Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2045 

We have developed a comprehensive 

Economic Analysis of Impacts that 

assesses the impacts of the final rule. 

The full analysis of economic impacts is 

available in the docket for this final rule 

(Ref. 1) and at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.30(h) 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. 

VIII. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

IX. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects 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. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 

X. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this rule in 

accordance with the principles set forth 

in Executive Order 13175. We have 

determined that the rule does not 

contain policies that have substantial 

direct effects 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. 

Accordingly, we conclude that the rule 

does not contain policies that have 

tribal implications as defined in the 

Executive Order and, consequently, a 

tribal summary impact statement is not 

required. 

XI. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m. Monday through Friday; it is 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA/Economics Staff, ‘‘Revised 

Procedures for the Announcement of 

Approvals and Denials of Premarket 

Approval Applications and 

Humanitarian Device Exemption 

Applications, Regulatory Impact 

Analysis, Regulatory Flexibility 

Analysis, Unfunded Mandates Reform 

Act Analysis,’’ 2020 (available at: https:// 

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

economic-impact-analyses-fdaregulations). 

List of Subjects in 21 CFR Part 814 

Administrative practice and 

procedure, Confidential business 

information, Medical devices, Medical 

research, Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 814 is 

amended as follows: 

PART 814—PREMARKET APPROVAL 

OF MEDICAL DEVICES 

■ 1. The authority citation for part 814 

continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 353, 360, 

360c–360j, 360bbb–8b, 371, 372, 373, 374, 

375, 379, 379e, 379k–1, 381. 

§ 814.40 [Amended] 

■ 2. In § 814.40, remove ‘‘515(d)(3)’’ and 

add in its place ‘‘515(d)(4)’’. 

§ 814.44 [Amended] 

■ 3. Amend § 814.44 as follows: 

■ a. In the fourth sentence in paragraph 

(d)(1), remove ‘‘515(d)(3)’’ and add in its 

place ‘‘515(d)(4)’’ and remove the sixth 

sentence; 

■ b. In paragraph (d)(2), remove 

‘‘Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852’’ and add in 

its place ‘‘Freedom of Information 

Staff’s address listed on the Agency’s 

website at https://www.fda.gov.’’; and 

■ c. In paragraphs (e)(2)(ii) and (f)(2), 

remove ‘‘515(d)(3)’’ and add in its place 

‘‘515(d)(4)’’. 

§ 814.45 [Amended] 

■ 4. Amend § 814.45 as follows: 

■ a. In paragraph (d)(1), remove the 

third sentence and 

■ b. In paragraph (e)(3), remove 

‘‘515(d)(3)’’ and add in its place 

‘‘515(d)(4)’’. 

■ 5. In § 814.116 revise the fourth 

sentence in paragraph (b) to read as 

follows: 

§ 814.116 Procedures for review of an 

HDE. 

* * * * * 

(b) * * * The notice of approval of an 

HDE will be placed on the FDA’s home 

page on the internet (https://

www.fda.gov) in accordance with the 

rules and policies applicable to PMAs 

submitted under § 814.20. * * * 

* * * * * 

§ 814.118 [Amended] 

■ 6. In § 814.118(c)(3), remove 

‘‘515(d)(3)’’ and add in its place 

‘‘515(d)(4)’’. 

Dated: January 6, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–00501 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 882 and 1270 

[Docket No. FDA–2020–N–1519] 

RIN 0910–AI41 

Revocation of the Regulations for 

Human Tissue Intended for 

Transplantation and Human Dura 

Mater 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is issuing a final rule to revoke the 

regulations for human tissue intended 

for transplantation and human dura 

mater recovered prior to May 25, 2005. 

The revocation does not affect the 

regulations for human cells, tissues, and 

cellular and tissue-based products 

(HCT/Ps) recovered on or after May 25, 

2005. The rule is being finalized 

because these regulations are obsolete or 

no longer necessary to achieve public 

health goals. 

