15140 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0105] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Mental Models 

Study of Food Bioterrorism Risk 

Awareness 

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 information collection provisions of 

the mental models study of food 

bioterrorism risk awareness. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 29, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

Mental Models Study of Food 

Bioterrorism Risk Awareness 

The proposed information collection 

will help FDA protect the public from 

food bioterrorism by preparing the 

agency to take appropriate action in the 

event of a crisis. Under the Federal 

Food, Drug, and Cosmetic Act of 1938, 

as amended, FDA has authority to act to 

protect the safety of the nation’s food 

supply. Under title 42 of the Public 

Health Service Act (1944), FDA has 

authority to act to protect the public 

health. In addition, title III of the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(Public Law 107–188), FDA has 

authority to act to improve the ability of 

the United States to prevent, prepare 

for, and respond to bioterrorism and 

other public health emergencies. 

FDA has crafted and disseminated 

messages intended to raise the 

awareness of state and local government 

agency and industry representatives 

regarding food defense issues and 

preparedness, but FDA does not 

currently have similar initiatives for 

consumers. Extensive research exists in 

disaster preparedness and in effective 

communication to the public of risk or 

crisis information by government or 

non-government entities. However, 

additional research is needed to help 

FDA design communications that will 

increase consumer awareness of the 

potential for food bioterrorism and help 

consumers to make good decisions in 

the event of a food bioterrorism 

emergency. 

The project will use ‘‘mental 

modeling,’’ a qualitative research 

method wherein the decision-making 

processes of a group of consumer 

respondents (described in the next 

paragraph) concerning food bioterrorism 

are modeled and compared to a model 

based on expert knowledge and 

experience in food bioterrorism. The 

information will be collected via a 

telephone interview concerning the 

factors that influence the perceptions 

and motivations related to the threat of 

food bioterrorism. A comparison 

between expert and consumer models 

based on the collected information may 

identify ‘‘consequential knowledge 

gaps’’ that can be redressed through 

messages or information campaigns 

designed by FDA. 

Description of Respondents: 

Respondents will be adult parents over 

the age of 18 who have at least one child 

age 4 to 13 residing in the home at least 

half-time. The sample will be divided 

by gender. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

45 1 1 .75 33.75 

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


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices 15141 

The study will involve 45 

respondents and take approximately 45 

minutes each to complete. These 

estimates are based on FDA’s experience 

with consumer research. 

Dated: March 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1577 Filed 3–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0089] 

Draft Guidance for Industry and 

Review Staff on Target Product 

Profile—A Strategic Development 

Process Tool; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and review staff entitled 

‘‘Target Product Profile—A Strategic 

Development Process Tool.’’ The 

purpose of this guidance is to inform 

sponsors and the review staff in the 

Center for Drug Evaluation and Research 

(CDER) of the availability and potential 

usefulness of a target product profile 

(TPP). A TPP can be prepared by a 

sponsor and then shared voluntarily 

with the appropriate FDA review staff to 

facilitate communication regarding a 

particular drug development program. 

This draft guidance describes the 

purposes of a TPP, provides guidance 

on how to complete a TPP, makes 

suggestions on how to best use a TPP, 

and relates case studies that 

demonstrate the potential usefulness of 

a TPP. 

DATES: Submit written or electronic 

comments on the draft guidance and/or 

on the collection of information by May 

29, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance and/or 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. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jeanne M. Delasko, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6474, 

Silver Spring, MD 20993–0002, 301–

796–0900. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and review 

staff entitled ‘‘Target Product Profile—A 

Strategic Development Process Tool.’’ In 

1997, a Clinical Development Working 

Group composed of representatives from 

FDA and pharmaceutical sponsors 

began discussions on ways to improve 

sponsor and FDA interactions in the 

drug development process. The working 

group recommended use of a template 

that provides a summary of drug 

labeling concepts to focus discussions 

and aid in the understanding between 

sponsors and FDA. The resulting TPP is 

a format for a summary of a drug 

development program described in 

terms of labeling concepts. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on target product profiles. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

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 below. 

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 on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Draft Guidance for Industry and 

Review Staff: Target Product Profile—A 

Strategic Development Process Tool. 

Description: The draft guidance is 

intended to provide sponsors and FDA 

review staff with information regarding 

TPPs. A TPP can be prepared by a 

sponsor and then shared voluntarily 

with the appropriate FDA review staff to 

facilitate communication regarding a 

particular drug development program. A 

Clinical Development Working Group 

recommended use of a template that 

provides a summary of drug labeling 

concepts to focus discussions and aid in 

the understanding between sponsors 

and FDA. The resulting TPP is a format 

for a summary of a drug development 

program described in terms of labeling 

concepts. With the TPP, a sponsor 

specifies the labeling concepts that are 

the goals of the drug development 

program, documents the specific studies 

that are intended to support the labeling 

concepts, and then uses the TPP to 

assist in a constructive dialogue with 

FDA. The draft guidance describes the 

purpose of a TPP, its advantages, and its 

optimal use. It also provides 

information on how to complete a TPP 

and relates case studies that 

demonstrate a TPP’s usefulness. 

Sponsors are not required to submit a 

TPP. The TPP does not represent an 

implicit or explicit obligation on the 

sponsor’s part to pursue all stated goals. 

Submission of a TPP summary does not 

constrain the sponsor to submit draft 

labeling in a new drug application 

(NDA) or biologics license application 

(BLA) that is identical to the TPP. The 

TPP is part of the proprietary 

investigational new drug application 

(IND) file. 


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