Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT FINAL 503B AE Guidance 7-20-2015.docx	Supporting Statement A	Uploaded 2015-07-20	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
217572	Records of Adverse Events, Including Records of Efforts to Obtain the Data Elements for Each Adverse Event Report	Other-Guidance	New
217571	Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance	Other-Guidance	New

ICR Details

OMB Control No: 0910-0800	ICR Reference No: 201507-0910-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Adverse Event Reporting for Outsourcing Facilities Under Section 503B 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: 09/30/2015
	Date Received in OIRA: 08/04/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	110	0	0
Time Burden (Hours)	941	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance implements provisions added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the Drug Quality and Security Act (DQSA), which created a statutory category of "outsourcing facilities" that compound human drugs. Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353b) requires compounders that register with FDA as outsourcing facilities to report adverse events to FDA. Specifically, under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA "in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)." We are requesting OMB approval of the information collection resulting from adverse event reporting for outsourcing facilities.

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Authorizing Statute(s): US Code: 21 USC 353b Name of Law: FFDCA
  

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:
	80 FR 8872	02/19/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 45999	08/03/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Submission of Adverse Event Reports Including Copy of Labeling and Other Information as Described in the Guidance
Records of Adverse Events, Including Records of Efforts to Obtain the Data Elements for Each Adverse Event Report

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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	110	0	0	110	0	0
Annual Time Burden (Hours)	941	0	0	941	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 data collection.

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Annual Cost to Federal Government: $275,000

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

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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: 08/04/2015

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