17950 Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under the 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 822 is 

amended as follows: 

PART 822—POSTMARKET 

SURVEILLANCE 

■ 1. The authority citation for part 822 

continues to read as follows: 

Authority: 21 U.S.C. 331, 352, 360i, 360l, 

371, 374. 

■ 2. Revise § 822.8 to read as follows: 

§ 822.8 When, where, and how must I 

submit my postmarket surveillance plan? 

You must submit your plan to 

conduct postmarket surveillance within 

30 days of the date you receive the 

postmarket surveillance order. For 

devices regulated by the Center for 

Biologics Evaluation and Research, send 

your submission to the Food and Drug 

Administration, Center for Biologics 

Evaluation and Research, Document 

Control Center, 10903 New Hampshire 

Ave., Bldg. 71, Rm. G112, Silver Spring, 

MD 20993–0002. For devices regulated 

by the Center for Drug Evaluation and 

Research, send your submission to the 

Central Document Room, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 5901–B, 

Ammendale Rd., Beltsville, MD 20705– 

1266. For devices regulated by the 

Center for Devices and Radiological 

Health, send your submission to the 

Document Mail Center, 10903 New 

Hampshire Ave., Bldg. 66, Rm. G609, 

Silver Spring, MD 20993–0002. When 

we receive your original submission, we 

will send you an acknowledgment letter 

identifying the unique document 

number assigned to your submission. 

You must use this number in any 

correspondence related to this 

submission. 

■ 3. Amend § 822.12 by revising the first 

sentence to read as follows: 

§ 822.12 Do you have any information that 

will help me prepare my submission or 

design my postmarket surveillance plan? 

Guidance documents that discuss our 

current thinking on preparing a 

postmarket surveillance submission and 

designing a postmarket surveillance 

plan are available on the Center for 

Devices and Radiological Health’s 

website, the Food and Drug 

Administration main website, and from 

the Food and Drug Administration, 

Center for Devices and Radiological 

Health, Office of Policy, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

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

MD 20993–0002. * * * 

■ 4. Revise § 822.21 to read as follows: 

§ 822.21 What must I do if I want to make 

changes to my postmarket surveillance 

plan after you have approved it? 

You must receive our approval in 

writing before making changes in your 

plan that will affect the nature or 

validity of the data collected in 

accordance with the plan. To obtain our 

approval, you must submit the request 

to make the proposed change and 

revised postmarket surveillance plan to 

the applicable address listed in § 822.8. 

You may reference information already 

submitted in accordance with § 822.14. 

In your cover letter, you must identify 

your submission as a supplement and 

cite the unique document number that 

we assigned in our acknowledgment 

letter for your original submission, 

specifically identify the changes to the 

plan, and identify the reasons and 

justification for making the changes. 

You must report changes in your plan 

that will not affect the nature or validity 

of the data collected in accordance with 

the plan in the next interim report 

required by your approval order. 

Dated: March 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06508 Filed 3–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

Income Taxes 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 26 of the Code of Federal 

Regulations, Part 1 (§§ 1.301 to 1.400), 

revised as of April 1, 2021, in 

§ 1.362–4, revise paragraph (j) to read as 

follows: 

§ 1.362–4 Basis of loss duplication 

property. 

* * * * * 

(j) Effective/applicability date. This 

section applies to transactions occurring 

after September 3, 2013, unless effected 

pursuant to a binding agreement that 

was in effect prior to September 3, 2013, 

and at all times thereafter. In addition, 

taxpayers may apply these regulations 

to transactions occurring after October 

22, 2004. The introductory text and 

Example 11 of paragraph (h) of this 

section apply with respect to 

transactions occurring on or after March 

28, 2016, and also with respect to 

transactions occurring before such date 

as a result of an entity classification 

election under § 301.7701–3 of this 

chapter filed on or after March 28, 2016, 

unless such transaction is pursuant to a 

binding agreement that was in effect 

prior to March 28, 2016 and at all times 

thereafter. In addition, taxpayers may 

apply such provisions to any transaction 

occurring after October 22, 2004. 

[FR Doc. 2022–06670 Filed 3–28–22; 8:45 am] 

BILLING CODE 0099–10–D 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

Income Taxes 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 26 of the Code of Federal 

Regulations, Part 1 (§§ 1.301 to 1.400), 

revised as of April 1, 2021, in 

§ 1.351–3, revise paragraph (f) to read as 

follows: 

§ 1.351–3 Records to be kept and 

information to be filed. 

* * * * * 

(f) Effective/applicability date. This 

section applies to any taxable year 

beginning on or after May 30, 2006. 

However, taxpayers may apply this 

section to any original Federal income 

tax return (including any amended 

return filed on or before the due date 

(including extensions) of such original 

return) timely filed on or after May 30, 

2006. For taxable years beginning before 

May 30, 2006, see § 1.351–3 as 

contained in 26 CFR part 1 in effect on 

April 1, 2006. Paragraphs (a)(3) and 

(b)(3) of this section apply with respect 

to exchanges under section 351 

occurring on or after March 28, 2016, 

and also with respect to exchanges 

under section 351 occurring before such 

date as a result of an entity classification 

election under § 301.7701–3 of this 

chapter filed on or after March 28, 2016, 

unless such exchange is pursuant to a 

binding agreement that was in effect 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 17951 

prior to March 28, 2016 and at all times 

thereafter. 

[FR Doc. 2022–06669 Filed 3–28–22; 8:45 am] 

BILLING CODE 0099–10–D 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

Income Taxes 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 26 of the Code of Federal 

Regulations, Part 1 (§§ 1.301 to 1.400), 

revised as of April 1, 2021, in § 1.358– 

6, revise paragraph (f)(1) and revise the 

first sentence of paragraph (f)(3) to read 

as follows: 

§ 1.358–6 Stock basis in certain triangular 

reorganizations. 

* * * * * 

(f) * * * 

(1) General rule. Except as otherwise 

provided in this paragraph (f), this 

section applies to triangular 

reorganizations occurring on or after 

December 23, 1994. 

* * * * * 

(3) Triangular G reorganization and 

special rule for triangular 

reorganizations involving members of a 

consolidated group. Paragraph (e)(1) of 

this section shall apply to triangular 

reorganizations occurring on or after 

September 17, 2008. * * * 

* * * * * 

[FR Doc. 2022–06668 Filed 3–28–22; 8:45 am] 

BILLING CODE 0099–10–D 

NATIONAL ARCHIVES AND RECORDS 

ADMINISTRATION 

Information Security Oversight Office 

32 CFR Part 2001 

[FDMS No. NARA–22–0002; NARA–2022– 

021] 

RIN 3095–AC06 

Classified National Security 

Information 

AGENCY: Information Security Oversight 

Office (ISOO), National Archives and 

Records Administration (NARA). 

ACTION: Direct final rule. 

SUMMARY: We are revising our Classified 

National Security Information 

regulation to permit digital signatures 

that meet certain requirements on the 

Standard Form (SF) 312, which is the 

non-disclosure agreement required prior 

to accessing classified information. Due 

to agency needs during the COVID–19 

pandemic and remote work situations, 

combined with developments in digital 

signatures since a regulatory prohibition 

on electronic signatures was 

implemented in 2010, it is both urgent 

and appropriate to make this 

administrative change at this time. 

DATES: This rule is effective on May 9, 

2022, unless we receive adverse 

comments by April 28, 2022 that 

warrant revising or rescinding this 

rulemaking. 

ADDRESSES: You may submit comments, 

identified by RIN 3095–AC06, by the 

following method: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Search for 

RIN 3095–AC06 and follow the site’s 

instructions for submitting comments. 

We may publish any comments we 

receive without changes, including any 

personal information you include. 

During the COVID–19 pandemic and 

remote work situation we cannot accept 

comments my mail or delivery because 

we do not have staff in the office. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Keravuori, Regulatory and 

External Policy Program Manager, by 

email at regulation_comments@

nara.gov, or by telephone at 

301.837.3151. 

SUPPLEMENTARY INFORMATION: These 

regulations were last revised in 2010. At 

that time, these regulations included a 

prohibition against signing the Standard 

Form (SF) 312 electronically, due to 

concerns about integrity and legal 

enforceability of any form of electronic 

signature (e-signature) at the time. In the 

decade-plus since then, encryption and 

other measures for e-signatures have 

advanced and they are now regularly 

encouraged or required and deemed 

legally enforceable. In addition, Federal 

agencies are required to digitize services 

and forms and accelerate the use of esignatures as much as possible (see, e.g., 

2018 21st Century Integrated Digital 

Experience Act (21st Century IDEA), 44 

U.S.C. 3501 note). 

Since the COVID–19 pandemic began 

in March 2020, numerous Federal 

agencies have had to engage in remote 

work to varying degrees and have had 

difficulty bringing new workers onboard 

who require access to classified 

information, due to the requirement for 

handwritten signatures on the SF 312. It 

has been placing employees at risk of 

spreading the virus, as well as creating 

logistical and other difficulties. Multiple 

agencies have been consistently 

requesting the ability to allow esignatures as a result, and the need 

became critical and urgent once the 

COVID–19 pandemic extended much 

longer than originally anticipated. 

The advances in technical ability to 

ensure valid e-signatures, and legal 

acceptance of such signatures, is clearly 

the way of the future and necessary to 

support a modernized classified 

national security information system. 

However, the timing to make this 

change is more urgent now because of 

COVID–19 related health risks. 

Under laws such as the Government 

Paperwork Elimination Act (GPEA), 44 

U.S.C. 3504 note, the Uniform 

Electronic Transactions Act (UETA), a 

model act since adopted by 47 states 

and the District of Columbia (the 

remaining three states have comparable 

laws), and the Electronic Signatures in 

Global and National Commerce Act 

(ESIGN), 15 U.S.C. 7001, et seq., an esignature has the same legal weight as 

a handwritten signature and cannot be 

considered invalid simply due to being 

electronic. The laws establish criteria 

for valid e-signatures, along the 

following lines: Intent to sign, consent 

to do business electronically, 

association of the signature with the 

record, attribution to the person signing, 

and a record of the digital transactions. 

The United States practices an opentechnology approach, meaning there’s 

no law requiring use of a specific 

signing technology for an e-signature to 

be legally binding, as long as it meets 

the criteria. 

However, for the purpose of esignatures on the SF 312, ISOO has 

established certain requirements 

agencies must meet if they wish to allow 

such signatures. We require that 

agencies use digital signatures (rather 

than other forms of e-signature) on the 

SF 312 because digital signatures 

provide the requisite level of security 

and authenticity appropriate for these 

agreements. Digital signatures are a 

specific signature technology type of esignature that allows users to sign 

documents and authenticate the signer. 

Digital signatures are based on a 

standard, accepted format, called public 

key infrastructure (PKI), to provide the 

highest levels of security and universal 

acceptance through use of a 

mathematical algorithm and other 

features. The mathematical algorithm 

acts like a cipher and encrypts the data 

matching the signed document. The 

resulting encrypted data is the digital 

signature, which is also marked with the 


lotter on DSK11XQN23PROD with RULES1