Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing; Request for Comments, 10740-10742 [2014-03986]
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10740
Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Proposed Rules
of the brain. We require characteristic
findings on microscopic examination of the
cerebral spinal fluid or of the biopsied brain
tissue to establish the diagnosis.
c. Primary effusion lymphoma (PEL,
114.11C) is also known as body cavity
lymphoma. We require characteristic
findings on microscopic examination of the
effusion fluid or of the biopsied tissue from
the affected internal organ to establish the
diagnosis.
d. Progressive multifocal
leukoencephalopathy (PML, 114.11D) is a
progressive neurological degenerative
syndrome caused by the JC virus in
immunosuppressed children. Clinical
findings of PML include clumsiness,
progressive weakness, and visual and speech
changes. Personality and cognitive changes
may also occur. We require appropriate
clinical findings, characteristic white matter
lesions on MRI, and a positive PCR test for
the JC virus in the cerebral spinal fluid to
establish the diagnosis. We also accept a
positive brain biopsy for JC virus to establish
the diagnosis.
e. Pulmonary Kaposi sarcoma (Kaposi
sarcoma in the lung, 114.11E) is the most
serious form of Kaposi sarcoma (KS). Other
internal KS tumors (for example, the
gastrointestinal tract) have a more variable
prognosis. We require characteristic findings
on microscopic examination of the induced
sputum or bronchoalveolar lavage washings,
or of the biopsied transbronchial tissue, to
establish the diagnosis.
4. CD4 measurement (114.11F). To
evaluate your HIV infection under 114.11F,
we require one measurement of your absolute
CD4 count (also known as CD4 count or
CD4+ T-helper lymphocyte count), for
children from age 5 to attainment of age 18,
or your CD4 percentage, for children from
birth to attainment of age 5. This
measurement (absolute CD4 count or CD4
percentage) must occur within the period we
are considering in connection with your
application or continuing disability review. If
you have more than one CD4 measurement
within this period, we will use your lowest
absolute CD4 count or CD4 percentage.
5. Growth failure due to HIV immune
suppression. We evaluate linear growth
failure under a growth impairment listing in
100.00. If your growth failure does not meet
or medically equal the criteria of a listing in
100.00, we will consider whether your HIV
infection meets or medically equals the
criteria of a listing in another body system.
For example, if your HIV infection has
resulted in weight loss or a combination of
weight loss and linear growth failure, we will
evaluate your impairment under a digestive
system listing in 105.00.
6. Complications of HIV infection requiring
hospitalization (114.11G).
a. Complications of HIV infection may
include infections (common or
opportunistic), cancers, and other conditions.
Examples of complications that may result in
hospitalization include: Depression; diarrhea;
immune reconstitution inflammatory
syndrome; malnutrition; and Pneumocystis
pneumonia and other severe infections.
b. Under 114.11G, we require three
hospitalizations within a 12-month period
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resulting from a complication(s) of HIV
infection. The hospitalizations may be for the
same complication or different complications
of HIV infection. All three hospitalizations
must occur within the period we are
considering in connection with your
application or continuing disability review.
7. Neurological manifestations specific to
children (114.11H). The methods of
identifying and evaluating neurological
manifestations may vary depending on a
child’s age. For example, in an infant,
impaired brain growth can be documented by
a decrease in the growth rate of the head. In
an older child, impaired brain growth may be
documented by brain atrophy on a CT scan
or MRI. Neurological manifestations in
infants and young children may present in
the loss of acquired developmental
milestones (developmental regression) or, in
school-age children and adolescents, the loss
of acquired intellectual abilities. A child may
demonstrate loss of intellectual abilities by a
decrease in IQ scores, by forgetting
information previously learned, by inability
to learn new information, or by a sudden
onset of a new learning disability. When
infants and young children present with
serious developmental delays (without
regression), we evaluate the child’s
impairment(s) under 111.00.
