The Development and Evaluation of Human Cytomegalovirus Vaccines; Public Workshop, 69743 [2011-29006]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 217 / Wednesday, November 9, 2011 / Notices
The estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
FDA has not received any new
enforcement notifications; therefore, the
Agency estimates that one or fewer
notifications will be submitted
annually. Although FDA has not
received any new enforcement
notifications in the last 3 years, it
believes these information collection
provisions should be extended to
provide for the potential future need of
a State government to submit
enforcement notifications informing
FDA when it intends to take
enforcement action under the FD&C Act
against a particular food located in the
State.
Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29058 Filed 11–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
The Development and Evaluation of
Human Cytomegalovirus Vaccines;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration,
Center for Biologics Evaluation and
Research, the National Institutes of
Health, the National Institute of Allergy
and Infectious Diseases, the Centers for
Disease Control and Prevention, and the
National Vaccine Program Office are
announcing a public workshop entitled
‘‘The Development and Evaluation of
Human Cytomegalovirus Vaccines.’’ The
purpose of the public workshop is to
identify and discuss key issues related
to the development and evaluation of
human cytomegalovirus (HCMV)
vaccines. The public workshop will
include presentations on HCMV disease
and pathogenesis and issues related to
vaccine development.
Date and Time: The public workshop
will be held on January 10 and January
11, 2012, from 8:30 a.m. to 5:30 p.m.
Location: The public workshop will
be held at Lister Hill Center
Auditorium, National Institutes of
Health, Bldg. 38A, 8600 Rockville Pike,
Bethesda, MD 20894. Pre-registered
participants will receive additional
VerDate Mar<15>2010
18:04 Nov 08, 2011
Jkt 226001
information on parking and public
transportation with their email
registration confirmation.
Contact Person: Manen Bishop,
Center for Biologics Evaluation and
Research (HFM–43), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
(301) 827–2000, FAX: (301) 827–3079,
email: CBERTraining@fda.hhs.gov
(Subject line: HCMV Vaccine
Workshop).
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Manen
Bishop (see Contact Person) or email to
CBERTraining@fda.hhs.gov (Subject
line: HCMV Workshop Registration) by
December 12, 2011. There is no
registration fee for the public workshop.
Early registration is recommended
because seating is limited. Registration
on the day of the public workshop will
be provided on a space available basis
beginning at 8 a.m.
If you need special accommodations
due to a disability, please contact
Manen Bishop (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: HCMV,
also known as human herpesvirus 5,
infects approximately half of the U.S.
population by adulthood. While most
infections are without symptoms, the
infection is lifelong. However, the
disease may become apparent in
children who were infected during
gestation (congenital HCMV) and in
infected individuals with weakened
immune systems. Congenital HCMV
infection causes mental retardation,
learning disabilities, hearing loss, vision
loss, and other disabilities. Patients
undergoing stem cell or solid-organ
transplants are at particularly high risk
for severe disease or death from HCMV
infection.
An effective vaccine could have a
significant impact on rates of congenital
anomalies and severe infections caused
by HCMV. However, efforts to develop
a vaccine against HCMV have not yet
been successful.
The public workshop will focus on
the status of knowledge about HCMV
biology and epidemiology and on
vaccine development strategies. Topics
for discussion will include: (1) HCMV
epidemiology and diagnosis, (2) HCMV
immunology and virology, (3)
manufacturers’ and regulators’
perspectives, (4) target populations for a
HCMV vaccine, (5) design of clinical
trials to study HCMV vaccines in the
setting of congenital HCMV and
transplants, and (6) next steps toward
development of HCMV vaccines.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
69743
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: November 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29006 Filed 11–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Application for Collaboration
With the NIH Center for Translational
Therapeutics (NCTT)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
(insert name of NIH Institute or Center),
the National Institutes of Health (NIH)
will publish periodic summaries of
proposed projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval.
Proposed Collection: Title:
Application for collaboration with the
NIH Center for Translational
Therapeutics (NCTT). Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
Programs at the NCTT provide
opportunities to partner with and gain
access to both common and specifically
rare and neglected disease through a
variety of programs delivering assay
development, screening, hit to lead
chemistry, lead optimization, chemical
biology studies, drug development
capabilities, expertise, and clinical/
regulatory resources in a collaborative
environment with the goal of moving
promising therapeutics into human
clinical trials. NCTT uses an application
and evaluation process to select
collaborators. Selected investigators
provide the drug project starting points
and ongoing biological/disease expertise
throughout the project. Frequency of
Response: Four per year. Affected
Public: Research scientists. Type of
Respondents: Academic scientists,
industry, not-for-profits, government
SUMMARY:
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Page 69743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29006]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
The Development and Evaluation of Human Cytomegalovirus Vaccines;
Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration, Center for Biologics Evaluation
and Research, the National Institutes of Health, the National Institute
of Allergy and Infectious Diseases, the Centers for Disease Control and
Prevention, and the National Vaccine Program Office are announcing a
public workshop entitled ``The Development and Evaluation of Human
Cytomegalovirus Vaccines.'' The purpose of the public workshop is to
identify and discuss key issues related to the development and
evaluation of human cytomegalovirus (HCMV) vaccines. The public
workshop will include presentations on HCMV disease and pathogenesis
and issues related to vaccine development.
Date and Time: The public workshop will be held on January 10 and
January 11, 2012, from 8:30 a.m. to 5:30 p.m.
Location: The public workshop will be held at Lister Hill Center
Auditorium, National Institutes of Health, Bldg. 38A, 8600 Rockville
Pike, Bethesda, MD 20894. Pre-registered participants will receive
additional information on parking and public transportation with their
email registration confirmation.
Contact Person: Manen Bishop, Center for Biologics Evaluation and
Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448, (301) 827-2000, FAX: (301) 827-
3079, email: CBERTraining@fda.hhs.gov (Subject line: HCMV Vaccine
Workshop).
Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone, and fax numbers) to Manen
Bishop (see Contact Person) or email to CBERTraining@fda.hhs.gov
(Subject line: HCMV Workshop Registration) by December 12, 2011. There
is no registration fee for the public workshop. Early registration is
recommended because seating is limited. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 8 a.m.
If you need special accommodations due to a disability, please
contact Manen Bishop (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: HCMV, also known as human herpesvirus 5,
infects approximately half of the U.S. population by adulthood. While
most infections are without symptoms, the infection is lifelong.
However, the disease may become apparent in children who were infected
during gestation (congenital HCMV) and in infected individuals with
weakened immune systems. Congenital HCMV infection causes mental
retardation, learning disabilities, hearing loss, vision loss, and
other disabilities. Patients undergoing stem cell or solid-organ
transplants are at particularly high risk for severe disease or death
from HCMV infection.
An effective vaccine could have a significant impact on rates of
congenital anomalies and severe infections caused by HCMV. However,
efforts to develop a vaccine against HCMV have not yet been successful.
The public workshop will focus on the status of knowledge about
HCMV biology and epidemiology and on vaccine development strategies.
Topics for discussion will include: (1) HCMV epidemiology and
diagnosis, (2) HCMV immunology and virology, (3) manufacturers' and
regulators' perspectives, (4) target populations for a HCMV vaccine,
(5) design of clinical trials to study HCMV vaccines in the setting of
congenital HCMV and transplants, and (6) next steps toward development
of HCMV vaccines.
Transcripts: Please be advised that as soon as possible after a
transcript of the public workshop is available, it will be accessible
at: https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Transcripts of the public workshop may also be requested in writing
from the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: November 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29006 Filed 11-8-11; 8:45 am]
BILLING CODE 4160-01-P
