[Federal Register Volume 68, Number 116 (Tuesday, June 17, 2003)]
[Notices]
[Pages 35901-35903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15168]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]


Draft Guidance for Industry on Continuous Marketing Applications: 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 the 
availability of a draft guidance for industry entitled ``Continuous 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.

DATES: Submit written comments on the draft guidance by August 1, 2003. 
General comments on agency guidance documents are welcome at any time. 
Submit written or electronic comments on the collection of information 
by August 15, 2003.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research (CDER), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857; or the Office of Communications, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. Send 
one self-addressed adhesive label to assist either office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidances.
    Submit written comments on the draft guidance and on the collection 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 Submit electronic comments on the draft guidance and the 
collection of information to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: John Jenkins, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-3937, or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Continuous Marketing Applications: Pilot 2--Scientific 
Feedback and Interactions During Development of Fast Track Products 
Under PDUFA.'' 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 this 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 Pilot 2. 
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. The FDA will begin accepting applications for 
participation in Pilot 2 on October 1, 2003.
    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 this topic. 
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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance 
and the information collection. Two copies of mailed comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. The draft guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (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. 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: (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

[[Page 35902]]

collected; and (4) ways to minimize the burden of the collection on 
respondents, including through the use of automated collection 
techniques and other forms of information technology, when appropriate.
    Title: Draft guidance for industry ``Continuous Marketing 
Applications: Pilot 2--Scientific Feedback and Interactions During 
Development of Fast Track Products Under PDUFA.
    Description: FDA is issuing a draft guidance on the implementation 
of a pilot program to provide selected applicants of Fast Track drugs 
or biologics with frequent scientific feedback and interactions during 
the IND development phase. The draft guidance describes the criteria, 
procedures, and the application process to participate in Pilot 2.
    The draft 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 draft 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.
    Section 312.23 (21 CFR 312.23) of the FDA regulations 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. FDA Form 1571 has a valid OMB control 
number: OMB Control No. 0910-0014, which expires January 31, 2006.
    In the draft 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 draft 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/biologic licensing applications submission;
    [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., continuous marketing applications, 
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.
    Description of Respondents: An applicant for a drug or biological 
product that has been designated as Fast Track under section 112 of the 
FDA Modernization Act (21 U.S.C. 356).
    Burden Estimate: Table 1 of this document provides an estimate of 
the annual reporting burden\1\ for the submission of a Pilot 2 
application under the guidance. Participation in this pilot program 
will be voluntary.
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    \1\ The burden estimate is for the application period because 
this is a pilot program and limited in duration.
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    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 
submitted in a Pilot 2 application in accordance with the draft 
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\1\
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     Pilot 2             No. of        No. of responses     Total annual        Hours per
   application        respondents       per respondent       responses           response         Total hours
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CDER                              85               1.06                 90                 80              7,200
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CBER                              29               1.20                 35                 80              2,800
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Total                                                                                                     10,000
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.


[[Page 35903]]

IV. Electronic Access

    Persons with access to the Internet can obtain the guidance at 
http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/guidelines.htm.

    Dated: June 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15168 Filed 6-12-03; 11:36 am]
BILLING CODE 4160-01-S