[Federal Register Volume 68, Number 174 (Tuesday, September 9, 2003)]
[Notices]
[Pages 53174-53175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22949]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]


Agency Emergency Processing Under Office of Management and Budget 
Review; 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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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for emergency processing 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
September 15, 2003.

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: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). This information is needed 
immediately, 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 PDUFA

    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 the Center for Drug Evaluation and Research (CDER) 
and the Center for Biologics Evaluation and Research (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.
    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. 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, 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 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 
applications/biologic licensing applications 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

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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 
submitted 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.
    In the Federal Register of June 17, 2003 (68 FR 35901), FDA 
announced the availability of the draft guidance and requested comments 
for 60 days on the information collection. Four comments were received 
that did not pertain to the information collection estimates.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                         Annual Frequency per
      Pilot 2 Application        Number of Respondents         Response         Total Annual 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 information collection.


    Dated: September 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22949 Filed 9-4-03; 3:01 pm]
BILLING CODE 4160-01-S