Secretary's Advisory Committee on Human Research Protections; Notice of Meetings, 60287-60288 [E8-24169]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices
mstockstill on PROD1PC66 with NOTICES
specifically requires packages or labels
to be marked with: (1) a statement of
identity; (2) a net quantity of contents
disclosure; and (3) the name and place
of business of a company that is
responsible for the product.
Estimated annual hours burden:
7,570,740 total burden hours (solely
relating to disclosure3).
As in the past, Commission staff has
used census data4 to estimate the
number of companies subject to the
FPLA. Staff conservatively estimates5
that approximately 757,074
manufacturers, packagers, distributors,
and retailers of consumer commodities
make disclosures at an average burden
of ten hours per entity, for a total
disclosure burden of 7,570,740 hours.
Estimated annual cost burden:
$158,985,540 (solely relating to labor
costs).
The estimated annual labor cost
burden associated with the FPLA
disclosure requirements consists of an
estimated hour of managerial and/or
professional time per covered entity (at
an estimated average hourly rate of $55),
plus two hours of specialized clerical
support6 (at an estimated average hourly
rate of $25), and seven hours of clerical
time per covered entity (at an estimated
average hourly rate of $15), for a total
of $158,985,540 ($210 per covered
entity x 757,074 entities).7
is customarily produced or distributed for sale
through retail sales agencies or instrumentalities for
consumption by individuals, or use by individuals
for purposes of personal care or in the performance
of services ordinarily rendered within the
household, and which usually is consumed or
expended in the course of such consumption or
use.’’ 16 CFR 500.2(c). For the precise scope of the
term’s coverage see 16 CFR 500.2(c); 503.2; 503.5.
See also (https://www.ftc.gov/os/statutes/fpla/
outline.html).
3 To the extent that the FPLA-implementing
regulations require sellers of consumer
commodities to keep records that substantiate
‘‘cents off,’’ ‘‘introductory offer,’’ and/or ‘‘economy
size’’ claims, staff believes that most, if not all, of
the records that sellers maintain would be kept in
the ordinary course of business, regardless of the
legal mandates.
4 Staff has drawn upon the U.S. Census Bureau’s
2002 economic census, the most recently complete
census available, for arriving at the instant
estimates. See (https://www.census.gov/econ/
census02/guide/SUBSUMM.HTM) and (https://
www.census.gov/prod/ec02/ec0231sg1.pdf) (Table
2).
5 Although the estimates are non-rounded figures,
they remain estimates as they are the sum total of
projected industry codes subject to the FPLA. But,
even allowing for industries that may apply, the
Census data do not separately break out nonhousehold products from household use and,
accordingly, overstate what is actually subject to the
FPLA.
6 ‘‘Specialized clerical support’’ consists of
graphic design specialists, working by computer to
design the appearance and layout of product
packaging, including appropriate display of the
disclosures required by the FPLA regulations.
7 Based generally on the National Compensation
Survey: Occupational Earnings in the United States,
VerDate Aug<31>2005
20:11 Oct 09, 2008
Jkt 217001
Total capital and start-up costs are de
minimis. For many years, the packaging
and labeling activities that require
capital and start-up costs have been
performed by covered entities in the
ordinary course of business
independent of the FPLA and
implementing regulations. Similarly,
firms provide in the ordinary course of
business the information that the statute
and regulations require be placed on
packages and labels.
William Blumenthal
General Counsel
[FR Doc. E8–24210 Filed 10–9–08: 8:45 am]
[Billing code: 6750–01–S]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Secretary’s Advisory Committee on
Human Research Protections; Notice
of Meetings
Office of Public Health and
Science, Office of the Secretary, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
U.S.C. Appendix 2, notice is hereby
given that the Secretary’s Advisory
Committee on Human Research
Protections (SACHRP) will hold its
seventeenth meeting. The meeting will
be open to the public.
DATES: The meeting will be held on
Monday, October 27, 2008 from 8:30
a.m. until 4:30 p.m. and Tuesday,
October 28, 2008 from 8:30 a.m. until
4:30 p.m.
ADDRESSES: The Sheraton National
Hotel, 900 South Orme Street,
Arlington, Virginia 22204. Phone: 703–
521–1900.
