[Federal Register: October 18, 2005 (Volume 70, Number 200)]
[Notices]
[Page 60536-60538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc05-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0410]
Prescription Drug User Fee Act; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting on the Prescription Drug User Fee Act (PDUFA). The legislative
authority for PDUFA expires in September 2007. Without further
legislation, we will no longer be able to collect user fees for the
prescription drug program and resources critical to running the program
would become unavailable to us. We invite public comment on the PDUFA
program and suggestions regarding what features we should propose for
the next PDUFA program.
DATES: The public meeting will be held on November 14, 2005, from 9
a.m. to 5 p.m. Registration to attend the meeting must be received by
October 31, 2005. You may register electronically at
CBERTraningSuggestions@cber.fda.gov. Walk-in registration at the
meeting site will also be accepted. Submit written comments by December
14, 2005.
ADDRESSES: The meeting will be held at the Natcher Conference Center,
National Institutes of Health, Bldg. 45, Center Dr., 9000 Rockville
Pike, Bethesda, MD 20815. Parking is limited, and there may be delays
entering the NIH campus due to increased security. All visitors'
vehicles will be inspected, and visitors must show one form of
identification (ID) (such as a government-issued photo ID, driver's
license, passport, etc.) We recommend arriving by subway (Metrorail) if
possible. NIH is accessible from the Metrorail's ``Red Line'' at the
Medical Center/NIH station.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT:
For information regarding this notice: Patricia A. Stewart, Office
of Policy and Planning (HFP-1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2647, FAX: 301-594-6777, e-
mail: Patricia.Stewart@oc.fda.gov.
For information regarding registration: Melanie Whelan or Kathy
Eberhart, Office of Communication, Training and Manufacturers
Assistance (HFM-49), Center for Biologics Evaluation and Research, 1401
Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-2000, FAX:
301-827-3079.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing its intention to hold a public meeting on PDUFA.
The authority for PDUFA expires in September 2007. Without further
legislation, FDA would no longer be able to collect user fees for the
prescription drug program. Resources critical to running the program
would become unavailable to FDA. We are now considering what features
we should propose for the next PDUFA program. We are convening a public
meeting to hear stakeholder views on this subject. We are offering the
following two general questions for consideration, and we are
interested in responses to these questions and any other pertinent
information stakeholders would like to share:
1. What is your assessment of the overall performance of the PDUFA
program thus far?
2. What aspects of PDUFA should be retained, or what should be
changed to further strengthen and improve the program?
We provide the following background on the PDUFA program so
potential participants can better understand the history and evolution
of the PDFUA program and its current status.
II. What is PDUFA? What Does It Do?
PDUFA, in broad terms, is a series of laws that have authorized us
to collect fees from companies that produce certain human drug and
biological products. The original PDUFA (PDUFA I) was enacted in 1992
(as the Prescription Drug User Fee Act, Public Law 102-571) and had a
5-year life. In 1997, as PDUFA I expired, Congress passed the FDA
Modernization Act (FDAMA, Public Law 105-115). FDAMA included, among
other things, an extension of PDUFA (PDUFA II) for an additional 5
years. In 2002, Congress extended PDUFA again for 5 years (PDUFA III)
through the Public Health Security and Bioterrorism Preparedness and
Response Act (Public Law 107-188).
PDUFA's original intent was to provide additional revenues to us so
that we could hire more staff to improve the process for the review of
human
[[Page 60537]]
drugs to make important drug therapies available to patients sooner
without compromising review quality.
Under PDUFA, the industry provided additional funds through user
fees that would be available to FDA, in addition to appropriated funds,
to spend on the process for the review of human drugs. Our authority to
collect user fees is ``triggered'' only when a base amount of
appropriated funds, adjusted for inflation, is spent.
In conjunction with PDUFA, we set review performance goals that
became more stringent each year. These goals applied to the review of
original new human drug and biological product applications,
resubmissions of original applications, and supplements to approved
applications. During the first few years of PDUFA I, we eliminated
backlogs of original applications and supplements that had formed in
earlier years when the program had fewer resources. Phased in over the
5 years of PDUFA I, the goals were to review and act on 90 percent of
priority new drug applications (NDAs), biologics license applications
(BLAs), and efficacy supplements (i.e., submissions for products
providing significant therapeutic gains) within 6 months of submission
of a complete application; to review and act on 90 percent of
nonpriority original NDAs, BLAs, and efficacy supplements within 12
months, and on resubmissions and manufacturing supplements within 6
months. Over the course of PDUFA I, we exceeded all of these
performance goals.
Under PDUFA II, some review performance goals continued to shorten.
For example, by 2002, the PDUFA II goals called on us to review and act
on 90 percent of the following:
Standard new drug and biological product applications and
efficacy supplements within 10 months;
Chemistry and Manufacturing Control supplements requiring
prior FDA approval within 4 months; and
Class 1 resubmissions (that respond to relatively minor
deficiencies such as labeling changes) within 2 months.
