51640 Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 

1See RCA-Upholstered-Furniture-FlammabilityStandard-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,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 

Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 51641 

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’’ 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 

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 

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 

51642 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 

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: 

Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules 51643 

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 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