Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 12582-12583 [2018-05797]
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Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices
science conducted at CBER by
showcasing how scientific research
informs regulatory decision making and
to provide a forum for developing
collaborations within FDA and with
external organizations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1094]
2018 Center for Biologics Evaluation
and Research Science Symposium
AGENCY:
II. Topics for Discussion at the Public
Symposium
Food and Drug Administration,
HHS.
ACTION:
Notice of public symposium.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
symposium entitled ‘‘2018 Center for
Biologics Evaluation and Research
Science Symposium.’’ The purpose of
the public symposium is to discuss
scientific topics related to the regulation
of biologics and highlight science
conducted at the Center for Biologics
Evaluation and Research (CBER) by
showcasing how scientific research
informs regulatory decision making and
to provide a forum for developing
collaborations within FDA and with
external organizations. The symposium
will include presentations by experts
from academic institutions, government
agencies, and research institutions.
DATES: The public symposium will be
held on June 25 and 26, 2018, from 9
a.m. to 3 p.m. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The public symposium will
be held at FDA’s White Oak campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public symposium
participants (non-FDA employees) is
through Bldg. 1, where routine security
check procedures will be performed. For
parking and security information, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Sherri Revell or Loni Warren
Henderson, Food and Drug
Administration, Center for Biologics
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, Rm. 1118,
Silver Spring, MD 20993, 240–402–
8010, email: CBERPublicEvents@
fda.hhs.gov (subject line: CBER Science
Symposium).
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the public symposium
is to discuss scientific topics related to
the regulation of biologics and highlight
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The public symposium will include
presentations on the following topics:
(1) Emerging and re-emerging diseases;
(2) diverse types of data in regulatory
decision making; (3) immune response
to vaccination; (4) immunotherapy; (5)
new technologies for research and
treatments; (6) the role of the
microbiome in human disease; and (7)
regenerative medicine.
III. Participating in the Public
Symposium
Registration: To register for the public
symposium, please visit the following
website: https://www.eventbrite.com/e/
2018-center-for-biologics-evaluationand-research-cber-science-symposiumtickets-39525851887. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public symposium (either
in person or by webcast) (see Streaming
Webcast of the Public Symposium) must
register online by June 18, 2018,
midnight Eastern Time. Early
registration is recommended because
seating is limited. There will be no
onsite registration; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation when they have
been accepted.
If you need special accommodations,
due to a disability, please contact Sherri
Revell or Loni Warren Henderson no
later than June 11, 2018.
Streaming Webcast of the Public
Symposium: This public symposium
will also be webcast. A link to the live
webcast of this symposium will be
provided upon registration at https://
www.eventbrite.com/e/2018-center-forbiologics-evaluation-and-research-cberscience-symposium-tickets39525851887. Persons interested in
viewing the live webcast must register
online by June 18, 2018. Early
registration is recommended because
webcast connections are limited. A
video record of the public symposium
will be available at https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
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WorkshopsMeetingsConferences/
default.htm for 1 year.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Dated: March 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05805 Filed 3–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1027; FDA–
2017–N–1064; FDA–2014–D–0329; FDA–
2013–N–1429; FDA–2009–N–0505; and
FDA–2014–N–0192]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices
12583
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB Control
No.
Title of collection
Infant Formula Recall Regulations ..........................................................................................................................
State Petitions for Exemptions from Preemption ....................................................................................................
Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and
744K of the Federal Food, Drug, and Cosmetic Act ...........................................................................................
Guidance for Industry: Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act .....................................................................................................
Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed
With, or Otherwise Containing, Material from Cattle ...........................................................................................
Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for
Young Children Manufactured/Processors with Interest in Exporting to China ..................................................
Dated: March 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05797 Filed 3–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Applications From
Individuals Interested in Being
Appointed to the Chronic Fatigue
Syndrome Advisory Committee
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Authority: 42 U.S.C. 217a, Section 222 of
the Public Health Service Act, as amended.
The Committee is governed by the provisions
of the Federal Advisory Committee Act,
Public Law 92–463, as amended (5 U.S.C.
App.), which sets forth standards for the
formation and use of advisory committees.
The Office of the Assistant
Secretary for Health (OASH), within the
Department of Health and Human
Services (HHS), is seeking nominations
of six qualified candidates to be
considered for appointment as members
of the Chronic Fatigue Syndrome
Advisory Committee (CFSAC). CFSAC
provides advice and recommendations
to the Secretary of HHS, through the
Assistant Secretary for Health (ASH), on
a broad range of issues and topics
related to myalgic encephalomyelitis/
chronic fatigue syndrome (ME/CFS).
DATES: Applications for individuals to
be considered for appointment to the
Committee must be received no later
than 5 p.m. EDT on April 23, 2018 at the
address listed below.
