81_FR_59803 81 FR 59635 - FDA Small Business and Industry Assistance Regulatory Education for Industry Fall Conference

81 FR 59635 - FDA Small Business and Industry Assistance Regulatory Education for Industry Fall Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 168 (August 30, 2016)

Page Range59635-59636
FR Document2016-20764

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) are sponsoring a 2 day conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Fall Conference.'' The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. However, anyone involved in the pharmaceutical and/device industry may attend.

Federal Register, Volume 81 Issue 168 (Tuesday, August 30, 2016) 
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59635-59636]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


FDA Small Business and Industry Assistance Regulatory Education 
for Industry Fall Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conference.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) and the Center for Devices and 
Radiological Health (CDRH) are sponsoring a 2 day conference entitled 
``FDA Small Business and Industry Assistance Regulatory Education for 
Industry (REdI) Fall Conference.'' The goal of this conference is to 
provide direct, relevant, and helpful information on the key aspects of 
drug and device regulations. Our primary audience is that of small 
manufacturers of drug and/or device medical products who want to learn 
about how FDA approaches the regulation of drugs and devices. However, 
anyone involved in the pharmaceutical and/device industry may attend.

DATES: The public conference will be held on September 27 and 28, 2016, 
from 8:15 a.m. to 4:15 p.m. See the SUPPLEMENTARY INFORMATION section 
for registration information.

ADDRESSES: The public conference will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Cypress and Magnolia Ballrooms (4th 
floor), Silver Spring, MD 20910.

FOR FURTHER INFORMATION CONTACT: Brenda Stodart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, 
[email protected]; or Elias Mallis, Center for Devices and 
Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-7100, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public conference entitled ``FDA Small Business 
and Industry Assistance Regulatory Education for Industry (REdI) Fall 
Conference.'' This conference is intended to increase the drug and 
device industry's awareness of applicable FDA regulations. There will 
be an opportunity for questions and answers following each 
presentation.

[[Page 59636]]

II. Topics for Discussion at the Conference

     CDER: Manufacturing Process Validation; Interactions with 
FDA; Emerging Technology and Inspection for New Drug Applications and 
Biologic License Applications.
     CDRH: 510(k); De Novo; Design Controls; and Complaints.
    Registration: There is no fee to attend the public conference. 
Space is limited, and registration will be on a first-come, first-
served basis. To register, please complete registration at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm514324.htm.
    If you need special accommodations due to disability, please 
contact [email protected] at least 7 days in advance.
    Streaming Webcast of the Conference: This public conference will 
also be Webcast. Persons interested in viewing the Webcast must 
register to receive a confirmation email with the Webcast link.
    Transcripts: Transcripts will not be available.

