81 FR 2219 - Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 10 (January 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 10 (January 15, 2016)
| Page Range | 2219-2219 | |
| FR Document | 2016-00694 |
[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)] [Notices] [Page 2219] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00694] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``Navigating CDER: What You Should Know for Effective Engagement.'' The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. DATES: The public workshop will be held on March 31, 2016, from 8:30 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 (The Great Room A, B, and C), 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 http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Shawn Brooks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6509, email: [email protected]. SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop entitled ``Navigating CDER: What You Should Know for Effective Engagement.'' This public workshop is intended to enhance the public and advocacy groups' ability to effectively engage FDA's CDER. The presentations are intended to provide information on how best to interact with CDER. 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 workshop must register online at http://www.fda.gov/Drugs/NewsEvents/ucm472604.htm before March 24, 2016. For those without Internet access, please contact Shawn Brooks (see FOR FURTHER INFORMATION CONTACT) to register. If you need special accommodations due to a disability, please contact Shawn Brooks (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Transcripts: A transcript of the workshop will be available for review at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet at http://www.regulations.gov approximately 30 days after the 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 http://www.fda.gov. Dated: January 8, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00694 Filed 1-14-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices 2219
ACTION: Notice. ACTION: Notice of public workshop. the Division of Dockets Management
(HFA–305), Food and Drug
SUMMARY: The Administration for SUMMARY: The Food and Drug Administration, 5630 Fishers Lane, Rm.
Community Living (ACL) is announcing Administrations (FDA) Center for Drug 1061, Rockville, MD 20852, and on the
that the proposed collection of Evaluation and Research (CDER), is Internet at http://www.regulations.gov
information listed below has been sponsoring a public workshop entitled approximately 30 days after the
submitted to the Office of Management ‘‘Navigating CDER: What You Should workshop. Transcripts will also be
and Budget (OMB) for review and Know for Effective Engagement.’’ The available in either hard copy or on CD–
clearance under the Paperwork purpose of this public workshop is to ROM, after submission of a Freedom of
Reduction Act of 1995. help the public and patient advocacy Information request. The Freedom of
DATES: Submit written comments on the groups gain a better understanding of Information office address is available
collection of information by February how to effectively engage CDER. on the Agency’s Web site at http://
16, 2016. DATES: The public workshop will be www.fda.gov.
ADDRESSES: Submit written comments held on March 31, 2016, from 8:30 a.m.
Dated: January 8, 2016.
on the collection of information by to 5 p.m.
Leslie Kux,
email to OIRA_submission@ ADDRESSES: The public workshop will
Associate Commissioner for Policy.
omb.eop.gov Attn: OMB Desk Officer for be held at FDA’s White Oak campus,
ACL, or by fax 202–395–6974, Office of 10903 New Hampshire Ave., Building [FR Doc. 2016–00694 Filed 1–14–16; 8:45 am]
Information and Regulatory Affairs, 31 (The Great Room A, B, and C), Silver BILLING CODE 4164–01–P
OMB. Spring, MD 20993. Entrance for the
FOR FURTHER INFORMATION CONTACT: Lori public workshop participants (non-FDA
employees) is through Building 1 where DEPARTMENT OF HEALTH AND
Stalbaum at (202) 357–3452, or HUMAN SERVICES
lori.stalbaum@acl.hhs.gov. routine security check procedures will
be performed. For parking and security Food and Drug Administration
SUPPLEMENTARY INFORMATION: In
information, please refer to http://
compliance with 44 U.S.C. 3507, ACL [Docket No. FDA–2016–N–0001]
www.fda.gov/AboutFDA/Workingat
has submitted the following proposed
FDA/BuildingsandFacilities/White
collection of information to OMB for Advisory Committee: Vaccines and
OakCampusInformation/
review and clearance. Related Biological Products Advisory
ucm241740.htm.
