51640 Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 
1See RCA-Upholstered-Furniture-Flammability- 
Standard-TB117-2013-DFR-and-NPR.pdf (cpsc.gov). interposed between the upholstery 
cover fabric and any interior filling material. The 2008 NPR on upholstered furniture flammability focused on performance standards which did not prescribe requirements for filling materials or require manufacturers or importers to use FR chemical additives to achieve compliance. 
B. The COVID–19 Act 
On December 27, 2020, the ‘‘COVID– 
19 Regulatory Relief and Work From 
Home Safety Act,’’ became law. Public Law 116–260. Section 2101(c) of the COVID–19 Act mandated that, 180 days after the date of enactment of the COVID–19 Act, the standard for upholstered furniture set forth by the Bureau of Electronic and Appliance Repair, Home Furnishings and Thermal Insulation of the Department of Consumer Affairs of the State of California in Technical Bulletin (TB) 117–2013 (TB 117–2013), entitled, ‘‘Requirements, Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture,’’ published June 2013, ‘‘shall be considered to be a flammability standard promulgated by the Consumer Product Safety Commission under section 4 of the Flammable Fabrics Act (15 U.S.C. 1193).’’ 
Thus, under the COVID–19 Act, the 
California standard, TB 117–2013, is a federal flammability standard promulgated under section 4 of the FFA. TB 117–2013 sets forth the requirements, test procedure, and apparatus for testing the smolder resistance of materials used in upholstered furniture from hazards associated with smoldering ignition. The standard provides methods for smolder resistance of cover fabrics, barrier materials, resilient filling materials, and decking materials for use 
in upholstered furniture. The COVID–19 Act and the FFA (15 U.S.C. 1191 et seq.) does not preempt or otherwise affect any State or local law, regulation, code, standard, or requirement that concerns health risks associated with upholstered furniture; and is not designed to protect against the risk of occurrence of fire, or to slow or prevent the spread of fire, with respect to upholstered furniture. In addition, sections 1374 through 1374.3 of title 4, California Code of Regulations (except for subsections (b) and (c) of section 1374 of that title), as in effect on the date of enactment of the COVID–19 Act are not preempted. Finally, the California standard may not be preempted. 
On April 9, 2021, the Commission 
published a direct final rule that codified the relevant statutory text of section 2101 of the COVID–19 Act under 16 CFR part 1640. 86 FR 18440. This part establishes the regulatory text of the California standard, TB 117–2013, as the mandatory federal flammability standard for upholstered furniture under section 4 of the FFA, and sets forth the statutory requirements. Because the Commission did not consider any comment received on the direct final rule to be a significant adverse comment, the rule went into effect on June 25, 2021, and applies to all upholstered furniture manufactured, imported, or reupholstered on or after that date. However, the compliance date for the new labeling requirement will go into effect on June 25, 2022. 
C. Termination of the Upholstered 
Furniture Rulemaking 
The direction in the COVID–19 Act 
requiring that the California standard, TB 117–2013, be a federally mandated flammability standard promulgated by the CPSC under section 4 of the FFA, supersedes the upholstered furniture rulemaking proceeding initiated by the Commission under the FFA in 1994. Accordingly, on March 30, 2021, the Commission voted to terminate the rulemaking associated with upholstered furniture and directed that notification of the termination of rulemaking be issued in the Federal Register.
1 
Through this document, the Commission has terminated the upholstered furniture rulemaking proceeding that began with the issuance of the ANPR in 1994, and all subsequent rulemakings in that proceeding including the 2008 NPR. 
Alberta E. Mills, 
Secretary, Consumer Product Safety 
Commission. 
[FR Doc. 2021–19939 Filed 9–15–21; 8:45 am] 
BILLING CODE 6355–01–P 
CONSUMER PRODUCT SAFETY 
COMMISSION 
16 CFR Part 1700 
[Docket No. CPSC–2021–0027] 
Poison Prevention Packaging 
Requirements; Proposed Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More Than 80 mg of the Drug 
AGENCY : Consumer Product Safety 
Commission. 
ACTION : Notice of proposed rulemaking. SUMMARY : The Consumer Product Safety 
Commission (Commission or CPSC) is 
proposing to amend the child-resistant packaging requirements to exempt baloxavir marboxil tablets in packages 
containing not more than 80 mg of the drug, currently marketed as XOFLUZA,
TMfrom the special 
packaging requirements. XOFLUZA is used to treat the flu, and is taken in one dose within 48 hours of experiencing flu symptoms. The proposed rule would exempt this prescription drug product on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness because the product is not acutely toxic and lacks adverse human experience associated with ingestion. 
