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58306 Federal Register / Vol. 72, No.

198 / Monday, October 15, 2007 / Notices

or health-related service or program is FEDERAL TRADE COMMISSION public comments, whether filed in
effective in preventing, treating, or paper or electronic form, will be
[File No. 072–3140]
curing osteoporosis, in preventing or considered by the Commission, and will
reducing the risk of estrogen-induced Lawrence and Stephanie Jordan, be available to the public on the FTC
endometrial cancer or breast cancer, or individuals trading and doing business Web site, to the extent practicable,
in the mitigation, treatment, prevention, as Springboard and Pro Health Labs; athttp://www.ftc.gov. As a matter of
or cure of any disease, illness, or health Analysis of Proposed Consent Order discretion, the FTC makes every effort to
condition; that it does not increase the to Aid Public Comment remove home contact information for
user’s risk of developing breast cancer, individuals from the public comments it
AGENCY: Federal Trade Commission. receives before placing those comments
is safe for human use, or has no side
ACTION: Proposed Consent Agreement. on the FTC Web site. More information,
effects; or about its health benefits,
performance, efficacy, safety, or side including routine uses permitted by the
SUMMARY: The consent agreement in this
Privacy Act, may be found in the FTC’s
effects. matter settles alleged violations of
privacy policy, athttp://www.ftc.gov/ftc/
Part II of the proposed order prevents federal law prohibiting unfair or
privacy.htm.
respondent from misrepresenting the deceptive acts or practices or unfair
methods of competition. The attached FOR FURTHER INFORMATION CONTACT:
existence, contents, validity, results, Laura DeMartino (202) 326-3030,
conclusions, or interpretations of any Analysis to Aid Public Comment
describes both the allegations in the Bureau of Consumer Protection, Room
test, study, or research. NJ-2122, 600 Pennsylvania Avenue,
draft complaint and the terms of the
Part III of the proposed order provides consent order—embodied in the consent NW., Washington, DC 20580.
that the order does not prohibit agreement—that would settle these SUPPLEMENTARY INFORMATION: Pursuant
respondent from making representations allegations. to section 6(f) of the Federal Trade
for any drug that are permitted in Commission Act, 38 Stat. 721, 15 U.S.C.
DATES: Comments must be received on
labeling for the drug under any tentative 46(f), and § 2.34 of the Commission
or before November 7, 2007.
final or final Food and Drug Rules of Practice, 16 CFR 2.34, notice is
ADDRESSES: Interested parties are
Administration (‘‘FDA’’) standard or hereby given that the above-captioned
invited to submit written comments. consent agreement containing a consent
under any new drug application Comments should refer to ‘‘Pro Health
approved by the FDA; representations order to cease and desist, having been
Labs, File No. 071 3140,’’ to facilitate filed with and accepted, subject to final
for any medical device that are the organization of comments. A
permitted in labeling under any new approval, by the Commission, has been
comment filed in paper form should placed on the public record for a period
medical device application approved by include this reference both in the text
the FDA; and representations for any of thirty (30) days. The following
and on the envelope, and should be Analysis to Aid Public Comment
product that are specifically permitted mailed or delivered to the following describes the terms of the consent
in labeling for that product by address: Federal Trade Commission/ agreement, and the allegations in the
regulations issued by the FDA under the Office of the Secretary, Room 135-H, complaint. An electronic copy of the
Nutrition Labeling and Education Act of 600 Pennsylvania Avenue, NW., full text of the consent agreement
1990. Washington, DC 20580. Comments package can be obtained from the FTC
Parts IV through VIII require containing confidential material must be Home Page (for October 5, 2007), on the
respondent to keep copies of relevant filed in paper form, must be clearly World Wide Web, at http://www.ftc.gov/
advertisements and materials labeled ‘‘Confidential,’’ and must os/2007/10/index.htm. A paper copy
comply with Commission Rule 4.9(c). can be obtained from the FTC Public
substantiating claims made in the
16 CFR 4.9(c) (2005).1 The FTC is Reference Room, Room 130-H, 600
advertisements; to provide copies of the
requesting that any comment filed in Pennsylvania Avenue, NW.,
order to certain of her personnel; to paper form be sent by courier or
notify the Commission of changes in Washington, DC 20580, either in person
overnight service, if possible, because or by calling (202) 326-2222.
corporate structure and changes in U.S. postal mail in the Washington area
employment that might affect Public comments are invited, and may
and at the Commission is subject to be filed with the Commission in either
compliance obligations under the order; delay due to heightened security
and to file compliance reports with the paper or electronic form. All comments
precautions. Comments that do not should be filed as prescribed in the
Commission. Part IX provides that the contain any nonpublic information may ADDRESSES section above, and must be
order will terminate after twenty (20) instead be filed in electronic form as received on or before the date specified
years under certain circumstances. part of or as an attachment to e-mail in the DATES section.
The purpose of this analysis is to messages directed to the following e-
facilitate public comment on the mail box: consentagreement@ftc.gov. Analysis of Agreement Containing
proposed order. It is not intended to The FTC Act and other laws the Consent Order to Aid Public Comment
constitute an official interpretation of Commission administers permit the The Federal Trade Commission
the agreement and proposed order or to collection of public comments to (‘‘FTC’’ or ‘‘Commission’’) has accepted,
consider and use in this proceeding as subject to final approval, an agreement
modify in any way their terms.
appropriate. All timely and responsive containing a consent order from
By direction of the Commission.
1 The comment must be accompanied by an
Lawrence Jordan and Stephanie Jordan,
Donald S. Clark, explicit request for confidential treatment,
individuals trading and doing business
as Springboard and Pro Health Labs
sroberts on PROD1PC70 with NOTICES

