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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo 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 FDAs 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-201509-18/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, 2404027500.
Transcripts of the meeting will be available on FDAs website at https
www.fda.gov/industry/prescriptiondrug-user-fee-amendments/pdufa-viifiscal-years-2023-2027 approximately 30
days after the meeting.
FOR FURTHER INFORMATION CONTACT:
Patrick Zhou, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 209930002, 301
3481817, Patrick.Zhou@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction FDA is announcing a virtual public meeting to discuss proposed recommendations for the
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reauthorization of PDUFA, the legislation that authorizes FDA to collect user fees to support the process for the review of human drug applications. The current authorization of the program PDUFA VI expires in September 2022. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the process for the review of human drug applications. Section 736Bf4 of the FD&C Act 21 U.S.C.
379h2f4 requires that after FDA
holds negotiations with regulated industry and periodic consultations with stakeholders, we do the following:
1 Present recommendations to the relevant Congressional committees, 2
publish recommendations in the Federal Register, 3 provide a period of 30 days for the public to provide written comments on the recommendations, 4
hold a meeting at which the public may present its views, and 5 after consideration of public views and comments, revise the recommendations as necessary.
This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. After the public meeting, we will revise the recommendations as necessary and present our proposed recommendations to the Congressional committees. The purpose of the meeting is to hear the publics views on the proposed recommendations for the reauthorized program PDUFA VII. The following information is provided to help potential meeting participants better understand the history and evolution of the PDUFA program and the status of the proposed PDUFA VII
recommendations.
II. What is PDUFA and what does it do?
The following information is provided to help potential meeting participants better understand the history and evolution of PDUFA and its status.
PDUFA is a law that authorizes FDA to collect fees from drug companies that submit marketing applications for certain human drug and biological products. PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act Pub. L. 102571 for a period of 5 years. In 1997, Congress passed the Food and Drug Administration Modernization Act of 1997 FDAMA, Pub. L. 105115, which renewed the program PDUFA II for an additional 5 years. Congress then extended PDUFA again for another 5
years PDUFA III, through FY 2007, in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 Pub. L. 107188.
In 2007, Title I of the Food and Drug
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Administration Amendments Act of 2007 FDAAA, Pub. L. 11085
reauthorized PDUFA through FY 2012
PDUFA IV, Pub. L. 112144 and in 2012 the Food and Drug Administration Safety and Innovation Act FDASIA
reauthorized the law through FY 2017
PDUFA V. PDUFA was most recently renewed in 2017 under Title I of the FDA Reauthorization Act of 2017
FDARA which lasts through FY 2022
PDUFA VI.
PDUFAs intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better managed human drug review process to make important therapies available to patients sooner without compromising review quality or FDAs high standards for safety, efficacy, and quality. As part of FDAs negotiated agreement with industry during each reauthorization, the Agency agrees to certain performance and procedural goals and other commitments that apply to aspects of the human drug review program. These goals apply, for example, to the process for the review of original new human drug and biological product applications, postmarket safety activities, and new data standards and technology enhancements.
During the first few years of PDUFA
I, the additional funding enabled FDA to eliminate backlogs of original applications and supplements. Phased in over the 5 years of PDUFA I, the goals were to review and act on 90 percent of priority new drug applications NDAs, biologics license applications BLAs, and efficacy supplements within 6
months of submission of a complete application; to review and act on 90
percent of standard original NDAs, BLAs, and efficacy supplements within 12 months, and to review and act on resubmissions and manufacturing supplements within 6 months. Over the course of PDUFA I, FDA exceeded all these performance goals and significantly reduced median review times of both priority and standard NDAs and BLAs.
Under PDUFA II, the review performance goals were shortened, and new procedural goals were added to improve FDAs interactions with industry sponsors and to help facilitate the drug development process. The procedural goals, for example, articulated time frames for scheduling sponsor-requested meetings intended to address issues or questions regarding specific drug development programs, as well as time frames for the timely response to industry-submitted questions on special study protocols.
FDA met or exceeded all the review and
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