This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

32813 

Vol. 86, No. 118 

Wednesday, June 23, 2021 

OFFICE OF PERSONNEL 

MANAGEMENT 

5 CFR Part 890 

RIN 3206–AO27 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 54 

RIN 1545–BQ10 

DEPARTMENT OF LABOR 

Employee Benefits Security 

Administration 

29 CFR Part 2590 

RIN 1210–AC07 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 149 

[CMS–9905–NC] 

RIN 0938–AU66 

Request for Information Regarding 

Reporting on Pharmacy Benefits and 

Prescription Drug Costs 

AGENCY: Office of Personnel 

Management; Internal Revenue Service, 

Department of the Treasury; Employee 

Benefits Security Administration, 

Department of Labor; Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services. 

ACTION: Request for information. 

SUMMARY: This document is a request for 

information on issues related to certain 

reporting requirements under section 

204 of Title II of Division BB of the 

Consolidated Appropriations Act, 2021 

(CAA) that are applicable to group 

health plans and health insurance 

issuers offering group or individual 

health insurance coverage. The 

Departments of Health and Human 

Services, Labor, and the Treasury (the 

Departments) are issuing this request for 

information to gather input from the 

public regarding implementation 

considerations for the data collection 

required under section 204 of Title II of 

Division BB of the CAA, and the 

associated impact on group health plans 

and health insurance issuers. As part of 

this request for information, the Office 

of Personnel Management (OPM) is also 

seeking input from the public regarding 

implementation considerations for the 

data collection required under section 

204 of Title II of Division BB of the CAA 

as it pertains to Federal Employees 

Health Benefits (FEHB) carriers 

(whether or not they are also health 

insurance issuers). The Departments 

and OPM also seek input on specific 

data elements, including the level of 

detail that is feasible to report for 

entities subject to the data collection 

requirements and the associated 

burdens and potential compliance costs. 

Public comments will inform the 

Departments’ and OPM’s 

implementation of section 204 through 

rulemaking and the establishment of 

processes to receive the required 

information. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on July 23, 2021. 

ADDRESSES: Written comments may be 

submitted to the addresses specified 

below. Any comment that is submitted 

will be shared among the Departments 

and OPM. Please do not submit 

duplicates. 

Comments will be publicly posted on 

Regulations.gov. Warning: Do not 

include any personally identifiable 

information (such as name, address, or 

other contact information) or 

confidential business information that 

you do not want publicly disclosed. 

Comments may be submitted 

anonymously. 

In commenting, refer to file code 

CMS–9905–NC. Because of staff and 

resource limitations, we cannot accept 

comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to https://www.regulations.gov/. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: 

Office of Health Plan Standards and 

Compliance Assistance, Employee 

Benefits Security Administration, US 

Department of Labor, Attention: Request 

for Information Regarding Reporting on 

Pharmacy Benefits and Prescription 

Drug Costs, 200 Constitution Avenue 

NW, Room N–5653, Washington, DC 

20210. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: 

Office of Health Plan Standards and 

Compliance Assistance, Employee 

Benefits Security Administration, US 

Department of Labor, Attention: Request 

for Information Regarding Reporting on 

Pharmacy Benefits and Prescription 

Drug Costs, 200 Constitution Avenue 

NW, Room N–5653, Washington, DC 

20210. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: Rina 

Shah, Office of Personnel Management, 

at (202) 606–0004. 

Christopher J. Dellana, Internal 

Revenue Service, Department of the 

Treasury, at (202) 317–5500. 

Matthew Litton, Employee Benefits 

Security Administration, Department of 

Labor, at (202) 693–8335. 

Christina Whitefield, Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, at (301) 492–4172. 

Customer Service Information: 

Individuals interested in obtaining 

information from the Department of 

Labor (DOL) concerning employmentbased health coverage laws may call the 

Employee Benefits Security 

Administration (EBSA) Toll-Free 

Hotline at 1–866–444–EBSA (3272) or 

visit the DOL’s website (www.dol.gov/ 

agencies/ebsa). In addition, information 

from the Department of Health and 

Human Services (HHS) on private 

health insurance coverage and nonFederal governmental group health 

plans can be found on the Centers for 

Medicare & Medicaid Services (CMS) 

website (www.cms.gov/cciio), and 

information on health care reform can 

be found at www.HealthCare.gov. 


jbell on DSKJLSW7X2PROD with PROPOSALS
32814 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Proposed Rules 

Information from OPM on Federal 

Employees Health Benefits (FEHB) 

plans can be found on the OPM website 

(www.opm.gov/healthcare-insurance). 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: 

Comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. Comments received before 

the close of the comment period are 

posted on the following website as soon 

as possible after they have been 

received: https://www.regulations.gov/. 

