2042 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

Analysis available at https://www.fda.gov/ 

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

List of Subjects in 21 CFR Part 169 

Food grades and standards, Oils and 

fats, Spices and flavorings. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 169 is 

amended as follows: 

PART 169—FOOD DRESSINGS AND 

FLAVORINGS 

■ 1. The authority citation for part 169 

continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 343, 348, 

371, 379e. 

§ 169.115 [Removed] 

■ 2. Remove § 169.115. 

Dated: January 6, 2022. 

Janet Woodcock, 

Acting Commissioner of Food and Drugs. 

[FR Doc. 2022–00494 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 814 

[Docket No. FDA–2019–N–3101] 

RIN 0910–AI10 

Revised Procedures for the 

Announcement of Approvals and 

Denials of Premarket Approval 

Applications and Humanitarian Device 

Exemption Applications 

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 amend the 

medical device regulations regarding the 

procedures for the announcement of 

approvals and denials of premarket 

approval applications (PMAs) and 

humanitarian device exemption 

applications (HDEs). This final rule 

discontinues the publication in the 

Federal Register after each quarter of a 

list of PMA and HDE approvals and 

denials announced in that quarter. We 

will continue to post approval and 

denial notices for PMAs and HDEs on 

FDA’s home page on the internet and 

will also continue to make available on 

the internet and place on public display 

summaries of safety and effectiveness 

data (SSED) for PMAs and summaries of 

safety and probable benefit (SSPB) for 

HDEs. FDA is taking this action to 

improve the efficiency of announcing 

approvals and denials of PMAs and 

HDEs and to eliminate duplication in 

the current process for announcing this 

information. We are also updating 

Agency contact information and 

statutory references in certain sections 

of the PMA and HDE regulations for 

purposes of accuracy, clarity, and 

consistency. 

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 

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: 

For information concerning the final 

rule as it relates to devices regulated by 

the Center for Biologics Evaluation and 

Research: Tami Belouin, 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. 

For information concerning the final 

rule as it relates to devices regulated by 

the Center for Devices and Radiological 

Health: Joshua Nipper, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 2438, 

Silver Spring, MD 20993–0002, 301– 

796–6524. 

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. Need for the Regulation 

B. History of the Rulemaking 

C. Summary of Comments to the Proposed 

Rule 

III. Legal Authority 

IV. Comments on the Proposed Rule and FDA 

Response 

A. Introduction 

B. Specific Comments and FDA Response 

C. Comments Outside the Scope of This 

Rulemaking 

V. Effective Date 

VI. Economic Analysis of Impacts 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Consultation and Coordination With 

Indian Tribal Governments 

XI. Reference 

I. Executive Summary 

A. Purpose of the Final Rule 

FDA is amending its medical device 

regulations regarding the procedures for 

the announcement of approvals and 

denials of PMAs and HDEs to 

discontinue the quarterly publication in 

the Federal Register of a list of 

approvals and denials of both PMAs and 

HDEs. FDA will continue to post 

approval and denial notices for PMAs 

and HDEs on FDA’s home page on the 

internet (https://www.fda.gov) and will 

also continue to make available on the 

internet and place on public display 

SSED for PMAs and SSPB for HDEs. 

FDA is taking this action to improve the 

efficiency of announcing approvals and 

denials of PMAs and HDEs and 

eliminate duplication in the current 

process for announcing this 

information. We are also updating 

Agency contact information and 

statutory references in certain PMA and 

HDE regulations for purposes of 

accuracy, clarity, and consistency. 

B. Summary of the Major Provisions of 

the Final Rule 

FDA is amending its regulations 

regarding the announcement procedures 

for the approval and denial of PMAs 

and HDEs. FDA is discontinuing 

publishing in the Federal Register after 

each quarter a list of PMA and HDE 

approvals and denials announced for 

that quarter. We will continue to post 

approval and denial notices for PMAs 

and HDEs on FDA’s home page on the 

internet, and we will also continue to 

make SSED for PMAs and SSPB for 

HDEs available on the internet and 

place them on public display. 

C. Legal Authority 

FDA is issuing this final rule under 

sections 515, 520(h), 520(m), and 701(a) 

of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360e, 360j(h), 

360j(m), and 371(a)). 

D. Costs and Benefits 

The benefit of this final rule is that it 

will result in cost savings to FDA from 

discontinuing publishing in the Federal 

Register, on a quarterly basis, a list of 

medical device PMA and HDE 

approvals and denials. Annualized over 

10 years, the estimated benefits (i.e., 

cost savings) to FDA range from $0.008 

million to $0.013 million at both 3 and 

7 percent discount rate, with a primary 

estimate of $0.010 million. We estimate 

that this final rule will result in no 

additional costs to industry because the 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2043 

rule will not require performance of any 

additional tasks and, therefore, will not 

impose any additional regulatory 

burden on the industry. 

