Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Notices 41965

(BHC Act), Regulation Y (12 CFR Part

225), and all other applicable statutes

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act.

Unless otherwise noted, nonbanking

activities will be conducted throughout

the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than August 29,

1997.

A. Federal Reserve Bank of Atlanta

(Lois Berthaume, Vice President) 104

Marietta Street, N.W., Atlanta, Georgia

30303-2713:

1. Northside Banking Corporation,

Tampa, Florida; to become a bank

holding company by acquiring 100

percent of the voting shares of Northside

Bank of Tampa, Tampa, Florida.

Board of Governors of the Federal Reserve

System, July 30, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–20465 Filed 8-1-97; 8:45 am]

BILLING CODE 6210-01-F

FEDERAL TRADE COMMISSION

[File No. 962–3210]

Global World Media Corporation; Sean

Shayan; Analysis to Aid Public

Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

SUMMARY: The consent agreement in this

matter settles alleged violations of

federal law prohibiting unfair or

deceptive acts or practices or unfair

methods of competition. The attached

Analysis to Aid Public Comment

describes both the allegations in the

draft complaint that accompanies the

consent agreement and the terms of the

consent order—embodied in the consent

agreement—that would settle these

allegations.

DATES: Comments must be received on

or before October 3, 1997.

ADDRESSES: Comments should be

directed to: FTC/Office of the Secretary,

Room 159, 6th St. and Pa. Ave., N.W.,

Washington, D.C. 20580.

FOR FURTHER INFORMATION CONTACT:

Joel Winston, Federal Trade

Commission, S–4002, 6th St. and Pa.

Ave., N.W., Washington, D.C. 20580.

(202) 326–3153.

Michelle Rusk, Federal Trade

Commission, S–466, 6th St. and Pa.

Ave., N.W., Washington, D.C. 20580.

(202) 326–3148.

Nancy Warder, Federal Trade

Commission, S–4002, 6th St. and Pa.

Ave., N.W., Washington, D.C. 20580.

(202) 326–3048.

SUPPLEMENTARY INFORMATION: Pursuant

to Section 6(f) of the Federal Trade

Commission Act, 38 Stat. 721, 15 U.S.C.

46, and Section 2.34 of the

Commission’s Rules of Practice (16 CFR

2.34), notice is hereby given that the

above-captioned consent agreement

containing a consent order to cease and

desist, having been filed with and

accepted, subject to final approval, by

the Commission, has been placed on the

public record for a period of sixty (60)

days. The following Analysis to Aid

Public Comment describes the terms of

the consent agreement, and the

allegations in the accompanying

complaint. An electronic copy of the

full text of the consent agreement

package can be obtained from the

Commission Actions section of the FTC

Home Page (for July 29, 1997), on the

World Wide Web, at

‘‘http:÷www.ftc.gov¤os¤actions¤htm.’’

A paper copy can be obtained from the

FTC Public Reference Room, Room H–

130, Sixth Street and Pennsylvania

Avenue, N.W., Washington, D.C. 20580,

either in person or by calling (202) 326–

3627. Public comment is invited. Such

comments or views will be considered

by the Commission and will be available

for inspection and copying at its

principal office in accordance with

Section 4.9(b)(6)(ii) of the Commission’s

Rules of Practice (16 CFR 4.9(b)(6)(ii)).

Analysis of Proposed Consent Order To

Aid Public Comment

The Federal Trade Commission has

accepted an agreement to a proposed

consent order from Global World Media

Corporation (‘‘GWMC’’), the marketer of

Herbal Ecstacy or Ecstacy (‘‘Ecstacy’’),

and its owner, Sean Shayan [hereinafter

sometimes referred to as respondents].

The proposed consent order has been

placed on the public record for sixty

(60) days for reception of public

comments by interested persons.

Comments received during this period

will become part of the public record.

After sixty (60) days, the Commission

will again review the agreement and the

comments received and will decide

whether it should withdraw from the

agreement or make final the agreement’s

proposed order.

The Commission’s complaint in this

matter concerns safety claims

respondents made in advertising for

Ecstacy, a dietary supplement that

respondents promoted as a natural

‘‘high’’ and expressly likened to the

illegal street drug MDMA. More

specifically, the complaint alleges that

respondents represented that Ecstacy,

when taken in the recommended doses

or other reasonably foreseeable

amounts, is absolutely safe and has no

side effects. The complaint explains that

Ecstacy contains a botanical source of

ephedrine alkaloids, which can have

dangerous effects on the nervous system

and heart. Thus, according to the

complaint, the claim that Ecstacy is safe

and side effect free is both false and

unsubstantiated.

In addition, the complaint charges

that respondents represented in their

advertising for Ecstacy, including in ads

that ran on cable programming stations

with substantial youth audiences, such

as Nickelodeon and MTV, that Ecstacy

is a safe alternative to illegal drugs to

produce euphoric, psychotropic (mindaltering), or sexual enhancement effects,

but failed to disclose the health and

safety risks of using the product.

According to the complaint the

undisclosed facts would be material to

consumers and, therefore, respondents’

omission of the facts about the health

and safety risks of Ecstacy in their

advertising is alleged to be a deceptive

practice.

