32006 Federal Register / Vol. 86, No. 114 / Wednesday, June 16, 2021 / Proposed Rules 

1See 80 FR 65291. 

2See 83 FR 25776. 

3See 40 CFR 81.321. 

from 9 a.m. to 9:30 a.m. on November 

17, 2021. 

(4) Paragraph (a)(5) of this section will 

be enforced: 

(i) From 6 a.m. to 7 a.m., from 8 a.m. 

to 9 a.m., and from 10 a.m. to 11 a.m. 

on October 7, 2021. If necessary due to 

inclement weather or other reason on 

October 7, 2021, it will be enforced from 

6 a.m. to 7 a.m., from 8 a.m. to 9 a.m., 

and from 10 a.m. to 11 a.m. on October 

11, 2021; 

(ii) from 10 a.m. to 10:30 a.m., from 

11 a.m. to 11:30 a.m., from 12 p.m. 

(noon) to 12:30 p.m., and from 1 p.m. 

to 1:30 p.m. on October 11, 2021. If 

necessary due to inclement weather or 

other reason on October 11, 2021, it will 

be enforced from 10 a.m. to 10:30 a.m., 

from 11 a.m. to 11:30 a.m., from 12 p.m. 

(noon) to 12:30 p.m., and from 1 p.m. 

to 1:30 p.m. on October 13, 2021; 

(iii) from 6 a.m. to 7 a.m., from 8 a.m. 

to 9 a.m., and from 10 a.m. to 11 a.m. 

on November 11, 2021. If necessary due 

to inclement weather or other reason on 

November 11, 2021, it will be enforced 

from 6 a.m. to 7 a.m., from 8 a.m. to 9 

a.m., and from 10 a.m. to 11 a.m. on 

November 15, 2021; and 

(iv) from 10 a.m. to 10:30 a.m., from 

11 a.m. to 11:30 a.m., from 12 p.m. 

(noon) to 12:30 p.m., and from 1 p.m. 

to 1:30 p.m. on November 15, 2021. If 

necessary due to inclement weather or 

other reason on November 15, 2021, it 

will be enforced from 10 a.m. to 10:30 

a.m., from 11 a.m. to 11:30 a.m., from 

12 p.m. (noon) to 12:30 p.m., and from 

1 p.m. to 1:30 p.m. on November 17, 

2021. 

(4) Paragraph (a)(6) of this section will 

be enforced: 

(i) From 12 p.m. (noon) to 1 p.m., 

from 2 p.m. to 3 p.m., and from 4 p.m. 

to 5 p.m. on October 7, 2021. If 

necessary due to inclement weather or 

other reason on October 7, 2021, it will 

be enforced from 12 p.m. (noon) to 1 

p.m., from 2 p.m. to 3 p.m., and from 

4 p.m. to 5 p.m. on October 11, 2021; 

(ii) from 2 p.m. to 2:30 p.m., from 3 

p.m. to 3:30 p.m., from 4 p.m. to 4:30 

p.m., from 5 p.m. to 5:30 p.m., from 6 

p.m. to 6:30 p.m., and from 7 p.m. to 

7:30 p.m. on October 11, 2021. If 

necessary due to inclement weather or 

other reason on October 11, 2021, it will 

be enforced from 2 p.m. to 2:30 p.m., 

from 3 p.m. to 3:30 p.m., from 4 p.m. 

to 4:30 p.m., from 5 p.m. to 5:30 p.m., 

from 6 p.m. to 6:30 p.m., and from 7 

p.m. to 7:30 p.m. on October 13, 2021; 

(iii) from 12 p.m. (noon) to 1 p.m., 

from 2 p.m. to 3 p.m., and from 4 p.m. 

to 5 p.m. on November 11, 2021. If 

necessary due to inclement weather or 

other reason on November 11, 2021, it 

will be enforced from 12 p.m. (noon) to 

1 p.m., from 2 p.m. to 3 p.m., and from 

4 p.m. to 5 p.m. on November 15, 2021; 

and 

(iv) from 2 p.m. to 2:30 p.m., from 3 

p.m. to 3:30 p.m., from 4 p.m. to 4:30 

p.m., and from 5 p.m. to 5:30 p.m. on 

November 15, 2021. If necessary due to 

inclement weather or other reason on 

November 15, 2021, it will be enforced 

from 2 p.m. to 2:30 p.m., from 3 p.m. 

to 3:30 p.m., from 4 p.m. to 4:30 p.m., 

and from 5 p.m. to 5:30 p.m. on 

November 17, 2021. 

Dated: June 10, 2021. 

David E. O’Connell, 

Captain, U.S. Coast Guard, Captain of the 

Port Maryland-National Capital Region. 

[FR Doc. 2021–12580 Filed 6–15–21; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2021–0052; FRL–10023– 

82–Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; Emissions Statement 

Requirement for the 2015 Ozone 

National Ambient Air Quality Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

state implementation plan (SIP) revision 

submitted by the State of Maryland. 

This revision fulfills Maryland’s 

emissions statement requirement for the 

2015 ozone national ambient air quality 

standard (NAAQS). This action is being 

taken under the Clean Air Act (CAA). 

DATES: Written comments must be 

received on or before July 16, 2021. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R03– 

OAR–2021–0052 at https://

www.regulations.gov, or via email to 

talley.david@epa.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. For either manner of 

submission, EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

confidential business information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. EPA will generally not consider 

comments or comment contents located 

outside of the primary submission (i.e., 

on the web, cloud, or other file sharing 

system). For additional submission 

methods, please contact the person 

identified in the FOR FURTHER

INFORMATION CONTACT section. For the 

full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Adam Yarina, Planning & 

Implementation Branch (3AD30), Air & 

Radiation Division, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. The telephone number is (215) 

814–2108. Mr. Yarina can also be 

reached via electronic mail at 

yarina.adam@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 26, 2015, EPA revised the 

ozone NAAQS from 0.075 parts per 

million (ppm) to 0.070 ppm,1 and 

subsequently designated the Baltimore, 

MD, Philadelphia-Wilmington-Atlantic 

City, PA-NJ-MD-DE, and Washington, 

DC-MD-VA areas as Marginal 

Nonattainment for the 2015 ozone 

NAAQS on June 4, 2018.2 These areas 

include the following Maryland 

counties: Anne Arundel, Baltimore, 

Baltimore City, Carroll, Harford, 

Howard, Cecil, Calvert, Charles, 

Frederick, Montgomery, and Prince 

George’s counties.3 Section 182 of the 

CAA identifies plan submissions and 

requirements for ozone nonattainment 

areas. Specifically, section 182(a)(3)(B) 

requires that states develop and submit 

rules which establish annual reporting 

requirements for certain stationary 

sources. Sources that are within 

marginal (or worse) ozone 

nonattainment areas must annually 

report the actual emissions of nitrogen 

oxides (NOX) and volatile organic 

compounds (VOC) to the state. 

However, states may waive reporting 

requirements for sources that emit 

under 25 tpy of NOX and VOC if the 

state provides an inventory of emissions 

from such class or category of sources. 

See CAA section 182(a)(3)(B)(ii). 

Additionally, Maryland is located in 

the ozone transport region (OTR) 


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4The Maryland Department of the Environment 

has previously formally submitted base year 2017 

emissions inventories for: The Baltimore, MD 2015 

Ozone NAAQS Nonattainment Area; the Cecil 

County, MD 2015 Ozone NAAQS Nonattainment 

Area; and the Washington DC–MD–VA 2015 Ozone 

NAAQS Nonattainment Area. 

5See CAA sections 182(f) and 184(b)(2). 

6See 59 FR 51517 (October 12, 1994). 

7See also ‘‘Guidance on the Implementation of an 

Emission Statement Program (July 1992).’’ 

established by Congress in section 184 

of the CAA. Pursuant to section 

184(b)(2), any stationary source that 

emits or has the potential to emit at least 

50 tons per year (tpy) of VOC shall be 

considered a major stationary source 

and subject to the requirements which 

would be applicable to major stationary 

sources if the area were classified as a 

moderate nonattainment area. See CAA 

section 184. Thus, states within the OTR 

are subject to certain plan requirements 

in CAA section 182(b) applicable to 

moderate nonattainment areas. Also, 

section 182(f)(1) of the CAA requires 

that the plan provisions required for 

major stationary sources of VOC also 

apply to major stationary sources of 

NOX for states with moderate (or worse) 

ozone nonattainment areas. A major 

stationary source of NOX is defined as 

a stationary facility or source of air 

pollutants which directly emits or has 

the potential to emit 100 tpy or more of 

NOX. See CAA section 302(j). Because 

Maryland is in the OTR, stationary 

sources located in attainment areas in 

Maryland and which emit above 50 tpy 

of VOC or 100 tpy of NOX are 

considered major sources and also 

subject to the requirements of major 

stationary sources in moderate (or 

worse) nonattainment areas, including 

the emissions statement submission 

required by CAA section 182(a)(3)(B). 

See CAA sections 182(f) and 184(b)(2). 

On July 6, 2020, the State of 

Maryland, through the Maryland 

Department of the Environment (MDE), 

submitted a SIP revision to satisfy the 

emissions statement requirement of 

CAA section 182(a)(3)(B) for the 2015 

ozone NAAQS. 

II. Summary of SIP Revision and EPA 

Analysis 

On October 12, 1994 (59 FR 51517), 

EPA first approved Maryland’s SIP 

submittal satisfying CAA section 

182(a)(3)(B) and has approved 

submissions for section 182(a)(3)(B) for 

each succeeding revision of the ozone 

NAAQS. Maryland’s emissions 

reporting requirements are codified in 

Code of Maryland Regulations (COMAR) 

26.11.01.05–1 ‘‘Emissions Statements.’’ 

COMAR 26.11.01.05–1 requires sources 

that emit above specified thresholds of 

NOX or VOC to submit an emissions 

statement to the State. The emissions 

threshold for reporting varies according 

to the county in which the source is 

located. The statement must be 

submitted by a certified individual who 

can verify the source’s actual emissions. 

COMAR 26.11.01.05–1.A(1) requires a 

person who owns or operates any 

installation, source, or premises that 

emits 25 tons or more of NOX or VOC 

during a calendar year and is located in 

Baltimore City or the counties of Anne 

Arundel, Baltimore, Calvert, Carroll, 

Cecil, Charles, Frederick, Harford, 

Howard, Kent, Montgomery, Prince 

George’s, or Queen Anne’s to submit an 

emissions statement to the state. These 

counties are included in various ozone 

nonattainment areas. See 40 CFR 

81.321. Per CAA section 182(a)(3)(B)(ii), 

states may waive this requirement for 

sources that emit less than 25 tpy of 

NOX or VOC if the state provides an 

inventory of emissions from such class 

or category of sources as required by 

CAA sections 172 and 182. Maryland 

provides emissions inventories for 

nonattainment areas as required by CAA 

sections 172(c)(3) and 182(a)(3)(B).4

COMAR 26.11.01.05–1 also requires a 

person who owns or operates any 

installation, source, or premises that 

emits 50 tons or more of VOC or 100 

tons or more of NOX during a calendar 

year to submit an emissions statement if 

they are located in the following 

counties: Allegany, Caroline, 

Dorchester, Garrett, St. Mary’s, 

Somerset, Talbot, Washington, 

Wicomico, or Worcester Counties. These 

counties are designated attainment/ 

unclassifiable for the 2015 ozone 

NAAQS but within the OTR; therefore, 

sources in attainment areas for the 2015 

ozone NAAQS that emit 50 tpy or more 

of VOC or 100 tpy or more of NOX are 

considered major sources and subject to 

the requirements for major stationary 

sources applicable to moderate 

nonattainment areas. Because the 

requirements for moderate 

nonattainment areas include all the 

requirements for marginal areas, major 

sources in these areas are also subject to 

the emission statement submission 

requirement specified in CAA section 

182(a)(3)(B).5

In Maryland’s July 6, 2020 SIP 

submittal, Maryland states that the 

existing COMAR 26.11.01.05–1 

‘‘Emissions Statements’’ continues to 

satisfy section 182(a)(3)(B) for the 2015 

ozone NAAQS because Maryland has 

not made any changes since EPA’s prior 

approval and COMAR 26.11.01.05–1 

meets the CAA requirements for 

emission statements.6 EPA is proposing 

to find that COMAR 26.11.01.05–1 

continues to satisfy CAA section 

182(a)(3)(B) because the existing rule is 

applicable to the entire State of 

Maryland and requires stationary 

sources that emit NOX or VOC to submit 

an emissions statement to the State 

detailing the sources’ emissions. EPA 

finds that Maryland’s emissions 

thresholds for stationary sources that are 

required to submit an emissions 

statement meet CAA requirements in 

sections 182 (plan submissions and 

requirements for ozone nonattainment 

areas) and 184 (OTR requirements).7

Therefore, EPA has determined that 

COMAR 26.11.01.05–1, which is 

currently in the Maryland SIP, is 

appropriate to address the emissions 

statement requirement in section 

182(a)(3)(B) and is proposing to approve 

this SIP revision. EPA is soliciting 

public comments on the issues 

discussed in this document. These 

comments will be considered before 

taking final action. 

III. Proposed Action 

EPA is proposing to approve the May 

12, 2020 Maryland SIP revision, 

submitted on July 6, 2020, certifying 

that Maryland’s existing SIP-approved 

emissions statement regulation meets 

the emissions statement requirement of 

section 182(a)(3)(B) of the CAA for the 

2015 ozone NAAQS. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves state law as meeting 

federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 


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• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this proposed 

rulemaking, which proposes to approve 

Maryland’s certification that Maryland’s 

SIP-approved emissions statement 

regulation meets the emissions 

statement requirement of section 

182(a)(3)(B) of the CAA, does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Nitrogen dioxide, Ozone, 

Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: May 28, 2021. 

Diana Esher, 

Acting Regional Administrator, Region III. 

[FR Doc. 2021–11924 Filed 6–15–21; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 51c 

RIN 0906–AB25 

Proposed Rescission of Executive 

Order 13937, ‘‘Executive Order on 

Access to Affordable Life-Saving 

Medications’’ 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The Department of Health and 

Human Services (HHS) proposes to 

rescind the final rule entitled 

‘‘Implementation of Executive Order on 

Access to Affordable Life-Saving 

Medications,’’ published in the 

December 23, 2020, Federal Register. 

HHS is proposing the rescission due to 

undue administrative costs and burdens 

that implementation would impose on 

health centers. In particular, the final 

rule would require health centers to 

create and sustain new practices 

necessary to determine patients’ 

eligibility to receive certain drugs at or 

below the discounted price paid by the 

health center or subgrantees under the 

340B Program, resulting in reduced 

resources available to support critical 

services to their patients—including 

those who use insulin and injectable 

epinephrine. These challenges would be 

significantly exacerbated by the 

multitude of demands on health centers 

related to the COVID–19 pandemic. 

HHS is seeking public comment on this 

notice of proposed rulemaking (NPRM). 

As Executive Order 13937 remains in 

effect, should the final rule be 

rescinded, other implementation 

approaches will be considered to 

effectuate the Executive Order. 

DATES: Written comments and related 

material to this proposed rule must be 

received to the online docket via https:// 

www.regulations.gov on or before July 

16, 2021. 

ADDRESSES: Comments must be 

identified by HHS Docket No. HRSA– 

2021–0003 and submitted electronically 

to the Federal eRulemaking Portal at 

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

instructions for submitting comments. 

Comments and attachments will be 

posted to the docket unchanged. 

Because your comments will be made 

public, you are solely responsible for 

ensuring that your comments do not 

include any confidential information 

that you or a third party may not wish 

to be posted, such as medical 

information, your or anyone else’s 

Social Security number, or confidential 

business information. Additionally, if 

you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Joseph, Director, Office of 

Policy and Program Development, 

Bureau of Primary Health Care, Health 

Resources and Services Administration, 

5600 Fishers Lane, Rockville, Maryland 

20857; email: jjoseph@hrsa.gov; 

telephone: 301–594–4300; fax: 301– 

594–4997. 

SUPPLEMENTARY INFORMATION: 

I. Background 

HHS published a notice of proposed 

rulemaking (NPRM) in the Federal 

Register on September 28, 2020 (85 FR 

60748), and a final rule on December 23, 

2020 (85 FR 83822) entitled, 

‘‘Implementation of Executive Order on 

Access to Affordable Life-Saving 

Medications.’’ This rule established a 

new requirement directing all health 

centers receiving grants under section 

330(e) of the Public Health Service 

(PHS) Act (42 U.S.C. 254b(e)) that 

participate in the 340B Program (42 

U.S.C. 256b), to the extent that they plan 

to make insulin and/or injectable 

epinephrine available to their patients, 

to provide assurances that they have 

established practices to provide these 

drugs at or below the discounted price 

paid by the health center or subgrantees 

under the 340B Program (plus a 

minimal administration fee) to health 

center patients with low incomes, as 

determined by the Secretary, who have 

a high cost sharing requirement for 

either insulin or injectable epinephrine; 

have a high unmet deductible; or who 

have no health insurance. 

Pursuant to the January 20, 2021, 

memorandum from the Assistant to the 

President and Chief of Staff, entitled 

‘‘Regulatory Freeze Pending Review,’’ 

and OMB Memorandum M–21–14, the 

effective date of the ‘‘Implementation of 

Executive Order on Access to Affordable 

Life-Saving Medications’’ rule, 

published in the December 23, 2020, 

Federal Register (85 FR 83822), was 

delayed from January 22, 2021, to March 

22, 2021 (86 FR 7069), to give HHS 

officials the opportunity for further 

review and consideration of the rule. 

On March 11, 2021 (86 FR 13872), 

HHS published a proposed rule to 

further delay the effective date of the 

‘‘Implementation of Executive Order on 

Access to Affordable Life-Saving 

Medications’’ rule. On March 22, 2021, 

the effective date of the 


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