Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices 38411

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product PANDEL

Cream (hydrocortisone buteprate).

PANDEL Cream is indicated for the

relief of the inflammatory and pruritic

manifestations of corticosteroidresponsive dermatoses in patients 18

years of age or older. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for PANDEL Cream (U.S.

Patent No. 4,290,962) from Taisho

Pharmaceutical Co. Ltd., and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated July 18, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of PANDEL Cream

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

PANDEL Cream is 4,165 days. Of this

time, 3,078 days occurred during the

testing phase of the regulatory review

period, 1,087 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

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

355) became effective: October 6, 1985.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on October 6, 1985.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: March 10, 1994. The

applicant claims March 1, 1994, as the

date the new drug application (NDA) for

PANDEL Cream (NDA 20–453) was

initially submitted. However, FDA

records indicate that NDA 20–453 was

submitted on March 10, 1994.

3. The date the application was

approved: February 28, 1997. FDA has

verified the applicant’s claim that NDA

20–453 was approved on February 28,

1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,096 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 14, 1998, submit

to the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before January 12, 1999, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 23, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–18878 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0508]

Medical Devices: Draft Global

Harmonization Task Force Study

Group 3 Process Validation Guidance;

Draft; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Draft Global

Harmonization Task Force Study Group

3 Process Validation Guidance.’’ The

draft guidance document has been

created by members of the International

Global Harmonization Task Force Study

Group 3 (GHTF SG3) to propose

harmonized international process

validation technical requirements and

guidance for the manufacture of medical

devices. The agency is requesting public

comment regarding the draft guidance

document as proposed by the GHTF

SG3. Because FDA intends to utilize the

GHTF document as guidance for the

agency and industry, FDA is also

publishing this document for comment

under its good guidance practices

(GGP’s).

DATES: Written comments concerning

this draft guidance document must be

received by August 14, 1998.

ADDRESSES: Submit written comments

concerning the draft guidance document

entitled ‘‘Draft Global Harmonization

Task Force Study Group 3 Process

Validation Guidance’’ to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

docket number found in brackets in the

heading of this document. Submit

written requests for single copies on a

3.5’’ diskette of the draft guidance

document to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT:

Collin L. Figueroa, Center for Devices

and Radiological Health (HFZ–341),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–4648.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

governmental regulatory authorities,

industry associations, and individual

sponsors to promote the international

harmonization of regulatory

requirements. FDA has participated in

numerous efforts to enhance this

harmonization and has expressed its

commitment to promote the

international harmonization of

regulatory requirements. As part of this

effort, FDA has been actively involved

in a Global Harmonization Task Force

(GHTF). The GHTF has subsequently

formed four study groups, each tasked

with aspects designed to facilitate global

harmonization.

Study Group 3 of the GHTF drafted

the process validation guidance to

harmonize quality systems requirements
38412 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

to ensure manufactured products meet

their intended requirements. FDA is

committed to publicizing the work

product of the GHTF study groups and

encourages dissemination of these

harmonization documents. Because

FDA intends to utilize this GHTF

document as guidance for the agency

and industry, FDA also is publishing

this document for comment under its

GGP’s. The information and guidance

contained in the draft document is

intended to help manufacturers

understand quality system requirements

that involve process validation and how

process validation relates to product

design and corrective actions.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on global harmonization and process

validation. 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 applicable

statute, regulations, or both. The agency has adopted GGP’s, which

set forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive the ‘‘Draft Global

Harmonization Task Force Study Group

3 Process Validation Guidance’’ via your

fax machine, call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number 2268 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request. Persons interested in obtaining a copy

of the draft guidance document may

also do so using the World Wide Web

(WWW). The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the WWW for easy access

to information including text, graphics,

and files that may be downloaded to a

PC with access to the Web. Updated on

a regular basis, the CDRH home page

includes ‘‘Draft Global Harmonization

Task Force Study Group 3 Process

Validation Guidance,’’ device safety

alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. The ‘‘Draft

Global Harmonization Task Force Study

Group 3 Process Validation Guidance’’

will be available at ‘‘http://

www.fda.gov/cdrh/comp/

ghtfproc.html’’ and ‘‘http://

www.fda.gov/cdrh/comp/ghtfproc.pdf’’. A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select MEDICAL

DEVICES AND RADIOLOGICAL

HEATLH. From there select CENTER

FOR DEVICES AND RADIOLOGICAL

HEALTH for general information, or

arrow down for specific topics.

IV. Comments

Interested persons may, on or before

August 14, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance document. 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. The draft

guidance document and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 9, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19109 Filed 7–14–98; 12:30 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0469]

Draft Guidance for Industry on

Labeling of OTC Topical Drug

Products for the Treatment of Vaginal

Yeast Infections (Vulvovaginal

Candidiasis); 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 ‘‘Labeling Guidance

for OTC Topical Drug Products for the

Treatment of Vaginal Yeast Infections

(Vulvovaginal Candidiasis).’’ The

guidance is intended to provide a

general labeling format for all over-thecounter (OTC) drug products for the

treatment of vaginal yeast infections.

The draft guidance provides

recommendations for both the carton

and the educational brochure.

DATES: Written comments on the draft

guidance may be submitted by October

14, 1998. General comments on the

agency guidances are welcome at any

time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm.’’ Submit written requests for

single copies of the draft guidance

entitled ‘‘Labeling Guidance for OTC

Topical Drug Products for the Treatment

of Vaginal Yeast Infections

(Vulvovaginal Candidiasis)’’ to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your request.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Requests

and comments are to be identified with

the docket number found in brackets in

the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Cheryl A. Turner, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Labeling

Guidance for OTC Topical Drug

Products for the Treatment of Vaginal

Yeast Infections (Vulvovaginal

Candidiasis).’’ Current labeling for such

OTC drug products varies widely among

manufacturers. However, the content to

be communicated in labeling is nearly

identical for each product; thus the

labeling for these products should

convey a clear and consistent message

for the consumer. The intent of this

document is to provide labeling

guidance for all OTC drug products to

treat vaginal yeast infections.

Until 1990, topical drug products for

the treatment of vulvovaginal

candidiasis were available by

prescription only. In 1990, FDA

convened an advisory committee