Describe Collection of Information Committee, Renewal
FOR FURTHER INFORMATION CONTACT:
ACL is requesting to continue an Shawn Brooks, Center for Drug AGENCY: Food and Drug Administration,
existing approved collection of Evaluation and Research, Food and HHS.
information for semi-annual and final Drug Administration, 10903 New ACTION:Notice; renewal of advisory
reports pursuant to the requirements of Hampshire Ave., Silver Spring, MD committee.
its discretionary grant programs. ACL 20993–0002, 240–402–6509, email:
estimates the burden of this collection NAV-CDER@fda.hhs.gov. SUMMARY: The Food and Drug
of information as follows: Frequency: Administration (FDA) is announcing the
SUPPLEMENTARY INFORMATION: FDA is
Semi-annually with the Final report renewal of the Vaccines and Related
announcing a public workshop entitled
taking the place of the semi-annual Biological Products Advisory
‘‘Navigating CDER: What You Should
report at the end of the final year of the Committee by the Commissioner of
Know for Effective Engagement.’’ This
grant. Respondents: States, public Food and Drugs (the Commissioner).
public workshop is intended to enhance
agencies, private nonprofit agencies, The Commissioner has determined that
the public and advocacy groups’ ability
institutions of higher education, and it is in the public interest to renew the
to effectively engage FDA’s CDER. The
organizations including tribal Vaccines and Related Biological
presentations are intended to provide
organizations. Estimated Number of Products Advisory Committee for an
information on how best to interact with
Responses: 600. Total Estimated Burden additional 2 years beyond the charter
CDER. There will be an opportunity for
Hours: 12,000. expiration date. The new charter will be
questions and answers following each
in effect until December 31, 2017.
Dated: January 12, 2016. presentation.
Registration: There is no registration DATES: Authority for the Vaccines and
Kathy Greenlee, Related Biological Products Advisory
Administrator and Assistant Secretary for fee to attend the public workshop. Early
registration is recommended because Committee will expire on December 31,
Aging. 2017, unless the Commissioner formally
[FR Doc. 2016–00762 Filed 1–14–16; 8:45 am]
seating is limited, and registration will
be on a first-come, first-served basis. determines that renewal is in the public
BILLING CODE 4154–01–P
There will be no onsite registration. interest.
Persons interested in attending this FOR FURTHER INFORMATION CONTACT:
workshop must register online at http:// Sujata Vijh, Division of Scientific
DEPARTMENT OF HEALTH AND Advisors and Consultants, Center for
HUMAN SERVICES www.fda.gov/Drugs/NewsEvents/
ucm472604.htm before March 24, 2016. Biologics Evaluation and Research,
Food and Drug Administration For those without Internet access, please Food and Drug Administration, 10903
contact Shawn Brooks (see FOR FURTHER New Hampshire Ave., Bldg. 71, Rm.
[Docket No. FDA–2015–N–0001] 6128, Silver Spring, MD 20993–0002,
mstockstill on DSK4VPTVN1PROD with NOTICES
INFORMATION CONTACT) to register.
If you need special accommodations 240–402–7107, Sujata.vijh@fda.hhs.gov.
Navigating the Center for Drug
due to a disability, please contact SUPPLEMENTARY INFORMATION: Pursuant
Evaluation and Research: What You
Shawn Brooks (see FOR FURTHER to 41 CFR 102–3.65 and approval by the
Should Know for Effective
INFORMATION CONTACT) at least 7 days in Department of Health and Human
Engagement; Public Workshop
advance. Services pursuant to 45 CFR part 11 and
AGENCY: Food and Drug Administration, Transcripts: A transcript of the by the General Services Administration,
HHS. workshop will be available for review at FDA is announcing the renewal of the
VerDate Sep<11>2014 20:01 Jan 14, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\15JAN1.SGM 15JAN1](https://thefederalregister.org/doc/81_FR_2229/page/1.svg)
Document Created: 2018-02-02 12:31:51
Document Modified: 2018-02-02 12:31:51
| 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 March 31, 2016, from 8:30 a.m. to 5 p.m. | |
| Contact | Shawn Brooks, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6509, email: NAV- [email protected] | |
| FR Citation | 81 FR 2219 |
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