Agency Forms Undergoing Paperwork Reduction Act Review, 22155-22156 [E8-8915]
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22155
Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–0263]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Requirements for a Special Permit to
Import Cynomolgus, African Green, or
Rhesus Monkeys into the United States
(OMB Control No. 0920–0263)—
Extension—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID), Centers
for Disease Control and Prevention
(CDC).
necessary for CDC to make public health
decisions. This information enables
CDC to evaluate compliance with the
standards and to determine whether the
measures being taken are adequate to
prevent exposure of persons and
animals during importation. CDC will
monitor at least 2 shipments to be
assured that the provisions of a special
permit plan are being followed by a new
permit holder. CDC will assure that
adequate disease control practices are
being used by new permit holders
before the special permit is extended to
cover the receipt of additional
shipments under the same plan for a
period of 180 days, and may be renewed
upon request. This extension eliminates
the burden on importers to repeatedly
report identical information, requiring
submission only of specific shipment
itineraries and information on changes
to the plan which require approval.
Respondents are commercial or notfor-profit importers of nonhuman
primates. These businesses and
organizations apply for limited and/or
extended permits to import these
nonhuman primates. The burden
represents full disclosure of information
and itinerary/change information,
respectively. There are no costs to
respondents except for their time to
complete the requisition process. The
annualized burden for this data
collection is 20 hours.
Background and Brief Description
CDC is requesting OMB approval to
continue its data collection,
‘‘Requirements for a Special Permit to
Import Cynomolgus, African Green, or
Rhesus Monkeys into the United
States’’, for another three years. There
are no revisions proposed to the
currently approved information
collection request.
A registered importer must request a
special permit to import Cynomolgus,
African Green, or Rhesus monkeys. To
receive a special permit to import
nonhuman primates, the importer must
submit a written plan to the Director of
CDC which specifies steps that will be
taken to prevent exposure of persons
and animals during the entire
importation and quarantine process for
the arriving nonhuman primates.
Under the special permit
arrangement, registered importers must
submit a plan to CDC for importation
and quarantine if they wish to import
the specific monkeys covered. The plan
must address disease prevention
procedures to be carried out in every
step of the chain of custody of such
monkeys, from embarkation in the
country of origin to release from
quarantine. Information such as species,
origin and intended use for monkeys,
transit information, isolation and
quarantine procedures, and procedures
for testing of quarantined animals is
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Businesses (limited permit) .........................................................................................................
Businesses (extended permit) .....................................................................................................
Organizations (extended permit) .................................................................................................
Dated: April 18, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–8888 Filed 4–23–08; 8:45 am]
Centers for Disease Control and
Prevention
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
[30Day–08–0337]
Proposed Project
Agency Forms Undergoing Paperwork
Reduction Act Review
National Blood Lead Surveillance
System (OMB No. 0920–0337)—
Extension—National Center for
Environmental Health (NCEH),
Coordinating Center for Environmental
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Centers for Disease Control and
Prevention (CDC) publishes a list of
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2
3
15
Number of
responses per
respondent
Average
burden per
response
(in hours)
5
5
5
30/60
10/60
10/60
Health and Injury Prevention (CCEHIP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The National Center for
Environmental Health requests an
extension for data collection through the
National Blood Lead Surveillance
System to continue its effort to collect
information related to lead exposure
among children and adults. The purpose
of this project is to support Childhood
Lead Surveillance Systems and the
Adult Blood Lead Epidemiology and
Surveillance Program (ABLES) at the
state and national levels. The objectives
for continuing data collection with the
use of these systems are three fold. First,
we would like to use surveillance data
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24APN1
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
to estimate the extent of elevated bloodlead levels (BLLs) among children less
than 6 years old. This is important
because it will allow us to
systematically track the management
and follow-up of those children found
to be poisoned with lead.
Our next objective for the continued
use of this system is to examine
potential sources of lead exposure.
Although we’ve been successful in
eliminating atmospheric lead with the
use of unleaded gasoline and have
continued to make strides in the
elimination of household sources of
lead commonly found in paint and dust,
recent events have highlighted other
potentially hidden sources of lead. This
system will allow us to track the burden
of such hidden sources and will help us
eliminate such threats with the
establishment of laws aimed at
preventing the importation of such
goods into our nation. The
establishment of such laws will of
course be a joint effort between several
federal agencies; however, this
surveillance system will help facilitate
our efforts.
The final objective of this system is to
facilitate the allocation of resources for
lead poison prevention activities. The
allocation of federal resources to State
surveillance systems are based on
reports of blood-lead tests from
laboratories. Ideally, laboratories report
results of all lead tests to the state health
department. State health departments
then send reports to CDC using deidentified data. It is from these reports
that CDC is able to determine funding
levels.
The use of both Childhood Lead
Surveillance System and the ABLES
Program will allow us to systematically
track pockets of exposure to lead. It will
also allow us to fully understand
exposure potential and ways in which
to prevent future sources of lead
poisoning. Both systems are invaluable
and will no doubt help us as we
continue our stride in the elimination of
lead poisoning in our nation.
There is no cost to respondents other
than their time. The total estimated
annualized burden hours are 656.
ESTIMATED ANNUALIZED BURDEN
Number of
response per
respondent
Number of
respondents
Respondents
Average
burden per
response
(in hrs.)
Total burden
hours
State and Local Health Departments for Child Surveillance ...........................
State and Local Health Departments for Adult Surveillance ...........................
42
40
4
4
2
2
336
320
Total ...................................................................................................
........................
........................
........................
