National Institute for Occupational Safety and Health Advisory Board on Radiation and Worker Health, 36188-36189 [05-12292]
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36188
Federal Register / Vol. 70, No. 119 / Wednesday, June 22, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Technical
Evaluation Panel (TEP): Pilot FollowUp of Former Workers at Vermiculite
Processing Sites in the United States,
Contract Solicitation Number
#0000HTB8–2005–19635
Advisory Committee on Immunization
Practices
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Advisory Committee on
Immunization Practices (ACIP).
Times and Dates: 8 a.m.–6:45 p.m., June
29, 2005;8 a.m.–3:35 p.m., June 30, 2005.
Place: Atlanta Marriott Century Center,
2000 Century Boulevard, NE., Atlanta,
Georgia 30345–3377.
Status: Open to the public, limited only by
the space available.
Purpose: The Committee is charged with
advising the Director, CDC, on the
appropriate uses of immunizing agents. In
addition, under 42 U.S.C. 1396s, the
Committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for administration
to vaccine-eligible children through the
Vaccines for Children (VFC) program, along
with schedules regarding the appropriate
periodicity, dosage, and contraindications
applicable to the vaccines.
Matters To Be Discussed: The agenda will
include discussions on pertussis adolescent
recommendation and use in adults; Hepatitis
B vaccine recommendation;
recommendations of use of Hepatitis A
vaccine and possibleVFC vote; Measles,
Mumps, Rubella, and Varicella VirusVaccine
(MMRV): Overview of varicella epidemiology
and possible VFC votes on second dose
varicella and MMRV; summary of American
Academy of Pediatrics recommendations;
Human Papilloma Virus vaccine working
group update; general recommendations:
vaccine storage and handling; adult
immunization schedule; Advisory Committee
on Immunization Practices and National
Vaccine Advisory Committee joint working
group and the preliminary results on
pandemic vaccine prioritization; Advisory
Committee on ImmunizationPractices and
Healthcare Infection Control
PracticesAdvisory Committee joint statement
on immunization of health care workers
against influenza; rotavirus; HIV vaccine
update; and Departmental updates.
Contact Person for more Information:
Demetria Gardner, Epidemiology and
Surveillance Division, NationalImmunization
Program, CDC, 1600 Clifton Road, NE., (E–
61),Atlanta, Georgia 30333, telephone 404/
639–8096, fax 404/639–8616.
Due to programmatic issues that had to be
resolved, the Federal Register notice is being
published less than fifteen days before the
date of the meeting.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
Name: Disease, Disability, and Injury
Prevention and Control Technical Evaluation
Panel (TEP): Pilot Follow-Up of Former
Workers at Vermiculite Processing Sites in
the United States, Contract Solicitation
Number #0000HTB8–2005–19635.
Times and Dates: 11:30 a.m.–12 p.m., July
7, 2005 (Open); 12 p.m.–3 p.m., July 7, 2005
(Closed).
Place: Teleconference (404) 498–0003.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to: Pilot Follow-Up of Former
Workers at Vermiculite Processing Sites in
the United States, Contract Solicitation
Number #0000HTB8–2005–19635.
Contact Person for More Information:
Mildred Williams-Johnson, Ph.D., D.A.B.T.,
Health Science Administrator, National
Center for Environmental Health, CDC, 1600
Clifton Road NE., Mailstop E28, Atlanta, GA
30333, Telephone (404) 498–0639.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 16, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–12296 Filed 6–21–05; 8:45 am]
BILLING CODE 4163–18–P
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In accordance with section 10(a)(2) of
the FederalAdvisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following Federal
Committee meeting.
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other committee management activities for
both the CDC and ATSDR.
Dated: June 16, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–12293 Filed 6–21–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
National Institute for Occupational
Safety and Health Advisory Board on
Radiation and Worker Health
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), and pursuant to the
requirements of 42 CFR 83.15(a), the
Centers for Disease Control and
Prevention (CDC) announces the
following committee meeting:
Name: Advisory Board on Radiation and
Worker Health(ABRWH), National Institute
for Occupational Safety andHealth (NIOSH)
and Subcommittee for Dose Reconstruction
andSite Profile Reviews.
