Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices 52137

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4549) has been filed by

Mitsui Petrochemical Industries, Ltd., c/

o Keller and Heckman LLP, 1001 G St.

NW., suite 500 West, Washington, DC

20001. The petition proposes to amend

the food additive regulations in

§ 177.1520 Olefin polymers (21 CFR

177.1520) to provide for the safe use of

ethylene/propylene copolymers that

contain up to 20 mole-percent of

polymer units derived from propylene,

with the remainder of the polymer

consisting of ethylene, and having a

minimum viscosity-average molecular

weight of 95,000 and a minimum

Mooney viscosity of 13 at up to 30

percent of other regulated polymer

blends.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before November 5,

1997 submit to the Dockets Management

Branch (address above) written

comments. 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. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: September 17, 1997.

Alan M. Rulis

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–26452 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0414]

Stilbene Whitening Agent Task Force;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the Stilbene Whitening Agent Task

Force has filed a petition proposing that

the food additive regulations be

amended to provide for the safe use of

benzenesulfonic acid,2′2′-(1,2-

ethenediyl)bis[5-[[4-[bis(2-

hydroxyethyl-amino]-6-[(4-

sulfophenyl)amino]-1,3,5-triazin-2-

yl]amino]-,tetrasodium salt as an optical

brightener in paper and paperboard

intended for use in contact with food.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

205), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4554) has been filed by

Stilbene Whitening Agent Task Force, c/

o Keller and Heckman LLP, 1001 G St.

NW., suite 500 West, Washington, DC

20001. The petition proposes to amend

the food additive regulations in

§ 176.170 Components of paper and

paperboard in contact with aqueous and

fatty foods (21 CFR 176.170) to provide

for the safe use of benzenesulfonic

acid,2′2′-(1,2-ethenediyl)bis[5-[[4-[bis(2-

hydroxyethyl)-amino]-6-[(4-

sulfophenyl)amino]-1,3,5-triazin-2-

yl]amino]-, tetrasodium salt as an

optical brightener in paper and

paperboard intended for use in contact

with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: September 17, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–26453 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96P–0181]

Determination that Chlorhexidine

Gluconate Topical Tincture 0.5% Was

Withdrawn From Sale for Reasons of

Safety

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that chlorhexidine gluconate topical

tincture 0.5% (Hibitane) was

withdrawn from sale for reasons of

safety. The agency will not accept

abbreviated new drug applications

(ANDA’s) for chlorhexidine gluconate

topical tincture 0.5%.

FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress passed into law 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 (the 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
52138 Federal Register / Vol. 62, No. 193 / Monday, October 6, 1997 / Notices

withdrawn from sale for reasons of

safety or effectiveness (§ 314.162 (21

CFR 314.162)).

FDA regulations provide that any

person may petition the agency for a

determination as to whether a listed

drug has been voluntarily withdrawn

from sale for reasons of safety

effectiveness (§ 314.161(b) (21 CFR

314.161(b))). Richard A. Hamer

submitted a citizen petition dated May

24, 1996, under 21 CFR 10.25(a), 10.30,

and 314.122(a), requesting that the

agency determine whether

chlorhexidine gluconate topical tincture

0.5% (Hibitane) was withdrawn from

sale for reasons of safety or

effectiveness. Zeneca Pharmaceuticals

(formerly Steuart Pharmaceuticals and

ICI Americas) obtained approval of NDA

18–049 for chlorhexidine gluconate

topical tincture 0.5% on December 18,

1978, as a patient preoperative skin

preparation. The product was

withdrawn from sale by the sponsor in

early 1984. Because the sponsor

discontinued marketing of the product,

the agency currently lists chlorhexidine

gluconate topical tincture 0.5% in the

Orange Book’s ‘‘Discontinued Drug

Product List.’’

FDA has reviewed its records and,

under §§ 314.161 and 314.162(a)(2), has

determined that chlorhexidine

gluconate topical tincture 0.5% was

withdrawn from sale for reasons of

safety. Specifically, the product was

withdrawn because of the significant

number of reports received concerning

chemical and thermal burns associated

with the use of the product. Therefore,

chlorhexidine gluconate topical tincture

0.5% will be removed from the list of

drug products with effective approvals

published in FDA’s publication,

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations.’’

FDA will not accept ANDA’s that refer

to this drug product.

Dated: September 26, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–26353 Filed 10–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0410]

Guidance for Industry on SUPAC–MR,

Modified Release Solid Oral Dosage

Forms; Scale-Up and Postapproval

Changes for Chemistry,

Manufacturing, and Controls;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘SUPAC–MR: Modified Release

Solid Oral Dosage Forms; Scale-Up and

Postapproval Changes: Chemistry,

Manufacturing, and Controls; In Vitro

Dissolution Testing and In Vivo

Bioequivalence Documentation.’’ The

purpose of this guidance document is to

provide insight and recommendations to

pharmaceutical sponsors of new drug

applications (NDA’s), abbreviated new

drug applications (ANDA’s), and

abbreviated antibiotic applications

(AADA’s) who intend to change the

components or composition, the

manufacturing (process or equipment),

the scale-up/scale-down of manufacture,

and/or the site of manufacture of a

modified release solid oral formulation

during the postapproval period. This

guidance document represents the

agency’s current thinking on scale-up

and postapproval changes (SUPAC) for

modified release solid oral dosage forms

regulated by the Center for Drug

Evaluation and Research (CDER).

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of ‘‘SUPAC–MR: Modified

Release Solid Oral Dosage Forms; ScaleUp and Postapproval Changes:

Chemistry, Manufacturing, and

Controls; In Vitro Dissolution Testing

and In Vivo Bioequivalence

Documentation’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send two

self-addressed adhesive labels to assist

that office in processing your requests.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Mehul U. Mehta, Center for Drug

Evaluation and Research (HFD–860),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–0501.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled ‘‘SUPAC–

MR: Modified Release Solid Oral Dosage

Forms; Scale-Up and Postapproval

Changes: Chemistry, Manufacturing,

and Controls; In Vitro Dissolution

Testing and In Vivo Bioequivalence

Documentation.’’ The purpose of this

guidance document is to provide insight

and recommendations to

pharmaceutical sponsors of NDA’s,

ANDA’s, and AADA’s who intend to

change: (1) The components or

composition; (2) the manufacturing

(process or equipment); (3) the scale-up/

scale-down of manufacture; and/or (4)

the site of manufacture of a modified

release solid oral formulation during the

postapproval period. The guidance

document defines the following: (1)

Levels of change; (2) recommended

chemistry, manufacturing, and controls

(CMC) tests to support each level of

change; (3) recommended in vitro

dissolution release tests and/or in vivo

bioequivalence tests to support each

level of change; and (4) documentation

to support the change.

For postapproval changes for

modified release dosage forms that

affect components and composition,

manufacturing process or equipment

changes, scale-up, and site change, this

guidance supersedes the

recommendations in section 4.G of the

Office of Generic Drugs Policy and

Procedure Guide 22–90 (FDA,

September 11, 1990). For all other

dosage forms and changes, this guidance

does not affect the recommendations in

Guide 22–90.

This guidance document represents

the agency’s current thinking on SUPAC

for modified release solid oral dosage

forms regulated by CDER. 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 statute, regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance document to the Dockets

Management Branch (address above).

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. A copy of the guidance