656
Dated: April 18, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–8915 Filed 4–23–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0180]
Draft Guidance for Industry on
Developing Coronary Drug Eluting
Stents; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice of a public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘Coronary
Drug-Eluting Stent (DES) Guidance
Document Workshop.’’ FDA is
cosponsoring the workshop with the
Advanced Medical Technology
Association (AdvaMed). The purpose of
the workshop is to discuss the draft
guidance entitled ‘‘Coronary DrugEluting Stents: Nonclinical and Clinical
Studies’’ announced in the Federal
Register of March 27, 2008, and its
companion document entitled
‘‘Coronary Drug-Eluting Stents-
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16:49 Apr 23, 2008
Jkt 214001
Nonclinical and Clinical Studies
(Companion Document)’’ (the
Companion Document). The workshop
intends to solicit additional comments
on the issues and questions presented in
the draft guidance during the open
comment period.
DATES: The public workshop will be
held on April 29, 2008, from 8 a.m. to
6 p.m. Participants are encouraged to
arrive early to ensure time for parking,
security screening, and registration
before the meeting. Security screening
will begin at 7 a.m., and registration will
begin at 7:30 a.m. Please preregister by
April 22, 2008, according to the
instructions in section I.C of this
document.
ADDRESSES: The public conference will
be held at the Food and Drug
Administration, White Oak Campus,
Bldg. 2, located at 10903 New
Hampshire Ave., Silver Spring, MD
20993.
FOR FURTHER INFORMATION CONTACT:
Ashley Boam, Center for Devices and
Radiological Health, 9200 Corporate
Blvd. (HFZ–400), Rockville, MD
20850, 240–276–3983
ashley.boam@fda.hhs.gov or
Elizabeth Hillebrenner, Center for
Devices and Radiological Health,
9200 Corporate Blvd. (HFZ–450),
Rockville, MD, 20850, 240–276–
4222,
elizabeth.hillebrenner@fda.hhs.gov
PO 00000
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SUPPLEMENTARY INFORMATION:
I. The Public Workshop
A. Why Are We Holding This Public
Workshop?
The purpose of the workshop is to
discuss the draft guidance announced in
the Federal Register of March 27, 2008
(73 FR 16311), and any issues that it
may raise, and to solicit additional
input on the issues and questions
presented in this draft guidance. In
addition, the purpose of this workshop
is to discuss the Companion Document.
B. What Are the Topics We Intend To
Address at the Workshop?
We hope to discuss a large number of
issues at the workshop, including, but
not limited to:
• How to characterize the drug
substance, including chemistry,
nonclinical systemic and local tissue
pharmacology and toxicology, and how
to evaluate potential for and
consequences of systemic clinical
exposure.
• How to characterize the drug-device
combination product, including the
chemical/physical/mechanical
properties of the DES, the nonclinical
local vascular and regional myocardial
toxicology, and the clinical performance
of the drug-stent combination.
• Regulatory considerations that are
unique to DES combination products.
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]]>Agencies
[Federal Register Volume 73, Number 80 (Thursday, April 24, 2008)]
[Notices]
[Pages 22155-22156]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8915]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-0337]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
National Blood Lead Surveillance System (OMB No. 0920-0337)--
Extension--National Center for Environmental Health (NCEH),
Coordinating Center for Environmental Health and Injury Prevention
(CCEHIP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The National Center for Environmental Health requests an extension
for data collection through the National Blood Lead Surveillance System
to continue its effort to collect information related to lead exposure
among children and adults. The purpose of this project is to support
Childhood Lead Surveillance Systems and the Adult Blood Lead
Epidemiology and Surveillance Program (ABLES) at the state and national
levels. The objectives for continuing data collection with the use of
these systems are three fold. First, we would like to use surveillance
data
[[Page 22156]]
to estimate the extent of elevated blood-lead levels (BLLs) among
children less than 6 years old. This is important because it will allow
us to systematically track the management and follow-up of those
children found to be poisoned with lead.
Our next objective for the continued use of this system is to
examine potential sources of lead exposure. Although we've been
successful in eliminating atmospheric lead with the use of unleaded
gasoline and have continued to make strides in the elimination of
household sources of lead commonly found in paint and dust, recent
events have highlighted other potentially hidden sources of lead. This
system will allow us to track the burden of such hidden sources and
will help us eliminate such threats with the establishment of laws
aimed at preventing the importation of such goods into our nation. The
establishment of such laws will of course be a joint effort between
several federal agencies; however, this surveillance system will help
facilitate our efforts.
The final objective of this system is to facilitate the allocation
of resources for lead poison prevention activities. The allocation of
federal resources to State surveillance systems are based on reports of
blood-lead tests from laboratories. Ideally, laboratories report
results of all lead tests to the state health department. State health
departments then send reports to CDC using de-identified data. It is
from these reports that CDC is able to determine funding levels.
The use of both Childhood Lead Surveillance System and the ABLES
Program will allow us to systematically track pockets of exposure to
lead. It will also allow us to fully understand exposure potential and
ways in which to prevent future sources of lead poisoning. Both systems
are invaluable and will no doubt help us as we continue our stride in
the elimination of lead poisoning in our nation.
There is no cost to respondents other than their time. The total
estimated annualized burden hours are 656.
Estimated Annualized Burden
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of response per per response Total burden
respondents respondent (in hrs.) hours
----------------------------------------------------------------------------------------------------------------
State and Local Health Departments for Child 42 4 2 336
Surveillance...................................
State and Local Health Departments for Adult 40 4 2 320
Surveillance...................................
---------------------------------------------------------------
Total................................... .............. .............. .............. 656
----------------------------------------------------------------------------------------------------------------
Dated: April 18, 2008.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E8-8915 Filed 4-23-08; 8:45 am]
BILLING CODE 4163-18-P
