Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 16327 

(3) If a ferrule is installed on the rotating 

star, before further flight, dye-penetrant 

inspect the rotating star for a crack in areas 

‘‘Z’’ depicted in Figure 1 of Airbus 

Helicopters ASB No. EC130 62A010, ASB 

No. AS350 62.00.34, or ASB No. AS355 

62.00.33, all Revision 0, and all dated April 

28, 2014, as applicable to your model 

helicopter. 

(i) If the rotating star has a crack, before 

further flight, remove from service the 

rotating star; ferrule; and the screws, washers 

and nuts used to attach the pitch change 

rods, compass, and the rotating star deflector. 

(ii) If the rotating star does not have a 

crack, within 160 hours TIS, remove from 

service the rotating star; ferrule; and the 

screws, washers and nuts used to attach the 

pitch change rods, compass, and the rotating 

star deflector. 

(4) Do not install a rotating star P/N 

350A371003–04, 350A371003–05, 

350A371003–06, 350A371003–07, or 

350A371003–08 with a ferrule. 

(f) Special Flight Permit 

Special flight permits are prohibited. 

(g) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Group, FAA, may approve AMOCs for this 

AD. Send your proposal to: Robert Grant, 

Aviation Safety Engineer, Safety Management 

Group, FAA, 2601 Meacham Blvd., Fort 

Worth, Texas 76137; telephone (817) 222– 

5110; email robert.grant@faa.gov. 

(2) For operations conducted under a 14 

CFR part 119 operating certificate or under 

14 CFR part 91, subpart K, we suggest that 

you notify your principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office or 

certificate holding district office before 

operating any aircraft complying with this 

AD through an AMOC. 

(h) Additional Information 

The subject of this AD is addressed in the 

European Aviation Safety Agency (EASA) AD 

No. 2014–0132R1, dated June 2, 2014. You 

may view the EASA AD on the Internet at 

http://www.regulations.gov in the AD Docket. 

(i) Subject 

Joint Aircraft Service Component (JASC) 

Code: 6200, Main Rotor System. 

Issued in Fort Worth, Texas, on March 18, 

2015. 

Lance T. Gant, 

Acting Directorate Manager, Rotorcraft 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–06805 Filed 3–26–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2015–N–0540] 

Homeopathic Product Regulation: 

Evaluating the Food and Drug 

Administration’s Regulatory 

Framework After a Quarter-Century; 

Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to obtain information 

and comments from stakeholders about 

the current use of human drug and 

biological products labeled as 

homeopathic, as well as the Agency’s 

regulatory framework for such products. 

These products include prescription 

drugs and biological products labeled as 

homeopathic and over-the-counter 

(OTC) drugs labeled as homeopathic. 

FDA is seeking participants for the 

public hearing and written comments 

from all interested parties, including, 

but not limited to, consumers, patients, 

caregivers, health care professionals, 

patient groups, and industry. FDA is 

seeking input on a number of specific 

questions, but is interested in any other 

pertinent information participants 

would like to share. 

DATES: The public hearing will be held 

on April 20 and 21, 2015, from 9 a.m. 

to 4 p.m. The meeting may be extended 

or may end early depending on the level 

of public participation. Register to 

attend or provide oral testimony at the 

hearing by April 13, 2015. See 

Registration and Request to Provide Oral 

Testimony for information on how to 

register or make an oral presentation at 

the hearing. Written or electronic 

comments will be accepted until June 

22, 2015. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503A, Silver Spring, MD, 20993– 

0002. Participants must enter through 

Building 1 and undergo security 

screening. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Lesley DeRenzo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903–0002, 240–402–4612, FAX: 301– 

847–8747, Lesley.derenzo@fda.hhs.gov; 

or Cynthia Ng, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903–0002, 301–796–7512, FAX: 301– 

847–8747, cynthia.ng.@fda.hhs.gov. 

Registration and Request to Provide 

Oral Testimony: The public hearing is 

free and seating will be on a first-come, 

first-served basis. If you wish to attend 

or make an oral presentation, see section 

III (Attendance and/or Participation in 

the Public Hearing) for information on 

how to register and the deadline for 

registration. If you cannot attend in 

person, information about how you can 

access a live Webcast will be located at 

https://collaboration.fda.gov/

hprapril2015/. 

