Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations 1367 

1 42 U.S.C. 1320a–7d. 

2Section 1128B of the Act; 42 U.S.C. 1320a–7b(b). 

3The safe harbor regulations are set forth at 42 

CFR 1001.952. 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (UMRA) (2 U.S.C. 1501 et 

seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule 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. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 5, 2022. 

Marietta Echeverria, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, for the reasons stated in the 

preamble, EPA is amending 40 CFR 

chapter I as follows: 

PART 180—TOLERANCES AND 

EXEMPTIONS FOR PESTICIDE 

CHEMICAL RESIDUES IN FOOD 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.555, amend the table in 

paragraph (a) by: 

■ a. Adding in alphabetical order the 

entries for ‘‘Caneberry, subgroup 13– 

07A’’; ‘‘Currant’’; ‘‘Pea and bean, 

succulent shelled, subgroup 6B’’; 

‘‘Tropical and subtropical, small fruit, 

edible peel, subgroup 23A’’; and 

‘‘Vegetable, legume, edible podded, 

subgroup 6A’’. 

■ b. Add footnote 4. 

The additions read as follows: 

§ 180.555 Trifloxystrobin; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*******

Caneberry, subgroup 13–07A4 ........................................................................................................................................................... 2 

*******

Currant 4 ............................................................................................................................................................................................... 3 

*******

Pea and bean, succulent shelled, subgroup 6B4 ............................................................................................................................... 0.2 

* * * * * * * 

Tropical and subtropical, small fruit, edible peel, subgroup 23A4 ...................................................................................................... 0.3 

*******

Vegetable, legume, edible podded, subgroup 6A4 ............................................................................................................................. 1.5 

*******

3 ******* 4There are no U.S. registrations on this commodity as of January 11, 2022. 

* * * * * 

[FR Doc. 2022–00311 Filed 1–10–22; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1008 

Medicare and State Health Care 

Programs: Fraud and Abuse; 

Procedures Regarding the Submission 

of Advisory Opinion Requests to, and 

the Issuance of Advisory Opinions by, 

OIG 

AGENCY: Office of Inspector General 

(OIG), Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: OIG is amending the 

regulations governing the procedures for 

the submission of advisory opinion 

requests to, and the issuance of advisory 

opinions by, OIG. 

DATES: This final rule is effective 

February 10, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Christina Hinkle, Office of Counsel to 

the Inspector General, (202) 465–6245. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Pursuant to section 1128D of the 

Social Security Act (the Act),1 HHS, 

through OIG, publishes advisory 

opinions regarding the application of 

the Federal anti-kickback statute 2 and 

the safe harbor provisions, as well as 

OIG’s administrative sanction 

authorities, to parties’ proposed or 

existing arrangements. More 

specifically, in consultation with the 

Department of Justice (DOJ) OIG issues 

written advisory opinions to requesting 

parties with regard to: (1) What 

constitutes prohibited remuneration 

under the Federal anti-kickback statute; 

(2) whether an arrangement or proposed 

arrangement satisfies the criteria in 

section 1128B(b)(3) of the Act, or 

established by regulation (i.e., safe 

harbors),3 for activities that do not result 

in prohibited remuneration; (3) what 

constitutes an inducement to reduce or 


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1368 Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations 

4 42 U.S.C. 1320a–7a(b). 

5 42 U.S.C. 1320a–7. 

6 62 FR 7350 (Feb. 19, 1997). 

7 63 FR 38311 (July 16, 1998). 

8 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July 

17, 2008). 

9OIG, OIG Modernization Initiative To Improve 

Its Publicly Available Resources—Request for 

Information, 86 FR 53072 (Sept. 24, 2021). 

limit services to Medicare or Medicaid 

program beneficiaries under section 

1128A(b) of the Act; 4 and (4) whether 

an activity or proposed activity 

constitutes grounds for the imposition 

of sanctions under section 1128,5

1128A, or 1128B of the Act. 

