Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 16393 

2For the purposes of this guidance, pending 

applications include applications on which FDA 

has taken an action that is not an approval action 

and that are not currently pending review before the 

Agency (i.e., applications that have been tentatively 

approved or applications that have received a 

complete response letter) and applications currently 

pending review before the Agency (including 

supplements to approved applications). 

eye droppers, and ophthalmic 

dispensers are regulated as drugs when 

packaged with ophthalmic drugs is now 

obsolete, because these articles meet the 

‘‘device’’ definition. Accordingly, an 

ophthalmic dispenser that meets the 

definition of device in section 201(h) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 321(h)) and 

that is packaged together with an 

ophthalmic drug is now regulated as a 

device constituent part (see § 3.2(e)), 

and, as such, is subject to the 

requirements in part 4. Because the drug 

constituent part provides the primary 

mode of action of these combination 

products, generally FDA’s Center for 

Drug Evaluation and Research (CDER) 

will have primary jurisdiction over 

these products. 

This change impacts products subject 

to pending applications,2 approved 

products, and products marketed 

pursuant to section 505G of the FD&C 

Act (21 U.S.C. 355h) without an 

approved application under section 505 

of the FD&C Act (21 U.S.C. 355) 

(commonly referred to as over-thecounter monograph drugs). 

We recognize that some applicants 

and manufacturers may need to develop 

policies and procedures necessary to 

comply with the requirements in part 4. 

Therefore, we are issuing the guidance 

to communicate FDA’s compliance 

policy with respect to these products. 

The guidance explains FDA’s policy 

with respect to compliance with the 

requirements of part 4. Specifically, the 

guidance explains that FDA generally 

does not intend to take action with 

respect to noncompliance with part 820 

(21 CFR part 820) as described in part 

4, subpart A, with respect to ophthalmic 

products that were not previously 

regulated as combination products 

because of the now obsolete language in 

§ 200.50(c) for a period of 12 months 

following the publication of the 

guidance. Further, the guidance 

explains that, with respect to 

ophthalmic products affected by the 

Genus decision that incorporate lowerrisk device constituent parts, for 

example, eye dropper bottles/ampules 

that administer the drug directly to the 

eye, FDA does not intend to take action 

with respect to noncompliance with any 

applicable part 820 requirements for 

these products until FDA further 

considers the application of these 

requirements to these combination 

products. Additionally, the guidance 

describes FDA’s policy with respect to 

pending applications and how FDA will 

determine when compliance with the 

requirements of part 4, subpart A, must 

be demonstrated (i.e., during the review 

of the application or after approval). As 

part of this notice, FDA is soliciting 

feedback from stakeholders as to 

whether a 12-month period is sufficient 

for affected stakeholders to develop and 

implement the policies and procedures 

necessary to comply with the 

requirements of part 4, including 

whether different amounts of time 

should be considered with respect to 

compliance with subpart A and subpart 

B of part 4. Finally, in addition to the 

guidance for industry we are 

announcing today, FDA also encourages 

applicants and manufacturers to review 

other guidances for industry that apply 

to CDER-led drug-device combination 

products. 

This guidance is being issued 

consistent with FDA’s GGP regulation 

(§ 10.115). The guidance represents the 

current thinking of FDA on ‘‘Certain 

Ophthalmic Products: Policy Regarding 

Compliance With 21 CFR part 4.’’ It 

does not establish any rights for any 

person and is not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 314 are 

approved under OMB control numbers 

0910–0001, 0910–0230, and 0910–0291. 

The collections of information in 21 

CFR 600.80 and 600.81 are approved 

under OMB control number 0910–0308. 

The collections of information in 21 

CFR 606.171 are approved under OMB 

control number 0910–0458. The 

collections of information in 21 CFR 

803.50, 803.53, and 803.56 are approved 

under OMB control numbers 0910–0291 

and 0910–0437. The collections of 

information in 21 CFR 806.10 and 

802.20 are approved under OMB control 

number 0910–0359. The collections of 

information in 21 CFR part 211 have 

been approved under OMB control 

number 0910–0139. The collections of 

information in 21 CFR part 820 are 

approved under OMB control number 

0910–0073. The collections of 

information in 21 CFR parts 606 and 

640 are approved under OMB control 

number 0910–0116. The collections of 

information in 21 CFR part 610 are 

approved under OMB control numbers 

0910–0116 and 0910–0338 (also for 21 

CFR part 680 and Form FDA 356h). The 

collections of information in 21 CFR 

part 1271, subparts C and D, are 

approved under OMB control number 

0910–0543. The collections of 

information in 21 CFR 4.102, 4.103, and 

4.105 are approved under OMB control 

number 0910–0834. 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: March 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05776 Filed 3–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2019–N–4203] 

Advisory Committee; Bone, 

Reproductive and Urologic Drugs 

Advisory Committee; Change of Name 

and Function; Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

amending the standing advisory 

committees’ regulations to change the 

name and function of the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee. This action is 

being taken to reflect changes made to 

the charter for this advisory committee. 

DATES: This rule is effective March 23, 

2022. The changes are applicable March 

23, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Teresa Hays, Committee Management 

Officer, Food and Drug Administration, 


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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 


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