Document ID: FDA-2005-N-0464-0249
Agency: fda
Document Type: Rule
Title: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
Posted Date: 2021-04-01T04:00Z

[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Rules and Regulations]
[Page 17061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06677]

[[Page 17061]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 207

[Docket No. FDA-2005-N-0464]
RIN 0910-AA49

Requirements for Foreign and Domestic Establishment Registration 
and Listing for Human Drugs, Including Drugs That Are Regulated Under a 
Biologics License Application, and Animal Drugs; Corrections

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

ACTION: Final rule; correcting amendments.

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SUMMARY: On August 31, 2016, the Food and Drug Administration (FDA or 
Agency) published an amended final rule that listed inaccurate cross-
references to FDA's drug establishment registration and drug listing 
regulations. This document corrects the inaccurate cross-references 
used in the final regulations.

DATES: This rule is effective April 1, 2021.

FOR FURTHER INFORMATION CONTACT: Florine Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3521.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 31, 2016 (81 FR 60170), FDA 
published the final rule entitled ``Requirements for Foreign and 
Domestic Establishment Registration and Listing for Human Drugs, 
Including Drugs That Are Regulated Under a Biologics License 
Application, and Animal Drugs.'' That final rule amended current 
regulations in part 207 (21 CFR part 207) concerning who must register 
establishments and list human drugs, human drugs that are also 
biological products, and animal drugs.

II. Description of the Technical Amendments

    FDA is amending its regulations in part 207 to correct inaccurate 
cross-references used in the August 31, 2016, final rule. This document 
amends the Agency's regulations in part 207 through minor technical 
amendments to update references in Sec. Sec.  207.1, 207.3, 207.13, 
207.49, and 207.53 (21 CFR 207.1, 207.3, 207.13, 207.49, and 207.53) by 
replacing all cross-references to ``Sec.  207.1(b)'' with ``Sec.  
207.1''.

III. Notice and Public Comment

    Publication of this document constitutes final action on these 
changes under the Administrative Procedure 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 only technical changes to correct inaccurate cross-
references. 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 207

    Drugs, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR 
part 207 is amended as follows:

PART 207--REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT 
REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE 
REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, 
AND THE NATIONAL DRUG CODE

0
1. The authority citation for part 207 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 
374, 381, 393; 42 U.S.C. 262, 264, 271.

Sec.  207.1   [Amended]

0
2. Amend Sec.  207.1 in the definition of Bulk drug substance by 
removing ``Sec.  207.1(b)'' and adding in its place ``this section''.

Sec.  207.3   [Amended]

0
3. Amend Sec.  207.3 by removing ``Sec.  207.1(b)'' and adding in its 
place ``Sec.  207.1''.

Sec.  207.13   [Amended]

0
4. Amend Sec.  207.13(l)(1) by removing ``Sec.  207.1(b)'' and adding 
in its place ``Sec.  207.1''.

Sec.  207.49   [Amended]

0
5. Amend Sec.  207.49(a)(15)(i), (a)(15)(ii)(A) and (B), and 
(a)(15)(iii)(A) and (B) by removing ``Sec.  207.1(b)'' and adding in 
its place ``Sec.  207.1''.

Sec.  207.53   [Amended]

0
6. Amend Sec.  207.53(d)(1), (d)(2)(i) and (ii), and (d)(3)(i) and (ii) 
by removing ``Sec.  207.1(b)'' and adding in its place ``Sec.  207.1''.

    Dated: March 25, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-06677 Filed 3-31-21; 8:45 am]
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