Comments and Transcripts: You may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. You should 

annotate and organize your comments to 

identify the specific questions or topic 

to which they refer. It is only necessary 

to send one set of comments. Please 

identify your comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and at http://

www.regulations.gov approximately 45 

days after the hearing. You may submit 

a request to obtain a hard copy or CD– 

ROM transcript. Send your request to 

the Division of Freedom of Information 

(ELEM–1029), Office of Management 

Programs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: FDA is 

evaluating its current enforcement 

policies for drug products labeled as 

homeopathic from scientific, risk, and 

process perspectives. The Agency is 

now soliciting opinions about whether 

and how to adjust the current 

enforcement policies to reflect changes 

in the homeopathic product 

marketplace over the last approximately 

25 years. 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
16328 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 

I. Background 

A. Homeopathic Products and the 

Federal Food, Drug, and Cosmetic Act 

The definition of a ‘‘drug’’ under the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) includes: (1) Articles 

recognized in the official United States 

Pharmacopoeia (USP), official 

Homoeopathic Pharmacopoeia of the 

United States (HPUS); (2) articles 

intended for use in the diagnosis, cure, 

mitigation, treatment, or prevention of 

disease in man or other animals; and (3) 

articles (other than food) intended to 

affect the structure or any function of 

the body of man or other animals. See 

section 201(g)(1)(A) to (C) of the FD&C 

Act (21 U.S.C. 321(g)(1)(A) to(C)). 

Accordingly, an article that meets this 

definition of a ‘‘drug’’ is subject to 

regulation under the FD&C Act, 

regardless of whether it is labeled as 

homeopathic. An article that also meets 

the definition of a ‘‘biological product’’ 

(as defined in section 351(i) of the 

Public Health Service Act (PHS Act) (42 

U.S.C 262(i))) is subject to regulation 

under both the FD&C Act and the PHS 

Act. 

The FD&C Act recognizes the HPUS, 

along with the USP, as an official 

compendium. See section 201(j) of the 

FD&C Act. The HPUS is produced by a 

non-governmental organization known 

as the Homeopathic Pharmacop*ia 

Convention of the United States 

(HPCUS) and has been in continuous 

publication since 1897 (Ref. 1). The 

HPCUS determines which ingredients, 

including permissible potency levels, 

are officially monographed homeopathic 

ingredients. To date, there are over 1200 

officially monographed ingredients in 

the HPUS. Since 2004, the HPCUS has 

added over 500 new ingredient 

monographs. The standards set forth in 

the HPUS and the USP affect the 

naming, quality, and labeling of drug 

products. See e.g., sections 501(b) and 

502(g) of the FD&C Act (21 U.S.C. 351(b) 

and 352(g)). 

Nothing in the FD&C Act exempts 

drugs labeled as homeopathic from any 

of the requirements related to approval, 

adulteration, and misbranding, 

including labeling requirements. If a 

drug labeled as homeopathic is a new 

drug under the FD&C Act, it is subject 

to the same premarket approval 

requirements and the same standards for 

safety and efficacy as all new drugs. A 

new drug is defined, in part, as any drug 

that is not generally recognized, among 

experts qualified by scientific training 

and experience to evaluate the safety 

and effectiveness of drugs, as safe and 

effective for use under the condition 

prescribed, recommended, or suggested 

in the labeling thereof. See section 

201(p) of the FD&C Act). 

B. Homeopathic Drugs and the OTC 

Drug Review 

In 1972, FDA initiated rulemaking 

procedures (the OTC Drug Review) to 

determine which OTC drugs are 

generally recognized among qualified 

experts as safe and effective and not 

misbranded under prescribed, 

recommended, or suggested conditions 

of use. See ‘‘Procedures for 

Classification of Over-the-Counter 

Drugs’’ (37 FR 9464, May 11, 1972). 

