Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10835 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or Tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or Tribal Governments, on the 

relationship between the National 

Government and the States or Tribal 

Governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

X. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 23, 2020. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Add § 180.1381 to subpart D to read 

as follows: 

§ 180.1381 Oxalic Acid; exemption from 

the requirement of a tolerance. 

Residues of oxalic acid in or on honey 

and honeycomb are exempted from the 

requirement of a tolerance when oxalic 

acid is used as a miticide in honeybee 

hives. 

[FR Doc. 2021–03256 Filed 2–22–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 100 

RIN 0906–AB24 

National Vaccine Injury Compensation 

Program: Revisions to the Vaccine 

Injury Table; Delay of Effective Date 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: In accordance with the 

Presidential directive as expressed in 

the memorandum of January 20, 2021, 

from the Assistant to the President and 

Chief of Staff, entitled ‘‘Regulatory 

Freeze Pending Review,’’ this action 

delays until April 23, 2021, the effective 

date of the rule entitled ‘‘National 

Vaccine Injury Compensation Program: 

Revisions to the Vaccine Injury Table,’’ 

published in the Federal Register on 

January 21, 2021 (January 21, 2021 Final 

Rule). 

DATES: As of February 22, 2021, the 

effective date of the January 21, 2021 

Final Rule, published in the Federal 

Register at 86 FR 6249, is delayed for 60 

days, from February 22, 2021 to April 

23, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Please visit the National Vaccine Injury 

Compensation Program’s website, 

https://www.hrsa.gov/ 

vaccinecompensation/, or contact 

Tamara Overby, Acting Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

HRSA, Room 08N146B, 5600 Fishers 

Lane, Rockville, MD 20857; by email at 

vaccinecompensation@hrsa.gov; or by 

telephone at (855) 266–2427. 

SUPPLEMENTARY INFORMATION: 

I. Background 

HHS published a notice of proposed 

rulemaking on July 20, 2020 (85 FR 

43794), and a final rule on January 21, 

2021 (86 FR 6249). The January 20, 2021 

Final Rule amended the provisions of 42 

CFR 100.3 by removing Shoulder Injury 

Related to Vaccine Administration 

(SIRVA), vasovagal syncope, and Item 

XVII from the Vaccine Injury Table. The 

January 20, 2021 memorandum from the 

Assistant to the President and Chief of 

Staff, entitled ‘‘Regulatory Freeze 

Pending Review,’’ instructed Federal 

agencies to consider delaying the 

effective date of rules published in the 

Federal Register, but which have not 

yet taken effect, for a period of 60 days 

so that the new Administration may 

review recently published rules for ‘‘any 

questions of fact, law, and policy the 

rule may raise.’’ The memorandum 

notes certain exceptions that do not 

apply here. On January 20, 2021, the 

Office of Management and Budget 

(OMB) also published OMB 

Memorandum M–21–14, 

Implementation of Memorandum 

Concerning Regulatory Freeze Pending 

Review, which provides guidance 

regarding the Regulatory Freeze 

Memorandum. See OMB M–21–14, 

Implementation of Memorandum 

Concerning Regulatory Freeze Pending 

Review, https://www.whitehouse.gov/ 

wp-content/uploads/2021/01/M-21-14- 

Regulatory-Review.pdf. OMB M–21–14 

explains that pursuant to the Regulatory 

Freeze Memorandum, agencies ‘‘should 

consider postponing the effective dates 

for 60 days and reopening the 

rulemaking process’’ for ‘‘rules that have 

not yet taken effect and about which 

questions involving law, fact, or policy 

have been raised.’’ Id. 

On February 12, 2021, HHS published 

a notice of proposed rulemaking, 

proposing, after a brief public comment 

period, to delay the effective date of the 

January 21, 2021 Final Rule for 60 days, 

from February 22, 2021, to April 23, 

2021. HHS did so to determine whether 

the January 21, 2021 Final Rule’s 

promulgation raises any legal issues, 

including but not limited to (1) whether 

the Advisory Commission on Childhood 

Vaccines (ACCV) was properly notified 

of the proposed rule pursuant to 42 

10836 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 

U.S.C. 300aa–14(c) and (d), and (2) 

whether the public was properly 

notified of the entire revised regulation, 

42 CFR 100.3(b)–(e) (including the 

qualifications and aids to interpretation 

and the coverage provisions), given that 

both the proposed and final rules 

published in the Federal Register 

included only the revised Vaccine 

Injury Table itself, but not the entire 

revised regulation. 

