National Institute for Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), 40582 [E8-16065]
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40582
Federal Register / Vol. 73, No. 136 / Tuesday, July 15, 2008 / Notices
websites for ordinary business purposes,
including advertising their goods or
services and to facilitate communication
with the public. Accordingly, any costs
franchisors would incur specifically as
a result of electronic disclosure under
part 436 appear to be minimal.
As set forth in the 2005 Notices, staff
estimates that the non-labor burden
incurred by franchisors under part 436
will differ based on the length of the
disclosure document and the number of
disclosure documents produced. Staff
estimates that 2,000 franchisors (80% of
total franchisors covered by the Rule)
will print and mail 100 disclosure
documents at $35 each. Thus, these
franchisors will each incur $3,500 in
printing and mailing costs. Staff
estimates that the remaining 20% of
covered franchisors (500) will transmit
50% of their 100 disclosure documents
electronically, at $5 per electronic
disclosure. Thus, these franchisors will
each incur $2,000 in distribution costs
(($250 for electronic disclosure [$5 for
electronic disclosure x 50 disclosure
documents]) + ($1,750 for printing and
mailing [$35 for printing and mailing x
50 disclosure documents])).
Accordingly, the cumulative annual
non-labor costs for part 436 of the
amended Rule is approximately
$8,000,000 (($3,500 printing and
mailing costs x 2,000 franchisors =
$7,000,000) + ($250 electronic
distribution costs + $1,750 printing and
mailing costs) x 500 franchisors =
$1,000,000)).
William Blumenthal
General Counsel
[FR Doc. E8–16092 Filed 7–15–08: 8:45 am]
[BILLING CODE 6750–01–S]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
National Institute for Occupational
Safety and Health (NIOSH) Advisory
Board on Radiation and Worker Health
(ABRWH orAdvisory Board)
mstockstill on PROD1PC66 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following committee meeting:
Name: Advisory Board on Radiation and
Worker Health, National Institute for
Occupational Safety and Health.
Audio Conference Call Time And Date: 11
a.m.–4 p.m., EDT, Tuesday, August 5, 2008.
Place: Audio Conference Call via FTS
Conferencing. The USA toll free dial in
VerDate Aug<31>2005
15:01 Jul 14, 2008
Jkt 214001
number is 1–866–659–0537 with a pass code
of 9933701.
Status: Open to the public, but without a
public comment period.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the new compensation program. Key
functions of the Advisory Board include
providing advice on the development of
probability of causation guidelines which
have been promulgated by the Department of
Health and Human Services (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 Advisory
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, renewed at
appropriate intervals, most recently, August
3, 2007, and will expire on August 3, 2009.
Purpose: This Advisory 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, advising 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: The agenda for the
conference call includes: Special Exposure
Cohort (SEC) Petition Status Updates;
Updates from the Subcommittee on Dose
Reconstruction and Work Groups; Update on
selection of the Board’s contractor; Future
Plans; and Status of transcripts and minutes.
The agenda is subject to change as
priorities dictate.
Because there is not a public comment
period, written comments may be submitted.
Any written comments received will be
included in the official record of the meeting
and should be submitted to the contact
person below well in advance of the meeting.
Contact Person for More Information:
Zaida Burgos, Committee Management
Specialist, NIOSH, CDC, 1600 Clifton Road,
Atlanta, Georgia 30033, Telephone (404)
498–2548 e-mail: zab6@cdc.gov.
Toll Free 1–800–CDC-INFO, e-mail
ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
PO 00000
Frm 00104
Fmt 4703
Sfmt 4703
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: July 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–16065 Filed 7–14–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–P–0326]
Determination That SANOREX
(Mazindol) Tablets 1 and 2 Milligrams
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that SANOREX
(mazindol) Tablets, 1 and 2 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for mazindol
tablets if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
E:\FR\FM\15JYN1.SGM
15JYN1
]]>Agencies
[Federal Register Volume 73, Number 136 (Tuesday, July 15, 2008)]
[Notices]
[Page 40582]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH)
Advisory Board on Radiation and Worker Health (ABRWH orAdvisory Board)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention announces the following committee meeting:
Name: Advisory Board on Radiation and Worker Health, National
Institute for Occupational Safety and Health.
Audio Conference Call Time And Date: 11 a.m.-4 p.m., EDT,
Tuesday, August 5, 2008.
Place: Audio Conference Call via FTS Conferencing. The USA toll
free dial in number is 1-866-659-0537 with a pass code of 9933701.
Status: Open to the public, but without a public comment period.
Background: The Advisory Board was established under the Energy
Employees Occupational Illness Compensation Program Act of 2000 to
advise the President on a variety of policy and technical functions
required to implement and effectively manage the new compensation
program. Key functions of the Advisory Board include providing
advice on the development of probability of causation guidelines
which have been promulgated by the Department of Health and Human
Services (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 Advisory 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, renewed at
appropriate intervals, most recently, August 3, 2007, and will
expire on August 3, 2009.
Purpose: This Advisory 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, advising 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: The agenda for the conference call
includes: Special Exposure Cohort (SEC) Petition Status Updates;
Updates from the Subcommittee on Dose Reconstruction and Work
Groups; Update on selection of the Board's contractor; Future Plans;
and Status of transcripts and minutes.
The agenda is subject to change as priorities dictate.
Because there is not a public comment period, written comments
may be submitted. Any written comments received will be included in
the official record of the meeting and should be submitted to the
contact person below well in advance of the meeting.
Contact Person for More Information: Zaida Burgos, Committee
Management Specialist, NIOSH, CDC, 1600 Clifton Road, Atlanta,
Georgia 30033, Telephone (404) 498-2548 e-mail: zab6@cdc.gov.
Toll Free 1-800-CDC-INFO, e-mail ocas@cdc.gov.
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: July 8, 2008.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E8-16065 Filed 7-14-08; 8:45 am]
BILLING CODE 4163-18-P
