Expedited Programs for Serious Conditions-Drugs and Biologics

Forms and Documents

Document Name	Status
Clean_0765_Supporting Statement_2024-8-1.docx Supporting Statement A	2024-08-23

IC Document Collections

IC ID	Document Title	Status
269542	Premeeting Packages - CBER Other-Agency Guidance	Unchanged
269541	Fast Track Designation Requests - CBER Other-Agency Guidance	Unchanged
269540	Breakthrough Therapy Designation Requests - CBER Other-Agency Guidance	Unchanged
269539	Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER Other-Agency Guidance	Unchanged
269538	Accelerated Approval Designation - CDER Other-Agency Guidance	Unchanged
233190	RMAT Designation Requests - CBER Other-Agency Guidance	Unchanged
230039	Premeeting packages - CDER Other-Agency Guidance	Unchanged
230038	Fast Track Designation Requests - CDER Other-Agency Guidance	Unchanged
209910	Breakthrough Therapy Designation Requests - CDER Other-Agency Guidance	Unchanged
209909	Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0765	ICR Reference No: 202408-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202407-0910-004
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	Date Submitted to OIRA: 08/23/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	1,091	948
Time Burden (Hours)	81,440	71,090
Cost Burden (Dollars)	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

IC Title	Form No.	Form Name
Accelerated Approval Designation - CDER
Breakthrough Therapy Designation Requests - CBER
Breakthrough Therapy Designation Requests - CDER
Fast Track Designation Requests - CBER
Fast Track Designation Requests - CDER
Premeeting Packages - CBER
Premeeting packages - CDER
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER
RMAT Designation Requests - CBER

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,091	948	0	0	143	0
Annual Time Burden (Hours)	81,440	71,090	0	0	10,350	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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. Also, we have added the Regenerative Medicine Therapies for Serious Conditions program to this information collection as another expedited program. There is increased interest in the expedited programs and accelerated approval designations.

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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: 08/23/2024

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