Follow the search instructions on that 

website to view public comments. 

I. Background 

A. Purpose 

In recent years, there has been a broad 

effort toward promoting greater price 

transparency in health care as a means 

to promote competition and bring down 

overall costs. Section 204 of Title II of 

Division BB of the CAA added parallel 

provisions at section 2799A–10 of the 

Public Health Service Act (PHS Act), 

section 725 of the Employee Retirement 

Income Security Act of 1974 (ERISA), 

and section 9825 of the Internal 

Revenue Code (Code). These provisions 

include certain reporting requirements 

for group health plans (plans) and 

health insurance issuers offering group 

or individual health insurance coverage 

(issuers). The reporting requirements 

primarily relate to prescription drug 

expenditures, requiring that plans and 

issuers submit the relevant information 

to the Departments. The provisions also 

require the Departments to issue 

biannual public reports on prescription 

drug reimbursements under group 

health plans and individual health 

insurance coverage, prescription drug 

pricing trends, and the impact of 

prescription drug costs on premium 

rates, aggregated in such a way so that 

no drug or plan specific information 

will be made public. 

Title I of Division BB also amended 5 

U.S.C. 8902(p) to include specified 

provisions of the CAA into FEHB carrier 

contracts. Although section 204 is not 

enumerated as a specified provision in 

section 8902(p), FEHB carrier 

compliance with the Departments’ 

collection pursuant to this section helps 

accomplish the CAA’s intended purpose 

of achieving national health data 

transparency and lower costs. Therefore, 

references to ‘‘plans’’ for purposes of 

this request for information include 

FEHB health benefits plans. 

The Departments and OPM are 

requesting input from the public 

regarding implementation of the data 

collection, the data elements to be 

collected, and the associated impact on 

plans and issuers. Public input will 

inform the Departments’ and OPM’s 

implementation through rulemaking 

and establishment of processes to 

receive the information that must be 

reported. Using the information 

obtained through this data collection, 

the Departments and OPM intend to 

analyze trends in overall spending on 

prescription drugs and other health care 

services by plans and issuers and to 

publish the analysis in the required 

reports in a format that the Departments 

and OPM intend to enable plans and 

issuers to ultimately negotiate fairer 

rates and lower costs for participants, 

beneficiaries, and enrollees. 

B. Reporting Requirements 

By December 27, 2021, and not later 

than June 1 of each year thereafter, 

plans and issuers must submit to the 

Departments certain information with 

respect to the health plan or coverage 

for the previous plan year. This includes 

general information on the plan or 

coverage, such as the beginning and end 

dates of the plan year, the number of 

participants, beneficiaries, or enrollees, 

as applicable, and each state in which 

the plan or coverage is offered. Plans 

and issuers must also report the 50 most 

frequently dispensed brand prescription 

drugs, and the total number of paid 

claims for each such drug; the 50 most 

costly prescription drugs by total annual 

spending, and the annual amount spent 

by the plan or coverage for each such 

drug; and the 50 prescription drugs with 

the greatest increase in plan 

expenditures over the plan year 

preceding the plan year that is the 

subject of the report, and, for each such 

drug, the change in amounts expended 

by the plan or coverage in each such 

plan year. Additionally, plans and 

issuers must report total spending by 

the plan or coverage broken down by 

the type of health care services; 

spending on prescription drugs by the 

plan or coverage as well as by 

participants, beneficiaries, and 

enrollees, as applicable; and the average 

monthly premiums paid by participants, 

beneficiaries, and enrollees and paid by 

employers on behalf of participants, 

beneficiaries, and enrollees, as 

applicable. Plans and issuers must 

report rebates, fees, and any other 

remuneration paid by drug 

manufacturers to the plan or coverage or 

its administrators or service providers, 

including the amount paid with respect 

to each therapeutic class of drugs and 

for each of the 25 drugs that yielded the 

highest amount of rebates and other 

remuneration under the plan or 

coverage from drug manufacturers 

during the plan year. Finally, plans and 

issuers must report any reduction in 

premiums and out-of-pocket costs 

associated with these rebates, fees, or 

other remuneration. 

