Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 44891

room air conditioners was published on November

13, 1995 (60 FR 56945). Because the Commission

has never received any submissions of data for oilfired instantaneous water heaters, the ranges for

these products show ‘‘no data submitted’’ for all

size categories. The Commission will not, therefore,

amend the ranges for oil-fired instantaneous water

heaters because they have not changed.

4This figure, along with national average cost

figures for natural gas, propane, heating oil and

kerosene, is published annually by DOE for the

industry’s use in calculating, among other figures,

the cost figures required by the Commission’s Rule.

The data submissions for dishwashers

have resulted in new ranges of

comparability figures for these products,

which will supersede the current

ranges, published on September 16,

1996 (61 FR 48620).

The Commission also is amending the

cost calculation formulas appearing in

section 2 of appendices H and I to part

305. These sections contain heating and

cooling performance cost information

for central air conditioners and heat

pumps. Manufacturers must provide the

formulas on fact sheets and in

directories so consumers can calculate

their own costs of operation for the

central air conditioners and heat pumps

that they are considering purchasing.

This amendment changes the figures in

the formulas to reflect the current

Representative Average Unit Cost of

Electricity—8.31 cents per kilowatthour—that was published on November

18, 1996, by DOE (61 FR 58679) 4 and

by the Commission on February 5, 1997

(62 FR 5316).

In consideration of the foregoing, the

Commission revises appendix C,

appendix H, and appendix I of part 305

by publishing the following ranges of

comparability for use in required

disclosures (including labeling) for

dishwashers manufactured on or after

November 24, 1997. The Commission

also amends the cost calculation

formulas in appendices H and I of part

305 so they will include the 1997

Representative Average Unit Cost for

electricity. In addition, as of this

effective date, manufacturers must base

the disclosures of estimated annual

operating cost required at the bottom of

EnergyGuides for dishwashers on the

1997 Representative Average Unit Costs

of Energy for electricity (8.31 cents per

kilowatt-hour) and natural gas (61.2

cents per therm).

Regulatory Flexibility Act

The provisions of the Regulatory

Flexibility Act relating to a Regulatory

Flexibility Act analysis (5 U.S.C. 603–

604) are not applicable to this

proceeding because the amendments

will not have a ‘‘significant economic

impact on a substantial number of small

entities’’ (5 U.S.C. 605). The

Commission has determined that

virtually none of the manufacturers of

dishwashers fall within the definition of

‘‘small entity’’ as that term is defined in

section 601 of the Regulatory Flexibility

Act and in the regulations of the Small

Business Administration, found in 13

CFR part 121. The Commission has

concluded, therefore, that a regulatory

flexibility analysis is not necessary, and

certifies, under section 605 of the

Regulatory Flexibility Act (5 U.S.C.

605(b)), that the amendments

announced today will not have a

significant economic impact on a

substantial number of small entities.

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 C to part 305 is revised

to read as follows:

Appendix C To Part 305—Dishwashers

Range Information

‘‘Compact’’ includes countertop

dishwasher models with a capacity of fewer

than eight (8) place settings.

‘‘Standard’’ includes portable or built-in

dishwasher models with a capacity of eight

(8) or more place settings.

Place settings shall be in accordance with

appendix C to 10 CFR part 430, Subpart B.

Load patterns shall conform to the operating

normal for the model being tested.

Capacity

Range of estimated annual

energy consumption (kWh/

yr.)

Low High

Compact ............................ 302 302

Standard ............................ 344 699

3. In section 2 of Appendix H of Part 305,

the text and formulas are amended by

removing the figure ‘‘8.6¢’’ whenever it

appears and by adding, in its place, the figure

‘‘8.31¢’’. In addition, the text and formulas

are amended by removing the figure ‘‘12.90¢’’

whenever it appears and by adding, in its

place, the figure ‘‘12.47¢’’.

4. In section 2 of Appendix I of Part 305,

the text and formulas are amended by

removing the figure ‘‘8.6¢’’ wherever it

appears and by adding, in its place, the figure

‘‘8.31¢’’. In addition, the text and formulas

are amended by removing the figure ‘‘12.90¢’’

wherever it appears and by adding, in its

place, the figure ‘‘12.47¢’’.

By direction of the Commission.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–22489 Filed 8–22–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314, 600, 601, 610, and

640

[Docket No. 95N–0329]

Biologics Regulations; Reporting

Changes to an Approved Application;

Open Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Announcement of public

meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

open public meeting to discuss issues

related to the agency’s final rule

entitled, ‘‘Changes to an Approved

Application’’ announced previously in

the Federal Register. The final rule

amended the biologics regulations for

reporting changes to an approved

application reviewed in the Center for

Biologics Evaluation and Research

(CBER) and the corresponding drug

regulations for reporting changes to an

approved application for specified

biotechnology products reviewed in the

Center for Drug Evaluation and Research

(CDER). The purpose of the meeting is

to present the regulatory procedures set

forth in the final rule and to solicit

public comment on a portion of the final

rule that addresses the use of a

‘‘comparability protocol.’’

DATES: The open public meeting will be

held on Wednesday, September 24,

1997, from 8:30 a.m. to 5 p.m.