FDA deferred review of drugs labeled as 

homeopathic due to the uniqueness of 

homeopathic medicine and stated that 

FDA would review them as a separate 

category at a later time (37 FR 9464 at 

9466). To date, FDA has not reviewed 

this class of products for safety and 

efficacy. Accordingly, there are 

currently no FDA monographs for drug 

products labeled as homeopathic. 

C. FDA’s Compliance Policy Guide 

Since 1988, prescription and 

nonprescription drug products labeled 

as homeopathic have been 

manufactured and distributed without 

FDA approval under the enforcement 

policies set forth in FDA’s Compliance 

Policy Guide (CPG) 400.400 entitled 

‘‘Conditions Under Which Homeopathic 

Drugs May be Marketed’’ (see 53 FR 

21728, June 9, 1988). The CPG defines 

a homeopathic drug as any drug labeled 

as being homeopathic which is listed in 

the HPUS, an addendum to it, or its 

supplements. The CPG includes 

conditions specific to ingredients, 

labeling, prescription status, and current 

good manufacturing practice. The CPG 

can be found at http://www.fda.gov/

iceci/compliancemanuals/

compliancepolicyguidancemanual/

ucm074360.htm. 

D. Growth in the Sale of Drugs Labeled 

as ‘‘Homeopathic’’ 

The homeopathic drug industry has 

continued on an upward growth 

trajectory since FDA issued its CPG in 

1988, especially with respect to OTC 

drug products labeled as homeopathic. 

The CPG noted that, at the time of 

original publication in 1988, the 

homeopathic drug market was a 

multimillion dollar industry in the 

United States. In 2007, the National 

Health Interview Survey, conducted by 

the Centers for Disease Control and 

Prevention’s National Center for Health 

Statistics, estimated that adults spent 

about $2.9 billion on the purchase of 

homeopathic medicine (Ref. 2). Many 

drugs labeled as homeopathic are sold 

OTC in major retail stores and are often 

marketed as natural, safe, and effective 

alternatives to other prescription and 

nonprescription products. 

E. Safety of Drug Products Labeled as 

Homeopathic 

Drugs products labeled as 

homeopathic can contain a wide range 

of substances, including ingredients 

derived from plants, healthy or diseased 

animal or human sources, minerals, and 

chemicals (either as active or inactive 

ingredients). As with ingredients in 

other drug and biological products, 

homeopathic ingredients, even if highly 

diluted, can cause side effects, drug 

interactions, and allergic or other 

adverse reactions. Negative health 

effects from drug products labeled as 

homeopathic have been reported 

through the FDA’s Adverse Event 

Reporting System and the National 

Poison Data System (NPDS), which is 

maintained by the American 

Association of Poison Control Centers 

and tracks human poison exposure 

cases. Data in the NPDS pertaining to 

homeopathic drug products is tracked 

under the category ‘‘Homeopathic 

Agents.’’ The 2012 American 

Association of Poison Control Center 

Annual Report indicated that there were 

10,311 reported poison exposure cases 

related to ‘‘Homeopathic Agents,’’ with 

8,788 of those reported cases attributed 

to children 5 years of age and younger 

(Ref. 3). Of the 10,311 reported cases, 

697 required treatment in a health care 

facility (Id.). 

II. Scope of the Public Hearing 

FDA is seeking broad public input on 

the current enforcement policies related 

to drug products labeled as 

homeopathic in an effort to better 

promote and protect the public health. 

FDA has developed a list of questions to 

facilitate a more productive discussion 

at the public hearing. This list is not 

intended to be exclusive, and FDA 

encourages comments on other matters 

related to the development and 

regulation of drug and biological 

products labeled as homeopathic. Issues 

that are of specific interest to the 

Agency include the following: 

• What are consumer and health care 

provider attitudes towards human drug 

and biological products labeled as 

homeopathic? 

• What data sources can be identified 

or shared with FDA so that the Agency 

can better assess the risks and benefits 

of drug and biological products labeled 

as homeopathic? 

• Are the current enforcement 

policies under the CPG appropriate to 

protect and promote public health in 

light of the tremendous growth in the 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
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 


asabaliauskas on DSK5VPTVN1PROD with PROPOSALS