Federal Register - August 2, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any one year. The current threshold after adjustment for inflation is $158 million, using the most current 2020 Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
2. Summary of Costs and Benefits The final rule clarifies but does not change FDAs interpretation and application of existing intended use regulations for medical products.
The benefits of this rule are additional clarity and certainty for manufacturers and stakeholders regarding evidence that is relevant in evaluating whether an article is intended for use as a drug or device.
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This final rule is not expected to impose any significant additional costs on firms. Although this rule may impact firms future marketing, product development, and communication strategies, firms are not required to make any changes to labeling, marketing materials, or operating procedures.
Additionally, this rule does not extend FDAs jurisdiction to any new products.
TABLE 1SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
Units Category
Benefits:
Annualized Monetized $millions/year
Annualized Quantified
Qualitative
Costs:
Annualized Monetized $millions/year
Annualized Quantified
Primary estimate
Low estimate
High estimate
Discount rate %
Period covered
7
3
7
3
7
3
7
3
7
3
7
3
Notes
Clarification of intended use interpretation and application
Qualitative
Transfers:
Federal Annualized Monetized $millions/year
Year dollars
Negligible costs, if any
From/To
From:
Other Annualized Monetized $millions/year
From/To
From:
To:
To:
Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
3. Comments on the Preliminary Economic Analysis of Impacts and Our Response We did not receive any comments on the Preliminary Economic Analysis of Impacts.
4. Summary of Changes We have made no significant changes from the Preliminary Economic Analysis of Impacts.
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B. Final Economic Analysis of Impacts 1. Background This rule clarifies FDAs longstanding position that the intended use of a drug or device product can be based on any relevant source of evidence by describing types of evidence relevant to the intended use of a product and types
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of evidence that, standing alone, are not determinative of intended use.
One important clarification involves a manufacturers knowledge of unapproved uses of its approved product. Current versions of 201.128
and 801.4 specify that a manufacturer of a drug 201.128 or device 801.4
must include adequate labeling if it knows its product is used for an unapproved purpose. The September 2015 proposed rule 80 FR 57756 at 57764 removed the sentence regarding the requirement to provide adequate labeling if a firm knows its product is being used for an unapproved use. The amended January 2017 final rule 82 FR
2193 at 2217 was intended to clarify FDAs position by requiring manufacturers to include adequate labeling if the totality of the evidence
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establishes that a manufacturer objectively intends that a drug introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than ones for which it is approved if any.
In the Federal Register of February 7, 2017 82 FR 9501, FDA delayed the effective date of the January 2017 final rule until March 2017. In February 2017, various industry organizations filed a petition raising concerns with the January 2017 final rule, requesting reconsideration and a stay. The petition requested that FDA reconsider the amendments to the intended use regulations and issue a new final rule that, with respect to the intended use regulations at 201.128 and 801.4, reverted to the language of the September 2015 proposed rule. The
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