Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Proposed Rules 39553 

3 77 FR 62624 (October 15, 2012). NHTSA is 

statutorily required to conduct a de novo 

rulemaking on MY 2022 to 2025 standards for lightduty vehicles. NHTSA has recently taken the first 

step in this process by publishing the ‘‘Notice of 

Intent To Prepare an Environmental Impact 

Statement for Model Year 2022–2025 Corporate 

Average Fuel Economy Standards’’ on July 26, 

2017. 

4 81 FR 87927 (Dec. 6, 2016). 5 40 CFR 86.1818–12(h)(1). 

Evaluation process was codified in EPA 

regulation for greenhouse gas emission 

standards for model years 2017–2025 

light-duty vehicles, which requires EPA 

to determine no later than April 1, 2018, 

whether the standards for model years 

2022–2025 are appropriate.3 In 

November 2016, EPA issued a proposed 

determination for the Mid-Term 

Evaluation.4 On January 12, 2017, the 

EPA Administrator signed the Final 

Determination of the Mid-Term 

Evaluation. 

Some stakeholders previously 

commented that they were preparing 

studies to inform the Mid-term 

Evaluation that were not ready for 

submission during the previous Midterm Evaluation comment periods. This 

additional comment period provides an 

opportunity for commenters to submit 

to EPA additional studies and other 

materials as well as to complete the 

preparation of their comments, or 

submit additional comments in light of 

newly available information. There is an 

existing body of EPA analyses and 

public comments already in the docket. 

Please note that the agency is primarily 

interested in comments relevant to the 

reconsideration of the Final 

Determination, rather than the 

Technical Assessment Report (TAR), 

which is not being reopened for 

comment in this document. 

Additionally, NHTSA has been working 

closely with stakeholders to develop its 

forthcoming rulemaking since the 

March 2017 joint document with EPA, 

and encourages commenters wishing to 

inform those efforts to directly 

participate in NHTSA’s rulemaking 

process. 

EPA’s reconsideration will be 

conducted in accordance with the 

regulations EPA established for the Midterm Evaluation at 40 CFR 86.1818– 

12(h). These regulations state that in 

making the required determination as to 

whether the existing standards are 

appropriate under section 202(a) of the 

Clean Air Act, the Administrator shall 

consider the information available on 

the factors relevant to setting 

greenhouse gas emission standards 

under section 202(a) of the Clean Air 

Act for model years 2022 through 2025, 

including but not limited to: 

• The availability and effectiveness of 

technology, and the appropriate lead 

time for introduction of technology; 

• The cost on the producers or 

purchasers of new motor vehicles or 

new motor vehicle engines; 

• The feasibility and practicability of 

the standards; 

• The impact of the standards on 

reduction of emissions, oil conservation, 

energy security, and fuel savings by 

consumers; 

• The impact of the standards on the 

automobile industry; 

• The impacts of the standards on 

automobile safety; 

• The impact of the greenhouse gas 

emission standards on the Corporate 

Average Fuel Economy standards and a 

national harmonized program; and 

• The impact of the standards on 

other relevant factors.5

Pursuant to 40 CFR 86.1818– 

12(h)(1)(viii), EPA also invites 

comments on the following other factors 

relevant to setting greenhouse gas 

emission standards under section 202(a) 

of the Clean Air Act for model years 

2022 through 2025: 

• The impact of the standards on 

compliance with other air quality 

standards; 

• The extent to which consumers 

value fuel savings from greater 

efficiency of vehicles; 

• The ability for OEMs to incorporate 

fuel saving technologies, including 

those with ‘‘negative costs,’’ absent the 

standards; 

• The distributional consequences on 

households; 

• The appropriate reference fleet; 

• The impact of the standards on 

advanced fuels technology, including 

but not limited to the potential for highoctane blends; 

• The availability of realistic 

technological concepts for improving 

efficiency in automobiles that 

consumers demand, as well as any 

indirect impacts on emissions; 

• The advantages or deficiencies in 

EPA’s past approaches to forecasting 

and projecting automobile technologies, 

including but not limited to baseline 

projections for compliance costs, 

technology penetration rates, technology 

performance, etc.; 

• The impact of the standards on 

consumer behavior, including but not 

limited to consumer purchasing 

behavior and consumer automobile 

usage behavior (e.g. impacts on 

rebound, fleet turnover, consumer 

welfare effects, etc.); and 

• Any relevant information in light of 

newly available information. 

