64314 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

that is intended to use a direct current 

to introduce ions of soluble salts or 

other drugs into the body and induce 

sweating for diagnostic or other uses. If 

the iontophoresis device is intended for 

use in the diagnosis of cystic fibrosis or 

another intended use and the labeling of 

the drug intended for use with the 

device bears adequate directions for the 

device’s use with that drug, the device 

is categorized as class II. An 

iontophoresis device that is intended to 

introduce ions of soluble salts or other 

drugs into the body for other purposes 

is categorized as class III.

In the Federal Register of August 22, 

2000, FDA proposed to amend the 

physical medicine devices regulations 

to remove the class III (premarket 

approval) iontophoresis device 

identification. FDA proposed this action 

because it believed that there were no 

preamendments iontophoresis devices 

marketed for uses other than those 

described in the class II identification. 

FDA expected that manufacturers of 

those devices currently in class III 

would be able to relabel their devices to 

meet the class II identification.

In response to the August 2000 

proposed rule, FDA received seven 

comments. Several comments disagreed 

with FDA’s assertion that no class III 

preamendments iontophoresis devices 

existed. Two comments were confused 

as to whether the requirement that a 

drug used with an iontophoresis device 

bear adequate directions for use with 

that specific device applies to the 

diagnosis of cystic fibrosis or applies 

only to other uses. Two comments 

asserted that the assumption that there 

are differences in iontophoresis devices 

that would warrant linking a particular 

device to a particular drug is in error, 

and suggested that FDA should consider 

reclassification of iontophoresis devices 

into either class I or class II as drug 

delivery systems comparable to syringes 

and pumps. In contrast, another 

comment rejected what it perceived as 

the implication that all iontophoresis 

drug delivery systems were the same 

and that any iontophoresis device could 

be relabeled to reference any drug 

approved for iontophoretic 

administration, whether or not the drug 

had actually been tested for use with 

that particular device.

FDA is issuing this document to 

provide interested persons with an 

opportunity to submit any new 

information concerning the safety and 

effectiveness of the iontophoresis 

device. After FDA reviews any 

information that the agency receives in 

response to this document, FDA will 

decide whether the agency should go 

forward with the reclassification of 

those iontophoresis devices currently in 

class III and whether a panel meeting is 

necessary before taking any action.

II. 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 individuals 

may submit one paper copy. Comments 

are to be identified with the docket 

number found in brackets in the 

heading of this document. Any received 

information may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: October 25, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–24591 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0087]

Draft Guidance for Industry on Listed 

Drugs, 30-Month Stays, and Approval 

of Abbreviated New Drug Applications 

and 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act 

of 2003—Questions and Answers; 

Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Listed Drugs, 30-

Month Stays, and Approval of ANDAs 

and 505(b)(2) Applications Under 

Hatch-Waxman, as Amended by the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003—Questions and Answers.’’ This 

draft guidance follows the enactment of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Public Law 108–173) (MMA) on 

December 8, 2003. In part, this guidance 

satisfies FDA’s obligation under that law 

to clarify the definition of ‘‘listed drug’’

for persons who wish to submit a 

change (i.e., an amendment or 

supplement) to an abbreviated new drug 

application (ANDA). The guidance 

explains when a change to an 

application should reference a drug 

different from the drug listed in the 

original ANDA, requiring the change to 

be made through an entirely new 

application.

In addition to the definition of ‘‘listed 

drug,’’ the draft guidance clarifies 

certain other provisions of the MMA 

that significantly change the law that 

existed before the MMA’s enactment. 

These include changes regarding 30-

month stays and approval of ANDAs 

and new drug applications submitted 

under section 505(b)(2) of the Federal 

Food, Drug, and Cosmetic Act (505(b)(2) 

applications). The draft guidance also 

explains the effective dates that apply to 

the MMA’s provisions.

DATES: Submit written or electronic 

comments on the draft guidance by 

February 2, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Martin Shimer, Center for Drug 

Evaluation and Research (HFD–615), 

Food and Drug Administration, 7500 

Standish Pl., Rockville, MD 20855 301–

827–5710.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Listed Drugs, 30-Month Stays, and 

Approval of ANDAs and 505(b)(2) 

Applications Under Hatch-Waxman, as 

Amended by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003—Questions and Answers.’’

