Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 82395 

Dated: December 2, 2020. 

Stephen M. Hahn, 

Commissioner of Food and Drugs. 

Dated: December 11, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–27829 Filed 12–17–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 152 

[Docket No. FDA–2020–N–1690] 

RIN 0910–AI17 

Frozen Cherry Pie; Proposed 

Revocation of a Standard of Identity 

and a Standard of Quality 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or we) proposes to 

revoke the standard of identity and the 

standard of quality for frozen cherry pie. 

This action, in part, responds to a 

citizen petition submitted by the 

American Bakers Association (ABA). 

We tentatively conclude that these 

standards are no longer necessary to 

promote honesty and fair dealing in the 

interest of consumers. We also 

tentatively conclude that revoking the 

standards of identity and quality for 

frozen cherry pie would provide greater 

flexibility in the product’s manufacture, 

consistent with comparable, 

nonstandardized foods available in the 

marketplace. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by March 18, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 18, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 18, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2020–N–1690 for ‘‘Frozen Cherry Pie; 

Proposed Revocation of a Standard of 

Identity and a Standard of Quality.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, 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: 

Andrea Krause, Center for Food Safety 

and Applied Nutrition (HFS–820), Food 

and Drug Administration, 5001 Campus 

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

3719. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Executive Summary 

A. Purpose of the Proposed Rule 

B. Summary of the Major Provisions of the 

Proposed Rule 

C. Legal Authority 

D. Costs and Benefits 

II. Background 

III. ABA Citizen Petition and Grounds 

IV. Description of the Proposed Rule 

V. Preliminary Economic Analysis of Impacts 

VI. Analysis of Environmental Impact 

VII. Paperwork Reduction Act of 1995 

VIII. Consultation and Coordination With 

Indian Tribal Governments 

IX. Federalism 

X. Reference 

I. Executive Summary 

A. Purpose of the Proposed Rule 

This proposed rule, if finalized, 

would revoke the standards of identity 

and quality for frozen cherry pie. This 

action, in part, responds to a citizen 

petition submitted by the American 


khammond on DSKJM1Z7X2PROD with PROPOSALS
82396 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 

Bakers Association (ABA). We 

tentatively conclude that the standards 

of identity and quality for frozen cherry 

pie are no longer necessary to promote 

honesty and fair dealing in the interest 

of consumers and revoking these 

standards will provide greater flexibility 

in the product’s manufacture, consistent 

with comparable, nonstandardized 

foods available in the marketplace. 

B. Summary of the Major Provisions of 

the Proposed Rule 

This proposed rule, if finalized, 

would revoke the standards of identity 

and quality for frozen cherry pie. 

C. Legal Authority 

We are issuing this proposed rule to 

revoke the standards of identity and 

quality for frozen cherry pie consistent 

with our authority under section 401 of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 341), 

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 proposed rule would affect 

manufacturers of frozen cherry pie and 

would not require firms within the 

frozen cherry pie industry to change 

their manufacturing practices. Our 

analysis of current food manufacturing 

practices and the proposal to revoke the 

standards indicate that the proposed 

rule would provide benefits in terms of 

additional flexibility and the 

opportunity for innovation to the 

manufacturers. Therefore, we tentatively 

conclude that the proposed rule to 

revoke the standards for frozen cherry 

pie would, if finalized, provide social 

benefits at no cost to the respective 

industries. 

II. Background 

Section 401 of the FD&C Act 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. 

We proposed the standards of identity 

and quality for frozen cherry pie in the 

Federal Register of November 1, 1967 

(32 FR 15116), and finalized them in the 

Federal Register of February 23, 1971 

(36 FR 3364); the requirements were 

codified at 21 CFR 28.1 (‘‘Frozen cherry 

pie; identity; label statement of optional 

ingredients’’) and 21 CFR 28.2 (‘‘Frozen 

cherry pie; quality; label statement of 

substandard quality’’). We later 

amended the standards of identity and 

quality in the Federal Register of June 

13, 1973 (38 FR 15504), by removing 

minimum frozen cherry pie weight 

requirements, aligning the definition of 

blemished cherries with that in the 

United States Department of 

Agriculture’s U.S. Standards for Grades 

of Frozen Red Tart Pitted Cherries, and 

adding clarifying language. We 

renumbered the two sections in the 

Federal Register of March 15, 1977 (42 

FR 14302 at 14449), and combined them 

into § 152.126 (21 CFR 152.126), with 

the new section covering both the 

standards of identity and quality. 

FDA received a citizen petition from 

the ABA asking us, in part, to revoke the 

frozen cherry pie standards of identity 

and quality (Citizen Petition from the 

American Bakers Association, dated 

August 18, 2005, Docket No. FDA– 

2005–P–0435 (‘‘petition’’)). We propose 

to grant this request; our proposed 

action is to revoke part 152 (21 CFR part 

152 (‘‘Fruit pies’’)) in its entirety 

because the standards for frozen cherry 

pie are the only standards in part 152. 

III. ABA Citizen Petition and Grounds 

The petition asks us, in part, to revoke 

the standards of identity and quality for 

frozen cherry pie in 21 CFR 152.126 

(petition at page 10). 

The petition claims that the essential 

elements of § 152.126 are the 

requirements that the drained cherry 

content of frozen cherry pies cannot be 

less than 25 percent of the weight of the 

pie and that no more than 15 percent by 

count of the cherries in the pie can be 

blemished (id. at page 9). The petition 

asserts that the sole purpose of 

§ 152.126 is to establish a standard of 

quality, and not a standard of identity, 

for frozen cherry pie products (id.). The 

petition also opposes the use of any 

food standards to establish quality 

characteristics of foods and asserts that 

food manufacturers and consumers 

should determine food quality (id.). 

Consumers would decide whether they 

wish to spend more money on higherquality products or less money on 

lower-quality products. The petition 

further states that a product of 

unacceptably low quality will not 

survive in the marketplace (id.). 

The petition also states that there is 

no basis for singling out frozen cherry 

pie for the imposition of standards of 

identity and quality (id. at page 10). The 

petition observes that there are no 

standards of identity and quality for any 

other types of frozen fruit pies, or for 

any non-frozen fruit pies, including 

those filled with cherries (id.). The 

petition further asserts that 

nonstandardized fruit pies have been 

sold throughout the country for many 

years without any evidence of public 

confusion (id.). 

IV. Description of the Proposed Rule 

We disagree with the petition’s 

opposition to using standards to 

establish quality characteristics of foods. 

Congress has given us the authority to 

promulgate regulations establishing a 

reasonable standard of quality for any 

food. We may exercise this authority to 

promote honesty and fair dealing in the 

interest of consumers. Congress has 

placed few limitations on the foods for 

which standards of quality may be 

established, excluding only fresh or 

dried fruits, fresh or dried vegetables, 

and butter. Frozen cherry pie is not 

among these foods, and therefore, we 

have the authority to establish a 

standard of quality for frozen cherry pie 

if doing so promotes honesty and fair 

dealing in the interest of consumers. 

However, we tentatively conclude 

that the frozen cherry pie standards of 

identity and quality are no longer 

needed to promote honesty and fair 

dealing in the interest of consumers. 

Consequently, the proposed rule would 

revoke part 152 (‘‘Fruit pies’’) in its 

entirety because the standards for frozen 

cherry pie are the only standards in part 

152. 

As the petition notes, frozen cherry 

pie is the only fruit pie, either frozen or 

non-frozen, that is subject to standards 

of identity and quality. This means that: 

• Other cherry pies (i.e., baked, 

frozen cherry pie, which § 152.126(a)(1) 

expressly excludes from the standards, 

and baked, non-frozen cherry pie) are 

not subject to standards of identity or 

quality and 

• other fruit pies are not subject to 

standards of identity or quality. 

We are not aware of any evidence 

suggesting that consumers have 

different expectations for unbaked, 

frozen cherry pies than for other cherry 

pies. At the same time, no other cherry 

pies are subject to a standard of identity 

or a standard of quality, and we are 

aware of no evidence indicating that 

such standards are necessary to promote 

honesty and fair dealing in the interest 

of consumers or to ensure that those 

cherry pies meet consumer 

expectations. Similarly, other fruit pies 

are not subject to standards of identity 

or quality, and we are aware of no 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 82397 

evidence indicating that such standards 

are necessary to promote honesty and 

fair dealing in the interest of consumers 

or to ensure that the pies meet consumer 

expectations. 

Additionally, we tentatively conclude 

that the prohibition of artificial 

sweeteners in § 152.126(a)(2) does not 

promote honesty and fair dealing in the 

interest of consumers. Baked, frozen 

cherry pie and baked, non-frozen cherry 

pie may be made with artificial 

sweeteners to produce reduced-sugar 

varieties to accommodate consumer 

preferences and dietary restrictions. 

Other types of fruit pies are 

manufactured with artificial sweeteners 

to produce reduced-sugar varieties. 

These varieties appear to cater to 

consumer preferences and needs, and 

we are aware of no evidence that they 

create confusion or circumvent 

consumer expectations. If the standard 

of identity for frozen cherry pie is 

revoked, manufacturers could use 

artificial sweeteners to make unbaked, 

frozen cherry pie products, consistent 

with other reduced-sugar fruit pies 

available in the marketplace. 

Therefore, after considering the 

petition and related information, we 

tentatively conclude that the standards 

of identity and quality for frozen cherry 

pie are no longer needed to promote 

honesty and fair dealing in the interest 

of consumers consistent with section 

401 of the FD&C Act. We are interested 

in any information, including data and 

studies, on consumer expectations 

regarding unbaked, frozen cherry pies 

and whether the specifications in 

§ 152.126 are necessary to ensure that 

frozen cherry pie meets these 

expectations. 

In addition, our proposal to revoke 

the standards of identity and quality for 

frozen cherry pie is consistent with 

Executive Order 13771, ‘‘Reducing 

Regulation and Controlling Regulatory 

Costs’’ (January 30, 2017), and Executive 

Order 13777, ‘‘Enforcing the Regulatory 

Reform Agenda’’ (February 24, 2017). 

Executive Order 13771 and Executive 

Order 13777, taken together, direct 

agencies to offset the number and cost 

of new regulations by identifying prior 

regulations that can be eliminated 

because, for example, they are outdated, 

unnecessary, or ineffective. Our 

proposed revocation also 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. 

V. Preliminary Economic Analysis of 

Impacts 

We have examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, 

Executive Order 13771, 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). Executive Order 

13771 requires that the costs associated 

with significant new regulations ‘‘shall, 

to the extent permitted by law, be offset 

by the elimination of existing costs 

associated with at least two prior 

regulations.’’ We believe that this 

proposed 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 tentatively concluded, 

as set forth below, that this rule would 

not generate significant compliance 

costs, we propose to certify that the 

proposed 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 proposing 

‘‘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 

one year.’’ The current threshold after 

adjustment for inflation is $156 million, 

using the most current (2019) Implicit 

Price Deflator for the Gross Domestic 

Product. This proposed rule would not 

result in an expenditure in any year that 

meets or exceeds this amount. 

The proposed rule would affect 

manufacturers of unbaked, frozen cherry 

pie. Our review of supermarket scanner 

data for the year 2018 shows that a total 

of 40 distinct frozen cherry pie products 

sold that year were manufactured by 20 

firms. The proposed rule would not 

require any firms within the frozen 

cherry pie industry to change their 

manufacturing practices. Our analysis of 

current food manufacturing practices 

and the proposal to revoke the standards 

indicate that the proposed rule would 

provide benefits in terms of additional 

flexibility to the manufacturers of frozen 

cherry pie products. The proposed rule 

would promote innovation and the 

introduction of new unbaked, frozen 

cherry pie products, providing benefits 

to both consumers and industry. 

Therefore, we tentatively conclude that 

the proposed rule to revoke the 

standards for frozen cherry pie would, 

if finalized, provide social benefits at 

little to no cost to the respective 

industries (table 1). 

TABLE 1—SUMMARY OF BENEFITS, COSTS AND DISTRIBUTIONAL EFFECTS OF PROPOSED 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% 

7% 

Annualized Quantified .................... ........................ ........................ ........................ ........................ 3% 


khammond on DSKJM1Z7X2PROD with PROPOSALS
82398 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 

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

Category Primary 

estimate 

Low 

estimate 

High 

estimate 

Units 

Notes Year 

dollars 

Discount 

rate 

Period 

covered 

Qualitative ...................................... ........................ ........................ ........................ ........................ ........................ ........................ Benefits to manufacturers would 

be from additional flexibility 

for, and the opportunity for innovation regarding, 

frozen cherry pie 

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: 

In line with Executive Order 13771, in 

table 2 we estimate present and 

annualized values of costs and cost 

savings over an infinite time horizon. 

Based on these cost savings, this 

proposed rule, if finalized, would be 

considered a deregulatory action under 

E.O. 13771. 

TABLE 2—EXECUTIVE ORDER 13771 SUMMARY

[In $ millions 2016 dollars, over an infinite time horizon] 

Item 

Primary 

estimate 

(7%) 

Lower 

estimate 

(7%) 

Upper 

estimate 

(7%) 

Present Value of Costs ................................................................................................................ $0 $0 $0 

Present Value of Cost Savings ................................................................................................... 0 0 0 

Present Value of Net Costs ......................................................................................................... 0 0 0 

Annualized Costs ......................................................................................................................... 0 0 0 

Annualized Cost Savings ............................................................................................................. 0 0 0 

Annualized Net Costs .................................................................................................................. 0 0 0 

We have developed a comprehensive 

Preliminary Economic Analysis of 

Impacts that assesses the impacts of the 

proposed rule. The full preliminary 

analysis of economic impacts is 

available in the docket for this proposed 

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

AboutFDA/ReportsManualsForms/ 

Reports/EconomicAnalyses/default.htm. 

VI. Analysis of Environmental Impact 

We have tentatively determined under 

21 CFR part 25.32(a) that this action, if 

finalized, 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 

FDA tentatively concludes that this 

proposed 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. Consultation and Coordination 

With Indian Tribal Governments 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13175. We 

have tentatively concluded 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 tentatively 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. 

IX. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. We 

have determined that the proposed rule 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Proposed Rules 82399 

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. 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 addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Frozen Cherry Pie; Proposed Revocation of 

a Standard of Identity and a Standard of 

Quality: Preliminary Regulatory Impact 

Analysis, Initial Regulatory Flexibility 

Analysis, Unfunded Mandates Reform 

Act Analysis. Available at: https://

www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/

EconomicAnalyses/default.htm. 

List of Subjects in 21 CFR Part 152 

Bakery products, Food grades and 

standards, Frozen foods, Fruits. 

PART 152—[REMOVED] 

■ Therefore, consistent with our 

authority under 21 U.S.C. 321, 341, 343, 

348, 371, and 379e, under the Federal 

Food, Drug, and Cosmetic Act, it is 

proposed that 21 CFR part 152 be 

removed. 

Dated: December 2, 2020. 

Stephen M. Hahn, 

Commissioner of Food and Drugs. 

Dated: December 14, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–27823 Filed 12–17–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 38 

RIN 2900–AR03 

Referral for VA Administrative 

Decision for Character of Discharge 

Determinations 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend title 38 

of the Code of Federal Regulations (CFR) 

to clarify that, when determining 

eligibility for interment or 

memorialization benefits, the National 

Cemetery Administration (NCA) will 

refer cases involving other than 

honorable (OTH) discharges, certain 

other discharges, or potential statutory 

or regulatory bars to benefits, to the 

Veterans Benefits Administration (VBA) 

for character of discharge 

determinations. VA is merely updating 

its regulations to conform with statute 

and current practice. 

DATES: Comments must be received by 

VA on or before February 16, 2021. 

ADDRESSES: Written comments may be 

submitted through www.regulations.gov; 

or by mail to Director, Legislative and 

Regulatory Service (42E), Department of 

Veterans Affairs, 810 Vermont Ave. NW, 

Washington, DC 20420. Comments 

should indicate that they are submitted 

in response to ‘‘RIN 2900–AR03— 

Referral for VA Administrative Decision 

for Character of Discharge 

Determinations.’’ Comments received 

will be available for public inspection at 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Sowders, Division Chief, Eligibility 

Verification Division, National 

Cemetery Administration (NCA), 

Department of Veterans Affairs, 810 

Vermont Avenue NW, Washington, DC 

20420. Telephone: (314) 416–6369 (this 

is not a toll-free number). 

SUPPLEMENTARY INFORMATION: VA 

proposes to amend § 38.620 to clarify 

that, when determining eligibility for 

interment or memorialization benefits, 

NCA will refer cases involving other 

than honorable (OTH) discharges or 

other character of discharge issues to 

VBA for an administrative decision. 

Eligibility for NCA-administered 

benefits, including interment in national 

cemeteries, is tied to an individual 

establishing veteran status or meeting 

other specified conditions. See, e.g., 38 

U.S.C. 2402(a)(1) (stating any ‘‘veteran’’ 

may be buried in any open national 

cemetery); 112 (allowing VA to provide 

Presidential Memorial Certificates to 

those eligible for national cemetery 

burial); 2306(a) (authorizing VA to 

provide a government-furnished 

headstone or marker to those buried in 

a national cemetery or who meet other 

specified conditions); 2306(b)(2) (tying 

eligibility for memorial headstones or 

markers to ‘‘veteran’’ status); 2306(f) 

(authorizing caskets or urns for burial of 

deceased ‘‘veterans’’). Congress has 

defined a veteran as ‘‘a person who 

served in the active military, naval, or 

air service, and who was discharged or 

released therefrom under conditions 

other than dishonorable.’’ 38 U.S.C. 

101(2). 

Applying the ‘‘veteran’’ definition to 

the sections governing NCAadministered benefits, it is thus clear 

that, unless other specified conditions 

are met, a deceased individual must 

have been discharged or released from 

active service under conditions other 

than dishonorable; and an adjudication 

must sometimes be made as to an 

individual’s ‘‘veteran’’ status in order to 

determine eligibility for NCAadministered benefits. Some 

characterizations of service on a DD–214 

(such as honorable and general under 

honorable conditions) allow for 

relatively straightforward 

determinations that the character of 

discharge was other than dishonorable; 

however, other types of 

characterizations can be somewhat 

complex and require in-depth 

examination. For example, bad conduct 

discharges, OTH discharges, discharges 

upgraded from bad conduct or OTH, 

and uncharacterized administrative 

separations may require more extensive 

character of discharge determinations, 

including a review to determine 

whether any of the statutory bars to 

benefits contained in 38 U.S.C. 5303(a) 

apply. 

In this rulemaking, NCA clarifies that 

cases involving potential character of 

discharge bars will be referred to VBA 

for an administrative decision under 38 

CFR 3.12 (Character of discharge) or 

other applicable sections. NCA makes 

efficient use of VBA’s existing expertise 

and established procedures to 

adjudicate character of discharge and 

other complex eligibility issues when 

needed. Coordination with VBA for 

adjudication on such issues helps to 

ensure consistency in benefits 

determinations and minimizes 

confusion for claimants and 

beneficiaries that would likely result 

from VBA and NCA having differing 

protocols. NCA provides funding 

resources, equivalent to the amount 

necessary for two full time employees, 

to VBA to offset the additional workload 


khammond on DSKJM1Z7X2PROD with PROPOSALS