interested in seeking input on:

1. Topics for development of new clinical pharmacology/translational medicine guidances to improve clarity and promote effective drug development. Please provide a rationale to support your suggestion and highlight relevant aspects that could be considered in guidance development.

2. Topics and concepts where further clarity on OCP's existing guidances may be warranted. Please provide a rationale to support your suggestions and actionable recommendations.

3. Topics that promote patient centricity in drug development and regulatory assessment. For FDA, patient-centric drug development and providing patient-centered clinical recommendations are important priorities.

III. Electronic Access

Persons with access to the internet may obtain relevant clinical pharmacology guidances at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents.

Dated: April 22, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.