SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 29, 2016 (81 FR 85854), FDA published a final rule that established requirements for the electronic filing of entries for FDA-regulated products in the ACE or any other EDI system authorized by the CBP. The rule requires the submission of the Drug Registration Number for human and animal drugs in ACE at the time of entry. The Drug Registration Number that must be submitted at the time of entry in ACE is the unique facility identifier of the foreign establishment where the human or animal drug was manufactured, prepared, propagated, compounded, or processed before being imported or offered for import into the United States. The unique facility identifier is the identifier submitted by a registrant in accordance with the system specified under section 510 of the FD&C Act (21 U.S.C. 360).

II. Description of the Technical Amendments

We are amending the electronic import entries regulation to revise the statutory citation in the sections of that rule requiring submission of the Drug Registration Number for human drugs regulated by FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, and for animal drugs regulated by FDA's Center for Veterinary Medicine. The sections of the regulation specified in this rule, specifically 21 CFR 1.74(a)(1), 1.75(a), and 1.78(d), have been revised to change the reference from section 510(b) of the FD&C Act to section 510 of the FD&C Act, which is the correct statutory citation. The rule does not impose any new regulatory requirements on affected parties. The amendments are editorial in nature and should not be construed as modifying any substantive standards or requirements.

III. Notice and Public Comment

Publication of this document constitutes final action of these changes under the Administrative Procedures Act (APA) (5 U.S.C. 553). Section 553 of the APA exempts “rules of agency organization, procedure, or practice” from proposed rulemaking ( i.e., notice and comment rulemaking) (5 U.S.C. 553(b)(3)(A)). Rules are also exempt when an Agency finds “good cause” that notice and comment rulemaking procedures would be “impracticable, unnecessary, or contrary to the public interest” (5 U.S.C. 553(b)(3)(B).)

FDA has determined that this rulemaking meets the notice and comment exemption requirements in 5 U.S.C. 553(b)(3)(A) and (B). FDA's revisions make technical or nonsubstantive changes that pertain solely to ensuring that the regulations accurately cite the FD&C Act. FDA does not believe public comment is necessary for these minor revisions.

The APA allows an effective date less than 30 days after publication as “provided by the agency for good cause and published with the rule” (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because the amendments do not impose any new regulatory requirements on affected parties. As a result, affected parties do not need time to prepare before the rule takes effect. Therefore, FDA finds good cause for the amendments to become effective on the date of publication of this action.

Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR part 1 is amended as follows:

1. The authority citation for part 1 continues to read as follows:

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

2. Revise the third sentence of § 1.74(a)(1) to read as follows:

3. Revise the third sentence of § 1.75(a) to read as follows.

4. Revise the last sentence of § 1.78(d) to read as follows.