83 FR 8280 - Center for Drug Evaluation and Research and You: Keys to Effective Engagement; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 38 (February 26, 2018)

Page Range		8280-8281
FR Document		2018-03805

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the following public workshop entitled ``CDER and You: Keys to Effective Engagement.'' The purpose of the public workshop is to build upon previous efforts to help advocates understand how they can engage with FDA to enhance drug development and safety. This marks the third annual CDER public workshop for patient advocacy groups.

Federal Register, Volume 83 Issue 38 (Monday, February 26, 2018)

[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8280-8281]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Center for Drug Evaluation and Research and You: Keys to 
Effective Engagement; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing the following public 
workshop entitled ``CDER and You: Keys to Effective Engagement.'' The 
purpose of the public workshop is to build upon previous efforts to 
help advocates understand how they can engage with FDA to enhance drug 
development and safety. This marks the third annual CDER public 
workshop for patient advocacy groups.

DATES: The public workshop will be held on April 3, 2018, from 8 a.m. 
to 3 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20903. 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: Chris Melton, Center for Drug 
Evaluation and Research, Food and

[[Page 8281]]

Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7381, NAV-CDER@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA's CDER is announcing a public workshop entitled, ``CDER and 
You: Keys to Effective Engagement.'' This workshop is intended to help 
the public learn effective ways for engaging with CDER. There will be 
educational presentations about the drug approval process, an 
interactive panel featuring patient advocates who will offer engagement 
guidance, as well as an opportunity for questions and answers following 
many of the presentations. Finally, presenters will highlight 
innovative new procedures for requesting a meeting with CDER staff.

II. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop 
must register online at https://www.fda.gov/Drugs/NewsEvents/ucm592902.htm by 6 p.m. Eastern Time, Tuesday, March 20, 2018. Please 
provide complete 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. 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 time and space permit, onsite registration on 
the day of the public workshop will be provided beginning at 8 a.m. We 
will let registrants know if registration closes before the day of the 
public meeting/public workshop.
    If you need special accommodations due to a disability, please 
contact Chris Melton no later than March 26, 2018 (See FOR FURTHER 
INFORMATION CONTACT.)
    Streaming webcast of the public workshop: This public workshop will 
also be available via webcast at https://collaboration.fda.gov/cdereffectiveengagement/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852, approximately 30 days after the workshop. A link 
to the transcript will also be available on the internet at https://www.fda.gov/Drugs/NewsEvents/ucm472604.htm.

    Dated: February 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03805 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P

8280 Federal Register / Vol. 83, No. 38 / Monday, February 26, 2018 / Notices

4th Floor, Silver Spring, MD 20993– Ministry of Health, Labour, and Welfare; II. Electronic Access
0002, or the Office of Communication, the Japanese Pharmaceutical Persons with access to the internet
Outreach and Development, Center for Manufacturers Association; and the may obtain the document at https://
Biologics Evaluation and Research Pharmaceutical Research and www.regulations.gov, https://
(CBER), Food and Drug Administration, Manufacturers of America. The www.fda.gov/Drugs/
10903 New Hampshire Ave., Bldg. 71, Standing Members of the ICH GuidanceCompliance
Rm. 3128, Silver Spring, MD 20993– Association include Health Canada and RegulatoryInformation/Guidances/
0002. Send one self-addressed adhesive Swissmedic. Any party eligible as a default.htm, or https://www.fda.gov/
label to assist that office in processing Member in accordance with the ICH BiologicsBloodVaccines/
your requests. The guidance may also be Articles of Association can apply for GuidanceCompliance
obtained by mail by calling CBER at 1– membership in writing to the ICH RegulatoryInformation/Guidances/
800–835–4709 or 240–402–8010. See Secretariat. The ICH Secretariat, which default.htm.
the SUPPLEMENTARY INFORMATION section coordinates the preparation of
for electronic access to the guidance documentation, operates as an Dated: February 20, 2018.
document. international nonprofit organization and Leslie Kux,
is funded by the Members of the ICH Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Stephen Association. [FR Doc. 2018–03809 Filed 2–23–18; 8:45 am]
Miller, Center for Drug Evaluation and The ICH Assembly is the overarching BILLING CODE 4164–01–P

