[Federal Register: September 9, 2003 (Volume 68, Number 174)]
[Page 53174-53175]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 53174]]



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.


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
    [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
    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

[[Page 53175]]

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\
                                                         Annual Frequency per
      Pilot 2 Application        Number of Respondents         Response         Total Annual Responses      Hours per Response          Total Hours
CDER                                               85                   1.06                        90                        80                  7,200
CBER                                               29                   1.20                        35                        80                  2,800
Total                            .....................  .....................  ........................  ........................                10,000
\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]