81 FR 49224 - 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 144 (July 27, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 144 (July 27, 2016)
| Page Range | 49224-49225 | |
| FR Document | 2016-17729 |
[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)] [Notices] [Pages 49224-49225] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17729] ----------------------------------------------------------------------- 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 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 to attend in person at the FDA White Oak campus in Silver Spring, MD. Members will participate via teleconference. DATES: The meeting will be held on October 13, 2016, from 1 p.m. to 4:30 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/vrbpac101316/. 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 [[Page 49225]] link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On October 13, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season. 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 October 3, 2016. Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 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 September 23, 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 September 26, 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: July 21, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs. [FR Doc. 2016-17729 Filed 7-26-16; 8:45 am] BILLING CODE 4164-01-P
![49224 Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
B. The Division of Strategy, Policy, Office of Workforce Planning and DEPARTMENT OF HEALTH AND
and Governance responsibilities include Development (KPD) HUMAN SERVICES
strategy, policy, and IT governance, Office of Grants Management (KPG)
including performance measurement Food and Drug Administration
and innovation. Provides governance Grants Management Regional Units
(KPGDI–X) [Docket No. FDA–2016–N–0001]
and oversight of centralized enterprise-
wide IT functions, including enterprise Office of Diversity Management and Vaccines and Related Biological
architecture, creation and maintenance Equal Employment Opportunity Products Advisory Committee; Notice
of the technology roadmap. (KPH) of Meeting
C. The Division of Security, Privacy,
and Risk Management provides security, V. Under Chapter KP, Office of the AGENCY: Food and Drug Administration,
privacy, and risk management, Deputy Assistant Secretary for HHS.
including business continuity, Administration, Delete KP.20 Functions, ACTION: Notice.
standardization and oversight of Paragraph B, Office of Information
business processes, external SUMMARY: The Food and Drug
Systems, in its entirety.
compliance, and security strategy and Administration (FDA) announces a
VI. Under Chapter KN, Office of forthcoming public advisory committee
management. The OCIO will identify
the appropriate continuing education Communications, delete KN.20, meeting of the Vaccines and Related
for staff in the domain of records Functions, Paragraph C, in its entirety Biological Products Advisory
management, IT security and privacy, and replace with the following: Committee. The general function of the
and incident response protocols. Division of Digital Information is committee is to provide advice and
D. The Division of Infrastructure, Data responsible for the content of ACF’s recommendations to the Agency on
and Web Services provides service public-facing digital presence. It also FDA’s regulatory issues. The meeting
planning and architecture, program and coordinates printing services for ACF. will be open to the public to attend in
project management, portfolio The division conducts preparation and person at the FDA White Oak campus in
management, applications management, clearance of ACF communications Silver Spring, MD. Members will
development and maintenance, and IT participate via teleconference.
associated with web content,
infrastructure and operations, including audiovisual products, digital DATES: The meeting will be held on
data services, big data analytics, and publications and graphic designs, but October 13, 2016, from 1 p.m. to 4:30
business intelligence. does not include planning, budgeting, p.m.
III. Under KP, Office of the Deputy ADDRESSES: FDA White Oak Campus,
Assistant Secretary for Administration, and oversight of the Web site
maintenance and support contract. It 10903 New Hampshire Ave., Bldg. 31
delete KP.00 Mission in its entirety and Conference Center, the Great Room (Rm.
replace with: provides guidance and support to
program offices related to web content, 1503), Silver Spring, MD 20993–0002.
KP.00 MISSION. The Deputy
social media, print publications, audio- Answers to commonly asked questions
Assistant Secretary for Administration
visual materials, and digital information including information regarding special
serves as principal advisor to the
and communication activities. accommodations due to a disability,
Assistant Secretary for Children and
visitor parking, and transportation may
Families on all aspects of personnel VII. Delegation of Authority. Pending be accessed at: http://www.fda.gov/
administration and management; further redelegation, directives, or AdvisoryCommittees/
financial management activities; grants orders made by the Assistant Secretary AboutAdvisoryCommittees/
policy and overseeing the issuance of for Children and Families or Deputy ucm408555.htm. For those unable to
grants; acquisition advisory services; the Assistant Secretary for Administration, attend in person, the meeting will also
ethics program; staff development and all delegations and redelegations of be Webcast and will be available at the
training activities; organizational authority made to officials and following link: https://
development and organizational
employees of affected organizational collaboration.fda.gov/vrbpac101316/.
analysis; administrative services; and
components will continue in them or FOR FURTHER INFORMATION CONTACT:
facilities management. The Deputy
Assistant Secretary for Administration their successors pending further Sujata Vijh or Rosanna Harvey, Center
oversees the Diversity Management and redelegations, provided they are for Biologics Evaluation and Research,
Equal Employment Opportunity consistent with this reorganization. Food and Drug Administration, 10903
program and all administrative special VIII. Funds, Personnel, and New Hampshire Ave., Bldg. 71, Rm.
initiative activities for ACF. Equipment. Transfer of organizations 6128, Silver Spring, MD 20993–0002, at
IV. Under Chapter KP, Office of the and functions affected by this 240–402–7107, sujata.vijh@fda.hhs.gov
Deputy Assistant Secretary for reorganization shall be accompanied in and 240–402–8072, rosanna.harvey@
Administration, delete KP.10 fda.hhs.gov, or FDA Advisory
each instance by direct and support
Organization in its entirety and replace Committee Information Line, 1–800–
funds, positions, personnel, records,
with: 741–8138 (301–443–0572 in the
equipment, supplies, and other
KP.10 ORGANIZATION. The Office of Washington, DC area). A notice in the
resources. Federal Register about last minute
the Deputy Assistant Secretary for
Administration is headed by the Deputy Dated: July 21, 2016. modifications that impact a previously
announced advisory committee meeting
sradovich on DSK3GMQ082PROD with NOTICES
Assistant Secretary who reports to the Mark H. Greenberg,
Assistant Secretary for Children and Acting Assistant Secretary for Children and cannot always be published quickly
Families. The Office is organized as Families. enough to provide timely notice.
follows: [FR Doc. 2016–17737 Filed 7–26–16; 8:45 am] Therefore, you should always check the
Immediate Office of the Deputy Agency’s Web site at http://
BILLING CODE 4184–01–P
Assistant Secretary for Administration www.fda.gov/AdvisoryCommittees/
(KPA) default.htm and scroll down to the
Office of Financial Services (KPC) appropriate advisory committee meeting
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![Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices 49225
link, or call the advisory committee FDA is committed to the orderly SUPPLEMENTARY INFORMATION:
information line to learn about possible conduct of its advisory committee
I. Background
modifications before coming to the meetings. Please visit our Web site at
meeting. http://www.fda.gov/ Sections 744A and 744B of the FD&C
AdvisoryCommittees/ Act (21 U.S.C. 379j–41 and 379j–42)
SUPPLEMENTARY INFORMATION:
AboutAdvisoryCommittees/ establish fees associated with human
Agenda: On October 13, 2016, the
ucm111462.htm for procedures on generic drug products. Fees are assessed
committee will meet in open session to
public conduct during advisory on: (1) Certain applications in the
discuss and make recommendations on
committee meetings. backlog as of October 1, 2012 (only
the selection of strains to be included in
Notice of this meeting is given under applicable to FY 2013); (2) certain types
an influenza virus vaccine for the 2017
the Federal Advisory Committee Act (5 of applications and supplements for
southern hemisphere influenza season.
U.S.C. app. 2). human generic drug products; (3)
FDA intends to make background
certain facilities where APIs and FDFs
material available to the public no later Dated: July 21, 2016.
are produced; and (4) certain DMFs
than 2 business days before the meeting. Janice M. Soreth,
associated with human generic drug
If FDA is unable to post the background Acting Associate Commissioner, Special products (see section 744B(a)(1)–(4) of
material on its Web site prior to the Medical Programs.
the FD&C Act).
meeting, the background material will [FR Doc. 2016–17729 Filed 7–26–16; 8:45 am] For FY 2017, the generic drug fee
be made publicly available at the BILLING CODE 4164–01–P rates are: ANDA ($70,480), PAS
location of the advisory committee ($35,240), DMF ($51,140), domestic API
meeting, and the background material facility ($44,234), foreign API facility
will be posted on FDA’s Web site after DEPARTMENT OF HEALTH AND ($59,234), domestic FDF facility
the meeting. Background material is HUMAN SERVICES ($258,646), and foreign FDF facility
available at http://www.fda.gov/ ($273,646). These fees are effective on
AdvisoryCommittees/Calendar/ Food and Drug Administration
October 1, 2016, and will remain in
default.htm. Scroll down to the [Docket No. FDA–2016–N–0007] effect through September 30, 2017.
