Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 80821 

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: New collection (Request for a 

new OMB Control Number); Title of 

Information Collection: Medicaid State 

Plan Preprint for Use by States When 

Implementing Section 6505 of the 

[Patient Protection and] Affordable Care 

Act; Use: [The] CMS has developed a 

Medicaid State Plan Preprint for use by 

States and specific to support the 

January 1, 2011, mandate of the 

prohibition on payments outside of the 

United States. The Preprint follows the 

format and requested information from 

prior preprints provided to the States by 

CMS and provides a placeholder and 

assurance of compliance with section 

1902(a) of the Social Security Act; Form 

Number: CMS–10367 (OMB#: 0938– 

NEW); Frequency: Occasionally; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 5. (For policy questions 

regarding this collection contact Carla 

Ausby at 410–786–2153. For all other 

issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by February 22, 2011: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: December 17, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–32197 Filed 12–22–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0266] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Study of Clinical 

Efficacy Information in Professional 

Labeling and Direct-to-Consumer Print 

Advertisements for Prescription 

Drugs; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of December 3, 2010 (75 FR 

75477). The document announced a 

proposed collection of information that 

has been submitted to the Office of 

Management and Budget (OMB) for 

review and clearance under the 

Paperwork Reduction Act of 1995 (the 

PRA). The document was published 

with an error. FDA, upon further 

review, realized that 3 comments had 

been submitted in response to the 60- 

day notice and the responses to those 

comments are included in this notice. 

This document corrects that error. 

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: In FR Doc. 

2010–30385, appearing on page 75480, 

in the Federal Register of Friday, 

December 3, 2010, the following 

correction is made: 

On page 75480, in the third column, 

the last sentence in the sixth complete 

paragraph states that no comments were 

received on the paperwork burden for 

the 60-day notice that published in the 

Federal Register of June 16, 2010 (75 FR 

34142). FDA is correcting that statement 

to read: Three comments were received 

that expressed support for the research 

and recommended minor improvements 

to the study. The responses to those 

comments are included in the following 

paragraphs. 

(Comment 1) Several of this 

comment’s suggestions have already 

been incorporated into our study design. 

Specifically, we agree that the study 

design should include the variables of 

age, education, ethnicity, race, health 

literacy, and whether the respondent is 

currently being treated with a 

prescription drug, and have included 

them in the questionnaire. Also, we 

have contracted with an organization 

that produces realistic ads and stimuli 

to ensure that we will show respondents 

realistic materials. 

Another question from this comment 

was the presentation of our 

manipulations. To clarify, the specific 

format of the presentation will be text 

only. We are investigating the use of 

charts and other visuals in another 

study (FDA–2009–N–0263 (January 5, 

2010), ‘‘Presentation of Quantitative 

Effectiveness and Risk Information to 

Consumers in Direct-to-Consumer (DTC) 

Broadcast and Print Advertisements for 

Prescription Drugs,’’ OMB control 

number 0910–0663.) Because all of the 

respondents in the current study will 

see the information in the same format, 

this will not compromise our ability to 

answer the current research questions. 

The comment also recommends 

expanding the physician study to 

include all health care professionals 

who have the ability to prescribe (i.e., 

nurse practitioners and physician 

assistants). This is a good idea, but it 

changes our research question from how 

physicians use labels to how prescribers 

use labels. These groups vary in 

education and may vary in experience 

and training in how to interpret and use 

clinical trial data. Because we do not 

have a sample size that is large enough 

to analyze differences between these 

groups, we will limit the sample to 

physicians in this study. 

Finally, the comment recommends 

that FDA publish findings from the 

preliminary study related to the current 

project, ‘‘Mental Models Study of Health 

Care Providers’ Understanding of 

Prescription Drug Effectiveness’’ (FDA– 

2008–N–0589; April 3, 2009). We agree 

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80822 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 

and have taken steps to publish this 

report on FDA’s Division of Drug 

Marketing, Advertising, and 

Communications Web site: http:// 

www.fda.gov/AboutFDA/CentersOffices/ 

CDER/ucm090276.htm. 