DATES: This rule is effective February 

14, 2022. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 


jspears on DSK121TN23PROD with RULES1
2046 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

1The special controls for human dura matter 

recovered prior to May 25, 2005, can be found in 

‘‘Class II Special Controls Guidance Document: 

Human Dura Mater—Guidance for Industry and 

FDA Staff’’, available at https://www.fda.gov/ 

medical-devices/guidance-documents-medicaldevices-and-radiation-emitting-products/class-iispecial-controls-guidance-document-human-duramater-guidance-industry-and-fda-staff. 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Shruti Modi, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Final Rule 

B. Summary of the Major Provisions of the 

Final Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

A. Introduction 

B. Need for Regulation/History of 

Rulemaking 

C. Applicability of § 882.5975 and Part 

1270 

D. Comments to the Proposed Rule 

III. Legal Authority 

IV. Effective Date 

V. Economic Analysis of Impacts 

A. Introduction 

B. Summary of Costs and Benefits 

VI. Analysis of Environmental Impact 

VII. Paperwork Reduction Act of 1995 

VIII. Federalism 

IX. Consultation and Coordination With 

Indian Tribal Governments 

X. Reference 

I. Executive Summary 

A. Purpose of the Final Rule 

FDA is removing the regulations 

under part 1270 (21 CFR part 1270), 

‘‘Human Tissue Intended for 

Transplantation’’ and § 882.5975 (21 

CFR 882.5975), ‘‘Human dura mater.’’ 

These regulations apply to certain 

tissues recovered prior to May 25, 2005. 

The Agency does not believe there are 

currently any tissues intended for 

transplantation remaining in inventory 

that were recovered prior to this date 

and that would be subject to these 

regulations. Therefore, the regulations 

under this part are outdated and 

obsolete. All HCT/Ps recovered on or 

after May 25, 2005, are subject to the 

regulations under part 1271 (21 CFR 

part 1271), ‘‘Human Cells, Tissues, and 

Cellular and Tissue-Based Products.’’ 

B. Summary of the Major Provisions of 

the Final Rule 

The final rule removes part 1270, 

‘‘Human Tissue Intended for 

Transplantation,’’ which applies to 

certain human tissue and to 

establishments or persons engaged in 

the recovery, screening, testing, 

processing, storage, or distribution of 

human tissue. It also removes 

§ 882.5975, ‘‘Human dura mater,’’ which 

identifies and classifies human dura 

mater recovered prior to May 25, 2005. 

C. Legal Authority 

FDA is taking this action under the 

communicable disease provisions of the 

Public Health Service Act (the PHS Act) 

and the device provisions of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). 

D. Costs and Benefits 

Because this final rule will not 

impose any additional burden on the 

industry, this regulation is not 

anticipated to result in any compliance 

costs and the economic impact is 

expected to be minimal. 

II. Background 

A. Introduction 

FDA is issuing a final rule to revoke 

the regulations for human tissue 

intended for transplantation (part 1270) 

and human dura mater (§ 882.5975) 

recovered prior to May 25, 2005, 

because these regulations are obsolete or 

no longer necessary to achieve public 

health goals. The revocation does not 

affect the regulations for human cells, 

tissues, and cellular and tissue-based 

products (HCT/Ps) recovered on or after 

May 25, 2005. 

B. Need for Regulation/History of 

Rulemaking 

FDA regulates articles containing or 

consisting of human cells or tissues 

intended for implantation, 

transplantation, infusion, or transfer 

into a human recipient. These are 

defined in § 1271.3(d) (21 CFR 

1271.3(d)) as HCT/Ps. Tissues as 

defined in § 1270.3(j) (21 CFR 1270.3(j)) 

recovered prior to May 25, 2005, are 

regulated under part 1270. HCT/Ps 

recovered on or after May 25, 2005, are 

subject to the regulations in part 1271. 

