80_FR_12053 80 FR 12010 - Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges; Public Workshop

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 Range12010-12011
FR Document2015-05017

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.

-----------------------------------------------------------------------

    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]
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                                                  12010                         Federal Register / Vol. 80, No. 43 / Thursday, March 5, 2015 / Notices

                                                  product or otherwise relating to the                    DEPARTMENT OF HEALTH AND                              MD 20993–0002, 240–402–6019, email:
                                                  regulation of a drug product under the                  HUMAN SERVICES                                        COApublicworkshop@fda.hhs.gov.
                                                  FD&C Act and that the conduct                                                                                    Registration: Registration is free for
                                                  underlying the conviction undermines                    Food and Drug Administration                          the public workshop. Interested parties
                                                  the regulation of drugs. FDA has                        [Docket No. FDA–2015–N–0001]                          are encouraged to register early because
                                                  considered the relevant factors listed in                                                                     space is limited to 150 attendees.
                                                  section 306(c)(3) of the FD&C Act and                   Clinical Outcomes Assessment                          Workshop space will be filled in order
                                                  determined that a debarment of 2 years                  Development and Implementation:                       of receipt of registration. Those accepted
                                                  is appropriate.                                         Opportunities and Challenges; Public                  in to the workshop will receive
                                                                                                          Workshop                                              confirmation. Registration will close
                                                     As a result of the foregoing findings,                                                                     after the workshop is filled. Registration
                                                  Dr. Noonan is debarred for 2 years from                 AGENCY:    Food and Drug Administration,              at the site is not guaranteed but may be
                                                  providing services in any capacity to a                 HHS.                                                  possible on a space available basis on
                                                  person with an approved or pending                      ACTION:   Notice of public workshop.                  the day of the public workshop
                                                  drug product application under section                                                                        beginning at 7:30 a.m. If registration is
                                                  505, 512, or 802 of the FD&C Act (21                      The Food and Drug Administration
                                                                                                                                                                filled, attendance to the workshop will
                                                  U.S.C. 355, 360b, or 382), or under                     (FDA) is announcing a public workshop
                                                                                                                                                                be available only through the Webcast.
                                                                                                          entitled ‘‘Clinical Outcomes Assessment
                                                  section 351 of the Public Health Service                                                                         To register, visit http://www.fda.gov/
                                                                                                          Development and Implementation:
                                                  Act (42 U.S.C. 262), effective (see                                                                           Drugs/NewsEvents/ucm431040.htm. For
                                                                                                          Opportunities and Challenges.’’ The
                                                  DATES) (see 21 U.S.C. 335a(c)(1)(B) and                                                                       those without Internet access, please
                                                                                                          purpose of the public workshop is to
                                                  (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).                                                                        call Michelle Campbell (See Contact
                                                                                                          provide updates on accomplishments,
                                                  Any person with an approved, or                                                                               Person) to register.
                                                                                                          challenges, and ongoing efforts in the
                                                  pending, drug product application, who                                                                           If you need special accommodations
                                                                                                          use of clinical outcome assessments
                                                  knowingly uses the services of Dr.                                                                            due to a disability, please contact
                                                                                                          (COAs), and plan for the future of COA
                                                  Noonan, in any capacity during his                                                                            Michelle Campbell (See Contact Person)
                                                                                                          development and utilization in drug
                                                  period of debarment, will be subject to                                                                       at least 7 days in advance.
                                                                                                          development programs, including how
                                                  civil money penalties. If Dr. Noonan,                   to incorporate the patient voice in drug              SUPPLEMENTARY INFORMATION: The
                                                  during his period of debarment,                         development using well-defined and                    Center for Drug Evaluation and Research
                                                  provides services in any capacity to a                  reliable patient-centered outcome                     (CDER) reviews COAs, including
                                                  person with an approved or pending                      measures. The public workshop will                    patient-reported outcome measures,