DATES : Comments should be submitted 
no later than November 30, 2021. 
ADDRESSES : You may submit comments, 
identified by Docket No. CPSC–2021– 0027, by any of the following methods: 
Electronic Submissions: Submit 
electronic comments to the Federal eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The CPSC does not accept comments submitted by electronic mail (email), except through https://www.regulations.gov. The CPSC 
encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. 
Mail/Hand Delivery/Courier Written 
Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7479. 
Instructions: All submissions received 
must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: https://www.regulations.gov. Do not 
submit electronically confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information please submit it according to the instructions for written submissions. 
Docket: For access to the docket to 
read background documents or comments received, go to: https:// www.regulations.gov, and insert the 
docket number, CPSC–2021–0027, into the ‘‘Search’’ box, and follow the prompts. 
FOR FURTHER INFORMATION CONTACT : 
Cheryl A. Scorpio, Ph.D., Division of 
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1A third reasonable ground for an exemption is 
that special packaging is incompatible with the 
particular substance. 16 CFR 1702.17(c). The petitioner has not requested an exemption on this basis so it is not relevant here. 2The adverse events are: Diarrhea, bronchitis, 
nasopharyngitis, nausea, sinusitis, increase in the level of AST, headache, vomiting, dizziness, leukopenia and constipation. 
3The Adverse Event Reporting System (AERS) is 
a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. Pharmacology and Physiology 
Assessment, Directorate for Health Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone (301) 987–2572; cscorpio@cpsc.gov. 
SUPPLEMENTARY INFORMATION : 
A. Background 
1. The Poison Prevention Packaging Act 
of 1970 and Implementing Regulations 
The Poison Prevention Packaging Act 
of 1970 (PPPA), 15 U.S.C. 1471–1476, 
gives the Commission authority to establish standards for the ‘‘special packaging’’ of household substances, such as drugs, when child-resistant (CR) packaging is necessary to protect children from serious personal injury or illness due to the substance, and the special packaging is technically feasible, practicable, and appropriate for such substance. 15 U.S.C. 1472(a). Special packaging requirements under the PPPA have been codified at 16 CFR parts 1700 and 1702. Specifically, CPSC regulations require special packaging for oral prescription drugs. 16 CFR 1700.14(a)(10). CPSC regulations allow companies to petition the Commission for an exemption from CR requirements. 16 CFR part 1702. Two ‘‘reasonable grounds’’
1for granting an exemption 
from the special packaging requirements are: (1) That the degree or nature of the hazard to children in the availability of the substance, by reason of its packaging, is such that special packaging is not required to protect children from serious personal injury or serious illness resulting from handling, using or ingesting the substance; or (2) special packing is not technically feasible, practicable, or appropriate for the subject substance. 16 CFR 1702.17(a) and (b). 
If the Commission determines that 
reasonable grounds for an exemption are presented by a 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. 
2. The Product for Which an Exemption 
Is Sought 
On March 30, 2020, Genentech, Inc. 
(Genentech), petitioned the Commission to exempt two specified sized tablets of baloxavir marboxil, which it markets as XOFLUZA from the special packaging requirements for oral prescription drugs. XOFLUZA was approved by the U.S. Food and Drug Administration (FDA) in October 2018, with a two-tablet dose for the acute uncomplicated flu in patients older than 12 years old showing symptoms for less than 48 hours. Single tablet doses have recently been approved by the FDA in March 2021. XOFLUZA has been marketed in tablet form and is currently dispensed in CR packaging. The petitioner asserted that an exemption from special packaging is justified because of the lack of toxicity and lack of adverse human experience with the drug. The petitioner also claimed that special packaging is not technically feasible, practicable, or appropriate for XOFLUZA. Staff’s briefing memorandum provides a detailed assessment of the petitioner’s claims regarding a request for an exemption from the special packing requirements for XOFLUZA. https://cpsc-d8-media- prod.s3.amazonaws.com/s3fs-public/ Petition-to-Exempt-Baloxavir-Marboxil- XOFLUZA-in-40-mg-and-80-mg-Tablet-Doses-from-Special-Packaging- Requirements-of-the-PPPA-Cleared.pdf?VersionId=sLAhJ4THOBCtVMjgA4kxiFmI2.3LzqIj. 
