[Federal Register: June 17, 2003 (Volume 68, Number 116)]
[Notices]
[Page 35901-35903]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn03-68]
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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Draft Guidance for Industry on Continuous Marketing Applications: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availability of a draft guidance for industry entitled ``Continuous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DATES: Submit written comments on the draft guidance by August 1, 2003.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Submit written comments on the draft guidance and on the collection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 Submit electronic comments on the draft guidance and the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.
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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]
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