Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Proposed Rules 3257 

regulatory-information/search-fda-guidancedocuments/recommendations-premarketnotification-510k-submissions-nucleic-acidbased-human-leukocyte-antigen. 

5. FDA, ‘‘Medical Devices; Immunology 

and Microbiology Devices; Classification of 

Human Leukocyte, Neutrophil and Platelet 

Antigen and Antibody Tests,’’ Preliminary 

Regulatory Impact Analysis Initial Regulatory 

Flexibility Analysis Unfunded Mandates 

Reform Act Analysis,’’ 2019 (available at 

https://www.fda.gov/about-fda/reports/ 

economic-impact-analyses-fda-regulations. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, we propose that 21 

CFR part 866 be amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 866.5960 to subpart F to read 

as follows: 

§ 866.5960 Human Leukocyte, Human 

Neutrophil, and Human Platelet antigen and 

antibody devices. 

(a) Identification. Human Leukocyte, 

Human Neutrophil, and Human Platelet 

antigen and antibody devices consist of 

Human Leukocyte Antigen (HLA), 

Human Platelet Antigen (HPA), and 

Human Neutrophil Antigen (HNA) 

typing and antibody detection devices. 

(1) HLA typing devices are used to 

determine HLA types, to aid in 

transfusion or transplantation donor and 

recipient matching, or to aid in the 

diagnosis of diseases. 

(2) HLA antibody detection devices 

are used to detect antibodies to HLA 

antigens to aid in donor and recipient 

matching in transfusion or 

transplantation. 

(3) HPA typing devices are used for 

the detection of human platelet antigens 

to aid in donor and recipient matching 

in blood transfusion or to aid in the 

diagnosis of diseases. 

(4) HPA antibody detection devices 

are used to detect autoantibodies and 

alloantibodies against platelet 

glycoproteins to aid in donor and 

recipient matching in blood transfusion 

or to aid in the diagnosis of diseases. 

(5) HNA typing devices are used for 

the detection of human neutrophil 

antigens to aid in donor and recipient 

matching in blood transfusion or to aid 

in the diagnosis of diseases. 

(6) HNA antibody detection devices 

are used to detect autoantibodies and 

alloantibodies against neutrophil 

antigens to aid in donor and recipient 

matching in blood transfusion or to aid 

in the diagnosis of diseases. 

(b) Classification. Class II (special 

controls). HLA, HPA, and HNA typing 

devices must comply with the following 

special controls: 

(1) Premarket submissions must 

include detailed documentation of the 

following: 

(i) Device accuracy study using wellcharacterized samples representing as 

many targets as possible. 

(ii) Precision studies to evaluate 

possible sources of variation that may 

affect test results. 

(iii) Comparison studies to evaluate 

the device’s performance compared to a 

predicate. 

(iv) Specific information that 

addresses or mitigates risks associated 

with false positive antibody reactivity, 

e.g., reactivity with denatured/cryptic 

epitopes, if applicable. 

(v) Description of how the assay cutoff 

was established and validated as well as 

supporting data. 

(vi) Documentation for device 

software, including, but not limited to, 

software requirement specifications, 

software design specifications, e.g., 

algorithms, alarms, and device 

limitations; hazard analysis, traceability 

matrix, verification and validation 

testing, unresolved anomalies, hardware 

and software specifications; 

electromagnetic compatibility and 

wireless testing. 

(vii) Design specifications that are in 

place to prevent incorrect reactivity 

assignment or multiplex assays in 

which large numbers of probes and/or 

primers are handled during 

manufacturing process. 

(viii) Description of a plan on how to 

ensure the performance characteristics 

of the device remain unchanged over 

time when new HLA alleles are 

identified and/or reactivity assignments 

are changed from the assignments at the 

time the device was evaluated. 

(2) The device labeling must include: 

(i) A limitation statement that reads, 

‘‘The results should not be used as the 

sole basis for making a clinical 

decision.’’ 

(ii) A warning that reads ‘‘The device 

has not been cleared or approved for use 

as a companion diagnostic.’’ 

Dated: January 11, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–01156 Filed 1–20–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Department of the Army, Corps of 

Engineers 

33 CFR Part 334 

[COE–2021–0006] 

Eagle River From Bravo Bridge to 

Eagle Bay in Knik Arm, Richardson 

Training Area on Joint Base 

Elmendorf-Richardson, Alaska; 

Restricted Area 

AGENCY: U.S. Army Corps of Engineers, 

DoD. 

ACTION: Notice of proposed rulemaking 

and request for comments. 

