Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document Name	Status
0858SSACompounding 09.05.2024 FINAL.docx Supporting Statement A	2024-09-05

IC Document Collections

IC ID	Document Title	Status
267946	Reporting - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI Other-Agency Guidance	New
267944	Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI, Other-Agency Guidance	New
267943	Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI Other-Agency Guidance	New
248971	Biologics Compounding GFI Other-Agency Guidance	Removed
248970	Repackaging GFI Other-Agency Guidance	Removed
248607	Radiopharmaceutical Outsourcing & Repackaging GFI Other-Agency Guidance	Removed
232156	Radiopharmaceutical Compounding GFI Other-Agency Guidance	Removed

ICR Details

OMB Control No: 0910-0858	ICR Reference No: 202405-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202107-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/24/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2024
Responses	2,217	2,123
Time Burden (Hours)	1,082	968
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports FDA guidance regarding compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies, Federal facilities, or other facilities that are not outsourcing facilities and that hold a radioactive materials license for medical use issued by the Nuclear Regulatory Commission or by an Agreement State compounds or repackages radiopharmaceuticals for human use that are not registered as outsourcing facilities. Because these radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to drug production, FDA developed guidance to describe conditions under which the Agency does not intend to take action for violations of sections 505, 502(f)(1), and 501(a)(2)(B) of the FD&C Act when a state-licensed nuclear pharmacy or a federal facility that is not an outsourcing facility compounds or repackages radiopharmaceuticals for human use.

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Authorizing Statute(s): US Code: 21 USC 353 Name of Law: Federal Food, Drug and Cosmetic Act
  

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:
	89 FR 49880	06/12/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 77528	09/23/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Biologics Compounding GFI
Disclosure - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI, Biological Products GFI,
Radiopharmaceutical Compounding GFI
Radiopharmaceutical Outsourcing & Repackaging GFI
Recordkeeping - Radiopharmaceutical Compounding and Repackaging GFI, Biological Products GFI
Repackaging GFI
Reporting - Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities GFI, Repackaging GFI

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ICR Summary of Burden

	Total Request	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	2,217	2,123	0	0	94	0
Annual Time Burden (Hours)	1,082	968	0	0	114	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 burden estimate is adjusted to reflect a resulting increase of 114 hours and 94 responses annually.

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Annual Cost to Federal Government: $27,500

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.     No

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: 09/24/2024

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