Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 69853 

Brill, and Commissioner Terrell McSweeny, at 2 

(Nov. 17, 2014). 2 In the Matter of Shell Oil Co., 128 F.T.C. 749 

(1999). 3 Id. at *10 (Public Statement of Chairman 

Pitofsky, Commissioner Anthony and 

Commissioner Thompson) (emphasis added). 

Similarly, Commissioner Orson Swindle’s dissent 

stated that under FTC precedent, ‘‘means and 

instrumentalities is a form of primary liability in 

which the respondent was using another party as 

the conduit for disseminating the respondent’s 

misrepresentations to consumers.’’ Id. at *14–15 

(Dissenting Statement of Commissioner Orson 

Swindle) (emphasis added). Swindle’s dissent 

likewise emphasized that a defendant ‘‘may not be 

held primarily liable unless it has actually made a 

misrepresentation.’’ Id. (quoting In re JWP Inc. 

Securities Lit., 928 F. Supp. 1239, 1256 (S.D.N.Y. 

1996)). See also FTC v. Magui Publishers, Inc., Civ. 

No. 89–3818RSWL(GX), 1991 WL 90895, at *14, 

(C.D. Cal. 1991), aff’d, 9 F.3d 1551 (9th Cir. 1993) 

(‘‘One who places in the hands of another a means 

or instrumentality to be used by another to deceive 

the public in violation of the FTC Act is directly 

liable for violating the Act.’’). 

4 Magui Publishers, Inc., 1991 WL 90895, at *17. 

5 ‘‘[A] respondent who has provided assistance to 

another party that has made misrepresentations is 

at most secondarily liable—in particular, for aiding 

and abetting another’s misrepresentations.’’ Shell 

Oil Co., 128 F.T.C. 749, *15 (1999) (Swindle 

Dissent) (citing Wright v. Ernst & Young LLP, 152 

F.3d 169, 175 (2d Cir. 1998), cert. denied, 119 S.Ct. 

870 (1999); Shapiro v. Cantor, 123 F.3d 717, 720 (2d 

Cir. 1997); Anixter v. Home-Stake Production Co., 

77 F.3d 1215, 1225 (10th Cir. 1996) (‘‘the critical 

element separating primary from aiding and 

abetting violations is the existence of a 

representation, made by the defendant.’’)). 

6 Magui Publishers, Inc., 1991 WL 90895, at *15. 

7 Id. at *14. 

8Cent. Bank, N.A. v. First Interstate Bank, N.A., 

511 U.S. 164 (1994). 

9Shell Oil Co., 128 F.T.C. 749, *19 (Swindle 

Dissent). 

I disagree with this use of means and 

instrumentalities. To be liable of 

deception under means and 

instrumentalities requires that the party 

itself must make a misrepresentation, as 

the Commission detailed in Shell Oil 

Company.2 According to the majority in 

that case, ‘‘[T]he means and 

instrumentalities doctrine is intended to 

apply in cases . . . where the originator 

of the unlawful material is not in 

privity with consumers’’ and ‘‘it is well 

settled law that the originator is liable 

if it passes on a false or misleading 

representation with knowledge or 

reason to expect that consumers may 

possibly be deceived as a result.’’ 3 For 

example, in FTC v. Magui Publishers, 

Inc., the court found the defendant 

directly liable for providing the means 

and instrumentalities to violate Section 

5 when it sold Salvador Dali prints with 

forged signatures to retail customers, 

who then sold the prints to consumers.4

Unlike Shell and Magui Publishers, 

the statement that TRUSTe provided to 

its clients was indisputably truthful at 

the time. During the period in which 

TRUSTe required client privacy policies 

to state that TRUSTe was a non-profit, 

TRUSTe was, in fact, a non-profit. Once 

TRUSTe changed to for-profit status, it 

no longer required clients to state its 

non-profit status and actively 

encouraged clients to correct their 

privacy policies. TRUSTe did not pass 

to clients any false or misleading 

representations regarding its for-profit 

status. Nor was TRUSTe’s recertification 

of Web sites a misrepresentation of 

TRUSTe’s non-profit status to its clients; 

during recertification TRUSTe again 

clearly communicated its for-profit 

status to clients by requesting that its 

clients update their privacy policies. 

Because TRUSTe accurately represented 

its non-profit status to its clients, 

TRUSTe cannot be primarily liable for 

deceiving consumers under a means and 

instrumentalities theory. 

TRUSTe’s alleged recertifications of 

untrue statements are more properly 

analyzed as secondary liability for 

aiding and abetting.5 In Magui 

Publishers the court found that the 

defendant forgers were not only directly 

liable for their own misstatements, but 

also secondarily liable for the retailers’ 

fraudulent misrepresentations to 

consumers because defendants 

‘‘supplied their deceptive art work, 

certificates and promotional materials to 

their retail customers with full 

knowledge these customers would use 

the materials to deceive consumers.’’ 6

The court explained that aiding and 

abetting has three components: ‘‘(1) The 

existence of an independent primary 

wrong; (2) actual knowledge by the 

alleged aider and abettor of the wrong 

and of his or her role in furthering it; 

and (3) substantial assistance in the 

commission of the wrong.’’ 7

It is not clear that TRUSTe’s clients 

committed an independent primary 

wrong. However, TRUSTe certainly had 

knowledge of the misstatements in the 

privacy policies and of TRUSTe’s role in 

facilitating those misstatements. And, 

arguably, its certifications may have 

provided substantial assistance in 

deceiving consumers. Regardless, 

because TRUSTe never misrepresented 

its corporate status, TRUSTe’s actions 

regarding its corporate status at most 

comprise aiding and abetting its clients’ 

actions. 

Perhaps all this seems like legal 

hairsplitting, but it is not. Under the 

Supreme Court’s decision in Central 

Bank of Denver v. First Interstate Bank 

of Denver,8 the FTC ‘‘may well be 

precluded from bringing Section 5 cases 

under an aiding and abetting theory.’’ 9

By prosecuting activities more properly 

analyzed as aiding and abetting under 

the guise of means and instrumentalities 

liability, I am concerned that we are 

stepping beyond the limits the Supreme 

Court has established. I therefore dissent 

from Count II. 

[FR Doc. 2014–27733 Filed 11–21–14; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket No. CDC–2014–0015] 

Request for Comment on Draft 

Vaccines Adverse Event Reporting 

System (VAERS) 2.0 Form 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of request for public 

comment. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), is publishing 

this notice requesting public comment 

on the proposed VAERS 2.0 form, which 

is intended to replace the current 

VAERS–1 form (https://vaers.hhs.gov/

resources/vaers_form.pdf). CDC and the 

U.S. Food and Drug Administration 

(FDA) co-administer the Vaccines 

Adverse Event Reporting System 

(VAERS), a post-licensure (i.e., after 

vaccines have been licensed by the FDA 

and are being used in the community) 

reporting system that accepts submitted 

reports of adverse events that occur after 

vaccination from healthcare providers, 

manufacturers, and the public. 

Healthcare providers and vaccine 

manufacturers are required to submit 

VAERS reports. The National Childhood 

Vaccine Injury Act of 1986, section 2125 

of the Public Health Service Act (42 

U.S.C. 300aa–25) authorized VAERS. 

The current VAERS form has been used 

since 1990. 

DATES: Written comments must be 

received on or before January 23, 2015. 

ADDRESSES: You may submit comments, 

identified by docket number CDC– 

2014–0015 by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: You may also submit written 

comments to the following address: 

Centers for Disease Control and 

Prevention, (CDC), National Center for 

Emerging and Zoonotic Infectious 

Diseases, Division of Healthcare Quality 

Promotion, Immunization Safety Office, 

Attn: VAERS 2.0 form Docket No. CDC– 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
69854 Federal Register / Vol. 79, No. 226 / Monday, November 24, 2014 / Notices 

2014–0015, 1600 Clifton Rd. NE., 

Mailstop A–07, Atlanta, Georgia, 30333. 

Instructions: All submissions received 

must include the agency name and 

docket number. All relevant comments 

received will be posted without change 

to http://regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

http://www.regulations.gov. All 

materials submitted will be available for 

public inspection Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m., Eastern Standard 

Time, at 1600 Clifton Road NE., Atlanta, 

Georgia 30333. Please call ahead to 

(404) 639–4000 and ask for a 

representative from Immunization 

Safety Office to schedule your visit. You 

should be aware that this office is in a 

Federal government building; therefore, 

Federal security measures are 

applicable. For additional information, 

please see Roybal Campus Security 

Guidelines under SUPPLEMENTARY

INFORMATION. 

