42100 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

contact information for each attendee, 

including name, title, affiliation, 

address, email, and telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by midnight Eastern Time on 

September 25, 2017. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

If you need special accommodations 

due to a disability, please contact 

Juanita Yates (see FOR FURTHER

INFORMATION CONTACT) no later than 

September 18, 2017. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations and request time for a 

joint presentation. All requests to make 

oral presentations must be received by 

September 18, 2017. We will determine 

the amount of time allotted to each 

presenter and will select and notify 

participants by September 25, 2017. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Please visit the following 

Web site to register: https://

www.fda.gov/Food/NewsEvents/ 

WorkshopsMeetingsConferences/ 

default.htm. 

FDA has verified the Web site 

addresses, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

Internet at https://www.fda.gov/Food/ 

DietarySupplements/default.htm. 

Dated: August 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–18812 Filed 9–5–17; 8:45 am] 

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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. 

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 ‘‘PatientFocused 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, PASERARE-DISEASES@fda.hhs.gov 

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 


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