Finally, the complaint challenges an

endorsement of Ecstacy’s safety and lack

of side effects contained in respondents’

advertising and attributed to a Dr.

Steven Jonson of Tel Aviv, Israel.

According to the complaint, the

endorsement is false because Dr. Jonson

is a fictitious person.

The proposed consent order contains

provisions designed to remedy the

violations charged and to prevent

respondents from engaging in similar

acts and practices in the future.

Part I of the order prohibits (1) claims

that Ecstacy or any other food, drug, or

dietary supplement is safe or will cause

no side effects; or (2) any other safety or
41966 Federal Register / Vol. 62, No. 149 / Monday, August 4, 1997 / Notices

side effects claims, unless the claim is

true and substantiated by scientific

evidence.

Part II prohibits respondents from

making any representation for any food,

drug, or dietary supplement that

contains ephedrine alkaloids that

consumers can appropriately take such

product in an amount that exceeds the

level established by any regulation of

the Food and Drug Administration

(‘‘FDA’’) for ephedrine alkaloids or any

other ingredient in the product.

Part III requires the following clear

and prominent disclosure in all future

advertising and labeling of, and all

consumer communications concerning,

any ephedrine-alkaloid-containing

product sold by respondents:

Warning: This product contains

ephedrine which can have dangerous

effects on the central nervous system

and heart and could result in serious

injury. Risk of injury increases with

dose.

Under Part III, if the product is subject

to an FDA rule or regulation that

requires a labeling warning, that

warning is required in labeling in lieu

of the warning set forth above.

Part IV prohibits respondents from

assisting others, including by selling

product to them, when respondents

have reason to believe that they are

deceptively promoting respondents’

ephedrine-containing products.

Part V prohibits misrepresentations

about endorsements and testimonials.

Part VI prohibits respondents from

directing to individuals under the age of

twenty-one advertising and promotional

activities for Ecstasy or any other

ephedrine product marketed as an

alternative to an illegal drug or for its

euphoric, psychotropic, or sexual

effects. Part VI includes examples of

prohibited activity, including

advertisements and promotions to

audiences half or more under twentyone.

Part VII requires the respondents to

conduct and submit annual analyses of

the levels of ephedrine alkaloids in any

ephedrine-containing product that they

sell for the next five (5) years.

Part VIII provides that nothing in the

order permits the respondents to market

any product (1) in a state where its sale

has been banned; (2) in a manner that

is inconsistent with state restrictions on

its sale; or (3) in a way that is

inconsistent with any applicable FDA

rule or regulation.

Parts IX and X provide safe harbors

for claims approved pursuant to FDA’s

regulation of the labeling for drugs and

foods, respectively.

Part XI requires respondents to send

a letter (Attachment A to the order) to

anyone who provides the public with

information about any of respondents’

ephedrine-containing products. The

letter advises the recipient that the

disclosure required by Part III of the

order must be made in all

communications with consumers

concerning any of respondents’

ephedrine-containing products and that

the only permissible statement about the

dose of any such product is the

information on the label. Part XII sets

forth the record keeping and

surveillance requirements with respect

to Part XI.

Part XIII requires respondents to send

a letter (Attachment B to the order) to

distributors and resellers, including any

person who purchases more than 100

units of any of respondents’ ephedrinecontaining products in any there (3)

month period. The letter describes the

Commission’s action in this case and

advises recipients to discontinue use of

any promotional materials that do not

comply with the order. Part XIV set

forth the record keeping and

surveillance requirements with respect

to Part XIII.

The remaining parts of the order

contain standard provisions pertaining

to record keeping, compliance,

sunsetting of the order, and similar

matters.

The purpose of this analysis is to

facilitate public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

Donald S. Clark,

Secretary.

[FR Doc. 97–20450 Filed 8–1–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA) will

publish periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans, call the HRSA Reports Clearance

Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Reporting

Requirements for the National Health

Service Corps (NHSC) Non-Grant

Sites—New—The National Health

Service Corps (NHSC) is a component of

the Bureau of Primary Health Care,

Health Resources and Services

Administration, Department of Health

and Human Services. The mission of the

NHSC is to assist in the development,

recruitment, and retention of

community-responsive, culturally

competent, primary care providers to

serve people in health professional

shortage areas. The mission is

implemented through assignment of

personnel to 365 BPHC grant-supported

health care sites and 312 sites receiving

no grant support.

The NHSC is required to collect

specific data from the sites to which

NHSC providers are assigned. For grantsupported sites, this is accomplished

through the Uniform Data System

(UDS)(OMB No. 0915–0193). The UDS

data are utilized to comply with

congressionally mandated actions such

as billing sites for the reimbursement of

the cost of NHSC assignees and

preparing reports for Congress. The UDS

data are also utilized for evaluating the

overall effectiveness of the NHSC to

include appropriateness of NHSC

assignee placements and expenditure of

funds.

This request is to collect a subset of

the UDS data from the non-grant

supported sites in order to facilitate full

compliance with the congressionally

mandated billing and reporting

requirements.

For this purpose a modified reporting

tool with less burden has been

developed for the non-grant supported

sites which will collect information on

services provided, populations served,

staffing and utilization, finances, and

managed care enrollment.

The following burden table was

developed based on experience with