2038 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 169 

[Docket No. FDA–2020–N–1807] 

RIN 0910–AI16 

French Dressing; Revocation of a 

Standard of Identity 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is revoking 

the standard of identity for French 

dressing. This action, in part, responds 

to a citizen petition submitted by the 

Association for Dressings and Sauces 

(ADS). We conclude that this standard 

no longer promotes honesty and fair 

dealing in the interest of consumers. 

Revocation of the standard of identity 

for French dressing will provide greater 

flexibility in the product’s manufacture, 

consistent with comparable, 

nonstandardized foods available in the 

marketplace. 

DATES: This final rule is effective on 

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: 

Rumana Yasmeen, Center for Food 

Safety and Applied Nutrition (HFS– 

820), Food and Drug Administration, 

5001 Campus Dr., College Park, MD 

20740, 240–402–2371, or Carrol Bascus, 

Center for Food Safety and Applied 

Nutrition, Office of Regulations and 

Policy (HFS–024), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

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/History of This 

Rulemaking 

B. Summary of Comments to the Proposed 

Rule 

III. Legal Authority 

IV. Comments on the Proposed Rule and FDA 

Response 

A. Introduction 

B. Description of the Comments and FDA 

Response 

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. References 

I. Executive Summary 

A. Purpose of the Final Rule 

The final rule revokes the standard of 

identity for French dressing. This 

action, in part, responds to a citizen 

petition submitted by the ADS. We 

conclude that the standard of identity 

for French dressing no longer promotes 

honesty and fair dealing in the interest 

of consumers and revoking the standard 

could provide greater flexibility in the 

product’s manufacture, consistent with 

comparable, nonstandardized foods 

available in the marketplace. 

B. Summary of the Major Provision of 

the Final Rule 

The final rule revokes the standard of 

identity for French dressing. 

C. Legal Authority 

We are issuing the final rule to revoke 

the standard of identity for French 

dressing consistent with our authority 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act), which directs 

the Secretary of Health and Human 

Services (Secretary) to issue regulations 

fixing and establishing for any food a 

reasonable definition and standard of 

identity, quality, or fill of container 

whenever, in the Secretary’s judgment, 

such action will promote honesty and 

fair dealing in the interest of consumers. 

D. Costs and Benefits 

The final rule affects manufacturers of 

dressings for salad and does not require 

any of the affected firms within the 

industry to change their manufacturing 

practices. 

Our analysis of current food 

manufacturing practices and the 

petition to revoke the standard indicate 

that revoking the standard of identity 

could provide benefits in terms of 

additional flexibility and the 

opportunity for innovation to 

manufacturers. The potential for 

innovation is evidenced by the growing 

variety of dressings for salads on the 

market that are formulated to meet 

consumers’ preferences and needs. 

Therefore, we conclude that the final 

rule to revoke the standard of identity 

for French dressing would provide 

social benefits at no cost to the 

respective industries. 

II. Background 

A. Need for the Regulation/History of 

This Rulemaking 

Section 401 of the FD&C Act (21 

U.S.C. 341) directs the Secretary to issue 

regulations fixing and establishing for 

any food a reasonable definition and 

standard of identity, quality, or fill of 

container whenever, in the Secretary’s 

judgment, such action will promote 

honesty and fair dealing in the interest 

of consumers. The purpose of these 

standards is to protect consumers 

against economic adulteration and 

reflect consumers’ expectations about 

food. 

In the Federal Register of August 12, 

1950 (15 FR 5227), we established a 

standard of identity for French dressing. 

We later amended that standard of 

identity in the Federal Registers of May 

10, 1961 (26 FR 4012), February 12, 

1964 (29 FR 2382), February 1, 1967 (32 

FR 1127 at 1128), May 18, 1971 (36 FR 

9010), and November 8, 1974 (39 FR 

39554), to allow the use of certain 

ingredients in French dressing. We also 

re-designated the French dressing 

standard of identity as § 169.115 (21 

CFR 169.115) (42 FR 14481, March 15, 

1977). 

We received a citizen petition from 

the ADS asking us, in part, to revoke the 

standard of identity for French dressing 

(citizen petition from the ADS, dated 

January 13, 1998, submitted to the 

Division of Dockets Management, Food 

and Drug Administration, Docket No. 

FDA–1998–P–0669 (‘‘petition’’)). As a 

partial response to the petitioner’s 

request, we issued a proposed rule in 

the Federal Register of December 21, 

2020 (85 FR 82980), that would revoke 

the standard of identity for French 

dressing. 

