Medical Devices-The Case for Quality, 9469 [2014-03584]

Download as PDF Federal Register / Vol. 79, No. 33 / Wednesday, February 19, 2014 / Notices DATES). For additional information about the purpose of the meeting, topics for discussion, and registration see the September 23, 2013, Federal Register notice. Dated: February 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03587 Filed 2–18–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Medical Devices—The Case for Quality AGENCY: Food and Drug Administration, HHS. EMCDONALD on DSK67QTVN1PROD with NOTICES ACTION: Notice of meeting. The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Office, in cosponsorship with the FDA Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public workshop entitled ‘‘Medical Devices—the Case for Quality.’’ The public workshop is intended to seek input from representatives of medical device manufacturers and other stakeholders on best practices, what has worked for them, and what FDA can do to inspire quality efforts. This event will also focus on various topics of interest for those industry representatives who are responsible to ensure compliance with FDA regulations. Date and Time: The meeting will be held on April 11, 2014 from 8 a.m. to 5 p.m. Location: The meeting will be held at Wyndham Dallas Suites-Park Central, 7800 Alpha Rd., Dallas, TX 75240. Directions and lodging information are available at the FMDIC, Inc. Web site at http:/www.fmdic.org/. Contact: C. Sue Thomason, Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204, 214–253–5203, FAX: 214–253– 5318, email: sue.thomason@fda.hhs.gov. Registration: FMDIC has early registration (industry $250, government with ID $150, student $50) available until March 11, 2014. Registration after March 11, 2014, increases to industry $300, government with ID $200, with student registration staying the same at $50. To register online, please visit https://www.fmdic.org/. As an alternative, send registration information including the registrant’s name, title, organization, address, VerDate Mar<15>2010 16:15 Feb 18, 2014 Jkt 232001 telephone and fax numbers, and email address (for each registrant), along with a check or money order (covering all registration fees) payable to FMDIC, Inc., to FMDIC Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX 75205. FMDIC, Inc. accepts registrations onsite on the day of the event beginning at 7:30 a.m. at the regular registration fee stated above. Registration onsite will be accepted on a space-available basis on the day of the public workshop beginning at 7:30 a.m. Please note that due to popularity, similar past events have reached maximum capacity well before the day of the event. The cost of registration at the site is $300 payable to FMDIC, Inc. The registration fee will be used to offset expenses of hosting the event, including continental breakfast, lunch, audiovisual equipment, venue, materials, and other logistics associated with this event. If you need special accommodations due to a disability, please contact C. Sue Thomason (see Contact) at least 7 days in advance. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. The workshop is being held in response to the interest in the topics discussed from small medical device manufacturers in the Dallas District area. This workshop helps achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This workshop is also consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), as an outreach activity by Government agencies to small businesses. The goal of the public workshop is to present information that will enable manufacturers and regulated industry to better comply with FDA’s medical device requirements. Please visit the www.fmdic.org Web site for the agenda and for information about the presenters at the workshop. SUPPLEMENTARY INFORMATION: Dated: February 12, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–03584 Filed 2–18–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 9469 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0157] Study Approaches and Methods To Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting; Public Meeting, Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post-Approval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing pregnancy registries and other methods of evaluating the post-approval safety profile of drugs and biological products in pregnant women. The input from this meeting and public docket will be used to support the revision of a guidance for industry on establishing pregnancy exposure registries. Dates and Times: The meeting will be held on May 28, 2014, from 8 a.m. to 5 p.m. and May 29, 2014, from 8:30 a.m. to 12:30 p.m. Location: The meeting 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 20993–0002. Participants must enter through Building 1 and undergo security screening. For parking and security information, please visit https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Please arrive early to ensure time for parking and security screening. Contact Persons: For meeting background and content: Vicki Moyer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–6148, FAX: 301–796–9855, vicki.moyer@fda.hhs.gov. For registration, oral presentations, special accommodations, and other meeting logistics: Cherice Holloway, Center for E:\FR\FM\19FEN1.SGM 19FEN1

Agencies

[Federal Register Volume 79, Number 33 (Wednesday, February 19, 2014)]
[Notices]
[Page 9469]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03584]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Medical Devices--The Case for Quality

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

    The Food and Drug Administration (FDA), Office of Regulatory 
Affairs, Southwest Regional Office, in cosponsorship with the FDA 
Medical Device Industry Coalition, Inc. (FMDIC), is announcing a public 
workshop entitled ``Medical Devices--the Case for Quality.'' The public 
workshop is intended to seek input from representatives of medical 
device manufacturers and other stakeholders on best practices, what has 
worked for them, and what FDA can do to inspire quality efforts. This 
event will also focus on various topics of interest for those industry 
representatives who are responsible to ensure compliance with FDA 
regulations.
    Date and Time: The meeting will be held on April 11, 2014 from 8 
a.m. to 5 p.m.
    Location: The meeting will be held at Wyndham Dallas Suites-Park 
Central, 7800 Alpha Rd., Dallas, TX 75240. Directions and lodging 
information are available at the FMDIC, Inc. Web site at http:/
www.fmdic.org/.
    Contact: C. Sue Thomason, Food and Drug Administration, 4040 N. 
Central Expressway, Suite 300, Dallas, TX 75204, 214-253-5203, FAX: 
214-253-5318, email: sue.thomason@fda.hhs.gov.
    Registration: FMDIC has early registration (industry $250, 
government with ID $150, student $50) available until March 11, 2014. 
Registration after March 11, 2014, increases to industry $300, 
government with ID $200, with student registration staying the same at 
$50. To register online, please visit https://www.fmdic.org/. As an 
alternative, send registration information including the registrant's 
name, title, organization, address, telephone and fax numbers, and 
email address (for each registrant), along with a check or money order 
(covering all registration fees) payable to FMDIC, Inc., to FMDIC 
Registrar, 4447 N. Central Expressway, Suite 110 PMB197, Dallas, TX 
75205.
    FMDIC, Inc. accepts registrations onsite on the day of the event 
beginning at 7:30 a.m. at the regular registration fee stated above. 
Registration onsite will be accepted on a space-available basis on the 
day of the public workshop beginning at 7:30 a.m. Please note that due 
to popularity, similar past events have reached maximum capacity well 
before the day of the event. The cost of registration at the site is 
$300 payable to FMDIC, Inc. The registration fee will be used to offset 
expenses of hosting the event, including continental breakfast, lunch, 
audiovisual equipment, venue, materials, and other logistics associated 
with this event.
    If you need special accommodations due to a disability, please 
contact C. Sue Thomason (see Contact) at least 7 days in advance.
    Transcripts: Transcripts of the public workshop will not be 
available due to the format of this workshop.

SUPPLEMENTARY INFORMATION: The workshop is being held in response to 
the interest in the topics discussed from small medical device 
manufacturers in the Dallas District area. This workshop helps achieve 
objectives set forth in section 406 of the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115) (21 U.S.C. 393), which 
include working closely with stakeholders and maximizing the 
availability and clarity of information to stakeholders and the public. 
This workshop is also consistent with the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as an outreach 
activity by Government agencies to small businesses.
    The goal of the public workshop is to present information that will 
enable manufacturers and regulated industry to better comply with FDA's 
medical device requirements. Please visit the www.fmdic.org Web site 
for the agenda and for information about the presenters at the 
workshop.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03584 Filed 2-18-14; 8:45 am]
BILLING CODE 4160-01-P

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