81 FR 31642 - Advisory Committee; Blood Products Advisory Committee; Renewal

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range		31642-31643
FR Document		2016-11774

The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products 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 Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 13, 2018.

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

[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31642-31643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-11774]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Advisory Committee; Blood Products 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 Blood Products 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 Blood Products Advisory 
Committee for an additional 2 years beyond the charter expiration date. 
The new charter will be in effect until May 13, 2018.

DATES: Authority for the Blood Products Advisory Committee will expire 
on May 13, 2016, unless the Commissioner formally determines that 
renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific 
Advisors and Consultants, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm. 
6132, Silver Spring, MD 20993-0002, 240-402-8054, 
[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 Blood Products Advisory Committee. The committee is a 
discretionary Federal advisory committee established to provide advice 
to the Commissioner.
    The Blood Products 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 FDA has regulatory responsibility.
    The Committee shall consist of a core of 17 voting members 
including the Chair. Members and the Chair are selected by the 
Commissioner or designee from among authorities knowledgeable in the 
fields of clinical and administrative medicine, hematology, immunology, 
blood banking, surgery, internal medicine, biochemistry, engineering, 
biological and physical sciences, biotechnology, computer technology, 
statistics, epidemiology, sociology/ethics, and other related 
professions. 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.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to exceed 10 members) to serve temporarily as voting 
members and to designate consultants to serve temporarily as voting 
members when: (1) Expertise is required that is not available among 
current voting standing members of the Committee (when additional 
voting members are added to the Committee to provide needed expertise, 
a quorum will be based on the combined total of regular and added 
members), or (2) to comprise a quorum

[[Page 31643]]

when, because of unforeseen circumstances, a quorum is or will be 
lacking. Because of the size of the Committee and the variety in the 
types of issues that it will consider, FDA may, in connection with a 
particular committee meeting, specify a quorum that is less than a 
majority of the current voting members. The Agency's regulations (21 
CFR 14.22(d)) authorize a committee charter to specify quorum 
requirements.
    If functioning as a medical device panel, a non-voting 
representative of consumer interests and a non-voting representative of 
industry interests will be included in addition to the voting members.
    Further information regarding the most recent charter and other 
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm121602.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.

    Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11774 Filed 5-18-16; 8:45 am]
 BILLING CODE 4164-01-P

31642 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices

demographic and service utilization non-competing continuation application visiting services, they must also submit
data, performance measurement, and for Years 3–5 of the grant, Tribal Form 1: Demographic and Service
continuous quality improvement, and MIECHV grantees will update their Utilization Data.
participating in or conducting rigorous implementation plans as necessary to Respondents: Tribal Maternal, Infant,
evaluation activities. Grantees are ensure that the plan accurately reflects and Early Childhood Home Visiting
expected to submit the implementation activities to be completed throughout Program Grantees. (The information
plan by the end of Year 1 of the grant, the remainder of the grant. collection does not include direct
with draft submission milestones Following each year that Tribal interaction with individuals or families
throughout the first year. As part of the MIECHV grantees implement home that receive the services).

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Tribal Maternal, Infant, and Early Childhood Home Visiting Implementation
Plan Guidance .............................................................................................. 25 1 1000 25,000
Tribal MIECHV Form 1 Demographic & Service Utilization Data & Service
Data .............................................................................................................. 25 1 500 12,500

Estimated Annual Burden Hours: ............................................................. ........................ ........................ ........................ 37,500

Estimated Total Annual Burden ACTION:Notice; renewal of advisory The Committee shall consist of a core
Hours: 37,500. committee. of 17 voting members including the
Additional Information: Copies of the Chair. Members and the Chair are
proposed collection may be obtained by SUMMARY: The Food and Drug selected by the Commissioner or
writing to the Administration for Administration (FDA) is announcing the designee from among authorities
Children and Families, Office of renewal of the Blood Products Advisory knowledgeable in the fields of clinical
Planning, Research and Evaluation, 330 Committee by the Commissioner of and administrative medicine,
C Street SW., Washington, DC 20201. Food and Drugs (the Commissioner). hematology, immunology, blood
Attention Reports Clearance Officer. All The Commissioner has determined that banking, surgery, internal medicine,
requests should be identified by the title it is in the public interest to renew the biochemistry, engineering, biological
of the information collection. Email Blood Products Advisory Committee for and physical sciences, biotechnology,
address: infocollection@acf.hhs.gov. an additional 2 years beyond the charter computer technology, statistics,
OMB Comment: OMB is required to expiration date. The new charter will be epidemiology, sociology/ethics, and
make a decision concerning the in effect until May 13, 2018. other related professions. Members will
collection of information between 30 DATES: Authority for the Blood Products be invited to serve for overlapping terms
and 60 days after publication of this Advisory Committee will expire on May of up to 4 years. Almost all non-Federal
document in the Federal Register. 13, 2016, unless the Commissioner members of this committee serve as
Therefore, a comment is best assured of formally determines that renewal is in Special Government Employees. The
having its full effect if OMB receives it the public interest. core of voting members may include one
within 30 days of publication. Written FOR FURTHER INFORMATION CONTACT: technically qualified member, selected
comments and recommendations for the Bryan Emery, Division of Scientific by the Commissioner or designee, who
proposed information collection should Advisors and Consultants, Center for is identified with consumer interests
be sent directly to the following: Office Biologics Evaluation and Research, and is recommended by either a
of Management and Budget, Paperwork Food and Drug Administration, 10993 consortium of consumer-oriented
Reduction Project, Email: OIRA_ New Hampshire Ave., Bldg. 71, Rm. organizations or other interested
SUBMISSION@OMB.EOP.GOV, Attn: 6132, Silver Spring, MD 20993–0002, persons. In addition to the voting
Desk Officer for the Administration for 240–402–8054, Bryan.emery@ members, the Committee may include
Children and Families. fda.hhs.gov. one non-voting member who is
Robert Sargis, SUPPLEMENTARY INFORMATION: Pursuant identified with industry interests.
Reports Clearance Officer. to 41 CFR 102–3.65 and approval by the The Commissioner or designee shall
[FR Doc. 2016–11791 Filed 5–18–16; 8:45 am] Department of Health and Human have the authority to select members of
BILLING CODE 4184–01–P
Services pursuant to 45 CFR part 11 and other scientific and technical FDA
by the General Services Administration, advisory committees (normally not to
FDA is announcing the renewal of the exceed 10 members) to serve
DEPARTMENT OF HEALTH AND Blood Products Advisory Committee. temporarily as voting members and to
HUMAN SERVICES The committee is a discretionary designate consultants to serve
Federal advisory committee established temporarily as voting members when:
Food and Drug Administration to provide advice to the Commissioner. (1) Expertise is required that is not
mstockstill on DSK3G9T082PROD with NOTICES

The Blood Products Advisory available among current voting standing
[Docket No. FDA–2016–N–0001] Committee advises the Commissioner or members of the Committee (when
Advisory Committee; Blood Products designee in discharging responsibilities additional voting members are added to
Advisory Committee; Renewal as they relate to helping to ensure safe the Committee to provide needed
and effective drugs for human use and, expertise, a quorum will be based on the
AGENCY: Food and Drug Administration, as required, any other product for which combined total of regular and added
HHS. FDA has regulatory responsibility. members), or (2) to comprise a quorum

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Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices 31643

