90 FR 89 pgs. 19722-19724 - Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
Type: NOTICEVolume: 90Number: 89Pages: 19722 - 19724
Pages: 19722, 19723, 19724Docket number: [Docket No. FDA-2025-N-1090]
FR document: [FR Doc. 2025-08208 Filed 5-8-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1090]
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Request for Comments
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of availability; request for comments.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027." As part of FDA performance commitments described in this document, FDA is publishing the final assessment report and soliciting public comments.
DATES:
Submit either electronic or written comments on the final report by July 31, 2025.
ADDRESSES:
You may submit either electronic or written 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:
[top] • Mail/Hand delivery/Courier (for written/paper submissions): Dockets
• 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-2025-N-1090 for "Independent Assessment of Communication Through Product Quality Information Requests During Application Review." 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, 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:
Mahesh Ramanadham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3272, email: Mahesh.Ramanadham@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
PDUFA provides FDA with a source of stable, consistent funding that has made it possible for the Agency to focus on promoting innovative therapies and help bring to market critical products for patients. When PDUFA was originally authorized in 1992, it had a 5-year term. The program has been subsequently reauthorized every 5 years. To prepare for the reauthorization of PDUFA for years 2023 to 2027, FDA conducted negotiations with the regulated industry and held regular consultations with public stakeholders, including patient advocates, consumer advocates, and healthcare professionals between September 2020 and February 2021.
Following these discussions, related public meetings, and Agency requests for public comment, FDA published the "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027" document, available at https://www.fda.gov/media/151712/download, also known as the PDUFA VII "goals letter," to supplement the statute. The goals letter includes the performance goals, procedures, and commitments that apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. Several of these commitments aim to continue to enhance communication between FDA and applicants during application review.
FDA and applicants interact in a variety of ways throughout application review. One such way is via a communication called an information request (IR), sent to an applicant as the discipline review occurs. FDA uses IRs to request further information or clarification that is needed or would be helpful to allow completion of the discipline review. IRs may be in the form of letters, emails, or faxes.
FDA uses product quality IRs to request further information or clarification needed for FDA's assessment of identity, strength, quality, purity, or potency of drug substances or drug products. Ensuring that patients can have confidence in the safety and effectiveness of their medications is a longstanding priority for FDA. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have worked to address this priority in part by performing Chemistry, Manufacturing, and Controls (CMC) reviews for CDER-regulated and CBER-regulated products. CDER or CBER may issue a product quality, or CMC, IR as a result of CMC assessments conducted in support of the application.
CDER and CBER have established procedures for assessors to use Four-Part Harmony, a framework that describes four key elements that should be included in product quality IRs, specifically: (1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed. These procedures can be found in CDER's Manual of Policies and Procedures (MAPP) 5016.8 Rev. 1, "Using Four-Part Harmony in Quality-Related Assessment Communications" and CBER's Standard Operating Procedures and Policies (SOPP) 8401.1, "Issuance of and Review of Responses to Information Request Communications to Pending Applications." The PDUFA VII goals letter includes commitments for FDA to update and conduct training on existing policies and procedures (MAPPs and SOPPs), to reflect Four-Part Harmony. CDER MAPP 5016.8, "Communication Guidelines for Quality-Related Information Requests and Deficiencies" ( https://www.fda.gov/media/171613/download ) was revised in September 2023 and made public. CBER SOPP 8401.1, "Issuance of and Review of Responses to Information Request Communications to Pending Applications" ( https://www.fda.gov/media/85301/download ) was revised in October 2022.
[top] In addition to updating the documents and conducting training, FDA committed to contracting with an independent third party to assess current practices of CDER, CBER, and applicants in communicating through product quality IRs during application review and effectiveness of Four-Part Harmony. This assessment has been completed, and in accordance with the PDUFA VII goals letter, FDA is seeking public comment on this "Product Quality Information Request Communications Assessment: Final Report," available at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests.
II. Request for Comments
FDA is soliciting comments on the "Product Quality Information Request Communications Assessment: Final Report" from interested parties. We request feedback on: (1) the assessment findings and recommendations, (2) whether certain recommendations are more desirable than others, and (3) other actions FDA and applicants should consider and why.
III. Electronic Access
Persons with access to the internet may obtain the report at https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-assessment-fda-and-sponsor-communications-through-product-quality-information-requests.
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08208 Filed 5-8-25; 8:45 am]
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