80 FR 78742 - The Twentieth Food and Drug Administration International Separation Science Society Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products-WCBP 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 242 (December 17, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 242 (December 17, 2015)
| Page Range | 78742-78743 | |
| FR Document | 2015-31691 |
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)] [Notices] [Pages 78742-78743] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-31691] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No.FDA-2015-N-0001] The Twentieth Food and Drug Administration International Separation Science Society Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products--WCBP 2016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the International Separation Science Society (CASSS), is announcing a meeting entitled ``The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products--WCBP 2016.'' The purpose of the meeting is to discuss development of biotechnology- derived drug products and analytic methodologies for the development of biotechnology-derived drug products. DATES: The meeting will be held January 26, 2016, from 8 a.m., until January 28, 2016, at 5 p.m. ADDRESSES: The meeting will be held at The Mayflower Hotel, 1127 Connecticut Ave. NW., Washington, DC FOR FURTHER INFORMATION CONTACT: Linda Mansouria, CASSS, 5900 Hollis St., Suite R3, Emeryville, CA 94608, 510-428-0740, FAX: 510-428-0741, [email protected]. SUPPLEMENTARY INFORMATION: I. Background CASSS is a scientific society providing forums for the dissemination of information and discussions among industry, academic and regulatory professionals founded on the development and applications of separation science. This cosponsored meeting provides state-of-the-art presentations on the technologies used to produce and assess product quality of biotechnology-derived drug products. II. Registration and Accommodations A. Registration There is a registration fee to attend this meeting. The registration fee is charged to help defray the costs of programming and facilities. Seats are limited, and registration will be on a first- come, first-served basis. To register, please complete registration online at http://www.casss.org/?WCBP1600. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The costs of registration for the different categories of attendees are as follows: ------------------------------------------------------------------------ Category Cost ------------------------------------------------------------------------ Industry Representatives.................. $1995 (early bird); $2395 (onsite). Academic.................................. $795 (early bird); $895 (onsite). Government................................ $795 (early bird); $895 (onsite). ------------------------------------------------------------------------ B. Accommodations Attendees are responsible for their own hotel accommodations. Attendees making reservations at the Mayflower Hotel in Washington DC are eligible for a reduced rate of $295 USD, not including applicable taxes. To receive the reduced rate, contact the Mayflower [[Page 78743]] Hotel (1-877-212-5752) and identify yourself as an attendee of ``CASSS--WCBP 2016.'' If you need special accommodations due to a disability, please contact Linda Mansouria (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. III. Transcripts We expect that transcripts will be available approximately 30 days after the meeting. A transcript will be available in either hard copy or on CD-ROM, after submission of a Freedom of Information request. Send written requests to the Division of Freedom of Information (ELEM- 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Send faxed requests to 301-827-9267. Dated: December 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-31691 Filed 12-16-15; 8:45 am] BILLING CODE 4164-01-P
![78742 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
establishment to be removed from II. References Analytical Sciences for Biotechnology
FDA’s routine inspection work plan for The following references are on Health Products—WCBP 2016.’’ The
1 year from the last day of the ISO display in the Division of Dockets purpose of the meeting is to discuss
13485:2003 audit. The voluntary Management (HFA–305), Food and Drug development of biotechnology-derived
submitted ISO 13485:2003 audit report Administration, 5630 Fishers Lane, Rm. drug products and analytic
provides FDA some information on the 1061, Rockville, MD 20852 and are methodologies for the development of
conformance of the manufacturer with available for viewing by interested biotechnology-derived drug products.
basic and fundamental quality persons between 9 a.m. and 4 p.m., DATES: The meeting will be held January
management system requirements for Monday through Friday; they are also 26, 2016, from 8 a.m., until January 28,
medical devices. available electronically at http:// 2016, at 5 p.m.
In 2012, FDA started working on the www.regulations.gov. FDA has verified ADDRESSES: The meeting will be held at
MDSAP with other global regulators the Web site addresses, as of the date The Mayflower Hotel, 1127 Connecticut
within the International Medical Device this document publishes in the Federal Ave. NW., Washington, DC
Regulators Forum (IMDRF) for purposes Register, but Web sites are subject to FOR FURTHER INFORMATION CONTACT:
of leveraging work performed for other change over time. Linda Mansouria, CASSS, 5900 Hollis
medical device regulators to meet its 1. FDA Guidance, Guidance for Industry, St., Suite R3, Emeryville, CA 94608,
inspection obligations. On November Third Parties and Food and Drug 510–428–0740, FAX: 510–428–0741,
15, 2013 (78 FR 68853), FDA announced Administration Staff: Medical Device ISO lmansouria@casss.org.
its participation within the MDSAP 13485:2003 Voluntary Audit Report Pilot SUPPLEMENTARY INFORMATION:
Program, available at http://www.fda.gov/
consortium’s pilot program, which is downloads/MedicalDevices/ I. Background
effective January 1, 2014, through DeviceRegulationandGuidance/
December 31, 2016. CASSS is a scientific society
GuidanceDocuments/UCM212798.pdf.