Subcommittee Meeting Times and Dates:
7:30 a.m.–8:30 a.m., July 6, 2005.
7:30 a.m.–9 a.m., July 7, 2005.
Committee Meeting Times and Dates:
1 p.m.–6 p.m., July 5, 2005.
7:30 p.m.–9 p.m., July 5, 2005.
8:30 a.m.—5:30 p.m., July 6, 2005.
9 a.m.–4:15 p.m., July 7, 2005.
4:15 p.m.–5:45 p.m., July 7, 2005.
Place: Chase Park Plaza Hotel, 212–232 N.
Kingshighway Blvd., St. Louis, Missouri
63108, telephone: 314–633–1000, fax: 314–
633–1144.
Status: Open to the public, limited only by
the space available. The meeting space
accommodates approximately 200 people.
Background: The ABRWH was established
under the Energy Employees Occupational
Illness Compensation Program Act
(EEOICPA) of 2000 to advise the President,
delegated to the Secretary of Health and
Human Services (HHS), on a variety of policy
and technical functions required to
implement and effectively manage the new
compensation program. Key functions of the
Board include providing advice on the
development of probability of causation
guidelines which have been promulgated by
HHS as a final rule, advice on methods of
dose reconstruction which have also been
promulgated by HHS as a final rule, advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program, and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC). In December 2000, the
President delegated responsibility for
funding, staffing, and operating the Board to
HHS, which subsequently delegated this
E:\FR\FM\22JNN1.SGM
22JNN1
Federal Register / Vol. 70, No. 119 / Wednesday, June 22, 2005 / Notices
authority to the CDC. NIOSH implements this
responsibility for CDC. The charter was
issued on August 3, 2001, and renewed on
August 3, 2003.
Purpose: This board is charged with (a)
providing advice to the Secretary, HHS on
the development of guidelines under
Executive Order 13179; (b) providing advice
to the Secretary, HHS on the scientific
validity and quality of dose reconstruction
efforts performed for this Program; and (c)
upon request by the Secretary, HHS, advise
the Secretary on whether there is a class of
employees at any Department of Energy
facility who were exposed to radiation but for
whom it is not feasible to estimate their
radiation dose, and on whether there is
reasonable likelihood that such radiation
doses may have endangered the health of
members of this class.
Matters to be Discussed: Agenda for this
meeting will focus on comments by Members
of Congress; Review of the Draft Minutes;
Bethlehem Steel Technical Basis Document;
Y–12 Site Profile; Y–12 SEC Petition; Board
Discussion of Y–12 SEC Petition; Iowa Army
Ammunition Plant (IAAP) SEC Petition;
Board Discussion of IAAP SEC Petition;
Mallinckrodt Site Profile; Mallinckrodt SEC
Petition; Board Discussion of Mallinckrodt
SEC Petition; Policy Issues related to SEC
Petitions; SC&A Task III/Workbook Issues;
Report on the review of the first 20 Dose
Reconstructions; Report on the review of the
second 18 Dose Reconstructions; SC&A
Contract Issues; Board Discussion; Program
Updates; and Science Issues. There will be an
evening general public comment period
scheduled for July 5, 2005 and one on the
afternoon on July 7. Summaries of the
petitions for designation of classes of
employees at Mallinckrodt, IAAP, and the Y–
12 Plant as members of the SEC and the
NIOSH findings from evaluating the petitions
that will be considered are as follows:
Mallinckrodt Chemical Company, Destrehan
Street Plant, St. Louis, Missouri, the entire
uranium division, 1942–1957. The NIOSH
SEC Petition Evaluation Report and
Supplement for Mallinckrodt 1949–1957
finds sufficient scientific and technical basis
to estimate radiation doses.
IAAP, Line 1, Burlington, Iowa, 1947–
1974. The NIOSH SEC Petition Evaluation
Report finds it is not feasible to estimate
radiation doses potentially incurred by
radiographers with sufficient accuracy from
May 1948 to March 1949.
Y–12 Plant, Oak Ridge, Tennessee, Control
Operators, January 1944 through December
1945. The NIOSH SEC Petition Evaluation
Report finds it is not feasible to estimate
radiation doses with sufficient accuracy for
employees who worked in uranium
enrichment operations or other radiological
processes at the Y–12 facility from March
1943 through December 1947.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot attend,
written comments may be submitted. Any
written comments received will be provided
at the meeting and should be submitted to
the contact person below well in advance of
the meeting.
Contact Person for More Information: Dr.
Lewis V. Wade, Executive Secretary, NIOSH,
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21:12 Jun 21, 2005
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CDC, 4676 Columbia Parkway, Cincinnati,
Ohio 45226, telephone (513) 533–6825, fax
(513) 533–6826.
Due to programmatic issues that had to be
resolved, the Federal Register notice is being
published less than fifteen days before the
date of the meeting.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: June 16, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–12292 Filed 6–21–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0219]
Guidance for Industry: General
Principles for Evaluating the Safety of
Compounds Used in Food-Producing
Animals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised guidance for
industry entitled ‘‘General Principles for
Evaluating the Safety of Compounds
Used in Food-Producing Animals (GFI
#3).’’ This version of the guidance
replaces the version that was made
available in July 1994. This has been
revised to remove outdated information
on toxicological testing and to provide
references to other available guidance
on the topic. In addition, the document
has been revised to address minor
formatting issues.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
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36189
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Mark M. Robinson, Center for
Veterinary Medicine (HFV–150), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 301–827–
5282, e-mail: mrobinson@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA published the guidance for
industry entitled ‘‘General Principles for
Evaluating the Safety of Compounds
Used in Food-Producing Animals (GFI
#3)’’ in July 1994. Since that time, FDA
has published a number of guidance
documents in its participation with
International Cooperation on
Harmonization of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH)
that provide recommendations on
toxicological testing of compounds used
in food-producing animals. This version
of guidance #3 replaces the version that
was made available in July 1994. The
guidance has been updated to remove
outdated information on toxicological
testing and refers the reader to the
relevant Center for Veterinary Medicine/
VICH guidance documents. In addition,
the document was revised to address
minor formatting issues including
correcting an error in the numbering of
the guidance sections.
II. Significance of Guidance
This document is being revised as a
level 2 guidance consistent with FDA’s
good guidance practices regulation (21
CFR 10.115.) The guidance represents
the agency’s current thinking on the
subject matter. The document does not
create or confer any rights for or on any
person and will not operate to bind FDA
or the public. Alternative methods may
be used as long as they satisfy the
requirements of the applicable statutes
and regulations.
III. Comments
As with all of FDA’s guidances, the
public is encouraged to submit written
or electronic comments pertinent to this
guidance. FDA will periodically review
the comments in the docket and, where
appropriate, will amend the guidance.
The agency will notify the public of any
such amendments through a notice in
the Federal Register.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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Agencies
[Federal Register Volume 70, Number 119 (Wednesday, June 22, 2005)]
[Notices]
[Pages 36188-36189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12292]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health Advisory
Board on Radiation and Worker Health
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), and pursuant to the requirements of 42
CFR 83.15(a), the Centers for Disease Control and Prevention (CDC)
announces the following committee meeting:
Name: Advisory Board on Radiation and Worker Health(ABRWH),
National Institute for Occupational Safety andHealth (NIOSH) and
Subcommittee for Dose Reconstruction andSite Profile Reviews.
Subcommittee Meeting Times and Dates:
7:30 a.m.-8:30 a.m., July 6, 2005.
7:30 a.m.-9 a.m., July 7, 2005.
Committee Meeting Times and Dates:
1 p.m.-6 p.m., July 5, 2005.
7:30 p.m.-9 p.m., July 5, 2005.
8:30 a.m.--5:30 p.m., July 6, 2005.
9 a.m.-4:15 p.m., July 7, 2005.
4:15 p.m.-5:45 p.m., July 7, 2005.
Place: Chase Park Plaza Hotel, 212-232 N. Kingshighway Blvd.,
St. Louis, Missouri 63108, telephone: 314-633-1000, fax: 314-633-
1144.
Status: Open to the public, limited only by the space available.
The meeting space accommodates approximately 200 people.
