Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 11293 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

[FR Doc. 2022–04022 Filed 2–28–22; 8:45 a.m.] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. FDA–2022–N–0114] 

Medical Devices; Orthopedic Devices; 

Classification of the Screw Sleeve 

Bone Fixation Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the screw sleeve bone 

fixation device into class II (special 

controls). The special controls that 

apply to the device type are identified 

in this order and will be part of the 

codified language for the screw sleeve 

bone fixation device’s classification. We 

are taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES:

This order is effective March 1, 2022. 

The classification was applicable on 

May 1, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Jesse Muir, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4508, Silver Spring, 

MD 20993–0002, 240–402–6679, 

Jesse.Muir@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

screw sleeve bone fixation device as 

class II (special controls), which we 

have determined will provide a 

reasonable assurance of safety and 

effectiveness. In addition, we believe 

this action will enhance patients’ access 

to beneficial innovation, by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

When FDA classifies a device into 

class I or II via the De Novo process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (see section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On December 13, 2018, FDA received 

Woven Orthopedic Technologies, LLC’s 

request for De Novo classification of the 

OGmend® Implant System. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on May 1, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 888.3043.1 We have named the 

generic type of device ‘‘screw sleeve 

bone fixation device,’’ and it is intended 

to be implanted in conjunction with a 

non-resorbable, metallic bone screw 

where the screw has lost purchase due 

to loosening, backout, or breakage. The 

device fits between the screw threads 

and surrounding bone and provides 

increased surface area to create an 


jspears on DSK121TN23PROD with RULES1
11294 Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 

interference fit to restore stability of the 

implant construct. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in table 

1. 

TABLE 1—SCREW SLEEVE BONE FIXATION DEVICE RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Loss of function/mechanical integrity resulting from: 

D Device malposition. 

D Device breakage. 

D Damage to screw during insertion. 

D Deterioration due to aging. 

D Insufficient restoration of screw fixation. 

In vivo performance testing; Non-clinical performance testing; Shelf life 

testing; and Labeling. 

Revision .................................................................................................... In vivo performance testing; Non-clinical performance testing; and Labeling. 

Adverse tissue reaction ............................................................................ Biocompatibility evaluation; In vivo performance testing; Non-clinical 

performance testing; and Labeling. 

Infection .................................................................................................... Sterilization validation; and Shelf life testing. 

Febrile response due to endotoxins ......................................................... Pyrogenicity testing. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. For a device 

to fall within this classification, and 

thus avoid automatic classification in 

class III, it would have to comply with 

the special controls named in this final 

order. The necessary special controls 

appear in the regulation codified by this 

order. We encourage sponsors to consult 

with us if they wish to use a non-animal 

testing method that they believe is 

suitable, adequate, validated, and 

feasible. We will consider if such an 

alternative method could be assessed for 

equivalency to an animal test method. 

This device is subject to premarket 

notification requirements under section 

510(k) of the FD&C Act. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in 21 CFR 

part 860, subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, 

regarding premarket approval, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 888 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 888 is 

amended as follows: 

PART 888—ORTHOPEDIC DEVICES 

■ 1. The authority citation for part 888 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 888.3043 to subpart D to read 

as follows: 

§ 888.3043 Screw sleeve bone fixation 

device. 

(a) Identification. A screw sleeve bone 

fixation device is intended to be 

implanted in conjunction with a nonresorbable, metallic bone screw where 

the screw has lost purchase due to 

loosening, backout, or breakage. The 

device fits between the screw threads 

and surrounding bone and provides 

increased surface area to create an 

interference fit to restore stability of the 

implant construct. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) In vivo performance testing under 

anticipated conditions of use must 

demonstrate: 

(i) The device provides sufficient 

stability to allow for fracture healing; 

and 

(ii) A lack of adverse biologic 

response to the implant through 

histopathological and 

histomorphometric assessment. 

(2) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. Testing must: 

(i) Assess the stability of the device in 

a rescue screw scenario; 

(ii) Demonstrate that the device can be 

inserted and removed without damage 

to the implant or associated hardware; 

(iii) Demonstrate the device can 

withstand dynamic loading without 

device failure; and 

(iv) Characterize wear particle 

generation. 

(3) The device must be demonstrated 

to be biocompatible. 

(4) The device must be demonstrated 

to be non-pyrogenic. 

(5) Performance data must 

demonstrate the sterility of the device. 

(6) Performance data must support the 

labeled shelf life of the device by 

demonstrating continued sterility, 

package integrity, and device 

functionality over the established shelf 

life. 

(7) Labeling must include: 

(i) A detailed summary of the device 

technical parameters; 

(ii) Information describing all 

materials of the device; 

(iii) Instructions for use, including 

device removal; and 

(iv) A shelf life. 


jspears on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 11295 

1R.J. Reynolds Tobacco Co. et al. v. United States 

Food and Drug Administration et al., No. 6:20–cv– 

00176 (E.D. Tex. filed April 3, 2020). 

2R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. May 8, 2020) (order granting joint motion 

and establishing schedule), Doc. No. 33. 

3R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. December 2, 2020) (order granting 

Plaintiffs’ motion and postponing effective date), 

Doc. No. 80. 

4R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. March 2, 2021) (order granting Plaintiffs’ 

motion and postponing effective date), Doc. No. 89. 

5R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. May 21, 2021) (order granting Plaintiffs’ 

motion and postponing effective date), Doc. No. 91. 

