53312 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 

Center for Environmental Health 

(NCEH). Information was collected from 

adult smokers of full-flavor, light and 

ultralight cigarettes, however, the target 

number of respondents was not 

achieved during the initial project 

period. 

CDC requests OMB approval to 

reinstate the information collection in 

order to meet recruitment goals and 

complete the data analysis as planned. 

Changes include a reduction in the 

number of respondents and a 

corresponding reduction in the total 

estimated burden hours. In addition, 

minor changes will be made to account 

for changes in cigarette labels, which no 

longer use descriptors such as fullflavor, light or ultralight. There are no 

changes to the data collection 

instruments or the estimated burden per 

response. 

Respondents will be asked to 

participate in a descriptive study of 

smoking behavior that involves two 

laboratory visits. Established smokers 

who are interested in participating will 

be screened for eligibility during a brief 

five-minute computer-assisted 

telephone interview (CATI). We 

estimate screening approximately 150 

individuals annually to yield complete 

data collection on the annualized goal of 

61 respondents. After completing the 

CATI, individuals who express 

continued interest in study participation 

will undergo five additional minutes of 

eligibility screening at the first 

laboratory visit. 

Each respondent who enrolls in the 

study will make two one-hour visits to 

an assessment laboratory. The visits will 

occur on two consecutive days: Visit 1 

will be scheduled in the morning of the 

first day, and Visit 2 will be scheduled 

in the afternoon of the second day. 

Samples, measurements, and behavioral 

information will be collected at each 

visit. Visit 1 will include biologic 

sample collection (urine, saliva, breath 

carbon monoxide), smoking behavior of 

smoking one cigarette, ventilation hole 

blocking procedure and breath 

measurements. Visit 2 will include 

discussion of quit opportunities if 

requested, biologic sample collection 

(urine, saliva, breath carbon monoxide), 

smoking behavior of smoking one 

cigarette, ventilation hole blocking 

procedure and breath measurements. In 

addition, at Visit 2, each respondent 

will submit the cigarette butts of all 

cigarettes smoked since Visit 1 and a 

completed Smoking Diary Form. The 

estimated burden for the Smoking Diary 

Form is ten minutes. 

The goals of this project are to 

characterize the range of human 

smoking behavior for a variety of 

cigarette categories and machinesmoked yields, and to estimate the 

levels of biomarkers of exposure with 

the various cigarette styles. 

OMB approval is requested for two 

years. Participation in the study is 

voluntary. There are no costs to 

respondents other than their time. The 

total estimated burden hours are 151. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Adult Smokers ......................................................................... CATI Screener ....................... 150 1 5/60 

Visit 1 Screener ...................... 70 1 5/60 

Smoking Diary ........................ 61 1 10/60 

Laboratory Visit ...................... 61 2 1 

Dated: August 23, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–21723 Filed 8–30–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0417] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Format Variations in the Brief 

Summary of Direct-to-Consumer Print 

Advertisements 

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 

the Experimental Study of Format 

Variations in the Brief Summary of 

Direct-to-Consumer (DTC) Print 

Advertisements (ads). This study is 

designed to test different ways of 

presenting benefit and risk information 

in the brief summary in DTC print ads. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 1, 2010. 

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., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 53313 

1Aikin, K.J., Swasy, J.L. and Braman, A.C. (2004). 

Patient and Physician Attitudes and Behaviors 

Associated with DTC Promotion of Prescription 

Drugs: Summary of FDA Survey Research Results, 

Final Report. Available at http://www.fda.gov/cder/ 

ddmac/Final%20Report/FRfinal111904.pdf. Last 

accessed March 26, 2009. 2Aikin, K.J. (1998). Consumer Comprehension 

and Preference for Variations in the Proposed OverThe-Counter Drug Labeling Format, Final Report; 

Vigilante, W.J. & Wogalter, M.S. (1997). The 

preferred order of overt-the-counter (OTC) 

pharmaceutical label components. Drug 

Information Journal, 31, 973–988. 3Levy, A.S., Fein, S.B. & Schucker, R.E. (1992). 

