This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

19845

Vol. 60, No. 77

Friday, April 21, 1995

1 42 U.S.C. 6294.

2 44 FR 66466, 16 CFR Part 305 (Nov. 19, 1979).

The Statement of Basis and Purpose for the final

Rule describes the reasons the Commission

declined to cover the other categories of covered

products. Id. at 66467–69.

3 52 FR 46888 (Dec. 10, 1987).

4 54 FR 28031 (July 5, 1989).

5 58 FR 54955 (Oct. 25, 1993).

6 59 FR 25176 (May 13, 1993).

7 59 FR 34014. The effective date of the

amendments was December 28, 1994. On December

8, 1994, however, the Commission published a

partial delay of compliance dates for certain

covered products, including clothes washers. 59 FR

63688. As a result of this second notice,

manufacturers of clothes washers were given extra

time to prepare the new labels. They must begin

using the new labels, however, on all covered

products manufactured on or after the effective date

of today’s notice.

8Reports for clothes washers are due March 1. 9 56 FR 15274.

FEDERAL TRADE COMMISSION

16 CFR Part 305

Rule Concerning Disclosures

Regarding Energy Consumption and

Water Use of Certain Home Appliances

and Other Products Required Under

the Energy Policy and Conservation

Act (‘‘Appliance Labeling Rule’’)

AGENCY: Federal Trade Commission.

ACTION: Final rule.

SUMMARY: The Federal Trade

Commission amends its Appliance

Labeling Rule by publishing new ranges

of comparability to be used on required

labels for clothes washers.

EFFECTIVE DATE: July 20, 1995.

FOR FURTHER INFORMATION CONTACT:

James Mills, Attorney, Division of

Enforcement, Federal Trade

Commission, Washington, D.C. 20580

(202–326–3035).

SUPPLEMENTARY INFORMATION: Section

324 of the Energy Policy and

Conservation Act of 1975 (‘‘EPCA’’) 1

requires the Federal Trade Commission

to consider labeling rules for the

disclosure of estimated annual energy

cost or alternative energy consumption

information for at least thirteen

categories of appliances. Clothes

washers are included in those

categories. The statute also requires the

Department of Energy (‘‘DOE’’) to

develop test procedures that measure

how much energy the appliances use. In

addition, DOE is required to determine

the representative average cost a

consumer pays for the different types of

energy available.

On November 19, 1979, the

Commission issued a final rule covering

seven of the thirteen appliance

categories that were then covered by

DOE test procedures: refrigerators and

refrigerator-freezers, freezers,

dishwashers, water heaters, clothes

washers, room air conditioners and

furnaces (this category includes

boilers).2 The Commission has extended

the coverage of the Appliance Labeling

Rule (‘‘Rule’’) four times since it

originally issued the Rule: in 1987

(central air conditioners, heat pumps,

and pulse combustion and condensing

furnaces); 3 1989 (fluorescent lamp

ballasts); 4 and, 1993 (certain plumbing

products 5 and certain lighting

products 6). On July 1, 1994, the

Commission amended the Rule to make

certain improvements, including

making the label format more ‘‘userfriendly,’’ changing the energy usage

descriptors required on labels, and

adopting new product sub-categories for

ranges of comparability purposes.7 In

addition to the new format, which

applies to labels for all products, the

changes for clothes washer labels are the

requirement to disclose kilowatt-hour

use per year (instead of estimated

annual operating cost) for the primary

energy usage disclosure and ranges of

comparability, and the addition of the

‘‘front-loading’’ and ‘‘top-loading’’ subcategories to the ‘‘standard’’ and

‘‘compact’’ categories.

Section 305.8(b) of the Rule requires

manufacturers, after filing an initial

report, to report annually by specified

dates for each product type.8 These

reports, which are to assist the

Commission in preparing the ranges of

comparability, contain the estimated

annual energy consumption or energy

efficiency ratings for the appliances

derived from tests performed pursuant

to the DOE test procedures. Because

manufacturers regularly add new

models to their lines, improve existing

models, and drop others, the data base

from which the ranges of comparability

are calculated is constantly changing.

To keep the required information in line

with these changes, the Commission is

empowered, under § 305.10 of the Rule,

to publish new ranges (but not more

often than annually) if an analysis of the

new information indicates that the

upper or lower limits of the ranges have

changed by more than 15%. Otherwise,

the Commission must publish a

statement that the prior ranges remain

in effect for the next year.

The annual submissions of data for

clothes washers have been made and

have been analyzed by the Commission.

These submissions of data were made

by the affected manufacturers in

compliance with the new requirements

for new energy usage descriptors and

sub-categories in the amendments

published on July 1, 1994. These ranges

will supersede the current ranges for

clothes washers, which were published

on April 16, 1991.9

In consideration of the foregoing, the

Commission revises Appendix F of its

Appliance Labeling Rule by publishing

the following ranges of comparability

for use in required disclosures

(including labeling) for clothes washers

manufactured on or after July 20, 1995.

List of Subjects in 16 CFR Part 305

Advertising, Energy conservation,

Household appliances, Labeling,

Reporting and recordkeeping

requirements.

Accordingly, 16 CFR Part 305 is

amended as follows:

PART 305—[AMENDED]

1. The authority citation for Part 305

continues to read as follows:

Authority: 42 U.S.C. 6294.

