27986 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Notices

1NDA 8–915 also covered Clistin R–A, a

controlled-release form of carbinoxamine maleate

tablets. In the Federal Register of July 29, 1983 (48

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

CDC Advisory Committee on HIV and

STD Prevention; Meeting

In accordance with section l0(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting.

Name: CDC Advisory Committee on HIV

and STD Prevention.

Times and Dates:

8:30 a.m.–5 p.m., June 16, 1998.

8:30 a.m.–12 p.m., June 17, 1998.

Place: Corporate Square Office Park,

Corporate Square Boulevard, Building 11,

Room 1413, Atlanta, Georgia 30329.

Status: Open to the public, limited only by

the space available. The meeting room will

accommodate approximately 100 people.

Purpose: This Committee is charged with

advising the Director, CDC, regarding

objectives, strategies, and priorities for HIV

and STD prevention efforts including

maintaining surveillance of HIV infection,

AIDS, and STDs, the epidemiologic and

laboratory study of HIV/AIDS and STDs,

information/education and risk reduction

activities designed to prevent the spread of

HIV and STDs, and other preventive

measures that become available.

Matters to be Discussed: Agenda items

include issues pertaining to syphilis

elimination; HIV prevention activities in the

rural U.S.; and priority prevention services

for HIV-infected persons. Agenda items are

subject to change as priorities dictate.

Contact Person for More Information: Beth

Wolfe, Committee Management Analyst,

National Center for HIV, STD, and TB

Prevention, 1600 Clifton Road, NE, Mailstop

E–07, Atlanta, Georgia 30333, telephone

(404) 639–8008.

Dated: May 15, 1998.

Nancy C. Hirsch,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–13550 Filed 5–20–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Mine Health Research Advisory

Committee Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC),

announces the following committee

meeting.

Name: Mine Health Research Advisory

Committee (MHRAC).

Time and Date: 9 a.m.–4 p.m., June 26,

1998.

Place: The Washington Court Hotel,

Montpelier Room, 525 New Jersey Avenue,

NW., Washington, DC 20001.

Status: Open to the public, limited only by

space available. The meeting room

accommodates approximately 50 people.

Purpose: The Committee is charged with

advising the Secretary; the Assistant

Secretary for Health; the Director, Centers for

Disease Control and Prevention; and the

Director, National Institute for Occupational

Safety and Health, Centers for Disease

Control and Prevention, on priorities in mine

safety and health research, including grants

and contracts for such research, 30 U.S.C.

812(b)(2), ection 102(b)(2).

Matters to be Discussed: The agenda will

include MHRAC history; funding; the Federal

Advisory Committee Act; Research Program

Transition: FY 1996–FY 1998; FY 1997 and

FY 1998 Accomplishments in Disaster

Prevention and Response; and Mining

Research Gaps and Emerging Themes.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information: Larry

Grayson, Ph.D., Executive Secretary,

MHRAC, NIOSH, CDC, 200 Independence

Avenue, SW., Room 715–H, Humphrey

Building, Washington, DC 20201, telephone

(202) 401–2192, fax (202) 260–4464.

Dated: May 15, 1998.

Nancy C. Hirsch,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–13549 Filed 5–20–98; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98P–0062]

Determination That Carbinoxamine

Maleate 4–Milligram ImmediateRelease Tablets Were Not Withdrawn

From Sale for Reasons of Safety or

Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that carbinoxamine maleate (Clistin) 4-

milligram (mg) immediate-release

tablets were not withdrawn from sale for

reasons of safety or effectiveness. This

determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for

carbinoxamine maleate 4-mg

immediate-release tablets.

FOR FURTHER INFORMATION CONTACT:

Richard L. Schwartzbard, Center for

Drug Evaluation and Research (HFD–7),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20855,

301–594–2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), which

authorized the approval of duplicate

versions of drug products approved

under an ANDA procedure. ANDA

sponsors must, with certain exceptions,

show that the drug for which they are

seeking approval contains the same

active ingredient in the same strength

and dosage form as the ‘‘listed drug,’’

which is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(6)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).

FDA may not approve an ANDA that

does not refer to a listed drug.

In a citizen petition dated January 22,

1998 (Docket No. 98P–0062/CP1),

submitted in accordance with 21 CFR

314.122, Sage Pharmaceuticals

requested that the agency determine

whether carbinoxamine maleate

(Clistin) 4-mg immediate-release

tablets were withdrawn from sale for

reasons of safety or effectiveness.

Carbinoxamine maleate (Clistin) 4-mg

immediate-release tablets were the

subject of approved NDA 8–915.1 On
Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Notices 27987

FR 34514), FDA withdrew approval of NDA 8–915

as it pertained to Clistine R–A because no person

submitted bioavailability data showing that the

product was effective as a controlled-release dosage

form.

