81 FR 31644 - Advisory Committee; Drug Safety and Risk Management Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 97 (May 19, 2016)

Page Range		31644-31645
FR Document		2016-11773

The Food and Drug Administration (FDA) is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 31, 2018.

Federal Register, Volume 81 Issue 97 (Thursday, May 19, 2016)

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31644-31645]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11773]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee; Drug Safety and Risk Management Advisory 
Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
renewal of the Drug Safety and Risk Management Advisory Committee by 
the Commissioner of Food and Drugs (the Commissioner). The Commissioner 
has determined that it is in the public interest to renew the Drug 
Safety and Risk Management Advisory Committee for an additional 2 years 
beyond the charter expiration date. The new charter will be in effect 
until May 31, 2018.

DATES: Authority for the Drug Safety and Risk Management Advisory 
Committee will expire on May 31, 2016, unless the Commissioner formally 
determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Philip A. Bautista, 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, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
and by the General Services Administration, FDA is announcing the 
renewal of the Drug Safety and Risk Management Advisory Committee. The 
committee is a discretionary Federal advisory committee established to 
provide advice to the Commissioner. The Drug Safety and Risk Management 
Advisory Committee advises the Commissioner or designee in discharging 
responsibilities as they relate to helping to ensure safe and effective 
drugs for human use and, as required, any other product for which the 
Food and Drug Administration has regulatory responsibility. The 
Committee reviews and evaluates information on risk management, risk 
communication, and quantitative evaluation of spontaneous reports for 
drugs for human use and for any other product for which the Food and 
Drug Administration has regulatory responsibility. The Committee also 
advises the Commissioner of Food and Drugs regarding the scientific and 
medical evaluation of all information gathered by the Department of 
Health and Human Services and the Department of Justice with regard to 
safety, efficacy, and abuse potential of drugs or other substances, and 
recommends actions to be taken by the Department of Health and Human 
Services with regard to the marketing, investigation, and control of 
such drugs or other substances.
    The Committee shall consist of a core of 11 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of risk communication, risk management, drug safety, medical, 
behavioral, and biological sciences as they apply to risk management, 
and drug abuse. Members will be invited to serve for overlapping terms 
of up to 4 years. Almost all non-Federal members of this committee 
serve as Special Government Employees. The core of voting members may 
include one technically qualified member, selected by the Commissioner 
or designee, who is identified with consumer interests and is 
recommended by either a consortium of consumer-oriented organizations 
or other interested persons. In addition to the voting members, the 
Committee may include one non-voting member who is identified with 
industry interests.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm094886.htm or by 
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION 
CONTACT). In light of the fact that no change has been made to the 
committee name or description of duties, no amendment will be made to 
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5 
U.S.C. app.). For general information related to FDA advisory 
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.


[[Page 31645]]


    Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11773 Filed 5-18-16; 8:45 am]
BILLING CODE 4164-01-P