B. Toxicity and Injury Data for 
XOFLUZA 
Toxicity 
CPSC staff reviewed the toxicity of 
XOFLUZA. XOFLUZA has been studied 
in pediatric patients (Hirotsu, 2019; Heo, 2018; NCT03653364, CAPSTONE 2; Hayden, 2018; Dziewiatkowski et al., 2019). Overall, clinically relevant doses of XOFLUZA (40 or 80 mg total dose) in humans are well tolerated (Dziewiatkowski et al., 2019; Taieb et al., 2019; Ng, 2019; Hayden, 2018). 
The analysis of total adverse events 
(AE) included 10 studies with six treatments and 5628 patients. AE did not differ significantly between placebo and XOFLUZA. For drug-related vomiting, 3297 patients from five studies were included. XOFLUZA did not differ from placebo in these studies. (Taieb et al., 2019). The percentage of patients experiencing any adverse event
2of 610 patients (12 to 64 years 
old) in the CAPSTONE 1 clinical trial was 1.0% grade 3 or grade 4, which can be categorized as not serious. Five deaths have been reported by the AER System;
3however, these deaths have been determined to not be related to 
XOFLUZA. 
The most common AE of the correct 
dose of XOFLUZA was diarrhea (Heo, 2018; Shionogi prescribing info). The XOFLUZA Product Information, 2021 reported that diarrhea (3%), bronchitis (3%), nausea (2%), headache (1%) were the most significant adverse events found. 
Treatment of an overdose of 
XOFLUZA should consist of general supportive measures, including monitoring of vital signs and 
observations of the clinical status of the patient. There is no specific antidote for overdose with XOFLUZA and it is unlikely to be significantly removed by dialysis because it is highly protein bound (Prescribing Information for XOFLUZA, 2021; Poisindex, 2021). 
Overall, treatment with XOFLUZA is 
well tolerated. If accidentally ingested, the greatest potential for injury is diarrhea, nausea, and headache. For these reasons, CPSC staff determined that XOFLUZA will not cause serious injury or death upon acute exposure by a child under 5 years old. 
Injury Data 
CPSC staff searched the Consumer 
Product Safety Risk Management 
System (CPSRMS), the National Electronic Injury Surveillance System (NEISS) databases, and reviewed reports from FDA related to adverse events associated with XOFLUZA. CPSC staff found no incidents related to XOFLUZA in CPSRMS or NEISS from January 2015 through December 2020. CPSC staff also reviewed 12 reports received from FDA related to adverse events associated with XOFLUZA. Of the 12 reports, five involved XOFLUZA use only. Of these five incidents, two reported adverse effects. One patient experienced hallucination, fever, and sore throat, and the other patient suffered cardiac failure. Both were unrelated to XOFLUZA. Six incidents involved use of multiple drugs and were considered out of scope, and one was a duplicate. 
C. Action on the Petition 
After considering the information 
provided by the petitioner and other 
available toxicity and human experience data, the Commission concluded preliminarily that the ‘‘lack of toxicity and lack of adverse human experience for the substance’’ presented by the availability of 40 mg and 80 mg tablets 
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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 1702.17(a). Additionally, the Commission found that the petitioner’s 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 § 1700.14(a)(10)(xxiv). 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 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 Group’s 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 firm’s 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. 553(d)(1). 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 Commission’s regulations 
provide a categorical exclusion for the Commission’s 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 1021.5(c)(3). 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. 1476(a). 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 PPPA’s preemption clause and the Commission grants the exemption through a process specified at 16 CFR part 1061. 15 U.S.C. 1476(c)(1). 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 government’s own use. 15 U.S.C. 1476(b). 
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 1700—[AMENDED] 
■1. The authority citation for part 1700 
continues to read as follows: 
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1E.O. 14012, 86 FR 8277 (February 5, 2021). 2Proclamation No. 10014, 85 FR 23441 (April 27, 
2020). Authority: 15 U.S.C. 1471—76. Secs. 
1700.1 and 1700.14 also issued under 15 
U.S.C. 2079(a). 
■2. Section 1700.14 is amended by 
adding paragraph (a)(10)(xxiv) to read as 
follows: 
§ 1700.14 Substances requiring special 
packaging. 
(a) * * * 
(10) * * * (xxiv) Baloxavir marboxil tablets in 
packages containing not more than 80 
mg of the drug. 
* * * * * 
Alberta E. Mills, 
Secretary, U.S. Consumer Product Safety 
Commission. 
[FR Doc. 2021–19953 Filed 9–15–21; 8:45 am] 
BILLING CODE 6355–01–P 
DEPARTMENT OF STATE 
22 CFR Parts 40, 41, and 42 
[Public Notice: 11459] 
RIN 1400–AF30 
Visas: Immigrant Visas 
AGENCY : Department of State. 
