Regulatory Site Visit Training Program, 79133-79134 [E8-30659]
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Federal Register / Vol. 73, No. 248 / Wednesday, December 24, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
appointed to serve as public members
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honorarium for attending Committee
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authorized Committee-related business.
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as representative members for a
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nominations of qualified candidates to
fill positions on the NVAC that are
scheduled to be vacated in the public
member category. The positions are
scheduled to be vacated on March 31,
2009.
Nominations
In accordance with the charter,
persons nominated for appointment as
members of the NVAC should be among
authorities knowledgeable in areas
related to vaccine safety, vaccine
effectiveness, and vaccine supply.
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following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
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basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity); (2) a statement
from the nominee, bearing an original
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is willing to serve as a member of the
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Individuals can nominate themselves
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ensure that the membership of HHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made that a
broad representation of geographic
areas, gender, ethnic and minority
groups, and the disabled are given
VerDate Aug<31>2005
18:45 Dec 23, 2008
Jkt 217001
consideration for membership on HHS
Federal advisory committees.
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made without discrimination on the
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Committee. Individuals appointed to
serve as public members of the
Committee will be required to disclose
information regarding financial
holdings, consultancies, and research
grants and/or contracts.
Dated: December 8, 2008.
Bruce Gellin,
Director, National Vaccine Program Office,
Executive Secretary, National Vaccine
Advisory Committee.
[FR Doc. E8–30614 Filed 12–23–08; 8:45 am]
BILLING CODE 4150–44–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0045] (formerly
Docket No. 2004N–0408)
Regulatory Site Visit Training Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is reannouncing the invitation
for participation in its Regulatory Site
Visit Training Program (RSVP). This
training program is intended to give
CBER regulatory review, compliance,
and other relevant staff an opportunity
to visit biologics facilities. These visits
are intended to allow CBER staff to
directly observe routine manufacturing
practices and to give CBER staff a better
understanding of the biologics industry,
PO 00000
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Fmt 4703
Sfmt 4703
79133
including its challenges and operations.
The purpose of this notice is to invite
biologics facilities to contact CBER for
more information if they are interested
in participating in this program.
DATES: Submit a written or electronic
request for participation in this program
by January 23, 2009. The request should
include a description of your facility
relative to products regulated by CBER.
Please specify the physical address of
the site(s) you are offering.
ADDRESSES: If your biologics facility is
interested in offering a site visit or
learning more about this training
opportunity for CBER staff, or if your
biologics facility responded to a
previous RSVP notice announced in the
Federal Register, you should submit a
request to participate in the program to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic requests to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Lonnie Warren Myers, Division of
Manufacturers Assistance and Training,
Center for Biologics Evaluation and
Research (HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079,
email: matt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological
products including blood and blood
products, vaccines, and cellular, tissue,
and gene therapies. CBER is committed
to advancing the public health through
innovative activities that help ensure
the safety, effectiveness and timely
delivery of biological products to
patients. To support this primary goal,
CBER has initiated various training and
development programs to promote high
performance of its compliance staff,
regulatory review staff, and other
relevant staff. CBER seeks to
continuously enhance and update
review efficiency and quality, and the
quality of its regulatory efforts and
interactions, by providing CBER staff
with a better understanding of the
biologics industry and its operations.
Further, CBER seeks to improve: (1) Its
understanding of current industry
practices, and regulatory impacts and
needs; and (2) communication between
CBER staff and industry. CBER initiated
its RSVP in 2005, and through these
annual notices, is requesting those firms
that have previously applied and are
still interested in participating, to
reaffirm their interest, as well as
E:\FR\FM\24DEN1.SGM
24DEN1
79134
Federal Register / Vol. 73, No. 248 / Wednesday, December 24, 2008 / Notices
encouraging new interested parties to
apply.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. RSVP
Health Resources and Services
Administration
A. Regulatory Site Visits
In this program, over a period of time
to be agreed upon with the facility,
small groups of CBER staff may observe
operations of biologics establishments,
including for example, blood and tissue
establishments. The visits may include
packaging facilities, quality control and
pathology/toxicology laboratories, and
regulatory affairs operations. These
visits, or any part of the program, are
not intended as a mechanism to inspect,
assess, judge, or perform a regulatory
function, but are meant to improve
mutual understanding and to provide an
avenue for open dialogue between the
biologics industry and CBER.
B. Site Selection
All travel expenses associated with
the site visits will be the responsibility
of CBER; therefore, selection of potential
facilities will be based on the
coordination of CBER’s priorities for
staff training as well as the limited
available resources for this program. A
key element of site selection is a
successful compliance record with
CBER or another agency for which we
have a memorandum of understanding.
Facilities should also be advised that if
a site visit involves a separate physical
location of another firm under contract
to the applicant, then this contract site
must be in agreement to participate in
the program, as well as have a
satisfactory compliance history.
III. Requests for Participation
Requests are to be identified with the
docket number found in the brackets in
the heading of this document. Received
requests are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: December 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–30659 Filed 12–23–08; 8:45 am]
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 4160–01–S
VerDate Aug<31>2005
18:45 Dec 23, 2008
Jkt 217001
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Intervention Trials
To Retain HIV-Positive Patients in
Medical Care (NEW)
The purpose of this project is to
develop, implement, and test the
efficacy of an intervention designed to
increase client appointment attendance
among patients at risk of missing
scheduled appointments at HIV clinics.