FOR FURTHER INFORMATION CONTACT: Ivor
Pritchard, PhD, Acting Director, Office
for Human Research Protections
(OHRP), or Julia Gorey, JD, Executive
Director, Secretary’s Advisory
Committee on Human Research
Protections (SACHRP); U.S. Department
of Health and Human Services, 1101
Wootton Parkway, Suite 200, Rockville,
Maryland 20852; 240–453–8141; fax:
240–453–6909; e-mail address:
sachrp@osophs.dhhs.gov.
2007, U.S. Department of Labor, Bureau of Labor
Statistics (August 2008) (‘‘BLS National
Compensation Survey’’) (citing the mean hourly
earnings for management occupations, legal
occupations/lawyers, and assorted clerical
positions), available at (https://www.bls.gov/ncs/ocs/
sp/nctb0300.pdf). Clerical estimates are derived
from the above source data, applying roughly a midrange of mean hourly rates for potentially
applicable clerical types, e.g., computer operators,
data entry and information processing workers.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
60287
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services and the
Assistant Secretary for Health on issues
and topics pertaining to or associated
with the protection of human research
subjects.
On October 27, 2008, the morning
session will begin with a SACHRP
update. Members of OHRP and the
Office of the General Counsel will make
brief presentations on the status of
SACHRP recommendations that have
been approved to date, the OHRP
guidance and Federal rulemaking
process, and the status of OHRP budget
and staffing. This will be followed by a
period of discussion. In the afternoon,
SACHRP will receive a report from the
Subpart A Subcommittee. This
subcommittee is charged with
developing recommendations for
consideration by SACHRP regarding the
application of Subpart A of 45 CFR part
46 in the current research environment.
This subcommittee was established by
SACHRP at its October 4–5, 2006
meeting.
The following day, October 28, 2008,
the Subcommittee on Inclusion of
Individuals with Impaired DecisionMaking in Research will present and
discuss their current report. The
Subcommittee on Inclusion of
Individuals with Impaired DecisionMaking in Research is charged with
developing recommendations for
consideration by SACHRP about
whether guidance and/or additional
regulations are needed for research
involving individuals with impaired
decision-making capacity. This
subcommittee was formed as a result of
discussions during the July 31–August
1, 2006 SACHRP meeting. The afternoon
session will consist of an invited panel
of community and consumer
representatives who will discuss their
reaction and provide feedback on the
subcommittee’s recommendations.
Public attendance at the meeting is
limited to space available. Individuals
who plan to attend the meeting and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the designated contact persons.
Members of the public will have the
opportunity to provide comments on
both days of the meeting. Public
comment will be limited to five minutes
per speaker. Any members of the public
who wish to have printed materials
distributed to SACHRP members for this
scheduled meeting should submit
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10OCN1.SGM
10OCN1
60288
Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices
materials to the Acting Executive
Director, SACHRP, prior to the close of
business Tuesday, October 14, 2008.
Information about SACHRP and the
draft meeting agenda will be posted on
the SACHRP Web site at: https://
www.hhs.gov/ohrp/sachrp/.
Dated: October 7, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research
Protections, Acting Executive
Secretary,Secretary’s Advisory Committee on
Human Research Protections.
[FR Doc. E8–24169 Filed 10–9–08; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Toxicology Program (NTP);
Report on Carcinogens (RoC);
Availability of the Draft Background
Document for Cobalt-Tungsten
Carbide Powders and Hard Metals;
Request for Comments on the Draft
Background Document;
Announcement of the Cobalt-Tungsten
Carbide Powders and Hard Metals
Expert Panel Meeting
National Institute of
Environmental Health Sciences
(NIEHS); National Institutes of Health
(NIH).
ACTION: Availability of Background
Document; Request for Comments; and
Announcement of a Meeting.
mstockstill on PROD1PC66 with NOTICES
AGENCY:
SUMMARY: The NTP announces the
availability of the draft background
document for cobalt-tungsten carbide
powders and hard metals by October 10,
2008 on the RoC Web site (https://
ntp.niehs.nih.gov/go/29679) or in
printed text from the RoC (see
ADDRESSES below). The NTP invites the
submission of public comments on the
draft background document for cobalttungsten carbide powders and hard
metals. The expert panel will meet on
December 9–10, 2008, at the Sheraton
Chapel Hill Hotel, One Europa Drive,
Chapel Hill, NC 27514 to peer review
the draft background document for
cobalt-tungsten carbide powders and
hard metals and, once completed, make
a recommendation regarding the listing
status (i.e., known to be a human
carcinogen, reasonably anticipated to be
a human carcinogen, or not to list) for
cobalt-tungsten carbide powders and
hard metals in the 12th Edition of the
RoC (12th RoC). The RoC expert panel
meeting is open to the public with time
scheduled for oral public comments.
