82_FR_59055 82 FR 58816 - Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments

82 FR 58816 - Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 239 (December 14, 2017)

Page Range58816-58817
FR Document2017-26978

The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date.

Federal Register, Volume 82 Issue 239 (Thursday, December 14, 2017)
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58816-58817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26978]



[[Page 58816]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6312]


Patient-Focused Drug Development: Developing and Submitting 
Proposed Draft Guidance Relating to Patient Experience Data; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the following public workshop entitled ``Patient-Focused Drug 
Development: Developing and Submitting Proposed Draft Guidance Relating 
to Patient Experience Data.'' The purpose of the public workshop is to 
convene a discussion on how a person seeking to develop and submit 
proposed draft guidance relating to patient experience data for 
consideration by FDA may submit such proposed draft guidance to the 
Agency. This workshop will inform development of patient-focused drug 
development guidance as required by the 21st Century Cures Act (Cures 
Act). FDA plans to publish a background document approximately 2 weeks 
before the workshop date.

DATES: The public workshop will be held on March 19, 2018, from 1 p.m. 
to 5 p.m. Submit either electronic or written comments on this public 
workshop by May 18, 2018. See the SUPPLEMENTARY INFORMATION section for 
additional registration information.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. 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. 
Workshop updates, agenda, and background document will be made 
available at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm prior 
to the workshop.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before May 18, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of May 18, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6312 for ``Patient-Focused Drug Development: Developing and 
Submitting Proposed Draft Guidance Relating to Patient Experience 
Data.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, Meghana.Chalasani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    This public workshop is intended to support FDA implementation of 
requirements for guidance development under section 3002 of the Cures 
Act (Pub. L. 114-255). Section 3002 of Title III, Subtitle A, of the 
Cures Act directs

[[Page 58817]]

FDA to develop patient-focused drug development guidance to address a 
number of areas, including how a person seeking to develop and submit a 
proposed draft guidance relating to patient experience data for 
consideration by FDA may submit such proposed draft guidances.
    In FDA's ``Plan for Issuance of Patient-Focused Drug Development 
Guidance,'' (the Plan) available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM563618.pdf, the Agency 
proposed issuing a guidance addressing this topic described in section 
3002 during the second quarter of 2018. FDA recognizes that, like the 
other patient-focused drug development guidances described in the Plan, 
developing this draft guidance will also benefit from public input from 
the wider community of patients, patient advocates, academic 
researchers, expert practitioners, drug developers, and other 
stakeholders prior to FDA's drafting of the guidance. Accordingly, the 
Agency is scheduling this public workshop. After this public workshop, 
FDA will take into consideration the stakeholder input from the 
workshop and the public docket, and publish a draft guidance by the end 
of fiscal year 2018.

II. Purpose and Scope of Meeting

    FDA is announcing a public workshop to convene a discussion on 
topics related to developing and submitting proposed draft guidance 
relating to patient experience data by an external stakeholder. The 
purpose of this public workshop is to obtain input from stakeholders on 
considerations for development and submission of proposed draft 
guidance relating to patient experience data submitted by an external 
stakeholder, including: (1) Defining the scope of the proposed draft 
guidance, (2) developing the proposed draft guidance, and (3) 
submitting the proposed draft guidance to FDA, including the process 
and format. The Agency is seeking information and comments from a broad 
range of stakeholders, including patients, patient advocates, academic 
and medical researchers, expert practitioners, drug developers, and 
other interested persons. FDA will publish a background document 
outlining the topic areas that will be addressed in the draft guidance 
approximately 2 weeks before the workshop date at the following 
website: https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm.
    After this public workshop, FDA will take into consideration the 
stakeholder input from the workshop and the public docket, and publish 
a draft guidance by the end of fiscal year 2018.

III. Participating in the Public Workshop

    Registration: Interested parties are encouraged to register early. 
To register electronically, please visit https://pfdd-proposeddraftguidance.eventbrite.com. Persons without access to the 
internet can call 240-402-6525 to register. If you are unable to attend 
the public workshop in person, you can register to view a live webcast. 
You will be asked to indicate in your registration if you plan to 
attend in person or via the webcast. Seating will be limited, so early 
registration is recommended. Registration is free and will be on a 
first-come, first-served basis. However, FDA may limit the number of 
participants from each organization based on space limitations. 
Registrants will receive confirmation once they have been accepted. 
Onsite registration on the day of the public workshop will be based on 
space availability. If you need special accommodations because of a 
disability, please contact Meghana Chalasani (see FOR FURTHER 
INFORMATION CONTACT) at least 7 days before the public workshop.
    Open Public Comment: There will be time allotted during the public 
workshop for open public comment. Sign-up for this session will be on a 
first-come, first-serve basis on the day of the public workshop. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate, and request time for a joint presentation. 
No commercial or promotional material will be permitted to be presented 
or distributed at the public workshop.
    Transcripts: As soon as a transcript is available of the public 
workshop, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm.

    Dated: December 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26978 Filed 12-13-17; 8:45 am]
BILLING CODE 4164-01-P



                                                58816                     Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices

                                                DEPARTMENT OF HEALTH AND                                on or before May 18, 2018. The https://               https://www.regulations.gov or at the
                                                HUMAN SERVICES                                          www.regulations.gov electronic filing                 Dockets Management Staff between 9
                                                                                                        system will accept comments until                     a.m. and 4 p.m., Monday through
                                                Food and Drug Administration                            midnight Eastern Time at the end of                   Friday.
                                                                                                        May 18, 2018. Comments received by                       • Confidential Submissions—To
                                                [Docket No. FDA–2017–N–6312]
                                                                                                        mail/hand delivery/courier (for written/              submit a comment with confidential
                                                Patient-Focused Drug Development:                       paper submissions) will be considered                 information that you do not wish to be
                                                Developing and Submitting Proposed                      timely if they are postmarked or the                  made publicly available, submit your
                                                Draft Guidance Relating to Patient                      delivery service acceptance receipt is on             comments only as a written/paper
                                                Experience Data; Public Workshop;                       or before that date.                                  submission. You should submit two
                                                Request for Comments                                                                                          copies total. One copy will include the
                                                                                                        Electronic Submissions
                                                                                                                                                              information you claim to be confidential
                                                AGENCY:    Food and Drug Administration,                  Submit electronic comments in the                   with a heading or cover note that states
                                                HHS.                                                    following way:                                        ‘‘THIS DOCUMENT CONTAINS
                                                ACTION: Notice of public workshop;                        • Federal eRulemaking Portal:                       CONFIDENTIAL INFORMATION.’’ The
                                                request for comments.                                   https://www.regulations.gov. Follow the               Agency will review this copy, including
                                                                                                        instructions for submitting comments.                 the claimed confidential information, in
                                                SUMMARY:   The Food and Drug                            Comments submitted electronically,                    its consideration of comments. The
                                                Administration (FDA or Agency) is                       including attachments, to https://                    second copy, which will have the
                                                announcing the following public                         www.regulations.gov will be posted to                 claimed confidential information
                                                workshop entitled ‘‘Patient-Focused                     the docket unchanged. Because your                    redacted/blacked out, will be available
                                                Drug Development: Developing and                        comment will be made public, you are                  for public viewing and posted on
                                                Submitting Proposed Draft Guidance                      solely responsible for ensuring that your             https://www.regulations.gov. Submit
                                                Relating to Patient Experience Data.’’                  comment does not include any                          both copies to the Dockets Management
                                                The purpose of the public workshop is                   confidential information that you or a                Staff. If you do not wish your name and
                                                to convene a discussion on how a                        third party may not wish to be posted,                contact information to be made publicly
                                                person seeking to develop and submit                    such as medical information, your or                  available, you can provide this
                                                proposed draft guidance relating to                     anyone else’s Social Security number, or              information on the cover sheet and not
                                                patient experience data for                             confidential business information, such               in the body of your comments and you
                                                consideration by FDA may submit such                    as a manufacturing process. Please note               must identify this information as
                                                proposed draft guidance to the Agency.                  that if you include your name, contact                ‘‘confidential.’’ Any information marked
                                                This workshop will inform development                   information, or other information that                as ‘‘confidential’’ will not be disclosed
                                                of patient-focused drug development                     identifies you in the body of your                    except in accordance with 21 CFR 10.20
                                                guidance as required by the 21st                        comments, that information will be                    and other applicable disclosure law. For
                                                Century Cures Act (Cures Act). FDA                      posted on https://www.regulations.gov.                more information about FDA’s posting
                                                plans to publish a background                             • If you want to submit a comment                   of comments to public dockets, see 80
                                                document approximately 2 weeks before                   with confidential information that you                FR 56469, September 18, 2015, or access
                                                the workshop date.                                      do not wish to be made available to the               the information at: https://www.gpo.gov/
                                                DATES: The public workshop will be                      public, submit the comment as a                       fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                held on March 19, 2018, from 1 p.m. to                  written/paper submission and in the                   23389.pdf.
                                                5 p.m. Submit either electronic or                      manner detailed (see ‘‘Written/Paper                     Docket: For access to the docket to
                                                written comments on this public                         Submissions’’ and ‘‘Instructions’’).                  read background documents or the
                                                workshop by May 18, 2018. See the                       Written/Paper Submissions                             electronic and written/paper comments
                                                SUPPLEMENTARY INFORMATION section for                                                                         received, go to https://
                                                                                                          Submit written/paper submissions as
                                                additional registration information.                                                                          www.regulations.gov and insert the
                                                                                                        follows:
                                                ADDRESSES: The public workshop will                       • Mail/Hand delivery/Courier (for                   docket number, found in brackets in the
                                                be held at FDA’s White Oak Campus,                      written/paper submissions): Dockets                   heading of this document, into the
                                                10903 New Hampshire Ave., Bldg. 31                      Management Staff (HFA–305), Food and                  ‘‘Search’’ box and follow the prompts
                                                Conference Center, the Great Room (Rm.                  Drug Administration, 5630 Fishers                     and/or go to the Dockets Management
                                                1503), Silver Spring, MD 20993.                         Lane, Rm. 1061, Rockville, MD 20852.                  Staff, 5630 Fishers Lane, Rm. 1061,
                                                Entrance for the public workshop                          • For written/paper comments                        Rockville, MD 20852.
                                                participants (non-FDA employees) is                     submitted to the Dockets Management                   FOR FURTHER INFORMATION CONTACT:
                                                through Building 1 where routine                        Staff, FDA will post your comment, as                 Meghana Chalasani, Center for Drug
                                                security check procedures will be                       well as any attachments, except for                   Evaluation and Research, Food and
                                                performed. For parking and security                     information submitted, marked and                     Drug Administration, 10903 New
                                                information, please refer to https://                   identified, as confidential, if submitted             Hampshire Ave., Bldg. 51, Rm. 1146,
                                                www.fda.gov/AboutFDA/                                   as detailed in ‘‘Instructions.’’                      Silver Spring, MD 20993–0002, 240–
                                                WorkingatFDA/BuildingsandFacilities/                      Instructions: All submissions received              402–6525, Fax: 301–847–8443,
                                                WhiteOakCampusInformation/                              must include the Docket No. FDA–                      Meghana.Chalasani@fda.hhs.gov.
                                                ucm241740.htm. Workshop updates,                        2017–N–6312 for ‘‘Patient-Focused Drug                SUPPLEMENTARY INFORMATION:
                                                agenda, and background document will                    Development: Developing and
sradovich on DSK3GMQ082PROD with NOTICES




                                                be made available at https://                           Submitting Proposed Draft Guidance                    I. Background
                                                www.fda.gov/Drugs/NewsEvents/                           Relating to Patient Experience Data.’’                   This public workshop is intended to
                                                ucm582081.htm prior to the workshop.                    Received comments, those filed in a                   support FDA implementation of
                                                   You may submit comments as                           timely manner (see ADDRESSES), will be                requirements for guidance development
                                                follows. Please note that late, untimely                placed in the docket and, except for                  under section 3002 of the Cures Act
                                                filed comments will not be considered.                  those submitted as ‘‘Confidential                     (Pub. L. 114–255). Section 3002 of Title
                                                Electronic comments must be submitted                   Submissions,’’ publicly viewable at                   III, Subtitle A, of the Cures Act directs