January 26, 1993, the R. W. Johnson

Pharmaceutical Research Institute

notified FDA in writing that

carbinoxamine maleate (Clistin) 4-mg

immediate-release tablets were no

longer being marketed under NDA 8–

915 and requested the withdrawal of

that application. FDA complied and

announced the withdrawal of approval

for NDA 8–915 in the Federal Register

of March 2, 1994 (59 FR 9989).

FDA has reviewed its records and,

under § 314.161, has determined that

carbinoxamine maleate 4-mg

immediate-release tablets were not

withdrawn from sale for reasons of

safety or effectiveness. Accordingly, the

agency will maintain carbinoxamine

maleate 4-mg immediate-release tablets

in the ‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

identifies, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to carbinoxamine maleate 4-mg

immediate-release tablets may be

approved by the agency.

Dated: May 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13468 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0317]

Prompt Review of Supplemental

Applications for Approved Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration’s (FDA’s) Center for

Devices and Radiological Health (CDRH)

and Center for Biologics Evaluation and

Research (CBER), in accordance with

the FDA Modernization Act of 1997

(FDAMA), are publishing standards for

the prompt review of supplemental

applications submitted for devices

approved under the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

301 et seq.). Also, in accordance with

FDAMA, CDRH and CBER are

designating an individual within each

center to be responsible for encouraging

prompt review of supplements and for

working with sponsors to facilitate

development and submission of data to

support such supplements.

DATES: Written comments by August 19,

1998.

ADDRESSES: Submit written comments

concerning this notice to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Comments should be identified

with the docket number found in

brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Robert M. Navazio, Center for Devices

and Radiological Health (HFZ–30),

Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–1282, or

Jerome A. Donlon, Center for

Biologics Evaluation and Research

(HFM–200), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–3028,

301–827–3028.

SUPPLEMENTARY INFORMATION:

I. Background

FDAMA was enacted on November

21, 1997, in order to streamline the

process of bringing safe and effective

drugs, medical devices, and other

therapies to the U.S. market. Section

403 of FDAMA addresses FDA’s review

of supplemental applications

(‘‘supplements’’) submitted for articles

approved under the act or section 351

of the Public Health Service Act.

Section 403(a) of FDAMA requires

FDA to publish in the Federal Register,

not later than 180 days after enactment

of FDAMA, standards for the prompt

review of supplements. Section 403(b)

requires FDA to issue final guidances by

that same date to clarify the

requirements for, and facilitate the

submission of, data to support the

approval of supplements. Section 403(b)

also requires the guidance to clarify

those circumstances in which published

matter may be the basis for approval of

supplements, to specify data

requirements that will avoid duplication

of previously submitted data, and to

define those supplements that are

eligible for priority review. Section

403(c) requires FDA to designate an

individual within each center of FDA

(except the Center for Food Safety and

Applied Nutrition) to be responsible for

encouraging prompt review of

supplements and working with sponsors

to facilitate development and

submission of data to support

supplements. Section 403(d) requires

FDA to implement programs and

policies that will foster collaboration

between FDA, the National Institutes for

Health, and others to identify studies

that may support supplements and to

encourage sponsors to submit and

develop supplements based on such

studies.

In this notice, CDRH and CBER are

publishing performance standards they

have established for the prompt review

of premarket approval application

(PMA) supplements, in accordance with

section 403(a) of FDAMA. Also, the

Director, Office of Device Evaluation,

CDRH, and the Deputy Director,

Medical, CBER are designated as the

individuals within each center who will

be responsible for encouraging the

prompt review of PMA supplements

and working with sponsors to facilitate

development and submission of data to

support supplements, in accordance

with section 403(c). Elsewhere in this

issue of the Federal Register, CDRH is

publishing a notice of availability of

final guidance to industry to clarify the

requirements for, and facilitate the

submission of, data to support the

approval of supplements, in accordance

with section 403(b).

II. FDAMA Section 403(a)

Following approval of a PMA or

receipt of an order declaring a product

development protocol (PDP) completed,

the sponsor of the approved PMA or

completed PDP must submit a

supplement to the PMA or PDP for

review and approval by FDA before

making a change affecting the safety and

effectiveness of the device, unless the

device is of a type for which FDA has

advised that an alternate submission is

permitted.

FDA measures its performance with

respect to review of supplements by

tracking and analysis of groups of

incoming applications. These groups of

submissions are referred to as Receipt

Cohorts.

A. PDP Supplements

In accordance with 21 CFR 814.19, a

class III device for which a product

development protocol has been declared

completed by FDA will be considered to

have an approved PMA. Accordingly,

FDA intends to review PDP

supplements in the same timeframe it

reviews PMA supplements.

FDA does not have baseline data for

PDP supplements because no

submissions of such supplements have

been received. To the extent applicable,

FDA intends to apply to PDP

supplements the same performance

standards described below for PMA

supplements.