80_FR_76741 80 FR 76505 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

80 FR 76505 - Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range76505-76506
FR Document2015-30970

Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015) 
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76505-76506]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Psychopharmacologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 12, 2016, from 8 
a.m. to 5 p.m.
    Location: 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.
    Contact Person: Jennifer Shepherd, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, [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.
    Agenda: The committee will discuss new drug application (NDA) 
204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl 
acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, 
Inc., on behalf of Titan Pharmaceuticals for the proposed indication of 
maintenance treatment of opioid dependence.
    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 
December 28, 2015. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 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 December 17, 2015. 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 December 18, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 76506]]

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 Jennifer Shepherd 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: December 3, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-30970 Filed 12-8-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76505 and Procedures; Fiscal Years 2013 III. Electronic Access modifications that impact a previously through 2017,’’ the Center for Drug Persons with access to the Internet announced advisory committee meeting Evaluation and Research (CDER) and the may obtain the draft guidance at http:// cannot always be published quickly Center for Biologics Evaluation and www.fda.gov/Drugs/Guidance enough to provide timely notice. Research (CBER) agreed to publish a ComplianceRegulatoryInformation/ Therefore, you should always check the joint guidance for industry and review Guidances/default.htm, http://www.fda. Agency’s Web site at http://www.fda. staff on best practices for gov/BiologicsBloodVaccines/Guidance gov/AdvisoryCommittees/default.htm communication between IND sponsors ComplianceRegulatoryInformation/ and scroll down to the appropriate and FDA during drug development. default.htm, or http:// advisory committee meeting link, or call To establish the best practices the advisory committee information line www.regulations.gov. described in this guidance, CDER and to learn about possible modifications CBER gathered the experiences of Dated: December 3, 2015. before coming to the meeting. review staff and incorporated input Peter Lurie, Agenda: The committee will discuss from interested parties who responded Associate Commissioner for Public Health new drug application (NDA) 204442, to a notice published in the Federal Strategy and Analysis. PROBUPHINE (buprenorphine Register (79 FR 64397; October 29, [FR Doc. 2015–30931 Filed 12–8–15; 8:45 am] hydrochloride and ethylene vinyl 2014) or who provided input directly to BILLING CODE 4164–01–P acetate) subdermal implant, submitted CDER’s Enhanced Communication by Braeburn Pharmaceuticals, Inc., on Team. behalf of Titan Pharmaceuticals for the This guidance describes FDA’s DEPARTMENT OF HEALTH AND proposed indication of maintenance philosophy regarding timely interactive HUMAN SERVICES treatment of opioid dependence. communication with IND sponsors as a FDA intends to make background core activity; the scope of appropriate Food and Drug Administration material available to the public no later interactions between the review team [Docket No. FDA–2015–N–0001] than 2 business days before the meeting. and the sponsor; the types of advice If FDA is unable to post the background appropriate for sponsors to seek from Psychopharmacologic Drugs Advisory material on its Web site prior to the FDA in pursuing their drug Committee; Notice of Meeting meeting, the background material will development program; the general AGENCY: Food and Drug