50028 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

typically require that a certification 

form accompany the application/ 

submission, as described in our April 

2008 Draft Guidance. Added to the 

burden were generic applications/ 

submissions, which were originally not 

included in the burden calculations, but 

have since been determined to require a 

certification form accompany the 

application/submission. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Investigational 

Applications 

Marketing 

Applications 

Hours per 

Response Total Hours 

CDER (new application) 1,837 ---- .25 459 

CBER (new application) 206 ---- .25 52 

CDER (amendment) 20,969 ---- .25 5,242 

CBER (amendment) 826 ---- .25 207 

CDER (annual report) 4,764 .25 1,191 

CBER (annual report) 878 .25 220 

CDER/CBER (new application/resubmission) ---- 214 .75 161 

CDRH (new application) ---- 424 .75 318 

CDER/CBER (amendment) ---- 4,451 .75 3,338 

CDRH (amendment) ---- 2,267 .75 1,700 

CDER/CBER (efficacy supplement/resubmission) ---- 259 .75 194 

CDER (annual report) ---- 7,753 .75 5,815 

CBER (annual report) ---- 629 .75 472 

CDER/CBER (labeling supplement) ---- 1,273 .75 955 

CDRH (supplement) ---- 2,526 .75 1,895 

CDRH (annual report) 433 .75 325 

OGD (original) 563 .75 422 

OGD ( BE amendment/supplement) 477 .75 358 

OGD (labeling supplement) 723 .75 542 

OGD (annual report) 5,173 .75 3,880 

TOTAL 27,746 

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

We believe the estimate of 27,746 

hours per year accurately reflects the 

burden. We recognize that individuals 

or entities less familiar with FDA forms 

and the clinical trials data bank 

(ClinicalTrials.gov) may require greater 

than 15 and 45 minutes (depending on 

the type of application/submission) per 

response. 

Dated: August 19, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19625 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0259] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

24, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0389. Also 

include the FDA docket number found 


ebenthall on PRODPC60 with NOTICES
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50029 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application 

Review—(OMB Control Number 0910–

0389)—Extension 

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) by adding section 

506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate a 

potential to address an unmet medical 

need. Under FDAMA section 112(b), 

FDA issued guidance to industry on fast 

track policies and procedures outlined 

in section 506 of the act. The guidance 

discusses collections of information that 

are specified under section 506 of the 

act, other sections of the Public Health 

Service Act (the PHS Act), or 

implementing regulations. The guidance 

describes three general areas involving 

collection of information: (1) Fast track 

designation requests, (2) premeeting 

packages, and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and 

premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it. 

Under section 506(a)(1) of the act, an 

applicant who seeks fast track 

designation is required to submit a 

request to the agency showing that the 

product: (1) Is intended for a serious or 

life-threatening condition; and (2) the 

product has the potential to address an 

unmet medical need. Mostly, the agency 

expects that information to support a 

designation request will have been 

gathered under existing provisions of 

the act, the PHS Act, or the 

implementing regulations. If such 

information has already been submitted 

to the agency, the information may be 

summarized in the fast track designation 

request. The guidance recommends that 

a designation request include, where 

applicable, additional information not 

specified elsewhere by statute or 

regulation. For example, additional 

information may be needed to show that 

a product has the potential to address an 

unmet medical need where an approved 

therapy exists for the serious or lifethreatening condition to be treated. 

Such information may include clinical 

data, published reports, summaries of 

data and reports, and a list of references. 

The amount of information and 

discussion in a designation request need 

not be voluminous, but it should be 

sufficient to permit a reviewer to assess 

whether the criteria for fast track 

designation have been met. 

After the agency makes a fast track 

designation, a sponsor or applicant may 

submit a premeeting package which 

may include additional information 

supporting a request to participate in 

certain fast track programs. The 

premeeting package serves as 

background information for the meeting 

and should support the intended 

objectives of the meeting. As with the 

request for fast track designation, the 

agency expects that most sponsors or 

applicants will have gathered such 

information to meet existing 

requirements under the act, the PHS 

Act, or implementing regulations. These 

may include descriptions of clinical 

safety and efficacy trials not conducted 

under an investigational new drug 

application (i.e., foreign studies), and 

information to support a request for 

accelerated approval. If such 

information has already been submitted 

to FDA, the information may be 

summarized in the premeeting package. 

Consequently, FDA anticipates that the 

additional collection of information 

attributed solely to the guidance will be 

minimal. 

Under section 506(c) of the act, a 

sponsor must submit sufficient clinical 

data for the agency to determine, after 

preliminary evaluation, that a fast track 

product may be effective. Section 506(c) 

of the act also requires that an applicant 

provide a schedule for the submission of 

information necessary to make the 

application complete before FDA can 

commence its review. The guidance 

does not provide for any new collection 

of information regarding the submission 

of portions of an application that is not 

required under section 506(c) of the act 

or any other provision of the act. All 

forms referred to in the guidance have 

a current OMB approval: FDA Forms 

1571 (OMB Control No. 0910–0014); 

356h (OMB Control No. 0910–0338); 

and 3397 (OMB Control No. 0910–

0297). 

