Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices 46499

year on compliance with the Rule, for a

total estimate of 16,213,300 burden

hours.

No provisions in the Mail or

Telephone Order Merchandise Rule

have been amended or changed in any

manner. All of the requirements relating

to disclosure and notification remain

the same. We have, however, reduced

the 1995 total burden estimate of

16,213,300 hours for the reasons

discussed below.

In the OMB regulation implementing

the PRA, burden is defined to exclude

any effort that would be expended

regardless of any regulatory

requirement. 5 CFR 1320.3(b)(2). In past

rulemaking proceedings, industry trade

associations and individual witnesses

have testified that compliance with the

Rule is now widely regarded by direct

marketers as being good business

practice. The Rule’s notification

requirements would be followed in any

event by most merchants to meet

consumer expectations with respect to

timely shipment, notification of delay,

and prompt and full refunds. Providing

consumers with notice about the status

of their orders fosters consumer loyalty

and encourages repeat purchases that

are important to the success of direct

marketers. Thus, much of the time and

expense associated with Rule

compliance is not properly treated as

burden under the PRA.

In estimating any remaining burden,

the agency has considered ‘‘the total

time, effort, or financial resources

expended by persons to generate,

maintain, retain, disclose or provide

information to or for a Federal agency.’’

5 CFR 1320.3(b)(1). This includes

‘‘developing, acquiring, installing, and

utilizing technology and systems for the

purpose of disclosing and providing

information.’’ 5 CFR 1320.3(b)(1)(iv).

Although not expressly stated in the

regulation, it seems reasonable to infer

that the definition of burden would

include upgrading and maintaining

computer systems used to comply with

the Rule’s requirements.

The mail order industry has been

subject to the basic provisions of the

Rule since 1976 and the telephone order

industry since 1994. Thus, businesses

have had several years (and some have

had decades) to integrate compliance

systems into their business procedures.

Nonetheless, staff has allocated some

hours, estimated at 150 hours annually

per company, toward the maintenance

of computer systems by the affected

companies, even though maintenance

and upkeep arguably would also be part

of ordinary business practice in the

industry.

Further, in our best judgment (more

accurate data from the industry is not

currently available), approximately

1,000 new companies have entered the

market since 1995. Thus, the current

total affected firms would consist of

approximately 71,560 companies.

Additionally, staff estimates that the

approximately 1,000 new companies

enter the covered market each year.

Further, we estimate that new

companies entering the market would

need 230 hours per year (1995 figure of

229.78 rounded to 230) for compliance

measures associated with system startup, although again, it could be argued

that such efforts would be undertaken

even absent the Rule. We have therefore

estimated that the total burden for

compliance with the Rule would be

approximately 10,964,000 hours.

(1,000×230=230,000)+

(71,560×150=10,734,000.)

To emphasize, the FTC has not

amended, nor is it in the process of

amending, the Mail or Telephone Order

Merchandise Rule. The burden hours

associated with the Rule have been

recalculated because the originallyestimated hours included one-time start

up tasks (i.e., implementing systems and

processes to meet the Rule’s

requirements) that have now been

completed by most of the affected

companies.

FOR FURTHER INFORMATION CONTACT:

Elaine W. Crockett (202) 326–2453; FAX

(202) 326–2447; E-mail:

ecrockett@ftc.gov.

Jay C. Shaffer,

Acting General Counsel.

[FR Doc. 97–23311 Filed 9–2–97; 8:45 am]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS

ANNOUNCEMENT: 62 F.R., Friday, August

22, 1997, Page No. 44698.

PREVIOUSLY ANNOUNCED TIME AND DATE OF

THE MEETING: 10:00 a.m., Wednesday,

September 4, 1997.

CHANGES IN THE AGENDA: The Federal

Trade Commission has canceled its

previously scheduled Oral Argument

meeting for September 4, 1997, at 10:00

a.m.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–23385 Filed 8–28–97; 4:11 pm]

BILLING CODE 6750–01–M

FEDERAL TRADE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS

ANNOUNCEMENT: 62 F.R., Friday, August

22, 1997, Page No. 44698.

PREVIOUSLY ANNOUNCED TIME AND DATE OF

THE MEETING: 2:00 p.m., Wednesday,

September 3, 1997.

CHANGES IN THE AGENDA: The Federal

Trade Commission has cancelled its

previously scheduled Oral Argument

meeting for September 3, 1997, at 2:00

p.m.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 97–23527 Filed 8–29–97; 3:28 pm]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

The Department of Health and Human

Services, Office of the Secretary

publishes a list of information

collections it has submitted to the Office

of Management and Budget (OMB) for

clearance in compliance with the

Paperwork Reduction Act of 1995 (44

U.S.C. Chapter 35) and 5 CFR 1320.5.

The following are those information

collections recently submitted to OMB.