2. Appendix F to Part 305 is revised

to read as follows:

Appendix F to Part 305—Clothes

Washers

Range Information:

‘‘Compact’’ includes all household clothes

washers with a tub capacity of less than 1.6

cu. ft. or 13 gallons of water.

‘‘Standard’’ includes all household clothes

washers with a tub capacity of 1.6 cu. ft. or

13 gallons of water or more.
19846 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Rules and Regulations

Capacity

Range of estimated annual

energy consumption

(kWh/yr.)

Low High

Compact:

Top Loading .................. 607 1,226

Front Loading ................ (1) (1)

Standard:

Top Loading .................. 603 1,818

Front Loading ................ 306 395

1 No data submitted.

By direction of the Commission.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 95–9930 Filed 4–20–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 206

[Docket Nos. 88P–0380 and 89P–0163]

Imprinting of Solid Oral Dosage Form

Drug Products for Human Use;

Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; clarification.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations requiring the imprinting of

solid oral dosage form drug products for

human use. This final rule clarifies

FDA’s intent regarding the effective date

for drug products introduced or

delivered for introduction into interstate

commerce.

DATES: Effective September 13, 1995;

written comments by July 20, 1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Deborah A. Wolf, Center for Drug

Evaluation and Research (HFD–362),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–1046.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

13, 1993 (58 FR 47948), FDA published

a final rule requiring the imprinting of

all solid oral dosage form drug products

for human use. The regulation requires

that all drugs covered by it bear an

imprint that will permit the

identification of the drug product,

including its active ingredients and

dosage strength, and its manufacturer or

distributor. The regulation was based on

a proposed rule that was published in

the Federal Register of May 15, 1991 (56

FR 22370). The preamble to the

proposed rule stated that, among other

things, any final rule based on the

proposal would become effective 1 year

after its date of publication in the

Federal Register. The preamble also

stated that any drug product subject to

the requirements of this rule that is

‘‘introduced or delivered for

introduction into interstate

commerce’’after the effective date would

be deemed to be adulterated,

misbranded, or an unapproved new

drug, unless it is imprinted in

compliance with the regulation (see 56

FR 22370 at 22375 (emphasis added)).

Under the proposed rule, FDA intended

the rule to be effective for drug products

entering interstate commerce at the

manufacturing level 1 year after the date

of publication of a final rule in the

Federal Register.

In response to the proposed rule,

many drug companies commented that

1 year was insufficient time to comply

with the requirements of the rule.

Industry comments indicated that it

would take longer than 1 year for

equipment retooling and product

imprinting.

In response to industry’s concerns,

FDA provided for an implementation

period of 2 years. The agency intended

to provide an effective date of

September 13, 1995, which is 2 years

after its date of publication in the

Federal Register.

However, in revising the final rule to

provide for a 2-year implementation

period, the agency inadvertently

replaced the reference to drug products

‘‘introduced or delivered for

introduction into interstate commerce’’

with a reference to drug products

‘‘distributed in interstate commerce’’

(see 58 FR 47948 at 47950) (emphasis

added). This change created the

misimpression that FDA intended the

rule to apply to drug products

distributed by manufacturers, repackers,

and retail distributors, thereby

increasing, rather than decreasing, the

burden on the pharmaceutical industry.

FDA has received inquires expressing

concern that FDA intended to initiate

recall actions at the retail level because

‘‘distribution’’ would include sale at

that level.

This final rule amends 21 CFR

206.10(a) by replacing the language

‘‘distributed in interstate commerce’’

with ‘‘introduced or delivered for

introduction into interstate commerce.’’

This will clarify the requirements of the

rule as it pertains to products in

interstate commerce.

Because this amendment to the

imprinting regulations makes only a

change necessary to conform the rule to

FDA’s original intention as stated in the

preamble to the proposed rule and to be

consistent with the agency’s intent to

provide a 2-year implementation period

as provided for in the final rule, notice

and public procedure are unnecessary.

FDA finds that there is good cause to

dispense with notice of proposed

rulemaking, pursuant to 5 U.S.C.

553(b)(3)(B). FDA is therefore

publishing this revision as a final rule

effective September 13, 1995. However,

the agency is giving interested persons

90 days to comment on this final rule.

II. Request for Comments

Interested persons may, on or before

July 20, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this final

rule. 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.

List of Subjects in 21 CFR Part 206

Drugs.

PART 206—IMPRINTING OF SOLID

ORAL DOSAGE FORM DRUG

PRODUCTS FOR HUMAN USE

1. The authority citation for 21 CFR

part 206 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 505,

507, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

355, 357, 371); sec. 351 of the Public Health

Service Act (42 U.S.C. 262).

2. Section 206.10 is amended by

revising the first sentence of paragraph

(a) to read as follows:

§ 206.10 Code imprint required.

(a) Unless exempted under § 206.7,

no drug product in solid oral dosage

form may be introduced or delivered for

introduction into interstate commerce

unless it is clearly marked or imprinted

with a code imprint that, in conjunction

with the product’s size, shape, and

color, permits the unique identification

of the drug product and the

manufacturer or distributor of the

product. * * *

* * * * *