Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50737 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Extra Label Drug Use in Animals—21 

CFR Part 530 (OMB Control Number 

0910–0325—Extension) 

The Animal Medicinal Drug Use 

Clarification Act of 1994 allows a 

veterinarian to prescribe the extra-label 

use of approved new animal drugs. 

Also, it permits FDA, if it finds that 

there is a reasonable probability that the 

extra-label use of an animal drug may 

present a risk to the public health, to 

establish a safe level for a residue from 

the extra-label use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. 

Although to date, we have not 

established a safe level for a residue 

from the extra-label use of any new 

animal drug, and therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are 

therefore estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal and/or State Agencies, 

academia, or individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response Total hours 

530.22(b) .......................................................... 2 1 2 4,160 8,320 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: August 10, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20813 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0568] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study: Disease Information in Branded 

Promotional Material 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. 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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

research entitled ‘‘Experimental Study: 

Disease Information in Branded 

Promotional Material.’’ The proposed 

research will explore the nature of 

including information about a disease 

and promotional information about a 

specific drug treatment in the same 

advertising piece. 

DATES: Submit either electronic or 

written comments on the collection of 

information by October 17, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3972, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Study: Disease 

Information in Branded Promotional 

Material—(OMB Control Number 0910– 

New) 

Regulatory Background: Section 

1701(a)(4) of the Public Health Service 


emcdonald on DSK2BSOYB1PROD with NOTICES
50738 Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 

1See 21 CFR 202.1(e)(6): ‘‘An advertisement for 

a prescription drug is false, lacking in fair balance, 

or otherwise misleading, or otherwise violative of 

section 502(n) of the act, among other reasons if it: 

(i) Contains a representation or suggestion, not 

approved or permitted for use in the labeling, that 

a drug is better, more effective, useful in a broader 

range of patients (as used in this section, patients 

means humans and in the case of veterinary drugs, 

other animals), safer, has fewer, or less incidence 

of, or less serious side effects or contraindications 

than has been demonstrated by substantial evidence 

or substantial clinical experience (as described in 

paragraphs (e)(4)(ii)(b) and (c) of this section) 

whether or not such representations are made by 

comparison with other drugs or treatments * * *.’’ 

2See Draft Guidance for Industry: ‘‘ ‘HelpSeeking’ and Other Disease Awareness 

Communications by or on Behalf of Drug and 

Device Firms’’ (p. 1), available at http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatoryInformation/ 

Guidances/ucm070068.pdf. Last accessed February 

16, 2011. 

3Lee-Wingate, S. and Y. Xie, ‘‘Consumer 

perceptions of product-claim versus help-seeking 

direct-to-consumer advertising,’’ International 

Journal of Pharmaceutical and Healthcare 

Marketing, 4(3), 232–246, 2010. 

4Burke, R.R., W.S. DeSarbo, R.L. Oliver, and T.S. 

Robertson, ‘‘Deception by implication: An 

experimental investigation,’’ Journal of Consumer 

Research, 14(4), 483–494, 1988; Harris, R.J., 

‘‘Comprehension of pragmatic implication in 

advertising,’’ Journal of Applied Psychology, 62, 

603–608, 1977; Jacoby, J., and W. Hoyer, ‘‘The 

comprehension and miscomprehension of print 

communications,’’ New York: The Advertising 

Educational Foundation, 1987. 

Act (42 U.S.C. 300u(a)(4)) authorizes 

FDA to conduct research relating to 

health information. Section 903(b)(2)(c) 

of the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

393(b)(2)(c)) authorizes FDA to conduct 

research relating to drugs and other FDA 

regulated products in carrying out the 

provisions of the FD&C Act. 

FDA regulations require prescription 

drug advertisements to contain accurate 

information about the benefits and risks 

of the drug advertised. Generally, the 

advertising must not be misleading 

about the effectiveness of the drug. 

Specifically, the ad must not contain a 

representation or suggestion that the 

drug is better than has been shown by 

substantial evidence or useful in a 

broader range of patients.1 The 

regulations prohibit sponsors from, for 

example, disseminating promotional 

information that may broaden the 

indications of medications beyond the 

indication for which they have been 

approved. This regulation is designed to 

avoid misleading the audience by 

overpromising the outcomes of a 

particular drug and also to maintain a 

level playing field among competitors. 

As a public health agency, FDA 

encourages the communication of 

accurate health messages about medical 

conditions and treatments. One way in 

which broad disease information is 

communicated to the public is through 

disease awareness communications: 

‘‘Disease awareness communications are 

communications disseminated to consumers 

or health care practitioners that discuss a 

particular disease or health condition, but do 

not mention any specific drug or device or 

make any representation or suggestion 

concerning a particular drug or device. Helpseeking communications are disease 

awareness communications directed at 

consumers. FDA believes that disease 

awareness communications can provide 

important health information to consumers 

and health care practitioners, and can 

encourage consumers to seek, and health care 

practitioners to provide, appropriate 

treatment. This is particularly important for 

under-diagnosed, under-treated health 

conditions, such as depression, 

hyperlipidemia, hypertension, osteoporosis, 

and diabetes. Unlike drug and device 

promotional labeling and prescription drug 

and restricted device advertising, disease 

awareness communications are not subject to 

the requirements of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) and FDA 

regulations.’’ 2

Some research has shown that disease 

awareness advertising is viewed by 

consumers as more informative and 

containing less persuasive intent than 

full product advertising.3

Sponsors may choose to include 

disease information in their full product 

promotions. Such information is 

designed to educate the patient about 

his or her disease condition. However, 

in some cases a full description of the 

medical condition may include 

information about specific health 

outcomes that are not part of a drug’s 

approved indication. The current 

project is designed to determine if 

providing such information in branded 

full product advertisements affects 

perceptions of the product. 