C. Public Report and Privacy Protections 

Not later than 18 months after the 

date on which plans and issuers must 

first submit the information described in 

section B and biannually thereafter, the 

Departments and OPM will publish on 

the internet reports on prescription drug 

reimbursements under group health 

plans and group and individual health 

insurance coverage, prescription drug 

pricing trends, and the role of 

prescription drug costs in contributing 

to premium increases or decreases 

under such plans or coverage, 

aggregated so that no drug or plan 

specific information is made public. 

Furthermore, these reports will not 

include any confidential or trade secret 

information submitted pursuant to the 

reporting requirements of PHS Act 

section 2799A–10, ERISA section 725, 

and Code section 9825. 

II. Solicitation of Comments 

The Departments and OPM request 

comments from all interested 

stakeholders to gain a better 

understanding of the issues related to 

compliance with this provision, 

including reporting on premiums, 

enrollment, pharmacy drug benefits, 

and prescription drug costs, and to 

estimate the impact of any potential 

rules, both generally and with respect to 

the following specific areas: 

A. General Implementation Concerns 

1. What, if any, challenges do plans 

and issuers anticipate facing in meeting 

the statutory reporting obligations? For 

example, do plans or issuers currently 

have access to all the information they 

are required to report under PHS Act 

section 2799–10, ERISA section 725, 

and Code section 9825? If not, which 

statutory data elements are not readily 

accessible to plans and issuers, and how 

could plans and issuers obtain the 

information necessary to comply with 

the reporting requirements? Are there 

ways in which the Departments and 

OPM could structure the reporting 

requirements to facilitate compliance? 

2. Are FEHB carriers (including those 

that are also issuers) able to report data 

separately for each FEHB plan? 

3. After the Departments and OPM 

finalize rulemaking and publish the 

reporting format and instructions, how 

much time will plans and issuers need 

to prepare their data and submit it to the 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Proposed Rules 32815 

Departments and OPM? What data 

sources are readily available and which 

data may take longer to compile? Are 

there operational, formatting, or 

technical considerations that the 

Departments and OPM should be aware 

of that may impact plans’ and issuers’ 

abilities to meet the statutory deadline 

for reporting? 

4. Are there different considerations 

regarding data reporting by health 

insurance issuers versus group health 

plans that would affect their ability to 

comply with the statutory reporting 

obligations? Among group health plans, 

are there different considerations for 

reporting by fully-insured versus selfinsured plans, or for insured plans with 

small group versus large group 

coverage? Are there different 

considerations for reporting FEHB 

carrier data versus other plans and 

issuers? Are there different 

considerations for reporting of 

premiums, spending, and other data by 

partially-insured group health plans, 

such as those that utilize minimum 

premium, stop-loss, or similar coverage? 

Are there special considerations the 

Departments should take into account 

for multiemployer plans, or that OPM 

should take into account for policies 

offered by FEHB carriers that are not 

issuers? 

5. What data reporting tools and 

systems should the Departments and 

OPM consider when deciding on the 

format of the data collection? What are 

the operational advantages and 

disadvantages of various reporting 

formats, such as Excel spreadsheets, 

fillable PDF forms, or flat files? How can 

the Departments and OPM reduce the 

need for manual data entry? What are 

the ways in which the Departments and 

OPM could implement the reporting 

requirements to facilitate compatibility 

with the systems most commonly used 

by plans and issuers? 

6. Are there state laws with similar 

reporting requirements that could serve 

as models for implementing the 

requirements under PHS Act section 

2799A–10, ERISA section 725, and Code 

section 9825? If so, in what ways are 

these state laws directly comparable to 

PHS Act section 2799A–10, ERISA 

section 725, and Code section 9825, and 

what should the Departments and OPM 

consider when deviating from the state 

requirements? 

