[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Rules and Regulations]
[Pages 17059-17060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06679]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2016-N-1487]


Electronic Import Entries; Technical Amendments

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending its electronic import entries regulation to correct the 
statutory citation in the sections of that regulation requiring 
submission of the

[[Page 17060]]

Drug Registration Number for human drugs and for animal drugs. The 
present revisions are necessary to correct editorial errors and to 
ensure that the codified cites the correct section of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). The electronic import entries 
regulation provides that the Drug Registration Number, which must be 
submitted at the time of entry in the Automated Commercial Environment 
(ACE) or any other electronic data interchange (EDI) system authorized 
by the U.S. Customs and Border Protection Agency (CBP), is the unique 
facility identifier specified in the FD&C Act. This rule does not 
impose any new regulatory requirements on affected parties. This action 
is editorial in nature and is intended to improve the accuracy of the 
Agency's regulations.

DATES: This rule is effective April 1, 2021.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ann Metayer, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4375, Silver Spring, MD 20903-0002, 301-796-3324, 
Ann.Metayer@fda.hhs.gov.

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.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting and recordkeeping requirements.

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

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
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.


0
2. Revise the third sentence of Sec.  1.74(a)(1) to read as follows:


Sec.  1.74  Human drugs.

* * * * *
    (a) * * *
    (1) * * * The unique facility identifier is the identifier 
submitted by a registrant in accordance with the system specified under 
section 510 of the Federal Food, Drug, and Cosmetic Act. * * *
* * * * *

0
3. Revise the third sentence of Sec.  1.75(a) to read as follows.


Sec.  1.75   Animal drugs.

* * * * *
    (a) * * * The Unique Facility Identifier is the identifier 
submitted by a registrant in accordance with the system specified under 
section 510 of the Federal Food, Drug, and Cosmetic Act. * * *
* * * * *

0
4. Revise the last sentence of Sec.  1.78(d) to read as follows.


Sec.  1.78   Biological products, HCT/Ps, and related drugs and medical 
devices.

* * * * *
    (d) * * * The unique facility identifier is the identifier 
submitted by a registrant in accordance with the system specified under 
section 510 of the Federal Food, Drug, and Cosmetic Act.
* * * * *

    Dated: March 25, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-06679 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P


