82_FR_42271 82 FR 42100 - Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development

82 FR 42100 - Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 171 (September 6, 2017)

Page Range42100-42100
FR Document2017-18810

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.'' This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the ``Patient-Focused Drug Development'' provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.

Federal Register, Volume 82 Issue 171 (Wednesday, September 6, 2017) 
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Page 42100]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Food and Drug Administration, Center for Drug Evaluation and 
Research Rare Diseases Public Workshop: Strategies, Tools, and Best 
Practices for Effective Advocacy in Rare Diseases Drug Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER), is sponsoring a public workshop 
entitled ``CDER Rare Diseases Public Workshop: Strategies, Tools, and 
Best Practices for Effective Advocacy in Rare Diseases Drug 
Development.'' This public workshop builds upon previous CDER patient 
advocacy public workshops and is primarily for the rare disease 
community to help them effectively understand what FDA needs to enhance 
drug development. This effort is consistent with FDA's efforts to 
support the integration of patient experience in drug development 
programs, including through implementation of the ``Patient-Focused 
Drug Development'' provisions of the 21st Century Cures Act (Cures 
Act). This public workshop will include case studies demonstrating the 
beneficial overlap of effective advocacy techniques and FDA regulations 
in rare disease drug development.

DATES: The public workshop will be held on October 30, 2017, from 8 
a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 (the Great Room), 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.

FOR FURTHER INFORMATION CONTACT: Francis Kalush, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5429, [email protected]

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled 
``CDER Rare Diseases Public Workshop: Strategies, Tools, and Best 
Practices for Effective Advocacy in Rare Diseases Drug Development.'' 
The purpose of the public workshop, consistent with FDA's broad effort 
to more comprehensively include patients' perspectives and experiences 
with a disease or condition in the drug development process, including 
through implementation of the ``Patient-Focused Drug Development'' 
provisions of the Cures Act, is to aid in bridging the gap between rare 
disease patients' stories and data needed to support drug development. 
This public workshop will include presentations on strategies, tools, 
and best practices on key aspects of rare diseases drug development and 
engaging with FDA. There will be an opportunity for questions and 
answers following each presentation.
    Registration: There is no registration fee to attend the public 
workshop. Early registration is recommended because seating is limited, 
and registration will be on a first-come, first-served basis. There 
will be no onsite registration. Persons interested in attending this 
public workshop must register online at https://www.fda.gov/Drugs/NewsEvents/ucm565398.htm before September 30, 2017. For those without 
internet access, please contact Francis Kalush (see FOR FURTHER 
INFORMATION CONTACT) to register.
    If you need special accommodations due to a disability, please 
contact Francis Kalush (see FOR FURTHER INFORMATION CONTACT) no later 
than October 23, 2017.
    Transcripts: A transcript of the public workshop will be available 
for review at the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
on the internet at https://www.regulations.gov approximately 30 days 
after the public workshop. Transcripts will also be available in either 
hard copy or on CD-ROM, after submission of a Freedom of Information 
request. The Freedom of Information office address is available on the 
Agency's Web site at https://www.fda.gov.

    Dated: August 30, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18810 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P

