Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Proposed Rules 52051 

Until 1951, the act did not contain 

criteria for determining when to limit a 

drug’s approval to prescription use. 

Consequently, different manufacturers 

made different decisions about whether 

to market a drug as prescription or OTC. 

This resulted in confusion and 

uncertainty for pharmacists and 

consumers, and made it difficult for 

FDA to ensure that the only drugs 

available OTC were those that were safe 

for use without the supervision of a 

licensed medical practitioner. 

To eliminate this confusion and 

uncertainty, and to protect the public 

health, Congress enacted the DurhamHumphrey Amendments in 1951 (Public 

Law 82–215, 65 Stat. 648). Congress had 

two primary objectives in enacting the 

Amendments: (1) To protect the public 

from abuses in the sale of potent Rx 

drugs; and (2) to relieve retail 

pharmacists and the public from 

burdensome and unnecessary 

restrictions on the dispensing of drugs 

that are safe for use without the 

supervision of a physician. See S. Rep. 

No. 946, at 1 (1951), reprinted in 1951 

U.S.C.C.A.N. 2454. To this end, the new 

legislation codified a statutory 

definition of prescription drug in 

section 503(b) of the act. 

Section 503(b) of the act sets forth the 

Federal standard used to classify drugs 

as prescription or OTC, and it describes 

when and how to switch a drug from 

prescription to OTC status. Section 

503(b)(1) of the act defines a 

prescription drug as: 

(1) A drug intended for use by man 

which—

(A) because of its toxicity or other 

potentiality for harmful effect, or the method 

of its use, or the collateral measures 

necessary to its use, is not safe for use except 

under the supervision of a practitioner 

licensed by law to administer such drug; or 

(B) is limited by an approved application 

under section 505 to use under the 

professional supervision of a practitioner 

licensed by law to administer such drug. 

The act does not define ‘‘OTC drug,’’

but the term has been adopted to refer 

to any drug that does not meet the 

definition of prescription drug in 

section 503(b) of the act. 

Given this dichotomy between 

prescription and OTC drugs, questions 

have arisen over the years about 

whether there are any conditions under 

which an active ingredient may be 

simultaneously marketed in both a 

prescription drug product and an OTC 

drug product. FDA has interpreted the 

language in 503(b)(1) of the act to allow 

marketing of the same active ingredient 

in products that are both prescription 

and OTC, assuming some meaningful 

difference exists between the two that 

makes the prescription product safe 

only under the supervision of a licensed 

practitioner. Examples of such drugs 

include: Meclizine (prescription for 

vertigo/OTC for nausea with motion 

sickness); Clotrimazol (prescription for 

candidiasis/OTC for athlete’s foot, ring 

worm, jock itch); Loperamide 

(prescription for chronic diarrhea/OTC 

for acute diarrhea); Nicotine products 

(prescription for administration through 

inhalers and nasal sprays/OTC in gums, 

lozenges and patches); ibuprofren 

(prescription at 400mg+ for arthritis/ 

OTC at 400mg and below for aches and 

pains); and H2 blockers (prescription at 

300mg+ for ulcers/OTC at 200mg for 

heartburn). The key distinction in these 

examples is that there is some 

meaningful difference between the two 

products (e.g., indication, strength, 

route of administration, dosage form) 

that makes the prescription product safe 

only under the supervision of a licensed 

practitioner. To date, FDA has not 

allowed marketing of the same active 

ingredient in a prescription product for 

one population and in an OTC product 

for a subpopulation. 

II. Agency Request for Information 

Despite the preceding examples, we 

recognize that FDA’s interpretation of 

section 503(b) of the act has not been 

explicitly set forth in any of the 

regulations that discuss the process by 

which FDA classifies (or re-classifies) 

drugs as OTC or prescription. See, e.g., 

21 CFR 310.200 and 310.201. 

To address this concern, we therefore 

ask for comments on the following 

questions: 

1. 

A. Should FDA initiate a rulemaking 

to codify its interpretation of section 

503(b) of the act regarding when an 

active ingredient can be simultaneously 

marketed in both a prescription drug 

product and an OTC drug product? 