II. Background 

A. Need for the Regulation 

FDA is amending its medical device 

regulations regarding the procedures for 

the announcement of approvals and 

denials of PMAs and HDEs to 

discontinue the quarterly publication in 

the Federal Register of a list of 

approvals and denials of both PMAs and 

HDEs. FDA is taking this action to 

improve the efficiency of announcing 

approvals and denials of PMAs and 

HDEs and eliminate duplication in 

announcing this information. The final 

rule allows FDA staff to focus on other 

Agency priorities and utilize FDA staff 

resources more efficiently. FDA is also 

revising § 814.44(d)(2) (21 CFR 

814.44(d)(2)) to be consistent with 

§ 814.45(d)(2) (21 CFR 814.45(d)(2)), 

which states that requests for copies of 

the current PMA approvals and denials 

document and copies of SSED must be 

sent in writing to FDA’s Freedom of 

Information Staff. In addition, FDA is 

updating outdated references to section 

515(d)(3) of the FD&C Act in the PMA 

(§§ 814.40 (21 CFR 814.40), 814.44, and 

814.45) and HDE (§ 814.118 (21 CFR 

814.118)) regulations. 

B. History of the Rulemaking 

Section 515(d)(4) of the FD&C Act 

permits an interested person to obtain 

review of an order approving a PMA in 

accordance with section 515(g) of the 

FD&C Act. The statute does not require 

the Agency to publish the approval of a 

PMA in the Federal Register; however, 

FDA issued in the Federal Register of 

July 22, 1986 (51 FR 26342) a final rule 

that provided, among other things, that 

notice of approval of a PMA, notice of 

an order denying approval of a PMA, 

and notice of an order withdrawing 

approval of a PMA will be published in 

the Federal Register. In the Federal 

Register of June 26, 1996 (61 FR 33232), 

FDA issued a final rule prescribing, 

among other things, the procedures for 

submitting HDEs, HDE amendments, 

and HDE supplements, and the criteria 

for FDA review and approval of HDEs. 

Furthermore, the final rule of June 26, 

1996, provided that the notice of 

approval of an HDE be published in the 

Federal Register in accordance with the 

rules and policies applicable to PMAs 

submitted under 21 CFR 814.20. That 

final rule also provided that, if FDA 

issues an order denying approval of an 

HDE, FDA will comply with the same 

notice and disclosure provisions 

required for PMAs under § 814.45(b) 

and (d), as applicable. 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA issued a final 

rule discontinuing the publication of 

individual PMA approvals and denials 

in the Federal Register. The final rule 

provided that FDA would notify the 

public of PMA approvals and denials by 

posting them on FDA’s home page on 

the internet, by making available on the 

internet and placing on public display 

SSED, and by publishing in the Federal 

Register after each quarter a list of the 

PMA approvals and denials announced 

in that quarter. FDA stated that it 

believed that this procedure would 

expedite public notification of these 

actions because announcements could 

be placed on the internet more quickly 

than they could be published in the 

Federal Register, and FDA believed that 

the internet would be accessible to more 

people than the Federal Register. 

In the Federal Register of December 

17, 2019 (84 FR 68829), FDA published 

a proposed rule entitled ‘‘Revised 

Procedures for the Announcement of 

Approvals and Denials of Premarket 

Approval Applications and 

Humanitarian Device Exemption 

Applications’’ to discontinue publishing 

in the Federal Register after each 

quarter a list of PMA and HDE 

approvals and denials announced in 

that quarter. We also proposed to update 

Agency contact information and 

statutory references in certain sections 

of the PMA and HDE regulations for 

purposes of accuracy, clarity, and 

consistency. After consideration of the 

comments received, we are now 

finalizing the proposed rule without 

change. 

C. Summary of Comments to the 

Proposed Rule 

We received comments on the 

proposed rule from individual 

submitters. We received one comment 

in support of the proposed rule and one 

comment against discontinuing the 

quarterly publication in the Federal 

Register of a list of approvals and 

denials of PMAs and HDEs. These 

comments are further summarized in 

section IV. 

III. Legal Authority 

We are issuing this final rule under 

the authority of sections 515, 520(h), 

and 520(m) of the FD&C Act, which set 

forth requirements for device premarket 

approval, release of detailed summaries 

of information respecting the safety and 

effectiveness of devices, and 

humanitarian device exemptions, and 

under section 701(a) of the FD&C Act, 

which provides FDA the authority to 

issue regulations for the efficient 

enforcement of the FD&C Act. 

