Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-AI94-Drug_Establishment_SSA_7.13.26.docx	Supporting Statement A	Uploaded 2026-07-13	Available
0910-AI94-Drug_Establishment-PRIA_7.10.2026.pdf	Supplementary Document	Uploaded 2026-07-10	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
281436	June and December review and update (or certification) of listing		New
281435	Initial listing (including National Drug Code (NDC)) associated with section 2511 of the PREVENT Pandemics Act		New
281434	Annual review and update of registration information (including expedited updates)		New
281432	Initial foreign establishment registration associated with section 2511 of the PREVENT Pandemics Act		New
281429	Updates to registration, for DMUs		New
281427	Registration of DME		New

ICR Details

OMB Control No:	ICR Reference No: 202607-0910-004
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/14/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	52,355	0
Time Burden (Hours)	103,819	0
Cost Burden (Dollars)	7,786,425	0

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Abstract: This proposed rule, if finalized, would revise the current registration regulations in part 207 to provide clear instructions specific to registering a distributed manufacturing establishment (DME). The proposed rule would eliminate duplicate submission of registration information by not treating distributed manufacturing units (DMUs) within a DME as individual establishments requiring separate registrations. The proposed rule, if finalized, would also clarify the requirement of registration of foreign establishments that manufacture, prepare, propagate, compound, or process a drug that is imported or offered for import into the United States, regardless of whether the drug first undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States. The proposed rule would also clarify that such foreign establishments must list such drugs.

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Authorizing Statute(s): US Code: 21 USC 360(i) Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 360(j) 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:
0910-AI94	Proposed rulemaking	91 FR 42888	07/13/2026

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Annual review and update of registration information (including expedited updates)
Initial foreign establishment registration associated with section 2511 of the PREVENT Pandemics Act
Initial listing (including National Drug Code (NDC)) associated with section 2511 of the PREVENT Pandemics Act
June and December review and update (or certification) of listing
Registration of DME
Updates to registration, for DMUs

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ICR Summary of Burden

table that charts list 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	52,355	0	0	52,355	0	0
Annual Time Burden (Hours)	103,819	0	0	103,819	0	0
Annual Cost Burden (Dollars)	7,786,425	0	0	7,786,425	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $33,333

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: 07/14/2026

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