Economic Hardship Fee Reduction Guidance

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SS- 0910-NEW- Economic Hardship ( FSMA ).doc	Supporting Statement A	Uploaded 2011-12-09	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
200421	Reporting: Request for Reduction of Fees Under Section 743 of the FD&C Act		New

ICR Details

OMB Control No:	ICR Reference No: 201112-0910-002
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Economic Hardship Fee Reduction Guidance
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/06/2012
OIRA Conclusion Action: Withdrawn	Conclusion Date: 03/29/2012
	Date Received in OIRA: 12/12/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, the ICR has been withdrawn at the request of the agency.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		6 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: On January 4, 2011, the President signed into law the FDA Food Safety Modernization Act (FSMA) (P.L. 111-353). Section 743 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by FSMA, requires the Food and Drug Administration (FDA) to consider the burden of fee amounts on small businesses. Section 743(b)(2)(B)(iii) of FD&C Act requires the FDA to publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. FDA published a Federal Register Notice (FRN), on August 1, 2011 (76 FR 45818), to seek public comments and gather information to assist the Agency to develop such guidelines. FDA will review the comments (comment period closes on November 30, 2011) and then develop the proposed set of guidelines; FDA wants to consider the public comments from the small business FRN before finalizing such guidance. Also, in the recent Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act published September 30, 2011 (76 FR 62073), FDA stated that it would "not intend to issue invoices for reinspection or recall order fees until this guidance document has been finalized." Therefore, FDA will publish such guidance soon after November 30, 2011, in order to: 1) issue invoices, and 2) provide important information for qualified firms to apply for fee reductions, which will help them to sustain their businesses.

Emergency Justfication: On January 4,2011, the President signed into law the FDA Food Safety Modernization Act ( P.L. 111 - 353)( FSMA). Section 743 of the Federal Food and Drug Cosmetic Act ( FD&C Act) amended by FSMA, requires the Food and Drug Administration ( FDA) to consider the burden of fee amounts on small businesses. FDA is currently developing a guidance to outline the process through which firms may request a reduction of fees based on economic hardship. FDA published a notice on August 1, 2011 seeking public comment and to gather additional information related to small business burdens associated with fees to set forth criteria and a rational for such criteria when a user fee reduction is appropriate ( comment period closes November 30, 2011). However, FDA needs to consider the comments from the small business FRN before finalizing the guidance. To further comply with the statutory provisions of FSMA , FDA needs to publish the guidance soon after November 30, 2011 in order to : 1) issue invoices, and also 2) provide important information for qualified firms to apply for fee reductions which will help them sustain their businesses.The use of the normal process for obtaining OMB approval of this ICR would likely cause delay in publishing the guidance and subsequently cause delay of issuing invoices.

---

Authorizing Statute(s): PL: Pub.L. 111 - 353 743 Name of Law: null
  

Citations for New Statutory Requirements: Statute at Large: 21 Stat. 743 Name of Statute: null

---

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:
	76 FR 227	11/25/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 227	11/25/2011
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Reporting: Request for Reduction of Fees Under Section 743 of the FD&C Act

---

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: This is a new collection of information submitted for short term OMB approval under the emergency processing provisions of the PRA. Please refer to item # 15 of the supporting statement regarding the agreement between OMB and FDA for submission of the final version of the guidance instrument

---

Annual Cost to Federal Government: $89,033

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: 12/12/2011

---