[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Rules and Regulations]
[Pages 18037-18038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06260]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. FDA-2023-N-0986]


Change of Address; Technical Amendment

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

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
amending its regulations to update the address, email address, and 
office name for the Office of Policy, Legislation, and International 
Affairs, Office of Global Policy and Strategy. This technical amendment 
is to ensure accuracy and clarity in the Agency's regulations and is 
nonsubstantive.

DATES: This rule is effective March 27, 2023.

FOR FURTHER INFORMATION CONTACT: Jeff Nelligan, Office of Global Policy 
and Strategy, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 3438, Silver Spring, MD 20993, 301-796-8814, 
[email protected].

SUPPLEMENTARY INFORMATION:  FDA is amending 21 CFR part 312 to update 
the name of an office, its physical address, and instructions for 
sending certifications via email. Publication of this document 
constitutes final action on the changes under the Administrative 
Procedure Act (5 U.S.C. 553). FDA has determined that notice and public 
comment are unnecessary because this amendment to the regulations 
provides only technical changes to update organizational information.

List of Subjects in 21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
312 is amended as follows:

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

0
1. The authority citation for part 312 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 
42 U.S.C. 262.


0
2. In Sec.  312.110, revise paragraph (b)(4) introductory text to read 
as follows:


Sec.  312.110  Import and export requirements.

* * * * *
    (b) * * *
    (4) Except as provided in paragraph (b)(5) of this section, the 
person exporting the drug sends an email certification to the Office of 
Global Policy and Strategy at [email protected], or a written 
certification to the Office of Global Policy and Strategy (HFG-1), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 3420, 
Silver Spring, MD 20993, at the time the drug is first exported and 
maintains records documenting compliance with this paragraph (b)(4). 
The certification shall

[[Page 18038]]

describe the drug that is to be exported (i.e., trade name (if any), 
generic name, and dosage form), identify the country or countries to 
which the drug is to be exported, and affirm that:
* * * * *

    Dated: March 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06260 Filed 3-24-23; 8:45 am]
BILLING CODE 4164-01-P


