[Federal Register: February 26, 2004 (Volume 69, Number 38)]
[Notices]
[Page 8978-8980]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe04-92]
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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