31644 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices

796–9001, FAX: 301–847–8533, PCNS@ U.S.C. app.). For general information as required, any other product for which
fda.hhs.gov. related to FDA advisory committees, the Food and Drug Administration has
SUPPLEMENTARY INFORMATION: Pursuant please visit us at http://www.fda.gov/ regulatory responsibility. The
to 41 CFR 102–3.65 and approval by the AdvisoryCommittees/default.htm. Committee reviews and evaluates
Department of Health and Human Dated: May 13, 2016. information on risk management, risk
Services pursuant to 45 CFR part 11 and communication, and quantitative
Jill Hartzler Warner,
by the General Services Administration, evaluation of spontaneous reports for
Associate Commissioner for Special Medical
FDA is announcing the renewal of the drugs for human use and for any other
Programs.
Peripheral and Central Nervous System product for which the Food and Drug
[FR Doc. 2016–11776 Filed 5–18–16; 8:45 am]
Drugs Advisory Committee. The Administration has regulatory
BILLING CODE 4164–01–P responsibility. The Committee also
committee is a discretionary Federal
advisory committee established to advises the Commissioner of Food and
provide advice to the Commissioner. Drugs regarding the scientific and
DEPARTMENT OF HEALTH AND medical evaluation of all information
The Peripheral and Central Nervous HUMAN SERVICES
System Drugs Advisory Committee gathered by the Department of Health
advises the Commissioner or designee Food and Drug Administration and Human Services and the
in discharging responsibilities as they Department of Justice with regard to
[Docket No. FDA–2016–N–0001] safety, efficacy, and abuse potential of
relate to helping to ensure safe and
effective drugs for human use and, as drugs or other substances, and
Advisory Committee; Drug Safety and recommends actions to be taken by the
required, any other product for which Risk Management Advisory
the Food and Drug Administration has Department of Health and Human
Committee, Renewal Services with regard to the marketing,
regulatory responsibility. The
Committee reviews and evaluates data AGENCY: Food and Drug Administration, investigation, and control of such drugs
concerning the safety and effectiveness HHS. or other substances.
ACTION:Notice; renewal of advisory The Committee shall consist of a core
of marketed and investigational human
of 11 voting members including the
drug products for use in the treatment committee.
Chair. Members and the Chair are
of neurologic diseases.
SUMMARY: The Food and Drug selected by the Commissioner or
The Committee shall consist of a core
Administration (FDA) is announcing the designee from among authorities
of nine voting members including the knowledgeable in the fields of risk
Chair. Members and the Chair are renewal of the Drug Safety and Risk
Management Advisory Committee by communication, risk management, drug
selected by the Commissioner or safety, medical, behavioral, and
designee from among authorities the Commissioner of Food and Drugs
(the Commissioner). The Commissioner biological sciences as they apply to risk
knowledgeable in the fields of management, and drug abuse. Members
neurology, neuropharmacology, has determined that it is in the public
interest to renew the Drug Safety and will be invited to serve for overlapping
neuropathology, otolaryngology, terms of up to 4 years. Almost all non-
epidemiology or statistics, and related Risk Management Advisory Committee
for an additional 2 years beyond the Federal members of this committee
specialties. Members will be invited to serve as Special Government
serve for overlapping terms of up to 4 charter expiration date. The new charter
will be in effect until May 31, 2018. Employees. The core of voting members
years. Almost all non-Federal members may include one technically qualified
of this committee serve as Special DATES: Authority for the Drug Safety
and Risk Management Advisory member, selected by the Commissioner
Government Employees. The core of or designee, who is identified with
voting members may include one Committee will expire on May 31, 2016,
unless the Commissioner formally consumer interests and is recommended
technically qualified member, selected by either a consortium of consumer-
by the Commissioner or designee, who determines that renewal is in the public
interest. oriented organizations or other
is identified with consumer interests interested persons. In addition to the
and is recommended by either a FOR FURTHER INFORMATION CONTACT:
voting members, the Committee may
consortium of consumer-oriented Philip A. Bautista, Center for Drug include one non-voting member who is
organizations or other interested Evaluation and Research, Food and identified with industry interests.
persons. In addition to the voting Drug Administration, 10903 New Further information regarding the
members, the Committee may include Hampshire Ave., Bldg. 31, Rm. 2417, most recent charter and other
one non-voting member who is Silver Spring, MD 20993–0002, 301– information can be found at http://
identified with industry interests. 796–9001, DSARM@fda.hhs.gov. www.fda.gov/AdvisoryCommittees/
Further information regarding the most SUPPLEMENTARY INFORMATION: Pursuant CommitteesMeetingMaterials/Drugs/
recent charter and other information can to 41 CFR 102–3.65 and approval by the DrugSafetyandRiskManagement
be found at http://www.fda.gov/ Department of Health and Human AdvisoryCommittee/ucm094886.htm or
AdvisoryCommittees/Committees Services pursuant to 45 CFR part 11 and by contacting the Designated Federal
MeetingMaterials/Drugs/Peripheraland by the General Services Administration, Officer (see FOR FURTHER INFORMATION
CentralNervousSystemDrugsAdvisory FDA is announcing the renewal of the CONTACT). In light of the fact that no
Committee/ucm107494.htm or by Drug Safety and Risk Management change has been made to the committee
contacting the Designated Federal Advisory Committee. The committee is name or description of duties, no
Officer (see FOR FURTHER INFORMATION a discretionary Federal advisory amendment will be made to 21 CFR
mstockstill on DSK3G9T082PROD with NOTICES