The petition asked us to revoke the 

standard of identity for French dressing 

(petition at page 1). The petition stated 

that there has been a proliferation of 

nonstandardized pourable dressings for 

salads with respect to flavors (Italian, 

Ranch, cheese, fruit, peppercorn, varied 

vinegars, and other flavoring concepts) 

and composition (including a wide 

range of reduced fat, ‘‘light,’’ and fat-free 

dressings) (petition at page 3). The 

French dressing standard of identity, 

according to the petition, no longer 

serves as a benchmark for other 

dressings because of the wide variation 

in composition to meet consumer 

interests (id.). Instead, the petition 

claimed that the standard of identity has 

become marginalized and restricts 

innovation (id.). Therefore, the petition 


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stated that the French dressing standard 

of identity no longer promotes honesty 

and fair dealing in the interest of 

consumers (id.). 

We reviewed the petition and 

tentatively concluded that the standard 

of identity for French dressing no longer 

promotes honesty and fair dealing in the 

interest of consumers. Therefore, we 

proposed to revoke the French dressing 

standard of identity at § 169.115. 

When the standard of identity was 

established in 1950, French dressing 

was one of three types of dressings we 

identified (15 FR 5227). We generally 

characterized the dressings as 

containing a fat ingredient, an acidifying 

ingredient, and seasoning ingredients. 

The French dressing standard allowed 

for certain flexibility in manufacturers’ 

choice of oil, acidifying ingredients, and 

seasoning ingredients. Tomatoes or 

tomato-derived ingredients were among 

the seasoning ingredients permitted, but 

not required. Amendments to the 

standard since 1950 have permitted the 

use of additional ingredients, such as 

any safe and suitable color additives 

that impart the color traditionally 

expected (39 FR 39543 at 39554–39555). 

Most, if not all, products currently 

sold under the name ‘‘French dressing’’ 

contain tomatoes or tomato-derived 

ingredients and have a characteristic red 

or reddish-orange color. They also tend 

to have a sweet taste. Consumers appear 

to expect these characteristics when 

purchasing products represented as 

French dressing. Thus, it appears that, 

since the establishment of the standard 

of identity, French dressing has become 

a narrower category of products than 

prescribed by the standard. These 

products maintain the above 

characteristics without a standard of 

identity specifically requiring them. 

Additionally, French dressing 

products are manufactured and sold in 

lower-fat varieties that contain less than 

the minimum amount of vegetable oil 

(35 percent by weight) required by 

§ 169.115(a). In the preamble to the 

proposed rule, we stated that we were 

unaware of any evidence that 

consumers are deceived or misled by 

the reduction in vegetable oil when 

these varieties are sold under names 

including terms such as ‘‘fat free’’ or 

‘‘low-fat’’ (85 FR 82980 at 82982). By 

contrast, these varieties appear to 

accommodate consumer preferences and 

dietary restrictions. 

Therefore, after considering the 

petition and related information, 

through the proposed rule, we 

tentatively concluded that the standard 

of identity for French dressing no longer 

promotes honesty and fair dealing in the 

interest of consumers consistent with 

section 401 of the FD&C Act and 

proposed to revoke the standard of 

identity for French dressing. The 

preamble to the proposed rule also 

noted that the proposed revocation is 

consistent with section 6 of Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review’’ (January 18, 

2011), which requires agencies to 

periodically conduct retrospective 

analyses of existing regulations to 

identify those ‘‘that might be outmoded, 

ineffective, insufficient, or excessively 

burdensome, and to modify, streamline, 

expand, or repeal them’’ accordingly. 

B. Summary of Comments to the 

Proposed Rule 

There were more than 20 comments to 

the proposed rule. A trade association, 

a business association, and individuals 

submitted the comments. Some 

comments appeared to have been 

submitted as part of a university course 

assignment. In general, most comments 

supported the revocation of the French 

dressing standard of identity; their 

reasons supporting the revocation 

ranged from promoting innovation, 

believing that consumers are not misled, 

or stating that the standard of identity 

was obsolete. A small number of 

comments misinterpreted the proposed 

rule as removing or prohibiting the use 

of the name ‘‘French dressing,’’ and one 

comment opposed revoking the 

standard of identity because of public 

health concerns. 

III. Legal Authority 

We are issuing this final rule to 

revoke the standard of identity for 

French dressing consistent with our 

authority under the FD&C Act, which 

directs the Secretary to issue regulations 

fixing and establishing for any food a 

reasonable definition and standard of 

identity, quantity, or fill of container, 

whenever, in the Secretary’s judgment, 

such action will promote honesty and 

fair dealing in the interest of consumers. 

