Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

Forms and Documents

Document Name	Status
0045 Drug Reg and Listing SSA 2024 Rev for clarifications.docx Supporting Statement A	2024-12-20
0045 Change Request 2022.docx Justification for No Material/Nonsubstantive Change	2022-12-29

IC Document Collections

IC ID	Document Title	Status
5696	Initial establishment registration Other-Agency Guidance	Modified
257653	Reporting and Mitigating Animal Drug Shortages Other-Reporting and Mitigating Animal Drug Shortages - Agency Gu	Unchanged
257647	Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Recordkeeping; developing and updating plan) Other-Planning for the Effects of Absenteeism Guidance	Removed
257646	Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation) Other-Planning for the Effects of Absenteeism - Agency Guidance	Unchanged
250057	Manufacture amounts and exemption from reporting - drug shortage determinations Other-Public Law: CARES Act	Modified
187821	RECORDKEEPING: One-Time Preparation of SOP	Removed
187820	Waiver requests	Unchanged
183175	June and December review and updates (or certifications) of listing (including NDC) information Other-Agency Guidance	Modified
183174	Requests for exemptions from public disclosures Other-Agency Guidance	Modified
183173	Initial listing (including NDC) information Other-Agency Guidance	Modified
183172	Annual Updates of Registration Information (including expedited updates) Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0045	ICR Reference No: 202408-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/20/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2024
Responses	353,659	420,663
Time Burden (Hours)	323,271	235,858
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports implementation of requirements related to drug establishment registration and listing governed by section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), including registrant reporting under section 510(j)(3) of the FD&C Act (21 U.S.C. 360(j)(3)) with respect to listed drugs. Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed. Drug listing information gives FDA a current inventory of drugs manufactured, repacked, relabeled, or salvaged for commercial distribution. Data reported by registrants under section 510(j)(3) of the FD&C Act on the amount of listed drugs they annually manufacture, prepare, propagate, compound or process provide FDA with a more comprehensive picture of the drug supply chain, which can inform operational decisions and support the Agency’s efforts to reduce drug shortage risk.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, & Cosmetic Act; Registration of producers of drugs or devices
  

Citations for New Statutory Requirements: PL: Pub.L. 110 - 85 224 Name of Law: FDA Amendments Act; Electronic Registration and Listing

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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 72403	09/05/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 104188	12/20/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Annual Updates of Registration Information (including expedited updates)
Initial establishment registration
Initial listing (including NDC) information
June and December review and updates (or certifications) of listing (including NDC) information
Manufacture amounts and exemption from reporting - drug shortage determinations
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Recordkeeping; developing and updating plan)
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation)
RECORDKEEPING: One-Time Preparation of SOP
Reporting and Mitigating Animal Drug Shortages
Requests for exemptions from public disclosures
Waiver requests

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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	353,659	420,663	0	0	-67,004	0
Annual Time Burden (Hours)	323,271	235,858	0	0	87,413	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: Cumulative adjustments and modifications result in a decrease of 67,004 responses and an increase of 87,413 burden hours, annually. We discuss these fluctuations more fully at Q-15 of our SSA.

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Annual Cost to Federal Government: $3,250,000

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: 12/20/2024

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