2. Medical Device Single Audit Program providing forums for the dissemination
After review of the MDSAP Mid-Pilot of information and discussions among
(MDSAP) Mid-Pilot Status Report, January
Report, which published in August 2015 industry, academic and regulatory
2014–December 2016, available http://
(Ref. 2), FDA announced that it will www.fda.gov/downloads/MedicalDevices/ professionals founded on the
participate with the other MDSAP InternationalPrograms/MDSAPPilot/ development and applications of
Consortium regulators from Australia, UCM461661.pdf. separation science. This cosponsored
Brazil, Canada, and Japan in the 3. Medical Device Single Audit Program meeting provides state-of-the-art
implementation of the operational phase (MDSAP) Pilot, available at http://
presentations on the technologies used
of the program starting January 1, 2017. www.fda.gov/MedicalDevices/
InternationalPrograms/MDSAPPilot/. to produce and assess product quality of
The MDSAP program provides FDA 4. Health Canada’s transition strategy from biotechnology-derived drug products.
better assurances than the ISO CMDCAS to MDSAP, available at http://
13485:2003 Voluntary Audit Report II. Registration and Accommodations
www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/
Submission Pilot because FDA’s index-eng.php. A. Registration
requirements under 21 CFR 820 or other Dated: December 8, 2015. There is a registration fee to attend
FDA regulations typically covered this meeting. The registration fee is
Leslie Kux,
during FDA inspections are charged to help defray the costs of
Associate Commissioner for Policy.
encompassed within the MDSAP audit programming and facilities. Seats are
[FR Doc. 2015–31692 Filed 12–16–15; 8:45 am]
model. limited, and registration will be on a
BILLING CODE 4164–01–P
On January 1, 2017, MDSAP will first-come, first-served basis.
become fully operational to include To register, please complete
opening applications for additional DEPARTMENT OF HEALTH AND registration online at http://
auditing organizations beyond the HUMAN SERVICES www.casss.org/?WCBP1600. (FDA has
limited eligible auditing organizations verified the Web address, but FDA is not
within the pilot phase. Each regulator Food and Drug Administration responsible for subsequent changes to
within the consortium has committed to the Web site after this document
[Docket No.FDA–2015–N–0001]
continuing to utilize the MDSAP audits publishes in the Federal Register.) The
during the pilot as well as during the The Twentieth Food and Drug costs of registration for the different
operational phase as described in the Administration International categories of attendees are as follows:
MDSAP public announcements posted Separation Science Society
on FDA’s Web page (Ref. 3). Symposium on the Interface of Category Cost
Also, Health Canada in a recent Regulatory and Analytical Sciences for Industry Rep- $1995 (early bird);
announcement laid out the timeframe Biotechnology Health Products— resentatives. $2395 (onsite).
for which they will terminate their WCBP 2016 Academic ........... $795 (early bird);
Canadian Medical Device Conformity $895 (onsite).
AGENCY: Food and Drug Administration, Government ....... $795 (early bird);
Assessment System (CMDCAS) program HHS.
and utilize MDSAP as the means by $895 (onsite).
ACTION: Notice of meeting.
which manufacturers will obtain a
asabaliauskas on DSK5VPTVN1PROD with NOTICES
medical device license for distribution SUMMARY: The Food and Drug B. Accommodations
of medical devices in Canada (Ref. 4). Administration’s (FDA) Center for Drug Attendees are responsible for their
As a result of the implementation of the Evaluation and Research, in own hotel accommodations. Attendees
MDSAP program, FDA will no longer cosponsorship with the International making reservations at the Mayflower
accept ISO 13485:2003 Voluntary Audit Separation Science Society (CASSS), is Hotel in Washington DC are eligible for
Report Submissions after March 31, announcing a meeting entitled ‘‘The a reduced rate of $295 USD, not
2016, to assist transitioning Twentieth FDA CASSS Symposium on including applicable taxes. To receive
manufacturers over to MDSAP. the Interface of Regulatory and the reduced rate, contact the Mayflower
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![Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78743
Hotel (1–877–212–5752) and identify 10.115(g)(5)), to ensure that the Agency submitted as ‘‘Confidential
yourself as an attendee of ‘‘CASSS— considers your comment on this draft Submissions,’’ publicly viewable at
WCBP 2016.’’ If you need special guidance before it begins work on the http://www.regulations.gov or at the
accommodations due to a disability, final version of the guidance, submit Division of Dockets Management
please contact Linda Mansouria (see FOR either electronic or written comments between 9 a.m. and 4 p.m., Monday
FURTHER INFORMATION CONTACT) at least 7 on the draft guidance by February 16, through Friday.