Attendance is limited only by the
available meeting room space.
Following the expert panel meeting and
VerDate Aug<31>2005
20:11 Oct 09, 2008
Jkt 217001
completion of the expert panel report,
the NTP will post the final background
document and the expert-panel peer
review report on the RoC Web site.
DATES: The expert panel meeting for
cobalt-tungsten carbide powders and
hard metals will be held on December
9–10, 2008. The draft background
document for cobalt-tungsten carbide
powders and hard metals will be
available for public comment by
October 10, 2008. The deadline to
submit written comments is November
24, 2008, and the deadline for preregistration to attend the meeting and/
or to provide oral comments at the
meeting is December 1, 2008.
ADDRESSES: The RoC expert panel
meeting on cobalt-tungsten carbide
powders and hard metals will be held
at Sheraton Chapel Hill Hotel, One
Europa Drive, Chapel Hill, NC 27514.
Access to on-line registration and
materials for the meeting are available
on the RoC Web site (https://
ntp.niehs.nih.gov/go/29679). Comments
on the draft background document
should be sent to Dr. Ruth M. Lunn,
NIEHS, P.O. Box 12233, MD EC–14,
Research Triangle Park, NC 27709, FAX:
(919) 541–0144, or lunn@niehs.nih.gov.
Courier address: Report on Carcinogens
Office, 79 T.W. Alexander Drive,
Building 4401, Room 3118, Research
Triangle Park, NC 27709. Persons
needing interpreting services in order to
attend should contact 301–402–8180
(voice) or 301–435–1908 (TTY).
Requests should be made at least seven
business days in advance of the
meeting.
FOR FURTHER INFORMATION CONTACT: Dr.
Ruth M. Lunn, Director, RoC Office,
919–316–4637, lunn@niehs.nih.gov.
SUPPLEMENTARY INFORMATION:
Background
The NTP announced the RoC review
process for the 12th RoC on April 16,
2007 in the Federal Register
(72FR18999 available at https://
ntp.niehs.nih.gov/go/15208). An expert
panel meeting is being convened on
December 9–10, 2008, to review cobalttungsten carbide powders and hard
metals for possible listing in the 12th
RoC. The draft background document
for cobalt-tungsten carbide hard metals
and powders will be available on the
RoC Web site by October 10, 2008 or in
printed text from the RoC Office (see
ADDRESSES above). Persons can register
free-of-charge with the NTP listserv to
receive notification when draft RoC
background documents for candidate
substances for the 12th RoC are made
available on the RoC Web site (https://
ntp.niehs.nih.gov/go/231).
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Cobalt-tungsten carbide hard metals
are composites of carbides (including
tungsten carbide alone or in
combination with small amounts of
other carbides) with a metallic cobalt
binder, pressed into a compact, solid
form at high temperatures by a process
known as ‘‘sintering.’’ Cobalt-tungsten
carbide hard metals are used primarily
in cutting tools. Cobalt-tungsten carbide
hard metals are manufactured and used
in the United States. Occupational
exposure to cobalt-tungsten carbide
hard-metal particles can occur during
hard-metal production, recycling of
hard-metal products, and grinding and
sharpening of hard-metal tools.
Preliminary Agenda, Request for
Comments, and Registration
Preliminary agenda topics include:
• Oral public comments on cobalttungsten carbide powders and hard
metals.
• Peer review of the draft background
document on cobalt-tungsten carbide
powders and hard metals.
• Recommendation for listing status
in the 12th RoC for cobalt-tungsten
carbide powders and hard metals and
scientific justification.
The meeting is scheduled for
December 9–10, 2008, from 8:30 a.m. to
adjournment each day. A copy of the
preliminary agenda, expert panel roster,
and any additional information, when
available, will be posted on the RoC
Web site or may be requested from the
Director of the RoC Office (see
ADDRESSES above). Individuals who
plan to attend the meeting are
encouraged to register on-line by
December 1, 2008, to facilitate planning
for the meeting.
