29182 Federal Register / Vol. 76, No. 98 / Friday, May 20, 2011 / Proposed Rules 

Dated: May 9, 2011. 

W.C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2011–12509 Filed 5–19–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2011–0030; FRL–9308–4] 

Revisions to the California State 

Implementation Plan, Mojave Desert 

Air Quality Management District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

revisions to the Mojave Desert Air 

Quality Management District 

(MDAQMD) portion of the California 

State Implementation Plan (SIP). These 

revisions concern negative declarations 

for volatile organic compound (VOC) 

source categories for the MDAQMD. We 

are proposing to approve these negative 

declarations under the Clean Air Act as 

amended in 1990 (CAA or the Act). 

DATES: Any comments on this proposal 

must arrive by June 20, 2011. 

ADDRESSES: Submit comments, 

identified by docket number EPA–R09– 

OAR–2011–0030, by one of the 

following methods: 

1. Federal eRulemaking Portal: 

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

on-line instructions. 

2. E-mail: steckel.andrew@epa.gov. 

3. Mail or deliver: Andrew Steckel 

(Air-4), U.S. Environmental Protection 

Agency Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901. 

Instructions: All comments will be 

included in the public docket without 

change and may be made available 

online at http://www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Information that 

you consider CBI or otherwise protected 

should be clearly identified as such and 

should not be submitted through 

http://www.regulations.gov or e-mail. 

http://www.regulations.gov is an 

‘‘anonymous access’’ system, and EPA 

will not know your identity or contact 

information unless you provide it in the 

body of your comment. If you send email directly to EPA, your e-mail 

address will be automatically captured 

and included as part of the public 

comment. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: The index to the docket for 

this action is available electronically at 

http://www.regulations.gov and in hard 

copy at EPA Region IX, 75 Hawthorne 

Street, San Francisco, California. While 

all documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

either location (e.g., CBI). To inspect the 

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Allen, EPA Region IX, (415) 

947–4120, allen.cynthia@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal addresses the following 

negative declarations listed in Table 1: 

TABLE 1—SUBMITTED NEGATIVE DECLARATIONS

Local agency Title Adopted Submitted 

MDAQMD ......... Pneumatic Rubber Tire Manufacturing ..................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Large Petroleum Dry Cleaners ................................................................................................. 01/22/07 07/11/07 

MDAQMD ......... Surface Coating of Cans .......................................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Surface Coating of Coils ........................................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Surface Coating Fabrics ........................................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Surface Coating Operations at Automotive and Light Duty Truck Assembly Plants ............... 01/22/07 07/11/07 

MDAQMD ......... Surface of Coating of Large Appliances .................................................................................. 01/22/07 07/11/07 

MDAQMD ......... Surface of Coating of Magnet Wire .......................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Vacuum Producing Devices or Systems .................................................................................. 01/22/07 07/11/07 

MDAQMD ......... Leaks From Petroleum Refinery Equipment ............................................................................ 01/22/07 07/11/07 

MDAQMD ......... Process Unit Turnarounds ........................................................................................................ 01/22/07 07/11/07 

MDAQMD ......... Equipment Leaks From Natural Gas/Gasoline Processing Plants .......................................... 01/22/07 07/11/07 

MDAQMD ......... Synthesized Pharmaceutical Products ..................................................................................... 01/22/07 07/11/07 

MDAQMD ......... Air Oxidation Process—SOCMI ................................................................................................ 01/22/07 07/11/07 

MDAQMD ......... Polymer Manufacturing SOCMI and Polymer Manufacturing Equipment Leaks ..................... 01/22/07 07/11/07 

MDAQMD ......... Reactor Processes and Distillation Operations in SOCMI ....................................................... 01/22/07 07/11/07 

MDAQMD ......... Synthetic Organic Chemical Polymer and Resin Manufacturing ............................................. 01/22/07 07/11/07 

MDAQMD ......... Petroleum Refinery Equipment ................................................................................................. 08/23/10 10/22/10 

MDAQMD ......... Manufacture of High-Density Polyethylene, Polypropylene, and Polystyrene Resins ............. 08/23/10 10/22/10 

MDAQMD ......... Fugitive Emissions from Synthetic Organic Chemical Polymer and Resin Manufacturing 

Equipment.