*
*
*
*
*
114.11 Human immunodeficiency virus
(HIV) infection. With documentation as
described in 114.00F1 and one of the
following:
A. Multicentric Castleman disease (see
114.00F3a). OR
B. Primary central nervous system
lymphoma (see 114.00F3b). OR
C. Primary effusion lymphoma (see
114.00F3c). OR
D. Progressive multifocal
leukoencephalopathy (see 114.00F3d). OR
E. Pulmonary Kaposi sarcoma (see
114.00F3e). OR
F. Absolute CD4 count or CD4 percentage
(see 114.00F4):
1. For children from birth to attainment of
age 5, CD4 percentage of less than 15 percent;
or
2. For children age 5 to attainment of age
18, absolute CD4 count of 50 cells/mm3 or
less. OR
G. Complications(s) of HIV infection
requiring at least three hospitalizations
within a 12-month period and at least 30
days apart (see 114.00F6). Each
hospitalization must last at least 48 hours,
including hours in a hospital emergency
department immediately before the
hospitalization. OR
H. A neurological manifestation of HIV
infection (for example, HIV encephalopathy
or peripheral neuropathy) (see 114.00F7)
resulting in one of the following:
1. Loss of previously acquired
developmental milestones or intellectual
ability (including the sudden onset of a new
learning disability), documented on two
examinations at least 60 days apart; or
2. Progressive motor dysfunction affecting
gait and station or fine and gross motor skills,
documented on two examinations at least 60
days apart; or
3. Microcephaly with head circumference
that is less than the third percentile for age,
PO 00000
Frm 00048
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documented on two examinations at least 60
days apart; or
4. Brain atrophy, documented by
appropriate medically acceptable imaging.
[FR Doc. 2014–04124 Filed 2–25–14; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA–2013–N–0402]
Generic Drug User Fee Amendments of
2012; Regulatory Science Initiatives;
Public Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notification of public hearing;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public hearing that will provide an
overview of the current status of
regulatory science initiatives for generic
drugs and an opportunity for public
input on research priorities in this area.
FDA is seeking this input from a variety
of stakeholders—industry, academia,
patient advocates, professional societies,
and other interested parties—as it
fulfills its commitment under the
Generic Drug User Fee Amendments of
2012 (GDUFA) to develop an annual list
of regulatory science initiatives specific
to generic drugs. FDA will take the
information it obtains from the public
hearing into account in developing the
fiscal year (FY) 2015 Regulatory Science
Plan.
DATES: The public hearing will be held
on May 16, 2014, from 9 a.m. to 5 p.m.
The public hearing may be extended or
may end early depending on the level of
public participation.
ADDRESSES: The public hearing will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public hearing
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Thushi Amini, Center for Drug
Evaluation and Research, Food and
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Drug Administration, 7520 Standish Pl.,
MPN–1, Rm. 1444, Rockville, MD
20855, 240–276–8810, email:
Thushi.Amini@fda.hhs.gov; or Robert
Lionberger, Center for Drug Evaluation
and Research, Food and Drug
Administration, 7520 Standish Pl.,
MPN–1, Rm. 1449, Rockville, MD
20855, 240–276–8619, email:
Robert.Lionberger@fda.hhs.gov.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
SUPPLEMENTARY INFORMATION:
Registration and Requests for Oral
Presentations: The FDA Conference
Center at the White Oak location is a
Federal facility with security procedures
and limited seating. Attendance will be
free and on a first-come, first-served
basis. If you wish to attend (either in
person or by Webcast (see Streaming
Webcast of the Public Hearing)) and/or
present at the hearing, please register for
the hearing and/or make a request for
oral presentations or comments by email
to GDUFARegulatoryScience@
fda.hhs.gov by April 25, 2014. The
email should contain complete contact
information for each attendee (i.e.,
name, title, affiliation, address, email
address, and telephone number). Those
without email access can register by
contacting Thushi Amini by April 25,
2014 (see Contact Person).
FDA will try to accommodate all
persons who wish to make a
presentation. Individuals wishing to
present should identify the number of
the topic, or topics, they wish to address
(see section IV). This will help FDA
organize the presentations. FDA will
notify registered presenters of their
scheduled presentation times. The time
allotted for each presentation will
depend on the number of individuals
who wish to speak. Once FDA notifies
registered presenters of their scheduled
times, they are encouraged to submit an
electronic copy of their presentation to
GDUFARegulatoryScience@fda.hhs.gov
on or before May 9, 2014. Persons
registered to make an oral presentation
are encouraged to arrive at the hearing
room early and check in at the onsite
registration table to confirm their
designated presentation time. An
agenda for the hearing and other
background materials will be made
available 5 days before the hearing at
https://www.fda.gov/Drugs/NewsEvents/
ucm344710.htm.
