Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations 26463 

Name of non-regulatory SIP revision Applicable 

geographic area 

State submittal 

date EPA approval date Additional explanation 

*******

Section 110(a)(2) Infrastructure Requirements for the 2010 NO2

NAAQS.

Statewide .......... 7/15/14 5/8/15 [Insert Federal 

Register citation].

This rulemaking action addresses the 

following CAA elements: 

110(a)(2)(A), (B), (C), (D)(i)(II) (prevention of significant deterioration), 

(D)(ii), (E), (F), (G), (H), (J), (K), (L), 

and (M). 

Section 110(a)(2) Infrastructure Requirements for the 2012 PM2.5

NAAQS.

Statewide .......... 7/15/14 5/8/15 [Insert Federal 

Register citation].

This rulemaking action addresses the 

following CAA elements: 

110(a)(2)(A), (B), (C), (D)(i)(II) (prevention of significant deterioration), 

(D)(ii), (E), (F), (G), (H), (J), (K), (L), 

and (M). 

* * * * * 

[FR Doc. 2015–11033 Filed 5–7–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 80 

[EPA–HQ–OAR–2011–0135; FRL–9927–17– 

OAR] 

RIN 2060–AS36 

Partial Withdrawal of Technical 

Amendments Related to: Tier 3 Motor 

Vehicle Fuel and Quality Assurance 

Plan Provisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Partial withdrawal of direct 

final rule. 

SUMMARY: Because EPA received 

adverse comment on certain elements of 

the Tier 3 Amendments direct final rule 

published on February 19, 2015, we are 

withdrawing those elements of the 

direct final rule. EPA intends to 

consider the comments received and 

proceed with a new final rule for the 

withdrawn elements. The remaining 

elements will go into effect pursuant to 

the direct final rule. 

DATES: Effective May 5, 2015, EPA 

withdraws the amendments to 40 CFR 

80.1453, 80.1616, and 80.1621 

published at 80 FR 9078 on February 19, 

2015. 

FOR FURTHER INFORMATION CONTACT: Julia 

MacAllister, Office of Transportation 

and Air Quality, Assessment and 

Standards Division, 2000 Traverwood 

Drive, Ann Arbor, Michigan 48105; 

telephone number: 734–214–4131; 

email address: MacAllister.Julia@

epa.gov. 

SUPPLEMENTARY INFORMATION: We stated 

in the Tier 3 Technical Amendments 

direct final rule published on February 

19, 2015 (80 FR 9078) that if we 

received adverse comment by April 6, 

2015, as to any part of the direct final 

rule, those parts would be withdrawn by 

publishing a timely notice in the 

Federal Register. Because EPA received 

adverse comment, we are withdrawing 

the amendments that were the subject of 

these adverse comments and they will 

not take effect. Three specific provisions 

are being withdrawn, as described 

below. 

First, 40 CFR 80.1453: In the 

Renewable Fuel Standard (RFS) Quality 

Assurance Program (QAP) Rule (79 FR 

42078, July 18, 2014), EPA added 

additional product transfer document 

(PTD) requirements for renewable fuels 

that informed parties that took 

ownership of the renewable fuel that 

they would need to (a) use the fuel as 

it was intended, i.e., for transportation 

use; and, (b) incur a renewable volume 

obligation (RVO) if the fuel was 

exported. Shortly after publication of 

the QAP final rule, we received 

questions on whether these PTD 

requirements would apply downstream 

to the end users, including residential 

heating oil owners and people filling up 

their fuel tanks at fuel retail stations. 

EPA provides downstream end user 

exemptions to the PTD requirements in 

other fuels programs, and the direct 

final rule included similar exemptions 

for RFS PTD requirements. The words 

‘‘or custody’’ were inadvertently added 

to the RFS PTD requirements and we 

received several comments pointing out 

that applying the PTD requirements to 

the transfer of custody of renewable 

fuels would be costly to industry and 

not beneficial to the RFS program. In 

this action we are withdrawing all of the 

changes to 40 CFR 80.1453. 