Examples of HCT/Ps include, but are 

not limited to the following: Bone, 

ligament, skin, cornea, dura mater, heart 

valve, hematopoietic stem/progenitor 

cells derived from peripheral and cord 

blood, and semen or other reproductive 

tissue. Vascularized human organs for 

transplantation are not considered HCT/ 

Ps. FDA previously regulated human 

dura mater recovered prior to May 25, 

2005, under § 882.5975 subject to 

special controls and premarket 

notification.1

In the Federal Register of December 

14, 1993 (58 FR 65514), FDA published 

an interim rule (1993 interim rule) for 

human tissue intended for 

transplantation. This rule provided 

specific donor suitability and testing 

requirements for certain tissue products. 

As the use of human tissue for 

transplantation increased, FDA 

determined that there was a need for a 

much more comprehensive set of 

regulatory requirements that included a 

broader scope of products. In the 

Federal Register of July 29, 1997 (62 FR 

40429), FDA issued a final rule that 

clarified and modified provisions of the 

1993 interim rule. 

In the Federal Register of March 4, 

1997 (62 FR 9721), FDA announced the 

availability of a document entitled 

‘‘Proposed Approach to the Regulation 

of Cellular and Tissue-Based Products’’ 

that detailed how cellular and tissuebased products would be regulated with 

a tiered approach based on risk and the 

necessity for FDA review. 

As part of this approach, FDA 

advanced three regulatory proposals 

including: (1) Registration and listing; 

(2) communicable-disease screening and 

testing; and (3) processing standards. 

FDA published three final rules to 

implement the proposed approach, 

which are codified in part 1271 as 

follows: (1) ‘‘Human Cells, Tissues, and 

Cellular and Tissue-Based Products; 

Establishment Registration and Listing’’ 

(66 FR 5447, January 19, 2001); (2) 

‘‘Eligibility Determination for Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products’’ (69 FR 29786, 

May 25, 2004); and (3) ‘‘Current Good 

Tissue Practice for Human Cell, Tissue, 

and Cellular and Tissue-Based Product 

Establishments, Inspection and 

Enforcement’’ (69 FR 68611, November 

24, 2004). 

FDA issued these regulations to 

increase the safety of HCT/Ps, and 

public confidence in their safety, by 

helping to prevent the introduction, 

transmission, and spread of 

communicable disease. The regulations 

were issued to protect the public health 

while minimizing regulatory burden, 

which in turn would encourage 

significant innovation. 

C. Applicability of § 882.5975 and Part 

1270 

The Agency did not revoke part 1270 

at the same time the Agency proposed 

part 1271 because it would have been 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2047 

impractical to apply part 1271 

retroactively to human tissue, as defined 

in § 1270.3(j), that was recovered before 

the effective date of the final rule. 

Instead, the Agency decided that human 

tissue, as defined in § 1270.3(j), that was 

recovered prior to May 25, 2005, would 

remain subject to the regulations in part 

1270. However, in the final rules 

applicable to HCT/Ps (66 FR 5447 at 

5448; 69 FR 68611), FDA noted its 

intention to revoke part 1270 in the 

future when we were confident that 

there was no human tissue regulated 

under part 1270 available for use. 

Part 1270 applies only to human 

tissue defined in § 1270.3(j) and 

recovered prior to May 25, 2005. The 

device classification set forth in 

§ 882.5975, ‘‘Human dura mater,’’ is 

only applicable to human dura mater 

recovered prior to May 25, 2005. Human 

dura mater recovered on or after May 

25, 2005, is subject to the regulations in 

part 1271 when an establishment does 

not qualify for any of the exceptions in 

21 CFR 1271.15. Further, human dura 

mater is regulated solely under section 

361 of the PHS Act (42 U.S.C. 264) and 

part 1271 when the HCT/P meets all the 

criteria set out in 21 CFR 1271.10(a). 