In addition, PDUFA II added a new set of procedural goals intended
to improve our interactions with industry sponsors during the early
years of drug development. For example, these goals called for us to
meet with sponsors and provide followup meeting minutes within a
certain number of days, and provide responses to questions on industry
submitted special study protocols within a certain number of days.
We met or exceeded nearly all of our goals for application review
and for these other procedures under PDUFA II.
Under PDUFA III, additional money from user fees was authorized,
and a mechanism placed in the act to annually account for increases in
workload associated with the process for the review of human drugs. For
the first time, PDUFA III also authorized us to spend user fee funds on
certain aspects of postmarket risk management. The review performance
and procedural goals associated with PDUFA III were similar to those
under PDUFA II for fiscal year (FY) 2002 performance levels, but the
PDUFA III program addressed drug safety issues and established several
new initiatives to improve application submissions and agency-sponsor
interactions during drug development and application review.
The goals under PDUFA III also included new provisions, for
example, to develop guidance for industry on good risk assessment, risk
management, and pharmacovigilance practices, to fund outside expert
consultants to help evaluate and improve review management processes,
and to centralize accountability and funding for all PDUFA information
technology initiatives and activities.
Furthermore, in conjunction with PDUFA's reauthorization in 2002,
we committed to the creation of a guidance for our review staff and
industry on good review management principles and practices as they
apply to the first cycle review of NDAs, BLAs, and efficacy
supplements, and we announced the guidance's availability in the
Federal Register of March 31, 2005 (70 FR 16507). We also set a goal of
testing whether providing early review of selected applications and
additional feedback and advice to sponsors during drug development for
selected products can shorten drug development and review times. There
were two continuous marketing application (CMA) pilot programs; CMA
Pilot 1 provides for the review of a limited number of presubmitted
portions of NDAs and BLAs. Under CMA Pilot 2, FDA and applicants can
enter into agreements to engage in frequent scientific feedback and
interactions during the investigational new drug phase of product
development. The first-cycle and CMA initiatives are currently being
evaluated to determine their impact on the effectiveness and efficiency
of FDA-sponsor communications, product development, and regulatory
review.
We have published a number of reports that may help inform the
public about PDUFA and its implementation. Key Federal Register
documents, such as, PDUFA-related guidances, legislation, performance
reports, and financial reports, can be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa/
and www.fda.gov/cder/pdufa. We may make additional information
about PDUFA available on our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa.
Additional information about the activities of the involved FDA product
centers can be found in the Center for Drug Evaluation and Research
2004 Report to the Nation (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/reports/rtn/2004/rtn2004.htm
), and the Center for Biologics Evaluation and Research FY
2004 Annual Report (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/inside/annrpt.htm).
III. What Information Should You Know About the Meeting?
A. When and Where Will the Meeting Occur? What Format Will We Use?
Through this notice, we are announcing that we will convene a
public meeting to hear stakeholder views on what features we should
advance in proposing the PDUFA IV program.
We will conduct the meeting on November 14, 2005, at the Natcher
Conference Center, National Institutes of Health (NIH) (see ADDRESSES).
In general, the meeting format will include presentations by FDA and a
series of panels representing different stakeholder interest groups
(such as patient advocates, consumer protection, industry, health
professionals, and academic researchers). We will also provide an
opportunity for individuals to make presentations at the meeting, and
for organizations and individuals to submit written comments to the
docket after the meeting
B. What Questions Would We Like the Public to Consider?
Please consider the following questions for this meeting:
1. What is your assessment of the overall performance of the PDUFA
program thus far?
2. What aspects of PDUFA should be retained, or what should be
changed to further strengthen and improve the program?
C. How Do You Register for the Meeting or Submit Comments?
If you wish to attend and/or make a presentation at the meeting,
please send an e-mail message to: CBERTrainingSuggestions@cber.fda.gov
by October 31, 2005. Your e-mail should include the following
information: Name, company, company address, company phone number, and
e-mail address. You will receive a confirmation within 2 business days.
We also will accept walk-in registration at the meeting site, but
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space is limited, and we will close registration when maximum seating
capacity (approximately 500) is reached.
We will try to accommodate all persons who wish to make a
presentation. The time allotted for presentations may depend on the
number of persons who wish to speak.
If you require special accommodations due to a disability, please
contact Patricia A. Stewart at least 7 days in advance.
If you would like to submit comments regarding PDUFA IV, please
send your comments to the Division of Dockets Management (see
ADDRESSES). Submit a single copy of electronic comments or two paper
copies of any written comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
D. Will Meeting Transcripts Be Available?
We will prepare a meeting transcript, and we will make the
transcript available on our Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov) after the
meeting. We anticipate that transcripts will be available approximately
30 working days after the meeting. The transcript will also be
available for public examination at the Division of Dockets Management
(see ADDRESSES), between 9 a.m. and 4 p.m. Monday through Friday.
Dated: October 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-20875 Filed 10-14-05; 8:57 am]
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