Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Rules and Regulations 31955 

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 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this 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. Send one self-addressed adhesive 

label to assist that office in processing 

your request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Lyndsay Hennessey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–7605. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Importation of Prescription Drugs Final 

Rule Questions and Answers.’’ We are 

issuing this guidance in accordance 

with section 212 of the Small Business 

Regulatory Enforcement Fairness Act 

(Pub. L. 104–121, as amended by Pub. 

L. 110–28) to help small entities better 

understand and comply with the final 

rule, ‘‘Importation of Prescription 

Drugs,’’ published in the Federal 

Register of October 1, 2020 (85 FR 

62094). The final rule will implement 

section 804(b) through (h) of the FD&C 

Act (21 U.S.C. 384(b) through (h)) to 

allow importation of certain 

prescription drugs from Canada. The 

final rule, which is codified in 21 CFR 

parts 1 and 251, became effective 

November 30, 2020. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 

10.115(c)(2)). The guidance represents 

the current thinking of FDA on 

Importation of Prescription Drugs Final 

Rule Questions and Answers. 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 251 have 

been approved under OMB control 

number 0910–0888. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

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: May 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11276 Filed 5–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2021–0472; FRL–9646–02– 

R4] 

Air Plan Approval; North Carolina; 

Repeal of Delegation Authority 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a State 

Implementation Plan (SIP) revision 

submitted by the State of North 

Carolina’s Department of Environmental 

Quality (DEQ), Division of Air Quality 

(DAQ or Division), via a letter dated 

April 13, 2021. This rulemaking 

addresses the repeal of a State 

regulation related to delegation of 

authority and removal of the regulation 

from the North Carolina SIP. EPA is 

finalizing approval of these changes 

pursuant to the Clean Air Act (CAA or 

Act). 

DATES: This rule is effective June 27, 

2022. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2021–0472. All documents in the docket 

are listed on the www.regulations.gov 

website. Although listed in the index, 

some information may not be publicly 

available, i.e., Confidential Business 

Information or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically through 

www.regulations.gov or in hard copy at 

the Air Regulatory Management Section, 

Air Planning and Implementation 

Branch, Air and Radiation Division, 

U.S. Environmental Protection Agency, 

Region 4, 61 Forsyth Street SW, Atlanta, 

Georgia 30303–8960. EPA requests that 

if at all possible, you contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT section to schedule your 

inspection. The Regional Office’s 

official hours of business are Monday 

through Friday 8:30 a.m. to 4:30 p.m., 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Andres Febres, Air Regulatory 

Management Section, Air Planning and 

Implementation Branch, Air and 

Radiation Division, U.S. Environmental 

Protection Agency, Region 4, 61 Forsyth 

Street SW, Atlanta, Georgia 30303–8960. 


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31956 Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Rules and Regulations 

1EPA received the submittal on April 14, 2021, 

and for clarity, refers to the submission per its 

‘‘letter date’’ of April 13, 2021, throughout this 

notice. 

2EPA notes that the Agency received several 

revisions to the North Carolina SIP that were 

transmitted with the same April 13, 2021, cover 

letter. EPA will be considering action for these 

other SIP revisions in separate rulemakings. 

The telephone number is (404) 562– 

8966. Mr. Febres can also be reached via 

electronic mail at febresmartinez.andres@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On April 13, 2021, the State of North 

Carolina submitted changes to the North 

Carolina SIP for EPA’s approval.1

Through this final rulemaking, EPA is 

approving changes to the North Carolina 

SIP related to 15A North Carolina 

Administrative Code (NCAC) 

Subchapter 02D, Rule .0615, 

Delegation.2 The April 13, 2021, SIP 

revision removes the aforementioned 

regulation from the SIP because the 

regulation is unnecessary and has been 

repealed at the state level. 