HHS received 29 comments on the 

notice of proposed rulemaking, most in 

support of the delay of the effective date 

to April 23, 2021, with only two 

anonymous comments against. After 

careful consideration of the comments 

received, HHS has decided to delay the 

January 21, 2021 Final Rule’s effective 

date to April 23, 2021. HHS continues 

to believe that the delay is reasonable 

and will not be disruptive because the 

underlying rule has not yet been 

implemented or taken effect. 

Section 553(d) of the Administrative 

Procedure Act (APA) (5 U.S.C. 551 et 

seq.) requires that Federal agencies 

provide at least 30 days after 

publication of a final rule in the Federal 

Register before making it effective, 

unless good cause can be found not to 

do so. HHS finds that there is good 

cause for making this final rule effective 

less than 30 days after publication in the 

Federal Register given that failure to do 

so would result in the January 21, 2021 

Final Rule going into effect before it can 

be reviewed by the new Administration 

pursuant to the Regulatory Freeze 

Memorandum and OMB M–21–14, and 

because the majority of public 

comments received support the delay 

and HHS’s plans to more closely review 

the January 21, 2021 Final Rule’s 

promulgation for both procedural and 

policy reasons. 

II. Analysis and Responses to Public 

Comments 

In the notice of proposed rulemaking, 

HHS solicited comments regarding 

whether to delay the January 21, 2021 

Final Rule’s effective date for 60 days, 

from February 22, 2021, to April 23, 

2021. We received 29 comments. The 27 

comments in support of the delay of the 

effective date of the January 21, 2021 

Final Rule to April 23, 2021, were from 

a broad range of patients, vaccine 

attorneys and legal clinics, biotech trade 

associations, pharmacist and drug store 

associations, and non-profit 

organizations. HHS only received two 

anonymous comments opposing the 

delay of the effective date of the January 

21, 2021 Final Rule. HHS took into 

consideration comments on the 

underlying rule to the extent they shed 

light on the reasons commenters were 

for or against the delay; other comments 

that raised issues beyond the scope of 

the proposed rule delaying the effective 

date are not addressed here, but will be 

considered by the agency in 

determining future actions related to the 

underlying rule. We have summarized 

the relevant comments received and 

provided our answers below. 

Eight commenters, including the 

Biotechnology Innovation Organization, 

American Association for Justice, 

Walgreens, and the National Association 

of Chain Drug Stores, support delaying 

the January 21, 2021 Final Rule because 

they believe that the rule contravenes 

the purpose of the National Childhood 

Vaccine Injury Act. Thirteen 

commenters, including the National 

Community Pharmacists Association, 

the Vaccine Injured Petitioners Bar 

Association, the American Pharmacists 

Association, the National Alliance of 

State Pharmacy Associations, and 

various petitioners’ attorneys, support 

the delay of the final rule because they 

believe the final rule did not adequately 

take into account the recommendations 

of the ACCV or the public. Four 

commenters, including a petitioner’s 

attorney, supported the delay so that, 

pursuant to the Regulatory Freeze 

memorandum, the new Administration 

may review the rule and the comments 

submitted during that rulemaking 

process. Another commenter expressed 

concern with the promulgation of the 

final rule, specifically that the contents 

of the November 9, 2020 hearing have 

not been made publicly available, and 

as such supported the delay. Many 

commenters who said they had their 

own SIRVA injuries supported the 

delay. Finally, four commenters stated 

that the January 21, 2021 Final Rule 

contravenes the science surrounding 

SIRVA. HHS agrees that delaying the 

effective date of the final rule would 

provide the agency time to ensure the 

rule was properly promulgated and 

consider the other issues surrounding 

the rule. 

Two anonymous commenters 

opposed the delay of the final rule. One 

anonymous commenter stated the final 

rule should go into effect without delay 

for the reasons stated in the Department 

of Justice’s (DOJ) May 15, 2020 letter. 

