Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting, 30176-30177 [2011-12741]
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30176
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
and review of clinical investigators’
financial disclosures. Specifically, the
draft guidance will describe: (1) The
sponsor’s responsibility to collect the
financial disclosure information prior to
an investigator participating in a study
and ensure that all required forms and
attachments are submitted in marketing
applications; (2) what is meant by ‘‘due
diligence’’ in obtaining financial
disclosures from investigators; and (3)
how FDA will review financial
disclosure information. The guidance
will also seek comment on the
circumstances under which FDA should
consider public release of financial
disclosure information related to an
approved marketing application.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in part 54 and 21 CFR
parts 312 and 812 have been approved
under OMB control number 0910–0396;
OMB control number 0910–0014; and
OMB control number 0910–0078.
jlentini on DSK4TPTVN1PROD with NOTICES
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this draft guidance
document. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov or https://
www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
ProposedRegulationsand
DraftGuidances/default.htm.
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Dated: May 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12623 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2001–D–0066] (Formerly
Docket No. 2001D–0107)
Expedited Review for New Animal Drug
Applications for Human Pathogen
Reduction Claims; Withdrawal of
Guidance
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; withdrawal.
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Dated: May 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12624 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
The Food and Drug
Administration (FDA) is announcing the
withdrawal of a guidance that was
issued on March 9, 2001.
DATES: May 24, 2011.
FOR FURTHER INFORMATION CONTACT:
Steven Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300.
SUPPLEMENTARY INFORMATION: In a notice
published in the Federal Register of
March 9, 2001 (66 FR 14155), FDA
announced the availability of a guidance
for industry #121 entitled ‘‘Expedited
Review for New Animal Drug
Applications for Human Pathogen
Reduction Claims.’’
The guidance predates the enactment
of the Animal Drug User Fee Act
(ADUFA) of 2003, which was
reauthorized by Congress in 2008.
ADUFA authorized FDA to collect fees
for certain animal drug applications and
for the establishments, products, and
sponsors associated with these and
previously approved animal drug
applications, in support of the review of
animal drug products. As a result of
these increased resources, the
efficiencies of our current
administrative processes, including the
phased review and end review
amendment processes, we have
significantly reduced our review
timeframes and afford sponsors a more
efficient pathway to regulatory
approval.
At the time the guidance was issued,
FDA’s review timeframes for new
animal drug applications were
considerably longer. As noted
previously, significant changes have
occurred in the Agency’s processes and
timeframes for reviewing new animal
SUMMARY:
drug applications and the process for
expedited review status contained in
this guidance is outdated and no longer
needed to assure the efficient review of
these new animal drug applications.
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dermatologic
and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 17, 2011, from 8 a.m. to
4:30 p.m.
Location: The Marriott Inn and
Conference Center, University of
Maryland University College (UMUC),
3501 University Blvd. East, Adelphi,
MD. The conference center telephone
number is 301–985–7300.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, e-mail:
DODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
E:\FR\FM\24MYN1.SGM
24MYN1
30177
Federal Register / Vol. 76, No. 100 / Tuesday, May 24, 2011 / Notices
possible modifications before coming to
the meeting.
Agenda: On June 17, 2011, the
committee will discuss biologics license
application (BLA) 125387, aflibercept
ophthalmic solution, proposed trade
name EYLEA, sponsored by Regeneron
Pharmaceuticals, Inc., indicated for the
treatment of neovascular age-related
macular degeneration (wet AMD).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at: https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 3, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before May 25,
2011. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 26, 2011.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–12741 Filed 5–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed collection; comment
request; Web-Based Skills Training for
SBIRT (Screening Brief Intervention
and Referral to Treatment)
In compliance with the
requirement of Section 3506(c) (2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
SUMMARY:
National Institute on Drug Abuse, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Web-based Skills Training for
SBIRT (Screening Brief Intervention and
Referral to Treatment).
Type of Information Collection
Request: New.
Need and Use of Information
Collection: The project aims to increase
the provision of screening, brief
intervention, and referral to treatment
(SBIRT) for substance use in primary
care by developing an engaging,
interactive case-based training program
that will be delivered over the Internet,
providing convenient access to
screening and brief intervention skills
training and resources for busy PCPs.
The goal of this study is to evaluate the
effectiveness of this training on provider
behavior and/or patient outcome and
the program’s utility as a training tool in
a real-world medical setting. The
training is named SBIRT–PC. Study
participants will be randomly assigned
to complete SBIRT–PC or a control
training, consisting of online reading
materials. Effectiveness will be
evaluated in terms of differential SBIRTrelated knowledge, attitudes, selfefficacy, self-reported clinical practices,
skills as measured by virtual
standardized patient evaluations (VSPE)
and a telephone-based standardized
patient (SP) interaction. Participants in
each condition will also complete a
training satisfaction questionnaire.
Frequency of Response: On occasion.
Affected Public: Private Sector;
Businesses or other for-profit.
Type of Respondents: Primary Care
Providers.
The annual reporting burden is as
follows:
Estimated
number of
respondents
Estimated
number of responses per
respondent
Average burden hours per
set of
responses
Estimated total
annual burden
hours
requested
Primary Care Providers ...................................................................................
jlentini on DSK4TPTVN1PROD with NOTICES
Type of respondents
94
1
2.0
188
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
VerDate Mar<15>2010
16:47 May 23, 2011
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performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
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information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
E:\FR\FM\24MYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Notices]
[Pages 30176-30177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Dermatologic and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on June 17, 2011, from 8
a.m. to 4:30 p.m.
Location: The Marriott Inn and Conference Center, University of
Maryland University College (UMUC), 3501 University Blvd. East,
Adelphi, MD. The conference center telephone number is 301-985-7300.
Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-
8533, e-mail: DODAC@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about
[[Page 30177]]
possible modifications before coming to the meeting.
Agenda: On June 17, 2011, the committee will discuss biologics
license application (BLA) 125387, aflibercept ophthalmic solution,
proposed trade name EYLEA, sponsored by Regeneron Pharmaceuticals,
Inc., indicated for the treatment of neovascular age-related macular
degeneration (wet AMD).
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
3, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before May 25, 2011. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by May 26, 2011.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12741 Filed 5-23-11; 8:45 am]
BILLING CODE 4160-01-P