Through a Notice of Proposed 

Rulemaking (NPRM), EPA proposed to 

approve these changes on March 31, 

2022. See 87 FR 18759. More details on 

North Carolina’s April 13, 2021, 

submission and EPA’s rationale for 

approving the aforementioned changes 

can be found in the March 31, 2022, 

NPRM. Comments on the NPRM were 

due on or before May 2, 2022. No 

comments were received on the March 

31, 2022, NPRM. 

II. Incorporation by Reference 

In this document, EPA is finalizing 

regulatory text that includes 

incorporation by reference. Specifically, 

EPA is finalizing the removal of 15A 

NCAC 02D, Rule .0615, Delegation, from 

the North Carolina State 

Implementation Plan, which is 

incorporated by reference in accordance 

with the requirements of 1 CFR part 51. 

EPA has made and will continue to 

make the SIP generally available at the 

EPA Region 4 Office (please contact the 

person identified in the FOR FURTHER

INFORMATION CONTACT section of this 

preamble for more information). 

III. Final Action 

EPA is finalizing the approval of 

changes to the North Carolina SIP. 

Specifically, for the reasons described in 

the March 31, 2022, NPRM, EPA is 

finalizing the removal of 15 NCAC 02D, 

Rule .0615, Delegation, from the North 

Carolina SIP. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

See 42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. This action merely approves 

state law as meeting Federal 

requirements and does not impose 

additional requirements beyond those 

imposed by state law. For that reason, 

this action: 

• Is not a significant regulatory action 

subject to review by the Office of 

Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

The SIP is not approved to apply on 

any Indian reservation land or in any 

other area where EPA or an Indian tribe 

has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications as specified by Executive 

Order 13175 (65 FR 67249, November 9, 

2000), nor will it impose substantial 

direct costs on tribal governments or 

preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by July 25, 2022. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this action for the purposes of 

judicial review nor does it extend the 

time within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: May 20, 2022. 

Daniel Blackman, 

Regional Administrator, Region 4. 

For the reasons stated in the 

preamble, the EPA amends 40 CFR part 

52 as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 


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Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Rules and Regulations 31957 

Subpart II—North Carolina 

§ 52.1770 [Amended] 

■ 2. In § 52.1770(c), amend Table (1) 

‘‘EPA Approved North Carolina 

Regulations’’ by removing the entry for 

‘‘Section .0615.’’ 

[FR Doc. 2022–11290 Filed 5–25–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 212, 225, and 252 

[Docket DARS–2020–0031] 

RIN 0750–AK97 

Defense Federal Acquisition 

Regulation Supplement: Prohibition on 

Contracting With Persons That Have 

Business Operations With the Maduro 

Regime (DFARS Case 2020–D010) 

AGENCY: Defense Acquisition 

Regulations System, Department of 

Defense (DoD). 

ACTION: Final rule. 

SUMMARY: DoD is issuing a final rule 

amending the Defense Federal 

Acquisition Regulation Supplement 

(DFARS) to implement a statute that 

prohibits DoD from entering into 

contracts for the procurement of goods 

and services with any person that has 

business operations with an authority of 

the government of Venezuela that is not 

recognized as the legitimate government 

of Venezuela by the United States 

Government. 

DATES: Effective May 26, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Bass, telephone 571–372– 

6174. 

SUPPLEMENTARY INFORMATION: 

I. Background 

DoD published a proposed rule in the 

Federal Register at 85 FR 53751 on 

August 31, 2020, to implement section 

890 of the National Defense 

Authorization Act (NDAA) for Fiscal 

Year (FY) 2020 (Pub. L. 116–92). Section 

890 prohibits contracts for the 

procurement of goods and services with 

any person that has business operations 

with an authority of the government of 

Venezuela, subject to exceptions. Six 

respondents submitted public 

comments in response to the proposed 

rule. 

