89 FR 76 pgs. 27767-27769 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expedited Programs for Serious Conditions—Drugs and Biologics
Type: NOTICEVolume: 89Number: 76Pages: 27767 - 27769
Pages: 27767, 27768, 27769Docket number: [Docket No. FDA-2023-N-4804]
FR document: [FR Doc. 2024-08293 Filed 4-17-24; 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-2023-N-4804]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Submit written comments (including recommendations) on the collection of information by May 20, 2024.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 0910-0765. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Expedited Programs for Serious Conditions-Drugs and Biologics
OMB Control Number 0910-0765-Extension
[top] This information collection supports regulations governing FDA expedited programs for serious conditions. These provisions are set forth in 21 CFR part 312, subpart E and are intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory
To assist respondents with the information collection, we developed Agency guidance entitled "Guidance for Industry Expedited Programs for Serious Conditions-Drugs and Biologics" (May 2014). The guidance is a resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) fast track designation; (2) breakthrough therapy designation; (3) accelerated approval; and (4) priority review designation, and describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. The guidance addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and additional detail on possible flexibility in manufacturing and product quality. It also clarifies the qualifying criteria for breakthrough therapy designation, provides examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval, and priority review.
In addition, we developed Agency guidance entitled "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions," (February 2019) describing the criteria for participation in the Regenerative Medicine Advanced Therapy (RMAT) program. The RMAT expedited program was approved as part of the 21st Century CURES Act, signed December 13, 2016. An RMAT product is intended to treat, modify, reverse, or cure serious or life-threatening diseases or conditions, and preliminary clinical evidence indicate that the drug has the potential to address unmet medical needs for such diseases or conditions. This is a Center Biologics Evaluation and Research (CBER) program and is included as an expedited program available for serious conditions.
For a sponsor or applicant who seeks fast track, priority, breakthrough, RMAT or accelerated approval designation review, approval is required to submit a request showing that the drug product: (1) is intended for a serious or life-threatening condition and (2) has the potential to address an unmet medical need, demonstrate substantial improvement over available therapy, or fill an unmet need to be approved based on a surrogate endpoint. We expect that most information to support a designation request will have been gathered under existing requirements for preparing an investigational new drug (IND), new drug application (NDA), or biologics license application (BLA). If such information has already been submitted to us, the information may be summarized in the designation request. A designation request should include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request should be sufficient to permit a reviewer to assess whether the criteria for fast track, priority, breakthrough, RMAT or accelerated approval designation have been met.
After we make an expedited programs designation, a sponsor or applicant may submit a premeeting package that may include additional information supporting a request to participate in certain expedited programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for expedited programs designation, we expect that most sponsors or applicants will have gathered such information to meet existing requirements for preparing an IND, NDA, or BLA. These may include descriptions of clinical safety and efficacy trials not conducted under an IND ( e.g., foreign studies) and information to support a request for accelerated approval. If such information has already been submitted to us, the information may be summarized in the premeeting package.
The guidance documents are available on our website at www.fda.gov/regulatory-information/search-fda-guidance-documents and were issued consistent with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.
In the Federal Register of January 9, 2024 (89 FR 1101), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited.
FDA estimates the burden of this collection of information as follows:
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| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| CDER: | |||||
| Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section VIII) | 81 | 1.53 | 124 | 30 | 3,720 |
| Breakthrough Therapy Designation Requests (EPSC Section VI) | 71 | 1.08 | 77 | 70 | 5,390 |
| Fast Track Designation Requests (EPSC Section V) | 235 | 1.18 | 277 | 60 | 16,620 |
| Accelerated Approval Designation (EPSC Section VII) | 26 | 1.27 | 33 | 100 | 3,300 |
| Premeeting Packages (21 CFR 312.82) | 163 | 1.01 | 165 | 100 | 16,500 |
| CDER Subtotal | 676 | 45,530 | |||
| CBER: | |||||
| Priority Review Designation Request (EPSC Section VIII) | 8 | 1 | 8 | 30 | 240 |
| Breakthrough Therapy Designation Request (EPSC Section VI) | 15 | 1.1 | 17 | 70 | 1,190 |
| Fast Track Designation Requests (EPSC Section VII) | 64 | 1.2 | 77 | 60 | 4,620 |
| RMAT Designation Requests (Regenerative Medicine Therapies for Serious Conditions Guidance (RMAT) Section III) | 33 | 1.1 | 36 | 60 | 2,160 |
| Premeeting Packages (RMAT Section V) | 146 | 1.9 | 277 | 100 | 27,700 |
| CBER Subtotal | 415 | 35,910 | |||
| Total | 1,091 | 81,440 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on FY 2022 receipts, we estimate that for Center for Drug Evaluation and Research (CDER) products, 81 respondents will submit 124 requests for priority review designation annually, and we assume 30 hours are needed to prepare such a request. We estimate 71 respondents will submit 77 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 235 respondents will submit 277 requests for fast-track designation requests annually, and we assume 60 hours are required to prepare such a request. We estimate 26 respondents will submit 33 accelerated approval designation requests annually and we assume 100 hours are required to prepare such a request. Finally, CDER received 165 pre-meeting package submissions from 163 respondents. We assume 100 hours are needed to prepare a pre-meeting package.
Similarly, also based on FY 2022 receipts, we estimate that for CBER products, 8 applicants will submit 8 requests for priority review designation annually, and we assume 30 hours are required to prepare such a request. We estimate 15 respondents will submit 17 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 64 respondents will submit 78 requests for fast-track designation annually, and we assume 60 hours is required to prepare such a request. We also estimate 33 respondents will submit 35 requests for RMAT designation annually and assume that 60 hours are needed to prepare each RMAT designation request. Finally, CBER received 283 pre-meeting package submissions from 146 respondents. We assume 100 hours are needed to prepare a pre-meeting package.
Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 143 responses and 10,350 hours to reflect actual submissions we have received. We attribute these changes to increased interest in the expedited programs, new expedited programs, and an increase in the number of submissions we received over the last few years.
Dated: April 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08293 Filed 4-17-24; 8:45 am]
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