ADDRESSES: All nominations should be
mailed or delivered to Commander
(CDR) Gustavo Ceinos, MPH, Designated
Federal Officer, Chronic Fatigue
Syndrome Advisory Committee, Office
on Women’s Health, Office of the
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SUMMARY:
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Assistant Secretary for Health,
Department of Health and Human
Services, 200 Independence Avenue
SW, Room 728F6, Washington, DC
20201. Nomination materials, including
attachments, may be submitted
electronically to cfsac@hhs.gov.
FOR FURTHER INFORMATION CONTACT: CDR
Gustavo Ceinos, Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Office on
Women’s Health, Office of the Assistant
Secretary for Health, Department of
Health and Human Services, 200
Independence Ave. SW, Room 728F6,
Washington, DC 20201. Inquiries may
also be made to cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002.
The purpose of the CFSAC is to provide
advice and recommendations to the
Secretary of HHS, through the ASH, on
issues related to ME/CFS. The CFSAC
advises and makes recommendations on
a broad range of topics including: (1)
Opportunities to improve knowledge
and research about the epidemiology,
etiologies, biomarkers and risk factors
for ME/CFS; (2) research on the
diagnosis, treatment, and management
of ME/CFS and potential impact of
treatment options; (3) strategies to
inform the public, health care
professionals, and the biomedical
academic and research communities
about ME/CFS advances; (4)
partnerships to improve the quality of
life of ME/CFS patients; and (5)
strategies to insure that input from ME/
CFS patients and caregivers is
incorporated into HHS policy and
research. The CFSAC charter is
available at: https://www.hhs.gov/
advcomcfs/charter/.
Management and support services for
Committee activities are provided
within the OASH. The ASH provides
direction and guidance for services
performed to support CFSAC activities
and operation.
Nominations: OASH is requesting
nominations to fill six CFSAC positions.
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Date approval
expires
0910–0188
0910–0277
12/31/2020
12/31/2020
0910–0776
12/31/2020
0910–0777
12/31/2020
0910–0623
1/31/2021
0910–0839
1/31/2021
The Committee composition consists of
thirteen members:
• Seven biomedical research
scientists with demonstrated expertise
in biomedical research applicable to
ME/CFS;
• at least three patients or caregivers
affected by ME/CFS; and
• three individuals with expertise in
health care delivery, private health care
services or insurers, or voluntary
organizations concerned with the
problems of individuals with ME/CFS.
The breakdown of the six vacant
positions OASH is seeking is as follows:
• Four positions for biomedical
research scientists with demonstrated
expertise in biomedical research
applicable to ME/CFS;
• one position for patients or
caregivers affected by ME/CFS; and
• one position for an individual with
expertise in health care delivery, private
health care services or insurers, or
voluntary organizations concerned with
the problems of individuals with ME/
CFS.
Individuals selected for appointment
to the Committee will serve as voting
members and may be invited to serve for
a period of four years. CFSAC members
are authorized to receive a stipend for
conducting committee related business
including attending Committee
meetings. Committee members also are
authorized to receive per diem and
reimbursement for travel expenses
incurred for conducting Committee
related business. To qualify for
consideration of appointment to the
Committee, an individual must possess
demonstrated experience and
knowledge in the designated fields or
disciplines, as well as expert knowledge
of the broad issues and topics pertinent
to ME/CFS.
Nomination materials should be
typewritten. If mailed, please submit
original documents. The nomination
materials should be submitted
(postmarked or received) no later than
5:00 p.m. EDT on the specified date.
The following information must be part
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]]>Agencies
[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Pages 12582-12583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2014-N-1027; FDA-2017-N-1064; FDA-2014-D-0329; FDA-
2013-N-1429; FDA-2009-N-0505; and FDA-2014-N-0192]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
[[Page 12583]]
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB Control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Infant Formula Recall Regulations....... 0910-0188 12/31/2020
State Petitions for Exemptions from 0910-0277 12/31/2020
Preemption.............................
Guidance for Industry: Fees for Human 0910-0776 12/31/2020
Drug Compounding Outsourcing Facilities
Under Sections 503B and 744K of the
Federal Food, Drug, and Cosmetic Act...
Guidance for Industry: Registration of 0910-0777 12/31/2020
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act...
Reporting and Recordkeeping Requirements 0910-0623 1/31/2021
for Human Food and Cosmetics
Manufactured from, Processed With, or
Otherwise Containing, Material from
Cattle.................................
Establishing and Maintaining a List of 0910-0839 1/31/2021
U.S. Milk and Milk Product, Seafood,
Infant Formula, and Formula for Young
Children Manufactured/Processors with
Interest in Exporting to China.........
------------------------------------------------------------------------
Dated: March 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05797 Filed 3-21-18; 8:45 am]
BILLING CODE 4164-01-P
