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

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

IC Document Collections

IC ID	Document Title	Status
212979	Copy of small business designation letter	Removed
212978	Appeal request	Removed
212977	Reconsideration request	Removed
212976	Payment of reinspection fee	Removed
212975	Retention of small business designation notification	Modified
212974	Registration of Oursourcing Facilitites and Payment of Fees	Modified

ICR Details

OMB Control No: 0910-0776	ICR Reference No: 202011-0910-001
Status: Active	Previous ICR Reference No: 201710-0910-008
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/30/2020
	Date Received in OIRA: 11/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved	12/31/2020
Responses	116	0	109
Time Burden (Hours)	429	0	425
Cost Burden (Dollars)	0	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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 51442	08/20/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 73483	11/18/2020
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
Payment of reinspection fee	3908
Reconsideration request	3908
Appeal request	3908
Copy of small business designation letter	3908
Registration of Oursourcing Facilitites and Payment of Fees	3908
Retention of small business designation notification	3908

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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	116	109	0	0	7	0
Annual Time Burden (Hours)	429	425	0	0	4	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 changes and adjustments. We have consolidated activity pertaining to the assessment of fees established under 0910-0777 into this collection established for registration of the outsourcing facilities that incur those fees. We have also adjusted the number of respondents to the collection consistent with submissions received since last review of the information collection.

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Annual Cost to Federal Government: $208,103

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: 11/27/2020

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