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withdrawn from sale for reasons of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.
27988 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 / Notices

B. PMA Supplements

In accordance with FDA regulations,

PMA supplements ordinarily are

required to be reviewed within 180 days

(21 CFR 814.39(c)).

The legislative history of section 403

of FDAMA indicates that Congress

expected FDA to publish performance

standards for those supplements

submitted for changes in product use.

Therefore, the data that follow do not

reflect FDA performance standards for

PMA supplements submitted for other

changes, e.g., labeling or manufacturing.

Historically, FDA has received

approximately 300 to 500 PMA

supplements per year. Approximately

10 percent of these supplements address

changes in the indication for use.

Performance for the PMA supplement

receipt cohort for changes in indication

received during fiscal year (FY) 1996

and FY 97 was just over 70 percent

completed within 180 days.

Tracking for PMA supplements will

continue to be accomplished using

Receipt Cohorts as the basis for program

performance. Projected performance for

the FY 98 receipt cohort for changes in

indication is expected to be 65 percent

reviewed within 180 days. This estimate

is based on making the best use of

available FY 98 resources during a time

of increasing workload attributable to

implementation of FDAMA. In FY 99,

FDA will continue reengineering the

device review process with emphasis on

these new requirements. If adequate

funding is provided, FDA expects that

performance will be back to 70 percent

in FY 99 and anticipates enhanced

performance levels in subsequent years.

III. FDAMA Section 403(c)

FDA has designated the following

individuals within CDRH and CBER to

work with sponsors to facilitate the

development and submission of data to

support supplemental applications for

approved articles in accordance with

section 403(c) of FDAMA:

Director, Office of Device Evaluation,

Center for Devices and Radiological

Health (HFZ–400), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2022,

and

Deputy Director, Medical Center for

Biologics Evaluation and Research

(HFM–1), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3028.

IV. Comments

Interested persons may, on or before

August 19, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

Two copies of any 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. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: May 18, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–13721 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0333]

Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously

Submitted Materials, and Priority

Review; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guidance entitled,

‘‘Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously Submitted

Materials, and Priority Review.’’ The

FDA Modernization Act of 1997

(FDAMA) requires the agency to issue

final guidance to clarify circumstances

in which published matter may be the

basis for approval of a supplemental

application, specify data requirements

that will avoid duplication of previously

submitted data by recognizing the

availability of data previously submitted

in support of an original application and

define supplemental applications that

are eligible for priority review.

DATES: Written comments concerning

this guidance may be submitted at

anytime.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

guidance document entitled, ‘‘Guidance

for Industry, Supplements to Approved

Applications for Class III Medical

Devices: Use of Published Literature,

Use of Previously Submitted Materials,

and Priority Review’’ to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818.

Submit written comments on

‘‘Guidance for Industry, Supplements to

Approved Applications for Class III

Medical Devices: Use of Published

Literature, Use of Previously Submitted

Materials, and Priority Review’’ to the

contact persons listed below. See the

SUPPLEMENTARY INFORMATION

section for information on electronic

access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration,

9200 Corporate Blvd., Rockville,

MD 20850, 301–594–2186; or

Jerome A. Donlon, Center for

Biologics Evaluation and Research,

1401 Rockville Pike (HFM–200),

Rockville, MD 20852–1448, 301–

827–3028.

SUPPLEMENTARY INFORMATION:

I. Background

Section 403(b) of FDAMA (Pub.

L.105–115) provides that not later than

180 days after the date of enactment, the

Secretary of the Department of Health

and Human Services (FDA by

delegation) shall issue final guidances to

clarify the requirements for, and

facilitate the submission of data to

support, the approval of supplemental

applications for approved articles under

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et seq.) or

section 351 of the Public Health Service

Act (42 U.S.C. 262). The guidances

shall:

(1) Clarify circumstances in which

published matter may be the basis for

approval of a supplemental application;

(2) Specify data requirements that will

avoid duplication of previously

submitted data by recognizing the

availability of data previously submitted

in support of an original application;

and

(3) Define supplemental applications

that are eligible for priority review.

Section 403(b) of FDAMA is

applicable to multiple centers within

FDA. Availability of the draft guidance

prepared by the Center for Drug

Evaluation and Research (CDER) and the

Center for Biologics Evaluation and

Research (CBER) (CDER/CBER draft

guidance) was announced in the

Federal Register of March 21, 1997 (62

FR 13650). The CDER/CBER draft

guidance describes the use of literature

and the types of study design that may

support supplemental effectiveness

claims for approved drug and biological

products. CDRH issued draft guidance