B. Definitions 

1. What considerations should the 

Departments and OPM take into account 

in defining ‘‘rebates, fees, and any other 

remuneration’’? Should bona fide 

service fees—for example, 

administrative fees, data sharing fees, 

formulary placement fees, credits, and 

market share incentives—be included in 

this definition? Are there additional fees 

that the Departments and OPM should 

include in this definition? How should 

manufacturer copay assistance programs 

and coupon cards be accounted for? 

How should copay accumulator 

programs be accounted for? 

2. What considerations should the 

Departments and OPM take into account 

in defining the term ‘‘pharmacy’’? Are 

there different considerations for retail 

pharmacies versus mail order or 

specialty pharmacies? Are there 

different considerations for prescription 

drugs dispensed in an inpatient, 

outpatient, office, home, or other 

setting? 

3. What considerations should the 

Departments and OPM take into account 

in defining the term ‘‘prescription 

drug’’? Should prescription drugs be 

identified by National Drug Codes 

(NDCs)? Are there other prescription 

drug classification systems that should 

be considered, such as the first nine 

digits of the NDC, the RxNorm Concept 

Unique Identifier (RxCUI), or the United 

States Pharmacopeia Drug Classification 

(USP–DC)? How does the choice of 

prescription drug classification 

influence plan and issuer operational 

costs? 

4. Should there be different 

definitions of ‘‘prescription drug’’ for 

different elements of the PHS Act 

section 2799A–10, ERISA section 725, 

and Code section 9825 data collection, 

such as the 9-digit NDC for identifying 

the 25 drugs with the highest rebates 

and the RxCUI for identifying the 50 

most costly drugs? What classification 

systems do plans and issuers currently 

use for internal needs and compliance 

with reporting requirements other than 

those under PHS Act section 2799A–10, 

ERISA section 725, and Code section 

9825? 

5. What considerations should the 

Departments and OPM take into account 

in defining the term ‘‘therapeutic 

class’’? How do plans and issuers 

currently classify prescription drugs by 

therapeutic class? Does the 

classification method rely on 

proprietary software, and how would 

the choice of therapeutic classification 

method influence plan and issuer 

operational costs? 

6. What considerations should the 

Departments and OPM take into account 

in defining ‘‘health care services’’? It is 

preferable to define the term as a service 

or bundle of services necessary to treat 

an illness (for example, by DiagnosisRelated Group code)? Or would it be 

preferable to disaggregate by particular 

services (for example, by Current 

Procedure Technology code)? In what 

ways could this definition help reduce 

burdens or increase the utility of data 

reporting? 

C. Entities That Must Report 

1. Are there special considerations for 

certain types or sizes of group health 

plans, such as individual coverage 

health reimbursement arrangements and 

other account-based plans, that make it 

challenging or not feasible for these 

plans to satisfy the reporting 

requirements? What are those specific 

challenges? If exemptions are provided 

for certain plans, how might that affect 

the value of the required public 

analysis? 

2. Should the Departments expect that 

self-insured and partially-insured group 

health plans will contract with thirdparty administrators or other service 

providers to submit the required data on 

their behalf? Is there any relevant 

information or data that may be helpful 

in determining how widespread this 

approach may be? 

3. Are there ways for issuers and plan 

service providers to submit data on 

behalf of multiple plans and coverage 

options, consistent with the statutory 

requirements? What benefit would there 

be to issuers and plan service providers 

having the ability to submit aggregated 

data as opposed to reporting 

information separately for each group 

health plan, to the extent consistent 

with the statutory requirements? What 

considerations exist with respect to 

issuers that participate in the FEHB 

Program submitting FEHB-specific data 

separately as opposed to including 

FEHB data in their general book of 

business? 

4. What role, if any, will Pharmacy 

Benefits Managers (PBMs) play in 

furnishing necessary information to 

plans and issuers, or to the Departments 

or OPM? If permitted, would plans and 

issuers rely on PBMs to help satisfy 

their reporting obligations, such as by 

retaining PBMs to conduct some or all 

of the reporting? Could PBMs obtain all 

the information required to be reported, 

including general information on the 

plan or coverage, such as the number of 

participants, beneficiaries, and 

enrollees; each state in which the plan 

or coverage is offered; monthly 

premiums paid by employers and by 

participants, beneficiaries, and 

enrollees; total spending on health care 

services broken down by type; and the 

impact on premiums of prescription 

drug rebates, fees, and any other 

remuneration paid by drug 

manufacturers to the plan or coverage or 

its administrators or service providers? 

