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OMB Control No: 0910-0045	ICR Reference No: 202603-0910-008
Status: Active	Previous ICR Reference No: 202408-0910-003
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/21/2026
	Date Received in OIRA: 03/16/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	07/31/2028
Responses	381,362	0	353,659
Time Burden (Hours)	339,474	0	323,271
Cost Burden (Dollars)	0	0	0

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. This information collection supports agency rulemaking titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The rule will standardize the format of National Drug Codes (NDC) assigned under section 510(e) of the FD&C Act (21 U.S.C. 360(e)). This final rule modifies FDA's prescription drug product labeling regulations in 21 CFR parts 201 and 207. We are revising 21 CFR part 207 to establish a uniform, 12-digit format for the NDC (21 CFR 207.33). We are also revising the drug barcode label requirements (21 CFR 201.25) to allow the use of either linear or nonlinear barcodes, so long as the barcode format conforms to certain standards and is recognized by FDA. The rule will require manufacturers, repackers, relabelers, drug product salvagers, and private label distributors of such products to update labels with the new NDC format and require application holders and license holders to report label changes under 21 CFR 314.81, 514.80, or 601.12, respectively.

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: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI52	Final or interim final rulemaking	91 FR 10749	03/05/2026

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	381,362	353,659	27,703
Annual Time Burden (Hours)	339,474	323,271	16,203
Annual Cost Burden (Dollars)	0	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: We request OMB approval of the information collection associated with the final rule. We estimate the rulemaking will result in a one-time burden increase of 16,203 hours and 27,703 records to account for labeling changes made to reflect the revised NDC format and not made in coordination with a periodic labeling change. Over the 3-year transition period, and as distributed across three affected Centers, this represents an increase of 1,800 hours per year, per Center. The previously approved burden was 323,271 hours and 353,659 responses. With the burden of this rule incorporated, the requested total is 339,474 hours and 381,362 responses.

Annual Cost to Federal Government: $3,265,841

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

Agency Contact: Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov

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