47670 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices

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 September 3, 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, subject to final

approval, to a proposed consent order from

respondent London International Group, Inc.

(‘‘London International’’) a New Jersey

corporation.

The proposed consent order has been

placed on the public record for sixty (60)

days for reception of 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 and

take other appropriate action or make final

the agreement’s proposed order.

London International manufactures and

markets various brands of condoms to the

public, including Ramses brand condoms.

The Commission’s complaint charges that

respondent’s advertising contained

unsubstantiated comparative strength

representations. Specifically, the complaint

alleges that the respondent did not possess

adequate substantiation for claims that: (1)

Ramses brand condoms are thirty percent

stronger than the leading brand; and (2)

Ramses brand condoms break thirty percent

less often than the leading brand.

The proposed consent order contains

provisions designed to remedy the violations

charged and to prevent the respondent from

engaging in similar acts and practices in the

future.

Part I of the proposed order would prohibit

the respondent from making any claim about:

(1) The comparative or quantifiable strength

of any condom; (2) the comparative or

quantifiable risk of breakage of any condom;

or (3) the comparative or quantifiable efficacy

of any condom, unless at the time of making

the claim, it possesses and relies upon

competent and reliable evidence.

Part I contains a provision that would

permit respondent to make any claim about

condoms that is approved by the Food and

Drug Administration (‘‘FDA’’) without

violating the settlement. This provision,

however, excludes claims that the FDA has

permitted through clearing a ‘‘premarket

notification report,’’ unless the clearance was

based on a review and evaluation of the

substantiation submitted with the report.

The proposed order also requires the

respondent to maintain materials relied upon

to substantiate claims covered by the order;

to provide a copy of the consent agreement

to all employees or representatives involved

in the preparation and placement of the

company’s advertisements, as well as to all

company executives and marketing and sales

managers; to notify the Commission of any

changes in corporate structure that might

affect compliance with the order; and to file

one or more reports detailing compliance

with the order.

The purpose of this analysis is to facilitate

public comment on the proposed order. 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. 97–23979 Filed 9–9–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0391]

Central Georgia Plasma Lab, Inc.;

Revocation of U.S. License No. 0649–

001

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 0649–001) and

product license issued to Central

Georgia Plasma Lab, Inc. (Central

Georgia), for the manufacture of Source

Plasma. A notice of opportunity for a

hearing on a proposal to revoke the

licenses was published in the Federal

Register of May 20, 1994 (59 FR 26503).

Central Georgia subsequently requested

a hearing. However, in a letter dated

July 12, 1996, the firm notified FDA that

it had ceased operations effective June

25, 1996, and voluntarily requested

revocation of its licenses. The request

for an opportunity for a hearing on the

issue of license revocation became

moot. FDA, therefore, proceeded to

revoke the firm’s licenses.

DATES: The revocation of the

establishment license (U.S. License No.

0649–001) and product license became

effective August 21, 1996.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA has

revoked the establishment license (U.S.

License No. 0649–001), which includes

the product license issued to Central

Georgia Plasma Lab, Inc., 652 Third St.,

Macon, GA 31201, for the manufacture

of Source Plasma.

By letter dated May 27, 1993, FDA

notified Central Georgia that it was

instituting proceedings to revoke U.S.

License No. 0649–001, and announced

its intent to issue a notice of

opportunity for a hearing. Central

Georgia responded in a letter of June 1,

1993, and advised FDA that the firm did

not wish to waive its opportunity for a

hearing. In the Federal Register of May

20, 1994 (59 FR 26503), FDA announced

an opportunity for a hearing on the

proposal to revoke the establishment

and product license issued to Central

Georgia. In the notice of opportunity for

a hearing, FDA described its finding that

Central Georgia had willfully not

complied with the applicable standards

and regulations. As described in the

notice of opportunity for a hearing, the

grounds for the proposed license

revocation included the following: (1)

