SUPPORTING STATEMENT

Guidance for Industry - Continuous Marketing Applications: Pilot 2 ---
Scientific Feedback and Interactions During Development of Fast Track
Products Under PDUFA

Docket No. 03D-0229

A. [Justification]{.underline}

1\. [Circumstances of Information Collection]{.underline}

This information collection approval request is for a Food and Drug
Administration (FDA) guidance for industry entitled "Continuous
Marketing Applications: Pilot 2 --- Scientific Feedback and Interactions
During Development of Fast Track Products Under PDUFA." This guidance
discusses how the agency will implement a pilot program for frequent
scientific feedback and interactions between FDA and applicants during
the investigational phase of development of certain Fast Track drug and
biological products. Applicants are being asked to apply to participate
in the Pilot 2 program.

2\. [Purpose and Use of Information]{.underline}

In conjunction with the June 2002 reauthorization of the Prescription
Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet specific
performance goals (PDUFA Goals). The PDUFA Goals include two pilot
programs to explore the continuous marketing application (CMA) concept.
The CMA concept builds on the current practice of interaction between
FDA and applicants during drug development and application review and
proposes opportunities for improvement. Under the CMA pilot program,
Pilot 2, certain drug and biologic products that have been designated as
Fast Track (i.e., products intended to treat a serious and/or
life-threatening disease for which there is an unmet medical need) are
eligible to participate in the program. Pilot 2 is an exploratory
program that will allow FDA to evaluate the impact of frequent
scientific feedback and interactions with applicants during the
investigational new drug application (IND) phase. Under the pilot
program, a maximum of one Fast Track product per review division in CDER
and CBER will be selected to participate. This guidance provides
information regarding the selection of participant applications for
Pilot 2, the formation of agreements between FDA and applicants on the
IND communication process, and other procedural aspects of Pilot 2. FDA
will begin accepting applications for participation in Pilot 2 on
October 1, 2003.

3\. [Use of Improved Information Technology]{.underline}

The following guidances for industry have been developed to improve the
use of information technology in the submission of investigational and
new drug applications and related reports:

In January 1999, FDA announced the availability of a guidance entitled
\"Providing Regulatory Submissions in Electronic Format ------ NDAs.\"
The guidance provides information on how to submit a complete archival
copy of an NDA in electronic format and applies to the submission of
original NDAs as well as to the submission of supplements and amendments
to NDAs. The guidance recommends that labeling text be submitted as a
PDF file. In June 2002, FDA announced the availability of a guidance
entitled \"Providing Regulatory Submissions in Electronic Format ------
ANDAs.\" In January 1999, FDA issued a guidance on general
considerations for electronic submissions entitled \"Providing
Regulatory Submissions in Electronic Format ------ General
Considerations.\" The guidance includes a description of the types of
electronic file formats that the agency is able to accept to process,
review, and archive electronic documents. In November 1999, FDA
published a guidance to assist applicants in submitting documents in
electronic format for review and archive purposes as part of a biologics
license application (BLA), product license application (PLA), or
establishment license application (ELA). In January 2001, FDA issued a
guidance entitled \"Providing Regulatory Submissions in Electronic
Format --- Prescription Drug Advertising and Promotional Labeling.\" In
May 2001, FDA issued a guidance entitled \"Providing Regulatory
Submissions In Electronic Format - Postmarketing Expedited Saftey
Reports.\" In June 2003, FDA issued a guidance entitled \"Providing
Regulatory Submissions In Electronic Format - Postmarketing Periodic
Adverse Drug Experience Reports.\"

4\. [Efforts to Identify Duplication]{.underline}

The information collection requested under the guidance does not
duplicate any other information collection.

5\. [Involvement of Small Entities]{.underline}

Although new drug development is typically an activity completed by
large multinational drug firms, the information collection requested
under the guidance applies to small as well as large companies. Under
the Regulatory Flexibility Act, FDA regularly analyzes regulatory
options that would minimize any significant impact on small entities.
FDA also assists small businesses in complying with regulatory
requirements.

6\. [Consequences If Information Collected Less Frequently]{.underline}

As discussed, the information as requested is necessary for frequent
scientific feedback and interactions between FDA and applicants during
the investigational phase of development of certain Fast Track drug and
biological products.

7\. [Consistency with the Guidelines in 5 CFR 1320.5(d)(2)]{.underline}

Inconsistency with the guidelines concerning the number of copies
submitted is approved by OMB under OMB Control Number 0910-0014.

8\. [Consultation Outside the Agency]{.underline}

In the [Federal Register]{.underline} of November 20, 2003, (68 FR
65457) FDA announced the availability of the draft guidance and
requested comments for 60 days on the information collection. One
comment was received that did not pertained to the information
collection estimates.

9\. [Remuneration of Respondents]{.underline}

FDA has not provided and has no intention to provide any payment or gift
to respondents under this guidance.

10\. [Assurance of Confidentiality]{.underline}

Confidentiality of the information submitted under this guidance is
protected under 21 CFR 312.130 and 314.430 and under 21 CFR part 20. The
unauthorized use or disclosure of trade secrets required in applications
is specifically prohibited under Section 310(j) of the Act.

11\. [Questions of a Sensitive Nature]{.underline}

There are no questions of a sensitive nature.