In addition, EPA seeks comment on 

the use of alternative methodologies and 

modeling systems to assess both 

analytical inputs and the standards, 

including but not limited to the 

Department of Energy’s (DOE’s) 

Argonne National Laboratory’s 

Autonomie full vehicle simulation tool 

and DOT’s CAFE Compliance and 

Effects Model. 

In accord with the schedule set forth 

in its regulations, the EPA intends to 

make a Final Determination regarding 

the appropriateness of the model year 

2022–2025 greenhouse gas standards, 

and potentially the model year 2021 

greenhouse gas standard, no later than 

April 1, 2018. 

In this document, in the interest of 

harmonization between the GHG and 

CAFE programs, EPA is also requesting 

comment on the separate question of 

whether the light-duty vehicle 

greenhouse gas standards established for 

model year 2021 are appropriate. In its 

July 26, 2017, ‘‘Notice of Intent To 

Prepare an Environmental Impact 

Statement for Model Year 2022–2025 

Corporate Average Fuel Economy 

Standards,’’ NHTSA stated that as part 

of its upcoming CAFE rulemaking, it 

may evaluate the model year 2021 

standards it finalized in 2012 to ensure 

they remain ‘‘maximum feasible’’ (See 

82 FR 34742). Please provide comment 

on the continued appropriateness of the 

model year 2021 GHG standards based 

on the application of the factors 

described above or any other factors that 

commenters believe are appropriate. 

Dated: August 10, 2017. 

Elaine L. Chao, 

Secretary, Department of Transportation. 

Dated: August 10, 2017. 

E. Scott Pruitt, 

Administrator, Environmental Protection 

Agency. 

[FR Doc. 2017–17419 Filed 8–18–17; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 10 

RIN 0906–AB11 

340B Drug Pricing Program Ceiling 

Price and Manufacturer Civil Monetary 

Penalties Regulation 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice of proposed rulemaking; 

further delay of effective date. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 


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39554 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Proposed Rules 

1See: https://www.whitehouse.gov/the-pressoffice/2017/01/20/memorandum-heads-executivedepartments-and-agencies. 2See: https://www.whitehouse.gov/the-pressoffice/2017/01/2/executive-order-minimizingeconomic-burden-patient-protection-and 

administers section 340B of the Public 

Health Service Act (PHSA), which is 

referred to as the ‘‘340B Drug Pricing 

Program’’ or the ‘‘340B Program.’’ HHS 

is soliciting comments on delaying the 

effective date of the January 5, 2017 

final rule that sets forth the calculation 

of the ceiling price and application of 

civil monetary penalties, and applies to 

all drug manufacturers that are required 

to make their drugs available to covered 

entities under the 340B Program. HHS 

proposes to delay the effective date of 

the final rule published in the Federal 

Register (82 FR 1210, January 5, 2017) 

to July 1, 2018. HHS proposes this 

action in order to allow a more 

deliberate process of considering 

alternative and supplemental regulatory 

provisions and to allow for sufficient 

time for additional rulemaking, as set 

forth below. 

DATES: Submit comments on or before 

September 20, 2017. 

ADDRESSES: You may submit comments, 

identified by the Regulatory Information 

Number (RIN) 0906–AB11, by any of the 

following methods. Please submit your 

comments in only one of these ways to 

minimize the receipt of duplicate 

submissions. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow 

instructions for submitting comments. 

This is the preferred method for the 

submission of comments. 

• Email: 340BCMPNPRM@hrsa.gov. 

Include 0906–AB11 in the subject line 

of the message. 

• Mail: Office of Pharmacy Affairs 

(OPA), Healthcare Systems Bureau 

(HSB), Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Mail Stop 08W05A, Rockville, MD 

20857. 

All submitted comments will be 

available to the public in their entirety. 

Please do not submit confidential 

commercial information or personal 

identifying information that you do not 

want in the public domain. 

FOR FURTHER INFORMATION CONTACT: 

CAPT Krista Pedley, Director, OPA, 

HSB, HRSA, 5600 Fishers Lane, Mail 

Stop 08W05A, Rockville, MD 20857, or 

by telephone at 301–594–4353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On September 30, 2010, HHS 

published an advanced notice of 

proposed rulemaking (ANPRM) in the 

Federal Register, ‘‘340B Drug Pricing 

Program Manufacturer Civil Monetary 

Penalties’’ (75 FR 57230, September 20, 

2010). HHS subsequently published a 

notice of proposed rulemaking (NPRM) 

on June 17, 2015 to implement CMPs for 

manufacturers who knowingly and 

intentionally charge a covered entity 

more than the ceiling price for a covered 

outpatient drug; to provide clarity 

regarding the requirement that 

manufacturers calculate the 340B 

ceiling price on a quarterly basis; and to 

establish the requirement that a 

manufacturer charge $.01 (penny 

pricing) for each unit of a drug when the 

ceiling price calculation equals zero (80 

FR 34583, June 17, 2015). The public 

comment period closed on August 17, 

2015, and HRSA received 35 comments. 