Research, Food and Drug body of the Association and includes
Administration, 10903 New Hampshire representatives from each of the ICH
Ave., Bldg. 22, Rm. 1446, Silver Spring, members and observers. The Assembly DEPARTMENT OF HEALTH AND
MD 20993–0002, 301–796–1418, or is responsible for the endorsement of HUMAN SERVICES
Stephen Ripley, Center for Biologics draft guidelines and adoption of final
guidelines. FDA publishes ICH Food and Drug Administration
Evaluation and Research, Food and
Drug Administration, 10903 New guidelines as FDA guidances. [Docket No. FDA–2018–N–0001]
Hampshire Ave., Bldg. 71, Rm. 7301, In the Federal Register of February
Silver Spring, MD 20993–0002, 240– 21, 2017 (82 FR 11225), FDA published Center for Drug Evaluation and
402–7911. a notice announcing the availability of Research and You: Keys to Effective
Regarding the ICH: Amanda Roache, a draft guidance entitled ‘‘Q11 Engagement; Public Workshop
Center for Drug Evaluation and Development and Manufacture of Drug
AGENCY: Food and Drug Administration,
Research, Food and Drug Substances—Questions and Answers
HHS.
Administration, 10903 New Hampshire (Regarding the Selection and
Justification of Starting Materials).’’ The ACTION: Notice of public workshop.
Ave., Bldg. 51, Rm. 1176, Silver Spring,
MD 20993–0002, 301–796–4548. notice gave interested persons an SUMMARY: The Food and Drug
SUPPLEMENTARY INFORMATION: opportunity to submit comments by Administration’s (FDA) Center for Drug
March 23, 2017. Evaluation and Research (CDER) is
I. Background After consideration of the comments announcing the following public
In recent years, regulatory authorities received and revisions to the guideline, workshop entitled ‘‘CDER and You:
and industry associations from around a final draft of the guideline was Keys to Effective Engagement.’’ The
the world have participated in many submitted to the ICH Assembly and purpose of the public workshop is to
important initiatives to promote endorsed by the regulatory agencies in build upon previous efforts to help
international harmonization of August 2017. advocates understand how they can
regulatory requirements under the ICH. The guidance consists of questions engage with FDA to enhance drug
FDA has participated in several ICH and answers that were developed to development and safety. This marks the
meetings designed to enhance clarify the principles for selecting third annual CDER public workshop for
harmonization and FDA is committed to starting materials described in the ICH patient advocacy groups.
seeking scientifically based harmonized guidance ‘‘Q11 Development and
DATES: The public workshop will be
technical procedures for pharmaceutical Manufacture of Drug Substances,’’
held on April 3, 2018, from 8 a.m. to 3
development. One of the goals of published November 20, 2012 (77 FR
p.m.
harmonization is to identify and reduce 69634). The guidance provides guidance
on selecting and justifying starting ADDRESSES: The public workshop will
differences in technical requirements for
drug development among regulatory materials, in particular for the synthesis be held at the FDA White Oak Campus,
agencies. of chemical entity drug substances. 10903 New Hampshire Ave., Bldg. 31
ICH was established to provide an This guidance is being issued Conference Center, the Great Room (Rm.
opportunity for harmonization consistent with FDA’s good guidance 1503), Silver Spring, MD 20903.
initiatives to be developed with input practices regulation (21 CFR 10.115). Entrance for the public workshop
from both regulatory and industry The guidance represents the current participants (non-FDA employees) is
representatives. FDA also seeks input thinking of FDA on ‘‘Q11 Development through Building 1 where routine
from consumer representatives and and Manufacture of Drug Substances— security check procedures will be
others. ICH is concerned with Questions and Answers (Chemical performed. For parking and security
harmonization of technical Entities and Biotechnological/Biological information, please refer to https://
daltland on DSKBBV9HB2PROD with NOTICES

requirements for the registration of Entities).’’ It does not establish any www.fda.gov/AboutFDA/
pharmaceutical products for human use rights for any person and is not binding WorkingatFDA/BuildingsandFacilities/
among regulators around the world. The on FDA or the public. You can use an WhiteOakCampusInformation/
six founding members of the ICH are the alternative approach if it satisfies the ucm241740.htm.
European Commission; the European requirements of the applicable statutes FOR FURTHER INFORMATION CONTACT:
Federation of Pharmaceutical Industries and regulations. This guidance is not Chris Melton, Center for Drug
Associations; the FDA; the Japanese subject to Executive Order 12866. Evaluation and Research, Food and

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Document Created: 2018-02-24 01:00:45
Document Modified: 2018-02-24 01:00:45

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
Dates		The public workshop will be held on April 3, 2018, from 8 a.m. to 3 p.m.
Contact		Chris Melton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 301-796-7381, [email protected]
FR Citation		83 FR 8280

83 FR 8280 - Center for Drug Evaluation and Research and You: Keys to Effective Engagement; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 38 (February 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration