User Fees; Technical Amendment
| Published date | 26 February 2024 |
| Record Number | 2024-03777 |
| Citation | 89 FR 13979 |
| Court | Food And Drug Administration |
| Section | Rules and Regulations |
Federal Register, Volume 89 Issue 38 (Monday, February 26, 2024)
[Federal Register Volume 89, Number 38 (Monday, February 26, 2024)]
[Rules and Regulations]
[Pages 13979-13980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03777]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1150
[Docket No. FDA-2012-N-0920]
User Fees; Technical Amendment
AGENCY: Food and Drug Administration, (HHS).
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
its regulations to update a link regarding user fee disputes. This
technical amendment is non-substantive.
DATES: This rule is effective February 26, 2024.
FOR FURTHER INFORMATION CONTACT: Nate Mease and Tamika Hopkins, Center
for Tobacco Products, Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993-0002, 1-877-287-1373, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is amending Sec. 1150.15 (21 CFR
1150.15) to update the web address for information regarding user fee
disputes. FDA's user fee dispute regulations currently link to FDA's
general web page on tobacco products. FDA is revising Sec. 1150.15 to
specifically direct firms to FDA's web page on tobacco product user
fees by replacing ``https://www.fda.gov/tobacco-products'' with
``https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fees'' in two places.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (APA) (5 U.S.C. 553).
The APA generally exempts rules from the requirements of notice and
comment rulemaking when an agency ``for good cause finds (and
incorporates the finding and a brief statement of reasons therefor in
the rules issued) that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest'' (5
U.S.C. 553(b)(B)).
FDA has determined that notice and public comment are unnecessary
because this amendment to the regulation provides only technical or
non-substantive, ministerial changes to specify the location of
information on FDA's web page regarding tobacco product user fee
program. Such technical, non-substantive changes are ``routine
determination[s], insignificant in nature and impact, and
inconsequential to the industry and to the public.'' (Mack Trucks, Inc.
v. EPA, 682 F.3d 87, 94 (D.C. Cir. 2012)) (quotation marks and citation
omitted). Accordingly, FDA for good cause finds that notice and public
procedure thereon are unnecessary for changing the cited FDA web page
on tobacco user fees.
In addition, FDA finds good cause for these amendments to become
effective on the date of publication of this action. The APA allows an
effective date of less than 30 days after publication as ``provided by
the agency for good cause found 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 this correction to become effective on the date of publication of
this action.
List of Subjects in 21 CFR Part 1150
Tobacco products, User fees.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1150 is amended as follows:
PART 1150--USER FEES
0
1. The authority citation for part 1150 continues to read as follows:
Authority: 21 U.S.C. 371, 387a, 387b, 387i, 387s, 21 CFR
1100.1.
[[Page 13980]]
0
2. Amend Sec. 1150.15 by revising paragraphs (a)(4) and (d) to read as
follows:
Sec. 1150.15 Disputes.
(a) * * *
(4) Sent to the address found on our website (https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fees).
* * * * *
(d) A request for further Agency review under Sec. 10.75 of this
chapter may be submitted. Such a request must be submitted in writing
by the domestic manufacturer or importer and received by FDA within 30
days from the date on FDA's response. The request for further Agency
review must be legible, in English, and submitted to the address found
on our website (https://www.fda.gov/tobacco-products/manufacturing/tobacco-user-fees).
Dated: February 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03777 Filed 2-23-24; 8:45 am]
BILLING CODE 4164-01-P
