E.O. 12866 Meeting Request - Email Verification

Before we can proceed with the scheduling process for your E.O. 12866 meeting request, we must authenticate and verify your email address. You will receive an email. Follow the instructions to verify your email address and proceed with scheduling your EO meeting.

RIN:
0910-ZC68

Title:
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability

Agency/Subagency:
Department of Health and Human Services (HHS) / Food and Drug Administration (FDA)

Received Date:

12/01/2025

EO Review Status:

Pending Review

Legal Deadline:

None

International Impacts:

Stage:

Notice

Economically Significant:

Affordable Care Act [Pub. L. 111-148 & 111-152]:

Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]:

Pandemic Response:

Verify Email

Requestor's Name

Please fill in a valid first name.

Please fill in a valid last name.

Are you requesting this meeting on behalf of:

Yourself (e.g., John Doe)
Your organization (e.g., John's Small Business)
Another person or organization (e.g., Doe Law Firm for Group X)

Your Organization

The Individual and Organization For Whom You Are Requesting The Meeting

Email Address

Please fill in a valid email address.

Confirm Email Address

Email address does not match. Please confirm email address again.

Phone Number (Format: 123-456-7890 x123)

Please fill in a valid phone number.

The public reporting burden to complete this information collection is estimated at 20 minutes per response, including for reviewing instructions, searching data sources, gathering and maintaining the data needed, and the completing and reviewing the collected information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection information, including suggestions for reducing this burden to PRA@omb.eop.gov. Current information regarding this collection of information - including all background materials -- can be found at https://www.reginfo.gov/public/do/PRAMain by using the search function to enter either the title of the collection or the OMB Control Number.

Privacy Act Statement: The purpose of this form is to facilitate meeting requests with OMB as authorized by E.O. 12866. Your submission of a request for a meeting pursuant to E.O. 12866 is voluntary. The information you provide will be used to schedule meetings, facilitate outreach, and obtain information regarding your meeting request. Please note that all submissions received in response to this notice will be posted on Reginfo.gov or otherwise released in their entirety, including any personal and business confidential information provided. Do not include in your submissions any copyrighted material; information of a confidential nature, such as personal or proprietary information; or any information you would not like to be made publicly available. The OMB System of Records Notice, OMB Public Input System of Records, OMB/INPUT/01, 88 FR 20913 (https://www.federalregister.gov/documents/2023/04/07/2023-07452/privacy-act-of-1974-system-of-records), includes a list of routine uses associated with the collection of this information.

Please contact the OIRA Records Manager at Oira_submission@omb.eop.gov if you have any questions.