1. Information Collection

Requirements Contained in 42 CFR part

1004 (Revised Peer Review Organization

Sanctions for Failing to Meet Statutory

Obligations)—This information

collection requirement is necessary to

enable a Peer Review Organization

(PRO) to submit a report and

recommendation to the OIG if PROidentified violations have not been

resolved. In addition, an alternative

sanctions notification process provides

sanctioned practitioners or other

persons the option of informing patients

directly to the sanction action taken

against them.—Respondents:

Individuals, Business or other for-profit;

Not-for-profit institutions—Burden

Information for the PRO Report—

Annual Responses: 7;Annual Burden

per Response: 4 hours;Annual Burden

for PRO Report: 28 hours—Burden

Information for the Sanction

Notification—Annual Responses:

5;Annual Burden per Response: 2

hours;Annual Burden for Sanction

Notification: 10 hours—Total Burden:

38 hours.

OMB Desk Officer: Allison Eydt.
46500 Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices

Copies of the information collection

packages listed above can be obtained

by calling the OS Reports Clearance

Officer on (202) 690–6207. Written

comments and recommendations for the

proposed information collection should

be sent directly to the OMB desk officer

designated above at the following

address: Human Resources and Housing

Branch, Office of Management and

Budget, New Executive Office Building,

Room 10235, 725 17th Street NW.,

Washington, DC 20503.

Comments may also be sent to

Cynthia Agens Bauer, OS Reports

Clearance Officer, Room 503H,

Humphrey Building, 200 Independence

Avenue SW., Washington, DC 20201.

Written comments should be received

within 30 days of this notice.

Dated: August 27, 1997.

William R. Beldon,

Acting Deputy Assistant Secretary, Budget.

[FR Doc. 97–23304 Filed 9–2–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of Two Meetings of the National

Bioethics Advisory Commission

(NBAC): One Each of its Genetics and

Human Subjects Subcommittees

SUMMARY: Pursuant to Section 10(d) of

the Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is given of two meetings of the National

Bioethics Advisory Commission.

Commission members will solicit

testimony on the protection of the rights

and welfare of human subjects in

research including decisionally and/or

cognitively impaired populations and

will address the use of genetic

information involved in tissue storage.

The meetings are open to the public and

opportunities for statements by the

public will be provided.

DATES/TIMES/LOCATIONS:

Human Subjects Subcommittee

September 18, 1997, 8:15 am–5:30 pm,

(9:00 am–12 noon public hearing)—

National Institutes of Health, 9000

Rockville Pike, Building 31, 6th Floor,

Conference Room 10, Bethesda,

Maryland 20892

Genetics Subcommittee

September 18, 1997, 3:00 pm–5:30 pm—

National Institutes of Health, 9000

Rockville Pike, Building 31, 6th Floor,

Conference Room 9, Bethesda,

Maryland 20892

September 19, 1997, 8:30 am–12:30

pm—Same Location as Above

SUPPLEMENTARY INFORMATION: The

President established the National

Bioethics Advisory Commission (NBAC)

by Executive Order 12975 on October 3,

1995. The mission of the NBAC is to

advise and make recommendations to

the National Science and Technology

Council and other entities on bioethical

issues arising from the research on

human biology and behavior, and in the

applications of that research including

clinical applications.

Public Participation

All meetings are open to the public

with attendance limited by the

availability of space. On September 18,

1997, the Human Subjects

Subcommittee of the National Bioethics

Advisory Commission will discuss

possible guidelines for research

involving decisionally or cognitively

impaired subjects, and public testimony

is invited on the ethical issues of such

research. A public hearing will be held

on ethical issues in research involving

decisionally or cognitively impaired

individuals from 9:00 am—12 noon on

September 18, 1997. Members of the

public who wish to present oral

statements should contact the Deputy

Executive Director of the NBAC by

telephone, fax machine, or mail as

shown below prior to the meeting as

soon as possible. Individuals unable to

make oral presentations are encouraged

to mail or fax their comments to the

NBAC staff office for distribution to the

subcommittee members or Commission

and inclusion in the public record.

Persons needing special assistance,

such as sign language interpretation or

other special accommodations, should

contact NBAC staff at the address or

telephone number listed below as soon

as possible.

FOR FURTHER INFORMATION CONTACT: Ms.

Henrietta D. Hyatt-Knorr, National

Bioethics Advisory Commission, MSC–

7508, 6100 Executive Boulevard, Suite

5B01, Rockville, Maryland 20892–7508,

telephone 301–402–4242, fax number

301–480–6900.

Dated: August 28, 1997.

Henrietta D. Hyatt-Knorr,

Deputy Executive Director, Acting, National

Bioethics Advisory Commission.

[FR Doc. 97–23377 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0353]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by October 3,

1997.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Food Additives and Food Additive

Petitions (21 CFR Parts 171, 172, 173,

175 to 178, and 180) (OMB Control

Number 0910–0016—Reinstatement)

Section 409(a) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 348(a)) provides that any

particular use or intended use of a food

additive shall be deemed to be unsafe,

unless the additive and its use or

intended use are in conformity with a

regulation issued under section 409 of

the act that describes the condition(s)

under which the additive may be safely

used, or unless the additive and its use

or intended use conform to the terms of

an exemption for investigational use.

Food additive petitions are submitted by

individuals or companies to obtain

approval of a new food additive or to

amend the conditions of use permitted

under an existing food additive

regulation. Section 171.1 (21 CFR 171.1)