II. Discussion and Analysis 

DoD reviewed the public comments in 

the development of the final rule. A 

discussion of the comments and the 

changes made to the rule as a result of 

those comments is provided, as follows: 

A. Summary of Significant Changes 

From the Proposed Rule 

To further clarify and to eliminate any 

ambiguity, the solicitation provision 

252.225–7055, Representation 

Regarding Business Operations with the 

Maduro Regime, was revised to clarify 

that ‘‘. . . by submission of its offer, the 

Offeror represents that the Offeror is a 

person that—(1) Does not have any 

business operations with an authority of 

the Maduro regime or the government of 

Venezuela that is not recognized as the 

legitimate government of Venezuela by 

the U.S. Government; or . . .’’. The 

contract clause 252.225–7056, 

Prohibition Regarding Business 

Operations with the Maduro Regime, 

applies to the entity that was awarded 

the contract. Therefore, no change was 

made to the clause. 

Additional revisions were made to the 

text and clause number designations to 

accommodate updated numerical 

designations required in the final rule. 

In addition, a revision was made to 

225.7020–4, Joint Determination, to 

explicitly state that delegation authority 

is to remain at the level of Secretary of 

Defense and Secretary of State without 

power of redelegation. 

B. Analysis of Public Comments 

1. Support for the Rule 

Comment: Several respondents 

provided overall support of the rule. A 

respondent expressed support for the 

rule because it is an effectual way to 

limit the Maduro regime’s access to 

American made or American preferred 

military technology. The respondent 

also expressed support for the 

exceptions for humanitarian aid. 

Another respondent supported the rule 

overall because limiting contracts is a 

push in opposition of the Maduro 

regime. A respondent commended the 

rule and hopes this is not a final step 

in solving unrest in Venezuela. 

Response: DoD acknowledges the 

respondents’ support for the rule. 

2. Joint Determination 

Comment: A respondent expressed 

concern that requiring a joint 

determination of both the Secretary of 

Defense and the Secretary of State that 

the restriction does not apply to certain 

acquisitions may limit the relief that can 

be provided to the people of Venezuela. 

Another respondent expressed similar 

concern with the high level of approval 

necessary for the joint determination 

and also expressed concern with the 

process for making the joint 

determination. A respondent included a 

list of proposed factors to consider in 

whether to seek a joint determination. A 

respondent further stated that there 

were no procedures or guidance on the 

Government determination process. 

Response: The proposed rule 

implements section 890 of the NDAA 

for FY 2020. Section 890 prohibits DoD 

from entering into a contract for the 

procurement of goods or services with 

any person that has business operations 

with an authority of the government of 

Venezuela that is not recognized as the 

legitimate government of Venezuela by 

the United States Government. Section 

890 does not apply the prohibition to 

acquisitions where the Secretary of 

Defense and Secretary of State have 

jointly determined that the acquisition 

is necessary for providing humanitarian 

assistance, disaster relief, or urgent 

lifesaving measures to the people of 

Venezuela; carrying out noncombatant 

evacuations; or is otherwise vital to U.S. 

national security interests. The process 

of the joint determination is in 

accordance with internal Government 

operating procedures. The rule’s 

implementation is consistent with the 

statutory requirements of section 890 

and does not allow for further 

delegation of the authority for the joint 

determination. Thus, the final rule 

implements the authority for the joint 

determination at the level of the 

Secretary of Defense and Secretary of 

State. 

3. National Security Waiver 

Comment: A couple of respondents 

provided questions relating to the lack 

of guidelines for securing a national 

security interest exception in the 

proposed rule. 

Response: The final rule is directly 

aligned with the statutory language and 

implements section 890 of the NDAA 

for FY 2020. The reference to national 

security interests appears in section 

890(b)(1)(A) and was implemented 

accordingly in DFARS 225.7020–4(a)(2) 

of the final rule. 

4. Definitions 

Comment: A respondent stated that 

the definition of ‘‘person’’ is overly 

broad and could adversely affect 

contracts held by businesses that have 

no operations in, or connections with, 

Venezuela. Another respondent further 

stated that in light of the broad 

definition of ‘‘person’’ and ‘‘business 

operations’’ in the rule, there is a lack 

of clarity in the solicitation provision 

252.225–7055 as to whether an ‘‘offeror’’ 

who certifies that it does not have any 

business operations with an authority of 


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