See https://www.hrsa.gov/sites/default/ 

files/hrsa/advisory-committees/ 

vaccines/hunt-letter-sirva.pdf. That 

letter outlines DOJ’s views with respect 

to the July 20, 2020 notice of proposed 

rulemaking (NPRM) (85 FR 43794), 

specifically the view that SIRVA should 

not be a compensable injury under the 

VICP, but does not discuss why the 

commenter opposes delaying the 

effective date of the final rule. As such, 

HHS is unable to respond to this 

comment as it does not state why the 

commenter does not support the delay. 

The other anonymous commenter 

asserted, without indicating the factual 

basis for the assertion, that the ACCV 

had been properly notified about the 

NPRM to remove SIRVA, vasovagal 

syncope, and Item XVII from the Table. 

Furthermore, the anonymous 

commenter pointed out that ‘‘HHS says 

it needs time to determine whether the 

ACCV ‘was properly notified of the 

proposed rule pursuant to 42 U.S.C. 

300aa–14(c).’ 86 FR 9308, 9309 (Feb. 12, 

2021) (the notice refers to 42 U.S.C. 

300aa–14(c), but presumably it meant to 

refer to 300aa–14(d).).’’ HHS disagrees 

with this commenter’s views about the 

ACCV and is concerned that the ACCV 

may not have been properly notified. 

We also note that 300aa–14(c) discusses 

the process for promulgating regulations 

to revise the Table, but agree that 

section that 300aa–14(d) discusses the 

role of the ACCV in the regulation 

process more specifically. That 

subsection states the ‘‘Secretary may not 

propose a regulation under subsection 

(c) or any revision thereof, unless the 

Secretary has first provided to the 

Commission a copy of the proposed 

regulation or revision, requested 

recommendations and comments by the 

Commission, and afforded the 

Commission at least 90 days to make 

such recommendations.’’ [emphasis 

added] Per the March 6, 2020 ACCV 

meeting minutes, found at https://

www.hrsa.gov/sites/default/files/hrsa/ 

advisory-committees/vaccines/ 

meetings/2020/accv-march-meetingminutes.pdf, ACCV members said 

during the March meeting that, because 

the NPRM was marked as ‘‘privileged 

and confidential’’ and was not on the 

agenda for the meeting, they were 

uncertain whether they were allowed to 

discuss the NPRM at the ACCV meeting 

as a group. The fact that ACCV members 

were uncertain as to whether the ACCV 

as a group could discuss the NPRM at 

that meeting raises the issue about 

whether the ACCV as a whole actually 

was provided with the statutorilyrequired 90 days to provide its 

comments and recommendations on the 

NPRM. This sentiment was echoed in 

the May 18, 2020 meeting minutes, 

found at https://www.hrsa.gov/sites/ 

default/files/hrsa/advisory-committees/ 

vaccines/meetings/2020/accv-maymeeting-minutes.pdf, where, for an 

example, an ACCV member raised the 

issue that ‘‘ACCV commissioners 

received this draft VICP NPRM in 

February of 2020, at that time 

commissioners were told it was 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10837 

privileged, confidential document that 

could not be discussed. It was not on 

the agenda for the March 6, 2020 

meeting.’’ While the member 

acknowledged a brief discussion did 

occur, it remains clear that not all ACCV 

members believed they could discuss 

the NPRM during the March meeting. In 

a letter to the Secretary of HHS dated 

May 20, 2020, with the recommendation 

to oppose the proposed changes to the 

Table, the ACCV again expressed 

dissatisfaction with the ACCV 

recommendation process, stating, 

‘‘During its March 6 Meeting, the 

Commission briefly discussed this draft 

NPRM; however, no representative from 

HHS was present to address questions 

from ACCV members, and discussion of 

the draft NPRM was not an agenda item. 

Therefore, ACCV members requested, 

among other things, a meeting with an 

HHS official to respond to their 

questions about the NPRM. Thus, the 

May 18, 2020 meeting was scheduled, 

but an HHS official who could respond 

to the ACCV’s questions did not 

attend.’’ (See https://www.hrsa.gov/ 

sites/default/files/hrsa/advisorycommittees/vaccines/reports/accvrecommendation-may-2020.pdf.) 