More effective nutrition label formats are not 

necessarily more preferred. Journal of the American 

Dietetic Association, 92(10), 1230–1234. 4Lorch, R. & Lorch, E. (1995). Effects of 

organizational signals on text-processing strategies. 

Journal of Educational Psychology, 87(4), 537–544; 

Lorch, R. & Lorch, E. (1996). Effects of 

organizational signals on free recall of expository 

text. Journal of Educational Psychology, 88(1), 38– 

48; Lorch, R., Lorch, E. & Inman, W. (1993). Effects 

of signaling topic structure on text recall. Journal 

of Educational Psychology, 85(2), 281–290. 5Schwartz, L.M., Woloshin, S., & Welch, H.G. 

(2009). Communicating drug benefits and harms 

with a drug facts box: Two randomized trials. 

Annals of Internal Medicine, 150(8). Available 

online at http://www.annals.org/cgi/content/full/ 

0000605-200904210-00106v1. Last accessed March 

26, 2009. 

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 of Format 

Variations in the Brief Summary of 

Direct-to-Consumer Print 

Advertisements—New 

Section 502(n) of the Federal Food, 

Drug, and Cosmetic Act specifies that 

ads for prescription drugs and biological 

products must provide a true statement 

of information ‘‘in brief summary’’ about 

the advertised product’s ‘‘side effects, 

contraindications, and effectiveness.’’ 

The prescription drug advertising 

regulations (§ 202.1(e)(3)(iii) (21 CFR 

202.1(e)(3)(iii))) specify that the 

information about risks must include 

each specific side effect and 

contraindication from the advertised 

drug’s FDA-approved labeling, 

including the Warnings, Precautions, 

Adverse Reactions, and other relevant 

sections. Some of the current 

approaches to fulfilling the brief 

summary requirement, while adequate 

from a regulatory perspective, result in 

ads that may be difficult to read and 

understand when used in consumerdirected promotion. In recent years, FDA has become 

concerned about the adequacy of the 

brief summary in DTC print 

advertisements for prescription drugs. 

Because the regulations do not specify 

how to address each risk, sponsors can 

use discretion in fulfilling the brief 

summary requirement under 

§ 202.1(e)(3)(iii). Frequently, sponsors 

print in small type, verbatim, the riskrelated sections of the approved product 

labeling (also called the package insert, 

professional labeling, prescribing 

information, and direction circular). 

This labeling is written for health 

professionals, using medical 

terminology. While adequate to fulfill 

the brief summary requirement for print 

advertisements, this method may not be 

the most ideal. Research has shown that 

while many consumers will make the 

effort to read the brief summary in 

prescription drug print advertisements 

if they are especially interested in the 

drug, as a general rule consumers 

typically read little or none of the brief 

summary information.1 Health 

practitioners themselves have indicated 

they often have difficulty finding 

information they actively seek in 

package inserts (see 65 FR 80733 at 

81082, December 22, 2000, for a 

discussion of studies supporting the use 

of a highlights section in physician 

labeling). There may be other ways to 

fulfill this requirement that improve 

consumers’ ability to find and 

comprehend the information in this 

important document. There is evidence suggesting that both 

information content and the format in 

which it is presented will impact 

comprehension. For instance, research 

with the format of over-the-counter 

(OTC) drug 

(OTC) drug labels,2 the nutrition facts 

label,3 and other information formats4

demonstrates that information presented 

with section headings, graphics (such as 

bullets), and other design elements is 

more easily read than information 

presented in paragraph format. Research conducted by FDA and 

others has examined the content and 

format of the brief summary specifically. 

For instance, FDA conducted a series of 

relevant studies (OMB control numbers 

0910–0591 and 0910–0611). Schwartz, 

Woloshin, and Welch have compared 

one format for adding quantitative and 

qualitative benefit and risk information 

to the brief summary.5 Specifically, 

Schwartz et al. designed a prescription 

drug facts box similar in format to the 

Nutrition Facts panel and OTC Drug 

Facts panel. The box contains a number 

of elements, including qualitative and 

quantitative (both absolute frequency 

and absolute difference) information 

about benefits and risks. This study 

showed that consumers who were 

provided efficacy information in a 

prescription drug facts box were more 

likely to correctly choose the product 

with the higher efficacy than consumers 

who saw the brief summary using 

medical language from the prescribing 

information. However, it is unclear 

which elements of the drug facts box are 

necessary to improve consumer 

understanding. For instance, it is not 

known whether simply adding efficacy 

rate information to a consumer-friendly 

brief summary would be sufficient to 

enable consumers to understand a 

product’s efficacy, or whether 

qualitative summations are necessary as 

well. 

The current study will add to 

previous research by systematically 

examining these different elements to 

determine whether and how to add 

qualitative and quantitative benefit and 

risk information to the brief summary. 

The results of this study will inform 

FDA of the usefulness and parameters of 

various format and content options for 

the brief summary. 

Design Overview: This study will be 

conducted in two concurrent parts; one 

examining variations on the benefit 

information presented in DTC print 

advertisements and the other examining 

variations on the risk information 

presented in DTC print advertisements. 

The factors studied will be the type of 

information (i.e., the addition of 

quantitative and qualitative information 

in a box format) and the level of efficacy 

or risk. We will vary the level of efficacy 

and risk such that the largest effect is 

noticeably different from the placebo, 

whereas the smallest effect is minimally 

different from the placebo. These factors 

will be combined in a factorial design as 

follows: 


srobinson on DSKHWCL6B1PROD with NOTICES
53314 Federal Register / Vol. 75, No. 168 / Tuesday, August 31, 2010 / Notices 

TABLE 1.—PROPOSED DESIGN (4 X 5 + 2) 

Information Type 

Efficacy Level 

Smallest Effect Smaller Effect Mid-Size Effect Larger Effect Largest Effect 

Absolute Frequency 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82% 

Absolute Frequency + 

Qualitative Label 

Fewer 

81% vs. 82% 

Fewer 

61% vs. 82% 

Fewer 

41% vs. 82% 

Fewer 

21% vs. 82% 

Fewer 

1% vs. 82% 

Absolute Difference + 

Qualitative Label 

Fewer (1%) Fewer (21%) Fewer (41%) Fewer (61%) Fewer (81%) 

Absolute Frequency + 

Absolute Difference + 

Qualitative Label 

Fewer (1%) 

81% vs. 82% 

Fewer (21%) 

61% vs. 82% 

Fewer (41%) 

41% vs. 82% 

Fewer (61%) 

21% vs. 82% 

Fewer (81%) 

1% vs. 82% 

Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk 

information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ‘‘fewer people taking drug 

X had disease/symptom Y.’’ 

The test product will be for the 

treatment of high prevalence medical 

condition and modeled on an actual 

drug used to treat that condition. 

Participants will be consumers who 

have been diagnosed with the medical 

condition of interest. They will be 

randomly assigned to read one ad 

version. After reading the ad, 

participants will answer a series of 

questions about the drug. We will test 

how the information type affects 

perceived efficacy, perceived risk, 

behavioral intention, and accurate 

understanding of the benefit and risk 

information. 

Interviews are expected to last no 

more than 20 minutes. A total of 11,750 

participants will be involved in the 

study. This will be a one-time (rather 

than annual) collection of information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Pretest 750 1 750 20 minutes 250 

Main Study 11,000 1 11,000 20 minutes 3,667 

Total 3,917 

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

Dated: August 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21629 Filed 8–30–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0084] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; PRISTIQ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

PRISTIQ and is publishing this notice of 

that determination as required by law. 

FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim that human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 


srobinson on DSKHWCL6B1PROD with NOTICES