Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6247 

thereafter be continuously published in the 

Chart Supplement. 

* * * * * 

ACE KS E2 Manhattan, KS [Amended] 

Manhattan Regional Airport, KS 

(Lat. 39°08′28′′ N, long. 96°40′19′′ W) 

That airspace extending upward from the 

surface within a 4.3-mile radius of Manhattan 

Regional Airport excluding that airspace 

within the Fort Riley, KS, Class D airspace 

and Class E surface airspace areas and 

excluding that airspace within Restricted 

Area R–3602B. This Class E airspace area is 

effective during the specific dates and times 

established in advanced by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Chart Supplement. 

Paragraph 6004. Class E Airspace Areas 

Designated as an Extension to a Class D or 

Class E Surface Area. 

* * * * * 

ACE KS E4 Manhattan, KS [Amended] 

Manhattan Regional Airport, KS 

(Lat. 39°08′28′′ N, long. 96°40′19′′ W) 

Manhattan VOR/DME 

(Lat. 39°08′44′′ N, long. 96°40′07′′ W) 

That airspace extending upward from the 

surface within 1.3 miles each side of the 042° 

radial from the Manhattan VOR/DME 

extending from the 4.3-mile radius of the 

Manhattan Regional Airport to 5.2 miles 

northeast of the airport, and within 2.4 miles 

each side of the 211° radial from the 

Manhattan VOR/DME extending from the 

4.3-mile radius of the Manhattan Regional 

Airport to 7 miles southwest of the 

Manhattan VOR/DME excluding that airspace 

within the Fort Riley, KS, Class D airspace 

and Class E surface airspace areas and 

excluding that airspace within Restricted 

Area R–3602B. 

Paragraph 6005. Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ACE KS E5 Fort Riley, KS [Establish] 

Marshall AAF, KS 

(Lat. 39°03′10′′ N, long. 96°45′52′′ W) 

Freeman Field, KS 

(Lat. 39°02′36′′ N, long. 96°50′36′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.4-mile 

radius of Marshall AAF, and within a 6.4- 

mile radius of Freeman Field excluding that 

airspace within Restricted Areas R–3602A 

and R–3602B. 

* * * * * 

ACE KS E5 Manhattan, KS [Amended] 

Manhattan Regional Airport, KS 

(Lat. 39°08′28′′ N, long. 96°40′19′′ W) 

That airspace extending upward from 700 

feet above the surface within a 6.8-mile 

radius of the Manhattan Regional Airport, 

and within 4 miles each side of the 040° 

bearing from the Manhattan Regional Airport 

extending from the 6.8-mile radius of the 

airport to 10.6 miles northeast of the airport 

excluding that airspace within Restricted 

Areas R–3602A and R–3602B. 

Issued in Fort Worth, Texas, on January 13, 

2021. 

Martin A. Skinner, 

Acting Manager, Operations Support 

Group,ATO Central Service Center. 

[FR Doc. 2021–01020 Filed 1–19–21; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2020–0459] 

RIN 1625–AA00 

Safety Zone; Tanapag Harbor, Saipan, 

CNMI 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is 

establishing a annually recurring safety 

zone for navigable waters within 

Tanapag Harbor, Saipan. This safety 

zone will encompass the designated 

swim course for the Escape from 

Managaha swim event in the waters of 

Tanapag Harbor, Saipan, 

Commonwealth of the Northern Mariana 

Islands. This action is necessary to 

protect all persons and vessels 

participating in this marine event from 

potential safety hazards associated with 

vessel traffic in the area. Race 

participants, chase boats, and organizers 

of the event will be exempt from the 

safety zone. Entry of persons or vessels 

into the safety zone is prohibited unless 

authorized by the Captain of the Port 

(COTP) Guam. 

DATES: This rule is effective February 

22, 2021. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2020– 

0459 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Chief Petty Officer Robert Davis, 

Sector Guam, U.S. Coast Guard, by 

telephone at (671) 355–4866, or email at 

WWMGuam@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The purpose of this rule is to ensure 

the safety of the participants and the 

navigable waters in the safety zone 

before, during, and after the scheduled 

swim event. In response, on November 

20, 2020, the Coast Guard published a 

notice of proposed rulemaking (NPRM) 

titled Safety Zone; Tanapag Harbor, 

Saipan, CNMI (85 FR 74304–74306). 

There we stated why we issued the 

NPRM, and invited comments on our 

proposed regulatory action related to 

this safety zone. During the comment 

period that ended December 21, 2020, 

we received no comments. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under its authority in 46 U.S.C 70034 

(previously 33 U.S.C. 1231). The 

Captain of the Port (COTP) Guam has 

determined that potential hazards exist, 

and the purpose of this rule is to protect 

all persons and vessels participating in 

this marine event from potential safety 

hazards associated with vessel traffic in 

the area. 

