26910 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices

The total burden is 8,520. Send

comments to Desk Officer, CDC; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503.

Dated: May 22, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evalution, Center for Disease Control

and Prevention (CDC).

[FR Doc. 96–13393 Filed 5–28–96; 8:45 am]

BILLING CODE 4163–18–P

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Plan for the Child Care and

Development Block Grant.

OMB No.: 0970–0114.

Description: This legislativelymandated plan serves as the agreement

between the grantee and the Federal

Government as to how CCDBG programs

will be operated. The plans provide

assurances that the funds will be

administered in conformance with the

legislative requirements, pertinent

Federal Regulations, and other

applicable instructions or guidelines

issued by ACF.

Respondents: State governments.

Annual Burden Estimates:

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

ACF–700 ........................................................................................................... 282 1 40 11,280

Estimated Total Annual Burden

Hours: 11,280.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: May 6, 1996.

Roberta Katson,

Director, Office of Information Resource

Management Services.

[FR Doc. 96–13317 Filed 5–28–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 94N–0155]

Nutrient Values for the Voluntary

Nutrition Labeling of Raw Fruits,

Vegetables, and Fish; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of updated nutrition

labeling values for the 20 most

frequently consumed raw fruits,

vegetables, and fish in the United States.

The agency is making these values

available to assist those food retailers

who wish to update the voluntary

nutrition labeling information that they

make available to consumers before

FDA’s next survey of retail stores to

determine whether there is substantial

compliance with the voluntary nutrition

labeling program.

ADDRESSES: Submit written requests for

single copies of the nutrition labeling

values to the Division of Technical

Evaluation (HFS–165), Office of Food

Labeling, Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204. Requests should

be identified with the docket number

found in brackets in the heading of this

document. Send a self-addressed

adhesive label or fax number to assist

that office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

Mary M. Bender, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5592,

FAX 202–205–5532.

SUPPLEMENTARY INFORMATION: The

Nutrition Labeling and Education Act of

1990 amended the Federal Food, Drug,

and Cosmetic Act (the act) to require,

among other things, that under section

403(q)(4) of the act (21 U.S.C. 343(q)(4)),

FDA: (1) Identify the 20 most frequently

consumed raw fruits, vegetables, and

fish in the United States; (2) establish

guidelines for the voluntary nutrition

labeling of these raw fruits, vegetables,

and fish; and (3) issue regulations that

define ‘‘substantial compliance’’ with

respect to the adherence by food

retailers with those guidelines. In the

Federal Register of July 2, 1991 (56 FR

30468 at 30479 through 30481), FDA

responded to these requirements by

issuing a proposal, and, in the Federal

Register of November 27, 1991 (56 FR

60880), the agency published a final

rule on the nutrition labeling of raw

fruits, vegetables, and fish (corrected on

March 6, 1992 (57 FR 8174)). In the

Federal Register of July 18, 1994 (59 FR

36379) (corrected on July 21, 1994 (59

FR 37190)), FDA published a proposal

to revise the guidelines and the labeling

values for the 20 most frequently

consumed raw fruits, vegetables, and

fish. FDA plans to publish a final rule

on that rulemaking in the near future.

Under the guidelines of the voluntary

labeling program, nutrition labeling

information should be provided in close

proximity to the place in the retail

establishment where raw fruits,

vegetables, and fish are displayed for

sale. Information may be made available

in signs, posters, brochures, notebooks,

or leaflets and may be supplemented by

video, live demonstration, or other

media. Nutrition labeling information

may also be provided on the individual

food package.

In § 101.43 (21 CFR 101.43), FDA

defined substantial compliance to mean

that at least 60 percent of the food

retailers sampled in a representative

survey provide nutrition labeling

information (as specified in the

guidelines) for at least 90 percent of the

foods that they sell that are included on

the listing of the most frequently

consumed raw fruits, vegetables, and

fish. Section 403(q)(4)(C)(ii) of the act

states that if substantial compliance is

achieved by food retailers, FDA is to

reassess voluntary labeling compliance

every 2 years. The act also states that,

if substantial compliance is not

achieved, FDA is to propose to require

that nutrition information be provided

by any person who offers raw fruits and

vegetables or raw fish to consumers

(section 403(q)(4)(D)(i)).
Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices 26911

Because substantial compliance was

achieved in 1993 and 1995, section

403(q)(4)(C)(ii) of the act requires that

FDA reassess voluntary labeling

compliance and issue a report in 1997.

FDA will survey retail stores under

contract in November and December of

1996 to determine whether substantial

compliance in the voluntary provision

of labeling information for raw fruits,

vegetables, and fish continues to exist.

If substantial compliance is not met, the

agency will propose to modify § 101.43

to make the program mandatory.

The industry has informed the agency

that many retailers need new posters,

charts, or brochures, and rather than

reprinting the old values, they would

prefer to wait until they have the new

values to print the necessary materials.

The timeframe by which the agency

intends to publish a final rule to update

the voluntary labeling program,

however, may not allow food retailers

and trade associations adequate time to

print, distribute, and post nutrition

labeling information before the next

compliance survey. Therefore, because

FDA considers that both industry and

consumers will benefit if the most

current nutrition labeling values for the

20 most frequently consumed raw fruits,

vegetables, and fish are made available

for use in the voluntary program, FDA

is publishing these values at this time,

in advance of completion of work on the

final rule. The agency encourages

retailers to use these new values when

they print their posters, charts, or

brochures on raw fruits, vegetables, and

fish. However, because of the short

amount of time before the 1996 survey,

FDA is allowing retailers who choose to

participate in the voluntary nutrition

labeling program to use the old 1991

values or these new values.

Therefore, firms interested in

obtaining the nutrition labeling values

for the 20 most frequently consumed

raw fruits, vegetables, and fish should

submit a written request, accompanied

by a self-addressed adhesive label or a

fax number, to the Division of Technical

Evaluation (HFS–165), Office of Food

Labeling, Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204.

Dated: May 20, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13309 Filed 5–28–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0045]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; COREG

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

COREG 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 product COREG

(carvedilol). COREG is indicated for

the management of essential

hypertension. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for COREG (U.S. Patent

No. 4,503,067) from Boehringer

Mannheim GmbH, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated February 22, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of COREG

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

COREG is 3,625 days. Of this time,

2,727 days occurred during the testing

phase of the regulatory review period,

while 898 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: October 13, 1985. FDA

has verified the applicant claim that the

day the investigational new drug

application became effective was on

October 13, 1985.

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: March 31, 1993. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

COREG (NDA 20–297) was initially

submitted on March 31, 1993.

3. The date the application was

approved: September 14, 1995. FDA has

verified the applicant’s claim the NDA

20–297 was approved on September 14,

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 1,825 days of patent

term extension.