National Institute for Occupational Safety and Health Advisory Board on Radiation and Worker Health, 42067-42068 [05-14380]
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42067
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
Dated: July 15, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–14370 Filed 7–20–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–05–05CN]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–371–5983 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
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. Written comments should
be received within 60 days of this
notice.
Proposed Project
2005 Business Responds to AIDS
(BRTA) Survey—New—National Center
for HIV, STD, and TB Prevention
(NCHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Business Responds to AIDS
(BRTA) program is a partnership among
CDC, business, labor, and the public
health sector that began in 1992. The
purpose of the program is to encourage
businesses to implement HIV/AIDS
policies and education programs in the
workplace. CDC is requesting a 3-year
approval from OMB to administer a
survey to business owners or human
resource directors to assess business
practices and policies relating to HIV/
Number of
respondents
Respondents
Business Owners or Human Resources Directors ..........................................
Dated: July 15, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–14371 Filed 7–20–05; 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), the Centers for Disease
Control and Prevention (CDC)
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19:42 Jul 20, 2005
Jkt 205001
Name: Advisory Board on Radiation and
Worker Health (ABRWH), National Institute
for Occupational Safety and Health (NIOSH)
and Subcommittee for Dose Reconstruction
and Site Profile Reviews.
Working Group Meeting Time and Date: 11
a.m.–1 p.m., EDT, Tuesday, July 26, 2005.
Place: Teleconference call via FTS
Conferencing. The USA toll free dial in
number is 1–800–988–9740 with a pass code
of 56001.
Status: Open to the public, but without a
public comment period.
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
Frm 00044
Fmt 4703
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Number of
responses per
respondent
Average
burden per response
(in hrs)
1
20/60
2,200
announces the following committee
meeting:
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AIDS in the workplace. This proposed
data collection will incorporate some
questions, but will be a shorter version,
from a previously approved data
collection, ‘‘Business Responds to AIDS
Benchmark Study,’’ OMB No. 0920–
0359, which expired on January 31,
1996.
The target population for the 2005
survey will be private-sector worksites
employing 15 or more individuals and
operating in the United States at the
time of the survey. Selected worksites
will be able to respond to the survey by
telephone or electronically through the
internet. An introductory letter
describing the BRTA program and the
survey will be mailed to each selected
worksite two weeks prior to
implementation of the actual survey.
The initial point of contact at the
worksites is expected to be the business
owner for smaller sites and the human
resources director for larger sites. This
individual will be asked to either
complete the interview or provide an
appropriate referral within the
company. CDC anticipates that
information from the survey will allow
the agency to revise and strengthen the
objectives and strategies of the BRTA
program in an effort to support business
practices and policies related to HIV/
AIDS.
There is no cost to respondents
participate in the survey other than their
time.
Total burden
hours
733
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 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)
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42068
Federal Register / Vol. 70, No. 139 / Thursday, July 21, 2005 / Notices
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 priority issues related
to the Mallinckrodt Site Profile Review.
Specifically, the identification and
clarification of specific issues to be included
in the review; finalization of a timeline to
complete the review; setting a time and
location for future meetings and interactions;
and initiating discussions of technical issues
as appropriate.
The agenda is subject to change as
priorities dictate.
In the event a member of the working
group 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.
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: July 15, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–14380 Filed 7–20–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0083]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, and Forms FDA 356h and
2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
VerDate jul<14>2003
19:42 Jul 20, 2005
Jkt 205001
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 22,
2005.
ADDRESSES: OMB is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension, and Forms
FDA 356h and 2567—(OMB Control
Number 0910–0338)—Extension
Under Section 351 of the Public
Health Services Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to insure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as
prescribed by regulations in part 601 (21
CFR part 601).
Section 601.2(a) requires
manufacturers of a biological product to
submit an application with
accompanying information, including
labeling information, to FDA for
approval to market a product in
interstate commerce. The container and
package labeling requirements are
provided under part 610 (21 CFR part
610) §§ 610.60, 610.61, and 610.62. The
estimate for these regulations is
included in the estimate under
§ 601.2(a) in table 1 of this document.
Section 601.5(a) requires licensees to
submit to FDA notice of its intention to
discontinue manufacture of a product or
all products. Section 601.6(a) requires
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licensees to notify selling agents and
distributors upon suspension of its
license, and provide FDA with records
of such notification.
Section 601.12(a)(2) requires,
generally, that the holder of an
approved biologics license application
must assess the effects of a
manufacturing change before
distributing a biological product made
with the change. Section 601.12(a)(4)
requires applicants to promptly revise
all promotional labeling and advertising
to make it consistent with certain
labeling changes implemented. Section
601.12(a)(5) requires applicants to
include a list of all changes contained
in the supplement or annual report; for
supplements, this list must be provided
in the cover letter. The burden estimates
for § 601.12(a)(2) are included in the
estimates for supplements (§ 601.12(b)
and (c)) and annual reports
(§ 601.12(d)). The burden estimates for
§ 601.12(a)(4) are included in the
estimates under § 601.12(f)(4) in table 1
of this document or OMB control
number 0910–0001 (expires May 31,
2008) because the required information
is submitted with Forms FDA 2567 or
2253.
Section 601.12(b)(1) and (b)(3), (c)(1)
and (c)(3), (c)(5), and (d)(1) and (d)(3)
require applicants to follow specific
procedures to inform FDA of each
change, in the product, production
process, quality controls, equipment,
facilities, responsible personnel or
labeling established in an approved
license application. The appropriate
procedure depends on the potential for
the change to have a substantial,
moderate, or minimal adverse effect on
the identity, strength, quality, purity, or
potency of the products as they may
relate to the safety or effectiveness of the
product. Under § 601.12(b)(4),
applicants may ask FDA to expedite its
review of a supplement for public
health reasons or if a delay in making
the change described in it would impose
an extraordinary hardship on the
applicant. The burden estimate for
§ 601.12(b)(4) is minimal and included
in the estimate under § 601.12(b)(1) and
(b)(3) in table 1 of this document.
Section 601.12(e) requires applicants
to submit a protocol, or change to a
protocol, as a supplement requiring
FDA approval before distributing the
product. Section 601.12(f)(1), (f)(2), and
(f)(3) requires applicants to follow
specific procedures to report labeling
changes to FDA. The appropriate
procedure depends on the potential for
the change to have a substantial,
moderate, or minimal adverse effect on
the safety or effectiveness of the
product. Section 601.12(f)(4) requires
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]]>Agencies
[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Notices]
[Pages 42067-42068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14380]
-----------------------------------------------------------------------
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), 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 and Health (NIOSH) and
Subcommittee for Dose Reconstruction and Site Profile Reviews.
Working Group Meeting Time and Date: 11 a.m.-1 p.m., EDT,
Tuesday, July 26, 2005.
Place: Teleconference call via FTS Conferencing. The USA toll
free dial in number is 1-800-988-9740 with a pass code of 56001.
Status: Open to the public, but without a public comment period.
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 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)
[[Page 42068]]
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
priority issues related to the Mallinckrodt Site Profile Review.
Specifically, the identification and clarification of specific
issues to be included in the review; finalization of a timeline to
complete the review; setting a time and location for future meetings
and interactions; and initiating discussions of technical issues as
appropriate.
The agenda is subject to change as priorities dictate.
In the event a member of the working group 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.
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: July 15, 2005.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 05-14380 Filed 7-20-05; 8:45 am]
BILLING CODE 4163-18-P
