[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Notices]
[Pages 56201-56205]
From the Federal Register Online via the Government Publishing 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 http://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 http://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, [email protected].
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 (http://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 http://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 http://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
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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
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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:
[email protected] 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 http://www.regulations.gov and http://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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