(Comment 2) This comment had 

several suggestions regarding the 

physician study. First, it recommended 

that we show physicians the Prescribing 

Information (PI) in a manner consistent 

with how physicians usually view 

sections of it, particularly since how 

each physician views the PI may be 

highly individualized. We agree. 

Because there is likely much variability 

in the way physicians view prescription 

drug information, we have designed this 

part of the study to examine specifically 

those habits. To do so, we will show 

physicians a highlights section that is 

hyperlinked to the more complete 

sections of the PI. We will record the 

order in which physicians access each 

section and how much time they spend 

there. This will provide us with 

information to gauge how physicians 

view the information in the PI, 

something that we currently have no 

data on. 

Second, this comment recommends 

that we show physicians final magazine 

ads rather than conceptual ads. We 

agree and, as discussed in the response 

to the previous comment, we have 

contracted with an organization that 

produces professional-quality ads. 

Third, this comment recommends 

increasing the sample size from 500 to 

800 individuals. We agree that a larger 

sample would be desirable, however, 

given resource constraints we are not 

able to increase the sample size. 

Moreover, we have conducted a power 

analysis and have determined that our 

current sample size is adequate to 

answer our research questions. 

Fourth, the comment recommends the 

removal of statements in the 

questionnaire that the drug is fictitious 

and instead label it a ‘‘potentially new 

drug.’’ FDA had many internal 

discussions regarding this issue and 

decided that because of the particular 

sample, it is necessary to be upfront 

with them about the nature of the drug. 

Physicians will be more savvy about the 

particulars of the chemical entities and 

the realism of the clinical benefits and 

we do not wish to make them skeptical 

of our purposes. We agree that this 

approach is preferable for consumers 

and so we will inform them that this is 

a potentially new drug in that part of the 

study. 

Fifth, we agree that the characteristics 

of participants who are at risk and those 

who are or are not treating with a 

prescription drug may differ and we 

will include these variables in our 

analyses. 

Sixth, the comment recommends 

altering question 17 of the questionnaire 

to reflect the physicians’ use of the DTC 

ad versus their guess as to the 

understandability of the ad for patients. 

We agree that we are asking physicians 

to estimate the level of understanding 

their patients have. These perceptions 

are of specific interest to us as they 

relate to physicians’ perceptions of DTC 

advertising and of the presentation of 

information in the ads. Physicians who 

have been in practice for any length of 

time may have a sense of how their 

patients will understand materials. This 

is a question that we will also 

investigate in relation to the number of 

years physicians have been in practice. 

Seventh, the comment recommends 

that question 30 be split into two 

questions to separately assess the effect 

of DTC advertising on patients and the 

effect of DTC advertising on their 

practice. We agree and will make that 

change. 

This comment also had two 

suggestions for the consumer part of the 

study. First, the comment recommended 

against delivering this study on a 

handheld device, as the viewing of the 

ad may render the concept unclear. We 

agree and have struggled with this issue, 

but due to the constraints of the internet 

panel, we cannot specify the type of 

device on which participants must take 

the survey. We have included a question 

to assess this variable, and we will 

analyze it to determine if there are 

sizable differences based on viewing 

medium. 

Second, the comment recommends 

that the questionnaire avoid medical 

terminology and reference to the 

‘‘prescribing information.’’ We have 

attempted to make the questionnaire 

clear for consumers and do not see the 

word ‘‘prescribing information’’ in the 

questionnaire. The questionnaire 

provided for comment includes 

programming notes that the respondent 

will not see. 

(Comment 3) First, this comment 

recommends evaluating the benefits and 

risks together and in a similar format so 

as not to bias the results. We agree that 

the benefits and risks should be 

evaluated together and have several 

measures to investigate both. We are 

keeping the risk information constant 

across all of our conditions specifically 

so as not to bias the results. Our 

research questions involve the 

conveyance of information about 

benefits. Because of the complexity of 

DTC ads, we cannot manipulate both 

benefits and risks at the same time. We 

are conducting other studies examining 

the presentation of risk information (For 

example, FDA–2010–N–0417 (August 

26, 2010), ‘‘Experimental Study of 

Format Variations in the Brief Summary 

of Direct-to-Consumer Print 

Advertisements’’) and collectively, this 

body of research will answer questions 

of benefit and risk presentation. To 

clarify, risk information will be 

presented similarly to how it is 

currently presented in DTC print ads. 

Second, the comment recommends 

the introduction of a control arm that is 

similar to what is currently being used 

in the marketplace. Our design includes 

control conditions that do not present 

placebo information. These ads will 

look identical to the ads for products 

that are currently on the market. 

Third, the comment questions the use 

of comparative benefit and comparative 

safety questions. We are using these 

measures for reliability as another way 

to assess consumers’ perceived risk and 

benefits. As recommended in the 

comment, we are using them for 

informational purposes only and not as 

a specific, separate measure of 

comparative advertising. 

Fourth, the comment recognizes the 

complexity of the data that are available 

to be conveyed in DTC ads. We agree 

that there are a number of questions to 

be answered that cannot be addressed in 

the current study: E.g., variations in 

clinical study designs, instruments 

used, populations studied, and varying 

degrees of severity of illness. We cannot 

address all questions in one study and 

have chosen to focus on the issues of 

placebo and framing in a treatment and 

prevention approach. We hope that the 

results of this study will spur additional 

follow on studies conducted by FDA 

and others. Although the issue of 

different therapeutic areas is also 

relevant, and a study looking at the two 

ends of the disease-seriousness 

spectrum would be a great follow on, 

the basic concepts of information 

processing should not differ depending 

on drug class. Although we agree that 

replication is valuable and necessary, 

we do not believe that limiting the study 

to two therapeutic areas impugns the 

internal validity of the study. 

Fifth, the comment recommends 

wording changes to the question about 

taking the drug if the doctor prescribed 

it. Although we understand the 

rationale for changing this question, it is 

a measure of behavioral intention and as 

such, we wanted to have a more blunt 

measure of intention. It will not be used 

to assess doctor-patient interaction 

issues. 

Sixth, the comment questions the 

inclusion of physicians in the study, 

citing concerns that consumer responses 

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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 80823 

cannot be compared to physician 

responses and that this comparison is 

not relevant to the regulation of DTC 

advertisements. Indeed, the primary 

reason for conducting the study with 

physicians is to explore their processing 

of the prescribing information (PI), 

wholly separate from the consumer 

study. Nevertheless, since we have the 

two samples, we are conducting some 

exploratory analyses to compare the 

responses of consumers to information 

about a drug to the physicians’ 

understanding of the drug. While this 

does have relevance to the regulation of 

DTC advertising (e.g., a DTC ad that 

features a presentation of information 

that brings consumers closer to the 

assessment of the physician will be 

preferred over that same ad with a 

presentation of information that moves 

them farther away), we are approaching 

this comparison as a first, exploratory 

attempt at this type of analysis. 

Dated: December 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32278 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0074] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, e-mail: 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 7, 2010 (75 FR 

25267), the Agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0650. The 

approval expires on December 31, 2012. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: December 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32277 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0631] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request; Guidance for 

Industry on Updating Labeling for 

Susceptibility Test Information in 

Systemic Antibacterial Drug Products 

and Antimicrobial Susceptibility 

Testing Devices 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA’s ‘‘Guidance for Industry on 

Updating Labeling for Susceptibility 

Test Information in Systemic 

Antibacterial Drug Products and 

Antimicrobial Susceptibility Testing 

Devices.’’ The guidance describes 

procedures and responsibilities for 

updating information on susceptibility 

test interpretive criteria, susceptibility 

test methods, and quality control 

parameters in the labeling for systemic 

antibacterial drug products for human 

use, and also describes procedures for 

making corresponding changes to 

susceptibility test interpretive criteria 

for antimicrobial susceptibility testing 

(AST) devices. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 22, 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– 

796–3792, 

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, 

including each proposed extension of an 

existing 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 below 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) 

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