SUMMARY: The U.S. Army Corps of 

Engineers (Corps) is proposing to revise 

its regulations to establish a restricted 

area within the Richardson Training 

Area on Joint Base ElmendorfRichardson (JBER), at Eagle River. The 

United States Army, Alaska (USARAK) 

G3/5/7 Training and Support ActivityAlaska (TSA–AK) requested 

establishment of a restricted area which 

would be located in the area of 

navigable waters extending from the 

span on Bravo Bridge across Eagle River 

to the mouth of Eagle River Knik Arm 

(Eagle River channel). Establishment of 

the restricted area would prevent all 

watercraft navigations and individuals 

from entering an active military range 

munitions impact area at all times, 

except for authorized vessels and 

individuals engaged in support of 

military training and management 

activities. This restricted area is 

necessary to avoid inadvertent entry 

into the impact area during live-fire 

weapons training, exposure to 

hazardous noise, and inadvertent 

encounters with unexploded ordnance. 

DATES: Written comments must be 

submitted on or before February 22, 

2022. 

ADDRESSES: You may submit comments, 

identified by docket number COE– 

2021–0006, by any of the following 

methods: 

Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

Email: david.b.olson@usace.army.mil. 

Include the docket number, COE–2021– 

0006, in the subject line of the message. 

Mail: U.S. Army Corps of Engineers, 

Attn: CECW–CO–R (David B. Olson), 

441 G Street NW, Washington, DC 

20314–1000. 

Hand Delivery/Courier: Due to 

security requirements, we cannot 

receive comments by hand delivery or 

courier. 


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3258 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Proposed Rules 

Instructions: Direct your comments to 

docket number COE–2021–0006. All 

comments received will be included in 

the public docket without change and 

may be made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the commenter indicates that the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI, or otherwise 

protected, through regulations.gov or 

email. The regulations.gov website is an 

anonymous access system, which means 

we will not know your identity or 

contact information unless you provide 

it in the body of your comment. If you 

send an email directly to the Corps 

without going through regulations.gov, 

your email address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

internet. If you submit an electronic 

comment, we recommend that you 

include your name and other contact 

information in the body of your 

comment and with any compact disk 

you submit. If we cannot read your 

comment because of technical 

difficulties and cannot contact you for 

clarification, we may not be able to 

consider your comment. Electronic 

comments should avoid the use of any 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: For access to the docket to 

read background documents or 

comments received, go to 

www.regulations.gov. All documents in 

the docket are listed. Although listed in 

the index, some information is not 

publicly available, such as CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the internet and will be 

publicly available only in hard copy 

form. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Olson, Headquarters, U.S. Army 

Corps of Engineers, Operations and 

Regulatory Community of Practice, 

Washington, DC at 202–761–4922. 

SUPPLEMENTARY INFORMATION: 

Background 

Pursuant to its authorities in Section 

7 of the Rivers and Harbors Act of 1917 

(40 Stat 266; 33 U.S.C. 1) and Chapter 

XIX of the Army Appropriations Act of 

1919 (40 Stat 892; 33 U.S.C. 3) the Corps 

is proposing to amend the regulations at 

33 CFR part 334 by establishing a 

restricted area in the Eagle River 

channel. The amendment to this 

regulation will allow the USARAK 

Commander to prevent all watercraft 

navigations and individuals from 

entering an active military range 

(Richardson Training Area, Joint Base 

Elmendorf-Richardson) munitions 

impact area at all times, except for 

authorized vessels and individuals 

engaged in support of military training 

and management activities. This 

restricted area will be in place as a 

precautionary measure to protect the 

public from inadvertently entering the 

impact area during live-fire weapons 

training, encountering hazardous noise 

in the vicinity of the impact area, and 

encountering unexploded ordnance. 

Procedural Requirements 

a. Regulatory Planning and Review. 

This proposed rule is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866 (58 FR 51735, October 4, 

1993) and it was not submitted to the 

Office of Management and Budget for 

review. 

b. Regulatory Flexibility Act, as 

Amended by the Small Business 

Regulatory Enforcement Fairness Act of 

1996, 5 U.S.C. 601 et seq. This rule has 

been reviewed under the Regulatory 

Flexibility Act (Pub. L. 96–354). The 

Regulatory Flexibility Act generally 

requires an agency to prepare a 

regulatory flexibility analysis of any rule 

subject to notice-and-comment 

rulemaking requirements under the 

Administrative Procedure Act or any 

other statute unless the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities (i.e., small 

businesses and small governments). 

The Corps certifies under 5 U.S.C. 

