Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 16391 

§ 157.208(d) and Table II of § 157.215(a), 

are hereby issued. 

Effective Date 

This final rule is effective March 23, 

2022. The provisions of 5 U.S.C. 804 

regarding Congressional review of Final 

Rules does not apply to the Final Rule 

because the rule concerns agency 

procedure and practice and will not 

substantially affect the rights or 

obligations of non-agency parties. The 

Final Rule merely updates amounts 

published in the Code of Federal 

Regulations to reflect the Department of 

Commerce’s latest annual determination 

of the Gross Domestic Product (GDP) 

implicit price deflator, a mathematical 

updating required by the Commission’s 

existing regulations. 

List of Subjects in 18 CFR Part 157 

Administrative practice and 

procedure, Natural gas, Reporting and 

recordkeeping requirements. 

Issued: March 15, 2022. 

Terry L. Turpin, 

Director, Office of Energy Projects. 

Accordingly, 18 CFR part 157 is 

amended as follows: 

PART 157—APPLICATIONS FOR 

CERTIFICATES OF PUBLIC 

CONVENIENCE AND NECESSITY AND 

FOR ORDERS PERMITTING AND 

APPROVING ABANDONMENT UNDER 

SECTION 7 OF THE NATURAL GAS 

ACT 

■ 1. The authority citation for part 157 

continues to read as follows: 

Authority: 15 U.S.C. 717–717w, 3301– 

3432; 42 U.S.C. 7101–7352. 

■ 2. In § 157.208(d), revise Table I to 

read as follows: 

§ 157.208 Construction, acquisition, 

operation, replacement, and miscellaneous 

rearrangement of facilities. 

* * * * * 

(d) * * * 

TABLE I TO PART 157 

Year 

Limit 

Auto. proj. 

cost limit 

(col. 1) 

Prior notice 

proj. cost 

limit (col. 2) 

1982 .......... $4,200,000 $12,000,000 

1983 .......... 4,500,000 12,800,000 

1984 .......... 4,700,000 13,300,000 

1985 .......... 4,900,000 13,800,000 

1986 .......... 5,100,000 14,300,000 

1987 .......... 5,200,000 14,700,000 

1988 .......... 5,400,000 15,100,000 

1989 .......... 5,600,000 15,600,000 

1990 .......... 5,800,000 16,000,000 

1991 .......... 6,000,000 16,700,000 

TABLE I TO PART 157—Continued 

Year 

Limit 

Auto. proj. 

cost limit 

(col. 1) 

Prior notice 

proj. cost 

limit (col. 2) 

1992 .......... 6,200,000 17,300,000 

1993 .......... 6,400,000 17,700,000 

1994 .......... 6,600,000 18,100,000 

1995 .......... 6,700,000 18,400,000 

1996 .......... 6,900,000 18,800,000 

1997 .......... 7,000,000 19,200,000 

1998 .......... 7,100,000 19,600,000 

1999 .......... 7,200,000 19,800,000 

2000 .......... 7,300,000 20,200,000 

2001 .......... 7,400,000 20,600,000 

2002 .......... 7,500,000 21,000,000 

2003 .......... 7,600,000 21,200,000 

2004 .......... 7,800,000 21,600,000 

2005 .......... 8,000,000 22,000,000 

2006 .......... 9,600,000 27,400,000 

2007 .......... 9,900,000 28,200,000 

2008 .......... 10,200,000 29,000,000 

2009 .......... 10,400,000 29,600,000 

2010 .......... 10,500,000 29,900,000 

2011 .......... 10,600,000 30,200,000 

2012 .......... 10,800,000 30,800,000 

2013 .......... 11,000,000 31,400,000 

2014 .......... 11,200,000 31,900,000 

2015 .......... 11,400,000 32,400,000 

2016 .......... 11,600,000 32,800,000 

2017 .......... 11,800,000 33,200,000 

2018 .......... 12,000,000 33,800,000 

2019 .......... 12,300,000 34,600,000 

2020 .......... 12,500,000 35,200,000 

2021 .......... 12,600,000 35,600,000 

2022 .......... 13,100,000 37,100,000 

* * * * * 

■ 3. In § 157.215(a)(5), revise Table II to 

read as follows: 

§ 157.215 Underground storage testing 

and development. 

