Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices 46501

specifies the information that a

petitioner must submit in order to

establish that the proposed use of a food

additive is safe and to secure the

publication of a food additive regulation

describing the conditions under which

the additive may be safely used. Parts

172, 173, 175 to 178, and 180 (21 CFR

parts 172, 173, 175 to 178, and 180)

contain labeling requirements for

certain food additives to ensure their

safe use.

FDA scientific personnel review food

additive petitions to ensure the safety of

the intended use of the food additive in

or on food, or of a food additive that

may be present in food as a result of its

use in articles that contact food. FDA

requires food additive petitions to

contain the information specified in

§ 171.1 in order to determine whether a

petitioned use for a food additive is safe,

as required by the act. This regulation

(§ 171.1) implements section 409(b)(2)

of the act.

Respondents are businesses engaged

in the manufacture or sale of food, food

ingredients, or substances used in

materials that come into contact with

food.

FDA estimates the burden of

complying with the information

collection provisions of the agency’s

food additive petition regulations as

follows:

TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN

21 CFR No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

171.1 44 1 44 2,876 126,560

Part 172 44 1 44 0 0

Part 173 44 1 44 0 0

Parts 175 to 178 44 1 44 0 0

Part 180 44 1 44 0 0

Total 44 126,560

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

This estimate is based on the average

number of new food additive petitions

received in fiscal year 1995 and the total

hours expended by petitioners to

prepare the petitions. The burden varies

with the complexity of the petition

submitted, because food additive

petitions involve the analysis of

scientific data and information, as well

as the work of assembling the petition

itself. Because labeling requirements

under parts 172, 173, 175 to 178, and

180 for particular food additives involve

information required as part of the food

additive petition safety review process

under § 171.1, the estimate for the

number of respondents is the same and

the burden hours for labeling are

included in the estimate for § 171.1.

Dated: August 26, 1997.

William B. Schultz,

Deputy Commissione for Policy.

[FR Doc. 97–23246 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0145]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PRELAYTM and REZULINTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PRELAYTM and REZULINTM 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

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

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 products PRELAYTM

and REZULINTM (troglitazone).

PRELAYTM and REZULINTM are

indicated for use in patients with type

II diabetes currently on insulin therapy

whose hyperglycemia is inadequately

controlled (HbAlc>8.5%) despite insulin

therapy of over 30 units per day given

as multiple injections. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for PRELAYTM and

REZULINTM (U.S. Patent No. 4,572,912)

from Sankyo 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 January 21, 1997, FDA

advised the Patent and Trademark
46502 Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices

Office that these human drug products

had undergone a regulatory review

period and that the approvals of

PRELAYTM and REZULINTM

represented the first permitted

commercial marketing or use of the

products. Shortly thereafter, the Patent

and Trademark Office requested that the

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

PRELAYTM and REZULINTM is 2,885

days. Of this time, 2,703 days occurred

during the testing phase of the

regulatory review period, while 182

days occurred during the approval

phase. These periods of time were

derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: March 9, 1989. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on March 9, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: August 1, 1996. The

applicant claims July 31, 1996, as the

date the New Drug Applications

(NDA’s) for PRELAYTM (NDA 20–719)

and REZULINTM (NDA 20–720) were

initially submitted. However, FDA

records indicate that NDA’s 20–719 and

20–720 were submitted on August 1,

1996.

3. The date the application was

approved: January 29, 1997. FDA has

verified the applicant’s claim that

NDA’s 20–719 and 20–720 were

approved on January 29, 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 1,534 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before November 3, 1997, 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 March 2, 1998, 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: July 24, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–23244 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Open Meeting for Representatives of

Health Professional Organizations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

open meeting with representatives of

health professional organizations. The

meeting will be chaired by Sharon

Smith Holston, Deputy Commissioner

for External Affairs. This meeting will

provide participants an opportunity to

hear a discussion on the Food Safety

Initiative and reducing food-borne

illness.

DATES: The meeting will be held on

Monday, October 6, 1997, from 1:30

p.m. to 3:30 p.m.

ADDRESSES: The meeting will be held at

the Bethesda Holiday Inn, 8210

Wisconsin Ave., Bethesda, MD.

Interested persons may register with

Betty Palsgrove at 301–443–1652.

Registrations also may be transmitted by

FAX to 1–800–344–3332 or 301–443–

2446.

FOR FURTHER INFORMATION CONTACT:

Peter H. Rheinstein, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5470.

SUPPLEMENTARY INFORMATION: The

purpose of the meeting is to provide an

opportunity for representatives of health

professional organizations and other

interested persons to be briefed by

senior FDA staff as well as

representatives from the Centers for

Disease Control and Prevention (CDC),

the U.S. Department of Agriculture

(USDA), and the Environmental

Protection Agency (EPA). It will also

provide an opportunity for informal

discussion on the role of the Federal

Government and health professional

organizations in reducing food-borne

illness in general, as well as identifying

and treating the illness in patients.

This public meeting is free of charge;

however, space is limited. Registration

for the meeting will be accepted in the

order received and should be sent to the

contact person listed above. Registration

should include the name and title of the

person attending and the name of the

organization being represented, if any.

Dated: August 27, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–23299 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Proposed Review Criterion for Grants

for Primary Care Training Programs for

Fiscal Year 1998

Grants for Primary Care Training

programs are authorized under sections

747 (a) and (b), 748, 750 and 751, title

VII of the Public Health Service Act, as

amended by the Health Professions

Education Extension Amendments of

1992, Pub. L. 102–408, dated October

13, 1992. These grant programs include:

Grants for Predoctoral Training in

Family Medicine

Grants for Faculty Development in

Family Medicine

Grants for Graduate Training in Family

Medicine

Grants for Establishment of Departments

of Family Medicine

Grants for Residency Training in

General Internal Medicine and

General Pediatrics

Grants for Faculty Development in

General Internal Medicine and

General Pediatrics

Grants for Physician Assistant Training

Grants for Podiatric Primary Care

Residency Training

Proposed Review Criterion

The following criterion is proposed to

be added to the existing review criteria

established in 61 FR 52034 on October

4, 1996:

‘‘5. Project impact/influence in

shaping the curriculum, program,

department, institution and the

community.’’