605(b) that this proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

The restricted area is necessary to 

protect public safety. This restricted 

regulation would prevent all watercraft 

and individuals from entering an 

activity military range munitions impact 

area at all times, except for authorized 

vessels and individuals engaged in 

support of military training and 

management activities. The regulation 

would allow people, watercraft, or 

vessels to enter or remain in the waters 

in the restricted area as long as they are 

authorized by the enforcing agency. 

Small entities can utilize navigable 

waters outside of the restricted area. 

Unless information is obtained to the 

contrary during the comment period, 

the Corps expects that the economic 

impact of the proposed restricted area 

would have practically no impact on the 

public, any anticipated navigational 

hazard or interference with existing 

waterway traffic. After considering the 

economic impacts of this restricted area 

regulation on small entities, I certify 

that this proposed rule would not have 

a significant impact on a substantial 

number of small entities. 

c. Review Under the National 

Environmental Policy Act. Due to the 

administrative nature of this action and 

because there is no intended change in 

the use of the area, the Corps expects 

that this regulation, if adopted, will not 

have a significant impact on the quality 

of the human environment and, 

therefore, preparation of an 

environmental impact statement will 

not be required. An environmental 

assessment will be prepared after the 

public notice period is closed and all 

comments have been received and 

considered. 

d. Unfunded Mandates Act. This 

proposed rule does not contain a federal 

mandate that may result in expenditures 

of $100 million or more for tribal, state, 

and local governments, in the aggregate, 

or the private sector in any one year. 

Therefore, this proposed rule is not 

subject to the requirements of Sections 

202 and 205 of the Unfunded Mandates 

Reform Act (UMRA). The proposed rule 

contains no regulatory requirements that 

might significantly or uniquely affect 

small governments. Therefore, the 

proposed rule is not subject to the 

requirements of Section 203 of UMRA. 

List of Subjects in 33 CFR Part 334 

Danger zones, Navigation (water), 

Restricted areas, Waterways. 

For the reasons set forth in the 

summary above, the Corps proposes to 

amend 33 CFR part 334 as follows: 

PART 334—DANGER ZONE AND 

RESTRICTED AREA REGULATIONS 

■ 1. The authority citation for part 334 

continues to read as follows: 

Authority: 40 Stat. 266 (33 U.S.C. 1) and 

40 Stat. 892 (33 U.S.C. 3). 

■ 2. Add § 334.1305 to read as follows: 

§ 334.1305 Eagle River from Bravo Bridge 

to its mouth at Eagle Bay in Knik Arm, 

Richardson Training Area on Joint Base 

Elmendorf-Richardson, Alaska; restricted 

area. 

(a) Restricted area. The restricted area 

consists of navigable waters within an 

area defined as beginning a point on 

shore at latitude 61°19′40.1′′ N, 

longitude 149°44′20.336′′ W; thence 

easterly to latitude 61°19′41.59′′ N, 

longitude 149°44′6.825′′ W; 3.06 

nautical miles southerly along the river 

to latitude 61°18′40.13′′ N, longitude 


jspears on DSK121TN23PROD with PROPOSALS1
Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Proposed Rules 3259 

149°41′16.12′′ W; thence southerly to 

latitude 61°18′38.404′′ N, to longitude 

149°41′14.73′′ W. The datum for these 

coordinates is NAD–83. 

(b) The regulation. The restricted area 

is permanently closed for public use at 

all times. No persons, watercraft, or 

vessels shall enter, or remain, in the 

area except for those authorized by the 

enforcing agency. 

(c) Enforcement. This regulation will 

be enforced by the Commander, United 

States Army-Alaska. 

Thomas P. Smith, 

Chief, Operations and Regulatory Division. 

[FR Doc. 2022–01011 Filed 1–20–22; 8:45 am] 

BILLING CODE 3720–58–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2021–0854; FRL–9381–01– 

R3] 

Air Plan Approval; Delaware; 

Philadelphia Area 2017 Base Year 

Inventory for the Ozone National 

Ambient Air Quality Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

state implementation plan (SIP) revision 

formally submitted by the State of 

Delaware. This revision consists of the 

base year inventory for the Delaware 

portion of the Philadelphia-WilmingtonAtlantic City, PA-NJ-MD-DE marginal 

nonattainment area (Philadelphia Area) 

for the 2015 ozone national ambient air 

quality standards (NAAQS). This action 

is being taken under the Clean Air Act 

(CAA). 

