*3 Maximum total annual responses for any regulatory requirement within each category. Individual regulatory requirements within the category may involve fewer total annual responses.
*4 Rounded to three decimals. Total hours reflect a more precise, non-rounded average burden per response. An approximate (non-rounded) conversion to minutes is shown in parentheses.
*5 Total hours are based on a more precise burden per response than the rounded value shown in these tables.
The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507(d) of the PRA.
Before the effective date of this final rule,
VI. Environmental Impact
FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
VII. Effective Dates
A. Effective Dates. This rule is effective on
* SUBSEC 830.100, 830.110, 830.120, and 830.130--Provisions regarding
B. Compliance Dates.
Compliance dates for:
FDA is establishing compliance dates for SUBSEC 801.18, 801.20, 801.50, and 830.300 as follows for any device that its labeler puts in commercial distribution after the applicable date indicated below:
1. For a class III medical device or a device licensed under the Public Health Service Act,
a. Identify the device or devices that would be subject to the extension;
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