Otherwise the HCT/P is regulated as a 

drug, device, and/or biological product 

under the FD&C Act, and/or section 351 

of the PHS Act (42 U.S.C. 262), and 

applicable regulations, including part 

1271. 

Products that meet the definition of 

an HCT/P in § 1271.3(d) that are 

recovered on or after May 25, 2005, 

including those that have been regulated 

after May 25, 2005, as drugs, devices, 

and/or biological products under 

section 351 of the PHS Act and/or the 

FD&C Act will not be affected by 

revocation of part 1270. 

We do not believe there are currently 

any tissues intended for transplantation 

remaining in inventory that were 

recovered prior to May 25, 2005, that 

would be subject to these regulations. 

Therefore, the regulations under 

§ 882.5975 and its accompanying 

special control guidance, and the 

regulations under part 1270 are 

outdated and obsolete. 

D. Comments to the Proposed Rule 

In the Federal Register of December 

21, 2020 (85 FR 82990), FDA published 

a proposed rule entitled ‘‘Revocation of 

the Regulations for Human Tissue 

Intended for Transplantation and 

Human Dura Mater’’ to revoke the 

regulations for human tissue intended 

for transplantation and human dura 

mater recovered prior to May 25, 2005. 

We did not receive any comments on 

the proposed rule. Therefore, we are 

finalizing the proposed rule without 

change. 

III. Legal Authority 

FDA is issuing this final rule under 

the communicable disease provisions of 

the PHS Act, which provide FDA with 

the authority to issue and enforce 

regulations designed to prevent the 

introduction, transmission, and spread 

of communicable disease (42 U.S.C. 216, 

243, 264, and 271), and provisions of 

the FD&C Act applicable to devices (21 

U.S.C. 351, 360, 360c, 360e, 360j, 360l, 

and 371)). 

IV. Effective Date 

This final rule will become effective 

30 days after the date of its publication 

in the Federal Register. 

V. Economic Analysis of Impacts 

A. Introduction 

We have examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct us to assess all 

costs and benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). We believe that 

this final rule is not a significant 

regulatory action as defined by 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the rule will not create new 

regulatory responsibilities for small 

entities, we certify that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

The Unfunded Mandates Reform Act 

of 1995 (section 202(a)) requires us to 

prepare a written statement, which 

includes an assessment of anticipated 

costs and benefits, before issuing ‘‘any 

rule that includes any Federal mandate 

that may result in the expenditure by 

State, local, and tribal governments, in 

the aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any one year.’’ 

The current threshold after adjustment 

for inflation is $158 million, using the 

most current (2020) Implicit Price 

Deflator for the Gross Domestic Product. 

This final rule would not result in an 

expenditure in any year that meets or 

exceeds this amount. 

B. Summary of Costs and Benefits 

This final rule will remove the 

obsolete regulations under part 1270 for 

human tissue intended for 

transplantation into a human recipient 

and § 882.5975 for human dura matter. 

These regulations only apply to certain 

tissue derived from a human body and 

recovered prior to May 25, 2005. We 

believe it is highly unlikely any such 

human tissues remain available for use 

today. The final rule, therefore, is not 

anticipated to result in any compliance 

costs to the industry. We expect the 

economic impact on FDA resulting from 

removing an obsolete regulation to be 

minimal. 

Table 1 summarizes the estimated 

benefits and costs of the final rule. 

Annualized over 10 years, the estimated 

benefits (i.e. cost savings) of the final 

rule will be $0 at both the 3 and 7 

percent discount rate. The present value 

of the estimated benefits (i.e., cost 

savings) of the final rule will also be $0 

at both the 3 and 7 percent discount 

rate. The annualized costs of the final 

rule will be $0 at both 3 and 7 percent 

discount rate. The present value of costs 

of the final rule will also be $0 at both 

3 and 7 percent discount rate. 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Benefits: 

Annualized Monetized $millions/year .............................. $0 $0 $0 2020 7 10 

0 0 0 2020 3 10 

Annualized Quantified ...................................................... .................. .................. .................. .................. .................. ..................