DATES: Written comments must be 

received on or before February 22, 2022. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R03– 

OAR–2021–0854 at https://

www.regulations.gov, or via email to 

Gordon.Mike@epa.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. For either manner of 

submission, EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

confidential business information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. EPA will generally not consider 

comments or comment contents located 

outside of the primary submission (i.e., 

on the web, cloud, or other file sharing 

system). For additional submission 

methods, please contact the person 

identified in the FOR FURTHER

INFORMATION CONTACT section. For the 

full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Adam Yarina, Planning & 

Implementation Branch (3AD30), Air & 

Radiation Division, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. The telephone number is (215) 

814–2103. Mr. Yarina can also be 

reached via electronic mail at 

Yarina.Adam@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

October 9, 2020, the Delaware 

Department of Natural Resources and 

Environmental Control (DNREC) on 

behalf of the State of Delaware, 

submitted a revision to the Delaware SIP 

entitled, ‘‘2017 Base Year Emissions 

Inventory State Implementation Plan for 

VOC, NOX, and CO for Areas of 

Marginal Nonattainment of the 2015 

Ozone NAAQS in Delaware.’’ New 

Castle County comprises Delaware’s 

portion of the Philadelphia-WilmingtonAtlantic City, PA-NJ-MD-DE 2015 ozone 

NAAQS nonattainment area. This SIP 

revision, referred to in this rulemaking 

action as the ‘‘New Castle County base 

year inventory SIP,’’ addresses 

Delaware’s base year inventory 

requirement for the 2015 ozone NAAQS. 

I. Background 

On October 1, 2015, EPA strengthened 

the 8-hour ozone NAAQS, lowering the 

level of the NAAQS from 0.075 ppm 

parts per million (ppm) to 0.070 ppm. 

See 80 FR 65292 (October 26, 2015). 

Effective August 3, 2018, EPA 

designated the Philadelphia Area, 

which consists of New Castle County in 

Delaware and counties in Maryland, 

New Jersey, and Pennsylvania, as 

marginal nonattainment for the 2015 

ozone NAAQS. See 83 FR 25776 (June 

4, 2018). CAA section 182(a)(1) requires 

ozone nonattainment areas classified as 

marginal or above to submit a 

comprehensive, accurate, current 

inventory of actual emissions from all 

emissions sources in the nonattainment 

area, known as a ‘‘base year inventory.’’ 

The New Castle County base year 

inventory SIP addresses a base year 

inventory requirement for the 

Philadelphia Area. 

II. Summary of SIP Revision and EPA 

Analysis 

A. EPA Evaluation of the New Castle 

County Base Year Inventory SIP 

EPA’s review of Delaware’s base year 

inventory SIP indicates that it meets the 

base year inventory requirements for the 

2015 ozone NAAQS. As required by 40 

CFR 51.1315(a), DNREC selected 2017 

for the base year inventory, which is 

consistent with the baseline year for the 

RFP because it is the year of the most 

recent triennial inventory. DNREC 

included actual ozone season emissions, 

pursuant to 40 CFR 51.1315(c). 

EPA prepared a Technical Support 

Document (TSD) in support of this 

rulemaking. In that TSD, EPA reviewed 

the results, procedures, and 

methodologies for the SIP base year, and 

found them to be acceptable and 

developed in accordance with EPA’s 

technical guidance. The TSD is 

available online at http://

www.regulations.gov, Docket ID No. 

EPA–R03–OAR–2021–0854. 

B. Base Year Inventory Requirements 

In EPA’s December 6, 2018 (83 FR 

62998) rulemaking, ‘‘Implementation of 

the 2015 National Ambient Air Quality 

Standards for Ozone: Nonattainment 

Area State Implementation Plan 

Requirements,’’ known as the ‘‘SIP 

Requirements Rule,’’ EPA set out 

nonattainment area requirements for the 

2015 ozone NAAQS. SIP Requirements 

Rule established base year inventory 

requirement, which were codified at 40 

CFR 51.1315. As per 40 CFR 51.1315(a), 

each 2015 ozone nonattainment area is 

required to submit a base year inventory 

within 2 years of designation (i.e., no 

later than August 3, 2020). 

Also, 40 CFR 51.1315(a) requires that 

the inventory year be selected consistent 

with the baseline year for the reasonable 

further progress (RFP) plan as required 

by 40 CFR 51.1310(b), which states that 

the baseline emissions inventory shall 

be the emissions inventory for the most 

recent calendar year for which a 

complete triennial inventory is required 

to be submitted to the EPA under the 

provisions of subpart A of 40 CFR part 

51, Air Emissions Reporting 

Requirements, 40 CFR 51.1 through 

51.50. The most recent triennial 

inventory year conducted for the 

National Emissions Inventory (NEI) 

pursuant to the Air Emissions Reporting 

Requirements (AERR) rule is 2017. See 


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