Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges; Public Workshop, 12010-12011 [2015-05017]
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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
product or otherwise relating to the
regulation of a drug product under the
FD&C Act and that the conduct
underlying the conviction undermines
the regulation of drugs. FDA has
considered the relevant factors listed in
section 306(c)(3) of the FD&C Act and
determined that a debarment of 2 years
is appropriate.
As a result of the foregoing findings,
Dr. Noonan is debarred for 2 years from
providing services in any capacity to a
person with an approved or pending
drug product application under section
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see
DATES) (see 21 U.S.C. 335a(c)(1)(B) and
(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved, or
pending, drug product application, who
knowingly uses the services of Dr.
Noonan, in any capacity during his
period of debarment, will be subject to
civil money penalties. If Dr. Noonan,
during his period of debarment,
provides services in any capacity to a
person with an approved or pending
drug product application he will be
subject to civil money penalties. In
addition, FDA will not accept or review
any abbreviated new drug applications
submitted by or with the assistance of
Dr. Noonan during his period of
debarment.
Any application by Dr. Noonan for
termination of debarment under section
306(d) of the FD&C Act should be
identified with Docket No. FDA–2010–
N–0300 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. The public availability of
information in these submissions is
governed by 21 CFR 10.20(j). Publicly
available submissions may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday. Persons with access to
the Internet may obtain documents in
the Docket at https://
www.regulations.gov/.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: February 24, 2015.
Stephen Ostroff,
Director, Office of the Chief Scientist.
[FR Doc. 2015–05042 Filed 3–4–15; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Clinical Outcomes Assessment
Development and Implementation:
Opportunities and Challenges; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Clinical Outcomes Assessment
Development and Implementation:
Opportunities and Challenges.’’ The
purpose of the public workshop is to
provide updates on accomplishments,
challenges, and ongoing efforts in the
use of clinical outcome assessments
(COAs), and plan for the future of COA
development and utilization in drug
development programs, including how
to incorporate the patient voice in drug
development using well-defined and
reliable patient-centered outcome
measures. The public workshop will
also discuss standards for COA use and
collaborative processes for COA
development and dissemination.
Date and Time: The public workshop
will be held on April 1, 2015, from 8:30
a.m. to 5 p.m. Participants are
encouraged to arrive early to ensure
time for parking and routine security
checks before the workshop.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, The Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Entrance for the public workshop
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. Attendees are
responsible for their own
accommodations.
The public workshop will also be
available to be viewed online via
Webcast at https://
collaboration.fda.gov/
COApublicworkshop2015. Persons
interested in participating by Webcast
must register online by March 27, 2015.
Contact Person: Michelle Campbell,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6471, Silver Spring,
PO 00000
Frm 00035
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MD 20993–0002, 240–402–6019, email:
COApublicworkshop@fda.hhs.gov.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited to 150 attendees.
Workshop space will be filled in order
of receipt of registration. Those accepted
in to the workshop will receive
confirmation. Registration will close
after the workshop is filled. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 7:30 a.m. If registration is
filled, attendance to the workshop will
be available only through the Webcast.
To register, visit https://www.fda.gov/
Drugs/NewsEvents/ucm431040.htm. For
those without Internet access, please
call Michelle Campbell (See Contact
Person) to register.
If you need special accommodations
due to a disability, please contact
Michelle Campbell (See Contact Person)
at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The
Center for Drug Evaluation and Research
(CDER) reviews COAs, including
patient-reported outcome measures,
clinician-reported outcome measures,
and observer-reported outcome
measures, when submitted with an
investigational new drug application, a
new drug application, or a biologics
licensing application. CDER also
reviews a COA when submitted for
qualification as a drug development
tool. Qualification of a COA is a
regulatory determination that the COA
is well-suited for a specific context of
use in drug development. Following a
public announcement of the
qualification decision by FDA, the COA
will be publicly available for use in any
appropriate drug development program.
This workshop will focus on current
challenges and opportunities in COA
development and use, including
establishing appropriate standards for
use; current efforts to encourage
inclusion of well-defined and reliable
patient-centered outcome measures in
drug development; use of collaborative
efforts in developing and utilizing COAs
through various partnerships; and future
efforts to address challenges and gaps of
COA development and use for patientcentered drug development and medical
product labeling.
For more information on this public
workshop, visit https://www.fda.gov/
Drugs/NewsEvents/ucm431040.htm.
The Agency encourages patient
advocates, health care providers,
researchers, regulators, individuals from
academia, industry, and other interested
persons to attend this public workshop.
E:\FR\FM\05MRN1.SGM
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Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20857. 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 Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm431040.htm approximately 45 days
after the workshop.
Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05017 Filed 3–4–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
I. Background
[Docket No. FDA–2011–D–0147]
Demonstrating the Substantial
Equivalence of a New Tobacco
Product: Responses to Frequently
Asked Questions; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance for industry
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ This guidance provides
information in response to questions
that FDA has received from
manufacturers on demonstrating the
substantial equivalence of a new
tobacco product, including questions on
when a modification to the label
requires a premarket submission and
review by FDA.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions’’ to the Center for Tobacco
Products, Food and Drug
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. Send one self-addressed
adhesive label to assist that office in
processing your request or include a fax
number to which the guidance
document may be sent. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance document.
Submit electronic comments on the
guidance 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. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Annette Marthaler, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002; 1–877–287–1373,
CTPRegulations@fda.hhs.gov, email:
annette.marthaler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a guidance for industry entitled
‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ In this guidance, FDA
addresses questions from manufacturers
on demonstrating the substantial
equivalence of a new tobacco product.
In the Federal Register of September 9,
2011 (76 FR 55927), FDA announced the
availability of the draft guidance of the
same title. After carefully reviewing and
considering comments and information
submitted in response to the draft
guidance, which covered a range of
topics on demonstrating the substantial
equivalence of a new tobacco product,
FDA is finalizing this guidance on many
of the topics, including modifications to
labels and changes to product quantity
and intends to address the other topics
in future regulatory documents.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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 statute and regulations.
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III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved information collections 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 sections
905(j) and 910 of the FD&C Act (21
U.S.C. 387e(j) and 387j), as amended by
the Tobacco Control Act, have been
approved under OMB control number
0910–0673; the collections of
information in 21 CFR part 25 have been
approved under OMB control number
0910–0322.
IV. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/
GuidanceComplianceRegulatory
Information/default.htm.
Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05023 Filed 3–4–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0303]
William F. DeLuca, Jr.; Denial of
Hearing; Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying a
request for a hearing submitted by Dr.
William F. DeLuca, Jr. and is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) debarring
Dr. DeLuca for 5 years from providing
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12010-12011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Clinical Outcomes Assessment Development and Implementation:
Opportunities and Challenges; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Clinical Outcomes Assessment Development and
Implementation: Opportunities and Challenges.'' The purpose of the
public workshop is to provide updates on accomplishments, challenges,
and ongoing efforts in the use of clinical outcome assessments (COAs),
and plan for the future of COA development and utilization in drug
development programs, including how to incorporate the patient voice in
drug development using well-defined and reliable patient-centered
outcome measures. The public workshop will also discuss standards for
COA use and collaborative processes for COA development and
dissemination.
Date and Time: The public workshop will be held on April 1, 2015,
from 8:30 a.m. to 5 p.m. Participants are encouraged to arrive early to
ensure time for parking and routine security checks before the
workshop.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, The
Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public workshop 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. Attendees are responsible for their own accommodations.
The public workshop will also be available to be viewed online via
Webcast at https://collaboration.fda.gov/COApublicworkshop2015. Persons
interested in participating by Webcast must register online by March
27, 2015.
Contact Person: Michelle Campbell, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 6471, Silver Spring, MD 20993-0002, 240-402-6019, email:
COApublicworkshop@fda.hhs.gov.
Registration: Registration is free for the public workshop.
Interested parties are encouraged to register early because space is
limited to 150 attendees. Workshop space will be filled in order of
receipt of registration. Those accepted in to the workshop will receive
confirmation. Registration will close after the workshop is filled.
Registration at the site is not guaranteed but may be possible on a
space available basis on the day of the public workshop beginning at
7:30 a.m. If registration is filled, attendance to the workshop will be
available only through the Webcast.
To register, visit https://www.fda.gov/Drugs/NewsEvents/ucm431040.htm. For those without Internet access, please call Michelle
Campbell (See Contact Person) to register.
If you need special accommodations due to a disability, please
contact Michelle Campbell (See Contact Person) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: The Center for Drug Evaluation and Research
(CDER) reviews COAs, including patient-reported outcome measures,
clinician-reported outcome measures, and observer-reported outcome
measures, when submitted with an investigational new drug application,
a new drug application, or a biologics licensing application. CDER also
reviews a COA when submitted for qualification as a drug development
tool. Qualification of a COA is a regulatory determination that the COA
is well-suited for a specific context of use in drug development.
Following a public announcement of the qualification decision by FDA,
the COA will be publicly available for use in any appropriate drug
development program.
This workshop will focus on current challenges and opportunities in
COA development and use, including establishing appropriate standards
for use; current efforts to encourage inclusion of well-defined and
reliable patient-centered outcome measures in drug development; use of
collaborative efforts in developing and utilizing COAs through various
partnerships; and future efforts to address challenges and gaps of COA
development and use for patient-centered drug development and medical
product labeling.
For more information on this public workshop, visit https://www.fda.gov/Drugs/NewsEvents/ucm431040.htm.
The Agency encourages patient advocates, health care providers,
researchers, regulators, individuals from academia, industry, and other
interested persons to attend this public workshop.
[[Page 12011]]
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857.
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 Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be available on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm431040.htm approximately 45 days after
the workshop.
Dated: February 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05017 Filed 3-4-15; 8:45 am]
BILLING CODE 4164-01-P
