Prescription Drug User Fee Act; Public Meeting, 56201-56205 [2011-23251]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56201-56205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0128]


Prescription Drug User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss proposed recommendations for the reauthorization of 
the Prescription Drug User Fee Act (PDUFA), which authorizes FDA to 
collect user fees and use them for the process for the review of human 
drug applications for fiscal years (FYs) 2013 through 2017. The 
legislative authority for PDUFA expires in September 2012. At that 
time, new legislation will be required for FDA to collect prescription 
drug user fees for future fiscal years. Following discussions with the 
regulated industry and periodic consultations with public stakeholders, 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to 
publish the recommendations for the reauthorized program in the Federal 
Register, hold a meeting at which the public may present its views on 
such recommendations, and provide for a period of 30 days for the 
public to provide written comments on such recommendations. FDA will 
then consider such public views and comments and revise such 
recommendations as necessary.

DATES: The public meeting will be held on October 24, 2011, from 9 a.m. 
to 5 p.m. Registration to attend the meeting must be received by 
October 10, 2011. See section IV.B of this document for information on 
how to register for the meeting. Submit either electronic or written 
comments by October 24, 2011.

ADDRESSES: The meeting will be held at FDA's White Oak Campus, 10903 
New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD, 20993.
    Submit electronic comments to https://www.regulations.gov. Submit 
written comments 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.
    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 30 days after the public meeting (see 
section IV.C of this document).

FOR FURTHER INFORMATION CONTACT: Sunanda Bahl, Food and Drug 
Administration, Center for Drug Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993, 301-796-
3584, fax: 301-847-8443, PDUFAReauthorization@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    FDA is announcing a public meeting to discuss proposed 
recommendations for the reauthorization of the Prescription Drug User 
Fee Act (PDUFA), which authorizes FDA to collect user fees and use them 
for the process of the review of human drug applications for FYs 2013 
through 2017. Without new legislation, FDA will no longer be able to 
collect user fees for future fiscal years to fund the human drug review 
process. Section 736B(d)(4) (21 U.S.C. 379h-2(d)(4)) of the FD&C Act 
requires that after FDA holds negotiations with regulated industry and 
periodic consultations with stakeholders, we do the following: (1) 
Present recommendations to congressional committees, (2) publish 
recommendations in the Federal Register, (3) provide a period of 30 
days for the public to provide written comments on the recommendations, 
(4) hold a meeting at which the public may present its views, and (5) 
after consideration of public views and comments, revise the 
recommendations as necessary.
    This notice, the 30-day comment period, and the public meeting will 
satisfy some of these requirements. After the public meeting, we will 
revise the recommendations as necessary and present our proposed 
recommendations to the congressional committees.
    The purpose of the meeting is to hear the public's views on the 
proposed recommendations for the reauthorized program (PDUFA V). The 
following information is provided to help potential meeting 
participants better understand the history and evolution of the PDUFA 
program and the current status of the proposed PDUFA V recommendations.

II. The PDUFA Program

A. What is PDUFA? What does it do?

    FDA considers the timely review of the safety and effectiveness of 
new drug applications (NDAs) and biologics license applications (BLAs) 
to be central to the Agency's mission to protect and promote the public 
health. Prior to enactment of PDUFA in 1992, FDA's drug review process 
was not very predictable and was relatively slow compared to other 
countries. As a result of concerns expressed by both industry and 
patients, Congress enacted PDUFA, which provided the added funds 
through user fees that enabled FDA to hire additional reviewers and 
support staff and upgrade its information technology systems. At the 
same time, FDA committed to complete reviews in a predictable 
timeframe. These changes revolutionized the drug approval process in 
the United States and enabled FDA to speed the application review 
process for new drugs and biologics without compromising the Agency's 
high standards for demonstration of safety, efficacy, and quality of 
new drugs prior to approval.

B. PDUFA Achievements

    PDUFA has produced significant benefits for public health, 
providing patients faster access to over 1,500 new drugs and biologics 
since enactment in 1992, including treatments for cancer, infectious 
diseases, neurological and psychiatric disorders, and cardiovascular 
diseases. The United States now leads the world in the first 
introduction of new active drug substances.\1\ Since PDUFA was enacted, 
the median approval time of original NDAs and BLAs has been reduced by 
about 50 percent for standard applications (25.6 months in FY 1992 
versus 13 months in FY 2009) and 55 percent for priority applications 
(19.9 months in FY 1992 versus 9 months in 2009).
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    \1\ Scrip NCE Review/Scrip Yearbook/Scrip Magazine (1982-2005), 
PharmaProjects R&D Annual Review (2006-2009).
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    Increased resources provided by user fees have also enabled FDA to 
provide a large body of technical guidance to industry that has 
clarified the drug development pathway for many diseases. These 
resources have also enhanced FDA's ability to meet with companies 
during drug development to

