Establishing a Docket for the Development of Safety and Effectiveness Assessments of Vaccines Used for Pandemic Influenza; Availability, 56772-56773 [E7-19577]
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Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices
Submit electronic comments to
eitherhttps://www.fda.gov/dockets/
ecomments orhttps://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sharon Lappalainen, Center for Devices
and Radiological Health (HFZ–450),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4095, or by e-mail at
Sharon.Lappalainen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
pwalker on PROD1PC71 with NOTICES
In the Federal Register of February 5,
1980 (45 FR 7926), FDA issued a final
rule classifying the electrocardiograph
electrode into class II, under the Federal
Food, Drug, and Cosmetic Act (the act).
An electrocardiograph electrode is the
electrical conductor which is applied to
the surface of the body to transmit the
electrical signal at the body surface to a
processor that produces an
electrocardiogram or vectorcardiogram.
FDA has now developed a draft
guidance document for the device and,
under the act’s provisions, is proposing
to designate the draft guidance as the
special control that, when combined
with the general controls, the agency
believes will provide a reasonable
assurance of the safety and effectiveness
of this device type.
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule that would designate this draft
guidance document as the special
control for this device and would
exempt the device from premarket
notification requirements, subject to
limitations in 21 CFR 870.9, if the
device addresses the issues identified in
the special controls guidance by
following the draft guidance’s
recommendations.
The draft special controls guidance
document identifies the classification,
product code, and classification
identification for the electrocardiograph
electrode device. In addition, the draft
guidance document identifies the risks
to health and serves as a special control
that, when followed and combined with
the general controls, will generally
address the risks associated with this
generic device type and permit
introduction of the device to the market.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
VerDate Aug<31>2005
16:20 Oct 03, 2007
Jkt 214001
on the device. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute,
regulations, or both.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Class II Special
Controls Guidance Document:
Electrocardiograph Electrodes’’ you may
either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number (1597) to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
on the Division of Dockets Management
Internet site at https://www.fda.gov/
ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
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comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 26, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E7–19578 Filed 10–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0348]
Establishing a Docket for the
Development of Safety and
Effectiveness Assessments of
Vaccines Used for Pandemic Influenza;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
opening of a docket to receive
information and comments from
manufacturers of vaccines and other
interested persons concerning the
development of safety and effectiveness
assessments of vaccines used for
pandemic influenza. FDA is interested
in obtaining comments and information
to aid in the development of programs
for adverse events surveillance
following administration of pandemic
influenza vaccines, and in the
development of protocols to study
effectiveness of influenza vaccines in
pre-pandemic and pandemic situations.
DATES: Submit written or electronic
comments on the safety and
effectiveness assessments of vaccines for
pandemic influenza use, and comments
on information submitted to the docket
by other interested persons by December
3, 2007.
ADDRESSES: Submit written comments
and information to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852–
1448. Submit electronic comments or
information to either https://
www.fda.gov/dockets/ecomments or
https://www.regulations.gov.
E:\FR\FM\04OCN1.SGM
04OCN1
Federal Register / Vol. 72, No. 192 / Thursday, October 4, 2007 / Notices
Paul
E. Levine, Jr. Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
pwalker on PROD1PC71 with NOTICES
FOR FURTHER INFORMATION CONTACT:
I. Background
The National Strategy for Pandemic
Influenza was issued by President Bush
in November 2005. This National
Strategy identifies the U.S. Department
of Health and Human Services (HHS) as
the lead for medical response and is
intended to guide our nation’s
preparedness and response to pandemic
influenza.
The Implementation Plan for the
National Strategy for Pandemic
Influenza (the Implementation Plan)
was issued by the President on May 3,
2006. The Implementation Plan
translates the Strategy into more than
300 actions for Federal departments and
agencies and sets expectations for State
and local governments and other nonFederal entities. FDA’s Center for
Biologics Evaluation and Research is the
lead for the vaccine action items under
section 6.1.13.9 parts (1) and (3) of
chapter 6 of the Implementation Plan.
This section, in part, states that HHS, in
coordination with the Department of
Defense, the Veteran’s Administration,
and in collaboration with State,
territorial, tribal, and local partners,
shall develop and refine mechanisms to:
(1) Track adverse events following
vaccine and antiviral administration;
and (2) define protocols for conducting
vaccine- and antiviral-effectiveness
studies during a pandemic, within 18
months.
FDA conveyed in our May 31, 2007,
Guidance for Industry: Clinical Data
Needed to Support the Licensure of
Pandemic Influenza Vaccines (72 FR
30599), that all sponsors who seek
licensure of a pandemic influenza
vaccine should expect FDA to seek their
involvement in working with FDA and
other governmental agencies on plans to
collect additional safety and
effectiveness data, such as through
epidemiological studies, when the
vaccine is used (see https://www.fda.gov/
cber/gdlns/panfluvac.htm). FDA and the
Centers for Disease Control and
Prevention are engaged in discussions
about adverse events surveillance
during early use of influenza vaccines
for pre-pandemic and pandemic
situations. Relevant to the actions
outlined in the preceding paragraph, we
are inviting vaccine manufacturers who
are pursuing the development of prepandemic and pandemic influenza
vaccines, as well as other interested
VerDate Aug<31>2005
16:20 Oct 03, 2007
Jkt 214001
persons, to provide comments and
information concerning mechanisms to
track adverse events following
vaccination, and the development of
protocols to study effectiveness of
influenza vaccines during a pandemic.
Specifically, we are requesting
information on the design of potential
studies to assess the effectiveness of
influenza vaccine in a pandemic
situation, including comments on the
potential usefulness of randomized
trials, case control studies, or additional
study designs, as well as, potential
endpoints. In addition, we are seeking
comments on organizations and entities,
such as managed care organizations, or
other public or private entities that may
be able to partner with manufacturers
and sponsors to assess safety and
effectiveness.