B. Is there significant confusion 

regarding FDA’s interpretation of 

section 503(b) of the act? 

C. If so, would a rulemaking on this 

issue help dispel that confusion? 

2. 

A. If FDA limited sale of an OTC 

product to a particular subpopulation, 

e.g., by making the product available to 

the subpopulation by prescription only, 

would FDA be able to enforce such a 

limitation as a matter of law? 

B. If it could, would it be able to do 

so as practical matter and, if so, how? 

3. 

A. Assuming it is legal to market the 

same active ingredient in both a 

prescription and OTC product, may the 

different products be legally sold in the 

same package? 

B. If the two products may be lawfully 

sold in a single package, under what 

circumstances would it be inappropriate 

to do so? 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Dated: August 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–17390 Filed 8–26–05; 4:59 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–102144–04] 

RIN 1545–BD10 

Dual Consolidated Loss Regulations; 

Hearing Cancellation 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Cancellation of notice of public 

hearing on proposed rulemaking. 

SUMMARY: This document cancels a 

public hearing on proposed regulations 

under section 1503(d) of the Internal 

Revenue Code (Code) regarding dual 

consolidated losses. 

DATES: The public hearing originally 

scheduled for September 7, 2005, at 10 

a.m., is cancelled. 

FOR FURTHER INFORMATION CONTACT: 

Robin R. Jones of the Publications and 

Regulations Branch, Legal Processing 

Division, Associate Chief Counsel 

(Procedure and Administration) at (202) 

622–7180 (not a toll-free number). 

SUPPLEMENTARY INFORMATION: A notice 

of proposed rulemaking and notice of 

public hearing that appeared in the 

Federal Register on Tuesday, May 24, 

2005 (70 FR 29868) announced that a 

public hearing was scheduled for 

September 7, 2005, at 10 a.m., in the IRS 

Auditorium, Internal Revenue Service 

52052 Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Proposed Rules 

Building, 1111 Constitution Avenue, 

NW., Washington, DC. The subject of 

the public hearing is under section 

1503(d) of the Internal Revenue Code. 

The public comment period for these 

regulations expired on August 17, 2005. 

The notice of proposed rulemaking 

and notice of public hearing, instructed 

those interested in testifying at the 

public hearing to submit a request to 

speak and an outline of the topics to be 

addressed. As of Wednesday, August 24, 

2005, no one has requested to speak. 

Therefore, the public hearing scheduled 

for September 7, 2005, is cancelled. 

Cynthia E. Grigsby, 

Acting Chief, Publications and Regulations 

Branch, Legal Processing Division, Associate 

Chief Counsel (Procedure and 

Administration). 

[FR Doc. 05–17377 Filed 8–31–05; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD05–05–107] 

RIN 1625–AA08 

Special Local Regulations for Marine 

Events; John H. Kerr Reservoir, 

Clarksville, VA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish special local regulations for 

the ‘‘Clarksville Hydroplane Challenge’’, 

a power boat race to be held on the 

waters of the John H. Kerr Reservoir 

adjacent to Clarksville, Virginia. These 

special local regulations are necessary to 

provide for the safety of life on 

navigable waters during the event. This 

action is intended to restrict vessel 

traffic in portions of the John H. Kerr 

Reservoir adjacent to Clarksville, 

Virginia during the power boat race. 

DATES: Comments and related material 

must reach the Coast Guard on or before 

September 16, 2005. 

ADDRESSES: You may mail comments 

and related material to Commander 

(oax), Fifth Coast Guard District, 431 

Crawford Street, Portsmouth, Virginia 

23704–5004, hand-deliver them to 

Room 119 at the same address between 

9 a.m. and 2 p.m., Monday through 

Friday, except Federal holidays, fax 

them to (757) 398–6203, or e-mail them 

to DSens@lantd5@uscg.mil. The 

Auxiliary and Recreational Boating 

Safety Branch, Fifth Coast Guard 

District, maintains the public docket for 

this rulemaking. Comments and 

material received from the public, as 

well as documents indicated in this 

preamble as being available in the 

docket, will become part of this docket 

and will be available for inspection or 

copying at the above address between 9 

a.m. and 2 p.m., Monday through 

Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Dennis Sens, Project Manager, Auxiliary 

and Recreational Boating Safety Branch, 

at (757) 398–6204. 

