38410 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section FDA Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

807.22(a) Form 2891–Initial Establishment. Registration1,462 1 1,462 .25 366

807.22(b) Form 2892–Device Listing (initial and update)5,640 1 5,640 .50 2,820

807.22(a) Form 2891a–Registration

Update

22,000 1 22,000 .25 5,500

807.31(e) 200 1 200 .50 100

TOTALS 8,786

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

807.31 7,900 10 79,000 0.5 39,500

TOTALS 39,500

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual reporting burden hours to

respondents for registering

establishments and listing devices is

estimated to be 8,786 hours, and

recordkeeping burden hours for

respondents is estimated to be 39,500

hours. The estimates cited in the tables

above are based primarily upon the

annual FDA Accomplishment Report,

which includes actual FDA registration

and listing figures from fiscal year (FY)

1997. These estimates are also based on

conversations with industry and trade

association representatives, and internal

review of the FDA forms and documents

referred to in the previous tables.

According to 21 CFR part 807, all

owners/operators are required to list,

and establishments are required to

register. Each owner/operator has an

average of two establishments,

according to statistics gathered from

FDA’s Registration and Listing Data

Base. The data base has 22,000

establishments listed in it. Based on

past experience, the agency anticipates

that approximately 1,462 registrations

will be processed annually, and that

5,640 initial and update device listings

will be submitted. Although FDA only

processed 12,237 annual registrations

during FY 1997 due to a delay in

sending out the annual registration

forms, the normal amount of processing

of annual registrations in the past has

been 22,000. FDA anticipates reviewing

200 historical files annually. Finally,

because initial importers (currently

estimated at 6,200) do not have to

maintain historical files, FDA estimates

that the number of recordkeepers

required to maintain the initial

historical information will be 7,900

(which is the number of establishments,

22,000 minus the number of initial

importers, 6,200, divided by 2, the

average number of establishments per

owner/operator).

Dated: July 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18877 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0271]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PANDEL Cream

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PANDEL Cream and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

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

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may
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