31954 Federal Register / Vol. 87, No. 102 / Thursday, May 26, 2022 / Rules and Regulations 

TSR: Yes, except for exports and reexports to 

destinations outside of those countries 

listed in Country Group A:5 (See 

Supplement No. 1 to part 740 of the EAR) 

of ‘‘software’’ controlled by 5D001.a and 

‘‘specially designed’’ for items controlled 

by 5A001.b.5 and 5A001.h, and N/A for 

‘‘software’’ classified under ECCN 5D001.a 

(for 5A001.j) or 5D001.c (for 5A001.j or 

5B001.a (for 5A001.j)). 

ACE: Yes for 5D001.a (for 5A001.j) and 

5D001.c (for 5A001.j or 5B001.a (for 

5A001.j)), except to Country Group E:1 or 

E:2. See § 740.22 of the EAR for eligibility 

criteria. 

Special Conditions for STA 

STA: License Exception STA may not be 

used to ship or transmit 5D001.a 

‘‘software’’ ‘‘specially designed’’ for the 

‘‘development’’ or ‘‘production’’ of 

equipment, functions or features, specified 

by ECCN 5D001.a (for 5A001.j) and 

5D001.c (for 5A001.j or 5B001.a (for 

5A001.j)) to any of the destinations listed 

in Country Group A:5 or A:6 (See 

Supplement No.1 to part 740 of the EAR); 

5A001.b.3, .b.5 or .h; and for 5D001.b. for 

‘‘software’’ ‘‘specially designed’’ or 

modified to support ‘‘technology’’ 

specified by the STA paragraph in the 

License Exception section of ECCN 5E001 

to any of the destinations listed in Country 

Group A:6. 

List of Items Controlled 

Related Controls: See also 5D980 and 5D991. 

Related Definitions: N/A 

Items: 

a. ‘‘Software’’ ‘‘specially designed’’ or 

modified for the ‘‘development’’, 

‘‘production’’ or ‘‘use’’ of equipment, 

functions or features controlled by 5A001; 

b. [Reserved] 

c. Specific ‘‘software’’ ‘‘specially designed’’ 

or modified to provide characteristics, 

functions or features of equipment, 

controlled by 5A001 or 5B001; 

d. ‘‘Software’’ ‘‘specially designed’’ or 

modified for the ‘‘development’’ of any of the 

following telecommunication transmission or 

switching equipment: 

d.1. [Reserved] 

d.2. Equipment employing a ‘‘laser’’ and 

having any of the following: 

d.2.a. A transmission wavelength 

exceeding 1,750 nm; or 

d.2.b. Employing analog techniques and 

having a bandwidth exceeding 2.5 GHz; or 

Note: 5D001.d.2.b does not control 

‘‘software’’ ‘‘specially designed’’ or modified 

for the ‘‘development’’ of commercial TV 

systems. 

d.3. [Reserved] 

d.4. Radio equipment employing 

Quadrature-Amplitude-Modulation (QAM) 

techniques above level 1,024. 

e. ‘‘Software’’, other than that specified by 

5D001.a or 5D001.c, ‘‘specially designed’’ or 

modified for monitoring or analysis by law 

enforcement, providing all of the following: 

e.1. Execution of searches on the basis of 

‘‘hard selectors’’ of either the content of 

communication or metadata acquired from a 

communications service provider using a 

‘handover interface’; and 

Technical Notes: 

1. For the purposes of 5D001.e, a ‘handover 

interface’ is a physical and logical interface, 

designed for use by an authorised law 

enforcement authority, across which targeted 

interception measures are requested from a 

communications service provider and the 

results of interception are delivered from a 

communications service provider to the 

requesting authority. The ‘handover 

interface’ is implemented within systems or 

equipment (e.g., mediation devices) that 

receive and validate the interception request, 

and deliver to the requesting authority only 

the results of interception that fulfil the 

validated request. 

2. ‘Handover interfaces’ may be specified 

by international standards (including but not 

limited to ETSI TS 101 331, ETSI TS 101 671, 

3GPP TS 33.108) or national equivalents. 

e.2. Mapping of the relational network or 

tracking the movement of targeted 

individuals based on the results of searches 

on content of communication or metadata or 

searches as described in 5D001.e.1. 

Note: 5D001.e does not apply to ‘‘software’’ 

‘‘specially designed’’ or modified for any of 

the following: 

a. Billing purposes; 

b. Network Quality of Service (QoS); 

c. Quality of Experience (QoE); 

d. Mediation devices; or 

e. Mobile payment or banking use. 

* * * * * 

Matthew S. Borman, 

Deputy Assistant Secretary for Export 

Administration. 

[FR Doc. 2022–11282 Filed 5–25–22; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 251 

[Docket No. FDA–2021–D–0958] 

Importation of Prescription Drugs Final 

Rule Questions and Answers; 

Guidance for Industry: Small Entity 

Compliance Guide; 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 

‘‘Importation of Prescription Drugs Final 

Rule Questions and Answers.’’ The 

guidance is intended to help small 

entities comply with the final rule 

entitled ‘‘Importation of Prescription 

Drugs.’’ The final rule was issued to 

implement a provision of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) to allow importation of certain 

prescription drugs from Canada. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on May 26, 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: 

• 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– 

2021–D–0958 for ‘‘Importation of 

Prescription Drugs Final Rule Questions 

and Answers.’’ 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 


khammond on DSKJM1Z7X2PROD with RULES
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. 


khammond on DSKJM1Z7X2PROD with RULES