Secretary. including the factual and legal basis for the request,
[FR Doc. E7–20276 Filed 10–12–07: 8:45 am] and must identify the specific portions of the (together, ‘‘respondents’’).
comment to be withheld from the public record. The proposed consent order has been
[BILLING CODE 6750–01–S] The request will be granted or denied by the
Commission’s General Counsel, consistent with
placed on the public record for thirty
applicable law and the public interest. See (30) days for reception of comments by
Commission Rule 4.9(c), 16 CFR 4.9(c). interested persons. Comments received

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Federal Register / Vol. 72, No. 198 / Monday, October 15, 2007 / Notices 58307

during this period will become part of for any medical device that are in the text and on the envelope, and
the public record. After thirty (30) days, permitted in labeling under any new should be mailed or delivered to the
the Commission will again review the medical device application approved by following address: Federal Trade
agreement and the comments received the FDA; and representations for any Commission/Office of the Secretary,
and will decide whether it should product that are specifically permitted Room 135-H, 600 Pennsylvania Avenue,
withdraw from the agreement or make in labeling for that product by NW, Washington, D.C. 20580.
final the agreement’s proposed order. regulations issued by the FDA under the Comments containing confidential
This matter involves the advertising Nutrition Labeling and Education Act of material must be filed in paper form,
and promotion of ProBalance and 1990. must be clearly labeled ‘‘Confidential,’’
ProBalance Plus, transdermal creams Parts IV through VIII require and must comply with Commission
that, according to their labels, contain, respondents to keep copies of relevant Rule 4.9(c). 16 CFR 4.9(c) (2005).1 The
among other ingredients, natural advertisements and materials FTC is requesting that any comment
progesterone. According to the FTC substantiating claims made in the filed in paper form be sent by courier or
complaint, respondents represented that advertisements; to provide copies of the overnight service, if possible, because
ProBalance and ProBalance Plus: (1) Are order to certain of their personnel; to U.S. postal mail in the Washington area
effective in preventing, treating, or notify the Commission of changes in and at the Commission is subject to
curing osteoporosis; (2) are effective in corporate structure and changes in delay due to heightened security
preventing or reducing the risk of employment that might affect precautions. Comments that do not
estrogen-inducted endometrial (uterine) compliance obligations under the order; contain any nonpublic information may
cancer; and (3) do not increase the and to file compliance reports with the instead be filed in electronic form as
user’s risk of developing breast cancer Commission. Part IX provides that the part of or as an attachment to email
and/or are effective in preventing or order will terminate after twenty (20) messages directed to the following email
reducing the user’s risk of developing years under certain circumstances. box: consentagreement@ftc.gov.
breast cancer. The complaint alleges The purpose of this analysis is to The FTC Act and other laws the
that respondents failed to have facilitate public comment on the Commission administers permit the
substantiation for these claims. The proposed order. It is not intended to collection of public comments to
complaint also alleges that respondents constitute an official interpretation of consider and use in this proceeding as
misrepresented that clinical testing the agreement and proposed order or to appropriate. All timely and responsive
proved that ProBalance and ProBalance modify in any way their terms. public comments, whether filed in
Plus are effective in preventing or By direction of the Commission. paper or electronic form, will be
reducing the risk of estrogen-induced considered by the Commission, and will