CONTACT). In light of the fact that no committee established to provide advice 14.100.
change has been made to the committee to the Commissioner. The Drug Safety This document is issued under the
name or description of duties, no and Risk Management Advisory Federal Advisory Committee Act (5
amendment will be made to 21 CFR Committee advises the Commissioner or U.S.C. app.). For general information
14.100. designee in discharging responsibilities related to FDA advisory committees,
This document is issued under the as they relate to helping to ensure safe please visit us at http://www.fda.gov/
Federal Advisory Committee Act (5 and effective drugs for human use and, AdvisoryCommittees/default.htm.

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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices 31645

Dated: May 13, 2016. 3561, and providing the following advance request for a presentation, but
Jill Hartzler Warner, information: desire to make an oral statement, may
Associate Commissioner for Special Medical Leaders Name: Dr. Narayan Nair announce it at the time of the public
Programs. Password: 8164763 comment period. Public participation
[FR Doc. 2016–11773 Filed 5–18–16; 8:45 am] 3. (Visual Portion) Connecting to the and ability to comment will be limited
BILLING CODE 4164–01–P ACCV Adobe Connect Pro Meeting to space and time as it permits.
using the following URL: https:// FOR FURTHER INFORMATION CONTACT:
hrsa.connectsolutions.com/accv/ (copy Anyone requiring information regarding
DEPARTMENT OF HEALTH AND and paste the link into your browser if the ACCV should contact Annie Herzog,
HUMAN SERVICES it does not work directly, and enter as Division of Injury Compensation
a guest). Participants should call and Programs, Healthcare Systems Bureau,
Health Resources and Services Health Resources and Services
connect 15 minutes prior to the meeting
Administration Administration, 5600 Fishers Lane,
in order for logistics to be set up. If you
Advisory Commission on Childhood have never attended an Adobe Connect Room 8N146B, Rockville, MD 20857;
Vaccines; Notice of Meeting meeting, please test your connection telephone (301) 443–6593, or email:
using the following URL: https:// aherzog@hrsa.gov.
In accordance with section 10(a)(2) of hrsa.connectsolutions.com/common/ Jason E. Bennett,
the Federal Advisory Committee Act help/en/support/meeting_test.htm and
Director, Division of the Executive Secretariat.
(Pub. L. 92–463), notice is hereby given get a quick overview by following URL:
[FR Doc. 2016–11790 Filed 5–18–16; 8:45 am]
of the following meeting: http://www.adobe.com/go/connectpro_
overview. BILLING CODE 4165–15–P
NAME: Advisory Commission on
Childhood Vaccines (ACCV). Call (301) 443–6634 or send an email
DATE AND TIME: June 3, 2016, 9:00 a.m.
to aherzog@hrsa.gov if you are having
trouble connecting to the meeting site. DEPARTMENT OF HEALTH AND
to 12:30 p.m. EDT. HUMAN SERVICES
Agenda: The agenda items for the
PLACE: 5600 Fishers Lane, Conference June 2016 meeting will include, but are
Room 08SW01, Rockville, MD 20857. Office of the Secretary
not limited to, updates from: The
STATUS: The ACCV will meet on Friday, Division of Injury Compensation [Document Identifier: HHS–OS–0945–0004]
June 3, 2016, from 9:00 a.m. to 12:30 Programs (DICP), Department of Justice
p.m. at 5600 Fishers Lane, Conference (DOJ), National Vaccine Program Office Agency Information Collection
Room 08SW01, Rockville, MD 20857. (NVPO), Immunization Safety Office Activities; Submission to OMB for
The public can join the meeting by: (Centers for Disease Control and Review and Approval; Public Comment
1. (In Person) Persons interested in Prevention), National Institute of Request
attending the meeting in person are Allergy and Infectious Diseases AGENCY: Office of the Secretary, HHS.
encouraged to submit a written (National Institutes of Health) and ACTION: Notice.
notification to: Annie Herzog, Division Center for Biologics, Evaluation and
of Injury Compensation Programs, Research (Food and Drug SUMMARY: In compliance with section