[[Page 56202]]

provide critical advice on specific development programs. In the past 5 
years alone, FDA has held over 7,000 meetings within a short time after 
a sponsor's request. Innovations in drug development are being advanced 
by many new companies as well as more established ones, and new 
sponsors may need, and often seek, more regulatory guidance during 
development. In FY 2009, more than half of the meetings FDA held with 
companies at the early investigational stage and midway through the 
clinical trial process were with companies that had no approved product 
on the U.S. market.
1. Application Review
    PDUFA provides FDA with a source of stable, consistent funding that 
has made possible our efforts to focus on promoting innovative 
therapies and help bring to market critical products for patients. As 
part of the PDUFA agreement, FDA agrees to certain review performance 
goals, such as reviewing and acting on standard applications within 10 
months and on priority applications within 6 months. Priority 
application reviews are for drugs that generally represent advances in 
public health, often targeted at severe illnesses where few or no 
therapeutic options exist.
    PDUFA funds help support the use of existing mechanisms in place to 
expedite the approval of certain promising investigational drugs and 
also to make them available to the very ill as early in the development 
process as possible, without unduly jeopardizing the patients' safety.
    One such program is the accelerated approval process, instituted by 
FDA in 1992. Accelerated approval allows earlier approval of drugs that 
treat serious diseases and that fill an unmet medical need. One pathway 
for accelerated approval is based on a surrogate endpoint--a marker 
used as substitute measurement to represent a clinically meaningful 
outcome, such as survival or symptom improvement--that is reasonably 
likely to predict clinical benefit; the other pathway bases approval on 
a clinical endpoint other than survival or irreversible morbidity. This 
program allows drugs to be approved before measures of effectiveness 
that would normally be required for approval are available. In these 
cases, approval is given on the condition that postmarketing clinical 
trials verify the anticipated clinical benefit. Over 100 critical 
products, including most HIV therapies and many cancer treatments, have 
been approved under accelerated approval since the program was 
established.
2. Drug Safety
    In parallel with improvements in the drug review process, PDUFA 
funds have enabled FDA to increase its focus on drug safety, including 
implementing the Food and Drug Administration Amendments Act of 2007 
(FDAAA). In FDAAA, Congress authorized additional user fees totaling 
$225 million for the 5 years of PDUFA IV reauthorization to enhance 
drug safety activities. FDAAA also provided FDA with important 
postmarket safety authorities. Under FDAAA, FDA was given the authority 
to require postmarketing studies and clinical trials to address 
important drug safety questions. Between the enactment of FDAAA on 
September 27, 2007, and June 1, 2011, FDA has required applicants to 
conduct approximately 375 postmarketing studies or trials to address 
important drug safety questions that could not be addressed before the 
drug was approved. FDAAA also gave FDA the authority to require safety 
labeling changes based on new safety information identified after a 
drug is on the market. FDA has used its new authority to require 
applicants to place important new safety information onto their drug 
labels quickly, in some cases using this authority to require changes 
to the labeling of all members of a class of drugs. FDAAA also provided 
FDA with authority to manage risks associated with marketed drug 
products through required risk evaluation and mitigation strategies 
(REMS). FDA has been using this new authority judiciously to ensure 
that drugs that could not otherwise be approved because the risks 
without a REMS would outweigh the benefits, are available to patients.
    FDA has implemented other important drug safety initiatives under 
FDAAA including, for example, initiating systematic reviews of the 
safety of marketed drugs 18 months after approval; conducting regular 
screening of the adverse event reporting system database and posting 
quarterly reports of new safety information or potential signals of 
serious risks identified from that screening; and developing an active 
post-market drug safety surveillance capability under the ``Sentinel'' 
initiative (https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm2007250.htm).

