Cooperative Agreement for Poison Prevention Education, 43203-43204 [E6-12178]
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43203
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
new information to Chile. Finally, the
revised guidance notes that FDA
considers the information on this list,
which is provided voluntarily with the
understanding that it will be posted on
FDA’s Internet site and communicated
to, and possibly further disseminated
by, Chile, to be information that is not
protected from disclosure under 5
U.S.C. 552(b)(4). Under this guidance,
FDA recommends that U.S. firms that
want to be placed on the list send the
following information to FDA: Name
and address of the firm and the
manufacturing plant; name, telephone
number, and e-mail address (if
available) of the contact person; a list of
products presently shipped and
expected to be shipped in the next 3
years; identities of agencies that inspect
the plant and the date of last inspection;
plant number and copy of last
inspection notice; and, if other than an
FDA inspection, copy of last inspection
report. FDA requests that this
information be updated every 2 years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
New written requests to be
placed on the list
15
1
15
1.5
22.5
Biannual update
55
1
55
1.0
55.0
Occasional updates
25
1
25
0.5
12.5
Total
sroberts on PROD1PC70 with NOTICES
1There
90
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biannual updates
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 3 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
To date, over 110 producers have
sought to be included on the list. FDA
estimates that, each year, approximately
15 new firms will apply to be added to
the list. We estimate that a firm will
require 1.5 hours to read the guidance,
gather the information needed, and to
prepare a communication to FDA that
contains the information and requests
that the firm be placed on the list.
Under the revised guidance, every 2
years each producer on the list must
provide updated information in order to
remain on the list. FDA estimates that
each year approximately half of the
firms on the list, 55 firms, will resubmit
the information to remain on the list.
We estimate that a firm already on the
list will require 1.0 hours to biannually
update and resubmit the information to
FDA, including time reviewing the
information and corresponding with
FDA. In addition, FDA expects that,
each year, approximately 25 firms will
need to submit an occasional update
and each firm will require 0.5 hours to
prepare a communication to FDA
reporting the change.
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Dated: July 21, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12160 Filed 7–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
the Internet address
‘‘http:www.fda.gov.ohrms/dockets/
default.htm’’ is corrected to read
‘‘https://www.fda.gov/ohrms/dockets/
98fr/06d-0246-gdl0001.pdf’’.
Dated: July 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12179 Filed 7–28–06; 8:45 am]
BILLING CODE 4160–01–S
[Docket No. 2006D–0246]
Draft Manufactured Food Regulatory
Program Standards; Availability;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Fmt 4703
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Health Resources and Services
Administration
Cooperative Agreement for Poison
Prevention Education
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
July 20, 2006. The document announced
the availability of a draft document
entitled ‘‘Manufactured Food Regulatory
Program Standards.’’ The document was
published with an incorrect Internet
address. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Beverly Kent, Division of Federal-State
Relations, Food and Drug
Administration, 300 Pearl St., suite 100,
Buffalo, NY 14202, 716–541–0331.
SUPPLEMENTARY INFORMATION: In FR Doc.
E6–11539, appearing on page 41221 in
the Federal Register of Thursday, July
20, 2006, the following correction is
made:
1. On page 41222, in the first column,
under the ‘‘Electronic Access’’ caption,
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Single Source Award.
AGENCY:
SUMMARY: HRSA will be forming a
partnership with the Home Safety
Council (HSC) to collaborate on
reaching America’s low literacy
population. Through this project, easy
to read and comprehend poison
prevention material will be developed
and distributed to the public, poison
centers, safety and injury prevention
professionals, health educators, and first
responders.
FOR FURTHER INFORMATION CONTACT:
Shkeda Johnson, Senior Public Health
Analyst, Healthcare Systems Bureau,
Division of Healthcare Preparedness,
Room 13–103, 5600 Fishers Lane,
Rockville, MD 20857. Telephone: 301–
443–1210 Email: sjohnson@hrsa.gov.
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43204
Federal Register / Vol. 71, No. 146 / Monday, July 31, 2006 / Notices
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award:
Home Safety Council.
Amount of the Award: $100,000.
Authority: Section 1271 et seq. of the
Public Health Service Act, 42 U.S.C.
Section 300d–71 et seq. as amended by
the Poison Center Stabilization and
Enhancement Grant Program.
Project Period: The period of the
award will begin on September 1, 2006,
through August 31, 2007.
Justification for the Exception to
Competition
This project will be implemented
through a single source cooperative
agreement because the HSC is uniquely
positioned to immediately undertake
and complete the activities within one
year. The HSC has existing
organizational knowledge and
experience in developing materials for
the low literacy population through its
Home Safety Literacy Project, which
this project will be a component; the
HSC has an existing relationship with
key stakeholders in place for reaching
this vulnerable population; and the HSC
project director has extensive expertise
in poison prevention education.
Dated: July 3, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6–12178 Filed 7–28–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Information (RFI): Change
in Grant Appendix Materials
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The National Institutes of
Health (NIH) and the Agency for
Healthcare Research and Quality
(AHRQ) are evaluating guidelines for
grant application appendixes in an
effort to streamline the application and
review processes. This RFI requests
input from interested applicants,
reviewers and other members of the
research community regarding the way
appendix materials should be used in
the grant submission, review and
management process. Comments will be
considered in the development of new
policies on appendix materials for
various grant programs.
DATES: Reponses must be received by
September 14, 2006 in order to ensure
that NIH and AHRQ will be able to
consider the comments in developing
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new policies on appendix materials for
various grant programs.
