Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 57629 

synergistic herbs (+ calcium in the 

tablets).’’ Cleansing Time Pro Black 

Salve is an ointment that respondent 

recommends for external use. 

Alternatively, respondent recommends 

that consumers take the product 

internally by purchasing Black Salve 

Tablets or by placing an amount of the 

Black Salve ointment into a gelatin 

capsule. 

The Commission’s complaint charges 

that respondent claimed that Cleansing 

Time Pro Black Salve & Tablets were 

effective to treat, prevent, or cure 

numerous forms of cancer and various 

viral infections, including hepatitis, 

HIV, SARS, West Nile Virus, and Avian 

Bird Flu. The complaint alleges that 

respondent did not have a reasonable 

basis for these claims. The 

Commission’s complaint also challenges 

respondent’s testimonial advertising. 

The complaint alleges that respondent 

failed to disclose adequately that one of 

the endorsers was respondent Holly A. 

Bacon herself. The complaint alleges 

that this was a deceptive act or practice, 

because the fact that one of the 

endorsers had a material connection 

with Cleansing Time Pro would 

materially affect the weight and 

credibility given by consumers to the 

endorsement and would be material to 

consumers in their purchase or use of 

the products. 

The proposed consent order contains 

provisions designed to prevent 

respondent from engaging in similar 

acts and practices in the future. Part I 

requires respondent to have competent 

and reliable scientific evidence 

substantiating any claim that Cleansing 

Time Pro Black Salve & Tablets, or any 

other covered product or service, is 

effective in the prevention, treatment or 

cure of cancer, cancer, hepatitis, HIV, 

SARS, West Nile Virus, or Avian Bird 

Flu. A ‘‘covered product or service’’ is 

defined as any food, dietary 

supplement, or drug, including, but not 

limited to, Cleansing Time Pro Black 

Salve & Tablets, or any other healthrelated product, service, or program. 

Part II requires that any future claim 

about the absolute or comparative 

benefits, performance, efficacy, safety or 

side effects of any covered product or 

service be truthful and supported by 

competent and reliable scientific 

evidence. 

Part III of the proposed order 

addresses the deceptive endorsement 

claim by requiring that respondent 

disclose any material connection 

between an endorser and respondent, if 

such a connection exists. ‘‘Material 

connection’’ is defined as any 

relationship that materially affects the 

weight or credibility of the user 

testimonial or endorsement and that 

would not reasonably be expected by 

consumers. 

Part IV of the proposed order provides 

that the order does not prohibit 

respondent from making representations 

for any drug that are permitted in 

labeling for the drug under any tentative 

or final Food and Drug Administration 

(‘‘FDA’’) standard or under any new 

drug application approved by the FDA; 

and representations for any product that 

are specifically permitted in labeling for 

that product by regulations issued by 

the FDA under the Nutrition Labeling 

and Education Act of 1990. 

Part V of the proposed order requires 

respondent to compile a list of all 

consumers who purchased Cleansing 

Time Pro Black Salve & Tablets from 

respondent since July 1, 2005, and to 

mail a letter (Attached to the proposed 

order as Attachment A) to each 

purchaser describing the scientific 

evidence related to these products. Part 

VI prohibits respondent from providing 

any identifying information about her 

purchasers to anyone other than the 

Commission, another law enforcement 

agency, or as required by law. 

Parts VII through X of the proposed 

order require respondent to keep copies 

of relevant advertisements and materials 

that substantiate claims made in the 

advertisements; to provide copies of the 

order to certain of her employees; to 

notify the Commission of her affiliation 

with any new health-related business or 

employment; and to file compliance 

reports with the Commission. Part XI of 

the proposed order is a ‘‘sunset’’ 

provision, dictating that the order will 

terminate twenty years from the date it 

is issued or twenty years after a 

complaint is filed in federal court, by 

either the United States or the FTC, 

alleging any violation of 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. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E8–23327 Filed 10–2–08; 8:45 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices, (ACIP) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting of the 

aforementioned committee: 

Time and Date: 8 a.m.–6 p.m., 

October 22, 2008; 8 a.m.–5 p.m., 

October 23, 2008. 

Place: CDC, Tom Harkin Global 

Communications Center, 1600 Clifton 

Road, NE., Building 19, Kent ‘‘Oz’’ 

Nelson Auditorium, Atlanta, Georgia 

30333. 

Status: Open to the public, limited 

only by the space available. 

Purpose: The committee is charged 

with advising the Director, CDC, on the 

appropriate uses of immunizing agents. 

In addition, under 42 U.S.C. 1396s, the 

committee is mandated to establish and 

periodically review and, as appropriate, 

revise the list of vaccines for 

administration to vaccine-eligible 

children through the Vaccines for 

Children (VFC) program, along with 

schedules regarding the appropriate 

periodicity, dosage, and 

contraindications applicable to the 

vaccines. 