III. Proposed PDUFA V Recommendations

    In preparing the proposed recommendations to Congress for PDUFA 
reauthorization, we have conducted discussions with the regulated 
industry, and we have consulted with stakeholders as required by the 
law. We began the PDUFA reauthorization process with a public meeting 
held on April 12, 2010 (75 FR 12555, March 16, 2010). The meeting 
included presentations by FDA and a series of panels representing 
different stakeholder groups, including patient advocates, consumer 
groups, regulated industry, health professionals, and academic 
researchers. The stakeholders were asked to respond to the following 
questions:
    1. What is your assessment of the overall performance of the PDUFA 
IV program thus far?
    2. What aspects of PDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
    Following the April 2010 public meeting, FDA conducted negotiations 
with regulated industry and continued monthly consultations with public 
stakeholders from July 2010 through May 2011. As directed by Congress, 
FDA posted minutes of these discussions on its Web site at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm117890.htm. 
The proposed enhancements for PDUFA V address many of the top 
priorities identified by public stakeholders, the top concerns 
identified by regulated industry, and the most important challenges 
identified within FDA. These include a new review program for new 
molecular entity NDAs and original BLAs, proposals to enhance 
regulatory science and expedite drug development, enhanced benefit-risk 
assessment, modernization of FDA's drug safety system, requirements for 
electronic submissions with standardized application data, a technical 
correction related to discontinued products, and modifications to the 
PDUFA inflation adjuster with continued evaluation of the workload 
adjuster. The full descriptions of these proposed enhancements can be 
found in the draft PDUFA V commitment letter (draft commitment letter) 
posted on FDA's Web site at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm. Each enhancement is briefly 
described below with reference to the section of the draft commitment 
letter where more detailed information can be found.

A. A Review Program for New Drug Applications (NDA), New Molecular 
Entities (NME), and Original Biologics License Applications (BLA)

    FDA's existing review performance goals for priority and standard

[[Page 56203]]

applications, 6 and 10 months respectively, were established in 1997. 
Since that time, additional requirements in the drug review process 
have made those goals increasingly challenging to meet, particularly 
for more complex applications like NME NDAs and original BLAs. FDA also 
recognizes that increasing communication between the Agency and 
sponsors or applicants during the application review has the potential 
to increase efficiency in the review process. To address the desire for 
increased communication and efficiency, FDA proposes a new review 
program for NME NDAs and original BLAs in PDUFA V that will include 
presubmission meetings, mid-cycle communications, and late-cycle 
meetings between FDA and sponsors for these applications. FDA's review 
clock will begin after the 60-day administrative filing review period 
to accommodate this increased interaction during regulatory review. The 
impact of these modifications on the efficiency of drug review for this 
subset of applications would be assessed during PDUFA V.

