Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0800 503A 503B SSA 2022 REV.docx	Supporting Statement A	Uploaded 2022-10-25	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256583	Outsourcing Facilities: Registration and reporting of drugs under 503B(b)	Other-Statutory Authority	New
241793	503A; Disclosure	Other-Memorandum of Understanding	Unchanged
241792	503A; Recordkeeping	Other-Memorandum of Understanding	Unchanged
241791	503A; Reporting	Other-Memorandum of Understanding	Unchanged
217572	503B Recordkeeping; AERs	Other-Guidance	Unchanged
217571	503B Reporting: AERs	Other-Guidance	Unchanged

ICR Details

OMB Control No: 0910-0800	ICR Reference No: 202210-0910-015
Status: Historical Active	Previous ICR Reference No: 202005-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/25/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/25/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2025	36 Months From Approved	10/31/2023
Responses	17,191	0	9,080
Time Burden (Hours)	8,944	0	8,730
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) - which governs pharmacy compounding and outsourcing facilities. The requirements include reporting, recordkeeping, and disclosures.

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Authorizing Statute(s): PL: Pub.L. 116 - 8 503A; 503B Name of Law: FD&C Act: Pharmacy Compounding; Outsourcing Facilities
  

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:
	87 FR 36507	06/17/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 61052	10/07/2022
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
503A; Disclosure
503A; Recordkeeping
503A; Reporting
503B Recordkeeping; AERs
503B Reporting: AERs
Outsourcing Facilities: Registration and reporting of drugs under 503B(b)

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ICR Summary of Burden

table that charts list 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	17,191	9,080	0	0	8,111	0
Annual Time Burden (Hours)	8,944	8,730	0	0	214	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: To account for revising the information collection to include registration of outsourcing facilities and reporting of drugs, we have adjusted the estimated burden by an increase of 8,111 responses and 214 hours annually. Upon OMB approval we intend to discontinue control no. 0910-0827.

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Annual Cost to Federal Government: $1,444,738

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.     Yes

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: 10/25/2022

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