The results of FDA’s inspections of the

firm, beginning in 1981, but most

recently from July 1989 through

February 1993; (2) a determination by

FDA that the deviations documented

during the inspections of the firm

demonstrated significant

noncompliance with the applicable

regulations and the standards and

conditions established in the firm’s

licenses; (3) a determination that the

nature of the deficiencies noted

demonstrated the continuing failure of

the Responsible Head to exercise control

of the establishment in all matters

relating to compliance and to assure that

personnel are adequately trained and

properly supervised and have a

thorough understanding of the

procedures that they perform, as

required by 21 CFR 600.10(a) and

606.20(a). Documentation in support of

the proposed revocation had been

placed on file for public examination

with the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Notices 47671

Following publication of the notice of

opportunity for a hearing and in

accordance with the procedures set

forth in parts 12 and 601 (21 CFR parts

12 and 601), on June 15, 1994, the

Responsible Head of Central Georgia

submitted a request for a hearing to the

Dockets Management Branch and, on

July 15, 1994, provided additional

supplemental information to justify the

request for a hearing.

While the request for a hearing was

pending, the owner and former

Responsible Head of Central Georgia

informed the agency by letter dated July

12, 1996, that Central Georgia had

closed its facility on June 24, 1996, and

ceased operations effective June 25,

1996, and was voluntarily surrendering

both the establishment and product

licenses. FDA notified Central Georgia

by letter of August 21, 1996, that the

licenses had been revoked.

Based on the voluntary surrender of

U.S. License No. 0649–001, Central

Georgia’s request for a hearing on the

issue of license revocation became

moot. Central Georgia effectively waived

an opportunity for a hearing on the

matter (§ 601.5(a)).

Accordingly, under § 601.5(a), section

351 of the Public Health Service Act (42

U.S.C. 262), and under authority

delegated to the Commissioner of Food

and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68), the establishment license

(U.S. License No. 0649–001) and the

product license issued to Central

Georgia Plasma Lab, Inc., for the

manufacture of Source Plasma were

revoked, effective August 21, 1996.

This notice is issued and published

under § 601.8 and the redelegation at 21

CFR 5.67.

Dated: August 25, 1997.

Mark Elengold,

Acting Deputy Director, Center for Biologics

Evaluation and Research.

[FR Doc. 97–23946 Filed 9-9-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: AIDS Drug

Assistance Program [ADAP]: Monthly

Client Utilization and Program

Expenditure Assessment Project—

NEW—State AIDS Drug Assistance

Programs [ADAP], funded under section

2611 of the Public Health Service Act

(commonly known as Title II of the

Ryan White Comprehensive AIDS

Resources Emergency [CARE] Act) are

designed to provide low income,

uninsured, and underinsured

individuals with access to HIV/AIDS

medications that prevent serious

deterioration of health arising from HIV

disease, including prevention and

treatment of opportunistic diseases.

Due to the increasing need for

pharmaceuticals among uninsured and

underinsured low-income individuals

who are HIV+ or diagnosed with AIDS,

and recognizing the importance of

program planning and budget

forecasting to maximize resources, the

Division of Service Systems [DSS],

Health Resources and Services

Administration [HRSA], proposes to

collect relevant client utilization data

and program expenditure information

on a voluntary monthly reporting basis

from State ADAPs. This effort is

designed to assist Title II grantees, State

ADAPs, the DSS/HRSA funding agency

staff, and policymakers at both the

Federal and State level to better

understand the level of client need for

medications that the programs are

functioning under and the resources

used to meet the needs, and to provide

indicators of where future action may be

required and the most appropriate

response(s).

A report is proposed that will collect

monthly data on the level of

expenditures and client utilization of

services. In addition, the report will

provide a forum for tracking the most

current changes in each State ADAP

with respect to available funding,

eligibility criteria, clinical guidelines,

and formulary changes. On a quarterly

basis, the report will also request the

prices of eight specified

pharmaceuticals dispensed by each

program. The individual State reports

will be compiled into summary reports

and distributed back to grantees and

State ADAPs on a monthly basis, and

will be available for use by HRSA and

the Office of Management and Budget.

These results will be used to guide

program planning, to formulate budget

recommendations, and to monitor the

balance between available resources and

State needs. The burden estimates are as

follows:

Type of form Number of respondents

Responses

per

respondent

Hours per

response

Total burden hours

ADAP Monthly Update ................................................................................................. 54 12 1 648

ADAP Quarterly Drug Pricing Update .......................................................................... 54 4 1 216

Total ................................................................................................................... 54 16 1 864