If you need special accommodations
because of a disability, please contact
Thushi Amini (see Contact Person) at
least 7 days before the hearing.
Streaming Webcast of the Public
Hearing: For those unable to attend in
person, FDA will provide a live Webcast
of the hearing. To join the hearing via
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the Webcast, please go to https://
collaboration.fda.gov/regscipart15/.
Comments: Regardless of attendance
at the public hearing, interested persons
may submit either electronic comments
to https://www.regulations.gov or written
comments to the Division of Dockets
Management (HFA–305), 5600 Fishers
Lane, Rm. 1061, Rockville, MD 20857.
The deadline for submitting comments
to the docket is June 13, 2014. It is only
necessary to send one set of 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, and
will be posted to the docket at https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may also be
viewed at the Division of Dockets
Management (see Comments). A
transcript will also be available in either
hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. Written requests are to be sent
to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857.
allocated to support internal research
related to generic drugs. This includes
rapid response capabilities through
equipment for FDA labs and support for
laboratory research fellows at FDA, as
well as research fellows to work on data
analysis and coordination of internal
activities with external grants and
contracts.
I. Background
In July 2012, Congress passed GDUFA
(Title III of the Food and Drug
Administration Safety and Innovation
Act (Pub. L. 112–144)). GDUFA is
designed to enhance public access to
safe, high-quality generic drugs and
reduce costs to industry. To support this
goal, FDA agreed in the GDUFA
commitment letter to work with
industry and interested stakeholders on
identifying regulatory science research
priorities specific to generic drugs for
each fiscal year covered by GDUFA. The
commitment letter outlines FDA’s
performance goals and procedures
under the GDUFA program for the years
2012–2017. The commitment letter can
be found at https://www.fda.gov/
downloads/ForIndustry/UserFees/
GenericDrugUserFees/UCM282505.pdf.
IV. Purpose and Scope of the May 16,
2014, Public Hearing
The purpose of the May 2014 public
hearing is to obtain input from industry
and other interested stakeholders on the
identification of regulatory science
priorities for FY 2015. To help fulfill
FDA’s mission, FDA is particularly
interested in receiving input on the
following topics:
1. Current regulatory science
challenges that limit the availability of
generic drugs,
2. Regulatory science approaches to
improve the preapproval evaluation of
therapeutic equivalence of generic
drugs,
3. Postapproval regulatory science
approaches to ensure the therapeutic
equivalence of approved generic drugs,
4. Prioritization of FY 2015 regulatory
science research topics for generic drugs
based on public health impact, and
5. The need for additional or revised
draft guidance to clarify FDA’s scientific
recommendations related to generic
drug development.
FDA will consider all comments made
at this hearing or received through the
docket (see Comments) as it develops its
FY 2015 GDUFA Regulatory Science
Plan. Additional information
concerning GDUFA, including the text
II. FY 2013 Regulatory Science
Priorities
The FY 2013 regulatory science
research priorities list was developed by
FDA and industry and included in the
GDUFA commitment letter. To
implement the FY 2013 priorities list,
the Office of Generic Drugs awarded $17
million in external contracts and grants
to initiate new research studies during
FY 2013. Four million dollars were
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III. FY 2014 Regulatory Science
Priorities
On June 21, 2013, the Office of
Generic Drugs held a public hearing to
gain input in developing the FY 2014
regulatory science priorities list. This
list was prepared based on internal
Center for Drug Evaluation and Research
discussions, comments received from
this public hearing, and comments
submitted to the public docket.
