Dual Consolidated Loss Regulations; Hearing Cancellation, 52051-52052 [05-17377]
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Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Proposed Rules
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
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15:24 Aug 31, 2005
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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
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52051
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
Internal Revenue Service (IRS),
Treasury.
ACTION: Cancellation of notice of public
hearing on proposed rulemaking.
AGENCY:
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
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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
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
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
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15:01 Aug 31, 2005
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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 45day 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
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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
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]]>Agencies
[Federal Register Volume 70, Number 169 (Thursday, September 1, 2005)]
[Proposed Rules]
[Pages 52051-52052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17377]
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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
[[Page 52052]]
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
