Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 60287 

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 (http://www.ftc.gov/os/statutes/fpla/

outline.html). 3To 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. 4Staff 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 (http://www.census.gov/econ/ 

census02/guide/SUBSUMM.HTM) and (http:// 

www.census.gov/prod/ec02/ec0231sg1.pdf) (Table 

2). 

5Although 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. 

7Based generally on the National Compensation 

Survey: Occupational Earnings in the United States, 

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 (http://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. 

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

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 

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 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 

mstockstill on PROD1PC66 with NOTICES

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: http:// 

www.hhs.gov/ohrp/sachrp/index.html. 

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 

AGENCY: 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. 

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 (http:// 

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 

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 (http:// 

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 http:// 

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 (http:// 

ntp.niehs.nih.gov/go/231). 

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 

mstockstill on PROD1PC66 with NOTICES