Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K

Forms and Documents

Document Name	Status
0776 Registration and Fees Outsourcing Facilities 2023 SSA EXT.docx Supporting Statement A	2023-12-01

IC Document Collections

IC ID	Document Title	Status
212975	Retention of small business designation notification Other-Guidance	Modified
212974	Registration of Oursourcing Facilitites and Payment of Fees Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0776	ICR Reference No: 202311-0910-015
Status: Received in OIRA	Previous ICR Reference No: 202011-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K
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: 12/01/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2023
Responses	206	116
Time Burden (Hours)	861	429
Cost Burden (Dollars)	0	0

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Abstract: This information collection helps to support implementation of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Drug Quality and Security Act (DQSA) regarding the registration of human drug compounding outsourcing facilities. The information collection also implements provisions applicable to registered outsourcing facilities and the assessment and remission of user fees under section 744K of the FD&C Act.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. 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:
	88 FR 55464	08/15/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 83949	12/01/2023
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Registration of Oursourcing Facilitites and Payment of Fees	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request
Retention of small business designation notification	3908	Outsourcing Facilities for Human Drug Compounding Small Business Establishment Fee Reduction Request

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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	206	116	0	0	90	0
Annual Time Burden (Hours)	861	429	0	0	432	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 reflects an increase in the number of annual registrations, but a decrease in reinspection fee submissions. The adjustments result in an increase of 90 responses and 432 hours annually.

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Annual Cost to Federal Government: $312,000

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: 12/01/2023

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