B. Enhancing Regulatory Science and Expediting Drug Development

    The following five enhancements focus on enhancing regulatory 
science and expediting drug development. Regulatory science is the 
science of developing and applying new tools, standards, and approaches 
to assess the safety, effectiveness, quality, and performance of FDA-
regulated products. The details of these enhancements can be found in 
section IX of the draft commitment letter.
1. Promoting Innovation Through Enhanced Communication Between FDA and 
Sponsors During Drug Development
    FDA recognizes that timely interactive communication with sponsors 
can help foster efficient and effective drug development. In some 
cases, a sponsor's questions may be complex enough to require a formal 
meeting with FDA, but in other instances, a question may be relatively 
straightforward such that a response can be provided more quickly. 
However, our review staff's workload and other competing public health 
priorities can make it challenging to develop an Agency response to 
matters outside of the formal meeting process.
    This enhancement involves a dedicated drug development 
communication and training staff, focused on improving communication 
between FDA and sponsors during development. This staff will be 
responsible for identifying best practices for communication between 
the Agency and sponsors, training review staff, and disseminating best 
practices through published guidance.
2. Methods for Meta-Analysis
    A meta-analysis typically attempts to combine the data or findings 
from multiple completed studies to explore drug benefits and risks and, 
in some cases, uncover what might be a potential safety signal in a 
premarket or postmarket context. However, there is no consensus on best 
practices in conducting a meta-analysis. With the growing availability 
of clinical trial data, an increasing number of meta-analyses are being 
conducted based on varying sets of data and assumptions. If such 
studies conducted outside FDA find a potential safety signal, FDA will 
work to try to confirm--or correct--the information about a potential 
harm that will create uncertainty for patients and health 
professionals. To do this, FDA must work quickly to conduct its own 
meta-analyses of publicly available data and the raw clinical trial 
data submitted by drug sponsors that would typically not be available 
to outside researchers. This is resource-intensive work that often 
exceeds the Agency's current scientific and computational capacity, 
causing delays in FDA findings that prolong public uncertainty.
    This proposed recommendation includes the development of a 
dedicated staff to evaluate best practices and limitations in meta-
analysis methods. Through a rigorous public comment process, FDA will 
develop guidance on best practices and the Agency's approach to meta-
analysis in regulatory review and decision-making.
3. Biomarkers and Pharmacogenomics
    Pharmacogenomics and the application of qualified biomarkers have 
the potential to decrease drug development time by helping to 
demonstrate benefits, to recognize unmet medical needs, and to identify 
patients who are predisposed to adverse events. FDA provides regulatory 
advice on the use of biomarkers to facilitate the assessment of human 
safety in early phase clinical studies to support claims of efficacy 
and to establish the optimal dose selection for pivotal efficacy 
studies. This is an area of new science where the Agency has seen a 
marked increase in sponsor submissions to FDA. In the 2008 to 2010 
period, the Agency experienced nearly a four-fold increase in this type 
of review work.
    In PDUFA V, FDA will augment the Agency's clinical, clinical 
pharmacology, and statistical capacity to adequately address 
submissions that propose to utilize biomarkers or pharmacogenomic 
markers. The Agency will also hold a public meeting to discuss 
potential strategies to facilitate scientific exchanges on biomarker 
issues between FDA and drug manufacturers.
4. Use of Patient-Reported Outcomes (PRO)
    Assessments of study endpoints known as patient-reported outcomes 
(PROs) are increasingly an important part of successful drug 
development. PROs measure treatment benefit or risk in medical product 
clinical trials from the patients' point of view. PROs are critical in 
understanding the drug benefits and harm from the patients' 
perspective. However, PROs require rigorous evaluation and statistical 
design and analysis to ensure reliability to support claims of clinical 
benefit. Early consultation between FDA and drug sponsors can ensure 
that endpoints are well-defined and reliable. However, the Agency does 
not have the capacity to meet the current demand from industry.
    This initiative will improve FDA's clinical and statistical 
capacity to address submissions involving PROs and other endpoint 
assessment tools, including providing consultation to sponsors during 
the early stages of drug development. In addition, FDA will convene a 
public meeting to discuss standards for PRO qualification, new theories 
in endpoint measurement, and the implications for multinational trials.
5. Development of Drugs for Rare Diseases
    FDA's oversight of rare disease drug development is complex and 
resource intensive. Rare diseases are a highly diverse collection of 
disorders, their natural histories are often not well-described, only 
small population sizes are often available for study, and the diseases 
do not usually have well-defined outcome measures. This makes the 
design, execution, and interpretation of clinical trials for rare 
diseases difficult and time consuming, requiring frequent interaction 
between FDA and drug sponsors. If recent trends in orphan designations 
are any indication, FDA can expect an increase in investigational 
activity and marketing applications for drug products for rare diseases 
in the future.
    This PDUFA V enhancement includes FDA facilitation of rare disease 
drug development by issuing relevant guidance, increasing the Agency's 
outreach efforts to the rare disease patient community, and providing 
specialized training in rare disease drug

[[Page 56204]]

development for sponsors and FDA staff.

C. Enhancing Benefit-Risk Assessment

    FDA has been exploring how to develop an enhanced structured 
approach to benefit-risk assessments that accurately and concisely 
describes the benefit and risk considerations in the Agency's drug 
regulatory decision-making. Part of FDA's decision-making lies in 
thinking about the context of the decision, including gaining a strong 
understanding of the condition treated and the nature and extent of the 
unmet medical need. Patients who live with a disease have a direct 
stake in the outcome of the drug review process. The FDA drug review 
process could benefit from a more systematic and expansive approach to 
obtaining the patient perspective on disease severity and the potential 
gaps or limitations in available treatments in a therapeutic area.
    During PDUFA V, FDA will expand its use of a benefit-risk framework 
in the drug review process, including holding public workshops to 
discuss the application of frameworks for considering benefits and 
risks that are most appropriate for the regulatory setting. FDA will 
also conduct a series of public meetings with the relevant patient 
advocacy communities to review the medical products available for use 
in specific therapeutic areas. The therapeutic areas to be discussed 
will be chosen through a public process. This enhancement is discussed 
in section X of the draft commitment letter.