Registration for persons who want to

participate at the meeting must be

submitted to the agency by September 3,

1997, including written copies or a brief

summary of the presentation, or any

written comments for possible

discussion at the meeting.

Preregistration for persons who want to

attend the meeting should be received

by September 18, 1997.

ADDRESSES: The open public meeting

will be held at the Quality Hotel, 8727

Colesville Rd., Silver Spring, MD 20910.

Submit written requests for

participation and written comments to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,
44892 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

Rockville, MD 20857, between 9 a.m.

and 4 p.m., Monday through Friday. To

expedite the processing, written notices

of participation may also be FAXED to

301–827–3079. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this notice.

Those persons interested in attending

this meeting should submit their

registration information, including

name, title, firm name, address,

telephone and fax number, to Toni

Toomer (address below).

FOR FURTHER INFORMATION CONTACT: Toni

Toomer, Center for Biologics Evaluation

and Research (HFM–49), Division of

Manufacturers Assistance and Training,

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–1310, FAX

301–827–3079.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 24, 1997, FDA

published a final rule entitled, ‘‘Changes

to an Approved Application’’ (62 FR

39890) and two notices of availability

announcing corresponding guidance

documents entitled, ‘‘Guidance for

Industry: Changes to an Approved

Application: Biological Products’’ (62

FR 39904) and ‘‘Guidance for Industry:

Changes to an Approved Application for

Specified Biotechnology and Specified

Synthetic Biological Products’’ (62 FR

39904).

FDA is announcing an open public

meeting to discuss regulatory issues

related to the final rule. The first part of

the meeting will include an agency

presentation of the regulatory provisions

of the final rule and a discussion of the

corresponding guidance documents,

followed by a question and answer

session.

In the second part of the meeting, the

agency will solicit public comment on

the use of a comparability protocol,

which is an option available to

applicants under the final rule. A

comparability protocol describes the

specific tests and validation studies and

acceptable limits to be achieved to

demonstrate the lack of adverse effect

for specified types of changes on the

safety or effectiveness of a product.

Every effort will be made to

accommodate each person who wants to

participate in the public meeting.

However, because presentations will be

limited to the second part of the

meeting, the agency may not be able to

accommodate all requests for formal

presentations. Nevertheless, each person

may participate in the open discussion

at the end of the meeting. Accordingly,

each person who wants to participate in

the meeting is encouraged to submit a

written request for participation, by

close of business on September 3, 1997,

and to include the following

information: (1) File a written request

for participation containing the name,

address, telephone and fax number,

affiliation, if any, of the participant, and

topic of the presentation, and (2) submit

a copy or a brief summary of their

presentation, or any written comments

for possible discussion at the meeting.

The requested information, including

the written notice for participation, may

be submitted to the Dockets

Management Branch (address above).

Registration at the site will be done on

a space-available basis on the day of the

open public meeting beginning at 8:30

a.m.

Prior to the meeting, CBER will

determine the schedule for the

presenters. A schedule of the presenters

will be filed with the Dockets

Management Branch (address above)

and mailed or faxed to each participant

before the meeting. Interested persons

attending the meeting who did not

request an opportunity to make a

presentation or those who did request

an opportunity to make a presentation

but due to the time limitations were not

granted the request will be given the

opportunity to make an oral

presentation at the conclusion of the

meeting, as time permits. There is no

registration fee for this public meeting,

but advance registration is suggested.

Interested persons are encouraged to

register early because space may be

limited.

FDA will consider information

presented and discussed at the meeting

and written comments submitted to the

Dockets Management Branch (address

above) in the development of future

guidance documents.

Dated: August 19, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22555 Filed 8-22-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Bacitracin Methylene

Disalicylate and Chlortetracycline;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of March 19, 1997 (62 FR

12951) that amended the animal drug

regulations to reflect approval of a

supplemental new animal drug

application (NADA) filed by Alpharma

Inc. The document stated incorrectly

that bacitracin methylene disalicylate

and chlortetracycline Type B feeds were

included in the approval. This

document corrects that error.

EFFECTIVE DATE: March 19, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

In FR Doc. 97–6876, appearing on

page 12951, in the Federal Register of

Wednesday, March 19, 1997, the

following correction is made:

1. On page 12951, in the third column

under the ‘‘SUMMARY’’caption, in line 9,

‘‘Types B and C’’ is corrected to read

‘‘Type C’’.

Dated: August 12, 1997.

Michael J. Blackwell,

Deputy Commissioner for Veterinary

Medicine.

[FR Doc. 97–22553 Filed 8-22-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 86F–0060]

Food Additives Permitted in Feed and

Drinking Water of Animals; Selenium

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is adopting

without change the provisions of an

interim rule regarding the approved use

of selenium as a food additive in animal

feeds. The interim rule implemented

certain provisions of the Agriculture,

Rural Development, FDA, and Related

Agencies Appropriations Act of 1994,

and the Federal Crop Insurance Reform

and Department of Agriculture

Reorganization Act of 1994.

EFFECTIVE DATE: September 9, 1997.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Benz, Center for Veterinary

Medicine (HFV–228), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1724.