when, because of unforeseen groups and industry to gain greater If you need special accommodations
circumstances, a quorum is or will be appreciation on the extent to which the due to a disability, please contact
lacking. Because of the size of the current regulatory paradigm for Francis Kalush (see FOR FURTHER
Committee and the variety in the types antidiabetic drug therapies addresses INFORMATION CONTACT) at least 7 days in
of issues that it will consider, FDA may, the needs of patients with diabetes and advance.
in connection with a particular to identify additional outcomes, beyond Transcripts: A transcript of the
committee meeting, specify a quorum HbA1c, that are of direct relevance and workshop will be available for review at
that is less than a majority of the current importance to patients living with the the Division of Dockets Management
voting members. The Agency’s disease. (HFA–305), Food and Drug
regulations (21 CFR 14.22(d)) authorize DATES: The public workshop will be Administration, 5630 Fishers Lane, Rm.
a committee charter to specify quorum held on August 29, 2016, from 9 a.m. to 1061, Rockville, MD 20852, and on the
requirements. 5 p.m. Internet at http://www.regulations.gov
If functioning as a medical device approximately 30 days after the
ADDRESSES: The public workshop will
panel, a non-voting representative of workshop. Transcripts will also be
be held at FDA’s White Oak campus,
consumer interests and a non-voting available in either hard copy or on CD–
10903 New Hampshire Ave., Building
representative of industry interests will ROM, after submission of a Freedom of
31 (The Great Room B, and C), Silver
be included in addition to the voting Information request. The Freedom of
Spring, MD 20993. Entrance for the
members. Information office address is available
Further information regarding the public workshop participants (non-FDA
employees) is through Building 1 where on the Agency’s Web site at http://
most recent charter and other www.fda.gov.
information can be found at http:// routine security check procedures will
www.fda.gov/AdvisoryCommittees/ be performed. For parking and security Dated: May 13, 2016.
CommitteesMeetingMaterials/ information, please refer to http://www. Leslie Kux,
BloodVaccinesandOtherBiologics/ fda.gov/AboutFDA/WorkingatFDA/ Associate Commissioner for Policy.
BloodProductsAdvisoryCommittee/ BuildingsandFacilities/WhiteOak [FR Doc. 2016–11846 Filed 5–18–16; 8:45 am]
CampusInformation/ucm241740.htm.
ucm121602.htm or by contacting the BILLING CODE 4164–01–P
Designated Federal Officer (see FOR FOR FURTHER INFORMATION CONTACT:
FURTHER INFORMATION CONTACT). In light Francis Kalush, Center for Drug
of the fact that no change has been made Evaluation and Research, Food and DEPARTMENT OF HEALTH AND
to the committee name or description of Drug Administration, 10903 New HUMAN SERVICES
duties, no amendment will be made to Hampshire Ave., Silver Spring, MD
21 CFR 14.100. 20993–0002, DIABHbA1c-CDER@ Food and Drug Administration
This document is issued under the fda.hhs.gov.
Federal Advisory Committee Act (5 SUPPLEMENTARY INFORMATION: FDA is [Docket No. FDA–2016–N–0001]
U.S.C. app.). For general information announcing a public workshop entitled
related to FDA advisory committees, ‘‘Diabetes Outcome Measures Beyond Advisory Committee; Peripheral and
please visit us at http://www.fda.gov/ Hemoglobin A1c.’’ This public Central Nervous System Drugs
AdvisoryCommittees/default.htm. workshop is intended to gain greater Advisory Committee, Renewal
Dated: May 13, 2016. appreciation on the extent to which the AGENCY: Food and Drug Administration,
Jill Hartzler Warner,
current regulatory paradigm for drugs to HHS.
treat diabetes addresses the needs of
Associate Commissioner for Special Medical ACTION:Notice; renewal of advisory
Programs.
patients with diabetes, to identify what
the most urgent unmet patient needs are committee.
[FR Doc. 2016–11774 Filed 5–18–16; 8:45 am]
and to identify measures beyond HbA1c SUMMARY: The Food and Drug
BILLING CODE 4164–01–P
that would reliably capture outcomes Administration (FDA) is announcing the
important to the health or quality of life renewal of the Peripheral and Central
of patients living with diabetes. The Nervous System Drugs Advisory
DEPARTMENT OF HEALTH AND
ultimate purpose of identifying and Committee by the Commissioner of
HUMAN SERVICES
qualifying these outcomes for regulatory Food and Drugs (the Commissioner).
Food and Drug Administration purposes would be to continue to The Commissioner has determined that
support the development of novel it is in the public interest to renew the
[Docket No. FDA–2016–N–0001] therapies that directly address the needs Peripheral and Central Nervous System
of patients living with the disease. Drugs Advisory Committee for an
Diabetes Outcome Measures Beyond
There will be an opportunity for additional 2 years beyond the charter
Hemoglobin A1c: CDER Public
questions and answers following each expiration date. The new charter will be
Workshop
presentation. in effect until June 4, 2018.
AGENCY: Food and Drug Administration, Registration: There is no registration
fee to attend the public workshop. Early DATES: Authority for the Peripheral and
HHS.
registration is recommended because Central Nervous System Drugs Advisory
ACTION: Notice of public workshop. Committee will expire on June 4, 2016,
seating is limited, and registration will
SUMMARY: The Food and Drug be on a first-come, first-served basis. unless the Commissioner formally
Administration’s (FDA) Center for Drug There will be no onsite registration. determines that renewal is in the public
mstockstill on DSK3G9T082PROD with NOTICES

Evaluation and Research (CDER), is Persons interested in attending this interest.
sponsoring a public workshop entitled workshop must register online at http:// FOR FURTHER INFORMATION CONTACT:
‘‘Diabetes Outcome Measures Beyond www.fda.gov/Drugs/NewsEvents/ Moon Hee V. Choi, Center for Drug
Hemoglobin A1c (HbA1c).’’ The ucm499281.htm by July 29, 2016. For Evaluation and Research, Food and
purpose of this public workshop is to those without Internet access, please Drug Administration, 10903 New
have a forum for dialogue with the contact Francis Kalush (see FOR FURTHER Hampshire Ave., Bldg. 31, Rm. 2417,
public, patients, patient advocacy INFORMATION CONTACT) to register. Silver Spring, MD 20993–0002, 301–

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Document Created: 2018-02-07 15:01:17
Document Modified: 2018-02-07 15:01:17

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 Blood Products Advisory Committee will expire on May 13, 2016, unless the Commissioner formally determines that renewal is in the public interest.
Contact		Bryan Emery, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10993 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054, [email protected]
FR Citation		81 FR 31642

81 FR 31642 - Advisory Committee; Blood Products 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