After review of the initial comments, 

HHS reopened the comment period (81 

FR 22960, April 19, 2016) to invite 

additional comments on the following 

areas of the NPRM: 340B ceiling price 

calculations that result in a ceiling price 

that equals zero (penny pricing); the 

methodology that manufacturers use 

when estimating the ceiling price for a 

new covered outpatient drug; and the 

definition of the ‘‘knowing and 

intentional’’ standard to be applied 

when assessing a CMP for 

manufacturers that overcharge a covered 

entity. The comment period closed May 

19, 2016, and HHS received 72 

comments. 

On January 5, 2017, HHS published a 

final rule in the Federal Register (82 FR 

1210, January 5, 2017); comments from 

both the original comment period 

established in the NPRM and the 

reopened comment period announced 

in the April 19, 2016 notice were 

considered in the development of the 

final rule. The provisions of that final 

rule were to be effective March 6, 2017; 

however, HHS issued a subsequent final 

rule (82 FR 12508, March 6, 2017) 

delaying the effective date to March 21, 

2017, in accordance with a January 20, 

2017 memorandum from the Assistant 

to the President and Chief of Staff, titled 

‘‘Regulatory Freeze Pending Review.’’ 1

In the January 5, 2017 final rule, HHS 

acknowledged that the effective date fell 

during the middle of a quarter and 

stakeholders needed time to adjust 

systems and update their policies and 

procedures. As such, HHS stated that it 

intended to enforce the requirements of 

the final rule at the start of the next 

quarter, which began April 1, 2017. 

After further consideration and to 

provide affected parties sufficient time 

to make needed changes to facilitate 

compliance, and because questions were 

raised, HHS issued an interim final rule 

(82 FR 14332, March 20, 2017), to delay 

the effective date of the final rule to May 

22, 2017, and solicited additional 

comments on whether that date should 

be further extended to October 1, 2017. 

HHS received several comments to the 

interim final rule, some supporting and 

some opposing the delay of the effective 

date to May 22, 2017, or alternatively to 

October 1, 2017. After careful 

consideration of the comments received, 

HHS delayed the effective date of the 

January 5, 2017 final rule to October 1, 

2017 (82 FR 22893, May 19, 2017). 

II. Proposal To Delay the Effective Date 

of the Final Rule 

HHS proposes to further delay the 

effective date of the January 5, 2017 

final rule because it continues to 

examine important substantive issues in 

matters covered by the rule. HHS 

intends to engage in additional 

rulemaking on these issues. HHS 

believes that the proposed delay will 

allow for necessary time to more fully 

consider the substantial questions of 

fact, law and policy raised by the rule, 

consistent with the aforementioned 

‘‘Regulatory Freeze Pending Review,’’ 

memorandum. Requiring manufacturers 

to make targeted and potentially costly 

changes to pricing systems and business 

procedures in order to comply with a 

rule that is under further consideration 

and for which substantive questions 

have been raised would be disruptive. 

We also believe additional time is 

needed to more fully consider previous 

objections regarding the timing of the 

effective date and challenges associated 

with complying with the rule, as well as 

other objections to the rule. 

In addition, the January 20, 2017, 

Executive Order entitled, ‘‘Minimizing 

the Economic Burden of the Patient 

Protection and Affordable Care Act 

Pending Repeal,’’ specifically instructs 

HHS and all other heads of executive 

offices to utilize all authority and 

discretion available to delay the 

implementation of certain provisions or 

requirements of the Patient Protection 

and Affordable Care Act.2 The January 

5, 2017 final rule is based on changes 

made to the 340B Program by the 

Patient Protection and Affordable Care 

Act. HHS is proposing to delay the 

effective date of the January 5, 2017 

final rule to July 1, 2018, to also allow 

for a sufficient amount of time to more 

fully consider the regulatory burdens 

that may be posed by this final rule. 