                                           VerDate Sep<11>2014   21:28 Dec 13, 2017   Jkt 244001   PO 00000   Frm 00025   Fmt 4703   Sfmt 4703   E:\FR\FM\14DEN1.SGM   14DEN1


                                                                          Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices                                             58817

                                                FDA to develop patient-focused drug                     docket, and publish a draft guidance by               licensing to achieve expeditious
                                                development guidance to address a                       the end of fiscal year 2018.                          commercialization of results of
                                                number of areas, including how a                                                                              federally-funded research and
                                                                                                        III. Participating in the Public
                                                person seeking to develop and submit a                                                                        development. Foreign patent
                                                                                                        Workshop
                                                proposed draft guidance relating to                                                                           applications are filed on selected
                                                patient experience data for                                Registration: Interested parties are               inventions to extend market coverage
                                                consideration by FDA may submit such                    encouraged to register early. To register             for companies and may also be available
                                                proposed draft guidances.                               electronically, please visit https://pfdd-            for licensing.
                                                   In FDA’s ‘‘Plan for Issuance of                      proposeddraftguidance.eventbrite.com.                 FOR FURTHER INFORMATION CONTACT: Dr.
                                                Patient-Focused Drug Development                        Persons without access to the internet                Natalie Greco, 301–761–7898;
                                                Guidance,’’ (the Plan) available at                     can call 240–402–6525 to register. If you             Natalie.Greco@nih.gov. Licensing
                                                https://www.fda.gov/downloads/                          are unable to attend the public                       information and copies of the patent
                                                ForIndustry/UserFees/                                   workshop in person, you can register to               applications listed below may be
                                                PrescriptionDrugUserFee/                                view a live webcast. You will be asked                obtained by communicating with the
                                                UCM563618.pdf, the Agency proposed                      to indicate in your registration if you               indicated licensing contact at the
                                                issuing a guidance addressing this topic                plan to attend in person or via the                   Technology Transfer and Intellectual
                                                described in section 3002 during the                    webcast. Seating will be limited, so                  Property Office, National Institute of
                                                second quarter of 2018. FDA recognizes                  early registration is recommended.                    Allergy and Infectious Diseases, 5601
                                                that, like the other patient-focused drug               Registration is free and will be on a first-          Fishers Lane, Rockville, MD 20852; tel.
                                                development guidances described in the                  come, first-served basis. However, FDA                301–496–2644. A signed Confidential
                                                Plan, developing this draft guidance                    may limit the number of participants                  Disclosure Agreement will be required
                                                will also benefit from public input from                from each organization based on space                 to receive copies of unpublished patent
                                                the wider community of patients,                        limitations. Registrants will receive                 applications.
                                                patient advocates, academic researchers,                confirmation once they have been                      SUPPLEMENTARY INFORMATION:
                                                expert practitioners, drug developers,                  accepted. Onsite registration on the day              Technology description follows.
                                                and other stakeholders prior to FDA’s                   of the public workshop will be based on
                                                drafting of the guidance. Accordingly,                  space availability. If you need special               Monoclonal Antibody Specific for DNA/
                                                the Agency is scheduling this public                    accommodations because of a disability,               RNA Hybrid Molecules
                                                workshop. After this public workshop,                   please contact Meghana Chalasani (see                 Description of Technology
                                                FDA will take into consideration the                    FOR FURTHER INFORMATION CONTACT) at
                                                stakeholder input from the workshop                                                                              NIAID has a hybridoma available for
                                                                                                        least 7 days before the public workshop.
                                                and the public docket, and publish a                       Open Public Comment: There will be                 non-exclusive licensing that produces a
                                                draft guidance by the end of fiscal year                time allotted during the public                       monoclonal antibody specific for DNA/
                                                2018.                                                   workshop for open public comment.                     RNA hybrids. This antibody, which has
                                                                                                        Sign-up for this session will be on a                 been extensively characterized by NIH