Donald S. Clark,
endometrial (uterine) cancer and breast be available to the public on the FTC
cancer. The proposed consent order Secretary. website, to the extent practicable, at
contains provisions designed to prevent [FR Doc. E7–20275 Filed 10–12–07: 8:45 am] www.ftc.gov. As a matter of discretion,
respondents from engaging in similar [BILLING CODE 6750–01–S] the FTC makes every effort to remove
acts and practices in the future. home contact information for
Part I of the proposed order requires individuals from the public comments it
respondents to have competent and FEDERAL TRADE COMMISSION receives before placing those comments
reliable scientific evidence [File No. 072 3143] on the FTC website. More information,
substantiating claims that any including routine uses permitted by the
progesterone product or any other Merilou Barnekow, an individual Privacy Act, may be found in the FTC’s
dietary supplement, food, drug, device trading and doing business as privacy policy, at http://www.ftc.gov/
or health-related service or program is Women’s Menopause Health Center; ftc/privacy.htm.
effective in preventing, treating, or Analysis of Proposed Consent Order FOR FURTHER INFORMATION CONTACT:
curing osteoporosis, in preventing or to Aid Public Comment Laura DeMartino (202) 326-3030,
reducing the risk of estrogen-induced Bureau of Consumer Protection, Room
endometrial cancer or breast cancer, or AGENCY: Federal Trade Commission.
ACTION: Proposed Consent Agreement. NJ-2122, 600 Pennsylvania Avenue,
in the mitigation, treatment, prevention, NW, Washington, D.C. 20580.
or cure of any disease, illness, or health SUMMARY: The consent agreement in this SUPPLEMENTARY INFORMATION: Pursuant
condition; that it does not increase the matter settles alleged violations of to section 6(f) of the Federal Trade
user’s risk of developing breast cancer, federal law prohibiting unfair or Commission Act, 38 Stat. 721, 15 U.S.C.
is safe for human use, or has no side deceptive acts or practices or unfair 46(f), and § 2.34 of the Commission
effects; or about its health benefits, methods of competition. The attached Rules of Practice, 16 CFR 2.34, notice is
performance, efficacy, safety, or side Analysis to Aid Public Comment hereby given that the above-captioned
effects. describes both the allegations in the
Part II of the proposed order prevents consent agreement containing a consent
draft complaint and the terms of the order to cease and desist, having been
respondents from misrepresenting the
consent order—embodied in the consent filed with and accepted, subject to final
existence, contents, validity, results,
agreement—that would settle these approval, by the Commission, has been
conclusions, or interpretations of any
allegations. placed on the public record for a period
test, study, or research.
Part III of the proposed order provides DATES: Comments must be received on of thirty (30) days. The following
that the order does not prohibit or before November 7, 2007.
1 The comment must be accompanied by an
respondents from making ADDRESSES: Interested parties are
explicit request for confidential treatment,
representations for any drug that are invited to submit written comments.
sroberts on PROD1PC70 with NOTICES

including the factual and legal basis for the request,


permitted in labeling for the drug under Comments should refer to ‘‘Women’s and must identify the specific portions of the
any tentative final or final Food and Menopause Health Center, File No. 071 comment to be withheld from the public record.
The request will be granted or denied by the
Drug Administration (‘‘FDA’’) standard 3143,’’ to facilitate the organization of Commission’s General Counsel, consistent with
or under any new drug application comments. A comment filed in paper applicable law and the public interest. See
approved by the FDA; representations form should include this reference both Commission Rule 4.9(c), 16 CFR 4.9(c).

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