Request for Comments
The NTP invites both written and oral
public comments on the draft
background document on cobalttungsten carbide powders and hard
metals. All written comments received
will be posted on the RoC Web site prior
to the meeting and distributed to the
expert panel and RoC staff for their
consideration in the peer review of the
draft background document and/or
preparation for the expert panel
meeting. Persons submitting written
comments are asked to include their
name and contact information
(affiliation, mailing address, telephone
and facsimile numbers, e-mail, and
sponsoring organization, if any) and
send them to Dr. Lunn (see ADDRESSES
above) for receipt by November 24,
2008. Time will be set aside at the
expert panel meeting for the
presentation of oral public comments.
Seven minutes will be available for each
E:\FR\FM\10OCN1.SGM
10OCN1
]]>Agencies
[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Notices]
[Pages 60287-60288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24169]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Secretary's Advisory Committee on Human Research Protections;
Notice of Meetings
AGENCY: Office of Public Health and Science, Office of the Secretary,
HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold its
seventeenth meeting. The meeting will be open to the public.
DATES: The meeting will be held on Monday, October 27, 2008 from 8:30
a.m. until 4:30 p.m. and Tuesday, October 28, 2008 from 8:30 a.m. until
4:30 p.m.
ADDRESSES: The Sheraton National Hotel, 900 South Orme Street,
Arlington, Virginia 22204. Phone: 703-521-1900.
FOR FURTHER INFORMATION CONTACT: Ivor Pritchard, PhD, Acting Director,
Office for Human Research Protections (OHRP), or Julia Gorey, JD,
Executive Director, Secretary's Advisory Committee on Human Research
Protections (SACHRP); U.S. Department of Health and Human Services,
1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-
8141; fax: 240-453-6909; e-mail address: sachrp@osophs.dhhs.gov.
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services and the Assistant Secretary for
Health on issues and topics pertaining to or associated with the
protection of human research subjects.
On October 27, 2008, the morning session will begin with a SACHRP
update. Members of OHRP and the Office of the General Counsel will make
brief presentations on the status of SACHRP recommendations that have
been approved to date, the OHRP guidance and Federal rulemaking
process, and the status of OHRP budget and staffing. This will be
followed by a period of discussion. In the afternoon, SACHRP will
receive a report from the Subpart A Subcommittee. This subcommittee is
charged with developing recommendations for consideration by SACHRP
regarding the application of Subpart A of 45 CFR part 46 in the current
research environment. This subcommittee was established by SACHRP at
its October 4-5, 2006 meeting.
The following day, October 28, 2008, the Subcommittee on Inclusion
of Individuals with Impaired Decision-Making in Research will present
and discuss their current report. The Subcommittee on Inclusion of
Individuals with Impaired Decision-Making in Research is charged with
developing recommendations for consideration by SACHRP about whether
guidance and/or additional regulations are needed for research
involving individuals with impaired decision-making capacity. This
subcommittee was formed as a result of discussions during the July 31-
August 1, 2006 SACHRP meeting. The afternoon session will consist of an
invited panel of community and consumer representatives who will
discuss their reaction and provide feedback on the subcommittee's
recommendations.
Public attendance at the meeting is limited to space available.
Individuals who plan to attend the meeting and need special assistance,
such as sign language interpretation or other reasonable
accommodations, should notify the designated contact persons. Members
of the public will have the opportunity to provide comments on both
days of the meeting. Public comment will be limited to five minutes per
speaker. Any members of the public who wish to have printed materials
distributed to SACHRP members for this scheduled meeting should submit
[[Page 60288]]
materials to the Acting Executive Director, SACHRP, prior to the close
of business Tuesday, October 14, 2008. Information about SACHRP and the
draft meeting agenda will be posted on the SACHRP Web site at: https://
www.hhs.gov/ohrp/sachrp/.
Dated: October 7, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections, Acting
Executive Secretary,Secretary's Advisory Committee on Human Research
Protections.
[FR Doc. E8-24169 Filed 10-9-08; 8:45 am]
BILLING CODE 4150-36-P