The FY 2014 Regulatory Science
Priorities are as follows:
1. Postmarket evaluation of generic
drugs,
2. Equivalence of complex products,
3. Equivalence of locally acting
products,
4. Therapeutic equivalence evaluation
and standards, and
5. Computational and analytical tools.
For more information on these topic
areas, please visit https://www.fda.gov/
ForIndustry/UserFees/
GenericDrugUserFees/ucm370952.htm.
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Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Proposed Rules
of the law and the commitment letter
can be found on the FDA Web site at
https://www.fda.gov/gdufa.
V. Notice of Hearing Under 21 CFR Part
15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR Part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Office of the
Commissioner and the Center for Drug
Evaluation and Research. Under
§ 15.30(f), the hearing is informal and
the rules of evidence do not apply. No
participant may interrupt the
presentation of another participant.
Only the presiding officer and panel
members may pose questions; they may
question any person during or at the
conclusion of each presentation. Public
hearings under part 15 are subject to
FDA’s policy and procedures for
electronic media coverage of FDA’s
public administrative proceedings (part
10, subpart C) (21 CFR Part 10, subpart
C)). Under § 10.205, representatives of
the media may be permitted, subject to
certain limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see Transcripts). To the
extent that the conditions for the
hearing, as described in this notice,
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03986 Filed 2–25–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Part 9
mstockstill on DSK4VPTVN1PROD with PROPOSALS
[Docket No. TTB–2014–0003; Notice No.
142]
RIN 1513–AC05
Proposed Establishment of The Rocks
District of Milton–Freewater Viticultural
Area
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking.
AGENCY:
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The Alcohol and Tobacco Tax
and Trade Bureau (TTB) proposes to
establish the approximately 3,770-acre
‘‘The Rocks District of Milton–
Freewater’’ viticultural area in Umatilla
County, Oregon. The proposed
viticultural area lies entirely within the
Walla Walla Valley viticultural area
which, in turn, lies within the Columbia
Valley viticultural area. TTB designates
viticultural areas to allow vintners to
better describe the origin of their wines
and to allow consumers to better
identify wines they may purchase. TTB
invites comments on this proposed
addition to its regulations.
DATES: Comments must be received by
April 28, 2014.
ADDRESSES: Please send your comments
on this notice to one of the following
addresses:
• Internet: https://www.regulations.gov
(via the online comment form for this
notice as posted within Docket No.
TTB–2014–0003 at ‘‘Regulations.gov,’’
the Federal e-rulemaking portal);
• U.S. Mail: Director, Regulations and
Rulings Division, Alcohol and Tobacco
Tax and Trade Bureau, 1310 G Street
NW., Box 12, Washington, DC 20005; or
• Hand delivery/courier in lieu of
mail: Alcohol and Tobacco Tax and
Trade Bureau, 1310 G Street NW., Suite
200–E, Washington, DC 20005.
See the Public Participation section of
this notice for specific instructions and
requirements for submitting comments,
and for information on how to request
a public hearing.
You may view copies of this notice,
selected supporting materials, and any
comments that TTB receives about this
proposal at https://www.regulations.gov
within Docket No. TTB–2014–0003. A
link to that docket is posted on the TTB
Web site at https://www.ttb.gov/wine/
wine-rulemaking.shtml under Notice
No. 142. You also may view copies of
this notice, all related petitions, maps,
or other supporting materials, and any
comments that TTB receives about this
proposal by appointment at the TTB
Information Resource Center, 1310 G
Street NW., Washington, DC 20005.
Please call 202–453–2270 to make an
appointment.
FOR FURTHER INFORMATION CONTACT:
Karen A. Thornton, Regulations and
Rulings Division, Alcohol and Tobacco
Tax and Trade Bureau, 1310 G Street
NW., Box 12, Washington, DC 20005;
phone 202–453–1039, ext. 175.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background on Viticultural Areas
TTB Authority
Section 105(e) of the Federal Alcohol
Administration Act (FAA Act), 27
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Sfmt 4702
U.S.C. 205(e), authorizes the Secretary
of the Treasury to prescribe regulations
for the labeling of wine, distilled spirits,
and malt beverages. The FAA Act
provides that these regulations should,
among other things, prohibit consumer
deception and the use of misleading
statements on labels, and ensure that
labels provide the consumer with
adequate information as to the identity
and quality of the product. The Alcohol
and Tobacco Tax and Trade Bureau
(TTB) administers the FAA Act
pursuant to section 1111(d) of the
Homeland Security Act of 2002,
codified at 6 U.S.C. 531(d). The
Secretary has delegated various
authorities through Treasury
Department Order 120–01 (Revised),
dated December 10, 2013, to the TTB
Administrator to perform the functions
and duties in the administration and
enforcement of this law.