When broad disease information 

accompanies or is included in an ad for 

a specific drug, consumers may 

mistakenly assume that the drug will 

address all of the potential 

consequences of the condition 

mentioned in the ad by making 

inferences that go beyond what is 

explicitly stated in an advertisement.4

For example, the mention of diabetic 

retinopathy in an advertisement for a 

drug that lowers blood glucose may lead 

consumers to infer that the drug will 

prevent diabetic retinopathy, even if no 

direct claim is made. The advertisement 

may imply broader indications for the 

promoted drug than are warranted, 

leading consumers to infer effectiveness 

of the drug beyond the indication for 

which it was approved. If consumers are 

able to distinguish between disease 

information and product claims in an 

ad, then they will not be misled by the 

inclusion of disease information in a 

branded ad. If consumers are unable to 

distinguish these two, however, then 

consumers may be misled into believing 

that a particular drug is effective against 

long-term consequences. The current 

study will explore perceptions that 

result from including both disease 

information and promotional 

information about a specific drug in the 

same advertising piece. 

Design Overview: We will investigate 

the effects of adding disease information 

to branded promotional materials on 

consumer perceptions and 

understanding. Disease information will 

be examined in the context of direct-toconsumer (DTC) prescription drug print 

advertisements. We hope to more 

readily generalize our findings by 

exploring the issues raised above in 

three medical conditions varying in 

severity and symptomatology. For 

example, disease information in a 

category such as oncology may be 

viewed differently than a mild skin 

condition or a non-symptomatic 

condition such as high cholesterol. 

We plan to examine two variables in 

this study: The type of disease 

information in the piece (information 

about the disease and its possible 

outcomes, versus information about the 

disease without outcomes, versus no 

information about the disease) and the 

format of the information (integrated 

with drug information versus 

separated). Some participants will see 

information about the disease that 

avoids discussion of disease outcomes 

the drug has not been shown to address, 

such as, ‘‘Diabetes is a disease in which 

blood sugar can vary uncontrollably, 

leading to uncomfortable episodes of 

high or low blood sugar.’’ Other 

participants will see disease information 

that mentions consequences of the 

disease that go beyond the indication of 

the advertised product, such as, 

‘‘Untreated diabetes can lead to 

blindness, amputation, and, in some 

cases, death.’’ We will also examine the 

way in which the disease information is 

presented relative to the product claims 

in the piece by varying the format: 

Disease information mixed (integrated) 

with product claims versus disease 

information apart (separated) from 

product claims. This study is 

experimental in method and utilizes 

random assignment to conditions. 

Within medical condition, participants 

will be randomly assigned to see one 

version of the ad. Participants will be 

recruited from a general population 

sample to control for prior knowledge 

about disease outcomes. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices 50739 

5There are no capital costs or operating and 

maintenance costs associated with this collection of 

information. 

The preliminary design is included as 

follows: 

TABLE 1—STUDY DESIGN

Medical condition Disease outcome 

information 

Format of disease information Control 

(no disease information) Integrated Separated 

Condition A ........................ No Outcomes 

Outcomes 

Condition B ........................ No Outcomes 

Outcomes 

Condition C ........................ No Outcomes 

Outcomes 

FDA estimates the burden of this 

collection of information as follows: We 

estimate the response burden to be 20 

minutes in the pretests and the study, 

for a burden of 1,985 hours. This will 

be a one time (rather than annual) 

collection of information. The 

questionnaire is available upon request. 

The response burden chart is listed as 

follows: 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN5

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

respondents 

Average burden 

per response Total hours 

Screener ............................................................ 6,750 1 6,750 0.03 (2 min.) ..... 203 

Pretests ............................................................. 900 1 900 0.33 (20 min.) ... 297 

Study ................................................................. 4,500 1 4,500 0.33 (20 min.) ... 1,485 

Total ........................................................... ............................ ............................ ............................ ........................... 1,985 

Dated: August 11, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20814 Filed 8–15–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0183] 

Hung Ta Fan: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Hung Ta Fan for a period of 5 years from 

importing articles of food or offering 

such articles for importation into the 

United States. FDA bases this order on 

a finding that Mr. Fan was convicted of 

a felony under Federal law for conduct 

relating to the importation into the 

United States of an article of food. Mr. 

Fan was given notice of the proposed 

debarment and an opportunity to 

request a hearing within the timeframe 

prescribed by regulation. As of July 13, 

2011 (30 days after receipt of the 

notice), Mr. Fan had not responded. 

Mr. Fan’s failure to respond constitutes 

a waiver of his right to a hearing 

concerning this action. 

DATES: This order is effective August 16, 

2011. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs (HFC–230), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On August 4, 2010, the United States 

District Court for the Northern District 

of Illinois accepted Mr. Fan’s guilty plea 

and entered judgment against him for 

the offense of conspiracy, in violation of 

18 U.S.C. 371 and 2, for conspiring to 

defraud the United States and to violate 

18 U.S.C. 542 (entry of Goods into the 

United States by means of false 

statements) and 18 U.S.C. 545 

(importation contrary to law). 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein for 

conduct relating to the importation into 

the United States of any food. The 

factual basis for this conviction is as 

follows: In or around March 2005 and 

continuing until in or around November 

2006, in violation of 18 U.S.C. 371 and 

2, Mr. Fan agreed and conspired with 

others to defraud the United States and 


emcdonald on DSK2BSOYB1PROD with NOTICES