Rule2023-06260
Change of Address; Technical Amendment
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 27, 2023
Effective
March 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 58 (Monday, March 27, 2023)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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,
<a href="/cdn-cgi/l/email-protection#58123d3e3e76163d3434313f3936183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="f2b8979494dcbc979e9e9b95939cb2949693dc9a9a81dc959d84">[email protected]</span></a>.
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 <a href="/cdn-cgi/l/email-protection#93dcd4c3c0d6ebf6f0c0f6f0d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="f7b8b0a7a4b28f9294a49294b7919396d99f9f84d9909881">[email protected]</span></a>, 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
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</html>Indexed from Federal Register on March 27, 2023.
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