On December 8, 2003, the MMA was 

signed into law. Among other things, 

Title XI of that law, ‘‘Access to 

Affordable Pharmaceuticals,’’ states that 

guidance will be issued to define the 

term ‘‘listed drug’’ with respect to 

amendments and supplements to 

ANDAs. This guidance is necessary 

because the MMA specifies that, ‘‘An 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64315

applicant may not amend or supplement 

an [ANDA] to seek approval of a drug 

referring to a different listed drug from 

the listed drug identified in the 

application as submitted to the 

Secretary’’ (MMA, Title XI, section 

1101(a)(1)(B)). In part, the draft 

guidance clarifies the definition of 

‘‘listed drug’’ in the context of ANDAs 

as directed by the MMA. Portions of the 

guidance addressing ‘‘listed drug’’ are 

expected to be of use to sponsors who 

are contemplating submitting an 

amendment or supplement to an 

existing ANDA rather than submitting a 

new application. The draft guidance 

should aid these sponsors in 

determining when to reference a 

different listed drug and, thus, when to 

submit a new application rather than an 

amendment or supplement. A situation 

that is not considered in this guidance 

is that where a pending ANDA was 

submitted referencing a petition 

approved under section 505(j)(2)(C) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 355(j)(2)(C)), and 

another application is approved for the 

product described in the petition before 

the pending ANDA is approved. FDA 

has not completed its analysis of this 

situation, and therefore the draft 

guidance does not cover it.

In addition to the definition of ‘‘listed 

drug,’’ the draft guidance clarifies 

certain other significant changes made 

by the MMA to provisions of the act that 

were originally added by the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (Hatch-Waxman). These include 

changes made by the MMA with respect 

to the availability and termination of 30-

month stays of approval on ANDAs and 

505(b)(2) applications under section 

505(j)(5)(B)(iii) and 505(c)(3)(C) of the 

act, respectively, and to requirements 

for notice of patent certifications 

described by section 505(b)(2)(A)(iv) 

and 505(j)(2)(A)(vii)(IV) of the act 

(paragraph IV certifications). The draft 

guidance also clarifies the applicability 

of certain changes made by the MMA 

regarding the period described by 

section 505(j)(5)(B)(iv) of the act during 

which ANDAs with paragraph IV 

certifications that were not the first to be 

submitted cannot be approved (180-day 

exclusivity). Finally, this guidance 

explains the effective dates that apply to 

the MMA’s amendments. FDA is aware 

that these changes are complex and 

include significant departures from 

previous law. The agency therefore 

wishes to provide guidance to industry 

to clarify these amendments.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the definition of ‘‘listed drug’’ for 

amendments and supplements to 

ANDAs, and on 30-month stays and 

certain other matters related to the 

approval of ANDAs and 505(b)(2) 

applications. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: October 18, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24675 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

DEPARTMENT OF TRANSPORTATION 

Maritime Administration 

[USCG–2004–16860] 

Gulf Landing, LLC Deepwater Port 

License Application

AGENCY: Coast Guard, DHS, and 

Maritime Administration, DOT.

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The U.S. Coast Guard (USCG) 

and the U.S. Maritime Administration 

(MARAD) will hold a public hearing to 

receive information relevant to the 

issuance or denial of the requisite 

federal license for the proposed Gulf 

Landing, LLC (Gulf Landing) Deepwater 

Port project. The proposed Gulf Landing 

Deepwater Port would be located in 

West Cameron Lease Block Number 213, 

approximately 38 miles south of 

Cameron, Louisiana. We encourage 

interested individuals and organizations 

to attend the public hearing and submit 

comments. We also seek comments from 

anyone unable to attend the public 

hearing. In conjunction with the public 

hearing, the USCG and MARAD will 

also hold an informational open house 

regarding the proposed Gulf Landing 

Deepwater Port project.

DATES: The public hearing will be held 

on Thursday, November 18, 2004, from 

5 to 7 p.m., in New Orleans, Louisiana. 

The informational open house will be 

held on Thursday, November 18, 2004, 

from 3 to 4:30 p.m., at the same location 

in New Orleans, Louisiana. The public 

hearing will continue beyond 7 p.m. if 

necessary to ensure all individuals 

present at that time who wish to 

comment have an opportunity to do so. 

Comments intended for inclusion in 

the public docket [USCG–2004–16860] 

must reach the Docket Management 

Facility on or before January 3, 2005.

ADDRESSES: The public hearing and 

informational open house will be held 

at the following location: Hyatt Regency 

New Orleans Hotel, Poydras at Loyola 

Avenue, New Orleans, Louisiana 70113, 

telephone 504–561–1234. 

You may submit comments identified 

by Coast Guard docket number USCG–

2004–16860 to the Docket Management 

Facility at the U.S. Department of 

Transportation. To avoid duplication, 

please use only one of the following 

methods: 

(1) Web Site: http://dms.dot.gov.

(2) Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street, SW., Washington, DC 

20590–0001. 

(3) Fax: 202–493–2251. 

(4) Delivery: Room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is 202–366–

9329. 

(5) Federal eRulemaking Portal:

http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For 

further information concerning this 

notice, the Gulf Landing Deepwater Port 

license application, or the public 

hearing or informational open house, 

contact LCDR Derek Dostie, U.S. Coast 

Guard at (202) 267–0662 or 

ddostie@comdt.uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Andrea M.