FOR FURTHER INFORMATION CONTACT: 

Tiffany Suragh; Centers for Disease 

Control and Prevention, National Center 

for Emerging and Zoonotic Infectious 

Diseases, Division of Healthcare Quality 

Promotion, Immunization Safety Office, 

l600 Clifton Road NE., Mailstop D–26; 

Atlanta, Georgia, 30329–4018; 

Telephone: (404) 639–4000. 

SUPPLEMENTARY INFORMATION: VAERS is 

an important and critical ‘‘early warning 

system’’ in the federal vaccine safety 

infrastructure for identifying adverse 

events after receipt of childhood, 

adolescent, and adult vaccines licensed 

for use in the United States (US). 

Healthcare providers and vaccine 

manufacturers are required under 

section 2125(b) of the Public Health 

Service Act (42 U.S.C. 300aa–25(b)) to 

file VAERS reports regarding the 

occurrence of any event set forth in the 

Vaccine Injury Table which occurs 

within 7 days of the administration of 

any vaccine set forth in the Table or 

within such longer period as is specified 

in the Table and the occurrence of any 

contraindicating reaction to a vaccine 

which is specified in the manufacturer’s 

package insert. VAERS also accepts 

reports on adverse events following 

receipt of other vaccines. Patients, 

parents and others aware of adverse 

events can also file VAERS reports. 

Although VAERS is not designed to 

assess if a vaccine caused an adverse 

event, VAERS provides CDC and FDA 

with important early information that 

might signal a potential problem. If the 

VAERS data suggest a possible 

association between an adverse event 

and vaccination, the relationship will be 

further assessed. In recent years VAERS 

has received approximately 30,000 US 

reports annually. 

VAERS is a mandated activity for the 

U.S. Department of Health and Human 

Services (HHS) and VAERS data are 

used by federal agencies, state health 

officials, health care providers, 

manufacturers, and the public, therefore 

it is important to maximize the 

usefulness of this system. The 

information collected by the proposed 

VAERS 2.0 form will be similar to that 

on the current VAERS–1 form so 

historical comparisons can be made; 

however, the changes in the draft 

VAERS 2.0 form should improve 

reporting efficiency and data quality. 

VAERS 2.0 offers standardized 

responses, clearer instructions and 

guidance, and improved online 

reporting. Select questions have been 

updated, with questions added, 

removed, and reorganized to decrease 

response burden and maximize 

usability. The draft VAERS 2.0 form can 

be found at http://www.regulations.gov. 

During the development of the draft 

VAERS 2.0 form, CDC and FDA sought 

input from key stakeholders in the 

federal government, state health officials 

involved in vaccine safety and vaccine 

programs, and other public health 

partners. In addition, the VAERS 2.0 

form was presented to three federal 

advisory committees, the Advisory 

Commission on Childhood Vaccines 

(September 5, 2014), the National 

Vaccine Advisory Committee 

(September 9, 2014), and the Advisory 

Committee on Immunization Practices 

(October, 2014) and was tested with 

potential reporters (e.g., physicians, 

nurses, pharmacists, patients, and 

parents). All public comments will be 

reviewed and considered prior to 

finalizing the VAERS 2.0 form. 

Roybal Campus Security Guidelines: 

The Edward R. Roybal Campus is the 

headquarters of the U.S. Centers for 

Disease Control and Prevention and is 

located at 1600 Clifton Road NE., 

Atlanta, Georgia. The Immunization 

Safety Office is in a Federal government 

building; therefore, Federal security 

measures are applicable. 

In planning your arrival time, please 

take into account the need to park and 

clear security. All visitors must enter 

the Roybal Campus through the 

entrance on Clifton Road; the guard 

force will direct visitors to the 

designated parking area. Upon arrival at 

the facility, visitors must present 

government issued photo identification 

(e.g., a valid federal identification 

badge, state driver’s license, state nondriver’s identification card, or passport). 

Non-United States citizens must 

complete the required security 

paperwork prior to the visit date and 

must present a valid passport, visa, 

Permanent Resident Card, or other type 

of work authorization document upon 

arrival at the facility. All persons 

entering the building must pass through 

a metal detector. Visitors will be issued 

a visitor’s ID badge at the entrance to 

Building 19 and will be escorted to a 

room to view the available materials. All 

items brought to HHS/CDC are subject 

to inspection. 

Dated: November 18, 2014. 

Ron A. Otten, 

Acting Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2014–27678 Filed 11–21–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10407 and CMS– 

R–245] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HSS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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. 


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