Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 16329 

homeopathic drug market? Are there 

alternatives to the current enforcement 

policies of the CPG that would inform 

FDA’s regulatory oversight of drugs 

labeled as homeopathic? If so, please 

explain. 

• Are there areas of the current CPG 

that could benefit from additional 

clarity? If so, please explain. 

• Is there information regarding the 

regulation of homeopathic products in 

other countries that could inform FDA’s 

thinking in this area? 

• A large majority of human drug 

products labeled as homeopathic are 

marketed as OTC drugs. These products 

are available for a wide variety of 

indications, and many of these 

indications have never been considered 

for OTC use under a formal regulatory 

process. What would be an appropriate 

regulatory process for evaluating such 

indications for OTC use? 

• Given the wide range of indications 

on drug products labeled as 

homeopathic and available OTC, what 

processes do companies currently use to 

evaluate whether such products, 

including their indications for use, are 

appropriate for marketing as an OTC 

drug? 

• Do consumers and health care 

providers have adequate information to 

make informed decisions about drug 

products labeled as homeopathic? If not, 

what information, including, for 

example, information in labeling, would 

allow consumers and health care 

providers to be better informed about 

products labeled as homeopathic? 

III. Attendance and/or Participation in 

the Public Hearing 

The public hearing is free and seating 

will be on a first-come, first-served 

basis. If you wish to make an oral 

presentation during the hearing, you 

must register by submitting either an 

electronic or a written request by 5 p.m. 

on April 13, 2015, to Lesley DeRenzo or 

Cynthia Ng (see FOR FURTHER

INFORMATION CONTACT). Submit 

electronic requests to 

CDERHOMEOPATHICPRODUCT@

fda.hhs.gov. You must provide your 

name, title, business affiliation (if 

applicable), address, telephone and fax 

numbers, email address, and type of 

organization you represent (e.g., 

industry, consumer organization, etc.). 

You also should submit a brief summary 

of the presentation, including the 

discussion topic(s) that will be 

addressed and the approximate time 

requested for your presentation. FDA 

encourages individuals and 

organizations with common interests to 

coordinate and give a joint, consolidated 

presentation. Registrants will receive 

confirmation once they have been 

accepted to attend the meeting. FDA 

may limit both the number of 

participants from individual 

organizations and the total number of 

attendees based on space limitations. 

Registered presenters should check in 

before the hearing. 

Participants should submit a copy of 

each presentation to Lesley DeRenzo or 

Cynthia Ng (see FOR FURTHER

INFORMATION CONTACT) no later than 5 

p.m. on April 13, 2015. We will file the 

hearing schedule, indicating the order 

and time allotted for each presenter, 

with the Division of Dockets 

Management (see COMMENTS AND 

TRANSCRIPTS). FDA will post an 

agenda of the public hearing and other 

background material at least 3 days 

before the public hearing, along with 

additional information, at: http://

www.fda.gov/Drugs/NewsEvents/

ucm132703.htm (select this hearing 

from the events list). 

We will mail, email, or telephone the 

schedule to each participant before the 

hearing. In anticipation of the hearing 

presentations moving ahead of 

schedule, participants are encouraged to 

arrive early to ensure their designated 

order of presentation. Participants who 

are not present when called risk 

forfeiting their scheduled time. 

If you need special accommodations 

due to a disability, contact Lesley 

DeRenzo or Cynthia Ng (see FOR

FURTHER INFORMATION CONTACT) at least 7 

days in advance of the hearing. 

IV. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). A presiding officer, 

who will be accompanied by FDA 

senior management from the Office of 

the Commissioner and the relevant 

centers, will conduct the hearing. 

Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. Only the presiding officer 

and panel members may question any 

person during or at the conclusion of 

each presentation (§ 15.30(e)). Public 

hearings under part 15 are subject to 

FDA’s policy and procedures for 

electronic media coverage of FDA’s 

public administrative proceedings (21 

CFR part 10, subpart C) (§ 10.203(a)). 

Under § 10.205, representatives of the 

electronic media may be permitted, 

subject to certain limitations, to 

videotape, film, or otherwise record 

FDA’s public administrative 

proceedings, including presentations by 

participants. The hearing will be 

transcribed as stipulated in § 15.30(b). 