Healthcare Systems Bureau, Health Administration). A draft agenda and 3507(a)(1)(D) of the Paperwork
Resources and Services Administration, additional meeting materials will be Reduction Act of 1995, the Office of the
5600 Fishers Lane, Room 8N146B, posted on the ACCV Web site (http:// Secretary (OS), Department of Health
Rockville, MD 20857 or email: aherzog@ www.hrsa.gov/advisorycommittees/ and Human Services, has submitted an
hrsa.gov. Since this meeting is held in childhoodvaccines/index.html) prior to Information Collection Request (ICR),
a Federal government building, the meeting. Agenda items are subject to described below, to the Office of
attendees will need to go through a change as priorities warrant. Management and Budget (OMB) for
security check to enter the building and Public Comment: Persons interested review and approval. The ICR is for
participate in the meeting. This written in providing an oral presentation should renewal of the approved information
notification is encouraged so that a list submit a written request, along with a collection assigned OMB control
of attendees can be provided for quicker copy of their presentation to: Annie number 0945–0004, scheduled to expire
entry through security. Persons may Herzog, Division of Injury on May 31, 2016. Comments submitted
attend in person without providing Compensation Programs, Healthcare during the first public review of this ICR
written notification, but their entry into Systems Bureau, Health Resources and will be provided to OMB. OMB will
the building may be delayed due to Services Administration, 5600 Fishers accept further comments from the
security checks and the requirement to Lane, Room 8N146B, Rockville, MD public on this ICR during the review
be escorted to the meeting by a Federal 20857 or email: aherzog@hrsa.gov. and approval period.
government employee. To request an Requests should contain the name, DATES: Comments on the ICR must be
escort to the meeting after entering the address, telephone number, email received on or before June 20, 2016.
building, call Mario Lombre at 301– address, and any business or
ADDRESSES: Submit your comments to
443–3196. The meeting will be held at professional affiliation of the person
5600 Fishers Lane, Conference Room desiring to make an oral presentation. OIRA_submission@omb.eop.gov or via
08SW01, Rockville, MD 20857. Groups having similar interests are facsimile to (202) 395–5806.
Individuals who plan to attend and requested to combine their comments FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK3G9T082PROD with NOTICES

need special assistance, such as sign and present them through a single Information Collection Clearance staff,
language interpretation or other representative. The allocation of time Information.CollectionClearance@
reasonable accommodations, should may be adjusted to accommodate the hhs.gov or (202) 690–6162.
notify the contact person listed below at level of expressed interest. DICP will SUPPLEMENTARY INFORMATION: When
least 10 days prior to the meeting. notify each presenter by email, mail, or submitting comments or requesting
2. (Audio Portion) Calling the telephone of the assigned presentation information, please include the OMB
conference phone number, 800–799– time. Persons who do not file an control number 0945–0004 and

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Document Created: 2018-02-07 15:01:22
Document Modified: 2018-02-07 15:01:22

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; renewal of advisory committee.
Dates		Authority for the Drug Safety and Risk Management Advisory Committee will expire on May 31, 2016, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Philip A. Bautista, 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, [email protected]
FR Citation		81 FR 31644

81 FR 31644 - Advisory Committee; Drug Safety and Risk Management Advisory Committee, Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 97 (May 19, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration