Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices 54821 

Interested persons may express their 

views in writing to the Reserve Bank 

indicated for that notice or to the offices 

of the Board of Governors. Comments 

must be received not later than 

November 9, 2009. 

A. Federal Reserve Bank of Kansas 

City (Todd Offenbacker, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. Philip Eugene Jossi, and Marian 

Joanne Hardin, both of Kearney, 

Nebraska; James Andrew Bodyfield, 

Ericson, Nebraska; and Keith Weldon 

Carlson, Lincoln, Nebraska; to acquire 

voting shares of Riverdale Bancshares, 

Inc., and thereby indirectly acquire 

voting shares of State Bank of Riverdale, 

both in Riverdale, Nebraska. 

Board of Governors of the Federal Reserve 

System, October 20, 2009. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E9–25520 Filed 10–22–09; 8:45 am] 

BILLING CODE 6210–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Office of Liaison, Policy and Review; 

Meeting of the NTP Board of Scientific 

Counselors 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health, 

HHS. 

ACTION: Meeting announcement and 

request for comments. 

SUMMARY: Pursuant to Public Law 92– 

463, notice is hereby given of a meeting 

of the NTP Board of Scientific 

Counselors (BSC). The BSC is a 

Federally chartered, external advisory 

group composed of scientists from the 

public and private sectors that provides 

primary scientific oversight to the NTP 

Director and evaluates the scientific 

merit of the NTP’s intramural and 

collaborative programs. 

DATES: The BSC meeting will be held on 

December 9–10, 2009. The deadline for 

submission of written comments is 

November 25, 2009, and for preregistration to attend the meeting, 

including registering to present oral 

comments, is December 2, 2009. Persons 

needing interpreting services in order to 

attend should contact 301–402–8180 

(voice) or 301–435–1908 (TTY). For 

other accommodations while on the 

NIEHS campus, contact 919–541–2475 

or e-mail niehsoeeo@niehs.nih.gov. 

Requests should be made at least 7 

business days in advance of the event. 

ADDRESSES: The BSC meeting will be 

held in the Rodbell Auditorium, Rall 

Building at the NIEHS, 111 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. Public comments on all 

agenda topics and any other 

correspondence should be submitted to 

Dr. Barbara Shane, Executive Secretary 

for the BSC, NTP Office of Liaison, 

Policy and Review, NIEHS, P.O. Box 

12233, K2–03, Research Triangle Park, 

NC 27709; telephone: 919–541–4253; 

fax: 919–541–0295; e-mail: 

shane@niehs.nih.gov. Courier address: 

NIEHS, 530 Davis Drive, Room K2138, 

Morrisville, NC 27560. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Barbara Shane (telephone: 919–541– 

4253 or e-mail: shane@niehs.nih.gov). 

SUPPLEMENTARY INFORMATION: 

Preliminary Agenda Topics and 

Availability of Meeting Materials 

• Report of the NTP Director. 

• NTP Update. 

• NTP Testing Program: Nominations 

and proposed research projects on 

Butterbur, Evening primrose oil, 

Hydroquinone, Silica flour, and 

Valerian extracts and oil. 

• Review of the NTP Host 

Susceptibility Program. 

• NTP’s Use of Contracts in the 

Testing Program. 

• Concept Contract Review for 

Chemistry Services to the NTP. 

• Concept Contract Review for NTP 

Reproductive and Developmental 

Toxicology and Perinatal 

Carcinogenicity Studies. 

• NTP Evaluation Process. 

• Update from the Center for the 

Evaluation of Risks to Human 

Reproduction. 

• NTP’s Dietary Supplements and 

Herbal Medicines Initiative. 

The preliminary agenda, roster of BSC 

members and ad hoc reviewers, 

background materials for agenda topics, 

public comments, and any additional 

information, when available, will be 

posted on the BSC meeting Web site 

(http://ntp.niehs.nih.gov/go/165) or may 

be requested in hardcopy from the 

Executive Secretary for the BSC (see 

ADDRESSES above). Updates to the 

agenda will also be posted to this site. 

Following the meeting, summary 

minutes will be prepared and made 

available on the BSC meeting Web site. 

NTP Testing Program: Nominations and 

Proposed Research Projects 

The NTP actively seeks to identify 

and select for study chemicals and other 

substances for which sufficient 

information is not available to 

adequately evaluate potential human 

health hazards. The NTP accomplishes 

this goal through a formal, open 

nomination and selection process. 