(a) * * * 

(5) * * * 

TABLE II TO PART 157 

Year Limit 

1982 ...................................... $2,700,000 

1983 ...................................... 2,900,000 

1984 ...................................... 3,000,000 

1985 ...................................... 3,100,000 

1986 ...................................... 3,200,000 

1987 ...................................... 3,300,000 

1988 ...................................... 3,400,000 

1989 ...................................... 3,500,000 

1990 ...................................... 3,600,000 

1991 ...................................... 3,800,000 

1992 ...................................... 3,900,000 

1993 ...................................... 4,000,000 

1994 ...................................... 4,100,000 

1995 ...................................... 4,200,000 

1996 ...................................... 4,300,000 

1997 ...................................... 4,400,000 

1998 ...................................... 4,500,000 

1999 ...................................... 4,550,000 

2000 ...................................... 4,650,000 

2001 ...................................... 4,750,000 

2002 ...................................... 4,850,000 

2003 ...................................... 4,900,000 

TABLE II TO PART 157—Continued 

Year Limit 

2004 ...................................... 5,000,000 

2005 ...................................... 5,100,000 

2006 ...................................... 5,250,000 

2007 ...................................... 5,400,000 

2008 ...................................... 5,550,000 

2009 ...................................... 5,600,000 

2010 ...................................... 5,700,000 

2011 ...................................... 5,750,000 

2012 ...................................... 5,850,000 

2013 ...................................... 6,000,000 

2014 ...................................... 6,100,000 

2015 ...................................... 6,200,000 

2016 ...................................... 6,300,000 

2017 ...................................... 6,400,000 

2018 ...................................... 6,500,000 

2019 ...................................... 6,600,000 

2020 ...................................... 6,700,000 

2021 ...................................... 6,800,000 

2022 ...................................... 7,100,000 

* * * * * 

[FR Doc. 2022–06085 Filed 3–22–22; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 4 

[Docket No. FDA–2022–D–0192] 

Certain Ophthalmic Products: Policy 

Regarding Compliance With 21 CFR 

Part 4; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry entitled ‘‘Certain 

Ophthalmic Products: Policy Regarding 

Compliance With 21 CFR part 4.’’ This 

guidance describes FDA’s compliance 

policy with respect to the requirements 

of FDA regulations that are now 

applicable to ophthalmic drugs that are 

packaged with eye cups, eye droppers, 

and other dispensers intended for 

ophthalmic use. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on March 23, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 


jspears on DSK121TN23PROD with RULES1
16392 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Rules and Regulations 

1For more information on FDA’s implementation 

of the Genus decision, please see Docket No. FDA– 

2021–N–0843, ‘‘Genus Medical Technologies LLC 

Versus Food and Drug Administration; Request for 

Information and Comments,’’ (86 FR 43553, August 

9, 2021). 

• 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– 

2022–D–0192 for ‘‘Certain Ophthalmic 

Products: Policy Regarding Compliance 

With 21 CFR part 4.’’ Received 

comments 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.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its 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. 

You may submit comments on any 

guidance at any time (see § 10.115(g)(5) 

(21 CFR 10.115(g)(5))). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002; or 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: John 

Barlow Weiner, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002, 301–796–8930, 

combination@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled ‘‘Certain 

Ophthalmic Products: Policy Regarding 

Compliance With 21 CFR part 4.’’ We 

are implementing this guidance without 

prior public comment because we have 

determined that prior public 

participation is not feasible or 

appropriate (§ 10.115(g)(2)). We made 

this determination because FDA needs 

to communicate its compliance policy 

in a timely manner given the urgency of 

these issues following the decision from 

the U.S. Court of Appeals for the District 

of Columbia Circuit in Genus Medical 

Technologies LLC v. U.S. Food and Drug 

Administration (Genus), 994 F.3d 631 

(D.C. Cir. 2021). Although this guidance 

document is immediately in effect, it 

remains subject to comment in 

accordance with FDA’s good guidance 

practices (GGP) regulation and FDA will 

consider all comments received and 

determine whether revisions to the 

guidance document are appropriate 

(§ 10.115(g)(3)). 

In accordance with § 200.50(c) (21 

CFR 200.50(c)), eye cups, eye droppers, 

and other dispensers intended for 

ophthalmic use (collectively referred to 

as ophthalmic dispensers) have been 

regulated as drugs when packaged 

together with the ophthalmic drug with 

which they were intended to be used. 

Therefore, products consisting of an 

ophthalmic drug packaged with an 

ophthalmic dispenser were not 

regulated as combination products as 

defined in § 3.2(e) (21 CFR 3.2(e)) and 

were not subject to the requirements of 

part 4 (21 CFR part 4). This practice is 

a departure from how FDA generally 

regulates other devices that are 

packaged with the drugs with which 

they are intended to be used. 

Specifically, when a device is packaged 

together with the drug with which it is 

intended to be used, FDA regulates that 

drug and the device together as a 

combination product (see § 3.2(e)). 

On April 16, 2021, the U.S. Court of 

Appeals for the District of Columbia 

Circuit issued its decision in Genus. The 

Genus court stated ‘‘[e]xcepting 

combination products, . . . devices 

must be regulated as devices and 

drugs—if they do not also satisfy the 

device definition—must be regulated as 

drugs.’’ 1 In implementing this decision, 

FDA has determined that the language 

in § 200.50(c) indicating that eye cups, 


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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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