52050 Federal Register / Vol. 70, No. 169 / Thursday, September 1, 2005 / Proposed Rules 

Corrective Actions for Certain Airplanes 

(i) For Model MD–90–30 airplanes and 

Model 717–200 airplanes: If any crack is 

found in the door jamb or jamb structure of 

a lower cargo door during any inspection 

required by paragraph (g)(1) or (g)(2) of this 

AD, and the service bulletin specifies 

contacting Boeing for appropriate action, 

before further flight, repair the crack using a 

method in accordance with paragraph (o) of 

this AD. 

Corrective Actions for Certain Other 

Airplanes 

(j) For Model DC–9–11, DC–9–12, DC–9–

13, DC–9–14, DC–9–15, DC–9–15F, DC–9–21, 

DC–9–31, DC–9–32, DC–9–32 (VC–9C), DC–

9–32F, DC–9–33F, DC–9–34, DC–9–34F, DC–

9–32F (C–9A, C–9B), DC–9–41, DC–9–51 

airplanes; Model DC–9–81 (MD–81), DC–9–

82 (MD–82), DC–9–83 (MD–83), and DC–9–

87 (MD–87) airplanes; and Model MD–88 

airplanes: If any crack is found during any 

inspection required by paragraph (g)(1), 

(g)(2), or (h) of this AD, do the corrective 

action at the applicable compliance time 

specified in paragraph 1.E. of the service 

bulletin, in accordance with the 

Accomplishment Instructions of the service 

bulletin, as applicable. 

Optional Replacement of Stop Pad Support 

Fittings 

(k) For all airplanes: Replacement of all 

early configuration stop pad support fittings 

installed on a lower cargo door with new 

configuration or new stop pad support 

fittings, as identified in the applicable service 

bulletin; and reidentification of the 

applicable lower cargo door; in accordance 

with the Accomplishment Instructions of the 

applicable service bulletin; terminates the 

repetitive inspections required by paragraphs 

(g)(1), (g)(2), and (h) of this AD, as applicable, 

for that lower cargo door only. 

Parts Installation 

(l) For all airplanes: As of the effective date 

of this AD, no person may install an early 

configuration stop pad support fitting having 

P/N 3925046–1, –501, –505, –507, or –509, or 

P/N 3926046–1 or –501, on any airplane. 

Credit for Previous Service Bulletin 

(m) Actions done before the effective date 

of this AD in accordance with Boeing Service 

Bulletin DC9–52–189, dated August 10, 2001, 

are acceptable for compliance with the 

corresponding requirements of this AD. 

Terminating Action for Certain 

Requirements of AD 96–10–11 

(n) For Model DC–9–11, DC–9–12, DC–9–

13, DC–9–14, DC–9–15, DC–9–15F, DC–9–21, 

DC–9–31, DC–9–32, DC–9–32 (VC–9C), DC–

9–32F, DC–9–33F, DC–9–34, DC–9–34F, DC–

9–32F (C–9A, C–9B), DC–9–41, and DC–9–51 

airplanes: Accomplishing the replacement 

specified in paragraph (k) of this AD for the 

forward and aft lower cargo doors terminates 

the repetitive inspections of the forward and 

aft lower cargo doors for cracks required by 

paragraph (b) of AD 96–10–11 as specified in 

McDonnell Douglas DC–9 Service Bulletin 

52–89, Revision 5, dated February 26, 1991. 

Alternative Methods of Compliance 

(AMOCs) 

(o)(1) The Manager, Los Angeles Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested in accordance with the procedures 

found in 14 CFR 39.19. 

(2) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD, if it is approved by an 

Authorized Representative for the Boeing 

Commercial Airplanes Delegation Option 

Authorization Organization who has been 

authorized by the Manager, Los Angeles 

ACO, to make those findings. For a repair 

method to be approved, the repair must meet 

the certification basis of the airplane and 14 

CFR 25.571, Amendment 45, and the 

approval must specifically refer to this AD. 

Issued in Renton, Washington, on August 

24, 2005. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 05–17402 Filed 8–31–05; 8:45 am] 

BILLING CODE 4910–13–U 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket No. 2005N–0345] 

RIN 0910–AF72 

Drug Approvals: Circumstances Under 

Which an Active Ingredient May Be 

Simultaneously Marketed in Both a 

Prescription Drug Product and an 

Over-the-Counter Drug Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

advance notice of proposed rulemaking 

to request comment on whether to 

initiate a rulemaking to codify its 

interpretation of section 503(b) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301, et seq.), regarding when 

an active ingredient may be 

simultaneously marketed in both a 

prescription drug product and an overthe-counter (OTC) drug product. 

DATES: Submit written or electronic 

comments by November 1, 2005. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005N–0345 

and/or RIN number 0910–AF72, by any 

of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by 

e-mail. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No. or Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received will be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: For 

further information contact the FDA at 

301–827–0002 or by e-mail at 

pcomments@fda.gov. This phone 

number and this e-mail account have 

been set-up to address questions relating 

to this notice. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Since Congress first enacted the 

Federal Food, Drug, and Cosmetic act 

(the act) in 1938, there has been a great 

deal of discussion about when drug 

products should be sold as prescription 

drugs as opposed to OTC drugs. 

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