Expedited Programs for Serious Conditions-Drugs and Biologics

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0765_Supporting Statement_2024.docx	Supporting Statement A	Uploaded 2024-04-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
263126	Premeeting Packages (RMAT Section V) - CBER	Other-Agency Guidance	New
263125	Fast Track Designation Requests (EPSC Section VII) - CBER	Other-Agency Guidance	New
263124	Breakthrough Therapy Designation Request (EPSC Section VI) - CBER	Other-Agency Guidance	New
263123	Priority Review Designation Request (EPSC Section VIII) - CBER	Other-Agency Guidance	New
263119	Accelerated Approval Designation (EPSC Section VII) - CDER	Other-Agency Guidance	New
233190	RMAT Designation Requests (Regenerative Medicine Therapies for Serious Conditions Guidance (RMAT) Section III) - CBER	Other-Agency Guidance	Modified
230039	Premeeting packages - CDER	Other-Agency Guidance	Modified
230038	Fast Track Designation Requests (EPSC Section V) - CDER	Other-Agency Guidance	Modified
209910	Breakthrough Therapy Designation Requests (EPSC Section VI) - CDER	Other-Agency Guidance	Modified
209909	Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section VIII) - CDER	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0765	ICR Reference No: 202309-0910-011
Status: Historical Inactive	Previous ICR Reference No: 202102-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Expedited Programs for Serious Conditions-Drugs and Biologics
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 07/22/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/18/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2024	36 Months From Approved	03/31/2025
Responses	948	0	948
Time Burden (Hours)	71,090	0	71,090
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation. Respondents to the collection are manufacturers or sponsors of drug and/or biologic products.

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Authorizing Statute(s): US Code: 21 USC 356 Name of Law: FFDCA; Expedited Approval of Drugs
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 11011	01/08/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 27767	04/18/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

table that charts list of burden

IC Title	Form No.	Form Name
Accelerated Approval Designation (EPSC Section VII) - CDER
Breakthrough Therapy Designation Request (EPSC Section VI) - CBER
Breakthrough Therapy Designation Requests (EPSC Section VI) - CDER
Fast Track Designation Requests (EPSC Section V) - CDER
Fast Track Designation Requests (EPSC Section VII) - CBER
Premeeting Packages (RMAT Section V) - CBER
Premeeting packages - CDER
Priority Review Designation Request (EPSC Section VIII) - CBER
Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section VIII) - CDER
RMAT Designation Requests (Regenerative Medicine Therapies for Serious Conditions Guidance (RMAT) Section III) - CBER

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Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $1,626,740

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/18/2024

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