08/23/10 10/22/10 

In the Rules and Regulations section 

of this Federal Register, we are 

approving these negative declarations in 

a direct final action without prior 

proposal because we believe these 

negative declarations are not 

controversial. If we receive adverse 

comments, however, we will publish a 

timely withdrawal of the direct final 

rule and address the comments in 

subsequent action based on this 

proposed rule. Please note that if we 

receive adverse comment on an 

amendment, paragraph, or section of 

this rule and if that provision may be 

severed from the remainder of the rule, 

we may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

We do not plan to open a second 

comment period, so anyone interested 

in commenting should do so at this 

time. If we do not receive adverse 

comments, no further activity is 

planned. For further information, please 

see the direct final action. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
Federal Register / Vol. 76, No. 98 / Friday, May 20, 2011 / Proposed Rules 29183 

Dated: April 25, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

[FR Doc. 2011–12364 Filed 5–19–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 10 

RIN 0906–AA94 

Exclusion of Orphan Drugs for Certain 

Covered Entities Under 340B Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The ‘‘Veterans Health Care 

Act of 1992,’’ enacted section 340B of 

the Public Health Service Act (PHSA) 

‘‘Limitation on Prices of Drugs 

Purchased by Covered Entities.’’ Section 

340B implemented a drug pricing 

program by which manufacturers who 

participate in Medicaid are required to 

sell covered outpatient drugs to 

particular covered entities listed in the 

statute and must agree to charge a price 

that will not exceed the amount 

determined under a statutory formula. 

The manufacturer’s obligation to sell at 

no greater than the ceiling price extends 

only to covered outpatient drugs and 

does not apply to inpatient drugs. 

Covered entities are required to ensure 

that drugs purchased under 340B are 

used only for outpatients. The Patient 

Protection and Affordable Care Act 

expanded the types of covered entities 

eligible to participate in the 340B Drug 

Pricing Program (340B Program) under 

the PHSA to include certain free 

standing cancer hospitals, rural referral 

centers, sole community hospitals, 

critical access hospitals, and children’s 

hospitals. Of these entities, children’s 

hospitals were already eligible to 

participate in the 340B drug pricing 

program under the Deficit Reduction 

Act of 2005. The Health Care and 

Education Reconciliation Act (HCERA) 

(the Patient Protection and Affordable 

Care Act and HCERA collectively 

hereinafter will be referred to as the 

‘‘Affordable Care Act’’), as amended by 

the Medicare and Medicaid Extenders 

Act of 2010, contained a provision that 

limits the types of drugs that free 

standing cancer hospitals, rural referral 

centers, sole community hospitals and 

critical access hospitals could obtain 

through the 340B Program. Under the 

changes made by the Affordable Care 

Act, orphan drugs, when used for the 

rare condition or disease for which that 

orphan drug was designated under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), are excluded from the 

definition of covered outpatient drug for 

the specified newly-eligible covered 

entity types for purposes of the 340B 

Program. This regulatory action details 

how these exclusions will be 

implemented under the 340B Program. 

DATES: Comments on this proposed rule 

must be submitted by July 19, 2011. 

ADDRESSES: You may submit comments, 

identified by the Regulatory Information 

Number (RIN) 0906–AA94, by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: opaorphan@hrsa.gov. 

Include RIN 0906–AA94 in the subject 

line of the message. 

• Mail: CDR Krista Pedley, Director, 

Office of Pharmacy Affairs (OPA), 

Healthcare Systems Bureau (HSB), 

Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Parklawn Building, Room 10C–03, 

Rockville, Maryland 20857. 

All submissions received must include 

the agency name and RIN for this 

rulemaking. All comments received will 

be available for public inspection and 

copying without charge, including any 

personal information provided, at 

Parklawn Building, 5600 Fishers Lane, 

Room 10C–03, Rockville, Maryland 

20857, weekdays (Federal holidays 

excepted) between the hours of 8:30 

a.m. and 5 p.m. 

FOR FURTHER INFORMATION CONTACT: CDR 

Krista Pedley at the mail address or by 

telephone at (301) 594–4353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The purpose of the 340B Program is 

to permit covered entities ‘‘to stretch 

scarce Federal resources as far as 

possible, reaching more eligible patients 

and providing more comprehensive 

services.’’ H.R. Rep. No.102–384(II), at 

12 (1992). The 340B Program was 

established by section 602 of the 

Veterans Health Care Act of 1992 (Pub. 

L. 102–585) and is codified as section 

340B of the PHSA. Section 340B 

instructs HHS to enter into 

Pharmaceutical Pricing Agreements 

(PPA) with drug manufacturers. (42 

U.S.C. 256b(a)). If manufacturers sign a 

PPA, they agree that the prices charged 

for covered outpatient drugs to covered 

entities (organizations eligible under 

section 340B to receive 340B discounted 

pricing) will not exceed defined ceiling 

prices, which are based on pricing data 

reported to the Centers for Medicare & 

Medicaid Services (CMS). The 340B 

ceiling price is calculated by subtracting 

the Unit Rebate Amount from the 

Average Manufacturer Price. Drugs 

purchased by covered entities through 

the 340B Program may not be sold or 

transferred to anyone other than the 

patients of the covered entities. Since 

1992, the program has grown; there are 

currently over 16,000 participating 

covered entity sites in the 340B 

Program. 

The Affordable Care Act introduced 

several changes to the 340B Program. 

The 340B Program has not previously 

published codified regulations on the 

operation of this program, instead 

relying on published program guidance 

documents, which were typically 

finalized after a notice and comment 

period. However, a number of the 

provisions of the Affordable Care Act 

necessitate the development and 

publication of regulations. This is the 

first of a series of regulations that will 

outline certain requirements in the 340B 

Program. 

Section 7101 of the Affordable Care 

Act added several new categories of 

eligibility for program participants, 

allowing them to have access to 340B 

drug pricing except in the case of an 

orphan drug when used for a rare 

disease or condition. The entity types 

added to the list of eligible entities 

listed under 340B(a)(4) included: 

340B(a)(4)(M) (children’s hospitals and 

free-standing cancer hospitals), 

340B(a)(4)(N) (critical access hospitals), 

and 340B(a)(4)(O) (rural referral centers 

and sole community hospitals). As 

amended by the Affordable Care Act, 

and section 204 of the Medicare and 

Medicaid Extenders Act of 2010 (Pub. L. 

111–309), section 340B(e) of the PHSA 

(42 U.S.C. 256b(e)) states the following: 

• EXCLUSION OF ORPHAN DRUGS FOR 

CERTAIN COVERED ENTITIES—For covered 

entities described in subparagraph (M), (other 

than a children’s hospital described in 

subparagraph (M)), (N), or (O) of subsection 

(a)(4), the term ‘covered outpatient drug’ 

shall not include a drug designated by the 

Secretary under section 526 of the Federal 

Food, Drug, and Cosmetic Act for a rare 

disease or condition. 

Congress passed the Orphan Drug Act of 

1983 to stimulate the development of 

drugs for rare diseases. The Food and 

Drug Administration (FDA), Office of 

Orphan Products Development, 

administers the Orphan Drug Act and 

reviews requests for designations. 

Orphan status designation by the FDA 

indicates that the drug has been found 

‘‘promising’’ for treating a rare disease. 

The award of an orphan designation 

does not alter the standard regulatory 

requirements and process for obtaining 


emcdonald on DSK2BSOYB1PROD with PROPOSALS