6R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. August 18, 2021) (order postponing 

effective date), Doc. No. 92. 

7R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. November 12, 2021) (order postponing 

effective date), Doc. No. 93. 

8R.J. Reynolds Tobacco Co., No. 6:20–cv–00176 

(E.D. Tex. February 10, 2022) (order postponing 

effective date), Doc. No. 94. 

Dated: February 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04154 Filed 2–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1141 

[Docket No. FDA–2019–N–3065] 

RIN 0910–AI39 

Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements; Delayed Effective 

Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: As required by an order 

issued by the U.S. District Court for the 

Eastern District of Texas, this action 

delays the effective date of the final rule 

(‘‘Tobacco Products; Required Warnings 

for Cigarette Packages and 

Advertisements’’), which published on 

March 18, 2020. The new effective date 

is April 9, 2023. 

DATES: The effective date of the rule 

amending 21 CFR part 1141 published 

at 85 FR 15638, March 18, 2020, and 

delayed at 85 FR 32293, May 29, 2020; 

86 FR 3793, January 15, 2021; 86 FR 

36509, July 12, 2021; 86 FR 50855, 

September 13, 2021; and 86 FR 70052, 

December 9, 2021, is further delayed 

until April 9, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Courtney Smith, Office of Regulations, 

Center for Tobacco Products, Food and 

Drug Administration, Document Control 

Center, 10903 New Hampshire Ave., 

Bldg. 71, Rm. G335, Silver Spring, MD 

20993–0002, 1–877–287–1371, email: 

CTPRegulations@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 18, 2020, the 

Food and Drug Administration (FDA or 

Agency) issued a final rule establishing 

new cigarette health warnings for 

cigarette packages and advertisements. 

The final rule implements a provision of 

the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) (Pub. L. 111–31) that requires FDA 

to issue regulations requiring color 

graphics depicting the negative health 

consequences of smoking to accompany 

new textual warning label statements. 

The Tobacco Control Act amends the 

Federal Cigarette Labeling and 

Advertising Act of 1965 (Pub. L. 89–92) 

to require each cigarette package and 

advertisement to bear one of the new 

required warnings. The final rule 

specifies the 11 new textual warning 

label statements and accompanying 

color graphics. Pursuant to section 

201(b) of the Tobacco Control Act, the 

rule was published with an effective 

date of June 18, 2021, 15 months after 

the date of publication of the final rule. 

On April 3, 2020, the final rule was 

challenged in the U.S. District Court for 

the Eastern District of Texas.1 On May 

8, 2020, the court granted a joint motion 

to govern proceedings in that case and 

postpone the effective date of the final 

rule by 120 days.2 On December 2, 2020, 

the court granted a new motion by the 

plaintiffs to postpone the effective date 

of the final rule by an additional 90 

days.3 On March 2, 2021, the court 

granted another motion by the plaintiffs 

to postpone the effective date of the 

final rule by an additional 90 days.4 On 

May 21, 2021, the court granted another 

motion by the plaintiffs to postpone the 

effective date of the final rule by an 

additional 90 days.5 On August 18, 

2021, the court issued an order to 

postpone the effective date of the final 

rule by an additional 90 days.6 On 

November 12, 2021, the court issued 

another order to postpone the effective 

date of the final rule by an additional 90 

days.7 On February 10, 2022, the court 

issued another order to postpone the 

effective date of the final rule by an 

additional 90 days.8 The court ordered 

that the new effective date of the final 

rule is April 9, 2023. Pursuant to the 

court order, any obligation to comply 

with a deadline tied to the effective date 

is similarly postponed, and those 

obligations and deadlines are now tied 

to the postponed effective date. 

To the extent that 5 U.S.C. 553 applies 

to this action, the Agency’s 

implementation of this action without 

opportunity for public comment, 

effective immediately upon publication 

in the Federal Register, is based on the 

good cause exception in 5 U.S.C. 

553(b)(B). Seeking public comment is 

impracticable, unnecessary, and 

contrary to the public interest. The 90- 

day postponement of the effective date, 

until April 9, 2023, is required by court 

order in accordance with the court’s 

authority to postpone a rule’s effective 

date pending judicial review (5 U.S.C. 

705). Seeking prior public comment on 

this postponement would have been 

impracticable, as well as contrary to the 

public interest in the orderly issuance 

and implementation of regulations. 

Dated: February 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04181 Filed 2–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 300 

[TD 9962] 

RIN 1545–BQ06 

User Fees Relating to the Enrolled 

Agent Special Enrollment Examination 

and the Enrolled Retirement Plan 

Agent Special Enrollment Examination 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: These final regulations amend 

existing regulations relating to the user 

fees for the special enrollment 

examinations for enrolled agents and 

enrolled retirement plan agents. The 

final regulations increase the amount of 

the user fee for each part of the special 

enrollment examination for enrolled 

agents (EA SEE). The final regulations 

also remove the user fee for the special 

enrollment examination for enrolled 

retirement plan agents (ERPA SEE) 

because the IRS no longer offers the 

ERPA SEE or new enrollment as an 

enrolled retirement plan agent. The final 

regulations affect individuals taking the 

EA SEE. The Independent Offices 

Appropriation Act of 1952 authorizes 

charging user fees. 

DATES: Effective date: These regulations 

are effective March 31, 2022. 

Applicability date: For the date of 

applicability, see § 300.4(d). 


jspears on DSK121TN23PROD with RULES1