If not, would allowing separate 


jbell on DSKJLSW7X2PROD with PROPOSALS
32816 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Proposed Rules 

1Section 1150A of the Social Security Act, and 

its implementing regulations at 45 CFR 156.295 and 

45 CFR part 184, require issuers of QHPs or their 

PBMs to report certain prescription drug 

information to HHS. 2 Id. 

reporting forms, modules, or data 

collection systems for PBMs and issuers 

and plan administrators to report such 

information be administratively and 

operationally feasible? How would 

separate reporting forms change the 

costs or burdens associated with 

compliance? 

D. Information Required To Be Reported 

1. What considerations are important 

for plans and issuers in determining the 

50 brand prescription drugs that are 

most frequently dispensed by 

pharmacies for claims paid by the plan 

or coverage, and the total number of 

paid claims for each drug? Should the 

determination be based on the number 

of claims, the number of days’ supply, 

or something else? Should the unique 

number of participants, beneficiaries, or 

enrollees that received a prescription be 

taken into account, and, if so, how? 

2. What considerations are important 

for plans and issuers in determining the 

50 prescription drugs with the greatest 

increase in plan expenditures? Should 

the increase be measured based on the 

absolute increase in dollars; percentage 

increase in price; the increase relative to 

another measure, such as overall 

spending by the plan or issuer; or 

something else? What factors should the 

Departments and OPM consider in 

selecting an approach? If the 

Departments and OPM define the 

increase in proportion to the change in 

overall spending, should the increase be 

measured in comparison to total 

spending or only to spending on 

prescription drugs? 

3. If the top prescription drugs are 

identified by RxCUI (or any 

classification other than NDC), is it 

feasible for plans and issuers to report 

the required information separately by 

NDC for each NDC associated with the 

given RxCUI? 

4. Which data elements can be 

directly tied to a specific prescription 

drug or class of prescription drugs, and 

which data elements must be allocated 

among prescription drugs or 

prescription drug classes? If an amount 

must be allocated, what allocation 

method(s) are preferable, and why? 

5. What considerations are important 

for plans and issuers in determining the 

25 drugs that yielded the highest 

amount of rebates and other 

remuneration from drug manufacturers 

during the plan year? Should rebates 

and other remuneration be measured by 

total dollar amount? Should rebates and 

other remuneration be measured in 

comparison to another measure, such as 

total spending on a drug or a unit price? 

If a price measure is used, which price 

measure should be used and why? 

6. PHS Act section 2799A–10, ERISA 

section 725, and Code section 9825 

require plans and issuers to report total 

spending on health care services 

separately for hospital costs, health care 

provider and clinical service costs (for 

primary care and specialty care 

separately), prescription drug costs, and 

other medical costs, including wellness 

services. Which cost elements should be 

included in each category? Should the 

Departments and OPM collect 

prescription drug spending information 

separately based on the setting of care? 

7. Should the Departments collect 

information separately by market, state, 

or employer size? If so, are there data 

elements that must be allocated among 

the categories? What allocation methods 

should be used? Are there differences in 

the capacities of different size entities to 

comply with the Departments’ and 

OPM’s reporting requirements, or in the 

costs and burdens of compliance? 

8. What considerations are important 

for plans and issuers in measuring the 

impact of drug manufacturer rebates on 

premiums and out-of-pocket costs? 

What quantitative or qualitative 

analyses might plans and issuers 

perform? What analyses do plans and 

issuers currently perform? 

9. Should the Departments and OPM 

collect information on rebates, fees, and 

any other remuneration at the total level 

or broken out by relevant subcategories? 

For example, in the PBM Transparency 

for Qualified Health Plans (QHPs) data 

collection,1 PBMs will report 

information for retained rebates, rebates 

expected but not yet received, PBM 

incentive payments, price concessions 

for administrative services from 

manufacturers, all other price 

concessions from manufacturers, 

amounts received and paid to 

pharmacies, and spread amounts for 

retail and mail order pharmacies. 

