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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
of baloxavir marboxil currently marketed as XOFLUZA is such that special packaging is not required to protect children from serious injury or serious illness from handling, using, or ingesting XOFLUZA. 16 CFR 1702.17a.
Additionally, the Commission found that the petitioners request for an exemption from special packaging, on the basis that it is not technically feasible, practicable, or appropriate for XOFLUZA, was not warranted based upon the information provided by the petitioner. Therefore, the Commission determined that reasonable grounds for an exemption were presented based on toxicity and voted to grant the petition and begin a rulemaking proceeding to exempt baloxavir marboxil tablets in packages containing not more than 80
mg of the drug from the special packaging requirements for oral prescription drugs.
Once the Commission determines that reasonable grounds for an exemption are presented by the petition, CPSC
regulations require publication in the Federal Register of a proposed amendment to the listing of substances that require special packaging, stating that the substance at issue is exempt. 16
CFR 1702.17. This document proposes to amend the listing of substances in 16
CFR part 1700 that require special packing to state that baloxavir marboxil tablets in packages containing not more than 80 mg of the drug do not require special packing.
D. Description of the Proposed Rule The proposed rule would amend 16
CFR part 1700 to include a new exemption from the special packaging requirements for baloxavir marboxil tablets in packages containing not more than 80 mg of the drug in proposed 1700.14a10xxiv. The proposed exemption is intended to cover baloxavir marboxil tablets for any dosage from 80 mg or below. The proposed rule would make no other changes to part 1700.
E. Regulatory Flexibility Act Under the Regulatory Flexibility Act RFA; 5 U.S.C. 601 et seq., an agency that engages in rulemaking generally must prepare initial and final regulatory flexibility analyses describing the impact of the rule on small businesses and other small entities. Section 605 of the Act provides that an agency is not required to prepare a regulatory flexibility analysis if the head of an agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.
CPSC staff prepared a preliminary assessment of the impact of the
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proposed rule to exempt baloxavir marboxil in 40 mg and 80 mg tablet form, currently marketed as XOFLUZA, from special packaging requirements.
Genentech, Inc., is a subsidiary of, and owned in its entirety by the multinational corporation, Roche Group, the company that markets XOFLUZA. Roche Group employs 97,735 workers worldwide, of which 26,176 are located in North America. As of February 2020, Genentech employed 13,638 people. Roche Groups operating businesses are organized into two divisions: Pharmaceuticals and Diagnostics. Genentech, as the former third segment, has been integrated into Roche Pharmaceuticals. Sales in the Pharmaceuticals Division were $48.1
billion in 2019.
There are two main economic reasons for why granting the petition would not result in the exemption having a significant economic impact on a substantial number of small entities.
First, the exemption for this drug is not likely to impact a large number of firms, therefore it is unlikely that granting the petition would impact a substantial number of small entities. Second, CR
packaging for XOFLUZA tablets is unlikely to be a significant amount of any firms business, therefore granting the petition would not have a significant economic impact on any small entity.
However, if the petitioner relocates packaging to another country, it could potentially result in some minor negative impacts for small domestic firms. Based on this assessment, we preliminarily conclude that the proposed amendment exempting baloxavir marboxil tablets in packages containing not more than 80 mg of the drug would not have a significant impact on a substantial number of small businesses or other small entities. We seek public comment on any small business impacts that might result from the exemption in the proposed rule.
F. Effective Date The Administrative Procedure Act APA generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553d1. The NPR
proposes an effective date of 30 days after publication of the final rule in the Federal Register, because the proposed rule would provide an exemption from the requirement to use special packaging for baloxavir marboxil tablets in packages containing not more than 80
mg of the drug.
G. Environmental Considerations The Commissions regulations provide a categorical exclusion for the
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Commissions rules from any requirement to prepare an environmental assessment or an environmental impact statement where they have little or no potential for affecting the human environment. 16
CFR 1021.5c3. Rules exempting products from poison prevention packaging rules fall within the categorical exclusion, so no environmental assessment or environmental impact statement is required.
H. Preemption The PPPA provides that, generally, when a special packaging standard issued under the PPPA is in effect, no State or political subdivision thereof shall have any authority either to establish or continue in effect, with respect to such household substance, any standard for special packaging and any exemption therefrom and requirement related thereto which is not identical to the PPPA standard.
15 U.S.C. 1476a. A state or local standard may be excepted from this preemptive effect if: 1 The state or local standard provides a higher degree of protection from the risk of injury or illness than the PPPA standard; and 2
the state or political subdivision applies to the Commission for an exemption from the PPPAs preemption clause and the Commission grants the exemption through a process specified at 16 CFR
part 1061. 15 U.S.C. 1476c1. In addition, the federal government, or a state or local government, may establish and continue in effect a nonidentical special packaging requirement that provides a higher degree of protection than the PPPA requirement for a household substance for the federal, state, or local governments own use. 15
U.S.C. 1476b.
Thus, with the exceptions noted above, the proposed rule exempting baloxavir marboxil tablets in packages containing not more than 80 mg of the drug from special packaging requirements, if finalized, would preempt nonidentical state or local special packaging standards for the substance.
List of Subjects in 16 CFR Part 1700
Consumer protection, Drugs, Infants and children, Packaging and containers, Poison prevention, Toxic substances.
For the reasons given above, the Commission proposes to amend 16 CFR
part 1700 as follows:
PART 1700AMENDED
1. The authority citation for part 1700
continues to read as follows:

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16SEP1