Substances considered appropriate for 

study generally fall into two broad, yet 

overlapping categories: (1) Substances 

judged to have high concern as possible 

public health hazards based on the 

extent of human exposure and/or 

suspicion of toxicity and (2) substances 

for which toxicological data gaps exist 

and additional studies would aid in 

assessing potential human health risks, 

e.g., by facilitating cross-species 

extrapolation or evaluating doseresponse relationships. Nominations are 

subject to a multi-step, formal process of 

review before selections for testing are 

made and toxicological studies are 

designed and implemented. The 

nomination review and selection 

process is accomplished through the 

participation of representatives from the 

NIEHS, other Federal agencies 

represented on the Interagency 

Committee for Chemical Evaluation and 

Coordination (ICCEC)—the NTP Federal 

interagency review committee for NTP 

study nominations, the BSC, the NTP 

Executive Committee—the NTP Federal 

interagency policy body, and the public. 

The nomination review and selection 

process is described in further detail on 

the NTP Web site (http:// 

ntp.niehs.nih.gov/, select ‘‘Nominations 

to the Testing Program’’). 

Table 1 lists new nominations to be 

reviewed at the BSC meeting. 

Background documents for each 

nomination are available on the NTP 

Web site http://ntp.niehs.nih.gov/go/ 

nom. The NTP invites interested parties 

to submit written comments, provide 

supplementary information, or present 

oral comments at the BSC meeting on 

the nominated substances and 

preliminary study recommendations 

(see ‘‘Request for Comments’’ below). 

The NTP welcomes toxicology study 

information from completed, ongoing, 

or anticipated studies, as well as 

information on current U.S. production 

levels, use or consumption patterns, 

human exposure, environmental 

occurrence, or public health concerns 

for any of the nominated substances. 

The NTP is interested in identifying 

appropriate animal and non-animal 

experimental models for mechanisticbased research, including genetically 

modified rodents and high-throughput 

in vitro test methods, and as such, 

solicits comments regarding the use of 

specific in vivo and in vitro 

experimental approaches to address 

questions relevant to the nominated 

substances and issues under 

consideration. Although the deadline 


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54822 Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices 

for submission of written comments to 

be considered at the BSC meeting is 

November 25, 2009 (see ‘‘Request for 

Comments’’ below), the NTP welcomes 

comments or additional information on 

these study nominations at any time. 

TABLE 1—TESTING RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES

Substance 

[CAS No.] Nomination source Nomination rationale Preliminary study recommendations 

Butterbur (Petasites hybridus) extract [90082–63–6].National Institute of Environmental 

Health Sciences1.

Use as a dietary supplement; lack 

of toxicological data; suspicion 

of toxicity based on pharmacological activity of constituents; 

potential presence of toxic 

pyrrolizidine alkaloids.

Comprehensive toxicological characterization. 

Evening primrose oil (Oenothera 

biennis L.) extract [90028–66–3].

NIEHS ........................................... Use as a dietary supplement, particularly for immune conditions; 

lack of adequate toxicological 

data.

—Initial toxicological characterization. 

—Immunotoxicity studies. 

—Reproductive toxicity studies. 

Hydroquinone [123–31–9] ............. U.S. Food and Drug Administration.Use in drugs and cosmetics; evidence of carcinogenicity from 

oral exposures in prior NTP 

studies; insufficient toxicological 

data for regulatory hazard determination.

—Dermal toxicity and carcinogenicity studies. 

—Reproductive toxicity studies. 

Silica flour [14808–60–7] ............... Private Individual .......................... Use in industrial and consumer 

products; inhalation exposures 

associated with autoimmune 

disease; lack of toxicity data for 

oral and dermal exposures; insufficient data to evaluate doseresponse for renal and autoimmune effects by any route of 

exposure.

—Initial toxicological characterization via oral and dermal routes 

of administration. 

—Immunotoxicity studies. 

Valerian (Valeriana officinalis L.) 

root extract [8057–49–6]; Valerian oil [8008–88–6].

NIEHS ........................................... Use as a dietary supplement; lack 

of toxicological data; concern 

for adverse developmental and 

reproductive effects.

Comprehensive toxicological characterization. 

1 National Institute of Environmental Health Sciences (NIEHS). 2 The terms ‘‘initial’’ and ‘‘comprehensive toxicological characterization’’ in this table refer to the approximate scope of a research program to 

address toxicological data needs. The types of toxicological studies that would be considered by NTP staff during the conceptualization and design of a research program are: 

• Initial toxicological characterization: biomolecular screening, in vitro mechanistic, in vitro and in vivo genotoxicity, absorption, disposition, metabolism, and elimination, and short-term repeat dose (2–4 weeks) in vivo studies. 

• Comprehensive toxicological characterization: all of the aforementioned plus subchronic toxicity (13–26 weeks), chronic toxicity (1–2 years), 

carcinogenicity in conventional or genetically modified rodent models, organ systems toxicity (immunotoxicity, reproductive and developmental 

toxicity, neurotoxicity), in vivo mechanistic, toxicokinetics, and other special studies as appropriate (e.g., chemistry, toxicogenomics, 

phototoxicity). 

