900 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

2 ‘‘Consumer commodity’’ means any article, 

product, or commodity of any kind or class which 

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 recent census 

available providing data for purposes of staff’s 

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. 

Act, may be found in the FTC’s privacy 

policy, at (http://www.ftc.gov/ftc/ 

privacy.shtm). 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information or 

copies of the proposed information 

requirements should be sent to Stephen 

Ecklund, Investigator, Division of 

Enforcement, Bureau of Consumer 

Protection, Federal Trade Commission, 

600 Pennsylvania Ave., N.W., 

Washington, D.C. 20580, (202) 326- 

2841. 

SUPPLEMENTARY INFORMATION: Under the 

PRA, 44 U.S.C. 3501-3521, Federal 

agencies must obtain approval from 

OMB for each collection of information 

they conduct or sponsor. ‘‘Collection of 

information’’ means agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. 44 U.S.C. 

3502(3); 5 CFR 1320.3(c). As required by 

the PRA, the FTC is providing this 

opportunity for public comment before 

requesting that OMB extend the existing 

paperwork clearance for the regulations 

noted herein. 44 U.S.C. 3506(c)(2)(A). 

On October 10, 2008, the Commission 

sought public comments concerning the 

proposed collection of information. See 

73 FR 60286. No comments were 

received. Pursuant to the OMB 

regulations that implement the PRA (5 

CFR Part 1320), the Commission is 

providing this second opportunity for 

public comment while seeking OMB 

clearance for the FPLA regulations. All 

comments should be filed as prescribed 

in the ADDRESSES section above, and 

must be received on or before February 

9, 2009. 

The FPLA, 15 U.S.C. 1451-1461, was 

enacted to eliminate consumer 

deception concerning product size 

representations and package content 

information. The regulations that 

implement the FPLA, 16 CFR Parts 500 

- 503, establish requirements for the 

manner and form of labeling applicable 

to manufacturers, packagers, and 

distributors of ‘‘consumer 

commodities.’’2 Section 4 of the FPLA 

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 blended labor 

cost 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. E9–178 Filed 1–8–09: 8:45 am] 

Billing code 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[ATSDR–249] 

Announcement of Final Priority Data 

Needs for Two Priority Hazardous 

Substances 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), U.S. 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

final priority data needs for two priority 

hazardous substances (see Table 1) as 

part of the continuing development and 

implementation of the ATSDR 

Substance-Specific Applied Research 

Program (SSARP). The notice also 

serves as a continuous call for voluntary 

research proposals. 

The exposure and toxicity priority 

data needs in this notice were distilled 

from the data needs identified in 

ATSDR’s toxicological profiles by the 

logical scientific approach described in 

a decision guide published in the 

Federal Register on September 11, 1989 

(54 FR 37618). The priority data needs 

represent essential information to 

improve the database for conducting 

public health assessments. Research to 

address these priority data needs will 

help to determine the types or levels of 

exposure that may present significant 

risks of adverse health effects in people 

exposed to the hazardous substances. 

The priority data needs announced in 

this notice reflect the opinion of 

ATSDR, in consultation with other 

federal programs, about the research 

needed pursuant to ATSDR’s authority 

under the Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

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Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 901 

(Superfund), or CERCLA, as amended 

by the Superfund Amendments and 

Reauthorization Act of 1986 (SARA) [42 

U.S.C. 9604(i)]. The needs identified 

here do not represent the priority data 

needs for any other agency or program. 

Consistent with section 104(i)(12) of 

CERCLA as amended [42 U.S.C. 

9604(i)(12)], nothing in this research 

program shall be construed to delay or 

otherwise affect or impair the President, 

the Administrator of ATSDR, or the 

Administrator of the Environmental 

Protection Agency (EPA) from 

exercising any authority regarding any 

other provision of law, including the 

Toxic Substances Control Act of 1976 

(TSCA), the Federal Insecticide, 

Fungicide, and Rodenticide Act of 1972 

(FIFRA), or the response and abatement 

authorities of CERCLA. 

ATSDR worked with other federal 

programs to determine common 

substance-specific data needs and 

mechanisms to implement research that 

may include authorities under TSCA 

and FIFRA, private-sector voluntarism, 

or the direct use of CERCLA funds. 

Table 1 presents the priority data 

needs for acrolein and barium, two 

priority substances included in the 

ATSDR Priority List of Hazardous 

Substances (73 FR 12178, March 6, 

2008). These priority data needs were 

initially announced by ATSDR in the 

Federal Register on September 8, 2006 

(71 FR 53102). The public was invited 

to comment on these data needs for 

these two substances during a 90-day 

period. No public comments were 

received. These priority data needs and 

accompanying documents were 

reviewed by EPA and the National 

Institute of Environmental Health 

Sciences (NIEHS), and will be addressed 

by the mechanisms described in the 

‘‘Implementation of Substance-Specific 

Applied Research Program’’ section of 

this Federal Register Notice. 

TABLE 1—SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR TWO PRIORITY HAZARDOUS SUBSTANCES

Substance Priority data needs 

Acrolein .......... Exposure levels in humans 

living near hazardous 

waste sites and other populations. 

Exposure levels in children. 

Dose-response data for 

chronic duration 1 via inhalation exposure. 

Barium ............ Dose-response data for 

acute duration 2 via oral 

exposure. 

1 365 days or more. 

2 14 days or less. 

The substance-specific priority data 

needs were based on and determined 

from information in corresponding 

ATSDR toxicological profiles. 

Background technical information and 

justification for the priority data needs 

in this notice are in the priority data 

needs documents, available on ATSDR’s 

Web site at http://www.atsdr.cdc.gov/ 

pdns/. Printed copies are also available 

by written request from ATSDR (see 

ADDRESSES section of this notice). 

Voluntary Research. This notice also 

serves as a continuous call for voluntary 

research proposals. Private-sector 

organizations may volunteer to conduct 

research to address specific priority data 

needs in this notice by submitting a 

letter of intent to ATSDR (see 

ADDRESSES section of this notice). A TriAgency Superfund Applied Research 

Committee (TASARC), comprised of 

scientists from ATSDR, the National 

Toxicology Program (NTP), and EPA 

will review all proposals. 

DATES: The ATSDR voluntary research 

program is a continuous program, and 

private-sector organizations can 

volunteer to fill identified data needs 

from now until ATSDR announces that 

other research has been initiated for a 

specific data need. 

ADDRESSES: The priority data needs are 

available on ATSDR’s Web site at 

http://www.atsdr.cdc.gov/pdns/. 

Private-sector organizations interested 

in volunteering to conduct research to 

fill identified priority data needs should 

write to Nickolette Roney, Applied 

Toxicology Branch, Division of 

Toxicology and Environmental 

Medicine, ATSDR, 1600 Clifton Road, 

NE., Mailstop F–32, Atlanta, Georgia 

30333; e-mail: NRoney@cdc.gov. 

Information about pertinent ongoing or 

completed research that may fill priority 

data needs cited in this notice should be 

similarly addressed. Also, use the same 

address to request printed copies of the 

priority data needs documents. 

FOR FURTHER INFORMATION CONTACT: 

Nickolette Roney, Applied Toxicology 

Branch, Division of Toxicology and 

Environmental Medicine, ATSDR, 1600 

Clifton Road, NE., Mailstop F–32, 

Atlanta, Georgia 30333; e-mail: 

NRoney@cdc.gov; telephone: (770) 488– 

3332; fax: (770) 488–4178. 

SUPPLEMENTARY INFORMATION: 

Background 

CERCLA, as amended by SARA [42 

U.S.C. 9604(i)], requires that ATSDR (1) 

develop jointly with EPA a list of 

hazardous substances found at National 

Priorities List (NPL) sites (in order of 

priority), (2) prepare toxicological 

profiles of these substances, and (3) 

ensure the initiation of a research 

program to address identified priority 

data needs associated with the 

substances. 

The SSARP was initiated in 1991. A 

list of priority data needs for 38 priority 

hazardous substances was announced 

for public comment in the Federal 

Register on October 17, 1991 (56 FR 

52178) and was published in final form 

on November 16, 1992 (57 FR 54150). In 

1997, after releasing for public 

comment, ATSDR finalized the priority 

data needs for a second list of 12 

substances and that priority data needs 

list was announced in the Federal 

Register on July 30, 1997 (62 FR 40820). 

ATSDR then identified priority data 

needs for a third list of 10 hazardous 

substances; this list was released as a 

draft for public comment and published 

in its final form on April 29, 2003 (68 

FR 22704). On September 8, 2006 (71 FR 

53102), ATSDR released for public 

comment the priority data needs for the 

two hazardous substances that are the 

subject of this final notice. 

The ATSDR SSARP supplies the 

necessary information to improve the 

database to conduct public health 

assessments. The link between research 

and public health assessments and the 

process for distilling priority data needs 

from the data needs identified in 

associated ATSDR toxicological profiles 

are described in the ATSDR ‘‘Decision 

Guide for Identifying Substance-Specific 

Data Needs Related to Toxicological 

Profiles’’ (54 FR 37618, September 11, 

1989). 

Implementation of Substance-Specific 

Applied Research Program 

In Section 104(i)(5)(D), CERCLA states 

that Congress believes the costs for 

conducting this research program 

should be borne by the manufacturers 

and processors of the hazardous 

substances found under the Toxic 

Substances Control Act of 1976 (TSCA); 

by registrants under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act of 1972 (FIFRA); or by cost recovery 

from responsible parties under CERCLA. 

To execute this statutory intent, ATSDR 

developed a plan whereby parts of 

SSARP are being conducted through 

regulatory mechanisms (TSCA/FIFRA), 

private-sector voluntarism, and the 

direct use of CERCLA funds. 

CERCLA also requires that ATSDR 

consider recommendations of the 

Interagency Testing Committee, 

established under section 4(e) of TSCA, 

for the types of research to be done. 

ATSDR actively participates on this 

committee. Federally funded projects 

that collect information from 10 or more 

respondents and that are funded by 

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902 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

cooperative agreements are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act. If the proposed project 

involves research on human subjects, 

the applicants must comply with 

Department of Health and Human 

Services regulations (45 CFR part 46) 

regarding the protection of human 

subjects. The applicants must ensure 

that the project will be subject to initial 

and continuing review by the 

appropriate institutional review 

committees. Overall, by providing 

additional scientific information for the 

risk assessment process, data generated 

from this research will support other 

researchers who are conducting human 

health assessments involving these two 

substances. 

The mechanisms for implementing 

SSARP are discussed next. The status of 

SSARP in addressing priority data needs 

of the first 60 priority hazardous 

substances through these mechanisms 

was described in a Federal Register 

Notice on December 13, 2005 (70 FR 

73749). 

A. TSCA/FIFRA 

In developing and implementing 

SSARP, ATSDR and EPA established 

procedures to identify priority data 

needs of common interest to multiple 

federal programs. Where practicable, 

these data needs will be addressed 

through a program of toxicologic testing 

under TSCA or FIFRA. This part of the 

research will be conducted according to 

established TSCA/FIFRA procedures 

and guidelines. 

B. Private-Sector Voluntarism 

As part of SSARP, on February 7, 

1992, ATSDR announced a set of 

proposed procedures for conducting 

voluntary research (57 FR 4758). 

Revisions based on public comments 

were published on November 16, 1992 

(57 FR 54160). ATSDR strongly 

encourages private-sector organizations 

to propose research to address priority 

data needs at any time until ATSDR 

announces that research has already 

been initiated for a specific priority data 

need. Private-sector organizations may 

volunteer to conduct research to address 

specific priority data needs identified in 

this notice by submitting a letter of 

intent. 

The letter of intent should be a brief 

statement (1–2 pages) that identifies the 

priority data need(s) to be filled and the 

methods to be used. TASARC will 

review these proposals and recommend 

to ATSDR the voluntary research 

projects that should be pursued—and 

how they should be conducted—with 

the volunteer organizations. ATSDR will 

enter into only those voluntary research 

projects that lead to high-quality, peerreviewed scientific work. Additional 

details regarding the process for 

voluntary research are in the Federal 

Register Notices cited in this section. 

C. CERCLA 

Those priority data needs that are not 

addressed by TSCA/FIFRA or initial 

voluntarism will be considered for 

funding by ATSDR through its CERCLA 

budget. Much of this research program 

is envisioned to be unique to CERCLA— 

for example, research on substances not 

regulated by other programs or research 

needs specific to public health 

assessments. A current example of the 

direct use of CERCLA funds is a 

cooperative agreement with the 

Association of Minority Health 

Professions Schools (AMHPS) that 

supports the AMHPS Environmental 

Health, Health Services, and Toxicology 

Research programs. 

Mechanisms to address these priority 

data needs may include a second call for 

voluntarism. Again, scientific peer 

review of study protocols and results 

would occur for all research conducted 

under this auspice. 

ATSDR encourages private-sector 

organizations and other governmental 

programs to use ATSDR’s priority data 

needs to plan their research activities. 

Dated: January 6, 2009. 

Ken Rose, 

Director, Office of Policy, Planning, and 

Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

[FR Doc. E9–189 Filed 1–8–09; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–262, CMS– 

10142 and CMS–R–137] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2010 Plan 

Benefit Package (PBP) and Formulary 

Submission for Medicare Advantage 

(MA) Plans and Prescription Drug Plans 

(PDP) Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the formulary 

file, Plan Benefit Package (PBP) 

software, and supporting documentation 

as necessary. MA and PDP organizations 

will generate a formulary to illustrate 

their list of drugs, including information 

on prior authorization, step therapy, 

tiering, and quantity limits. 

Additionally, the PBP software will be 

used to describe their organization’s 

plan benefit packages, including 

information on premiums, cost sharing, 

authorization rules, and supplemental 

benefits. CMS uses the formulary and 

PBP data to review and approve the 

plan benefit packages proposed by each 

MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed 

formulary and PBP as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. Based on 

operational changes and policy 

clarifications to the Medicare program 

and continued input and feedback by 

the industry, CMS has made the 

necessary changes to the plan benefit 

package submission. Form Number: 

CMS–R–262 (OMB# 0938–0763); 

Frequency: Yearly; Affected Public: 

Business or other for-profits b. Not-forprofit institutions; Number of 

Respondents: 475; Total Annual 

Responses: 4987.5; Total Annual Hours: 

12112.5. 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

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