    Dated: August 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20764 Filed 8-29-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices 59635 Biological Products Advisory available at http://www.fda.gov/ DEPARTMENT OF HEALTH AND Committee. The general function of the AdvisoryCommittees/Calendar/ HUMAN SERVICES committee is to provide advice and default.htm. Scroll down to the recommendations to the Agency on appropriate advisory committee meeting Food and Drug Administration FDA’s regulatory issues. The meeting link. [Docket No. FDA–2016–N–0001] will be open to the public. Procedure: Interested persons may DATES: The meeting will be held on FDA Small Business and Industry present data, information, or views, November 16, 2016, from 8:30 a.m. to Assistance Regulatory Education for orally or in writing, on issues pending 2:30 p.m. Industry Fall Conference before the committee. Written ADDRESSES: FDA White Oak Campus, submissions may be made to the contact AGENCY: Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31 person on or before November 1, 2016. HHS. Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993–0002. Oral presentations from the public will ACTION: Notice of conference. Answers to commonly asked questions be scheduled between approximately 12:15 p.m. to 1:15 p.m. Those SUMMARY: The Food and Drug including information regarding special Administration’s (FDA) Center for Drug accommodations due to a disability, individuals interested in making formal oral presentations should notify the Evaluation and Research (CDER) and the visitor parking, and transportation may Center for Devices and Radiological be accessed at: http://www.fda.gov/ contact person and submit a brief statement of the general nature of the Health (CDRH) are sponsoring a 2 day AdvisoryCommittees/ conference entitled ‘‘FDA Small AboutAdvisoryCommittees/ evidence or arguments they wish to Business and Industry Assistance ucm408555.htm. For those unable to present, the names and addresses of Regulatory Education for Industry attend in person, the meeting will also proposed participants, and an (REdI) Fall Conference.’’ The goal of this be Webcast and will be available at the indication of the approximate time conference is to provide direct, relevant, following link: https:// requested to make their presentation on and helpful information on the key collaboration.fda.gov/vrbac1116/. or before October 24, 2016. Time aspects of drug and device regulations. FOR FURTHER INFORMATION CONTACT: allotted for each presentation may be Our primary audience is that of small Sujata Vijh or Rosanna Harvey, Center limited. If the number of registrants manufacturers of drug and/or device for Biologics Evaluation and Research, requesting to speak is greater than can medical products who want to learn Food and Drug Administration, 10903 be reasonably accommodated during the about how FDA approaches the New Hampshire Ave., Bldg. 71, Rm. scheduled open public hearing session, regulation of drugs and devices. 6128, Silver Spring, MD 20993–0002, at FDA may conduct a lottery to determine However, anyone involved in the 240–402–7107, sujata.vijh@fda.hhs.gov the speakers for the scheduled open pharmaceutical and/device industry and 240–402–8072, rosanna.harvey@ may attend. public hearing session. The contact fda.hhs.gov, or FDA Advisory person will notify interested persons DATES: The public conference will be Committee Information Line, 1–800– 741–8138 (301–443–0572 in the regarding their request to speak by held on September 27 and 28, 2016, Washington, DC area). A notice in the October 25, 2016. from 8:15 a.m. to 4:15 p.m. See the Federal Register about last minute Persons attending FDA’s advisory SUPPLEMENTARY INFORMATION section for modifications that impact a previously committee meetings are advised that the registration information. announced advisory committee meeting Agency is not responsible for providing ADDRESSES: The public conference will cannot always be published quickly access to electrical outlets. be held at the Sheraton Silver Spring enough to provide timely notice. Hotel, 8777 Georgia Ave., Cypress and FDA welcomes the attendance of the Magnolia Ballrooms (4th floor), Silver Therefore, you should always check the public at its advisory committee Agency’s Web site at http:// Spring, MD 20910. meetings and will make every effort to www.fda.gov/AdvisoryCommittees/ FOR FURTHER INFORMATION CONTACT: accommodate persons with disabilities. Brenda Stodart, Center for Drug default.htm and scroll down to the If you require accommodations due to a Evaluation and Research, Food and appropriate advisory committee meeting link, or call the advisory committee disability, please contact Sujata Vijh at Drug Administration, 10001 New information line to learn about possible least 7 days in advance of the meeting. Hampshire Ave., Silver Spring, MD modifications before coming to the FDA is committed to the orderly 20993–0002, 301–796–6707, cdersbia@ meeting. conduct of its advisory committee fda.hhs.gov; or Elias Mallis, Center for SUPPLEMENTARY INFORMATION: meetings. Please visit our Web site at Devices and Radiological Health, 10903 Agenda: On November 16, 2016, the http://www.fda.gov/ New Hampshire Ave., Silver Spring, MD committee will meet in open session to AdvisoryCommittees/ 20993–0002, 301–796–7100, DICE@ discuss and make recommendations on AboutAdvisoryCommittees/ fda.hhs.gov. the safety and efficacy of a Hepatitis B ucm111462.htm for procedures on SUPPLEMENTARY INFORMATION: Vaccine manufactured by Dynavax. public conduct during advisory FDA intends to make background I. Background committee meetings. material available to the public no later Notice of this meeting is given under FDA is announcing a public than 2 business days before the meeting. conference entitled ‘‘FDA Small the Federal Advisory Committee Act (5 If FDA is unable to post the background Business and Industry Assistance mstockstill on DSK3G9T082PROD with NOTICES U.S.C. app. 2). material on its Web site prior to the Regulatory Education for Industry meeting, the background material will Dated: August 23, 2016. (REdI) Fall Conference.’’ This be made publicly available at the Leslie Kux, conference is intended to increase the location of the advisory committee Associate Commissioner for Policy. drug and device industry’s awareness of meeting, and the background material [FR Doc. 2016–20763 Filed 8–29–16; 8:45 am] applicable FDA regulations. There will will be posted on FDA’s Web site after be an opportunity for questions and BILLING CODE 4164–01–P the meeting. Background material is answers following each presentation. VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1

59636 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices II. Topics for Discussion at the collection provisions of our regulations the docket and, except for those Conference mandating the application of hazard submitted as ‘‘Confidential • CDER: Manufacturing Process analysis and critical control point Submissions,’’ publicly viewable at Validation; Interactions with FDA; (HACCP) principles to the processing of http://www.regulations.gov or at the Emerging Technology and Inspection for fruit and vegetable juices. Division of Dockets Management New Drug Applications and Biologic DATES: Submit either electronic or between 9 a.m. and 4 p.m., Monday License Applications. written comments on the collection of through Friday. • CDRH: 510(k); De Novo; Design information by October 31, 2016. • Confidential Submissions—To Controls; and Complaints. submit a comment with confidential ADDRESSES: You may submit comments Registration: There is no fee to attend information that you do not wish to be as follows: the public conference. Space is limited, made publicly available, submit your and registration will be on a first-come, Electronic Submissions comments only as a written/paper first-served basis. To register, please Submit electronic comments in the submission. You should submit two complete registration at: http://www.fda. following way: copies total. One copy will include the gov/Drugs/DevelopmentApproval • Federal eRulemaking Portal: http:// information you claim to be confidential Process/SmallBusinessAssistance/ www.regulations.gov. Follow the with a heading or cover note that states ucm514324.htm. instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS If you need special accommodations Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ The due to disability, please contact info@ including attachments, to http:// Agency will review this copy, including sbiaevents.com at least 7 days in www.regulations.gov will be posted to the claimed confidential information, in advance. the docket unchanged. Because your its consideration of comments. The Streaming Webcast of the Conference: comment will be made public, you are second copy, which will have the This public conference will also be solely responsible for ensuring that your claimed confidential information Webcast. Persons interested in viewing comment does not include any redacted/blacked out, will be available the Webcast must register to receive a confidential information that you or a for public viewing and posted on http:// confirmation email with the Webcast third party may not wish to be posted, www.regulations.gov. Submit both link. such as medical information, your or copies to the Division of Dockets Transcripts: Transcripts will not be anyone else’s Social Security number, or Management. If you do not wish your available. confidential business information, such name and contact information to be as a manufacturing process. Please note made publicly available, you can Dated: August 23, 2016. that if you include your name, contact provide this information on the cover Leslie Kux, sheet and not in the body of your Associate Commissioner for Policy. information, or other information that identifies you in the body of your comments and you must identify this [FR Doc. 2016–20764 Filed 8–29–16; 8:45 am] information as ‘‘confidential.’’ Any comments, that information will be BILLING CODE 4164–01–P posted on http://www.regulations.gov. information marked as ‘‘confidential’’ • If you want to submit a comment will not be disclosed except in with confidential information that you accordance with 21 CFR 10.20 and other DEPARTMENT OF HEALTH AND applicable disclosure law. For more HUMAN SERVICES do not wish to be made available to the public, submit the comment as a information about FDA’s posting of written/paper submission and in the comments to public dockets, see 80 FR Food and Drug Administration 56469, September 18, 2015, or access manner detailed (see ‘‘Written/Paper [Docket No. FDA–2013–N–1427] Submissions’’ and ‘‘Instructions’’). the information at: http://www.fda.gov/ regulatoryinformation/dockets/ Agency Information Collection Written/Paper Submissions default.htm. Activities; Proposed Collection; Submit written/paper submissions as Docket: For access to the docket to Comment Request; Hazard Analysis follows: read background documents or the and Critical Control Point Procedures • Mail/Hand delivery/Courier (for electronic and written/paper comments for the Safe and Sanitary Processing written/paper submissions): Division of received, go to http:// and Importing of Juice Dockets Management (HFA–305), Food www.regulations.gov and insert the AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers docket number, found in brackets in the HHS. Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the • For written/paper comments ‘‘Search’’ box and follow the prompts ACTION: Notice. and/or go to the Division of Dockets submitted to the Division of Dockets SUMMARY: The Food and Drug Management, FDA will post your Management, 5630 Fishers Lane, Rm. Administration (FDA or we) is comment, as well as any attachments, 1061, Rockville, MD 20852. announcing an opportunity for public except for information submitted, FOR FURTHER INFORMATION CONTACT: FDA comment on the proposed collection of marked and identified, as confidential, PRA Staff, Office of Operations, Food certain information by the Agency. if submitted as detailed in and Drug Administration, Three White Under the Paperwork Reduction Act of ‘‘Instructions.’’ Flint North, 10A63, 11601 Landsdown 1995 (the PRA), Federal Agencies are Instructions: All submissions received St., North Bethesda, MD 20852, required to publish notice in the must include the Docket No. FDA– PRAStaff@fda.hhs.gov. mstockstill on DSK3G9T082PROD with NOTICES Federal Register concerning each 2013–N–1427 for ‘‘Agency Information SUPPLEMENTARY INFORMATION: Under the proposed collection of information, Collection Activities; Proposed PRA (44 U.S.C. 3501–3520), Federal including each proposed extension of an Collection; Comment Request; Hazard Agencies must obtain approval from the existing collection of information, and Analysis and Critical Control Point Office of Management and Budget to allow 60 days for public comment in Procedures for the Safe and Sanitary (OMB) for each collection of response to the notice. This notice Processing and Importing of Juice.’’ information they conduct or sponsor. solicits comments on the information Received comments will be placed in ‘‘Collection of information’’ is defined VerDate Sep<11>2014 20:04 Aug 29, 2016 Jkt 238001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\30AUN1.SGM 30AUN1


Document Created: 2018-02-09 11:42:25
Document Modified: 2018-02-09 11:42:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of conference.
DatesThe public conference will be held on September 27 and 28, 2016, from 8:15 a.m. to 4:15 p.m. See the SUPPLEMENTARY INFORMATION section for registration information.
ContactBrenda Stodart, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6707, [email protected]; or Elias Mallis, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 301-796-7100, [email protected]
FR Citation81 FR 59635 
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