Background: The ABRWH was established under the Energy Employees
Occupational Illness Compensation Program Act (EEOICPA) of 2000 to
advise the President, delegated to the Secretary of Health and Human
Services (HHS), on a variety of policy and technical functions
required to implement and effectively manage the new compensation
program. Key functions of the Board include providing advice on the
development of probability of causation guidelines which have been
promulgated by HHS as a final rule, advice on methods of dose
reconstruction which have also been promulgated by HHS as a final
rule, advice on the scientific validity and quality of dose
estimation and reconstruction efforts being performed for purposes
of the compensation program, and advice on petitions to add classes
of workers to the Special Exposure Cohort (SEC). In December 2000,
the President delegated responsibility for funding, staffing, and
operating the Board to HHS, which subsequently delegated this
[[Page 36189]]
authority to the CDC. NIOSH implements this responsibility for CDC.
The charter was issued on August 3, 2001, and renewed on August 3,
2003.
Purpose: This board is charged with (a) providing advice to the
Secretary, HHS on the development of guidelines under Executive
Order 13179; (b) providing advice to the Secretary, HHS on the
scientific validity and quality of dose reconstruction efforts
performed for this Program; and (c) upon request by the Secretary,
HHS, advise the Secretary on whether there is a class of employees
at any Department of Energy facility who were exposed to radiation
but for whom it is not feasible to estimate their radiation dose,
and on whether there is reasonable likelihood that such radiation
doses may have endangered the health of members of this class.
Matters to be Discussed: Agenda for this meeting will focus on
comments by Members of Congress; Review of the Draft Minutes;
Bethlehem Steel Technical Basis Document; Y-12 Site Profile; Y-12
SEC Petition; Board Discussion of Y-12 SEC Petition; Iowa Army
Ammunition Plant (IAAP) SEC Petition; Board Discussion of IAAP SEC
Petition; Mallinckrodt Site Profile; Mallinckrodt SEC Petition;
Board Discussion of Mallinckrodt SEC Petition; Policy Issues related
to SEC Petitions; SC&A Task III/Workbook Issues; Report on the
review of the first 20 Dose Reconstructions; Report on the review of
the second 18 Dose Reconstructions; SC&A Contract Issues; Board
Discussion; Program Updates; and Science Issues. There will be an
evening general public comment period scheduled for July 5, 2005 and
one on the afternoon on July 7. Summaries of the petitions for
designation of classes of employees at Mallinckrodt, IAAP, and the
Y-12 Plant as members of the SEC and the NIOSH findings from
evaluating the petitions that will be considered are as follows:
Mallinckrodt Chemical Company, Destrehan Street Plant, St. Louis,
Missouri, the entire uranium division, 1942-1957. The NIOSH SEC
Petition Evaluation Report and Supplement for Mallinckrodt 1949-1957
finds sufficient scientific and technical basis to estimate
radiation doses.
IAAP, Line 1, Burlington, Iowa, 1947-1974. The NIOSH SEC
Petition Evaluation Report finds it is not feasible to estimate
radiation doses potentially incurred by radiographers with
sufficient accuracy from May 1948 to March 1949.
Y-12 Plant, Oak Ridge, Tennessee, Control Operators, January
1944 through December 1945. The NIOSH SEC Petition Evaluation Report
finds it is not feasible to estimate radiation doses with sufficient
accuracy for employees who worked in uranium enrichment operations
or other radiological processes at the Y-12 facility from March 1943
through December 1947.
The agenda is subject to change as priorities dictate.
In the event an individual cannot attend, written comments may
be submitted. Any written comments received will be provided at the
meeting and should be submitted to the contact person below well in
advance of the meeting.
Contact Person for More Information: Dr. Lewis V. Wade,
Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati,
Ohio 45226, telephone (513) 533-6825, fax (513) 533-6826.
Due to programmatic issues that had to be resolved, the Federal
Register notice is being published less than fifteen days before the
date of the meeting.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities for both the Centers for Disease Control and Prevention
and the Agency for Toxic Substances and Disease Registry.
Dated: June 16, 2005.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 05-12292 Filed 6-21-05; 8:45 am]
BILLING CODE 4163-19-P