D. Enhancement and Modernization of the FDA Drug Safety System

    The drug safety enhancements in PDUFA V focus on FDA's use of REMS 
and the Sentinel Initiative. Additional information on these proposals 
is found in section XI of the draft commitment letter.
1. Standardizing REMS
    FDAAA gave FDA authority to require a REMS when FDA finds that a 
REMS is necessary to ensure that the benefits of a drug outweigh its 
risks. Some REMS are more restrictive types of risk management programs 
that include elements to assure safe use (ETASU). These programs can 
require such tools as prescriber training or certification, pharmacy 
training or certification, dispensing only in certain health care 
settings, documentation of safe use conditions, patient monitoring, and 
patient registries. ETASU REMS can be challenging to implement and 
evaluate, involving cooperation of all segments of the health care 
system. Our experience with REMS to date suggests that the development 
of multiple individual programs has the potential to create burdens on 
the health care system and, in some cases, could limit appropriate 
patient access to important therapies.
    FDA will initiate a public process in PDUFA V to explore strategies 
and initiate projects to standardize REMS programs with the goal of 
reducing burden on practitioners, patients, and others in the health 
care setting. In addition, FDA will conduct public workshops and 
develop guidance on methods for assessing the effectiveness of REMS and 
the impact on patient access and burden on the health care system.
2. Using the Sentinel Initiative To Evaluate Drug Safety Issues
    FDA's Sentinel Initiative is a long-term program designed to build 
and implement a national electronic system for monitoring the safety of 
FDA-approved medical products. FDAAA required FDA to collaborate with 
Federal, academic, and private entities to develop methods to obtain 
access to disparate data sources and validated means to link and 
analyze safety data to monitor the safety of drugs after they reach the 
market, an activity also known as ``active postmarket drug safety 
surveillance.'' FDA will conduct a series of activities during PDUFA V 
to determine the feasibility of using Sentinel to evaluate drug safety 
issues that may require regulatory action (e.g., labeling changes, 
post-marketing requirements, or postmarketing commitments). This may 
shorten the time it takes to better understand new or emerging drug 
safety issues. By leveraging public and private health care data 
sources to quickly evaluate drug safety issues; this proposal may 
reduce the Agency's reliance on required postmarketing studies and 
clinical trials.

E. Required Electronic Submissions and Standardization of Electronic 
Application Data

    The predictability of the FDA review process relies heavily on the 
quality of sponsor and applicant submissions. The Agency currently 
receives submissions of original applications and supplements in 
formats ranging from paper-only to electronic-only, as well as hybrids 
of the two media. The variability and unpredictability of submitted 
formats and clinical data layout present major obstacles to conducting 
a timely, efficient, and rigorous review within current PDUFA goal time 
frames. A lack of standardized data also limits FDA's ability to 
transition to more standardized approaches to benefit-risk assessment 
and impedes conduct of safety analyses that inform FDA decisions 
related to REMS and other postmarketing requirements. The PDUFA V 
enhancements in this area include a phased-in requirement for 
standardized, fully electronic submissions for all marketing and 
investigational applications. Through partnership with open standards 
development organizations, the Agency will also conduct a public 
process to develop standardized terminology for clinical and 
nonclinical data submitted in marketing and investigational 
applications. More information on this initiative can be found in 
section XII of the draft commitment letter.

F. Technical Change to Section 736(a)(3)(B) of the FD&C Act Related to 
Discontinued Products

    FDA proposes to amend section 736(a)(3)(B) of the FD&C Act, which 
provides for an exception in assessing a product fee if the same 
product is approved as an NDA or ANDA. This amendment will clarify 
FDA's long-standing policy to use the active portion of the 
Prescription Drug Product List in the ``Approved Drug Products With 
Therapeutic Equivalence Evaluations'' (generally know as the ``Orange 
Book'') to identify fee-eligible prescription drug products. FDA will 
assess a product fee on a prescription drug product when there are no 
other products on the Prescription Drug Product List that are the same 
as that product.

G. PDUFA V Enhancements for a Modified Inflation Adjuster and 
Additional Evaluations of the Workload Adjuster

    In calculating user fees for each new fiscal year, FDA adjusts the 
base revenue amount by inflation and workload as specified in the 
statute. PDUFA V financial enhancements include a modification to the 
inflation adjuster to more accurately account for changes in FDA's 
costs related to payroll compensation and benefits as well as changes 
in non-payroll costs through use of the Consumer Price Index (CPI). 
This new weighted composite inflation adjuster will help ensure that 
increases in fees more closely mirror the inflationary pressures that 
have an impact on FDA's costs. FDA will also continue evaluating the 
workload adjuster that was developed during the PDUFA IV negotiations 
to ensure that it continues to adequately capture changes in FDA's 
workload during PDUFA V. These evaluations will include options to 
discontinue,

[[Page 56205]]

modify, or retain any element of the workload adjuster.