ACTION : Request for public input. 
SUMMARY : The Department of State 
(‘‘Department’’) seeks public comments 
identifying barriers that impede access to, and fair, efficient adjudication of, immigration benefits, and recommendations on how to remove those barriers, and identifying any Department actions that fail to promote access to the legal immigration system. 
DATES : Written comments must be 
received on or before October 18, 2021. 
ADDRESSES : You may submit comments, 
identified by RIN 1400–AF30, by either of the following methods: 
•Internet (preferred): At 
www.regulations.gov, you can search for 
the document using Docket Number DOS–2021–0017 or using the notice RIN 1400–AF30. 
•Email: Claire Kelly, Office of Visa 
Services, Bureau of Consular Affairs, U.S. Department of State, VisaRegs@state.gov. Please include the RIN or 
Docket Number in the Subject Line. 
FOR FURTHER INFORMATION CONTACT : 
Claire Kelly, Office of Visa Services, Bureau of Consular Affairs, Department of State, 600 19th St. NW, Washington, DC 20006, (202) 485–7586. 
SUPPLEMENTARY INFORMATION : 
I. Public Participation 
All interested parties are invited to 
respond to this Request for Public Input by submitting written views and comments on all aspects of the Department of State’s implementation and execution of its authorities relating to the immigrant visa function, including existing regulations, orders, guidance documents, policies, and any other similar agency actions. Comments must be submitted in English or commenters must submit an English translation. Comments that will provide the most assistance to the Department in considering recommendations will reference a specific existing regulation, order, guidance, policy, or any other similar agency action, explain the reason for any recommended change, and include information that supports the recommended change. 
II. Background 
Executive Order (E.O.) 14012 
describes a policy of the Administration 
to restore faith in our legal immigration system and to strengthen integration and inclusion efforts for new Americans. As a first step to advance this policy, section 3 of the E.O. tasked the Secretary of State, the Attorney General, and the Secretary of Homeland Security with identifying: 
•Barriers that impede access to 
immigration benefits and fair, efficient 
adjudications of these benefits and make recommendations on how to remove these barriers, as appropriate and consistent with applicable law; and 
•any agency actions that fail to promote 
access to the legal immigration system . . . and recommend steps, as appropriate and consistent with applicable law, to revise or rescind those agency actions.
1 
The Department of State’s role in 
facilitating access to the U.S. 
immigration system includes the issuance of immigrant visas to eligible individuals outside of the United States. The Department welcomes comments on: (1) Any existing barriers that impede access to, and fair, efficient adjudication of, immigrant visas, and (2) recommendations on actions the Department could take to improve access to adjudication of immigrant visas; however the Department is not soliciting comments on administrative processing or communication surrounding administrative processing as the Department at this time is unable to alter or improve communication surrounding administrative processing. Additionally, as the Department is already undertaking efforts to address the Immigrant Visa (including Diversity Visa) backlog caused by Presidential Proclamation 10014
2and the global 
pandemic’s effect on visa operations, comments on this area are less useful than comments on perceived systemic barriers pre-pandemic. This Request for Public Input is not soliciting comments on areas outside the Department’s responsibility, including the functions, roles and responsibilities vested in the Department of Homeland Security, the Department of Labor, or Department of Justice, though the Department is interested in learning whether there are areas of overlap between any of the policies of these agencies and the Department of State that create such barriers, inefficiencies, or that impede access to, fair and efficient adjudication of immigrant visas. The Department is not obligated to respond in any way to comments received in response to this Request for Public Input; however, the Department intends to consider all comments in developing the report to the President required under section 3(c) of E.O. 14012, describing its progress towards implementing a plan to advance the policy set forth in section 1 of E.O. 14012. This Request for Public Input does not create any right for members of the public who submit comments or any obligations for the Department of State. 
III. Request for Input A. Maximizing the Value of Public 
Feedback 
This notice contains a list of 
questions, the answers to which may assist the Department in identifying aspects of immigrant visa-related processes that may benefit from the Department’s review with the goals of eliminating any undue burdens on the public, saving costs for both the public and the Department, increasing navigability, saving time, reducing perceived confusion, promoting simplification, improving efficiency, and/or removing barriers that unnecessarily impede access to immigrant visas. The Department encourages public comment on these questions and seeks any other information or data commenters believe are relevant to this notice. The type of feedback that is most useful to the Department will identify specific regulations and/or processes and include actionable information and/or data and/or provide viable alternatives, that meet statutory obligations and regulatory objectives and requirements. Public feedback that simply states that a stakeholder feels strongly that the 
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