Respondents to this information 

collection are sponsors and applicants 

who seek fast track designation under 

section 506 of the act. The agency 

estimates the total annual number of 

respondents submitting requests for fast 

track designation to the Center for 

Biologics Evaluation and Research and 

the Center for Drug Evaluation and 

Research is approximately 64, and the 

number of requests received is 

approximately 77 annually. FDA 

estimates that the number of hours 

needed to prepare a request for fast track 

designation is approximately 60 hours 

per request. 

Not all requests for fast track 

designation may meet the statutory 

standard. Of the requests for fast track 

designation made per year, the agency 

granted 60 from 54 respondents, and for 

each of these granted requests a premeeting package was submitted to the 

agency. FDA estimates that the 

preparation hours are approximately 

100 hours per pre-meeting package. 

In the Federal Register of May 6, 2008 

(73 FR 25016), FDA published a 60-day 

notice requesting public comment on 

the information collection provisions. 

No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Reporting Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Designation Request 64 1.28 82 60 4,915 

Premeeting Packages 54 1.11 60 100 6,000 


ebenthall on PRODPC60 with NOTICES
50030 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Reporting Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 118 2.39 142 160 10,915 

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

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19626 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0087] (formerly 

Docket No. 2007N–0461) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mental Models 

Study of Communicating With Health 

Care Providers About the Risks and 

Benefits of Prescription Drug Use for 

Pregnant and Nursing Women With 

Chronic Conditions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by September 

24, 2008. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title, 

‘‘Mental Models Study of 

Communicating with Health Care 

Providers about the Risks and Benefits 

of Prescription Drug Use for Pregnant 

and Nursing Women with Chronic 

Conditions.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Mental Models Study of 

Communicating With Health Care 

Providers About the Risks and Benefits 

of Prescription Drug Use for Pregnant 

and Nursing Women With Chronic 

Conditions 

The authority for FDA to collect the 

information derives from the FDA 

Commissioner’s authority, as specified 

in section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

393(d)(2)). 

The proposed information collection 

will help FDA advance public health by 

identifying misperceptions and 

knowledge gaps about how health care 

providers use information to make 

decisions about the use of prescription 

drugs for the targeted patient groups. 

Knowledge of these misperceptions and 

gaps provides opportunities for FDA to 

target its communications more 

precisely to such gaps and areas of 

misperception in health care providers’

mental models regarding treatment 

decisions. 

FDA engages in various 

communication activities to ensure that 

patients and health care providers have 

the information they need to make 

informed decisions about treatment 

options, including the use of 

prescription drugs. FDA regulations (21 

CFR 201.57) describe the content of 

required product labeling, and FDA 

reviewers ensure that labeling contains 

accurate and complete information 

about the known risks and benefits of 

each drug. This data collection and 

analysis is designed to identify 

knowledge gaps that FDA could then 

address, which would ultimately 

improve decision making and 

potentially improve health outcomes. 

The project will use ‘‘mental 

modeling,’’ a qualitative research 

method that compares a model of the 

decision-making processes of a group or 

groups to an ‘‘expert model’’ of the same 

decision-making processes developed 

from expert knowledge and experience. 

In this study, the decision models of 

certain health care providers concerning 

treatment options for pregnant and 

nursing women will be compared to an 

expert model concerning such treatment 

options that was derived from the 

knowledge and experience of FDA 

reviewers responsible for product 

labeling. FDA will use telephone 

interviews to determine from the health 

care providers the factors that influence 

their treatment decisions for pregnant 

and nursing women with chronic 

conditions. A comparison between 

expert and health care provider models 

based on the collected information may 

identify consequential knowledge gaps 

that can be redressed through messages 

or information campaigns designed by 

FDA. 

Using a protocol derived from the 

research that resulted in the ‘‘expert 

model,’’ trained interviewers will 

conduct one-on-one telephone 

discussions with 24 to 30 members of 

each of 2 categories of health care 

providers (described in the following 

paragraph) who provide health care 

services to pregnant and nursing 

women. 

The two categories of health care 

providers are: 

(1) Those who directly care for 

pregnant and nursing women, including 

obstetricians, OB/GYNs (obstetrician/ 

gynecologists), nurse midwives, and 

primary care practitioners. 

(2) Selected specialties of healthcare 

providers who directly care for women 

of reproductive age who have chronic 

health conditions (allergists, 

psychiatrists, neurologists, and 

cardiologists). 

In the Federal Register of December 

11, 2007 (72 FR 70328), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


ebenthall on PRODPC60 with NOTICES