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, 28495-28496 [E7-9709]
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Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0278]
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.
pwalker on PROD1PC71 with NOTICES
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.
DATES: Fax written comments on the
collection of information by June 20,
2007.
ADDRESSES: 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: FDA Desk Officer, FAX:
202–395–6974. All comments should be
identified with the OMB control number
0910–0518. Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Liz
Berbakos, Office of the Chief
Information Officer (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—
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 (CMA): Pilot
2—Scientific Feedback and Interactions
VerDate Aug<31>2005
15:57 May 18, 2007
Jkt 211001
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
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 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
allows 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 FDA’s Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) is 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 § 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. 21 CFR part 312 and FDA Form
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
28495
1571 have a valid OMB control number:
OMB control number 0910–0014, which
expires May 31, 2009.
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 § 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:
• Cover letter prominently labeled
‘‘Pilot 2 application’’;
• IND number;
• Date of Fast Track designation;
• Date of the end-of-phase 1 meeting,
or equivalent meeting and summary of
the outcome;
• A timeline of milestones from the
drug or biological product development
program, including projected date of
new drug application (NDA)/biologics
license application submissions;
• 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);
• 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
• Draft agreement for proposed
feedback and interactions with FDA.
This information is used by the
agency to determine which Fast Track
products are eligible for participation in
Pilot 2. Participation in this pilot
program is voluntary.
Based on the number of Pilot 2
applications submitted to CDER and
CBER during fiscal year 2004 and 2005,
we estimate that the number of
applications received annually for Pilot
2 is 7 for products regulated by CDER
E:\FR\FM\21MYN1.SGM
21MYN1
28496
Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices
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.
and 1 for products regulated by CBER.
FDA anticipates that approximately 7
applicants (respondents) will submit
these Pilot 2 applications annually to
CDER and approximately 1 applicant
(respondent) will submit these Pilot 2
applications annually to CBER. The
hours per response, which is the
estimated number of hours that a
Therefore, the agency estimates that
applicants use approximately 640 hours
annually to submit the Pilot 2
applications.
In the Federal Register of July 24,
2006 (71 FR 41819), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Responsesper Response
No. of
Respondents
Pilot 2 Application
Total Responses
Hours per
Response
Total Hours
CDER
7
1
7
80
560
CBER
1
1
1
80
80
Total
640
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9709 Filed 5–18–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007E–0066]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NOXAFIL
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NOXAFIL and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy (HFD–007), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
VerDate Aug<31>2005
15:57 May 18, 2007
Jkt 211001
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
product becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human drug product and continues
until FDA grants permission to market
the drug product. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing
the human drug product NOXAFIL
(posaconazole). NOXAFIL is indicated
for prophylaxis of invasive Aspergillus
and Candida infections in patients, 13
years of age and older, who are at high
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
risk of developing these infections due
to being severely immunocompromised,
such as hematopoietic stem cell
transplant recipients with Graft versus
Host Disease or those with hematologic
malignancies with prolonged
neutropenia from chemotherapy.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
NOXAFIL (U.S. Patent No. 5,661,151)
from Schering Corp., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 12, 2007, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of NOXAFIL
represented the first permitted
commercial marketing or use of the
product. Shortly thereafter, the Patent
and Trademark Office requested that
FDA determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
NOXAFIL is 3,650 days. Of this time,
3,382 days occurred during the testing
phase of the regulatory review period,
while 268 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355(i)) became effective: September 19,
1996. The applicant claims November 6,
1996, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was September 19,
1996, which was 30 days after FDA
receipt of the first IND.
E:\FR\FM\21MYN1.SGM
21MYN1
]]>Agencies
[Federal Register Volume 72, Number 97 (Monday, May 21, 2007)]
[Notices]
[Pages 28495-28496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9709]
[[Page 28495]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0278]
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.
-----------------------------------------------------------------------
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.
DATES: Fax written comments on the collection of information by June
20, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974. All comments should be identified with the OMB
control number 0910-0518. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of the Chief
Information Officer (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--
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 (CMA): 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 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 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 allows 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 FDA's Center for Drug Evaluation and Research (CDER) and Center for
Biologics Evaluation and Research (CBER) is 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. 21 CFR part 312 and FDA Form 1571
have a valid OMB control number: OMB control number 0910-0014, which
expires May 31, 2009.
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:
Cover letter prominently labeled ``Pilot 2 application'';
IND number;
Date of Fast Track designation;
Date of the end-of-phase 1 meeting, or equivalent meeting
and summary of the outcome;
A timeline of milestones from the drug or biological
product development program, including projected date of new drug
application (NDA)/biologics license application submissions;
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);
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
Draft agreement for proposed feedback and interactions
with FDA.
This information is used by the agency to determine which Fast
Track products are eligible for participation in Pilot 2. Participation
in this pilot program is voluntary.
Based on the number of Pilot 2 applications submitted to CDER and
CBER during fiscal year 2004 and 2005, we estimate that the number of
applications received annually for Pilot 2 is 7 for products regulated
by CDER
[[Page 28496]]
and 1 for products regulated by CBER. FDA anticipates that
approximately 7 applicants (respondents) will submit these Pilot 2
applications annually to CDER and approximately 1 applicant
(respondent) will submit these Pilot 2 applications annually to CBER.
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 use approximately 640 hours annually
to submit the Pilot 2 applications.
In the Federal Register of July 24, 2006 (71 FR 41819), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of Responses Hours per
Pilot 2 Application Respondents per Response Total Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER 7 1 7 80 560
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER 1 1 1 80 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9709 Filed 5-18-07; 8:45 am]
BILLING CODE 4160-01-S