That anonymous commenter also 

stated that the public was made aware 

of the entire revised regulation, 

including the qualifications and aids to 

interpretation and coverage provisions, 

because ‘‘the NPRM and the Final Rule 

provide: ‘In 100.3, revise paragraph (a) 

and remove paragraphs (c)(10) and (13) 

and (e)(8).’ 85 FR 43,804; 86 FR 6249, 

6267 (Jan. 21, 2021).’’ The anonymous 

commenter said he or she believes it is 

sufficient to refer solely to the 

paragraphs being removed, and not spell 

out the entire revised regulation. 

However, the final rule says, ‘‘In § 100.3, 

revise paragraph (a) and remove 

paragraphs (c)(10) and (13) and (e)(8). 

The revision reads as follows . . .’’ 

After the ‘‘as follows,’’ the only text that 

is included is the Table itself, and not 

the revised qualifications and aids to 

interpretation and coverage provisions. 

Therefore, the language in the proposed 

and final rules is ambiguous because it 

implies that the entirety of the revised 

regulation is included, but then only 

includes the Table itself. Furthermore, 

the version of the Vaccine Injury Table 

that is currently displayed on the eCFR 

includes a link titled ‘‘Link to an 

amendment published at 86 FR 6267, 

Jan. 21, 2021.’’ This link displays only 

the Vaccine Injury Table that was 

published in the final rule, and this 

delay will permit HHS to clarify these 

seemingly conflicting instructions 

concerning 42 CFR 100.3(b)–(e). 

III. Regulatory Impact Analysis 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when rulemaking is necessary, to select 

regulatory approaches that provide the 

greatest net benefits (including potential 

economic, environmental, public health, 

safety, distributive, and equity effects). 

In addition, under the Regulatory 

Flexibility Act, if a rule has a significant 

economic effect on a substantial number 

of small entities, HHS must specifically 

consider the economic effect of a rule on 

small entities and analyze regulatory 

options that could lessen the impact of 

the rule. 

The Office of Information and 

Regulatory Affairs has determined that 

this rule is not a ‘‘significant regulatory 

action’’ under section 3(f) of Executive 

Order 12866. 

HHS has determined that no resources 

are required to implement the 

requirements in this rule because 

compensation will continue to be made 

consistent with the status quo. 

Therefore, in accordance with the 

Regulatory Flexibility Act of 1980 

(RFA), and the Small Business 

Regulatory Enforcement Act of 1996, 

which amended the RFA, HHS certifies 

that this rule will not have a significant 

impact on a substantial number of small 

entities. 

HHS has also determined that this 

rule does not meet the criteria for a 

major rule under the Congressional 

Review Act or Executive Order 12866 

and would have no major effect on the 

economy or Federal expenditures. 

Similarly, it will not have effects on 

State, local, and tribal governments and 

on the private sector such as to require 

consultation under the Unfunded 

Mandates Reform Act of 1995. Nor on 

the basis of family well-being will the 

provisions of this rule affect the 

following family elements: Family 

safety; family stability; marital 

commitment; parental rights in the 

education, nurture and supervision of 

their children; family functioning; 

disposable income or poverty; or the 

behavior and personal responsibility of 

youth, as determined under section 

654(c) of the Treasury and General 

Government Appropriations Act of 

1999. 

Impact of the New Rule 

This rule extends the effective date of 

the final rule titled ‘‘National Vaccine 

Injury Compensation Program: 

Revisions to the Vaccine Injury Table’’ 

until April 23, 2021, to determine 

whether that rule’s promulgation raises 

any legal issues. This delay is 

reasonable and will not be disruptive 

because the underlying rule has not yet 

been implemented or taken effect. 

Paperwork Reduction Act of 1995 

This rule has no information 

collection requirements. 

Norris Cochran, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2021–03747 Filed 2–19–21; 11:15 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2021–0003; Internal 

Agency Docket No. FEMA–8667] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur. 

Information identifying the current 

participation status of a community can 

be obtained from FEMA’s CSB available 

at www.fema.gov/flood-insurance/workwith-nfip/community-status-book. 

Please note that per Revisions to 

Publication Requirements for 

Community Eligibility Status 

Information Under the National Flood 

Insurance Program, notices such as this 

one for scheduled suspension will no 

longer be published in the Federal 

Register as of June 2021 but will be 

available at National Flood Insurance 

Community Status and Public 

Notification | FEMA.gov. Individuals 

without internet access will be able to 

contact their local floodplain 

management official and/or State NFIP 

Coordinating Office directly for 

assistance.