Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT FEES FINAL 9-4-14.doc	Supporting Statement A	Uploaded 2014-09-04	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
212979	Copy of small business designation letter	Other-Guidance	New
212978	Appeal request	Other-Guidance	New
212977	Reconsideration request	Other-Guidance	New
212976	Payment of reinspection fee	Other-Guidance	New
212975	Request for Small Business Establishment Fee Reduction (FDA Form 3908)	Other-Guidance	New
212974	Payment of annual establishment fee	Other-Guidance	New

ICR Details

OMB Control No: 0910-0776	ICR Reference No: 201409-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act
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: 10/17/2014
	Date Received in OIRA: 09/08/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2017	36 Months From Approved
Responses	104	0	0
Time Burden (Hours)	425	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: Once an entity has elected to register as an outsourcing facility, it must pay certain fees to be registered as an outsourcing facility. The guidance describes the types and amounts of fees that outsourcing facilities must pay, the adjustments to fees required by law, how outsourcing facilities may submit payment to FDA, the consequences of outsourcing facilities' failure to pay fees, and how an outsourcing facility may qualify as a small business to obtain a reduction in fees

---

Authorizing Statute(s): US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 352(F)(1) Name of Law: FD&C Act
  

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:
	79 FR 18297	04/01/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 52012	09/02/2014
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Reconsideration request	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Payment of annual establishment fee	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Request for Small Business Establishment Fee Reduction (FDA Form 3908)	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Payment of reinspection fee	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Appeal request	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Copy of small business designation letter	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request

---

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	104	0	0	104	0	0
Annual Time Burden (Hours)	425	0	0	425	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new data collection.

---

Annual Cost to Federal Government: $208,103

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: 09/08/2014

---