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2048 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE—Continued 

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

(%) 

Period 

covered 

(years) 

Qualitative ........................................................................ Field investigators will no longer need 

to reference the obsolete regulations, 

resulting in very minor cost savings 

for FDA in terms of employee time. 

Costs: 

Annualized Monetized $millions/year .............................. 0 0 0 2020 7 10 

0 0 0 2020 3 10 

Annualized Quantified ...................................................... .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

Qualitative ............................................................................... .................. .................. .................. .................. .................. ..................

Transfers: 

Federal Annualized Monetized $millions/year ................. .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

From/To ............................................................................ From: To: 

Other Annualized Monetized $millions/year .................... .................. .................. .................. .................. 7 ..................

.................. .................. .................. .................. 3 ..................

.......................................................................................... From/To From: 

Effects: 

State, Local or Tribal Government: None 

Small Business: None 

Wages: None 

Growth: None 

FDA has examined the economic 

implications of the rule as required by 

the Regulatory Flexibility Act. If a rule 

will have a significant economic impact 

on a substantial number of small 

entities, the Regulatory Flexibility Act 

requires us to analyze regulatory options 

that would lessen the economic effect of 

the rule on small entities. This rule will 

not impose any new burdens on small 

entities, and thus will not impose a 

significant economic impact on a 

substantial number of small entities. 

We have developed a comprehensive 

Economic Analysis of Impacts that 

assesses the impacts of the final rule. 

The full analysis of economic impacts is 

available in the docket for this final rule 

(Ref. 1) and at https://www.fda.gov/ 

about-fda/reports/economic-impactanalyses-fda-regulations. 

VI. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.31(h) 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. 

VII. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VIII. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

determined that the rule does not 

contain policies that have substantial 

direct effects 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. Accordingly, we 

conclude that the rule does not contain 

policies that have federalism 

implications as defined in the Executive 

Order and, consequently, a federalism 

summary impact statement is not 

required. 

IX. Consultation and Coordination With 

Indian Tribal Governments 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13175. We have 

determined that the rule does not 

contain policies that have substantial 

direct effects 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. 

Accordingly, we conclude that the rule 

does not contain policies that have 

tribal implications as defined in the 

Executive Order and, consequently, a 

tribal summary impact statement is not 

required. 

X. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA, Final Regulatory Impact Analysis; 

Final Regulatory Flexibility Analysis; 

Unfunded Mandates Reform Act 

Analysis, Revocation of the Regulations 

for Human Tissue Intended for 

Transplantation; Final Rule. Also 

available at: https://www.fda.gov/aboutfda/reports/economic-impact-analysesfda-regulations. 

List of Subjects 

21 CFR Part 882 

Medical devices. 

21 CFR Part 1270 

Communicable diseases, HIV/AIDS, 

Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 


jspears on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2049 

and Drugs, 21 CFR parts 882 and 1270 

are amended as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for part 882 

continues to read as follows: 

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

360j, 360l, 371. 

§ 882.5975 [Removed] 

■ 2. Remove § 882.5975. 

PART 1270—[REMOVED] 

■ 3. Under the authority of 42 U.S.C. 

216, 243, 264, 271, part 1270 is 

removed. 

Dated: January 6, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–00492 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0022] 

RIN 1625–AA00 

Safety Zones; Delaware River 

Dredging, Marcus Hook, PA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is reestablishing temporary safety zones on 

the waters of the Delaware River in 

portions of Marcus Hook Range and 

Anchorage 7 off Marcus Hook Range. 

The safety zones temporarily restrict 

vessel traffic from transiting or 

anchoring in portions of the Delaware 

River while maintenance dredging is 

being conducted within the Delaware 

River. The safety zones are needed to 

protect personnel, vessels, and the 

marine environment from hazards 

created by dredging operations. Entry of 

vessels or persons into these zones is 

prohibited unless specifically 

authorized by the COTP or his 

designated representatives. 

