[Federal Register: November 20, 2003 (Volume 68, Number 224)]
[Notices]               
[Page 65457-65459]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20no03-58]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0229]

 
Agency Information Collection Activities; Proposed Collection; 
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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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
contained in the 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 of 1992 (PDUFA).

DATES: Submit written or electronic comments on the collection of 
information by January 20, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments 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. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under 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. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. 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, including 
each proposed extension of an existing 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 these topics: (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 collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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)

    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 Prescription Drug User Fee Act.'' 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 PDUFA, FDA 
agreed to meet specific performance goals (PDUFA goals). The PDUFA 
goals include two pilot programs to explore the continuous marketing 
application

[[Page 65458]]

(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 the 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, 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 
data bases. 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 NDA/biologic 
license application 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. 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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   Pilot 2                               No. of Responses per                           Hours per
 Application     No. of Respondents           Respondent          Total 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 collection of
  information.



[[Page 65459]]

    Dated: November 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28984 Filed 11-19-03; 8:45 am]

BILLING CODE 4160-01-S