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.
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