Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

Forms and Documents

Document Name	Status
COMMENT HYMAN ATTACHMENT 2 8-27-13.pdf Supplementary Document	2013-12-09
COMMENT HYMAN WITH Attachment 8-27-13.pdf Supplementary Document	2013-12-09
COMMENT EVERYLIFE FOUND Attachment 1 8-26-13.pdf Supplementary Document	2013-12-09
COMMENT BIOTECHNOLOGY IND APPENDIX A 8-26-13.pdf Supplementary Document	2013-12-09
SUPPORTING STATEMENT FINAL 12-30-13.doc Supporting Statement A	2013-12-30

IC Document Collections

IC ID	Document Title	Status
209911	Promotional Materials for Accelerated Approval Under Section 314.550 Other-Guidance	New
209910	Breakthrough Therapy Designation Request Other-Guidance	New
209909	Priority Review Designation Request Other-Guidance	New

ICR Details

OMB Control No: 0910-0765	ICR Reference No: 201312-0910-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 21067
Title: Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/25/2014
	Date Received in OIRA: 12/31/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2017	36 Months From Approved
Responses	211	0	0
Time Burden (Hours)	19,890	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation and those who wish to disseminate promotional materials for a product under accelerated approval. FDA determines whether an application qualifies for priority review for every application, however, an applicant may expressly request priority review. Respondents submit information for priority review and breakthrough therapy designation requests, including the proposed indication and a summary of the information that supports the designation request, as described in the guidance. Respondents submit promotional materials for accelerated approval under 21 CFR 314.550, including promotional labeling as well as advertisements, as described in the regulation. FDA uses the information submitted in priority review and breakthrough therapy designation requests to assess whether drug products meet the criteria for the designations. FDA uses the information from promotional materials for accelerated approval products to assess whether the material complies with FDA requirements

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 38349	06/26/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 66939	11/07/2013
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Priority Review Designation Request
Breakthrough Therapy Designation Request
Promotional Materials for Accelerated Approval Under Section 314.550

---

ICR Summary of Burden

	Total Approved	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	211	0	0	211	0	0
Annual Time Burden (Hours)	19,890	0	0	19,890	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection request.

---

Annual Cost to Federal Government: $1,438,889

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

---

Common Form ICR:  No

---

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: 12/31/2013

---