Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 31957 

J.K., Cook, W.J., Thomas, F.T., & Neville, 

D.M. Jr. ‘‘Durable donor-specific T and B 

cell tolerance in rhesus macaques induced 

with peritransplantation anti-CD3 

immunotoxin and deoxyspergualin: 

Absence of chronic allograft nephropathy.’’ 

Transplantation 69(12):2497–2503, June 

27, 2000. (Retracted.) 

Thomas, J.M., Contreras, J.L., Jiang, X.L., 

Eckhoff, D.E., Wang, P.X., Hubbard, W.J., 

Lobashevsky, A.L., Wang, W., Asiedu, C., 

Stavrou, S., Cook, W.J., Robbin, M.L., 

Thomas, F.T., & Neville, D.M. Jr. 

‘‘Peritransplant tolerance induction in 

macaques: Early events reflecting the 

unique synergy between immunotoxin and 

deoxyspergualin.’’ Transplantation 

68(11):1660–1673, December 15, 1999. 

(Retracted.) 

Contreras, J.L., Eckhoff, D.E., Cartner, S., 

Frenette, L., Thomas, F.T., Robbin, M.L., 

Neville, D.M. Jr., & Thomas, J.M. 

‘‘Tolerability and side effects of anti-CD3- 

immunotoxin in preclinical testing in 

kidney and pancreatic islet transplant 

recipients.’’ Transplantation 68(2):215– 

219, July 27, 1999. (Retracted.) 

Contreras, J.L., Wang, P.X., Eckhoff, D.E., 

Lobashevsky, A.L., Asiedu, C., Frenette, L., 

Robbin, M.L., Hubbard, W.J., Cartner, S., 

Nadler, S., Cook, W.J., Sharff, J., Shiloach, 

J., Thomas, F.T., Neville, D.M. Jr., & 

Thomas, J.M. ‘‘Peritransplant tolerance 

induction with anti-CD3-immunotoxin: A 

matter of proinflammatory cytokine 

control.’’ Transplantation 65(9):1159–1169, 

May 15, 1998. (Retracted.) 

Asiedu, C.K., Goodwin, K.J., Balgansuren, G., 

Jenkins, S.M., Le Bas-Bernardet, S., Jargal, 

U., Neville, D.M. Jr. & Thomas, J.M. 

‘‘Elevated T regulatory cells in long-term 

stable transplant tolerance in rhesus 

macaques induced by anti-CD3 

immunotoxin and deoxyspergualin.’’ J 

Immunol. 175(12):8060–8068, December 5, 

2005. (Retracted.) 

4. 

Includes those cited in Endnote 3 plus: 

Thomas, J.M., Neville, D.M., Contreras, J.L., 

Eckhoff, D.E., Meng, G., Lobashevsky, A.L., 

Wang, P.X., Huang, Z.Q., Verbanac, K.M., 

Haisch, C.E., & Thomas, F.T. ‘‘Preclinical 

studies of allograft tolerance in rhesus 

monkeys: A novel anti-CD3-immunotoxin 

given peritransplant with donor marrow 

induces operational tolerance to kidney 

allografts.’’ Transplantation 64(1):124–135, 

July 15, 1997. 

[FR Doc. E9–15910 Filed 7–2–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Secretary’s Advisory Committee on 

Human Research Protections 

AGENCY: Office of Public Health and 

Science, Office of the Secretary, 

Department of Health and Human 

Services. 

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 

twentieth meeting. The meeting will be 

open to the public. 

DATE: The meeting will be held on 

Tuesday, July 21, 2009 from 8:30 a.m. 

until 5 p.m. and Wednesday, July 22, 

2009 from 8:30 a.m. until 5 p.m. 

ADDRESSES: The Sheraton National 

Hotel, 900 South Orme Street, 

Arlington, Virginia 22204. Phone: 703– 

521–1900. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections (OHRP), or 

Julia Gorey, J.D., Executive Director, 

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 July 21, 2009, the Committee will 

discuss a summary of comments from 

the recent OHRP-issued advance notice 

of proposed rulemaking on institutional 

review board (IRB) accountability, as 

well as hear a summary of Clinical and 

Translational Science Awards pediatric 

research issues. SACHRP will also 

spend time focusing on long-range 

future planning regarding new 

subcommittees and areas of focus. The 

day will conclude with a panel 

discussion addressing the question of 

how to evaluate IRB effectiveness. 

On July 22, 2009, the Committee will 

hear a report from the Subpart A 

Subcommittee focusing on issues 

surrounding consent for future use of 

specimens or data. This subcommittee 

was established by SACHRP at its 

October 4–5, 2006 meeting and is 

charged with developing 

recommendations for consideration by 

SACHRP about the application of 

Subpart A of 45 CFR part 46 in the 

current research environment. SACHRP 

will then hear a presentation of the 

recent National Academy of Sciences 

report entitled ‘‘Conflict of Interest in 

Medical Research, Education and 

Practice,’’ followed by a panel 

discussion. 

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 

materials to the Executive Director, 

SACHRP, prior to the close of business 

Friday, July 17, 2009. 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: June 29, 2009. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. E9–15783 Filed 7–2–09; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the National Vaccine 

Advisory Committee 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science. 

ACTION: Notice of meetings via 

conference call. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the National Vaccine Advisory 

Committee (NVAC) will hold two 

teleconference meetings. The meetings 

are open to the public. Pre-registration 

is required for both public attendance 

and comment. Individuals who wish to 

attend the meetings and/or participate 

in the public comment session should 

either e-mail nvpo@hhs.gov or call 202– 

690–5566 to register. 

DATES: The meetings will be held on 

July 27, 2009, from 3 p.m. to 5 p.m. EDT 

and on August 24, 2009, from 3 p.m. to 

5 p.m. EDT. 

ADDRESSES: The meetings will occur by 

teleconference. To attend, please call 1– 

888–677–1385, passcode ‘‘NVAC.’’ 

FOR FURTHER INFORMATION CONTACT: Ms. 

Andrea Krull, Public Health Advisor, 

mstockstill on PROD1PC66 with NOTICES

31958 Federal Register / Vol. 74, No. 127 / Monday, July 6, 2009 / Notices 

National Vaccine Program Office, 

Department of Health and Human 

Services, Room 715–H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue, SW., Washington, DC 20201. 

Phone: (202) 690–5566; Fax: (202) 260– 

1165; e-mail: nvpo@hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 2101 of the Public Health 

Service Act (42 U.S.C. section 300aa–1), 

the Secretary of Health and Human 

Services was mandated to establish the 

National Vaccine Program to achieve 

optimal prevention of human infectious 

diseases through immunization and to 

achieve optimal prevention against 

adverse reactions to vaccines. The 

National Vaccine Advisory Committee 

was established to provide advice and 

make recommendations to the Director 

of the National Vaccine Program on 

matters related to the Program’s 

responsibilities. The Assistant Secretary 

for Health serves as Director of the 

National Vaccine Program. 

These are special meetings of the 

NVAC. Discussions will surround issues 

related to the Novel Influenza A (H1N1) 

outbreak. The Committee will discuss 

the activities and actions of the various 

HHS agencies and Federal advisory 

committees that address vaccine issues 

as it relates to the mission of NVAC. 

Representatives of State and local health 

associations will also provide their 

perspective. 

For these special meetings, members 

of the public are invited to attend by 

teleconference via a toll-free call-in 

phone number. The call-in number will 

be operator assisted to provide members 

of the public the opportunity to provide 

comments to the Committee. Public 

participation and ability to comment 

will be limited to space and time 

available. