16394 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–8220. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing that the name of the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee, which was 

established on March 23, 1978, has been 

changed. The Agency decided that the 

name ‘‘Obstetrics, Reproductive and 

Urologic Drugs Advisory Committee’’ 

more accurately describes the subject 

areas for which the committee is 

responsible. The committee reviews and 

evaluates data on the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the practice of obstetrics, 

gynecology, urology and related 

specialties, and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. The mandate of the 

committee no longer includes 

osteoporosis and metabolic bone 

disease. As osteoporosis and metabolic 

bone diseases are topics related to 

endocrinology and metabolic disease, 

these will be discussed by the 

Endocrinologic and Metabolic Drugs 

Advisory Committee. 

The Obstetrics, Reproductive and 

Urologic Drugs Advisory Committee 

name was changed, and its functions 

changed in the charter renewal dated 

March 23, 2022. In this final rule, FDA 

is revising 21 CFR 14.100(c)(9) to reflect 

these changes. 

Publication of this final rule 

constitutes a final action on this change 

under the Administrative Procedure 

Act. Under 5 U.S.C. 553(b)(B) and (d)(3) 

and 21 CFR 10.40(d) and (e)(1), the 

Agency finds good cause to dispense 

with notice and public procedure and to 

proceed to an immediately effective 

regulation. Such notice and procedures 

are unnecessary and are not in the 

public interest because the final rule is 

merely codifying the new name and the 

function of the advisory committee to 

reflect the current committee charter. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under the 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for part 14 

continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155; Pub. L. 113–54. 

■ 2. Section 14.100 is amended by 

revising paragraph (c)(8) heading and 

paragraph (c)(8)(ii) to read as follows: 

§ 14.100 List of standing advisory 

committees. 

* * * * * 

(c) * * * 

(8) Obstetrics, Reproductive and 

Urologic Drugs Advisory Committee. 

* * * * * 

(ii) Function: The committee reviews 

and evaluates data on the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the practice of obstetrics, 

gynecology, urology and related 

specialties, and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs. 

* * * * * 

Dated: March 16, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–05965 Filed 3–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 130 and 131 

[Docket No. FDA–2000–P–0126 (formerly 

Docket No. 2000P–0658)] 

RIN 0910–AI40 

Milk and Cream; Petition for an 

Administrative Stay of Action: 

Definitions and Standards of Identity 

for Yogurt, Lowfat Yogurt, and Nonfat 

Yogurt 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; notification of 

administrative stay. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

providing notice of a stay of the 

effectiveness of certain provisions of a 

final rule published in the Federal 

Register of June 11, 2021. The final rule 

amended the definition and standard of 

identity for yogurt and revoked the 

definitions and standards of identity for 

lowfat yogurt and nonfat yogurt. FDA is 

publishing this notification in response 

to objections timely filed in accordance 

with regulatory requirements. 

DATES: FDA is administratively staying 

certain provisions in the final rule 

published on June 11, 2021 (86 FR 

31117). FDA will publish a document in 

the Federal Register lifting the stay or 

taking further action as needed. 

ADDRESSES: For access to the docket, 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, 

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

through Friday. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: Joan 

Rothenberg, Center for Food Safety and 

Applied Nutrition, Office of Regulations 

and Policy, Food and Drug 

Administration, 5001 Campus Dr., 

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

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 11, 

2021 (86 FR 31117), FDA issued a final 

rule (the 2021 final rule) amending the 

definition and standard of identity for 

yogurt ((§ 131.200) (21 CFR 131.200)) 

and revoking the definitions and 

standards of identity for lowfat yogurt 

(21 CFR 131.203) and nonfat yogurt (21 

CFR 131.206). The 2021 final rule’s 

effective date was July 12, 2021. 

Pursuant to section 701(e) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 371(e)), the 2021 final 

rule notified persons who would be 

adversely affected by the 2021 final rule 

that they could file objections, 

specifying with particularity the 

provisions of the 2021 final rule deemed 

objectionable, stating the grounds 

therefor, and requesting a public hearing 

upon such objections. 

The International Dairy Foods 

Association (IDFA) and Chobani timely 

filed objections and requests for a 

hearing with respect to several 

provisions in the 2021 final rule (see 

Objections and Request for Hearings 

submitted by Michael Dykes, DVM, 

President and Chief Executive Officer, 

International Dairy Foods Association, 

dated July 12, 2021, to the Dockets 

Management Staff, Food and Drug 

Administration (Comment ID FDA– 

2000–P–0126–0109) and Objection and 

Requests for Hearing submitted by 

Matthew Graziose, Ph.D., Director, 

Regulatory Affairs & Compliance, 

Chobani, dated July 12, 2021, to the 

Dockets Management Staff, Food and 

Drug Administration (Comment ID 

FDA–2000–P–0126–0108)). Section 

701(e)(2) of the FD&C Act provides that, 

until final action is taken by the 

Secretary, the filing of objections 


jspears on DSK121TN23PROD with RULES1
Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 16395 

operates to stay the effectiveness of 

those provisions to which the objections 

are made. We established the definition 

and standard of identity for yogurt in 

1981 (1981 final rule) (46 FR 9924 at 

9939, January 30, 1981). The 2021 final 

rule amended some provisions in the 

definition and standard of identity and 

maintained others. Staying the 

effectiveness of these provisions results 

in the corresponding requirements in 

the 1981 final rule remaining in effect. 

This notice provides clarification on 

which provisions of the 2021 final rule 

have been stayed and which 

requirements of the 1981 final rule are 

in effect pending final action under 

section 701(e) of the FD&C Act. 

II. Objections and Requests for Hearing 

IDFA’s objections were directed at 

several provisions in § 131.200(a) of the 

2021 final rule. IDFA objected to the 

requirement in § 131.200(a) that yogurt, 

before the addition of bulky flavoring 

ingredients, has either a titratable 

acidity of not less than 0.7 percent, 

expressed as lactic acid, or a pH of 4.6 

or lower. This provision of the 2021 

final rule is stayed. FDA notes that the 

definition and standard of identity 

established in 1981 included a 

minimum titratable acidity requirement 

of 0.9 percent, but that provision was 

stayed by the filing of objections in 1981 

(47 FR 41519 at 41523, September 21, 

1982). Consequently, no minimum 

titratable acidity requirement or 

maximum pH requirement is in effect. 

IDFA also objected to the provision 

that yogurt, before the addition of bulky 

flavoring ingredients, contains not less 

than 3.25 percent milkfat and the 

provision requiring pasteurized cream, 

if used as a basic dairy ingredient under 

§ 131.200(b) or an optional dairy 

ingredient under § 131.200(c), to be 

added before culturing. These 

provisions of the 2021 final rule are 

stayed. However, a minimum milkfat of 

3.25 percent before the addition of 

bulky flavors and the requirement that 

cream be included in the culturing 

process remain in effect under the 

definition and standard of identity 

established in the 1981 final rule. 

Chobani objected to the exclusion of 

ultrafiltered milk from the basic dairy 

ingredients in § 131.200(b). This 

provision is stayed insofar as it 

prohibits the use of ultrafiltered milk. 

However, the provision in the 1981 final 

rule remains in effect with respect to the 

use of ultrafiltered milk. This means 

that ultrafiltered milk may not be used 

as a basic dairy ingredient in the 

manufacture of yogurt. Because we 

received no objections to the use of 

ultrafiltered milk as an optional dairy 

ingredient under § 131.200(c) of the 

2021 final rule, ultrafiltered milk may 

be used to increase the milk solids, not 

fat content, of the food above 8.25 

percent, provided that the ratio of 

protein to total nonfat solids of the food 

and the protein efficiency ratio of all 

protein present is not decreased as a 

result. 

IDFA also objected to provisions in 

§ 131.200(d) for other optional 

ingredients. These provisions included 

§ 131.200(d)(2), which limits the use of 

sweeteners to nutritive carbohydrate 

sweeteners, and § 131.200(d)(8)(ii), 

which requires a minimum vitamin D 

content of 25 percent Daily Value (DV) 

per reference amount customarily 

consumed (RACC) if vitamin D is added. 

Both provisions in the 2021 final rule 

are stayed. Optional vitamin D addition 

has been permitted since 1982 at a level 

of 400 international units per quart (see 

47 FR 41519 at 41520 and 41524); this 

limitation on vitamin D addition 

remains in effect. The prohibition on the 

use of sweeteners other than nutritive 

carbohydrate sweeteners remains in 

effect under the 1981 final rule’s 

definition and standard of identity. 

Because we received no objections to 

permitting the use of all safe and 

suitable nutritive carbohydrate 

sweeteners, nutritive carbohydrate 

sweeteners are no longer limited to 

those listed under § 131.200(c)(2) in the 

1981 final rule. 

This notification does not constitute a 

determination that a hearing is justified 

on any objections or requests for hearing 

that have been filed (21 CFR 12.23). 

Until FDA makes such a determination 

and issues a notice under 21 CFR 12.28, 

12.26, or 12.35, we intend to exercise 

enforcement discretion with respect to 

the following: 

• Addition of vitamin D to yogurt 

under § 131.200 and lower fat yogurt 

products under § 130.10 (21 CFR 

130.10) such that the food contains at 

least 10 percent DV per RACC, within 

limits of current good manufacturing 

practices. 

• Use of nonnutritive sweeteners in 

yogurt under § 131.200 and lower fat 

yogurt products under § 130.10 that are 

not labeled with a statement of identity 

that includes an expressed nutrient 

content claim consistent with the use of 

nonnutritive sweeteners. 

• Use of bulky flavor ingredients in 

lower fat yogurt products under § 130.10 

that increase the total fat content above 

the level specified in § 101.62(b) (21 

CFR 101.62(b)) for the expressed 

nutrient content claim in the statement 

of identity, provided that the level of 

milkfat in the product is consistent with 

the level specified in § 101.62(b) and the 

statement of identity also includes a 

descriptor of the bulky flavor ingredient 

(e.g., ‘‘lowfat yogurt with coconut’’). 

Under this enforcement discretion, we 

do not intend to take action with respect 

to yogurt and lower fat yogurt products 

that meet these criteria provided that 

the products otherwise conform to the 

definition and standard of identity 

under § 131.200 or § 130.10. 

III. Provisions Stayed 

Pursuant to section 701(e) of the 

FD&C Act, we hereby announce that the 

following provisions of the 2021 final 

rule are stayed by the objections filed: 

1. The requirement in § 131.200(a) 

that yogurt, before the addition of bulky 

flavoring ingredients, has either a 

titratable acidity of not less than 0.7 

percent, expressed as lactic acid, or a 

pH of 4.6 or lower. 

2. The requirement in § 131.200(a) 

that yogurt, before the addition of bulky 

flavoring ingredients, contains not less 

than 3.25 percent milkfat. 

3. The prohibition in § 131.200(a), (b), 

and (c) on adding pasteurized cream 

after culturing. 

4. The exclusion of ultrafiltered milk 

from the basic dairy ingredients in 

§ 131.200(b). 

5. The limitation on the use of 

sweeteners in § 131.200(d)(2) to 

nutritive carbohydrate sweeteners. 

6. The requirement in 

§ 131.200(d)(8)(ii) that vitamin D, if 

added, must be present in such quantity 

that the food contains not less than 25 

percent DV per RACC, within limits of 

current good manufacturing practices. 

IV. Effective/Compliance Dates 

This document hereby confirms the 

effective date of the 2021 final rule as 

July 12, 2021, and the compliance date 

as January 1, 2024, except with respect 

to the provisions in § 131.200(a), (b), (c), 

(d)(2), and (d)(8)(ii) stated above, which 

are stayed. 

Dated: March 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05804 Filed 3–22–22; 8:45 am] 

BILLING CODE 4164–01–P 


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