80 FR 12010 - Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

Page Range		12010-12011
FR Document		2015-05017

Federal Register, Volume 80 Issue 43 (Thursday, March 5, 2015)

[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Pages 12010-12011]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05017]


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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.

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    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 http://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: 
[email protected].
    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 http://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 http://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 http://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 http://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

Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices 12011

Transcripts: Please be advised that as Administration, Document Control III. Paperwork Reduction Act of 1995
soon as a transcript is available, it will Center, Bldg. 71, Rm. G335, 10903 New This guidance refers to previously
be accessible at http:// Hampshire Ave., Silver Spring, MD approved information collections found
www.regulations.gov. It may be viewed 20993–0002. Send one self-addressed in FDA regulations. These collections of
at the Division of Dockets Management adhesive label to assist that office in information are subject to review by the
(HFA–305), Food and Drug processing your request or include a fax Office of Management and Budget
Administration, 5630 Fishers Lane, Rm. number to which the guidance (OMB) under the Paperwork Reduction
1061, Rockville, MD 20857. A transcript document may be sent. See the Act of 1995 (44 U.S.C. 3501–3520). The
will also be available in either hardcopy SUPPLEMENTARY INFORMATION section for
collections of information in sections
or on CD–ROM, after submission of a information on electronic access to the 905(j) and 910 of the FD&C Act (21
Freedom of Information request. Written guidance document. U.S.C. 387e(j) and 387j), as amended by
requests are to be sent to Division of Submit electronic comments on the the Tobacco Control Act, have been
Freedom of Information (ELEM–1029), guidance to http://www.regulations.gov. approved under OMB control number
Food and Drug Administration, 12420 Submit written comments to the 0910–0673; the collections of
Parklawn Dr., Element Bldg., Rockville, Division of Dockets Management (HFA– information in 21 CFR part 25 have been
MD 20857. Transcripts will also be 305), Food and Drug Administration, approved under OMB control number
available on the Internet at http:// 5630 Fishers Lane, Rm. 1061, Rockville, 0910–0322.
www.fda.gov/Drugs/NewsEvents/ MD 20852. Identify comments with the
ucm431040.htm approximately 45 days docket number found in brackets in the IV. Comments
after the workshop. heading of this document. Interested persons may submit either
Dated: February 27, 2015. FOR FURTHER INFORMATION CONTACT: electronic comments regarding this
Leslie Kux, Annette Marthaler, Center for Tobacco document to http://www.regulations.gov
Associate Commissioner for Policy. Products, Food and Drug or written comments to the Division of
[FR Doc. 2015–05017 Filed 3–4–15; 8:45 am]
Administration, Document Control Dockets Management (see ADDRESSES). It
Center, Bldg. 71, Rm. G335, 10903 New is only necessary to send one set of
BILLING CODE 4164–01–P
Hampshire Ave., Silver Spring, MD comments. Identify comments with the
20993–0002; 1–877–287–1373, docket number found in brackets in the
DEPARTMENT OF HEALTH AND CTPRegulations@fda.hhs.gov, email: heading of this document. Received
HUMAN SERVICES annette.marthaler@fda.hhs.gov. comments may be seen in the Division
SUPPLEMENTARY INFORMATION: of Dockets Management between 9 a.m.
Food and Drug Administration and 4 p.m., Monday through Friday, and
I. Background will be posted to the docket at http://
[Docket No. FDA–2011–D–0147]
FDA is announcing the availability of www.regulations.gov.
Demonstrating the Substantial a guidance for industry entitled
V. Electronic Access
Equivalence of a New Tobacco ‘‘Demonstrating the Substantial
Product: Responses to Frequently Equivalence of a New Tobacco Product: Persons with access to the Internet
Asked Questions; Guidance for Responses to Frequently Asked may obtain the document at either
Industry; Availability Questions.’’ In this guidance, FDA http://www.regulations.gov or
addresses questions from manufacturers http://www.fda.gov/TobaccoProducts/
AGENCY: Food and Drug Administration, on demonstrating the substantial GuidanceComplianceRegulatory
HHS. equivalence of a new tobacco product. Information/default.htm.
ACTION: Notice. In the Federal Register of September 9, Dated: February 27, 2015.
2011 (76 FR 55927), FDA announced the Leslie Kux,
SUMMARY: The Food and Drug availability of the draft guidance of the
Administration (FDA) is announcing the Associate Commissioner for Policy.
same title. After carefully reviewing and [FR Doc. 2015–05023 Filed 3–4–15; 8:45 am]
availability of the guidance for industry considering comments and information
entitled ‘‘Demonstrating the Substantial submitted in response to the draft
BILLING CODE 4164–01–P
Equivalence of a New Tobacco Product: guidance, which covered a range of
Responses to Frequently Asked topics on demonstrating the substantial
Questions.’’ This guidance provides DEPARTMENT OF HEALTH AND
equivalence of a new tobacco product, HUMAN SERVICES
information in response to questions FDA is finalizing this guidance on many
that FDA has received from of the topics, including modifications to
manufacturers on demonstrating the Food and Drug Administration
labels and changes to product quantity
substantial equivalence of a new and intends to address the other topics [Docket No. FDA–2010–N–0303]
tobacco product, including questions on in future regulatory documents.
when a modification to the label William F. DeLuca, Jr.; Denial of
requires a premarket submission and II. Significance of Guidance Hearing; Final Debarment Order
review by FDA. This guidance is being issued AGENCY: Food and Drug Administration,
DATES: Submit either electronic or consistent with FDA’s good guidance HHS.
written comments on Agency guidances practices regulation (21 CFR 10.115). ACTION: Notice.
at any time.
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The guidance represents the Agency’s
ADDRESSES: Submit written requests for current thinking on this topic. It does SUMMARY: The Food and Drug
single copies of the guidance document not create or confer any rights for or on Administration (FDA) is denying a
entitled ‘‘Demonstrating the Substantial any person and does not operate to bind request for a hearing submitted by Dr.
Equivalence of a New Tobacco Product: FDA or the public. An alternative William F. DeLuca, Jr. and is issuing an
Responses to Frequently Asked approach may be used if such approach order under the Federal Food, Drug, and
Questions’’ to the Center for Tobacco satisfies the requirements of the Cosmetic Act (the FD&C Act) debarring
Products, Food and Drug applicable statute and regulations. Dr. DeLuca for 5 years from providing

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
FR Citation		80 FR 12010

80 FR 12010 - Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 43 (March 5, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration