Federal Register / Vol. 87, No. 60 / Tuesday, March 29, 2022 / Rules and Regulations 17949 

Zoalene in grams/ton Combination in grams/ 

ton Indications for use Limitations Sponsor 

(i) 113.5 to 170.3 ........ Growing turkeys: For prevention and control of 

coccidiosis.

Feed continuously as sole ration. For turkeys 

grown for meat purposes only. Not to be fed to 

laying birds.

054771 

058198 

(ii) 113.5 to 170.3 ....... Bacitracin 

methylenedisalicylate, 

4 to 50.

Growing turkeys: For prevention and control of 

coccidiosis; and for increased rate of weight 

gain and improved feed efficiency.

Feed continuously as sole ration until 14 to 16 

weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds.

054771 

058198 

* * * * * 

Dated: March 21, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–06395 Filed 3–28–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 822 

[Docket No. FDA–2021–N–0246] 

Medical Devices; Technical 

Amendments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is amending its medical device 

regulations to update mailing address 

information and to reduce (from three to 

one) the number of copies of certain 

documents that need to be submitted to 

FDA. The rule does not impose any new 

regulatory requirements on affected 

parties. This action is editorial in nature 

and is intended to improve the accuracy 

of the Agency’s regulations, and to 

remove a submission requirement that is 

no longer necessary. 

DATES: This rule is effective March 29, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Madhusoodana Nambiar, Office of 

Policy, Center for Devices and 

Radiological Health, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5519, 

Silver Spring, MD 20993–0002, 301– 

796–5837. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The FDA Center for Devices and 

Radiological Health (CDRH) has 

reorganized to create an agile 

infrastructure that can adapt to future 

organizational, regulatory, and scientific 

needs (84 FR 22854, May 20, 2019; 85 

FR 18439, April 2, 2020). The newly 

formed Office of Product Evaluation and 

Quality (OPEQ) combined the former 

Office of Compliance, the Office of 

Device Evaluation, the Office of 

Surveillance and Biometrics, and the 

Office of In Vitro Diagnostics and 

Radiological Health, with a focus on a 

Total Product Lifecycle (TPLC) 

approach to medical device oversight. 

Within OPEQ there are Offices of Health 

Technology that focus on the TPLC 

review of specific types of medical 

devices as well as cross-cutting offices 

focusing on specific policy and 

programmatic needs including the 

Office of Regulatory Programs and the 

Office of Clinical Evidence and 

Analysis. As part of this technical 

amendment, we are making a change to 

correctly identify the address for 

obtaining particular information. We are 

also amending the requirement for the 

submission of multiple copies of certain 

documents to a single copy, as FDA’s 

receipt of multiple copies is no longer 

necessary. The changes published in 

this notice are non-substantive and 

editorial in nature. 

II. Description of the Technical 

Amendments 

One regulation specified in this notice 

is being revised to make a nonsubstantive editorial change to update 

particular mailing address information. 

For the other two regulations specified 

in this notice, we are removing the 

requirements for submission of multiple 

copies of certain postmarket 

surveillance-related documents, to 

instead require submission of only one 

copy, because the requirement for 

multiple copies is no longer necessary. 

The rule does not impose any new 

regulatory requirements on affected 

parties. The amendments are editorial in 

nature and should not be construed as 

modifying any substantive standards or 

requirements. 

III. Notice and Public Comment 

Publication of this document 

constitutes final action under the 

Administrative Procedure Act (APA). 

The APA generally exempts ‘‘rules of 

agency organization, procedure, or 

practice’’ from the requirements of 

notice and comment rulemaking. (5 

U.S.C. 553(b)(A)). Rules are also 

generally exempt from such 

requirements when an Agency ‘‘for good 

cause finds (and incorporates the 

finding and a brief statement of reasons 

therefor in the rules issued) that notice 

and public procedure thereon are 

impracticable, unnecessary, or contrary 

to the public interest’’ (5 U.S.C. 

553(b)(B)). 

FDA has determined that this 

rulemaking meets the APA’s notice and 

comment exemption requirements. All 

the revisions FDA publishes through 

this notice make technical or nonsubstantive changes. Some of these 

revisions pertain solely to the CDRH 

reorganization, and constitute ‘‘rules of 

agency organization, procedure, or 

practice’’ not subject to the 

requirements of notice and comment 

under 5 U.S.C. 553(b)(A). The balance of 

these revisions reduces (from three to 

one) the number of copies of certain 

documents that need to be submitted to 

FDA. Such technical, non-substantive 

change is ‘‘a routine determination, 

insignificant in nature and impact, and 

inconsequential to the industry and to 

the public.’’ (Mack Trucks, Inc. v. EPA, 

682 F.3d 87, 94 (D.C. Cir. 2012)) 

(quotation marks and citation omitted). 

FDA accordingly for good cause finds 

that notice and public procedure 

thereon are unnecessary for this 

reduction in the number of copies of 

certain documents that must be 

submitted. 

The APA allows an effective date less 

than 30 days after publication as 

‘‘provided by the agency for good cause 

found and published with the rule’’ (5 

U.S.C. 553(d)(3)). An effective date 30 or 

more days from the date of publication 

is unnecessary in this case because the 

amendments do not impose any new 

regulatory requirements on affected 

parties, and affected parties do not need 

time to ‘‘adjust to the new regulation’’ 

before the rule takes effect (Am. 

Federation of Government Emp., AFL– 

CIO v. Block, 655 F.2d 1153, 1156 (D.C. 

Cir. 1981)). Therefore, FDA finds good 

cause for the amendments to become 

effective on the date of publication of 

this action. 

List of Subjects in 21 CFR Part 822 

Medical devices, Reporting and 

recordkeeping requirements. 


lotter on DSK11XQN23PROD with RULES1
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