We are requesting comments and
information to help us understand the
complex issues encountered in trying to
obtain these data during a pandemic.
Your comments and information might
assist us in the development of
additional guidance documents for the
conduct of postmarketing safety
surveillance and effectiveness studies
for pandemic influenza vaccines.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments and information regarding
this document. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of this document and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the National Strategy for
Pandemic Influenza, issued November
2005, and the Implementation Plan for
the National Strategy, issued May 3,
2006, at (https://www.pandemicflu.gov/
plan/federal/).
Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–19577 Filed 10–3–07; 8:45 am]
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56773
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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 Office of Management
and Budget (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, 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: HRSA AIDS Drug
Assistance Program Quarterly Report—
(OMB No. 0915–0294): Revision
HRSA’s AIDS Drug Assistance
Program (ADAP) is funded through Part
B of Title XXVI of the Public Health
Service Act, the Ryan White HIV/AIDS
Program, which provides grants to
States and Territories. The ADAP
provides medications for the treatment
of HIV disease. Program funds may also
be used to purchase health insurance for
eligible clients or for services that
enhance access, adherence, and
monitoring of drug treatments.
Each of the 50 States, the District of
Columbia, Puerto Rico, and several
Territories receive ADAP grants. As part
of the funding requirements, ADAP
grantees submit quarterly reports that
include information on patients served,
pharmaceuticals prescribed, pricing,
and other sources of support to provide
AIDS medication treatment, eligibility
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 72, Number 192 (Thursday, October 4, 2007)]
[Notices]
[Pages 56772-56773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19577]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0348]
Establishing a Docket for the Development of Safety and
Effectiveness Assessments of Vaccines Used for Pandemic Influenza;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to receive information and comments from
manufacturers of vaccines and other interested persons concerning the
development of safety and effectiveness assessments of vaccines used
for pandemic influenza. FDA is interested in obtaining comments and
information to aid in the development of programs for adverse events
surveillance following administration of pandemic influenza vaccines,
and in the development of protocols to study effectiveness of influenza
vaccines in pre-pandemic and pandemic situations.
DATES: Submit written or electronic comments on the safety and
effectiveness assessments of vaccines for pandemic influenza use, and
comments on information submitted to the docket by other interested
persons by December 3, 2007.
ADDRESSES: Submit written comments and information to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852-1448. Submit electronic
comments or information to either https://www.fda.gov/dockets/ecomments
or https://www.regulations.gov.
[[Page 56773]]
FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr. Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
The National Strategy for Pandemic Influenza was issued by
President Bush in November 2005. This National Strategy identifies the
U.S. Department of Health and Human Services (HHS) as the lead for
medical response and is intended to guide our nation's preparedness and
response to pandemic influenza.
The Implementation Plan for the National Strategy for Pandemic
Influenza (the Implementation Plan) was issued by the President on May
3, 2006. The Implementation Plan translates the Strategy into more than
300 actions for Federal departments and agencies and sets expectations
for State and local governments and other non-Federal entities. FDA's
Center for Biologics Evaluation and Research is the lead for the
vaccine action items under section 6.1.13.9 parts (1) and (3) of
chapter 6 of the Implementation Plan. This section, in part, states
that HHS, in coordination with the Department of Defense, the Veteran's
Administration, and in collaboration with State, territorial, tribal,
and local partners, shall develop and refine mechanisms to: (1) Track
adverse events following vaccine and antiviral administration; and (2)
define protocols for conducting vaccine- and antiviral-effectiveness
studies during a pandemic, within 18 months.
FDA conveyed in our May 31, 2007, Guidance for Industry: Clinical
Data Needed to Support the Licensure of Pandemic Influenza Vaccines (72
FR 30599), that all sponsors who seek licensure of a pandemic influenza
vaccine should expect FDA to seek their involvement in working with FDA
and other governmental agencies on plans to collect additional safety
and effectiveness data, such as through epidemiological studies, when
the vaccine is used (see https://www.fda.gov/cber/gdlns/panfluvac.htm).
FDA and the Centers for Disease Control and Prevention are engaged in
discussions about adverse events surveillance during early use of
influenza vaccines for pre-pandemic and pandemic situations. Relevant
to the actions outlined in the preceding paragraph, we are inviting
vaccine manufacturers who are pursuing the development of pre-pandemic
and pandemic influenza vaccines, as well as other interested persons,
to provide comments and information concerning mechanisms to track
adverse events following vaccination, and the development of protocols
to study effectiveness of influenza vaccines during a pandemic.
Specifically, we are requesting information on the design of
potential studies to assess the effectiveness of influenza vaccine in a
pandemic situation, including comments on the potential usefulness of
randomized trials, case control studies, or additional study designs,
as well as, potential endpoints. In addition, we are seeking comments
on organizations and entities, such as managed care organizations, or
other public or private entities that may be able to partner with
manufacturers and sponsors to assess safety and effectiveness.
We are requesting comments and information to help us understand
the complex issues encountered in trying to obtain these data during a
pandemic. Your comments and information might assist us in the
development of additional guidance documents for the conduct of
postmarketing safety surveillance and effectiveness studies for
pandemic influenza vaccines.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments and information
regarding this document. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in the brackets in the heading of this document. A copy of
this document and received comments are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the National
Strategy for Pandemic Influenza, issued November 2005, and the
Implementation Plan for the National Strategy, issued May 3, 2006, at
(https://www.pandemicflu.gov/plan/federal/).
Dated: September 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19577 Filed 10-3-07; 8:45 am]
BILLING CODE 4160-01-S