appropriate advisory committee meeting Fees for ANDA and PAS will decrease
link. Generic Drug User Fee—Abbreviated in FY 2017 compared to the FY 2016
Procedure: Interested persons may New Drug Application, Prior Approval fees due to an increase in the number of
present data, information, or views, Supplement, Drug Master File, Final submissions estimated to be submitted
orally or in writing, on issues pending Dosage Form Facility, and Active in FY 2017 compared to the estimated
before the committee. Written Pharmaceutical Ingredient Facility Fee number of submissions to be submitted
submissions may be made to the contact Rates for Fiscal Year 2017 in FY 2016. Fees for DMFs will increase
person on or before October 3, 2016. in FY 2017 compared to the FY 2016 fee
Oral presentations from the public will AGENCY: Food and Drug Administration,
HHS. due to a decrease in the number of
be scheduled between approximately submissions estimated to be submitted
2:30 p.m. and 3:30 p.m. Those ACTION: Notice. in FY 2017 compared to the estimated
individuals interested in making formal number of submissions to be submitted
oral presentations should notify the SUMMARY: The Food and Drug
Administration (FDA) is announcing the in 2016. The fees for all types of
contact person and submit a brief facilities will increase in FY 2017
statement of the general nature of the rates for abbreviated new drug
applications (ANDAs), prior approval compared to the FY 2016 fees in due to
evidence or arguments they wish to a decrease in the number of facilities
present, the names and addresses of supplements to an approved ANDA
(PASs), drug master files (DMFs), that self-identified for FY 2017.
proposed participants, and an
indication of the approximate time generic drug active pharmaceutical II. Fee Revenue Amount for FY 2017
requested to make their presentation on ingredient (API) facilities, and finished
The base revenue amount for FY 2017
or before September 23, 2016. Time dosage form (FDF) facilities user fees
is $299 million, as set in the statute
allotted for each presentation may be related to the Generic Drug User Fee
prior to the inflation and final year
limited. If the number of registrants Program for fiscal year (FY) 2017. The
adjustments (see section 744B(c)(2) of
requesting to speak is greater than can Federal Food, Drug, and Cosmetic Act
the FD&C Act). GDUFA directs FDA to
be reasonably accommodated during the (the FD&C Act), as amended by the
use the yearly revenue amount as a
scheduled open public hearing session, Generic Drug User Fee Amendments of
starting point to set the fee rates for each
FDA may conduct a lottery to determine 2012 (GDUFA), authorizes FDA to
fee type. For more information about
the speakers for the scheduled open assess and collect user fees for certain
GDUFA, please refer to the FDA Web
public hearing session. The contact applications and supplements for
site (http://www.fda.gov/gdufa). The
person will notify interested persons human generic drug products, on
ANDA, PAS, DMF, API facility, and
regarding their request to speak by applications in the backlog as of October
FDF facility fee calculations for FY 2017
September 26, 2016. 1, 2012 (only applicable to FY 2013), on
are described in this document.
Persons attending FDA’s advisory FDF and API facilities, and on type II
committee meetings are advised that the active pharmaceutical ingredient DMFs A. Inflation Adjustment
Agency is not responsible for providing to be made available for reference. This GDUFA specifies that the $299
access to electrical outlets. document establishes the fee rates for
sradovich on DSK3GMQ082PROD with NOTICES
million is to be adjusted for inflation
FDA welcomes the attendance of the FY 2017. increases for FY 2017 using two
public at its advisory committee FOR FURTHER INFORMATION CONTACT: separate adjustments—one for personnel
meetings and will make every effort to David Haas, Office of Financial compensation and benefits (PC&B) and
accommodate persons with disabilities. Management, Food and Drug one for non-PC&B costs (see section
If you require accommodations due to a Administration, 8455 Colesville Rd., 744B(c)(1) of the FD&C Act).
disability, please contact Sujata Vijh at COLE–14202I, Silver Spring, MD The component of the inflation
least 7 days in advance of the meeting. 20993–0002, 240–402–9845. adjustment for PC&B costs shall be one
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Document Created: 2018-02-08 08:02:24
Document Modified: 2018-02-08 08:02:24
| 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 October 13, 2016, from 1 p.m. to 4:30 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 49224 |
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