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

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
241793	503A; Disclosure		New
241792	503A; Recordkeeping		New
241791	503A; Reporting		New
217572	503B Recordkeeping; AERs		Modified
217571	503B Reporting: AERs		Modified

ICR Details

OMB Control No: 0910-0800	ICR Reference No: 202005-0910-004
Status: Historical Active	Previous ICR Reference No: 201808-0910-004
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: 10/21/2020
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/14/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2023	36 Months From Approved	10/31/2021
Responses	9,080	0	110
Time Burden (Hours)	8,730	0	941
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) and includes reporting, recordkeeping, and disclosures. Section 503B pertains to outsourcing facilities and sets forth criteria under which sections 502(f)(1), 505, and 582 do not apply for a drug compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility. Section 503A pertains to human drug compounding and sets forth criteria under which sections 501(a)(2)(b), 502(f)(1), and 505 of the FD&C Act do not apply for a drug product compounded for an identified individual patient based on the receipt of a valid prescription order approved by a practitioner. Respondents to the collection are those who compound drugs, outsourcing facilities, and State Boards of Pharmacy or other State Agencies entering into a MOU with FDA to address certain distributions of compounded human drug products.

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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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45631	09/10/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 28961	05/14/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
503A; Disclosure
503A; Recordkeeping
503A; Reporting
503B Recordkeeping; AERs
503B Reporting: AERs

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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	9,080	110	0	0	8,970	0
Annual Time Burden (Hours)	8,730	941	0	0	7,789	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: The information collection is being revised to include the collection of related data elements. This results in an additional 8,970 annual responses and 7,789 additional hours of estimated burden to the information collection.

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Annual Cost to Federal Government: $1,180,197

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: 05/14/2020

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