IV. Comments on the Proposed Rule 

and FDA Response 

A. Introduction 

We received comments on the 

proposed rule from individual 

submitters. We describe and respond to 

the comments in sections IV.B and C of 

this document. We have numbered each 

comment to help distinguish between 

different comments. The number 

assigned to each comment or comment 

topic is purely for organizational 

purposes and does not signify the 

comment’s value or importance or the 

order in which comments were 

received. 

B. Specific Comments and FDA 

Response 

(Comment 1) One comment supported 

the proposed rule. 

(Response 1) We acknowledge and 

appreciate the supportive comment. 

(Comment 2) One comment opposed 

discontinuing the publication in the 

Federal Register after each quarter of a 

list of PMA and HDE approvals and 

denials announced in that quarter. The 

comment stated that the Federal 

Register provides a complete, 

archivable, and reviewable record of 

Federal Agency decisions, that the FDA 

website does not provide. The comment 

further noted that the quarterly Federal 

Register summary may be useful to 

persons searching for aggregate trends in 

FDA actions. 

(Response 2) We do not believe the 

quarterly Federal Register notice is 

needed to provide an adequate record of 

PMA and HDE approvals and denials. 

The Federal Register notice merely 

summarizes the quarterly PMA and HDE 

approvals and denials; it does not 

provide information on those approvals 

and denials beyond what can be 

obtained in other formats on the FDA 

website. Additionally, we will continue 

to give the public notice of PMA and 

HDE approvals and denials by placing 

notices of approvals and denials on 

FDA’s home page on the internet. These 

notices, along with certain supporting 

documentation, are also maintained and 

can be viewed online at https://

www.regulations.gov. 

Furthermore, we do not believe it is 

necessary to publish the quarterly 

Federal Register notices as a search tool 

for ‘‘aggregate trends in FDA actions.’’ 

We note that there are existing tools 

such as FDA’s searchable PMA database 

(https://www.accessdata.fda.gov/ 

scripts/cdrh/cfdocs/cfPMA/pma.cfm) 

and HDE database (https:// 


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2044 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfhde/hde.cfm; https://

www.fda.gov/vaccines-blood-biologics/ 

approved-blood-products/premarketapprovals-and-humanitarian-deviceexemptions-supporting-documents) that 

the public can utilize to search for 

information on PMA and HDE approvals 

over a certain period of time. 

C. Comment Outside the Scope of This 

Rulemaking 

(Comment 3) One comment 

questioned which products FDA 

evaluates before they are sold. 

(Response 3) We decline to respond 

because this comment is outside the 

scope of this final rule. 

V. Effective Date 

This final rule will become effective 

30 days after the date of its publication 

in the Federal Register. 

VI. Economic Analysis of Impacts 

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 this final rule will not impose 

any additional regulatory burden on the 

industry, 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. 

The benefit of this final rule is that it 

will result in cost savings to FDA from 

discontinuing publishing in the Federal 

Register, on a quarterly basis, a list of 

approvals and denials of PMAs and 

HDEs. Discontinuing publishing Federal 

Register notices with these approval 

and denial lists will eliminate 

duplication in announcing this 

information; information on these 

approvals and denials will continue 

being readily available to the public on 

FDA’s home page on the internet 

(https://www.fda.gov). 

We estimate that this final rule will 

result in no additional costs to industry 

because the rule will not require 

performance of any additional tasks. 

The rule, therefore, will not impose any 

additional regulatory burden on the 

industry. 

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 range from $0.008 million to $0.013 

million at both 3 and 7 percent discount 

rate, with a primary estimate of $0.010 

million. The present value of the 

estimated benefits (i.e. cost savings) of 

the final rule ranges from $0.068 million 

to $0.111 million at a 3 percent discount 

rate and from $0.056 million to $0.091 

million at a 7 percent discount rate. The 

annualized costs of the final rule are $0 

at both 3 and 7 percent discount rate. 

The present value of costs of the final 

rule is also $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 .................. $0.010 $0.008 $0.013 2020 7 10 Benefits are cost savings. 

0.010 0.008 0.013 2020 3 10 Benefits are cost savings. 

Annualized Quantified. 

Qualitative. 

Costs: 

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

0 0 0 2020 3 10 

Annualized Quantified. 

Qualitative. 

Transfers: 

Federal Annualized Monetized $millions/year.

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

Other Annualized Monetized $millions/year.

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

Effects: 

State, Local or Tribal Government: No significant effect. 

Small Business: No significant effect. 

Wages: N/A. 

Growth: N/A. 


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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 


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