At this time, HHS seeks public 

comments regarding the impact of 

delaying the effective date of the final 

rule, published January 5, 2017, for an 

additional nine months from the current 


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Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Proposed Rules 39555 

effective date of October 1, 2017 to July 

1, 2018, while a more deliberate 

rulemaking process is considered. HHS 

encourages all stakeholders to provide 

comments on this proposed rule. 

III. Regulatory Impact Analysis 

HHS has examined the effects of this 

proposed rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993), 

Executive Order 13563 on Improving 

Regulation and Regulatory Review 

(January 8, 2011), the Regulatory 

Flexibility Act (Pub. L. 96–354, 

September 19, 1980), the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132 on 

Federalism (August 4, 1999). 

Executive Orders 12866, 13563 and 

13771 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 is 

supplemental to and reaffirms the 

principles, structures, and definitions 

governing regulatory review as 

established in Executive Order 12866, 

emphasizing the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. Section 3(f) 

of Executive Order 12866 defines a 

‘‘significant regulatory action’’ as an 

action that is likely to result in a rule: 

(1) Having an annual effect on the 

economy of $100 million or more in any 

1 year, or adversely and materially 

affecting a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or Tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) creating 

a serious inconsistency or otherwise 

interfering with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. A 

regulatory impact analysis (RIA) must 

be prepared for major rules with 

economically significant effects ($100 

million or more in any 1 year), and a 

‘‘significant’’ regulatory action is subject 

to review by the Office of Management 

and Budget (OMB). 

HHS does not believe that the 

proposal to delay the effective date of 

the January 5, 2017, final rule will have 

an economic impact of $100 million or 

more, and is therefore not designated as 

an ‘‘economically significant’’ proposed 

rule under section 3(f)(1) of the 

Executive Order 12866. Therefore, the 

economic impact of having no rule in 

place related to the policies addressed 

in the final rule is believed to be 

minimal, as the policies would not yet 

be required or enforceable. 

Executive Order 13771, entitled 

Reducing Regulation and Controlling 

Regulatory Costs, was issued on January 

30, 2017. This proposed rule is not 

expected to be an EO 13771 regulatory 

action because this proposed rule is not 

significant under EO 12866. 

The Regulatory Flexibility Act (RFA) 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) (RFA) and the Small 

Business Regulatory Enforcement and 

Fairness Act of 1996, which amended 

the RFA, require HHS to analyze 

options for regulatory relief of small 

businesses. If a rule has a significant 

economic effect on a substantial number 

of small entities, the Secretary must 

specifically consider the economic 

effect of the rule on small entities and 

analyze regulatory options that could 

lessen the impact of the rule. HHS will 

use an RFA threshold of at least a 3 

percent impact on at least 5 percent of 

small entities. 

For purposes of the RFA, HHS 

considers all health care providers to be 

small entities either by meeting the 

Small Business Administration (SBA) 

size standard for a small business, or by 

being a nonprofit organization that is 

not dominant in its market. The current 

SBA size standard for health care 

providers ranges from annual receipts of 

$7 million to $35.5 million. As of 

January 1, 2017, over 12,000 covered 

entities participate in the 340B Program, 

which represent safety-net health care 

providers across the country. HHS has 

determined, and the Secretary certifies, 

that this proposed rule will not have a 

significant impact on the operations of 

a substantial number of small 

manufacturers; therefore, we are not 

preparing an analysis of impact for this 

RFA. HHS estimates that the economic 

impact on small entities and small 

manufacturers will be minimal. HHS 

welcomes comments concerning the 

impact of this proposed rule on small 

manufacturers and small health care 

providers. 

Unfunded Mandates Reform Act 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and Tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more (adjusted annually 

for inflation) in any one year.’’ In 2013, 

that threshold level was approximately 

$141 million. HHS does not expect this 

rule to exceed the threshold. 

Executive Order 13132—Federalism 

HHS has reviewed this proposed rule 

in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ This 

proposed rule would not ‘‘have 

substantial direct effects on the States, 

or on the relationship between the 

national government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government.’’ 

Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that OMB 

approve all collections of information 

by a federal agency from the public 

before they can be implemented. This 

proposed rule is projected to have no 

impact on current reporting and 

recordkeeping burden for manufacturers 

under the 340B Program. This proposed 

rule would result in no new reporting 

burdens. Comments are welcome on the 

accuracy of this statement. 

George Sigounas, 

Administrator, Health Resources and Services 

Administration. 

Approved: August 16, 2017. 

Thomas E. Price, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2017–17633 Filed 8–17–17; 11:15 am] 

BILLING CODE 4165–15–P 


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