42100 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices contact information for each attendee, DEPARTMENT OF HEALTH AND ‘‘CDER Rare Diseases Public Workshop: including name, title, affiliation, HUMAN SERVICES Strategies, Tools, and Best Practices for address, email, and telephone. Effective Advocacy in Rare Diseases Food and Drug Administration Drug Development.’’ The purpose of the Registration is free and based on space availability, with priority given to [Docket No. FDA–2017–N–0001] public workshop, consistent with FDA’s early registrants. Persons interested in broad effort to more comprehensively attending this public meeting must Food and Drug Administration, Center include patients’ perspectives and register by midnight Eastern Time on for Drug Evaluation and Research Rare experiences with a disease or condition Diseases Public Workshop: Strategies, in the drug development process, September 25, 2017. Early registration is Tools, and Best Practices for Effective including through implementation of recommended because seating is Advocacy in Rare Diseases Drug the ‘‘Patient-Focused Drug limited; therefore, FDA may limit the Development Development’’ provisions of the Cures number of participants from each organization. Registrants will receive AGENCY: Food and Drug Administration, Act, is to aid in bridging the gap confirmation when they have been HHS. between rare disease patients’ stories accepted. ACTION: Notice of public workshop. and data needed to support drug development. This public workshop If you need special accommodations SUMMARY: The Food and Drug will include presentations on strategies, due to a disability, please contact Administration (FDA), Center for Drug tools, and best practices on key aspects Juanita Yates (see FOR FURTHER Evaluation and Research (CDER), is of rare diseases drug development and INFORMATION CONTACT) no later than sponsoring a public workshop entitled engaging with FDA. There will be an September 18, 2017. ‘‘CDER Rare Diseases Public Workshop: opportunity for questions and answers Requests for Oral Presentations: Strategies, Tools, and Best Practices for following each presentation. During online registration you may Effective Advocacy in Rare Diseases Drug Development.’’ This public Registration: There is no registration indicate if you wish to present during a workshop builds upon previous CDER fee to attend the public workshop. Early public comment session and which patient advocacy public workshops and registration is recommended because topic(s) you wish to address. We will do is primarily for the rare disease seating is limited, and registration will our best to accommodate requests to community to help them effectively be on a first-come, first-served basis. make public comments. Individuals and understand what FDA needs to enhance There will be no onsite registration. organizations with common interests are drug development. This effort is Persons interested in attending this urged to consolidate or coordinate their consistent with FDA’s efforts to support public workshop must register online at presentations and request time for a the integration of patient experience in https://www.fda.gov/Drugs/NewsEvents/ joint presentation. All requests to make drug development programs, including ucm565398.htm before September 30, oral presentations must be received by through implementation of the ‘‘Patient- 2017. For those without internet access, September 18, 2017. We will determine Focused Drug Development’’ provisions please contact Francis Kalush (see FOR the amount of time allotted to each of the 21st Century Cures Act (Cures FURTHER INFORMATION CONTACT) to presenter and will select and notify Act). This public workshop will include register. participants by September 25, 2017. case studies demonstrating the If you need special accommodations Streaming Webcast of the Public beneficial overlap of effective advocacy techniques and FDA regulations in rare due to a disability, please contact Meeting: This public meeting will also disease drug development. Francis Kalush (see FOR FURTHER be webcast. Please visit the following INFORMATION CONTACT) no later than Web site to register: https:// DATES: The public workshop will be held on October 30, 2017, from 8 a.m. October 23, 2017. www.fda.gov/Food/NewsEvents/ WorkshopsMeetingsConferences/ to 5 p.m. Transcripts: A transcript of the public default.htm. ADDRESSES: The public workshop will workshop will be available for review at be held at FDA White Oak Campus, the Dockets Management Staff (HFA– FDA has verified the Web site 10903 New Hampshire Ave., Bldg. 31 305), Food and Drug Administration, addresses, as of the date this document (the Great Room), Silver Spring, MD 5630 Fishers Lane, Rm. 1061, Rockville, publishes in the Federal Register, but 20993. Entrance for the public MD 20852, and on the internet at Web sites are subject to change over workshop participants (non-FDA https://www.regulations.gov time. employees) is through Building 1 where approximately 30 days after the public Transcripts: Please be advised that as routine security check procedures will workshop. Transcripts will also be soon as a transcript of the public be performed. For parking and security available in either hard copy or on CD– meeting is available, it will be accessible information, please refer to https:// ROM, after submission of a Freedom of at https://www.regulations.gov. It may www.fda.gov/AboutFDA/ Information request. The Freedom of be viewed at the Dockets Management WorkingatFDA/BuildingsandFacilities/ Information office address is available Staff (see ADDRESSES). A link to the WhiteOakCampusInformation/ on the Agency’s Web site at https:// transcript will also be available on the ucm241740.htm. www.fda.gov. Internet at https://www.fda.gov/Food/ FOR FURTHER INFORMATION CONTACT: asabaliauskas on DSKBBXCHB2PROD with NOTICES Dated: August 30, 2017. DietarySupplements/default.htm. Francis Kalush, Center for Drug Anna K. Abram, Dated: August 28, 2017. Evaluation and Research, Food and Drug Administration, 10903 New Deputy Commissioner for Policy, Planning, Anna K. Abram, Legislation, and Analysis. Hampshire Ave., Silver Spring, MD Deputy Commissioner for Policy, Planning, 20993–0002, 301–796–5429, PASE- [FR Doc. 2017–18810 Filed 9–5–17; 8:45 am] Legislation, and Analysis. RARE-DISEASES@fda.hhs.gov BILLING CODE 4164–01–P [FR Doc. 2017–18812 Filed 9–5–17; 8:45 am] SUPPLEMENTARY INFORMATION: FDA is BILLING CODE 4164–01–P announcing a public workshop entitled VerDate Sep<11>2014 17:37 Sep 05, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\06SEN1.SGM 06SEN1


Document Created: 2017-09-06 00:56:31
Document Modified: 2017-09-06 00:56:31
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.
DatesThe public workshop will be held on October 30, 2017, from 8 a.m. to 5 p.m.
ContactFrancis Kalush, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5429, PASE-RARE- [email protected]
FR Citation82 FR 42100 
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