Administration, be made publicly available at the expectations for the timing of FDA HHS. location of the advisory committee response to IND sponsor inquiries; best meeting, and the background material practices and communication methods ACTION: Notice. will be posted on FDA’s Web site after to facilitate interactions between the FDA review team and the IND sponsor This notice announces a forthcoming the meeting. Background material is during drug development; and meeting of a public advisory committee available at http://www.fda.gov/ expectations on appropriate methods of the Food and Drug Administration AdvisoryCommittees/Calendar/ and frequency of such communications. (FDA). The meeting will be open to the default.htm. Scroll down to the This guidance does not apply to public. appropriate advisory committee meeting communications or inquiries from Name of Committee: link. industry trade organizations, consumer Psychopharmacologic Drugs Advisory Procedure: Interested persons may or patient advocacy organizations, other Committee. present data, information, or views, government agencies, or other General Function of the Committee: orally or in writing, on issues pending stakeholders not pursuing a To provide advice and before the committee. Written development program under an IND. recommendations to the Agency on submissions may be made to the contact This draft guidance is being issued FDA’s regulatory issues. person on or before December 28, 2015. consistent with FDA’s good guidance Date and Time: The meeting will be Oral presentations from the public will practices regulation (21 CFR 10.115). held on January 12, 2016, from 8 a.m. be scheduled between approximately 1 The draft guidance, when finalized, will to 5 p.m. p.m. and 2 p.m. Those individuals represent the current thinking of FDA Location: FDA White Oak Campus, interested in making formal oral on best practices for communication 10903 New Hampshire Ave., Bldg. 31, presentations should notify the contact between IND sponsors and FDA during Conference Center, the Great Room (Rm. person and submit a brief statement of drug development. It does not establish 1503), Silver Spring, MD 20993–0002. the general nature of the evidence or any rights for any person and is not Answers to commonly asked questions arguments they wish to present, the binding on FDA or the public. You can including information regarding special names and addresses of proposed use an alternative approach if it satisfies accommodations due to a disability, participants, and an indication of the the requirements of the applicable visitor parking, and transportation may approximate time requested to make statutes and regulations. be accessed at: http://www.fda.gov/ their presentation on or before AdvisoryCommittees/AboutAdvisory December 17, 2015. Time allotted for II. The Paperwork Reduction Act of Committees/ucm408555.htm. each presentation may be limited. If the 1995 Contact Person: Jennifer Shepherd, number of registrants requesting to This guidance refers to previously Center for Drug Evaluation and speak is greater than can be reasonably approved collections of information that Research, Food and Drug accommodated during the scheduled open public hearing session, FDA may mstockstill on DSK4VPTVN1PROD with NOTICES are subject to review by the Office of Administration, 10903 New Hampshire Management and Budget (OMB) under Ave., Bldg. 31, Rm. 2417, Silver Spring, conduct a lottery to determine the the Paperwork Reduction Act of 1995 MD 20993–0002, 301–796–9001, FAX: speakers for the scheduled open public (44 U.S.C. 3501–3520). The collections 301–847–8533, PDAC@fda.hhs.gov, or hearing session. The contact person will of information in 21 CFR parts 312 and FDA Advisory Committee Information notify interested persons regarding their 314 have been approved under OMB Line, 1–800–741–8138 (301–443–0572 request to speak by December 18, 2015. control numbers 0910–0014 and 0910– in the Washington, DC area). A notice in Persons attending FDA’s advisory 0001, respectively. the Federal Register about last minute committee meetings are advised that the VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1