Part 4 of the TTB regulations (27 CFR
Part 4) allows the establishment of
definitive viticultural areas and the use
of their names as appellations of origin
on wine labels and in wine
advertisements. Part 9 of the TTB
regulations (27 CFR Part 9) sets forth
standards for the preparation and
submission of petitions for the
establishment or modification of
American viticultural areas (AVAs) and
lists the approved AVAs.
Definition
Section 4.25(e)(1)(i) of the TTB
regulations (27 CFR 4.25(e)(1)(i)) defines
a viticultural area for American wine as
a delimited grape-growing region having
distinguishing features as described in
part 9 of the regulations and a name and
a delineated boundary as established in
part 9 of the regulations. These
designations allow vintners and
consumers to attribute a given quality,
reputation, or other characteristic of a
wine made from grapes grown in an area
to its geographic origin. The
establishment of AVAs allows vintners
to describe more accurately the origin of
their wines to consumers and helps
consumers to identify wines they may
purchase. Establishment of an AVA is
neither an approval nor an endorsement
by TTB of the wine produced in that
area.
Requirements
Section 4.25(e)(2) of the TTB
regulations outlines the procedure for
proposing an AVA and provides that
any interested party may petition TTB
to establish a grape-growing region as an
AVA. Section 9.12 of the TTB
regulations (27 CFR 9.12) prescribes
standards for petitions for the
establishment or modification of AVAs.
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]]>Agencies
[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Proposed Rules]
[Pages 10740-10742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03986]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2013-N-0402]
Generic Drug User Fee Amendments of 2012; Regulatory Science
Initiatives; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing that will provide an overview of the current status of
regulatory science initiatives for generic drugs and an opportunity for
public input on research priorities in this area. FDA is seeking this
input from a variety of stakeholders--industry, academia, patient
advocates, professional societies, and other interested parties--as it
fulfills its commitment under the Generic Drug User Fee Amendments of
2012 (GDUFA) to develop an annual list of regulatory science
initiatives specific to generic drugs. FDA will take the information it
obtains from the public hearing into account in developing the fiscal
year (FY) 2015 Regulatory Science Plan.
DATES: The public hearing will be held on May 16, 2014, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Thushi Amini, Center for Drug
Evaluation and Research, Food and
[[Page 10741]]
Drug Administration, 7520 Standish Pl., MPN-1, Rm. 1444, Rockville, MD
20855, 240-276-8810, email: Thushi.Amini@fda.hhs.gov; or Robert
Lionberger, Center for Drug Evaluation and Research, Food and Drug
Administration, 7520 Standish Pl., MPN-1, Rm. 1449, Rockville, MD
20855, 240-276-8619, email: Robert.Lionberger@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Registration and Requests for Oral
Presentations: The FDA Conference Center at the White Oak location is a
Federal facility with security procedures and limited seating.
Attendance will be free and on a first-come, first-served basis. If you
wish to attend (either in person or by Webcast (see Streaming Webcast
of the Public Hearing)) and/or present at the hearing, please register
for the hearing and/or make a request for oral presentations or
comments by email to GDUFARegulatoryScience@fda.hhs.gov by April 25,
2014. The email should contain complete contact information for each
attendee (i.e., name, title, affiliation, address, email address, and
telephone number). Those without email access can register by
contacting Thushi Amini by April 25, 2014 (see Contact Person).
FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the topic, or topics, they wish to address (see section IV). This
will help FDA organize the presentations. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to GDUFARegulatoryScience@fda.hhs.gov on or before May 9,
2014. Persons registered to make an oral presentation are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time. An
agenda for the hearing and other background materials will be made
available 5 days before the hearing at https://www.fda.gov/Drugs/NewsEvents/ucm344710.htm.
