Navigating the Center for Drug Evaluation and Research: What You Should Know for Effective Engagement; Public Workshop, 2219 [2016-00694]

Download as PDF Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices ACTION: Notice. ACTION: The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments on the collection of information by February 16, 2016. ADDRESSES: Submit written comments on the collection of information by email to OIRA_submission@ omb.eop.gov Attn: OMB Desk Officer for ACL, or by fax 202–395–6974, Office of Information and Regulatory Affairs, OMB. FOR FURTHER INFORMATION CONTACT: Lori Stalbaum at (202) 357–3452, or lori.stalbaum@acl.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Describe Collection of Information ACL is requesting to continue an existing approved collection of information for semi-annual and final reports pursuant to the requirements of its discretionary grant programs. ACL estimates the burden of this collection of information as follows: Frequency: Semi-annually with the Final report taking the place of the semi-annual report at the end of the final year of the grant. Respondents: States, public agencies, private nonprofit agencies, institutions of higher education, and organizations including tribal organizations. Estimated Number of Responses: 600. Total Estimated Burden Hours: 12,000. Dated: January 12, 2016. Kathy Greenlee, Administrator and Assistant Secretary for Aging. [FR Doc. 2016–00762 Filed 1–14–16; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 20:01 Jan 14, 2016 Jkt 238001 Notice of public workshop. 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/Workingat FDA/BuildingsandFacilities/White OakCampusInformation/ 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: NAV-CDER@fda.hhs.gov. 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 SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 2219 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Advisory Committee: Vaccines and Related Biological Products Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. Notice; renewal of advisory committee. ACTION: The Food and Drug Administration (FDA) is announcing the renewal of the Vaccines and Related Biological Products Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Vaccines and Related Biological Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 31, 2017. DATES: Authority for the Vaccines and Related Biological Products Advisory Committee will expire on December 31, 2017, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, 240–402–7107, Sujata.vijh@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the SUMMARY: E:\FR\FM\15JAN1.SGM 15JAN1

Agencies

[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Page 2219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: NAV-CDER@fda.hhs.gov.

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