81 FR 59634 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 168 (August 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 168 (August 30, 2016)
| Page Range | 59634-59635 | |
| FR Document | 2016-20763 |
[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)] [Notices] [Pages 59634-59635] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20763] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related [[Page 59635]] Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on November 16, 2016, from 8:30 a.m. to 2:30 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993- 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. For those unable to attend in person, the meeting will also be Webcast and will be available at the following link: https://collaboration.fda.gov/vrbac1116/. FOR FURTHER INFORMATION CONTACT: Sujata Vijh or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993- 0002, at 240-402-7107, [email protected] and 240-402-8072, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On November 16, 2016, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 1, 2016. Oral presentations from the public will be scheduled between approximately 12:15 p.m. to 1:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 24, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 25, 2016. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Sujata Vijh at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: August 23, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20763 Filed 8-29-16; 8:45 am] BILLING CODE 4164-01-P
![59634 Federal Register / Vol. 81, No. 168 / Tuesday, August 30, 2016 / Notices
• If you want to submit a comment 56469, September 18, 2015, or access and May 2015, we issued revised draft
with confidential information that you the information at: http://www.fda.gov/ guidances on the same subject. We are
do not wish to be made available to the regulatoryinformation/dockets/default. now issuing another revision of the draft
public, submit the comment as a htm. guidance for industry on BE
written/paper submission and in the Docket: For access to the docket to recommendations for generic
manner detailed (see ‘‘Written/Paper read background documents or the risperidone injection (Draft Guidance on
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments Risperidone).
received, go to http:// In February 2011, Johnson & Johnson
Written/Paper Submissions Pharmaceutical Research and
www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the Development, LLC, manufacturer of
follows: heading of this document, into the RISPERDAL CONSTA LONG-ACTING
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts INJECTION, the reference listed drug,
written/paper submissions): Division of and/or go to the Division of Dockets submitted a citizen petition requesting
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm. that FDA require that any ANDA
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852. referencing RISPERDAL CONSTA
Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single LONG-ACTING INJECTION meet certain
• For written/paper comments copies of the draft guidance to the requirements, including requirements
submitted to the Division of Dockets Division of Drug Information, Center for related to demonstrating BE (Docket No.
Management, FDA will post your Drug Evaluation and Research, Food FDA–2011–P–0086). FDA is reviewing
comment, as well as any attachments, the issues raised in the petition. FDA
and Drug Administration, 10001 New
except for information submitted, will consider any comments on the
Hampshire Ave., Hillandale Building,
marked and identified, as confidential, revised draft BE recommendations in
4th Floor, Silver Spring, MD 20993–
if submitted as detailed in responding to the petition.
0002. Send one self-addressed adhesive
‘‘Instructions.’’ This draft guidance is being issued
Instructions: All submissions received label to assist that office in processing
your requests. See the SUPPLEMENTARY consistent with FDA’s good guidance
must include the Docket No. FDA– practices regulation (21 CFR 10.115).
INFORMATION section for electronic
2007–D–0369 for ‘‘Bioequivalence The draft guidance, when finalized, will
Recommendations for Risperidone; access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
represent the current thinking of FDA
Draft Guidance for Industry.’’ Received on the design of BE studies to support
comments will be placed in the docket Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600), ANDAs for risperidone injection. It does
and, except for those submitted as not establish any rights for any person
‘‘Confidential Submissions,’’ will be Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. is not binding on FDA or the public.
publicly viewable at http:// You can use an alternative approach if
www.regulations.gov or at the Division 4730, Silver Spring, MD 20993–0002,
301–796–5850. it satisfies the requirements of the
of Dockets Management between 9 a.m. applicable statutes and regulations.
and 4 p.m., Monday through Friday. SUPPLEMENTARY INFORMATION:
• Confidential Submissions—To II. Electronic Access
submit a comment with confidential I. Background
Persons with access to the Internet
information that you do not wish to be In the Federal Register of June 11, may obtain the draft guidance at either
made publicly available, submit your 2010 (75 FR 33311), FDA announced the http://www.fda.gov/Drugs/
comments only as a written/paper availability of a guidance for industry GuidanceCompliance
submission. You should submit two entitled ‘‘Bioequivalence RegulatoryInformation/Guidances/
copies total. One copy will include the Recommendations for Specific default.htm or http://
information you claim to be confidential Products,’’ which explained the process www.regulations.gov.
with a heading or cover note that states that would be used to make product-
Dated: August 25, 2016.
‘‘THIS DOCUMENT CONTAINS specific BE recommendations available
CONFIDENTIAL INFORMATION.’’ The to the public on FDA’s Web site at Leslie Kux,
Agency will review this copy, including http://www.fda.gov/Drugs/ Associate Commissioner for Policy.
the claimed confidential information, in GuidanceCompliance [FR Doc. 2016–20778 Filed 8–29–16; 8:45 am]
its consideration of comments. The RegulatoryInformation/Guidances/ BILLING CODE 4164–01–P
second copy, which will have the default.htm. As described in that
claimed confidential information guidance, FDA adopted this process to
redacted/blacked out, will be available develop and disseminate product- DEPARTMENT OF HEALTH AND
for public viewing and posted on http:// specific BE recommendations and to HUMAN SERVICES
www.regulations.gov. Submit both provide a meaningful opportunity for
Food and Drug Administration
copies to the Division of Dockets the public to consider and comment on
Management. If you do not wish your those recommendations. This notice [Docket No. FDA–2016–N–0001]
name and contact information to be announces the availability of draft BE
made publicly available, you can recommendations for generic Vaccines and Related Biological
provide this information on the cover risperidone injection. Products Advisory Committee; Notice
sheet and not in the body of your FDA initially approved new drug of Meeting
comments and you must identify this application 021346 for RISPERDAL
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration,
information as ‘‘confidential.’’ Any CONSTA (risperidone) LONG-ACTING HHS.
information marked as ‘‘confidential’’ INJECTION in October 2003. Currently, ACTION: Notice.
will not be disclosed except in there are no approved ANDAs for this
accordance with 21 CFR 10.20 and other product. In February 2010, FDA issued SUMMARY: The Food and Drug
applicable disclosure law. For more a draft guidance for industry on BE Administration (FDA) announces a
information about FDA’s posting of recommendations for generic forthcoming public advisory committee
comments to public dockets, see 80 FR risperidone injection. In August 2013 meeting of the Vaccines and Related
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![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.
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Document Created: 2018-02-09 11:42:31
Document Modified: 2018-02-09 11:42:31
| 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. | |
| Dates | The meeting will be held on November 16, 2016, from 8:30 a.m. to 2:30 p.m. | |
| Contact | Sujata Vijh or Rosanna Harvey, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993- 0002, at 240-402-7107, [email protected] and 240-402-8072, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 81 FR 59634 |
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