Document ID: FDA-2016-N-1745-0001
Agency: fda
Document Type: Rule
Title: Maximum Civil Money Penalty Amounts; Technical Amendment
Posted Date: 2016-09-09T04:00Z

[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Rules and Regulations]
[Page 62358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21705]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2016-N-1745]

Maximum Civil Money Penalty Amounts; 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 we) is amending its 
regulations to remove the maximum civil money penalties table 
associated with statutory provisions. This information will be included 
in the Department of Health and Human Services' (HHS) regulations. We 
are taking this action to comply with the Federal Civil Penalties 
Inflation Adjustment Act of 2015.

DATES: This rule is effective September 9, 2016.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248, 
Silver Spring, MD 20993-0002, 301-796-4830.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 3, 2014 
(79 FR 6088), FDA issued a new regulation in 21 CFR 17.2 to adjust for 
inflation the maximum civil money penalty amounts for the various civil 
money penalty authorities within our jurisdiction and other matters.
    FDA is amending 21 CFR 17.2 to remove the maximum civil money 
penalties table associated with statutory provisions authorizing civil 
money penalties under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) or the Public Health Service Act (PHS Act). The Federal Civil 
Penalties Inflation Adjustment Act of 2015 (Pub. L. 114-74, November 2, 
2015) requires each Agency to adjust each civil money penalty provided 
by law within the jurisdiction of that Agency in one regulation. In 
accordance with this requirement, HHS is issuing a regulation that, in 
a consolidated table, adjusts the maximum civil money penalties 
associated with statutory provisions authorizing such penalties for all 
HHS Agencies. Because this consolidated table of these maximum civil 
money penalties, including those authorized under the FD&C Act and the 
PHS Act, can be found at 45 CFR 102.3, we are including a cross-
reference to 45 CFR 102.3 in our regulations. We are taking this action 
to comply with the Federal Civil Penalties Inflation Adjustment Act of 
2015.
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comments are unnecessary because the amendments to 
the regulations provide only technical changes to remove and update 
information and are nonsubstantive.

List of Subjects in 21 CFR Part 17

    Administrative practice and procedure, Penalties.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 17 is amended as follows:

PART 17--CIVIL MONEY PENALTIES HEARINGS

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1. The authority citation for part 17 continues to read as follows:

    Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554, 
555, 556, 557.

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2. Revise Sec.  17.2 to read as follows:

Sec.  17.2  Maximum penalty amounts.

    The maximum civil money penalties associated with the statutory 
provisions authorizing civil money penalties under the Federal Food, 
Drug, and Cosmetic Act or the Public Health Service Act can be found at 
45 CFR part 102. The table of these maximum civil money penalties can 
be found at 45 CFR 102.3.

    Dated: July 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21705 Filed 9-8-16; 8:45 am]
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