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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Rules and Regulations
petition also requested that FDA
indefinitely stay the rule because petitioners argued that the final rule was issued in violation of the fair notice requirement under the Administrative Procedure Act and that the totality of the evidence language in the 2017 final rule was a new and unsupported legal standard.
In the Federal Register of March 20, 2017 82 FR 14319, FDA further delayed the effective date of the final rule until March 2018 and opened the docket for additional public comment.
Following some comments supporting the delay and proposing specific changes to the language in 201.128
and 801.4, on March 16, 2018 83 FR
11639, FDA delayed the amendments to 201.128 and 801.4 until further notice. This final rule adopts the general approach set forth in the September 2015 proposed rule by deleting the final sentence; the final rule also clarifies FDAs interpretation and application of evidence relevant to determining intended use.
2. Benefits of the Final Rule The final rule clarifies FDAs existing interpretation of the determination of the intended use of drugs and devices.
This clarification should reduce manufacturer and stakeholder uncertainty regarding the scenarios in which specific types of evidence may or
may not show a product is intended for a drug or device use. The removal of the final sentence in 201.128 and 801.4
and the inclusion of new clarifying clauses provided, however, that a firm would not be regarded as intending an unapproved new use for a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firms knowledge that such product was being prescribed or used by health care providers for such use resolve questions about whether manufacturers need to think about developing an action plan or strategy related to a potential new intended use of their medical products that are approved, cleared, granted marketing authorization, or exempted from premarket notification simply because a manufacturer has knowledge of unapproved uses of these products by third parties. We believe this clarification is the benefit of the final rule.
3. Costs of the Final Rule The final rule is not expected to impose significant additional costs on manufacturers and distributors of FDAregulated products. The final rule does not extend FDAs regulatory authority to any new or additional products, nor
does the rule change the current approach to evaluating intended use or impose any additional requirements on manufacturers or distributors. We do not have any reason to believe firms will change their marketing or operating procedures as a result of this rule. We do not have evidence that this final rule would impose costs on currently marketed products.
C. Final Small Entity Analysis In table 2, we describe the Small Business Administrations size thresholds for industries affected by the final rule. Based on U.S. Census data, at least 22.9 percent of businesses in NAICS code 21323 Tobacco Manufacturing are considered small; at least 17.5 percent of businesses in NAICS code 32541 Pharmaceutical and Medicine Manufacturing are considered small; and at least 32.6
percent of businesses in NAICS code 33911 Medical Equipment and Supplies Manufacturing are considered small. Because the final rule is not expected to impose costs on manufacturers or distributors of FDAregulated products, the final rule is also not expected to impose costs on small entities. Therefore, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

TABLE 2SMALL BUSINESS ADMINISTRATION SIZE STANDARDS FOR AFFECTED INDUSTRIES

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NAICS code
Industry description
312230
325411
325412
325413
325414

339112
339113
339114
339115
339116

Tobacco Manufacturing
Medicinal and Botanical Manufacturing
Pharmaceutical Preparation Manufacturing
In-vitro Diagnostic Substance Manufacturing
Biological Product except Diagnostic Manufacturing.
Surgical and Medical Instrument Manufacturing Surgical Appliance and Supplies Manufacturing Dental Equipment and Supplies Manufacturing Ophthalmic Goods Manufacturing
Dental Laboratories

VIII. Analysis of Environmental Impact We have determined under 21 CFR
25.30h, i, and k 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.
IX. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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Small business threshold
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Fewer Fewer Fewer Fewer Fewer
than than than than than
1,500
1,000
1,250
1,250
1,250

Employees.
Employees.
Employees.
Employees.
Employees.

Fewer Fewer Fewer Fewer Fewer
than than than than than
1,000 Employees.
750 Employees.
750 Employees.
1,000 Employees.
500 Employees.

X. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive
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order and, consequently, a federalism summary impact statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal
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