[Federal Register Volume 69, Number 38 (Thursday, February 26, 2004)]
[Notices]
[Pages 8978-8980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Continuous Marketing Applications: Pilot 2-Scientific Feedback and 
Interactions During Development of Fast Track Products Under the 
Prescription Drug User Fee Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 8979]]

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 (the PRA).

DATES: Fax written comments on the collection of information by March 
29, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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 on Continuous Marketing Applications: Pilot 2-
Scientific Feedback and Interactions During Development of Fast Track 
Products Under the Prescription Drug User Fee Act (OMB Control Number 
0910-0518--Extension)

    FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for 
the reporting and recordkeeping requirements contained in the 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 the development of certain Fast Track drug and biological 
products. Applicants are being asked to apply to participate in the 
Pilot 2 program.
    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 
began accepting applications for participation in Pilot 2 on October 1, 
2003.
    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 FDA and the applicant during the 
product development process.
    FDA's regulation at Sec.  312.23 (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. Both 21 CFR part 312 and FDA Form 
1571 have a valid OMB control number (OMB control number 0910-0014), 
which expires January 31, 2006.
    In the guidance document, FDA's Center for Drug Evaluation and 
Research (CDER) and Center for Biologics Evaluation and Research (CBER) 
ask that a Pilot 2 application be submitted as an amendment to the 
application for the underlying product under the requirements of Sec.  
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 databases. Use of the information in the agency's 
tracking databases 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:
    [sbull] Cover letter prominently labeled ``Pilot 2 application;''
    [sbull] IND number;
    [sbull] Date of Fast Track designation;
    [sbull] Date of the end-of-phase 1 meeting, or equivalent meeting, 
and summary of the outcome;
    [sbull] A timeline of milestones from the drug or biological 
product development program, including projected date of new drug 
application (NDA)/ biologic licensing application (BLA) submissions;
    [sbull] 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);
    [sbull] 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
    [sbull] 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 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.

[[Page 8980]]

 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.
    On September 29, 2003, this guidance was approved on an emergency 
basis, which expires on March 30, 2004. This notice of request is to 
receive approval in the normal PRA process.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                          No. of Responses per
     Pilot 2 Application         No. of Respondents            Respondent              Total Responses         Hours per Response         Total Hours
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CDER                                               85                      1.06                        90                        80               7,200
CBER                                               29                      1.20                        35                        80               2,800
Total                         ........................  ........................  ........................  ........................             10,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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

    Dated: February 19, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-4248 Filed 2-25-04; 8:45 am]
BILLING CODE 4160-01-S