                                                II. Purpose and Scope of Meeting                                                                              researchers, is already a widely-used
                                                                                                        first-come, first-serve basis on the day of
                                                   FDA is announcing a public                           the public workshop. Individuals and                  research tool. It is currently the only
                                                workshop to convene a discussion on                     organizations with common interests are               monoclonal antibody available that is
                                                topics related to developing and                        urged to consolidate or coordinate, and               specific for DNA/RNA hybrids, making
                                                submitting proposed draft guidance                      request time for a joint presentation. No             it a unique reagent. It is used in
                                                relating to patient experience data by an               commercial or promotional material                    immuno-fluorescence (IF) microscopy,
                                                external stakeholder. The purpose of                    will be permitted to be presented or                  where it can be used to detect sites of
                                                this public workshop is to obtain input                 distributed at the public workshop.                   transcriptional activity and potentially
                                                from stakeholders on considerations for                    Transcripts: As soon as a transcript is            sites of viral replication. It has also been
                                                development and submission of                           available of the public workshop, FDA                 used in DNA/RNA immunoprecipitation
                                                proposed draft guidance relating to                     will post it at https://www.fda.gov/                  (DRIP) experiments by a variety of
                                                patient experience data submitted by an                 Drugs/NewsEvents/ucm582081.htm.                       researchers.
                                                external stakeholder, including: (1)                                                                             Aside from its use as a research tool,
                                                Defining the scope of the proposed draft                  Dated: December 11, 2017.                           this antibody has potential to be used in
                                                guidance, (2) developing the proposed                   Leslie Kux,                                           diagnostic kits for viral/bacterial
                                                draft guidance, and (3) submitting the                  Associate Commissioner for Policy.                    infections, cancers, and a variety of
                                                proposed draft guidance to FDA,                         [FR Doc. 2017–26978 Filed 12–13–17; 8:45 am]          other human diseases. DNA/RNA
                                                including the process and format. The                   BILLING CODE 4164–01–P                                hybrids arise during normal cellular
                                                Agency is seeking information and                                                                             function, but they are typically present
                                                comments from a broad range of                                                                                in cells at low levels. When DNA/RNA
                                                stakeholders, including patients, patient               DEPARTMENT OF HEALTH AND                              hybrids are found at high levels in a
                                                advocates, academic and medical                         HUMAN SERVICES                                        cell, it indicates that the cell is
                                                researchers, expert practitioners, drug                                                                       ‘‘abnormal’’. For example, the cell may
                                                developers, and other interested                        National Institutes of Health                         be cancerous or infected with a virus.
                                                persons. FDA will publish a background                                                                        NIH researchers have also incorporated
                                                document outlining the topic areas that                 Government-Owned Inventions;                          the antibody into a micro-array
                                                                                                        Availability for Licensing
sradovich on DSK3GMQ082PROD with NOTICES




                                                will be addressed in the draft guidance                                                                       platform, expanding its potential for use
                                                approximately 2 weeks before the                        AGENCY:    National Institutes of Health,             in diagnostic devices.
                                                workshop date at the following website:                 HHS.                                                     This technology is available for
                                                https://www.fda.gov/Drugs/NewsEvents/                   ACTION:   Notice.                                     licensing for commercial development
                                                ucm582081.htm.                                                                                                in accordance with 35 U.S.C. 209 and 37
                                                   After this public workshop, FDA will                 SUMMARY: The invention listed below is                CFR part 404, as well as for further
                                                take into consideration the stakeholder                 owned by an agency of the U.S.                        development and evaluation under a
                                                input from the workshop and the public                  Government and is available for                       research collaboration.


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Document Created: 2018-10-25 10:51:05
Document Modified: 2018-10-25 10:51:05
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; request for comments.
DatesThe public workshop will be held on March 19, 2018, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public workshop by May 18, 2018. See the SUPPLEMENTARY INFORMATION section for additional registration information.
ContactMeghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, [email protected]
FR Citation82 FR 58816 

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