Second, 40 CFR 80.1616: The direct 

final rule included some clarifying 

language for when credits expire and are 

reported. We received a comment 

advocating for small refiners and small 

volume refineries to be allowed to use 

credits past January 1, 2020—to 

effectively receive a small refiner- and 

small volume refinery-specific period of 

lead time before these parties must 

comply with the Tier 3 sulfur standards. 

Although it is not clear whether this 

comment is germane to the provisions of 

the direct final rule, in light of the short 

time frame for withdrawal of the direct 

final rule, we have decided to treat this 

as an adverse comment on the amended 

rulemaking provisions and we therefore 

are withdrawing the proposed changes 

to 40 CFR 80.1616. 

Third, 40 CFR 80.1621: Following 

publication of the Tier 3 Final Rule (79 

FR 23414, April 28, 2014) we were 

contacted by some refiners to clarify if/ 

when small volume refineries could be 

disqualified, because there was language 

inadvertently deleted from the 

regulatory text as part of the Tier 3 final 

rule. In re-inserting this text in the 

direct final rule, we clarified that small 

volume refinery disqualification was 

akin to small refiner disqualification. 

We received adverse comment raising 

the issue that the new wording is 

confusing because it does not explicitly 

state exactly when and under which 

circumstances that disqualification 

could occur, and also that the term 

‘‘small refinery’’ was used instead of the 

correct term ‘‘small volume refinery’’. In 

this action we are withdrawing all 

changes to 40 CFR 80.1621. 

EPA published a parallel proposed 

rule on the same day as the direct final 

rule. The proposed rule invited 

comment on the substance of the direct 

final rule. EPA intends to consider the 

comments received and proceed with a 

new final rule. As stated in the parallel 

proposal, EPA does not plan to institute 

a second comment period for the 

proposed action with respect to the 

provisions that are withdrawn by this 

notice. 

The amendments for which we did 

not receive adverse comment are not 

being withdrawn and will become 


asabaliauskas on DSK5VPTVN1PROD with RULES
26464 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations 

effective on May 5, 2015, as provided in 

the February 19, 2015 direct final rule. 

Accordingly, the amendments to 40 

CFR 80.1453, 80.1616 and 80.1621 on 

February 19, 2015 (80 FR 9078), are 

withdrawn as of May 5, 2015. 

List of Subjects in 40 CFR Part 80 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Confidential 

business information, Diesel fuel, Fuel 

additives, Gasoline, Imports, 

Incorporation by reference, Labeling, 

Motor vehicle pollution, Penalties, 

Petroleum, Reporting and recordkeeping 

requirements. 

Dated: April 30, 2015. 

Gina McCarthy, 

Administrator. 

[FR Doc. 2015–10487 Filed 5–6–15; 4:15 pm] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

42 CFR Part 86 

Grants for Education Programs in 

Occupational Safety and Health 

CFR Correction 

■ In Title 42 of the Code of Federal 

Regulations, Parts 1 to 399, revised as of 

October 1, 2014, on page 668, in § 86.33, 

in paragraph (b), remove the term 

‘‘068’’. 

[FR Doc. 2015–11141 Filed 5–7–15; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 121 

RIN 0906–AB05 

Organ Procurement and 

Transplantation: Implementation of the 

HIV Organ Policy Equity Act 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule amends the 

regulations implementing the National 

Organ Transplant Act of 1984, as 

amended, (NOTA) pursuant to statutory 

requirements of the HIV Organ Policy 

Equity Act (HOPE Act), enacted in 2013. 

In accordance with the mandates of the 

HOPE Act, this regulation removes the 

current regulatory provision that 

requires the Organ Procurement 

Transplantation Network (OPTN) to 

adopt and use standards for preventing 

the acquisition of organs from 

individuals known to be infected with 

human immunodeficiency virus (HIV). 