If you need special accommodations because of a disability, please
contact Thushi Amini (see Contact Person) at least 7 days before the
hearing.
Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live Webcast of the hearing. To join the
hearing via the Webcast, please go to https://collaboration.fda.gov/regscipart15/.
Comments: Regardless of attendance at the public hearing,
interested persons may submit either electronic comments to https://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), 5600 Fishers Lane, Rm. 1061, Rockville, MD 20857.
The deadline for submitting comments to the docket is June 13, 2014. It
is only necessary to send one set of 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, and will be posted to
the docket at https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
also be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
I. Background
In July 2012, Congress passed GDUFA (Title III of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144)). GDUFA is
designed to enhance public access to safe, high-quality generic drugs
and reduce costs to industry. To support this goal, FDA agreed in the
GDUFA commitment letter to work with industry and interested
stakeholders on identifying regulatory science research priorities
specific to generic drugs for each fiscal year covered by GDUFA. The
commitment letter outlines FDA's performance goals and procedures under
the GDUFA program for the years 2012-2017. The commitment letter can be
found at https://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.
II. FY 2013 Regulatory Science Priorities
The FY 2013 regulatory science research priorities list was
developed by FDA and industry and included in the GDUFA commitment
letter. To implement the FY 2013 priorities list, the Office of Generic
Drugs awarded $17 million in external contracts and grants to initiate
new research studies during FY 2013. Four million dollars were
allocated to support internal research related to generic drugs. This
includes rapid response capabilities through equipment for FDA labs and
support for laboratory research fellows at FDA, as well as research
fellows to work on data analysis and coordination of internal
activities with external grants and contracts.
III. FY 2014 Regulatory Science Priorities
On June 21, 2013, the Office of Generic Drugs held a public hearing
to gain input in developing the FY 2014 regulatory science priorities
list. This list was prepared based on internal Center for Drug
Evaluation and Research discussions, comments received from this public
hearing, and comments submitted to the public docket.
The FY 2014 Regulatory Science Priorities are as follows:
1. Postmarket evaluation of generic drugs,
2. Equivalence of complex products,
3. Equivalence of locally acting products,
4. Therapeutic equivalence evaluation and standards, and
5. Computational and analytical tools.
For more information on these topic areas, please visit https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm370952.htm.
IV. Purpose and Scope of the May 16, 2014, Public Hearing
The purpose of the May 2014 public hearing is to obtain input from
industry and other interested stakeholders on the identification of
regulatory science priorities for FY 2015. To help fulfill FDA's
mission, FDA is particularly interested in receiving input on the
following topics:
1. Current regulatory science challenges that limit the
availability of generic drugs,
2. Regulatory science approaches to improve the preapproval
evaluation of therapeutic equivalence of generic drugs,
3. Postapproval regulatory science approaches to ensure the
therapeutic equivalence of approved generic drugs,
4. Prioritization of FY 2015 regulatory science research topics for
generic drugs based on public health impact, and
5. The need for additional or revised draft guidance to clarify
FDA's scientific recommendations related to generic drug development.
FDA will consider all comments made at this hearing or received
through the docket (see Comments) as it develops its FY 2015 GDUFA
Regulatory Science Plan. Additional information concerning GDUFA,
including the text
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of the law and the commitment letter can be found on the FDA Web site
at https://www.fda.gov/gdufa.
V. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR Part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner and the Center for Drug Evaluation and Research. Under
Sec. 15.30(f), the hearing is informal and the rules of evidence do
not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members may pose
questions; they may question any person during or at the conclusion of
each presentation. Public hearings under part 15 are subject to FDA's
policy and procedures for electronic media coverage of FDA's public
administrative proceedings (part 10, subpart C) (21 CFR Part 10,
subpart C)). Under Sec. 10.205, representatives of the media may be
permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. The hearing will be transcribed as
stipulated in Sec. 15.30(b) (see Transcripts). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any provisions set out in part 15, this notice acts as a waiver of
those provisions as specified in Sec. 15.30(h).
Dated: February 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03986 Filed 2-25-14; 8:45 am]
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