Section 1128D(b) required the 

issuance of regulations to carry out the 

advisory opinion process and specified 

that the regulations must provide for 

‘‘the procedure to be followed by the 

[OIG] in responding to a request for an 

advisory opinion.’’ In response to this 

requirement, OIG issued an interim final 

rule with comment period in 1997.6 In 

this interim final rule, OIG established 

a new 42 CFR part 1008, which contains 

the specific procedures for the 

submission of requests by individuals or 

entities for advisory opinions to and the 

issuance of advisory opinions by OIG, in 

consultation with DOJ. We revised and 

clarified our regulations in a final rule 

issued in 1998.7 In 2008, we revised 

certain procedural requirements in 42 

CFR part 1008 for submitting payments 

for advisory opinion costs.8

In the 1997 interim final rule, OIG 

established a procedural regulation—42 

CFR 1008.15(c)—that describes the 

circumstances in which OIG will not 

accept a request or will not issue an 

opinion. Specifically, § 1008.15(c) 

provides that an advisory opinion 

request will not be accepted and/or an 

advisory opinion will not be issued 

when: (1) The request is not related to 

a named individual or entity; (2) the 

same or substantially the same course of 

action is under investigation, or is or 

has been the subject of a proceeding 

involving HHS or another governmental 

agency; or (3) an informed opinion 

cannot be made, or could be made only 

after extensive investigation, clinical 

study, testing, or collateral inquiry. 

Section 1008.15(c) has not been 

modified since it was promulgated in 

1997. 

II. Final Rule 

This final rule removes the procedural 

provision at 42 CFR 1008.15(c)(2), 

which precludes the acceptance of an 

advisory opinion request and/or 

issuance of an advisory opinion when 

the same or substantially the same 

course of action is under investigation 

or has been the subject of a proceeding 

involving HHS or another governmental 

agency. In addition, this final rule 

corrects a grammatical error in 

§ 1008.15(c). 

Section 1008.15(c) is a procedural 

rule that was promulgated consistent 

with our statutory obligation under 

section 1128D(b) of the Act. The 

purpose of § 1008.15(c)(2) is to prevent 

the advisory opinion process from 

interfering with the investigatory or 

prosecutorial authority of OIG, DOJ, or 

any other governmental agency. Under 

the current regulation, no advisory 

opinion is issued if the same or 

substantially the same course of action 

is under investigation or is the subject 

of a proceeding involving HHS or 

another governmental agency. 

We are removing § 1008.15(c)(2) for 

two reasons. First, removal of this 

provision will offer OIG more flexibility 

in responding to requests for advisory 

opinions. In particular, this final rule 

will afford OIG the flexibility to issue a 

favorable or unfavorable advisory 

opinion when an arrangement presented 

in an advisory opinion request involves 

conduct that is the same or substantially 

the same as conduct that is under 

investigation or subject to a proceeding. 

When OIG has rejected advisory opinion 

requests pursuant to the existing 

regulation, some requestors have 

expressed frustration with this 

regulatory provision because it prevents 

OIG from providing its legal opinion 

regarding the application of certain 

Federal fraud and abuse authorities. 

Second, removal of § 1008.15(c)(2) may 

provide industry stakeholders with 

greater transparency regarding factors 

the Government may consider in 

evaluating compliance with certain 

Federal fraud and abuse laws and 

distinguishing between similar 

arrangements. 

In conjunction with issuing this rule, 

OIG is publishing on its website an 

enforcement policy statement 

announcing that, as of the effective date 

of this rule, if the arrangement for which 

an advisory opinion is sought is the 

same or similar to conduct that is 

currently under investigation or is the 

subject of a proceeding involving a 

governmental agency, that fact will 

weigh against the issuance of a favorable 

advisory opinion because such 

circumstances generally indicate that 

the arrangement does not present a 

sufficiently low risk of fraud and abuse. 

That said, consistent with current 

practices, OIG will carefully consider 

the facts and circumstances of each 

advisory opinion request in our legal 

assessment. 

This rulemaking is separate and 

distinct from the Request for 

Information (RFI) entitled ‘‘OIG 

Modernization Initiative To Improve Its 

Publicly Available Resources,’’ 

published in the Federal Register on 

September 24, 2021.9 OIG has not yet 

reviewed and considered comments 

made in response to the RFI, and this 

rulemaking is not connected to any 

feedback received in response to the 

RFI. 

III. Regulatory Impact Statement 

As set forth below, we have examined 

the impact of this final rule as required 

by Executive Order 12866, the 

Regulatory Flexibility Act (RFA) of 

1980, the Unfunded Mandates Reform 

Act of 1995, Executive Order 13132, and 

Executive Order 13771. 