This project is a collaboration between
the Centers for Disease Control and
Prevention (CDC), the Health Resources
and Services Administration (HRSA),
and six university-affiliated HIV clinics
in the United States. The proposed
intervention will be implemented in
two phases. Phase 1 is a clinic-wide
intervention that includes the following
components: a theme slogan for the
intervention, brochures, posters with
messages to patients, brief verbal
retention in care messages from
providers to patients, buttons printed
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Fmt 4703
Sfmt 4703
with the theme of the intervention worn
by providers, and appointment
reminder cards with information on
how to cancel appointments. All clinic
patients will receive the Phase 1
intervention. Phase 2 of the project is a
two-arm randomized trial in which 300
patients will be enrolled and randomly
assigned to one of two study arms. In
Arm 1 (control arm), patients (n=100)
will receive the clinic-wide intervention
only. Patients (n=200) assigned to Arm
2 (intervention arm) will continue to
receive the clinic-wide intervention
plus a client-centered intervention from
two trained interventionists.
The efficacy of the intervention will
be assessed through data collection
efforts tailored to each phase of the
intervention. Phase 1 uses a pre-post
comparison of clinic attendance rates
before and during a clinic-wide
intervention. Specifically, in Phase 1,
the attendance rate for HIV primary care
is currently being assessed via
electronic medical records during the
12-month period before the clinic-wide
intervention begins. This preintervention assessment is being
collected for all patients who had at
least one HIV primary care visit at the
clinic during the preceding 12 months.
This cohort of patients will be
reassessed via electronic medical
records during the 12-month
intervention period. In addition,
provider surveys will be administered
quarterly during Phase 1 and semiannually during Phase 2 to obtain
information from primary care providers
(MD, DO, nurse practitioner, physician
assistant) about whether they talked to
their patients about the importance of
regular care.
In Phase 2, participants will be
enrolled over a period of 4–9-months to
allow flexibility for faster or slower
enrollment in the clinics. It is
anticipated that most clinics will
complete their enrollment in
approximately 6 months. On a daily
basis, clinic staff or the study
coordinator will generate a list of
patients who meet eligibility criteria
based on attendance history. The list
will be given to the study coordinator
who will approach patients to ask about
their interest in being screened for
eligibility in the study. When patients
agree to be screened for eligibility, the
study coordinator will administer an
eligibility screener. Patients who are
found to be eligible will be enrolled in
the project and all enrollees will
complete a baseline survey (that will
take approximately 30 minutes) before
being randomized to the intervention or
control arm. No follow-up surveys will
be collected. The survey will be
E:\FR\FM\24DEN1.SGM
24DEN1
]]>Agencies
[Federal Register Volume 73, Number 248 (Wednesday, December 24, 2008)]
[Notices]
[Pages 79133-79134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408)
Regulatory Site Visit Training Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is reannouncing the invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this notice is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.
DATES: Submit a written or electronic request for participation in this
program by January 23, 2009. The request should include a description
of your facility relative to products regulated by CBER. Please specify
the physical address of the site(s) you are offering.
ADDRESSES: If your biologics facility is interested in offering a site
visit or learning more about this training opportunity for CBER staff,
or if your biologics facility responded to a previous RSVP notice
announced in the Federal Register, you should submit a request to
participate in the program to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic requests to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Lonnie Warren Myers, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-
3079, email: matt@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
CBER regulates certain biological products including blood and
blood products, vaccines, and cellular, tissue, and gene therapies.
CBER is committed to advancing the public health through innovative
activities that help ensure the safety, effectiveness and timely
delivery of biological products to patients. To support this primary
goal, CBER has initiated various training and development programs to
promote high performance of its compliance staff, regulatory review
staff, and other relevant staff. CBER seeks to continuously enhance and
update review efficiency and quality, and the quality of its regulatory
efforts and interactions, by providing CBER staff with a better
understanding of the biologics industry and its operations. Further,
CBER seeks to improve: (1) Its understanding of current industry
practices, and regulatory impacts and needs; and (2) communication
between CBER staff and industry. CBER initiated its RSVP in 2005, and
through these annual notices, is requesting those firms that have
previously applied and are still interested in participating, to
reaffirm their interest, as well as
[[Page 79134]]
encouraging new interested parties to apply.
II. RSVP
A. Regulatory Site Visits
In this program, over a period of time to be agreed upon with the
facility, small groups of CBER staff may observe operations of
biologics establishments, including for example, blood and tissue
establishments. The visits may include packaging facilities, quality
control and pathology/toxicology laboratories, and regulatory affairs
operations. These visits, or any part of the program, are not intended
as a mechanism to inspect, assess, judge, or perform a regulatory
function, but are meant to improve mutual understanding and to provide
an avenue for open dialogue between the biologics industry and CBER.
B. Site Selection
All travel expenses associated with the site visits will be the
responsibility of CBER; therefore, selection of potential facilities
will be based on the coordination of CBER's priorities for staff
training as well as the limited available resources for this program. A
key element of site selection is a successful compliance record with
CBER or another agency for which we have a memorandum of understanding.
Facilities should also be advised that if a site visit involves a
separate physical location of another firm under contract to the
applicant, then this contract site must be in agreement to participate
in the program, as well as have a satisfactory compliance history.
III. Requests for Participation
Requests are to be identified with the docket number found in the
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30659 Filed 12-23-08; 8:45 am]
BILLING CODE 4160-01-S