IV. Comments on the Proposed Rule 

and FDA Response 

A. Introduction 

As stated earlier, there were more 

than 20 comments to the proposed rule. 

A trade association, a business 

association, and individuals submitted 

the comments. Several comments 

appeared to have been submitted as part 

of a university course assignment. In 

general, most comments supported the 

revocation of the French dressing 

standard of identity. 

A small number of comments 

misinterpreted the proposed rule as 

removing or prohibiting the use of the 

name ‘‘French dressing,’’ and one 

comment opposed revoking the 

standard of identity because of public 

health concerns. 

We describe and respond to the 

comments in section IV.B. of this 

document. We have numbered each 

comment to help distinguish between 

different comments. We have grouped 

similar comments together under the 

same number, and, in some cases, we 

have separated different issues 

discussed in the same comment and 

designated them as distinct comments 

for purposes of our responses. The 

number assigned to each comment or 

comment topic is for organizational 

purposes and does not signify the 

comment’s value or importance or the 

order in which comments were 

received. 

B. Description of the Comments and 

FDA Response 

(Comment 1) Most comments 

supported revoking the standard of 

identity for French dressing. In general, 

the comments agreed with us that 

revoking the standard of identity would: 

• Allow manufacturers to innovate 

their products in ways that consumers 

want; 

• Give French dressing manufacturers 

the same treatment or flexibility to 

innovate or modernize their products as 

other dressing manufacturers have. One 

comment added that revoking the 

standard of identity for French dressing 

would enable manufacturers to 

substitute ingredients to address 

allergies, ingredient sensitivities, or 

even consumer preferences (particularly 

consumers on a diet); and 

• Eliminate an obsolete standard that 

has not changed significantly over 70 

years. Some comments added that 

consumers recognize French dressing 

and can judge for themselves whether to 

buy a particular product. 

Other comments said that the 

standard of identity for French dressing 

is no longer needed to promote honesty 

and fair dealing for consumers. Some 

comments explained that State 

consumer protection laws and tort laws 

could protect consumer interests, while 

others said that consumers are able to 

determine a product’s ingredients 

through ingredient labeling. One 

comment said that the standard of 

identity for French dressing was 

‘‘unnecessary red tape.’’ 

(Response 1) We agree with the 

comments. The final rule revokes the 

standard of identity for French dressing. 

(Comment 2) Some comments 

interpreted the proposed rule as 

eliminating the name ‘‘French 

dressing.’’ One comment said that 


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products marketed as French dressing 

range in color from orange to red and 

differ in taste, so the product should 

lose the ‘‘title’’ of French dressing. 

Another comment said that they did not 

understand why the name ‘‘French 

dressing’’ has to be ‘‘revoked’’ and that 

the consumer base for the dressing will 

be ‘‘hurt’’ if they look for products 

named French dressing and are unable 

to find them. 

(Response 2) The comments may have 

misunderstood the scope of the 

proposed rule and the distinction 

between standards of identity and food 

names. Standards of identity are 

requirements related to the content and 

production of certain food products. 

They typically set forth permitted 

ingredients, both mandatory and 

optional, and sometimes describe the 

amount or proportion of each 

ingredient. They are established under 

the common or usual name of the food; 

however, a standard of identity does not 

need to be established for a food to be 

labeled with and sold under its common 

or usual name. Most foods are 

nonstandardized foods and are labeled 

with and sold under common or usual 

names that have been established by 

common usage. See 21 U.S.C. 343(i)(1) 

and 21 CFR 102.5(d). Revocation of the 

French dressing standard of identity 

will eliminate requirements related to 

the content and production of French 

dressing and effectively place French 

dressing in the category of 

nonstandardized foods. As a 

nonstandardized food, French dressing 

must be labeled with its common or 

usual name, ‘‘French dressing,’’ which 

is still in common usage. Thus, food 

products with the name French dressing 

will continue to be available to 

consumers. 

(Comment 3) One comment objected 

to the proposed rule. The comment said 

that consumer health would be at risk 

because consumers would be unaware 

of changes before they buy the product 

and that manufacturers might use more 

‘‘fillers’’ in a product so that it is less 

expensive to make. The comment said 

we should ‘‘reconsider’’ revoking the 

standard of identity for French dressing 

because ‘‘it would ultimately put the 

health of consumers at a slight risk.’’ 