Should the Departments use the same or 

similar subcategories for the reporting 

requirements under PHS Act section 

2799A–10, ERISA section 725, and Code 

section 9825? 

10. Are there types of payments that 

flow from plans, issuers, or PBMs 

directly to drug manufacturers? If so, 

how should these payments be treated? 

Should they be netted against rebates 

and other price concessions that are 

received from drug manufacturers? 

11. Are there types of rebates and 

price concessions that are passed 

directly to the participant, beneficiary, 

or enrollee? If so, how should they be 

treated? Should they be included or 

acknowledged in this data collection? 

E. Coordination With Other Reporting 

Requirements 

1. Are there opportunities to remove 

other reporting requirements applicable 

to plans and issuers or to leverage or 

combine those requirements with the 

reporting requirements under PHS Act 

section 2799A–10, ERISA section 725, 

and Code section 9825 to reduce 

administrative burdens or costs 

associated with complying with the new 

requirements? For example, the 

Departments are aware that there may 

be some overlap between the data 

subject to collection under PHS Act 

section 2799A–10, ERISA section 725, 

and Code section 9825 and the data 

subject to collection in the PBM 

Transparency for QHPs data collection,2

which requires issuers of QHPs or their 

PBMs to report prescription drug 

information to HHS. 

F. Public Report and Privacy Protections 

1. In what ways can the Departments 

and OPM facilitate use of the reports by 

a variety of interested parties, such as 

government entities, academics, 

industry entities, and consumers and 

their advocates? 

2. Should OPM issue a public report 

specifically for FEHB carriers? 

3. Would the Departments’ and OPM’s 

reports have greater value and utility if 

data were collected on a calendar year 

basis, by plan or policy years, or by 

some combination, to the extent 

consistent with the statutory 

requirements? If data were to be 

collected by plan or policy year, are 

there any considerations the 

Departments and OPM should take into 

account when determining the plan or 

policy year effective dates for reporting 

periods? For example, what is the last 

plan or policy year end date that should 

be included in data submitted by June 

1 of each year? 

4. Are there any examples of similar 

reports published by state agencies? If 

so, what are any strengths or limitations 

of the reports published by the state 

agencies that would be relevant to the 

Departments and OPM? In what ways 

should the Departments and OPM 

consider adapting or differentiating the 

process under PHS Act section 2799A– 

10, ERISA section 725, and Code section 

9825 from any similar state reporting 

processes? 

5. Should the public report include a 

comparative analysis of prescription 

drug costs for plans and issuers, relative 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Proposed Rules 32817 

to costs under Medicare or in other 

countries? 

G. Regulatory Impact Analysis 

1. What benefits, costs, and other 

impacts do plans, issuers, or other 

stakeholders anticipate from the 

reporting requirements of PHS Act 

section 2799A–10, ERISA section 725, 

and Code section 9825? 

2. Are there benefits to academics or 

other researchers? How will consumers 

benefit? 

3. What data, research, or other 

information is available to help quantify 

the benefits, costs, and other impacts of 

the reporting requirements? Are there 

existing data, research, or reporting 

analogues that could be extrapolated 

from to predict market impacts? 

4. What actions could the 

Departments and OPM take to minimize 

the compliance costs of the reporting 

requirements? 

5. Operationally, which types of 

employees will be necessary to ensure 

compliance with the reporting 

requirements? Will staff specialized in 

medical billing coding be needed for the 

purpose of reporting? 

6. Will new or additional technology 

be needed for the collection, 

maintenance, or storage of the data to be 

reported? 

7. Will there be coordination costs or 

benefits from simultaneously complying 

with state regulations that require the 

reporting of medical services costs or 

prescription drug costs? 

8. Would greater alignment with other 

Federal reporting requirements reduce 

associated compliance costs, and if so, 

how? 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping, or 

third-party disclosure requirements 

under the Paperwork Reduction Act of 

1995 (PRA). However, Section II of this 

document does contain a general 

solicitation of comments in the form of 

a request for information. In accordance 

with the implementing regulations of 

the PRA, specifically 5 CFR 

1320.3(h)(4), this general solicitation is 

exempt from the PRA. Facts or opinions 

submitted in response to general 

solicitations of comments from the 

public, published in the Federal 

Register or other publications, 

regardless of the form or format thereof, 

provided that no person is required to 

supply specific information pertaining 

to the commenter, other than that 

necessary for self-identification, as a 

condition of the agency’s full 

consideration, are not generally 

considered information collections and 

therefore not subject to the PRA. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the PRA. 

