Poison Prevention Packaging Requirements; Proposed Exemption of Baloxavir Marboxil Tablets in Packages Containing Not More Than 80 mg of the Drug, 51640-51643 [2021-19953]
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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
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
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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
Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
1 See RCA-Upholstered-Furniture-FlammabilityStandard-TB117-2013-DFR-and-NPR.pdf (cpsc.gov).
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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,TM from 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
SUMMARY:
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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’’ 1 for 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
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.
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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-mediaprod.s3.amazonaws.com/s3fs-public/
Petition-to-Exempt-Baloxavir-MarboxilXOFLUZA-in-40-mg-and-80-mg-TabletDoses-from-Special-PackagingRequirements-of-the-PPPA-Cleared.pdf?
VersionId=sLAhJ4THOBCtVM
jgA4kxiFmI2.3LzqIj.
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 2 of 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; 3 however, these deaths have
2 The adverse events are: Diarrhea, bronchitis,
nasopharyngitis, nausea, sinusitis, increase in the
level of AST, headache, vomiting, dizziness,
leukopenia and constipation.
3 The Adverse Event Reporting System (AERS) is
a computerized information database designed to
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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
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.
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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 1702.17(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
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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 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
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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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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]
II. Background
BILLING CODE 6355–01–P
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:
DEPARTMENT OF STATE
22 CFR Parts 40, 41, and 42
[Public Notice: 11459]
RIN 1400–AF30
Visas: Immigrant Visas
Department of State.
Request for public input.
AGENCY:
ACTION:
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:
SUMMARY:
I. Public Participation
All interested parties are invited to
respond to this Request for Public Input
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16:17 Sep 15, 2021
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.
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• 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
1 E.O.
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14012, 86 FR 8277 (February 5, 2021).
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51643
Proclamation 10014 2 and 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
2 Proclamation No. 10014, 85 FR 23441 (April 27,
2020).
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]]>Agencies
[Federal Register Volume 86, Number 177 (Thursday, September 16, 2021)]
[Proposed Rules]
[Pages 51640-51643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19953]
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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.
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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,TM from 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
[[Page 51641]]
Pharmacology and Physiology Assessment, Directorate for Health
Sciences, Consumer Product Safety Commission, 5 Research Place,
Rockville, MD 20850; telephone (301) 987-2572; [email protected].
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'' \1\ for
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).
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\1\ A 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.
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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 \2\ of 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; \3\ however, these deaths have been determined to not be
related to XOFLUZA.
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\2\ The adverse events are: Diarrhea, bronchitis,
nasopharyngitis, nausea, sinusitis, increase in the level of AST,
headache, vomiting, dizziness, leukopenia and constipation.
\3\ The 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.
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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
[[Page 51642]]
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 Sec. 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]
0
1. The authority citation for part 1700 continues to read as follows:
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Authority: 15 U.S.C. 1471--76. Secs. 1700.1 and 1700.14 also
issued under 15 U.S.C. 2079(a).
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2. Section 1700.14 is amended by adding paragraph (a)(10)(xxiv) to read
as follows:
Sec. 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