To facilitate review of proposed 

research projects by the BSC and the 

public, NTP staff developed a draft 

research concept document for each 

nomination recommended for study. A 

research concept is a brief document 

outlining the nomination or study 

rationale, and the significance, study 

approach, and expected outcome of a 

proposed research program tailored for 

each nomination. The purpose of these 

research concepts is to outline the 

general elements of a program of study 

that would address the specific issues 

that prompted the nomination and the 

preliminary study recommendations. A 

research concept may also encompass 

larger public health issues or topics in 

toxicology that could be appropriately 

addressed through studies on the 

nominated substance(s). Draft research 

concepts for the new nominations listed 

in Table 1 will be available on the BSC 

meeting page (http://ntp.niehs.nih.gov/ 

go/165) by October 26, 2009. 

Attendance and Registration 

The meeting is scheduled for 

December 9–10, 2009, beginning at 8:30 

a.m. on each day and continuing to 

approximately 5 p.m. on December 9 

and on December 10 until adjournment. 

The meeting is open to the public with 

attendance limited only by the space 

available. Individuals who plan to 

attend are encouraged to register online 

at the BSC meeting Web site (http:// 

ntp.niehs.nih.gov/go/165) by December 

2, 2009, to facilitate planning for the 

meeting. The NTP is making plans to 

videocast the meeting through the 

Internet at http://www.niehs.nih.gov/ 

news/video/live. 

Request for Comments 

Written comments submitted in 

response to this notice should be 

received by November 25, 2009. 

Comments will be posted on the BSC 

meeting Web site and persons 

submitting them will be identified by 

their name and affiliation and/or 

sponsoring organization, if applicable. 

Persons submitting written comments 

should include their name, affiliation (if 

applicable), phone, e-mail, and 

sponsoring organization (if any) with 

the document. 

Time will be allotted during the 

meeting for the public to present oral 

comments to the BSC on the agenda 

topics. Each organization is allowed one 

time slot per agenda topic. At least 7 

minutes will be allotted to each speaker, 

and if time permits, may be extended to 

10 minutes at the discretion of the BSC 

chair. Persons wishing to present oral 

comments are encouraged to pre-register 

on the NTP meeting Web site. 

Registration for oral comments will also 

be available on-site, although time 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices 54823 

allowed for presentation by on-site 

registrants may be less than that for preregistered speakers and will be 

determined by the number of persons 

who register at the meeting. 

Persons registering to make oral 

comments are asked, if possible, to send 

a copy of their statement to the 

Executive Secretary for the BSC (see 

ADDRESSES above) by December 2, 2009, 

to enable review by the BSC prior to the 

meeting. Written statements can 

supplement and may expand the oral 

presentation. If registering on-site and 

reading from written text, please bring 

40 copies of the statement for 

distribution to the BSC and NTP staff 

and to supplement the record. 

Background Information on the NTP 

Board of Scientific Counselors 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

biochemistry, epidemiology, risk 

assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. BSC meetings 

are held annually or biannually. 

Dated: October 16, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–25587 Filed 10–22–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–284 and 

CMS–10190] 

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: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicaid 

Statistical Information System; Use: 

State data are reported by the Federally 

mandated electronic process, known as 

(MSIS) Medical Statistical Information 

System. These data are the basis of 

actuarial forecasts for Medicaid service 

utilization and costs; of analysis and 

cost savings estimates required for 

legislative initiatives relating to 

Medicaid and for responding to requests 

for information from CMS components, 

the Department, Congress and other 

customers; Form Number: CMS–R–284 

(OMB#: 0938–0345); Frequency: 

Reporting—Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 51; Total 

Annual Responses: 204; Total Annual 

Hours: 2,040. (For policy questions 

regarding this collection contact Denise 

Franz 410–786–6117. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: State Plan 

Preprints to Implement Sections 6083, 

6036, 6041, 6042, 6043 and 6044 of the 

Deficit Reduction Act (DRA) of 1995; 

Use: These preprints allow States the 

opportunity and flexibility to request 

changes in benefit packages, cost 

sharing, non-emergency medical 

transportation services, etc.; Form 

Number: CMS–10190 (OMB#: 0938– 

0993); Frequency: Reporting—Once and 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 56; Total Annual 

Responses: 16; Total Annual Hours: 

699. (For policy questions regarding this 

collection contact Fran Crystal at 410– 

786–1195. For all other issues call 410– 

786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 23, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: October 16, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–25573 Filed 10–22–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–64] 

Agency Information Collection 

Activities: Proposed Collection; 

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) 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 functions; 

(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 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES