Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Revision of a currently approved collection
No
Regular
03/16/2026
Requested
Previously Approved
36 Months From Approved
07/31/2028
381,362
353,659
339,474
323,271
0
0
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.
US Code:
21 USC 301 et seq.
Name of Law: Federal Food, Drug, & Cosmetic Act; Registration of producers of drugs or devices
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.
$3,265,841
No
Yes
No
No
No
No
No
Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov
No
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:
(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;
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.
03/16/2026
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Initial establishment registration