Signed at Washington DC. 

Laurie Bodenheimer, 

Associate Director, Healthcare and Insurance, 

Office of Personnel Management. 

Signed at Washington DC. 

Rachel D. Levy, 

Associate Chief Counsel (Employee Benefits, 

Exempt Organizations, and Employment 

Taxes), Internal Revenue Service, Department 

of the Treasury. Signed at Washington DC. 

Carol A. Weiser, 

Benefits Tax Counsel, Department of the 

Treasury. 

Signed at Washington DC. 

Ali Khawar, 

Acting Assistant Secretary, Employee Benefits 

Security Administration, Department of 

Labor. 

Signed at Washington DC. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–13138 Filed 6–21–21; 8:45 am] 

BILLING CODE 4510–29–P; 6523–63–P; 4120–01–P; 

4830–01–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Chapter I 

[NRC–2017–0214] 

Retrospective Review of 

Administrative Requirements 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Availability of comment 

evaluation summary; public meeting 

and status of rulemaking activities. 

SUMMARY: The U.S. Nuclear Regulatory 

Commission (NRC), on February 4, 

2020, requested input from its licensees 

and members of the public on any 

administrative requirements that may be 

modified or eliminated without an 

adverse effect on public health or safety, 

common defense and security, 

protection of the environment, or 

regulatory efficiency and effectiveness. 

The public comment period ended on 

May 6, 2020, and the NRC evaluated the 

comments. This document announces 

the availability of the comment 

evaluation summary and provides the 

status of the NRC’s Retrospective 

Review of Administrative Requirements 

initiative. The NRC plans to hold a 

public meeting to discuss the comment 

evaluation process and answer 

stakeholder questions. 

DATES: The comment evaluation 

summary is available on June 23, 2021. 

A public meeting will be held on June 

30, 2021. 

ADDRESSES: Please refer to Docket ID 

NRC–2017–0214 when contacting the 

NRC about the availability of 

information for this action. You may 

obtain publicly available information 

related to this action by any of the 

following methods: 

• Federal Rulemaking website: Go to 

https://www.regulations.gov and search 

for Docket ID NRC–2017–0214. Address 

questions about NRC dockets to Dawn 

Forder; telephone: 301–415–3407; 

email: Dawn.Forder@nrc.gov. For 

technical questions contact the 

individual listed in the FOR FURTHER

INFORMATION CONTACT section of this 

document. 

• NRC’s Agencywide Documents 

Access and Management System 

(ADAMS): You may obtain publicly 

available documents online in the 

ADAMS Public Documents collection at 

https://www.nrc.gov/reading-rm/ 

adams.html. To begin the search, select 

‘‘Begin Web-based ADAMS Search.’’ For 

problems with ADAMS, please contact 

the NRC’s Public Document Room (PDR) 

reference staff at 1–800–397–4209, 301– 

415–4737, or by email to pdr.resource@

nrc.gov. The ADAMS accession number 

for each document referenced (if it is 

available in ADAMS) is provided the 

first time that it is mentioned in this 

document. 

• Attention: The PDR, where you may 

examine and order copies of public 

documents, is currently closed. You 

may submit your request to the PDR via 

email at pdr.resource@nrc.gov or call 1– 

800–397–4209 or 301–415–4737, 

between 8 a.m. and 4 p.m. (EST), 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: 

Andrew G. Carrera, telephone: 301– 

415–1078, email: Andrew.Carrera@

nrc.gov; or Solomon Sahle, telephone: 

301–415–3781, email: Solomon.Sahle@

nrc.gov. Both are staff of the Office of 

Nuclear Material Safety and Safeguards, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555–0001. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 4, 2020, the NRC 

published a document in the Federal 

Register (85 FR 6103) requesting input 

from its licensees and members of the 

public on any administrative 

requirements that may be modified or 

eliminated without an adverse effect on 


jbell on DSKJLSW7X2PROD with PROPOSALS