12\. [Estimates of Annualized Hour Burden]{.underline}

The guidance describes one collection of information: Applicants who
would like to participate in Pilot 2 must submit an application (Pilot 2
application) containing certain information outlined in the guidance.
The purpose of the Pilot 2 application is for the applicants to describe
how their designated Fast Track product would benefit from enhanced
communications between the FDA and the applicant during the product
development process.

FDA\'s regulation at 21 CFR 312.23 states that information provided to
the agency as part of an IND must be submitted in triplicate and with an
appropriate cover form. Form FDA 1571 must accompany submissions under
INDs. Part 312 and FDA Form 1571 have a valid OMB control number: OMB
Control No. 0910-0014, which expires January 31, 2006.

In the guidance document, CDER and CBER ask that a Pilot 2 application
be submitted as an amendment to the application for the underlying
product under the requirements of § 312.23; therefore, Pilot 2
applications should be submitted to the agency in triplicate with Form
FDA 1571. The agency recommends that a Pilot 2 application be submitted
in this manner for two reasons: (1) To ensure that each Pilot 2
application is kept in the administrative file with the entire
underlying application, and (2) to ensure that pertinent information
about the Pilot 2 application is entered into the appropriate tracking
data bases. Use of the information in the agency's tracking data bases
enables the agency to monitor progress on activities.

Under the guidance, the agency asks applicants to include the following
information in the Pilot 2 application:

-   Cover letter prominently labeled "Pilot 2 application;"

-   IND number;

-   Date of Fast Track designation;

-   Date of the end-of-phase 1 meeting, or equivalent meeting, and
    summary of the outcome;

-   A timeline of milestones from the drug or biological product
    development program, including projected date of NDA/BLA
    submissions;

-   Overview of the proposed product development program for a specified
    disease and indication(s), providing information about each of the
    review disciplines (e.g., chemistry/ manufacturing/ controls,
    pharmacology/toxicology, clinical, clinical pharmacology and
    biopharmaceutics);

-   Rationale for interest in participating in Pilot 2, specifying the
    ways in which development of the subject drug or biological product
    would be improved by frequent scientific feedback and interactions
    with FDA and the potential for such communication to benefit public
    health by improving the efficiency of the product development
    program; and

-   Draft agreement for proposed feedback and interactions with FDA.

This information will be used by the agency to determine which Fast
Track products are eligible for participation in Pilot 2. Participation
in this pilot program will be voluntary.

Based on the number of approvals for Fast Track designations and data
collected from the review divisions and offices within CDER and CBER,
FDA estimates that in fiscal year (FY) 2002, 109 drug product
applications and 46 biological products had Fast Track designation. FDA
anticipates that approximately 85 drug product applicants (respondents)
and approximately 29 biological product applicants (respondents) will
submit at least one Pilot 2 application. Based on information collected
from offices within CDER and CBER, the agency further anticipates that
the total responses, i.e., the total number of applications received for
Pilot 2, will be 90 for drug products and 35 for biological products.
The hours per response, which is the estimated number of hours that a
respondent would spend preparing the information to be submitting in a
Pilot 2 application in accordance with the guidance, is estimated to be
approximately 80 hours. Based on FDA's experience, we expect it will
take respondents this amount of time to obtain and draft the information
to be submitted with a Pilot 2 application. Therefore, the agency
estimates that applicants will use approximately 10,000 hours to
complete the Pilot 2 applications.

FDA invites comments on this analysis of information collection burdens.

Table 1.\--Estimated Annual Reporting Burden

  -------------------- ------------- -------------- ----------- ---------- --------
  Pilot 2 Application  Number of     Number of      Total       Hours per  Total
                       Respondents   Responses per  Responses   Response   Hours
                                     Respondent                            

  [CDER]{.underline}   85            1.06           90          80         7,200

  [CBER]{.underline}   29            1.20           35          80         2,800

  Total                                                                    10,000
  -------------------- ------------- -------------- ----------- ---------- --------

13\. [Estimates of Annualized Cost Burden to Respondents]{.underline}

FDA has estimated an average industry wage rate of \$50.00 per hour for
preparing and submitting the information collection requirements under
OMB Control Number 0910-0014. Using the averaged wage rate of \$50.00
per hour, and multiplied times the total hour burden estimated above,
the total cost burden to respondents is \$500,000 (10,000 x \$50).

14\. [Estimates of Annualized Cost Burden to the Government]{.underline}

FDA estimates that review of the Pilot 2 applications will take
approximately 2,520 hours (3 applications per review division x 21
divisions x 40 hours per application). Using the averaged cost of \$50
per hour for each reviewer, the cost to FDA is estimated to be
\$126,000.00.

15\. [Changes In Burden]{.underline}

This is a new collection.

16\. [Time Schedule, Publication, and Analysis Plans]{.underline}

There are no publications.

17\. [Displaying of OMB Expiration Date]{.underline}

The agency is not seeking to display the expiration date for

OMB approval of the information collection.

18\. [Exception to the Certification Statement - Item 19]{.underline}

There are no exceptions to the certification statement

identified in Item 19, \"Certification for Paperwork Reduction Act

Submission,\" of OMB Form 83-I.

OMB 83-I 10/95

83Icomre.sp

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