In its place, this regulation includes 

new requirements that organs from 

individuals infected with HIV may be 

transplanted only into individuals who 

are infected with HIV before receiving 

such organs and who are participating 

in clinical research approved by an 

institutional review board, as provided 

by regulation. The only exception to this 

requirement of participation in such 

clinical research is if the Secretary 

publishes a determination in the future 

that participation in such clinical 

research, as a requirement for 

transplants of organs from individuals 

infected with HIV, is no longer 

warranted. 

In addition, this regulatory change 

establishes that OPTN standards must 

ensure that any HIV-infected transplant 

recipients are participating in clinical 

research in accordance with the 

research criteria to be published by the 

Secretary. Alternately, if and when the 

Secretary determines that participation 

in such clinical research should no 

longer be a requirement for transplants 

with organs from donors infected with 

HIV to individuals infected with HIV, 

the regulation mandates that the OPTN 

adopt and use standards of quality, as 

directed by the Secretary, consistent 

with the law and in a way that ensures 

the changes will not reduce the safety of 

organ transplantation. 

DATES: This final rule is effective June 

8, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Robert W. Walsh, Director, Division of 

Transplantation, Healthcare Systems 

Bureau, Health Resources and Services 

Administration, 5600 Fishers Lane, 

Room 8W37, Rockville, MD 20857; or by 

telephone (301) 443–7577. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The U.S. Department of Health and 

Human Services (HHS), Health 

Resources and Services 

Administration’s (HRSA), Healthcare 

Systems Bureau (HSB), Division of 

Transplantation (DoT) is responsible for 

overseeing the operation of the nation’s 

Organ Procurement and Transplantation 

Network (OPTN), which has 

responsibilities including the equitable 

allocation of donor organs for 

transplantation. The allocation of organs 

is guided by organ allocation policies 

developed by the OPTN in accordance 

with the regulations governing the 

operation of the OPTN (sometimes 

referred to as the ‘‘OPTN final rule’’ and 

herein referred to as ‘‘OPTN 

regulations’’) (42 CFR part 121). The 

OPTN is also charged with developing 

policies on many subjects, including 

standards of quality pertaining to organs 

procured for use in transplantation. In 

addition to the efficient and effective 

allocation of donor organs through the 

OPTN, the Secretary also supports 

efforts to increase the supply of donor 

organs made available through 

transplantation. 

II. Summary of the HOPE Act 

Prior to the enactment of the HOPE 

Act, Public Law 113–51 (November 21, 

2013), NOTA required the OPTN to 

adopt and use standards of quality for 

preventing the acquisition of organs 

from individuals known to be infected 

with HIV. This requirement was further 

incorporated into regulation at 42 CFR 

121.6(b). Thus, OPTN members were 

prohibited from transplanting organs 

from individuals known to be infected 

with HIV into patients (including 

patients infected with HIV). 

The HOPE Act made an important 

change with respect to the 

transplantation of organs from 

individuals infected with HIV. Pursuant 

to the HOPE Act, organs from 

individuals infected with HIV may be 

transplanted so long as two sets of 

requirements are satisfied. First, organs 

from individuals infected with HIV may 

be transplanted only into individuals 

who were infected with HIV prior to 

receiving such an organ. 

Second, transplants from individuals 

infected with HIV are subject to one of 

two oversight frameworks. Specifically, 

under the initial framework envisioned 

by the HOPE Act, all recipients of 

organs from individuals infected with 

HIV must be participating in clinical 

research approved by an institutional 

review board under research criteria to 

be published by the Secretary as 

described in the HOPE Act and the 

standards of quality implemented by the 

OPTN pursuant to the HOPE Act. Based 

on this change, all transplant centers 

conducting such clinical research will 

be required to comply with research 

criteria published by the Secretary 

under subsection (a) of section 377E of 

the Public Health Service Act, as 

amended. Alternately, if the Secretary 

determines that participation in such 

clinical research is no longer warranted 

as a requirement for transplants of 

organs from individuals infected with 

HIV, the Secretary will publish such a 

determination. The Secretary must then, 

consistent with the HOPE Act, direct the 

OPTN to revise its standards, consistent 


asabaliauskas on DSK5VPTVN1PROD with RULES