Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices 18775

claim (21 CFR 101.13(b)). Such claims

must be made in accordance with FDA’s

regulations defining the claim (section

403(r)(1)(A) of the act). FDA cautions

that care must be taken in how claims

are made about diet plans to ensure that

the foods in the plan are not represented

as having lower, or higher, nutrient

levels than they actually contain. For

example, a claim that a plan has been

formulated to provide low fat foods, as

compared to a claim that the plan has

been formulated to provide a diet that

is low in fat, would imply that the foods

in the plan are low fat. Thus, every food

in the plan would have to meet the

definition for ‘‘low fat’’ in 21 CFR

101.62(b)(2) to avoid being misbranded.

C. Foods for Special Dietary Use

Foods that purport or are represented

as to be used to supply a special dietary

need that exists by reason of a physical,

physiological, pathological, or other

condition are foods for special dietary

use under section 411(c)(3)(A) of the act

(21 U.S.C. 350(c)(3)(A)). There is a

substantial possibility that a diet plan

may be represented in a way that

subjects the foods in the plan to

regulation as foods for special dietary

use. For example, a claim that the diet

plan provides a modified diet,

formulated for those who must restrict

their sodium intake, would present the

foods in the plan as foods for special

dietary use. Under section 403(j) of the

act, FDA has authority to require, on the

label of such foods, information

concerning their dietary properties that

it finds necessary to fully inform

purchasers about their value for special

dietary use.

FDA advises that, if these diet plans

appear on the market, FDA will

carefully scrutinize the labeling and

advertising for such plans to see

whether it is necessary for the agency to

invoke its authority under section 403(j)

of the act.

D. False or Misleading Claims

Under section 403(a)(1) of the act,

food is deemed to be misbranded if its

labeling is false or misleading in any

particular. FDA would expect that any

firm that markets a diet plan will have

evidence about the effects of following

the plan, and that that evidence would

establish that any claims that are made

about that plan and the food that makes

up the plan are truthful and not

misleading. FDA also would expect that

the firm will share that evidence with

FDA. For example, if there is a claim

that a plan has been clinically proven to

have a certain effect, FDA will expect

that at least one properly designed

clinical study has been done with the

particular diet plan, that the results of

the study or studies fully support the

claims that are made, and that the

results of the studies will be shared with

FDA.

E. Drug Claims

FDA is concerned that claims made

about a diet plan could evidence an

intent that the plan is to be used as a

drug. Under section 201(g)(1)(B) of the

act (21 U.S.C. 321(g)(1)(B)), articles

intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of

disease in humans or other animals are

deemed to be drugs. Thus, for example,

a claim that a diet plan is a ‘‘therapeutic

diet’’ could subject the plan to

regulation under the provisions of the

act that apply to drugs and, in

particular, new drugs. FDA therefore

cautions that manufacturers who decide

to market diet plans with claims that

subject the plans to regulation as drugs

must be prepared to satisfy the

applicable statutory requirements.

F. Meat and Poultry Products

FDA advises that diet plans that

include meat or poultry products are

also subject to regulation by the Food

Safety and Inspection Service of the

U.S. Department of Agriculture, under

the Meat Inspection Act and the Poultry

Products Inspection Act.

G. Conclusion

In conclusion, FDA advises that this

document’s discussion of the regulatory

requirements that apply to diet plans is

not intended to discourage such plans.

It is intended to ensure that

manufacturers who decide to go forward

with such plans do so with an

understanding of the act and FDA’s

regulations. The agency hopes that, by

laying out its concerns and

expectations, it will help to minimize

the problems that will develop should

firms proceed to market with these

plans and thus to maximize the

likelihood that consumers will fully

appreciate the benefits that they offer.

This draft guidance represents the

agency’s current thinking on food plans

that are marketed as a total diet. 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, on or before

July 1, 1997 submit to the Dockets

Management Branch (address above)

written comments on this draft

guidance. 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: April 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–9876 Filed 4–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0152]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; OXILANTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

OXILANTM 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
18776 Federal Register / Vol. 62, No. 74 / Thursday, April 17, 1997 / Notices

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 product OXILANTM

(loxilan). OXILANTM is indicated for

cerebral arteriography, coronary

arteriography and left ventriculography,

visceral angiography, aortography, and

peripheral arteriography. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for OXILANTM (U.S. Patent

No. 4,954,348) from Cook Imaging

Corp., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

May 28, 1996, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of OXILANTM 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

OXILANTM is 2,757 days. Of this time,

1,644 days occurred during the testing

phase of the regulatory review period,

while 1,113 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: June 5, 1988. The

applicant claims April 29, 1988, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was June 5, 1988,

which was 30 days after FDA receipt of

the IND.

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: December 4, 1992. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

OXILANTM (NDA 20–316) was initially

submitted on December 4, 1992.

3. The date the application was

approved: December 21, 1995. FDA has

verified the applicant’s claim that NDA

20–316 was approved on December 21,

1995.

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 737 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 16, 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 October 14, 1997, 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: April 4, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–9917 Filed 4–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[ORD–098–N]

New and Pending Demonstration

Project Proposals Submitted Pursuant

to Section 1115(a) of the Social

Security Act: February 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: No new proposals for

Medicaid demonstration projects were

submitted to the Department of Health

and Human Services during the month

of February 1997 under the authority of

section 1115 of the Social Security Act.

There were no proposals approved,

disapproved, or withdrawn during that

time period. (This notice can be

accessed on the Internet at HTTP://

WWW.HCFA.GOV/ORD/

ORDHP1.HTML.)

COMMENTS: We will accept written

comments on these proposals. We will,

if feasible, acknowledge receipt of all

comments, but we will not provide

written responses to comments. We

will, however, neither approve nor

disapprove any new proposal for at least

30 days after the date of this notice to

allow time to receive and consider

comments. Direct comments as

indicated below.

ADDRESSES: Mail correspondence to:

Susan Anderson, office of Research and

Demonstrations, ealth Care Financing

Administration, Mail Stop C3–11–07,

7500 Security Boulevard, Baltimore, MD

21244–1850.

FOR FURTHER INFORMATION CONTACT:

Susan Anderson (410) 786–3996.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 1115 of the Social

Security Act (the Act), the Department

of Health and Human Services (HHS)

may consider and approve research and

demonstration proposals with a broad

range of policy objectives. These

demonstrations can lead to

improvements in achieving the

purposes of the Act.

In exercising her discretionary

authority, the Secretary has developed a

number of policies and procedures for

reviewing proposals. On September 27,

1994, we published a notice in the

Federal Register (59 FR 49249) that

specified (1) the principles that we

ordinarily will consider when

approving or disapproving

demonstration projects under the