(Response 3) As explained in the 

proposed rule, the standard of identity 

does not appear to constrain French 

dressing products currently on the 

market. French dressing has become a 

narrower category of products than 

prescribed by the standard. These 

products maintain their characteristics 

without a standard of identity 

specifically requiring them. In the 

absence of a standard of identity, 

manufacturers will have the flexibility 

to use different ingredients to produce 

products that meet consumer 

expectations for French dressing. 

We received no information to 

support the assertion that manufacturers 

might use ‘‘fillers’’ to ‘‘make the product 

cheaper to produce.’’ It is unclear from 

the comment what ‘‘fillers’’ means, 

which ingredients this term would 

encompass, whether such ingredients 

are used in the manufacture of French 

dressing, whether such ingredients are 

prohibited under the standard of 

identity, and why the use of such 

ingredients in French dressing would 

constitute economic adulteration. We 

note that manufacturers must comply 

with the ingredient labeling 

requirements in 21 CFR 101.4. 

Therefore, consumers will still be 

informed about the ingredients in the 

French dressing they purchase. 

We also disagree that revoking the 

standard of identity ‘‘would ultimately 

put the health of consumers at a slight 

risk.’’ The comment did not provide 

information discussing what the health 

risks would be, and we are unaware of 

any evidence that supports this 

statement. 

(Comment 4) One comment said that 

it could not believe that the proposed 

rule was a priority. 

(Response 4) We have the authority to 

issue regulations establishing standards 

of identity if it promotes honesty and 

fair dealing in the interest of consumers. 

Standards of identity are intended to 

protect consumers against economic 

adulteration, maintain the integrity of 

food, and reflect consumers’ 

expectations about the food. This 

rulemaking is part of our comprehensive 

effort to modernize food standards to 

reduce regulatory burden and remove 

barriers to innovation. As stated in the 

proposed rule, it appears that French 

dressing has become a narrower 

category of products than prescribed by 

the standard (e.g., most, or all contain 

tomatoes or tomato-derived ingredients, 

which the standard of identity does not 

require). These products maintain their 

characteristics without a standard of 

identity specifically requiring them. We 

conclude that a standard of identity for 

French dressing no longer promotes 

honesty and fair dealing in the interest 

of consumers. Therefore, we are 

revoking the standard of identity for 

French dressing. 

This action is also consistent with our 

responsibilities under section 6 of 

Executive Order 13563, ‘‘Improving 

Regulation and Regulatory Review’’ 

(January 18, 2011), which requires 

agencies to periodically conduct 

retrospective analyses of existing 

regulations to identify those ‘‘that might 

be outmoded, ineffective, insufficient, 

or excessively burdensome, and to 

modify, streamline, expand, or repeal 

them’’ accordingly. 

V. Effective Date 

This rule is effective on February 14, 

2022. 

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 we have concluded, as set forth 

below, that this rule would not generate 

significant compliance costs, we certify 

that the final 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 private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any 1 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 final rule affects manufacturers of 

salad dressings. Our review of 

supermarket scanner data for the year 

2018 shows that a total of 227 distinct 

pourable products sold as ‘‘French 

dressing’’ that year were manufactured 

by 53 firms. The final rule does not 

require any of the affected firms to 

change their manufacturing practices. 

Our analysis of current food 

manufacturing practices and the 

petition to revoke the standard indicate 


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that revoking the standard of identity 

could provide benefits in terms of 

additional flexibility to the 

manufacturers of French dressing 

products. Revoking the standard of 

identity could provide an opportunity 

for innovation and the introduction of 

new French dressing products, 

providing benefits to both consumers 

and industry. Therefore, we conclude 

that the final rule, would provide social 

benefits at little to no cost to the 

respective industries (table 1). 

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 

Benefits: 

Annualized Monetized $millions/year .............................. $0 $0 $0 2018 7 

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

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

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

Qualitative ........................................................................ Benefits to manufacturers would be from additional flexibility, and the 

opportunity for innovation regarding, French dressing products. 

Costs: 

Annualized Monetized $millions/year .............................. 0 0 0 2018 7 

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

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: To: 

Effects: 

State, Local or Tribal Government: 

Small Business: 

Wages: 

Growth: 

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 

25.32(a) 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. References 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. French Dressing: Revocation of a 

Standard of Identity: Final Regulatory Impact 

Analysis, Final Regulatory Flexibility 

Analysis, Unfunded Mandates Reform Act 


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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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