FOR FURTHER INFORMATION CONTACT: Email inquiries will be accepted at
appendix_comments@od.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
The goal of changing the guidelines
for grant application appendix materials
is to encourage applications to be as
concise as possible while containing the
information needed for expert scientific
review. These changes should make
application preparation and handling
easier for both applicants and reviewers.
Current NIH and AHRQ policy
indicates that the Appendix may not be
used to circumvent the page limitations
of the Research Plan. Appended
publications may not be used to provide
further details of methodologies or
preliminary data described in the
Research Plan. All applications and
proposals for NIH and AHRQ funding
must be self-contained. NIH application
guide instructions note that the
Appendix is sent only to those members
of the Scientific Review Group (SRG)
assigned as primary reviewers of the
application. Currently, unless otherwise
stated in the solicitation, the following
materials may be included in a grant
application Appendix:
• Up to 10 publications or
manuscripts accepted for publication,
using URL links to publicly accessible
journal articles.
• Surveys, questionnaires, data
collection instruments, clinical
protocols, and informed consent
documents.
• Photographs or color images of gels,
micrographs, etc., provided that a
photocopy (may be reduced in size) is
also included within the 25-page limit
of Items a–d of the research plan. No
photographs or color images may be
included in the Appendix that are not
also represented within the Research
Plan.
Investigators spend much time and
energy developing applications to
Federal Agencies. It is unclear whether
appendix material which may or may
not be read by members of the SRG
improves current applications.
Submission of unnecessary materials
with grant applications wastes the time,
energy and resources of investigators,
applicant institutions, reviewers, and
the NIH and AHRQ.
Proposed Changes
The following changes are being
considered for implementation
concurrent with NIH/AHRQ’s transition
to the electronic grant application
process and the SF–424 (R&R):
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• Submission of photographs or color
images of gels, micrographs, etc., will
not be allowed in the Appendix. Use of
the SF–424 (R&R) electronic grant
application will permit insertion into
the body of the Research Plan high
resolution images of the same quality
found in scientific publications.
• Materials currently submitted in the
Appendix which are essential to the
review of the application will be
submitted as part of the grant
application itself. For example,
documents such as clinical protocols,
informed consent forms, key
questionnaires, surveys, and similar
items which are needed by the SRG to
adequately assess human subjects issues
will be submitted as part of the
’Protection of Human Subjects’ section
of the grant application.
• Reprints or preprints of
publications or their PDFs will no
longer be allowed as part of the
Appendix. Links (URLs) to PubMed
Central or publicly available on-line
journals will be permitted in the
Biographical Sketches, Bibliography &
References Cited, and the Research Plan
sections of the grant application. Critical
information and detail should be
included within the Research Plan and
cited in the Bibliography & References
Cited section and/or figure or table
legend(s) to indicate publication status.
• Materials specifically designated in
the Funding Opportunity
Announcement may be included in the
Appendix, within identified page limits.
It is anticipated that most FOAs will not
permit materials to be included in the
Appendix.
• All members of the SRG will
receive copies of the full application
including any permitted Appendix
materials thereby increasing the equity
of the review.
Information Requested
Information in the following areas
will assist the NIH and AHRQ in
developing new policies regarding
submission of appendix materials.
Respondents will be asked to indicate
what perspective(s) they represent, i.e.
reviewer and/or applicant, institutional
official, etc.
1. Is there a need to reduce the
material submitted in the Appendix? If
yes, please provide specific types of
material that could be eliminated.
2. Is there information essential to the
application’s review that cannot be
included in the body of a grant
application as proposed? If yes, please
describe the material and identify
applicable grant program(s).
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]]>Agencies
[Federal Register Volume 71, Number 146 (Monday, July 31, 2006)]
[Notices]
[Pages 43203-43204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Cooperative Agreement for Poison Prevention Education
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Notice of Single Source Award.
-----------------------------------------------------------------------
SUMMARY: HRSA will be forming a partnership with the Home Safety
Council (HSC) to collaborate on reaching America's low literacy
population. Through this project, easy to read and comprehend poison
prevention material will be developed and distributed to the public,
poison centers, safety and injury prevention professionals, health
educators, and first responders.
FOR FURTHER INFORMATION CONTACT: Shkeda Johnson, Senior Public Health
Analyst, Healthcare Systems Bureau, Division of Healthcare
Preparedness, Room 13-103, 5600 Fishers Lane, Rockville, MD 20857.
Telephone: 301-443-1210 Email: sjohnson@hrsa.gov.
[[Page 43204]]
SUPPLEMENTARY INFORMATION:
Intended Recipient of the Award: Home Safety Council.
Amount of the Award: $100,000.
Authority: Section 1271 et seq. of the Public Health Service Act,
42 U.S.C. Section 300d-71 et seq. as amended by the Poison Center
Stabilization and Enhancement Grant Program.
Project Period: The period of the award will begin on September 1,
2006, through August 31, 2007.
Justification for the Exception to Competition
This project will be implemented through a single source
cooperative agreement because the HSC is uniquely positioned to
immediately undertake and complete the activities within one year. The
HSC has existing organizational knowledge and experience in developing
materials for the low literacy population through its Home Safety
Literacy Project, which this project will be a component; the HSC has
an existing relationship with key stakeholders in place for reaching
this vulnerable population; and the HSC project director has extensive
expertise in poison prevention education.
Dated: July 3, 2006.
Elizabeth M. Duke,
Administrator.
[FR Doc. E6-12178 Filed 7-28-06; 8:45 am]
BILLING CODE 4165-15-P