SUPPLEMENTARY INFORMATION: 

Request for Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related material. If you 

do so, please include your name and 

address, identify the docket number for 

this rulemaking (CGD05–05–107), 

indicate the specific section of this 

document to which each comment 

applies, and give the reason for each 

comment. Please submit all comments 

and related material in an unbound 

format, no larger than 81⁄2 by 11 inches, 

suitable for copying. If you would like 

to know they reached us, please enclose 

a stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period. We may change 

this proposed rule in view of them. 

In order to provide notice and an 

opportunity to comment before issuing 

an effective rule, we are providing a 

shorter than normal comment period. 

Because the event organizer provided 

the Coast Guard late notice of the event, 

there is not sufficient time for a full 45- 

day comment period. We believe that by 

providing the possibility of facsimile 

and e-mail submission options, this 

shorter period will provide the public 

with sufficient time to comment on this 

regulation that will only affect a small 

portion of the waterway for a short 

period of time. 

We further anticipate that if a Final 

Rule is issued time constraints will 

require us to provide less than a 30-day 

period before the rule becomes effective. 

Immediate action is needed to protect 

the safety of life at sea from the danger 

posed by high-speed power boats. For 

the safety concerns noted, it is in the 

public interest to have the regulations in 

effect during the event. 

Public Meeting 

We do not now plan to hold a public 

meeting. But you may submit a request 

for a meeting by writing to the address 

listed under ADDRESSES explaining why 

one would be beneficial. If we 

determine that one would aid this 

rulemaking, we will hold one at a time 

and place announced by a later notice 

in the Federal Register. 

Background and Purpose 

On October 1 and 2, 2005, the 

Virginia Boat Racing Association will 

sponsor the ‘‘Clarksville Hydroplane 

Challenge’’, on the waters of the John H. 

Kerr Reservoir. The event will consist of 

approximately 60 inboard hydroplanes 

racing in heats counter-clockwise 

around an oval racecourse. A fleet of 

spectator vessels is anticipated to gather 

nearby to view the competition. Due to 

the need for vessel control during the 

event, vessel traffic will be temporarily 

restricted to provide for the safety of 

participants, spectators and transiting 

vessels. 

Discussion of Proposed Rule 

The Coast Guard proposes to establish 

temporary special local regulations on 

specified waters of the John H. Kerr 

Reservoir adjacent to Occoneechee State 

Park, Clarksville, Virginia and State 

Route 15 Highway Bridge. The regulated 

area includes a section of the John H. 

Kerr Reservoir approximately one half 

mile long, and bounded in width by 

each shoreline. This rule will be 

enforced from 7:30 a.m. to 6:30 p.m. on 

October 1 and 2, 2005, and will restrict 

general navigation in the regulated area 

during the power boat race. The Coast 

Guard, at its discretion, when practical 

will allow the passage of vessels when 

races are not taking place. Except for 

participants and vessels authorized by 

the Coast Guard Patrol Commander, no 

person or vessel will be allowed to enter 

or remain in the regulated area during 

the enforcement period. These 

regulations are needed to control vessel 

traffic during the event to enhance the 

safety of participants, spectators and 

transiting vessels. 

Regulatory Evaluation 

This proposed rule is not a 

‘‘significant regulatory action’’ under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, and 

does not require an assessment of 

potential costs and benefits under 

section 6(a)(3) of that Order. The Office 

of Management and Budget has not 

reviewed it under that Order. It is not 

‘‘significant’’ under the regulatory 

policies and procedures of the 

Department of Homeland Security 

(DHS). 

We expect the economic impact of 

this proposed rule to be so minimal that 

a full Regulatory Evaluation under the