To the extent that the conditions for the 

hearing as described in this document 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

those provisions as specified in 

§ 15.30(h). 

V. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

all the Web site addresses in this 

reference section, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. The Homeopathic Pharmacopoeia of the 

United States (HPUS), ‘‘What is the 

HPUS?’’, available at http://

www.hpus.com/what-is-the-hpus.php 

(last visited Dec. 23, 2014). 

2. Nahin, R. L., P. M. Barnes, B. J. Stussman, 

and B. Bloom, ‘‘Costs of Complementary 

and Alternative Medicine (CAM) and 

Frequency of Visits to CAM 

Practitioners: United States, 2007.’’ 

National Health Statistics Reports; no 

18. Hyattsville, MD: National Center for 

Health Statistics, 2009. 

3. James B. Mowry, et al., ‘‘2012 Annual 

Report of the American Association of 

Poison Control Centers’ National Poison 

Data System (NPDS): 30th Annual 

Report,’’ 51 Clinical Toxicology, 949, 

1188 (2013). 

Dated: March 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07018 Filed 3–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2015–0083; FRL–9924–74– 

Region 9] 

Revisions to the California State 

Implementation Plan, Placer County 

Air Pollution Control District and the 

Ventura County Air Pollution Control 

District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

revisions to the Placer County Air 

Pollution Control District (PCAPCD) and 

the Ventura County Air Pollution 

Control District (VCAPCD) portion of 


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16330 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 

the California State Implementation 

Plan (SIP). These revisions concern 

volatile organic compound (VOC) 

emissions from the surface coating of 

plastic parts and products, 

metalworking fluids and direct-contact 

lubricants. We are proposing to approve 

local rules to regulate these emission 

sources under the Clean Air Act (CAA 

or the Act). 

DATE: Any comments on this proposal 

must arrive by April 27, 2015. 

ADDRESSES: Submit comments, 

identified by docket number: EPA–R09– 

OAR–2015–0083 by one of the following 

methods: 

1. Federal eRulemaking Portal: 

www.regulations.gov. Follow the on-line 

instructions. 

2. Email: 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 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 

www.regulations.gov or email. 

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 email 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: Generally, documents in the 

docket for this action are available 

electronically at www.regulations.gov 

and in hard copy at EPA Region IX, 75 

Hawthorne Street, San Francisco, 

California 94105–3901. While all 

documents in the docket are listed at 

www.regulations.gov, some information 

may be publicly available only at the 

hard copy location (e.g., copyrighted 

material, large maps), 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: 

Arnold Lazarus, EPA Region IX, (415) 

972–3024, lazarus.arnold@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal addresses the following local 

rules: PCAPCD Rule 249 and VCAPCD 

Rule 74.31. In the Rules and Regulations 

section of this Federal Register, we are 

approving these local rules in a direct 

final action without prior proposal 

because we believe these SIP revisions 

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. 

Dated: February 27, 2015. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

[FR Doc. 2015–06857 Filed 3–26–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2014–0634; FRL–9925–18– 

Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Pennsylvania; Plan Approval and 

Operating Permit Fees 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the Comonwealth 

of Pennsylvania pertaining to minor 

editorial revisions to Pennsylvania’s 

existing plan approval and operating 

permit fee rules. In the Final Rules 

section of this Federal Register, EPA is 

approving the State’s SIP submittal as a 

direct final rule without prior proposal 

because the Agency views this as a 

noncontroversial submittal and 

anticipates no adverse comments. A 

detailed rationale for the approval is set 

forth in the direct final rule. If no 

adverse comments are received in 

response to this action, no further 

activity is contemplated. If EPA receives 

adverse comments, the direct final rule 

will be withdrawn and all public 

comments received will be addressed in 

a subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this action 

should do so at this time. 

DATES: Comments must be received in 

writing by April 27, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2014–0634, by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: Campbell.Dave@epa.gov. 

C. Mail: EPA–R03–OAR–2014–0634, 

Dave Campbell, Associate Director, 

Office of Permits and Air Toxics, 

Mailcode 3AP10, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2014– 

0634. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or email. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an email 

comment directly to EPA without going 

through www.regulations.gov, your 

email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS