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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80824 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 

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. 

Guidance for Industry on Updating 

Labeling for Susceptibility Test 

Information in Systemic Antibacterial 

Drug Products and Antimicrobial 

Susceptibility Testing Devices (OMB 

Control Number 0910–0638—Extension) 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

includes a requirement that FDA 

identify and periodically update 

susceptibility test interpretive criteria 

for antibacterial drug products and 

make those findings publicly available. 

As a result of this provision, the 

guidance explains the importance of 

making available to health care 

providers the most current information 

regarding susceptibility test interpretive 

criteria for antibacterial drug products. 

To address concerns about antibacterial 

drug product labeling with out-of-date 

information on susceptibility test 

interpretive criteria, quality control 

parameters, and susceptibility test 

methods, the guidance describes 

procedures for FDA, applications 

holders, and AST device manufacturers 

to ensure that updated susceptibility 

test information is available to health 

care providers. Where appropriate, FDA 

will identify susceptibility test 

interpretive criteria, quality control 

parameters, and susceptibility test 

methods by recognizing annually in a 

Federal Register notice, standards 

developed by one or more nationally or 

internationally recognized standard 

development organizations. The FDA 

recognized standards will be available 

to application holders of approved 

antibacterial drug products for updating 

their product labeling. 

Application holders can use one of 

the following approaches to meet their 

responsibilities to update their product 

labeling under the guidance and FDA 

regulations: Submit a labeling 

supplement that relies upon a standard 

recognized by FDA in a Federal Register 

notice, or submit a labeling supplement 

that includes data supporting a 

proposed change to the microbiology 

information in the labeling. In addition, 

application holders should include in 

their annual report an assessment of 

whether the information in the 

‘‘Microbiology’’ subsection of their 

product labeling is current or changes 

are needed. This information collection 

is already approved by OMB under 

Control Number 0910–0572 (the 

requirement in 21 CFR 201.56(a)(2) to 

update labeling when new information 

becomes available that causes the 

labeling to become inaccurate, false, or 

misleading) and Control Number 0910– 

0001 (the requirement in 21 CFR 

314.70(b)(2)(v) to submit labeling 

supplements for certain changes in the 

product’s labeling, and the requirement 

in 21 CFR 314.81(b)(2)(i) to include in 

the annual report a brief summary of 

significant new information from the 

previous year that might affect the 

labeling of the drug product). 

In addition, under the guidance, if the 

information in the applicant’s product 

labeling differs from the standards 

recognized by FDA in the Federal 

Register notice, and the applicant 

believes that changes to the labeling are 

not needed, the applicant should 

provide written justification to FDA 

why the recognized standard does not 

apply to its drug product and why 

changes are not needed to the 

‘‘Microbiology’’ subsection of the 

product’s labeling. This justification 

should be submitted as general 

correspondence to the product’s 

application, and a statement indicating 

that no change is currently needed and 

the supporting justification should be 

included in the annual report. Based on 

our knowledge of the need to update 

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 our 

experience with the FDAAA 

requirement and the guidance 

recommendations during the past 16 

months, we estimate that, annually, 

approximately two applicants will 

submit the written justification 

described previously and in the 

guidance, and that each justification 

will take approximately 16 hours to 

prepare and submit to FDA as general 

correspondence and as part of the 

annual report. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Hours per 

response 

Total 

hours 

Justification submitted as general correspondence and in 

the annual report .............................................................. 2 1 2 16 32 

Total .............................................................................. ........................ ........................ ........................ 32 

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

Dated: December 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32276 Filed 12–22–10; 8:45 am] 

BILLING CODE 4160–01–P 

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