76506 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices Agency is not responsible for providing (FD&C) Act (21 U.S.C. 360bbb–3a and declaration to cover vaccines, antivirals, access to electrical outlets. 360bbb–3b); extend the effective time diagnostics and other devices used FDA welcomes the attendance of the period of the prior declarations; against pandemic influenza A viruses; public at its advisory committee reformat the declarations for antivirals (2) extending coverage to additional meetings and will make every effort to and for diagnostics and devices; modify antivirals and devices and to biologics accommodate persons with disabilities. or clarify terms of the declarations; and and other drugs; (3) updating the If you require accommodations due to a republish the prior declarations as a description of Covered Countermeasures disability, please contact Jennifer single declaration in its entirety, as to include those authorized for use Shepherd at least 7 days in advance of amended. under sections 564A and 564B of the the meeting. DATES: The amendment of the October Federal Food, Drug, and Cosmetic FDA is committed to the orderly (FD&C) Act; 2 (4) clarifying the disease 10, 2008, declaration as amended June conduct of its advisory committee threat and the description of pandemic 11, 2009, the December 17, 2008, meetings. Please visit our Web site at influenza A viruses and influenza A declaration and February 29, 2012, http://www.fda.gov/Advisory viruses with pandemic potential; (5) declaration is effective as of January 1, Committees/AboutAdvisoryCommittees/ changing the description of qualified 2016. ucm111462.htm for procedures on persons to include persons authorized public conduct during advisory FOR FURTHER INFORMATION CONTACT: to prescribe, administer, or dispense committee meetings. Nicole Lurie, MD, MSPH, Assistant Covered Countermeasures in accordance Notice of this meeting is given under Secretary for Preparedness and with Section 564A of the FD&C Act; (6) the Federal Advisory Committee Act (5 Response, Office of the Secretary, clarifying that liability immunity for U.S.C. app. 2). Department of Health and Human antivirals, diagnostics and other devices Services, 200 Independence Avenue extends to other transactions and to Dated: December 3, 2015. SW., Washington, DC 20201; Telephone activities related to any federal Jill Hartzler Warner, 202–205–2882. agreements including clinical trials Associate Commissioner for Special Medical SUPPLEMENTARY INFORMATION: Programs. agreements by adding the terms ‘‘other Background transactions’’ and ‘‘other federal [FR Doc. 2015–30970 Filed 12–8–15; 8:45 am] agreements’’ to the clause describing the BILLING CODE 4164–01–P The Public Readiness and Emergency types of federal agreements for which Preparedness Act (PREP Act) authorizes immunity is in effect; (7) deleting the Secretary of Health and Human references to specific federal contracts DEPARTMENT OF HEALTH AND Services (the Secretary) to issue a in the antivirals declaration to clarify HUMAN SERVICES declaration to provide liability that immunity is not limited to activities immunity to certain individuals and conducted under listed contracts; (8) Office of the Secretary entities (Covered Persons) against any clarifying that liability immunity Pandemic Influenza Medical claim of loss caused by, arising out of, extends to activities directly conducted Countermeasures—Amendment relating to, or resulting from the by the federal government by adding the administration or use of medical phrase ‘‘or directly conducted by the ACTION: Notice of Amendment to the countermeasures (Covered federal Government’’ to the section October 17, 2008, Declaration under the Countermeasures), except for claims describing methods of distribution for Public Readiness and Emergency that meet the PREP Act’s definition of which liability immunity is in effect; (9) Preparedness Act, as amended June 11, willful misconduct. The Secretary may, narrowing the definition of 2009; the December 22, 2008, though publication in the Federal ‘‘administration’’ in the antivirals Declaration under the Public Readiness Register, amend any portion of a declaration and in the diagnostics and and Emergency Preparedness Act, and declaration. Using this authority, the other devices declaration to cover ‘‘slip- the February 29, 2012, Declaration Secretary issued several declarations for and-fall’’ claims only to the extent they under the Public Readiness and countermeasures against pandemic are directly tied to the operation of a Emergency Preparedness Act. influenza: (1) An October 10, 2008, countermeasure program; (10) extending declaration covering the neuraminidase the time period for which liability SUMMARY: The Secretary is amending the class of antivirals Oseltamivir immunity is in effect for all of the declarations issued on October 10, 2008 Phosphate (e.g., Tamiflu) and Zanamivir Covered Countermeasures to December (73 FR 61861), as amended June 11, (e.g. Relenza) (hereinafter, ‘‘antivirals 31, 2022, and; (11) changing the 2009 (74 FR 29213); December 17, 2008 declaration’’); (2) a December 17, 2008, antivirals declaration and the (73 FR 78362); and February 29, 2012 declaration covering pandemic diagnostics and other devices (77 FR 13329), pursuant to section influenza diagnostics, personal declaration to the format used for the 319F–3 of the Public Health Service Act respiratory protection devices, and February 29, 2012, amendment to the (42 U.S.C. 247d–6d) to: Cover vaccines, respiratory support devices (hereinafter declaration for pandemic influenza. antivirals, diagnostics and devices used ‘‘diagnostics and other devices Other minor modifications and against pandemic influenza A viruses in declaration’’); and a February 29, 2012, clarifications are also made, as more a single declaration; extend coverage to amended declaration covering fully explained below. additional antivirals and devices and to pandemic influenza vaccines The vaccines, antivirals, and biologics and other drugs; simplify (hereinafter, ‘‘vaccines declaration’’) diagnostics and other devices mstockstill on DSK4VPTVN1PROD with NOTICES descriptions of covered diagnostics and and is amending these declarations.1 declarations are republished as a single devices; clarify the disease threat and The major actions taken by this pandemic influenza countermeasures description of pandemic influenza A amendment to the pandemic influenza declaration (hereinafter, ‘‘declaration’’) viruses and influenza A viruses with countermeasures declarations include in full. We explain the substantive and pandemic potential; include coverage the following: (1) Issuing a single format changes in this supplementary for countermeasures authorized for use section. under sections 564A and 564B of the 1 73 FR 61861, 73 FR 78362, 74 FR 29213, 77 FR Federal Food, Drug, and Cosmetic 13329. 2 21 U.S.C. 360bbb–3a and 360bbb–3b. VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1


Document Created: 2015-12-14 13:32:25
Document Modified: 2015-12-14 13:32:25
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.
FR Citation80 FR 76505 
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