A. Administrative Procedure Act 

The advisory opinion process is an 

established OIG program. This final rule 

is limited to modifying the internal 

governmental procedure for handling 

advisory opinion requests involving 

conduct that is the same or similar to an 

ongoing investigation or proceeding. 

The modification likely will result in a 

similar outcome for most advisory 

opinion requests involving conduct that 

is the same or similar to an ongoing 

investigation in that those requests 

likely would not result in favorable 

advisory opinions. This rule does not 

modify eligibility of a party to request 

an advisory opinion or the process for 

requesting an advisory opinion. 

OIG expects that this final rule will 

further the public’s interest with 

minimal burden by fulfilling the 

statutory obligations to consult with 

DOJ as part of the advisory opinion 

process, providing greater flexibility for 

OIG in its procedures to be followed in 

responding to a request for an advisory 

opinion, and potentially promoting 

greater transparency regarding factors 

the Government may consider in 

evaluating compliance with certain 

Federal fraud and abuse laws and 

distinguishing between similar 

arrangements. Because this rule is 

procedural, notice and comment 

rulemaking is not required under 5 

U.S.C. 553(b)(A). 

B. Executive Order 12866 and 

Regulatory Flexibility Act 

Because no notice of proposed 

rulemaking is required for this rule, the 

provisions of the RFA do not apply. 

Furthermore, this document does not 

meet the criteria for a significant 

regulatory action as specified in 

Executive Order 12866. 


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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations 1369 

C. Unfunded Mandates Reform Act 

Section 202 of the Unfunded 

Mandates Reform Act of 1995, Public 

Law 104–4, requires that agencies assess 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditures in any one year by State, 

local, or tribal governments in the 

aggregate, or by the private sector, of 

$100 million or more (adjusted annually 

for inflation). We believe that this final 

rule will not impose any mandates on 

State, local, or tribal governments or the 

private sector that would result in an 

expenditure of $100 million or more 

(adjusted for inflation) in any given 

year, and that a full analysis under the 

Unfunded Mandates Reform Act is not 

necessary. 

D. Executive Order 13132 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a rule 

that imposes substantial direct 

requirements or costs on State and local 

governments, preempts State law, or 

otherwise has federalism implications. 

In reviewing this final rule under the 

threshold criteria of Executive Order 

13132, Federalism, we have determined 

that this final rule would not 

significantly limit the rights, roles, and 

responsibilities of State or local 

governments. We have determined, 

therefore, that a full analysis under 

Executive Order 13132 is not necessary. 

E. Executive Order 13771 

Executive Order 13771 requires that 

the costs associated with significant 

new regulations ‘‘to the extent permitted 

by law, be offset by the elimination of 

existing costs associated with at least 

two prior regulations.’’ This final rule 

imposes no more than de minimis costs 

and is neither a regulatory nor a 

deregulatory action under Executive 

Order 13771. 

IV. Paperwork Reduction Act 

In accordance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, we are required 

to solicit public comments, and receive 

final Office of Management and Budget 

(OMB) approval, on any information 

collection requirements set forth in 

rulemaking. This final rule will not 

impose any information collection 

burden or affect information currently 

collected by OIG. 

List of Subjects in 42 CFR Part 1008 

Administrative practice and 

procedure, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements. 

For the reasons set out in the 

preamble, 42 CFR part 1008 is amended 

as follows: 

PART 1008—ADVISORY OPINIONS BY 

THE OIG 

■ 1. The authority citation for part 1008 

continues to read as follows: 

Authority: 42 U.S.C. 1320a–7d(b). 

■ 2. Section 1008.15 is amended by 

revising paragraph (c) to read as follows: 

§ 1008.15 Facts subject to advisory 

opinions. 

* * * * * 

(c) An advisory opinion request will 

not be accepted, and/or an opinion will 

not be issued when— 

(1) The request is not related to a 

named individual or entity; or 

(2) An informed opinion cannot be 

made, or could be made only after 

extensive investigation, clinical study, 

testing, or collateral inquiry. 

* * * * * 

Dated: January 3, 2022. 

Christi A. Grimm, 

Principal Deputy Performing Duties of the 

Inspector General. 

Xavier Becerra, 

Secretary. 

[FR Doc. 2022–00313 Filed 1–7–22; 8:45 am] 

BILLING CODE 4152–01–P 


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