DATES: This rule is effective without 

actual notice from January 13, 2022 

through January 31, 2022. For the 

purposes of enforcement, actual notice 

will be used from January 6, 2022, until 

January 13, 2022. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2022– 

0022 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Petty Officer Jennifer Padilla, 

Waterways Management Branch, U.S. 

Coast Guard Sector Delaware Bay; 

telephone (215) 271–4889, email 

Jennifer.l.padilla@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 

On September 2, 2021, the Coast 

Guard established temporary safety 

zones on the waters of the Delaware 

River in portions of Marcus Hook Range 

and Anchorage 7 off Marcus Hook 

Range to temporarily restrict vessel 

traffic from transiting or anchoring in 

portions of the Delaware River in 

association with maintenance dredging 

within the Delaware River (86 FR 49241, 

Sept. 2, 2021). That rule expired 

November 2, 2021. On January 6, 2022, 

the dredging company informed the 

Coast Guard about additions to the 

original contract and the need to extend 

the project. The new estimated 

completion date is January 31, 2022. 

The Coast Guard is issuing this rule 

without prior notice and opportunity to 

comment pursuant to authority under 

section 4(a) of the Administrative 

Procedure Act (APA) (5 U.S.C. 553(b)). 

This provision authorizes an agency to 

issue a rule without prior notice and 

opportunity to comment when the 

agency for good cause finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing a notice of proposed 

rulemaking (NPRM) with respect to this 

rule because it is impracticable and 

contrary to the public interest. There is 

insufficient time to allow for a 

reasonable comment period prior to the 

start date for dredging operations. The 

rule must be in force by January 6, 2022, 

to serve its purpose of ensuring the 

safety of the public from hazards 

associated with dredging operations 

such as submerged and floating 

pipeline, booster pumps, head sections 

and vessels with a restricted ability to 

maneuver. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable and 

contrary to the public interest because 

immediate action is needed to mitigate 

the potential safety hazards associated 

with dredging operations in these 

locations. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034 

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

has determined that there are potential 

hazards associated with dredging 

operations. The purpose of this 

rulemaking is to ensure the safety of 

personnel, vessels, and the marine 

environment within a 250-yard radius of 

dredging operations and all associated 

pipeline and equipment. 

IV. Discussion of the Rule 

This rule re-establishes the safety 

zones established on September 2, 2021, 

(86 FR 49241, Sept. 2, 2021). The reestablished zones will be in effect from 

January 6, 2022, through January 31, 

2022. This change is reflected in a 

revised enforcement paragraph, 

paragraph (e). This rule makes no other 

changes to the previoius rule. The 

locations and restrictions of the safety 

zones established by the September rule 

remain the same. 

The safety zones are necessary to 

facilitate annual maintenance dredging 

of the Delaware River in the vicinity of 

Marcus Hook Range and Anchorage 7 

off Marcus Hook Range (as described in 

33 CFR 110.157(a)(8)). Dredging will 

most likely be conducted with the 

dredge ESSEX, though other dredges 

may be used, along with associated 

dredge pipeline and boosters. The 

pipeline consists of a combination of 

floating hoses immediately behind the 

dredge and submerged pipeline leading 

to upland disposal areas. Due to the 

hazards related to dredging operations, 

the associated pipeline, and the location 

of submerged pipeline, safety zones are 

being established in the following areas: 

(1) Safety zone one includes all 

navigable waters within 250 yards of the 

dredge displaying lights and shapes for 

vessels restricted in ability to maneuver 

as described in 33 CFR 83.27, and all 

related dredge equipment when the 

dredge is operating in Marcus Hook 

Range, and Anchorage 7. This safety 

zone is being established for the 

duration of the maintenance project. 

Vessels requesting to transit the safety 

zone must contact the dredge on VHF 

channel 13 or 16 at least 1 hour prior 


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