days in advance. 2016. Submit comments on the • Confidential Submissions—To
information collection issues under the submit a comment with confidential
III. Transcripts Paperwork Reduction Act of 1995 by information that you do not wish to be
We expect that transcripts will be February 16, 2016. made publicly available, submit your
available approximately 30 days after ADDRESSES: You may submit comments comments only as a written/paper
the meeting. A transcript will be as follows: submission. You should submit two
available in either hard copy or on CD– copies total. One copy will include the
ROM, after submission of a Freedom of Electronic Submissions information you claim to be confidential
Information request. Send written Submit electronic comments in the with a heading or cover note that states
requests to the Division of Freedom of following way: ‘‘THIS DOCUMENT CONTAINS
Information (ELEM–1029), Food and • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Drug Administration, 12420 Parklawn www.regulations.gov. Follow the Agency will review this copy, including
Dr., Element Bldg., Rockville, MD instructions for submitting comments. the claimed confidential information, in
20857. Send faxed requests to 301–827– Comments submitted electronically, its consideration of comments. The
9267. including attachments, to http:// second copy, which will have the
www.regulations.gov will be posted to claimed confidential information
Dated: December 11, 2015.
the docket unchanged. Because your redacted/blacked out, will be available
Leslie Kux, for public viewing and posted on http://
comment will be made public, you are
Associate Commissioner for Policy. solely responsible for ensuring that your www.regulations.gov. Submit both
[FR Doc. 2015–31691 Filed 12–16–15; 8:45 am] comment does not include any copies to the Division of Dockets
BILLING CODE 4164–01–P confidential information that you or a Management. If you do not wish your
third party may not wish to be posted, name and contact information to be
such as medical information, your or made publicly available, you can
DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or provide this information on the cover
HUMAN SERVICES confidential business information, such sheet and not in the body of your
as a manufacturing process. Please note comments and you must identify this
Food and Drug Administration information as ‘‘confidential.’’ Any
that if you include your name, contact
[Docket No. FDA–2015–D–4562] information, or other information that information marked as ‘‘confidential’’
identifies you in the body of your will not be disclosed except in
Safety Assessment for Investigational comments, that information will be accordance with 21 CFR 10.20 and other
New Drug Application Safety posted on http://www.regulations.gov. applicable disclosure law. For more
Reporting; Draft Guidance for Industry; • If you want to submit a comment information about FDA’s posting of
Availability with confidential information that you comments to public dockets, see 80 FR
do not wish to be made available to the 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration,
public, submit the comment as a the information at: http://www.fda.gov/
HHS. regulatoryinformation/dockets/
written/paper submission and in the
ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper default.htm.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
SUMMARY: The Food and Drug read background documents or the
Administration (FDA, we, or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing the availability of a draft Submit written/paper submissions as received, go to http://
guidance for industry entitled ‘‘Safety follows: www.regulations.gov and insert the
Assessment for IND Safety Reporting.’’ • Mail/Hand delivery/Courier (for docket number, found in brackets in the
The draft guidance provides written/paper submissions): Division of heading of this document, into the
recommendations to sponsors on Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts
developing a systematic approach to and Drug Administration, 5630 Fishers and/or go to the Division of Dockets
investigational new drug application Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm.
(IND) safety reporting for human drugs • For written/paper comments 1061, Rockville, MD 20852.
and biological products developed submitted to the Division of Dockets Submit comments on information
under an IND. This draft guidance is a Management, FDA will post your collection issues to the Office of
follow-on to the guidance for industry comment, as well as any attachments, Management and Budget in the
and investigators entitled ‘‘Safety except for information submitted, following ways:
Reporting Requirements for INDs and marked and identified, as confidential, • Fax to the Office of Information and
BA/BE Studies’’ that provides if submitted as detailed in Regulatory Affairs, OMB, Attn: FDA
recommendations for how sponsors of ‘‘Instructions.’’ Desk Officer, FAX: 202–395–7285, or
asabaliauskas on DSK5VPTVN1PROD with NOTICES
INDs can identify and evaluate Instructions: All submissions received email to oira_submission@omb.eop.gov.
important safety information that must must include the Docket No. FDA– All comments should be identified with
be submitted to FDA and all 2015–D–4562 for ‘‘Safety Assessment the title ‘‘Safety Assessment for IND
participating investigators, including a for Investigational New Drug Safety Reporting.’’
recommendation that sponsors develop Application Safety Reporting; Draft Submit written requests for single
a safety assessment committee. Guidance for Industry; Availability.’’ copies of the draft guidance to the
DATES: Although you can comment on Received comments will be placed in Division of Drug Information, Center for
any guidance at any time (see 21 CFR the docket and, except for those Drug Evaluation and Research, Food
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Document Created: 2018-03-02 09:18:31
Document Modified: 2018-03-02 09:18:31
| 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 meeting. | |
| Dates | The meeting will be held January 26, 2016, from 8 a.m., until January 28, 2016, at 5 p.m. | |
| Contact | Linda Mansouria, CASSS, 5900 Hollis St., Suite R3, Emeryville, CA 94608, 510-428-0740, FAX: 510-428-0741, [email protected] | |
| FR Citation | 80 FR 78742 |
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