H. Impact of PDUFA V Enhancements on User Fee Revenue

    Implementing the proposed enhancements discussed in the previous 
sections of this document will add $40.4 million to the PDUFA user fee 
revenue amount in FY 2012. The fee revenue amount for FY 2012 is 
$652,709,000 as published by notice in the Federal Register of August 
1, 2011 (76 FR 45831). This amount includes the additional user fee 
revenues for drug safety in FY 2012 totaling $65 million as specified 
in the statute. The additional user fee revenue for the PDUFA V 
enhancements translates to a 6-percent increase, and a total base of 
$693.1 million in FY 2013. The following table summarizes the FY 2013 
baseline and added resources to support the new PDUFA V enhancements:

------------------------------------------------------------------------
                   Financial baseline                        Dollars
------------------------------------------------------------------------
FY 2012 Baseline \1\...................................     $499,412,000
Cumulative Inflation Adjustment for FY 2012............      104,277,000
Cumulative Workload Adjustment for FY 2012.............       49,020,000
Fee Revenue Amount for FY 2012 \2\.....................      652,709,000
------------------------------------------------------------------------
                          PDUFA V Enhancements
------------------------------------------------------------------------
Increased Staff Capacity (129 FTE).....................       36,120,000
Other Direct Costs.....................................        4,270,000
Total Statutory Revenue Amount for FY 2013 \3\.........      693,099,000
------------------------------------------------------------------------

    \1\ In determining the fee revenue amount for FY 2012, sections 
736(b)(4)(A) and 736(b)(4)(B) of the FD&C Act direct the Secretary 
of Health and Human Services (Secretary) to substitute $392,783,000 
plus $65,000,000 (for FY 2012) for the amount in paragraph (1)(A). 
Furthermore, paragraph (1)(B) directs the Secretary to add the 
amount of the modified workload adjustment for FY 2007 to the amount 
in paragraph (1)(A) to determine the total revenue amount in FY 
2012. This total is $499,412,000.
    \2\ As published in the Federal Register of August 1, 2011 (76 
FR 45831).
    \3\ Of this amount, $652,709,000 will be further adjusted 
according to the new statutory provisions to account for inflation 
and workload adjustments in determining fees for FY 2013. These 
adjustments must be captured in calculations of user fee revenue for 
FYs 2014-2017.

IV. What information should you know about the meeting?

A. When and where will the meeting occur? What format will FDA use?

    We will convene a public meeting to hear the public's views on the 
proposed recommendations for reauthorization of PDUFA. We will conduct 
the meeting on October 24, 2011, at FDA's White Oak Campus (see 
ADDRESSES). The meeting will include a presentation by FDA and a series 
of panels representing different stakeholder groups identified in the 
statute (such as patient advocacy groups, consumer advocacy groups, 
health professionals, and regulated industry). We will also provide an 
opportunity for other organizations and individuals to make 
presentations at the meeting or to submit written comments to the 
docket before the meeting.

B. How do you register for the meeting or submit comments?

    If you wish to attend this meeting, please register by e-mail at: 
PDUFAReauthorization@fda.hhs.gov by October 10, 2011. Your e-mail 
should contain complete contact information for each attendee, 
including: Name, title, affiliation, address, e-mail address, and phone 
number. Registration is free and will be on a first-come, first-served 
basis, with the exception below. Early registration is recommended 
because seating is limited. FDA may limit the number of participants 
from each organization based on space limitations. Registrants will 
receive confirmation once they have been accepted. On-site registration 
on the day of the meeting will be based on space availability. We will 
try to accommodate all persons who wish to make a presentation. If you 
need special accommodations because of disability, please contact 
Sunanda Bahl (see FOR FURTHER INFORMATION CONTACT) at least 7 days 
before the meeting.
    In addition, interested persons may submit to the Division of 
Dockets Management (see ADDRESSES) either electronic or written 
comments regarding this document. It is only necessary to send one set 
of comments. It is no longer necessary to send two copies of mailed 
comments. Identify comments 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. To ensure consideration, all comments must be received 
by October 31, 2011.

C. Will meeting transcripts be available?

    Please be advised that as soon as a transcript is available, it 
will be accessible at https://www.regulations.gov and https://www.fda.gov. It may be viewed at the Division of Dockets Management 
(see ADDRESSES). A transcript will also be made available in either 
hard copy or on CD-ROM, after submission of a Freedom of Information 
request. Written requests are to be sent to Division of Freedom of 
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn 
Dr., Element Bldg., Rockville, MD 20857.

    Dated: September 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23251 Filed 9-9-11; 8:45 am]
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