Matters to be Discussed: The agenda 

will include discussions on 

Pneumococcal Vaccines; Anthrax 

Vaccine; General Recommendations; 

Human Papillomavirus Vaccines; Adult 

Immunization Schedules; 2009 

Immunization Schedules for children 0– 

18 years of age; Hepatitis Vaccines; 

Japanese Encephalitis Vaccine; Rabies 

Vaccine Supply; Influenza; 

Immunization Safety Update; Vaccine 

Supply; Adolescent National 

Immunization Survey Results; Rotavirus 

Vaccines; MMRV Vaccine; and Tdap 

(Boostrix) in Adults. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Antonette Hill, Immunization Services 

Division, National Center for 

Immunization and Respiratory Diseases, 

CDC, 1600 Clifton Road, NE., Mailstop 

(E–05), Atlanta, Georgia 30333, 

Telephone (404)639–8836, Fax 

(404)639–8905. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

mstockstill on PROD1PC66 with NOTICES

57630 Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: September 25, 2008. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E8–23397 Filed 10–2–08; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Prospective Granting of a CoExclusive License 

AGENCY: Technology Transfer Office, 

Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This is a notice in accordance 

with 35 U.S.C. 209(e) and 37 CFR 

404.7(a)(1)(i) that the Technology 

Transfer Office, Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (DHHS), is contemplating the 

granting of a co-exclusive worldwide 

license to practice the invention 

embodied in the patent application 

referred below to Mk-IX Technologies, 

having a place of business in Huntsville, 

Alabama. CDC intends to grant rights to 

practice this invention to no more than 

one other co-licensee. The patent rights 

in these inventions have been assigned 

to the government of the United States 

of America. The patent application to be 

licensed is: 

Non-Provisional Patent Application 

Title: Wipes and Methods for Removal 

of Metal Contamination from Surfaces. 

Serial No. 11/039,178. 

Filing date: 01/18/2005. 

Issue Date: Patent pending. 

The prospective exclusive license will 

be royalty-bearing and will comply with 

the terms and conditions of 35 U.S.C. 

209 and 37 CFR 404.7. 

ADDRESSES: Requests for a copy of these 

patent applications, inquiries, 

comments, and other materials relating 

to the contemplated license should be 

directed to Andrew Watkins, Director, 

Technology Transfer Office, Centers for 

Disease Control and Prevention (CDC), 

4770 Buford Highway, Mailstop K–79, 

Atlanta, GA 30341, telephone: (770) 

488–8610; facsimile: (770) 488–8615. 

Applications for an exclusive license 

filed in response to this notice will be 

treated as objections to the grant of the 

contemplated co-exclusive license. Only 

written comments and/or applications 

for a license which are received by CDC 

within thirty days of this notice will be 

considered. Comments and objections 

submitted in response to this notice will 

not be made available for public 

inspection, and, to the extent permitted 

by law, will not be released under the 

Freedom of Information Act, 5 U.S.C. 

552. A signed Confidential Disclosure 

Agreement will be required to receive a 

copy of any pending patent application. 

Dated: September 26, 2008. 

James D. Seligman, 

Chief Information Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E8–23398 Filed 10–2–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10001, CMS– 

10009, CMS–10272 and CMS–10242] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Health 

Insurance Portability and 

Accountability Act (HIPAA) 

Nondiscrimination Provisions and 

Supporting Regulations in 45 CFR 

146.121(h) and 121(i)(2)(i); Use: If 

coverage has been denied to any 

individual because the sponsor of a selffunded non-Federal governmental plan 

had exempt the plan from the 

nondiscrimination requirements under 

45 CFR 146.180 ‘‘Treatment of NonFederal Governmental Plans’’, and the 

plan sponsor subsequently chooses to 

bring the plan into compliance, the plan 

sponsor must comply with the 

requirements under 45 CFR 

146.121(i)(2)(i) ‘‘Special Transitional 

Rule for Self-Funded Non-Federal 

Governmental Plans Exempted under 45 

CFR 146.180’’. To bring the plan into 

compliance with the requirements, the 

plan must notify the individual that the 

plan will be coming into compliance, 

afford the individual an opportunity to 

enroll, specify the effective date of 

compliance, and inform the individual 

regarding any enrollment restrictions 

that may apply under the terms of the 

plan once the plan is in compliance. 

Form Number: CMS–10001 (OMB# 

0938–0827); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

18; Total Annual Responses: 18; Total 

Annual Hours: 194. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Health 

Insurance Portability and 

Accountability Act (HIPAA) 

Nondiscrimination Provisions and 

Supporting Regulations in 45 CFR 

146.121(f)(2)(v)(A); Use: Section 146.121 

of the regulations requires Health plans 

or issuers to disclose in all plan 

materials the terms of certain wellness 

programs including the availability of a 

reasonable alternative standard. Plan 

participants and their dependents need 

this information to understand the 

rights they have under HIPAA. States 

and the Federal government may need 

the information supplied by issuers to 

properly perform their regulatory 

functions. Form Number: CMS–10009 

(OMB# 0938–0819); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

2,600; Total Annual Responses: 2,600; 

Total Annual Hours: 1,300. 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Hospital 

Leadership Quality Assessment Tool 

(HLQAT); Use: In 2006, the Hospital 

Leadership Collaborative (HLC) 

launched a public-private partnership to 

develop a CMS-endorsed selfassessment tool, ‘‘The Hospital 

Leadership and Quality Assessment 

Tool’’ (HLQAT) to assist hospitals in the 

improvement of quality through 

enhanced hospital governance, 

mstockstill on PROD1PC66 with NOTICES