Agency Forms Undergoing Paperwork Reduction Act Review, 22155-22156 [E8-8915]

Download as PDF 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 BILLING CODE 4163–18–P sroberts on PROD1PC70 with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES The Centers for Disease Control and Prevention (CDC) publishes a list of VerDate Aug<31>2005 16:49 Apr 23, 2008 Jkt 214001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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 E:\FR\FM\24APN1.SGM 24APN1 22156 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] BILLING CODE 4163–18–P 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- VerDate Aug<31>2005 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 Frm 00032 Fmt 4703 Sfmt 4703 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. E:\FR\FM\24APN1.SGM 24APN1

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