IV. Discussion of Comments, Changes, 

and the Rule 

As noted above, we received no 

comments on our NPRM published 

November 20, 2020. There are no 

changes in the regulatory text of this 

rule from the proposed rule in the 

NPRM. 

This rule establishes a annual 

recurring safety zone from 5:00 a.m. 

until 8:30 a.m. on a Saturday or Sunday 

between February and April. The safety 

zone will cover all navigable waters 

within 100-yard radius of race 

participants in Tanapag Harbor, Saipan. 

This rulemaking would prohibit persons 

and vessels not involved in the event 

from being in the safety zone unless 

authorized by the COTP or a designated 

representative. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 


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6248 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

necessary, to select regulatory 

approaches that maximize net benefits. 

Executive Order 13771 directs agencies 

to control regulatory costs through a 

budgeting process. This rule has not 

been designated a ‘‘significant 

regulatory action,’’ under Executive 

Order 12866. Accordingly, this rule has 

not been reviewed by the Office of 

Management and Budget (OMB), and 

pursuant to OMB guidance it is exempt 

from the requirements of Executive 

Order 13771. 

This regulatory action determination 

is based on the size, location, duration, 

and time-of-day of the safety zone. 

Vessel traffic will be able to safely 

transit around this safety zone, which 

will impact a small designated area of 

Tanapag Harbor for 3.5 hours. Moreover, 

the Coast Guard will issue a Broadcast 

Notice to Mariners via VHF–FM marine 

channel 16 about the zone, and the rule 

allows vessels to seek permission to 

enter the zone. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, 5 U.S.C. 601–612, as amended, 

requires Federal agencies to consider 

the potential impact of regulations on 

small entities during rulemaking. The 

term ‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard received 00 comments 

from the Small Business Administration 

on this rulemaking. The Coast Guard 

certifies under 5 U.S.C. 605(b) that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

While some owners or operators of 

vessels intending to transit the safety 

zone may be small entities, for the 

reasons stated in section V.A above, this 

rule will not have a significant 

economic impact on any vessel owner 

or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the National Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969(42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting 3.5 hours that will prohibit 

entry within 100-yards of swim 

participants. It is categorically excluded 

from further review under paragraph 

L60(a) of Appendix A, Table 1 of DHS 

Instruction Manual 023–01–001–01, 

Rev. 1. A Record of Environmental 

Consideration supporting this 

determination is available in the docket. 

For instructions on locating the docket, 

see the ADDRESSES section of this 

preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—SAFETY ZONE; TANAPAG 

HARBOR, SAIPAN, CNMI 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add § 165.1417 to read as follows: 

165.1417 Safety Zone; Tanapag Harbor, 

Saipan, CNMI. 

(a) Location. The following area, 

within the Guam Captain of the Port 

(COTP) Zone (See 33 CFR 3.70–15), all 

navigable waters within a 100-yard 

radius of race participants for Escape for 

Managaha Swim in Tanapag Harbor, 

Saipan. Race participants, chase boats, 

and organizers of the event will be 

exempt from the safety zone. 

(b) Definitions. As used in this 

section, designated representative 

means a Coast Guard Patrol 

Commander, including a Coast Guard 

coxswain, petty officer, or other officer 

operating a Coast Guard vessel and a 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6249 

1National Vaccine Injury Compensation Program, 

Health Resources & Servs. Admin., https://

www.hrsa.gov/vaccine-compensation/index.html 

(last reviewed Jan. 2020). 

2H.R. Rep. No. 99–908, pt. 1, at 6 (1986). Even 

though in rare instances individuals may have 

adverse reactions to vaccines, the Centers for 

Disease Control and Prevention (CDC) recommends 

that individuals be vaccinated against a wide range 

of illnesses and diseases. See Recommended 

Vaccines by Age. Ctrs. for Disease Control & 

Prevention, https://www.cdc.gov/vaccines/vpd/ 

vaccines-age.html (last reviewed Nov. 22, 2016). 

3H.R. Rep. No. 99–908, at 6. 4See id. at 4–6. 

Federal, State, and local officer 

designated by or assisting the Captain of 

the Port (COTP) Sector Guam in the 

enforcement of the safety zone. 

(c) Regulations. (1) In accordance with 

the general regulations in section 

§ 165.23, entry into, transiting, or 

anchoring within this safety zone is 

prohibited unless authorized by the 

COTP or a designated on-scene 

representative. 

(2) This safety zone is closed to all 

persons and vessel traffic, except as may 

be permitted by the COTP or a 

designated on-scene representative. 

(3) The ‘‘on-scene representative’’ of 

the COTP is any Coast Guard 

commissioned, warrant, or petty officer 

who has been designated by the COTP 

to act on his or her behalf. 

(4) Persons and Vessel operators 

desiring to enter or operate within the 

safety zone must contact the COTP or an 

on-scene representative to obtain 

permission to do so. The COTP or an 

on-scene representative may be 

contacted via VHF Channel 16. Vessel 

operators given permission to enter or 

operate in the safety zone must comply 

with all directions given to them by the 

COTP or an on-scene representative. 

(d) Enforcement period. This safety 

zone will be enforced at a specified date 

between February and April. The Coast 

Guard will provide advance notice of 

enforcement and a broadcast notice to 

mariners to inform public of specific 

date. 

Dated: January 12, 2021. 

Christopher M. Chase, 

Captain, U.S. Coast Guard, Captain of the 

Port, Guam. 

[FR Doc. 2021–01084 Filed 1–19–21; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

42 CFR Part 100 

RIN 0906–AB24 

National Vaccine Injury Compensation 

Program: Revisions to the Vaccine 

Injury Table 

AGENCY: Public Health Service, Health 

Resources and Services Administration 

(‘‘HRSA’’), Department of Health and 

Human Services (‘‘HHS’’ or the 

‘‘Department’’). 

ACTION: Final rule. 

SUMMARY: The Secretary finalizes the 

proposed rule to amend the Vaccine 

Injury Table (Table) by regulation. This 

final rule will have effect only for 

petitions for compensation under the 

National Vaccine Injury Compensation 

Program (VICP) filed after this final rule 

become effective. This final rule does 

not impact COVID–19 vaccines or PREP 

Act immunity for Covered Persons (as 

defined in the PREP Act) who 

manufacture, distribute, order, or 

administer COVID–19 vaccines. 

DATES: This final rule is effective on 

February 22, 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: This is a 

final rule by which HHS amends the 

provisions of 42 CFR 100.3 by removing 

Shoulder Injury Related to Vaccine 

Administration, vasovagal syncope, and 

Item XVII from the Vaccine Injury 

Table. 

I. Background and Purpose 

Vaccination is one of the best ways to 

protect against potentially harmful 

diseases that can be very serious, may 

require hospitalization, or even be 

deadly. Almost all individuals who are 

vaccinated have no serious reactions.1

Nonetheless, in the 1980s, Congress 

became concerned that a small number 

of children who received 

immunizations had serious reactions to 

them, and it was not always possible to 

predict which children would have 

reactions, or what reactions they would 

have.2 Claimants alleging vaccinerelated injuries in civil litigation 

encountered a time-consuming, 

expensive, and often inadequate 

system.3 Moreover, increased litigation 

against vaccine manufacturers resulted 

in difficulties in their ability to secure 

affordable product liability insurance, 

stabilize vaccine prices and supply, and 

enter the market.4

Therefore, Congress enacted the 

National Childhood Vaccine Injury Act 

of 1986, title III of Public Law 99—660 

(42 U.S.C. 300aa–1 et seq.) (‘‘Vaccine 

Act’’ or ‘‘the Act’’), which established 

the National Vaccine Injury 

Compensation Program (VICP). The 

objectives of the VICP are to ensure an 

adequate supply of vaccines, stabilize 

vaccine costs, and establish and 

maintain an accessible and efficient 

forum for individuals found to be 

injured by certain vaccines to be 

federally compensated. Petitions for 

compensation under the VICP are filed 

in the United States Court of Federal 

Claims (Court), rather than the civil tort 

system, with a copy served on the 

Secretary, who is the Respondent. The 

U.S. Department of Justice (DOJ) 

represents HHS in Court, and the Court, 

acting through judicial officers called 

Special Masters, makes the final 

decision as to eligibility for, and the 

type and amount of, compensation. 

To gain entitlement to compensation 

under this Program, a petitioner must 

establish that a vaccine-related injury or 

death has occurred, either by proving 

that a vaccine actually caused or 

significantly aggravated an injury 

(causation-in-fact) or by demonstrating 

what is referred to as a ‘‘Table injury.’’ 

That is, a petitioner may show that the 

vaccine recipient (1) received a vaccine 

covered under the Act; (2) suffered an 

injury of the type enumerated in the 

regulations at 42 CFR 100.3—the 

‘‘Vaccine Injury Table’’ (Table)— 

corresponding to the vaccination in 

question; and (3) that the onset of such 

injury took place within the time period 

specified in the Table. If so, the injury 

is presumed to have been caused by the 

vaccine, and the petitioner is entitled to 

compensation (assuming that other 

requirements are satisfied), unless the 

respondent affirmatively shows that the 

injury was caused by some factor 

unrelated to the vaccination (see 42 

U.S.C. 300aa–11(c)(1)(C)(i), 300aa– 

13(a)(1)(B), and 300aa–14(a)). 

42 U.S.C. 300aa–14(c) and (e) permit 

the Secretary to revise the Table. The 

Table currently includes 17 vaccine 

categories, with 16 categories for 

specific vaccines, as well as the 

corresponding illnesses, disabilities, 

injuries, or conditions covered, and the 

requisite time period when the first 

symptom or manifestation of onset or of 

significant aggravation after the vaccine 

administration must begin to receive the 

Table’s legal presumption of causation. 

The final category of the Table, ‘‘Item 


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