                                                  drug product application he will be                     also discuss standards for COA use and                clinician-reported outcome measures,
                                                  subject to civil money penalties. In                    collaborative processes for COA                       and observer-reported outcome
                                                  addition, FDA will not accept or review                 development and dissemination.                        measures, when submitted with an
                                                  any abbreviated new drug applications                     Date and Time: The public workshop                  investigational new drug application, a
                                                  submitted by or with the assistance of                  will be held on April 1, 2015, from 8:30              new drug application, or a biologics
                                                  Dr. Noonan during his period of                         a.m. to 5 p.m. Participants are                       licensing application. CDER also
                                                                                                          encouraged to arrive early to ensure                  reviews a COA when submitted for
                                                  debarment.
                                                                                                          time for parking and routine security                 qualification as a drug development
                                                     Any application by Dr. Noonan for                    checks before the workshop.                           tool. Qualification of a COA is a
                                                  termination of debarment under section                    Location: The public workshop will                  regulatory determination that the COA
                                                  306(d) of the FD&C Act should be                        be held at the FDA White Oak Campus,                  is well-suited for a specific context of
                                                  identified with Docket No. FDA–2010–                    10903 New Hampshire Ave., Building                    use in drug development. Following a
                                                  N–0300 and sent to the Division of                      31 Conference Center, The Great Room                  public announcement of the
                                                  Dockets Management (see ADDRESSES).                     (Rm. 1503), Silver Spring, MD 20993–                  qualification decision by FDA, the COA
                                                  All such submissions are to be filed in                 0002. Entrance for the public workshop                will be publicly available for use in any
                                                  four copies. The public availability of                 participants (non-FDA employees) is                   appropriate drug development program.
                                                  information in these submissions is                     through Building 1 where routine                         This workshop will focus on current
                                                  governed by 21 CFR 10.20(j). Publicly                   security check procedures will be                     challenges and opportunities in COA
                                                  available submissions may be seen in                    performed. For parking and security                   development and use, including
                                                  the Division of Dockets Management                      information, please refer to http://                  establishing appropriate standards for
                                                  between 9 a.m. and 4 p.m., Monday                       www.fda.gov/AboutFDA/                                 use; current efforts to encourage
                                                  through Friday. Persons with access to                  WorkingatFDA/BuildingsandFacilities/                  inclusion of well-defined and reliable
                                                  the Internet may obtain documents in                    WhiteOakCampusInformation/                            patient-centered outcome measures in
                                                  the Docket at http://                                   ucm241740.htm. Attendees are                          drug development; use of collaborative
                                                  www.regulations.gov/.                                   responsible for their own                             efforts in developing and utilizing COAs
                                                                                                          accommodations.                                       through various partnerships; and future
                                                    Dated: February 24, 2015.                               The public workshop will also be                    efforts to address challenges and gaps of
                                                  Stephen Ostroff,                                        available to be viewed online via                     COA development and use for patient-
                                                  Director, Office of the Chief Scientist.                Webcast at https://                                   centered drug development and medical
                                                  [FR Doc. 2015–05042 Filed 3–4–15; 8:45 am]              collaboration.fda.gov/                                product labeling.
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                                                                                                          COApublicworkshop2015. Persons                           For more information on this public
                                                  BILLING CODE 4164–01–P
                                                                                                          interested in participating by Webcast                workshop, visit http://www.fda.gov/
                                                                                                          must register online by March 27, 2015.               Drugs/NewsEvents/ucm431040.htm.
                                                                                                            Contact Person: Michelle Campbell,                     The Agency encourages patient
                                                                                                          Center for Drug Evaluation and                        advocates, health care providers,
                                                                                                          Research, Food and Drug                               researchers, regulators, individuals from
                                                                                                          Administration, 10903 New Hampshire                   academia, industry, and other interested
                                                                                                          Ave., Bldg. 22, Rm. 6471, Silver Spring,              persons to attend this public workshop.


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                                                                                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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Document Created: 2015-12-18 12:08:56
Document Modified: 2015-12-18 12:08:56
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public workshop.
FR Citation80 FR 12010 

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