2022-03368. Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “FY 2022 Generic Drug Science and Research Initiatives Workshop.” The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.

DATES:

The public workshop will be held on May 9, 2022, and May 10, 2022, from 8:30 a.m. to 4:30 p.m. Eastern Time. Submit either electronic or written comments on this public workshop by June 10, 2022. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The public workshop will be held virtually. Registrants will have an opportunity to indicate their interest in attending the public workshop in person. If applicable health guidelines for in-person gatherings are permissive, interested registrants will be contacted no later than March 9, 2022 with details for attending the public workshop in person at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B, and C), Silver Spring, MD 20993-0002. If in-person attendance is determined to be feasible, the registration form will also be updated so that people registering for the public workshop from that point forward will be able to indicate their interest in attending the workshop in person, even if they are registering after March 9, 2022. Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm.

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 10, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 10, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is 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-2017-N-6644 for “FY 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments.” 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 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.

FOR FURTHER INFORMATION CONTACT:

Sam Raney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, [e-mail]; or Robert Lionberger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4722, Silver Spring, MD 20993, 240-402-7957, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In July 2012, Congress passed the Generic Drug User Fee Amendments of 2012 (GDUFA I) (Pub. L. 112-144). GDUFA I was designed to enhance public access to safe, high-quality generic drugs and to modernize the generic drug program. To support this goal, FDA agreed in the Generic Drug User Fee Act Program Performance Goals and Procedures (GDUFA I commitment letter) to work with industry and interested stakeholders on identifying science and research initiatives specific to generic drugs for each fiscal year covered by GDUFA I.

In August 2017, GDUFA I was reauthorized until September 2022 through the Generic Drug User Fee Amendments of 2017 (GDUFA II) (Pub. L. 115-52). In the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II commitment letter),^[1] FDA agreed to conduct annual public workshops “to solicit input from industry and stakeholders for inclusion in an annual list of GDUFA II [r]egulatory [s]cience initiatives.” The public workshop scheduled for May 9, 2022, and May 10, 2022, seeks to fulfill this agreement.

II. Topics for Discussion at the Public Workshop

The purpose of the public workshop is to obtain input from industry and other interested stakeholders on identifying generic drug science and research initiatives for FY 2023. FDA is particularly interested in receiving input about the next 5 years of the GDUFA science and research program.

Specific presentations and discussions at this workshop will be announced at a later date and may differ from the topic above. However, input about the topic above will help the Agency identify and expand its scientific focus for the next fiscal year.

FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES ) as it develops its FY 2023 science and research initiatives. Information concerning the science and research initiatives for generic drugs can be found on the Science & Research website at https://www.fda.gov/​drugs/​generic-drugs/​science-research.

III. Participating in the Public Workshop

Registration: Registration is free. Persons interested in attending this public workshop must register online at https://fda.zoomgov.com/​webinar/​register/​WN_​kY1uqyD1RLqyRL2XU1KDTA. Registration may be performed at any time before or during the workshop.

Requests for Oral Presentations: During online registration you may indicate if you wish to present your public comments. Public comment presentation requests must be submitted by 11:59 p.m. Eastern Time at the end of March 11, 2022. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the workshop. Based upon the public comment presentation requests received by March 11, 2022, at 11:59 p.m. Eastern Time, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin; we will select and notify participants by March 28, 2022. All public comment presentation requests must be received by March 11, 2022, at 11:59 p.m. Eastern Time. If selected for presentation, any presentation materials must be emailed to [e-mail] no later than April 29, 2022, 11:59 p.m. Eastern Time. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Streaming Webcast of the Public Workshop: This public workshop will be webcast. Please register online (as described above) to attend the workshop remotely. Registrants will receive a hyperlink that provides access to the webcast on both days.

FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov or https://www.fda.gov/​gdufaregscience. It may be viewed at the Dockets Management Staff (see ADDRESSES ).

Dated: February 10, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  The GDUFA II commitment letter is available at https://www.fda.gov/​downloads/​ForIndustry/​UserFees/​GenericDrugUserFees/​UCM525234.pdf.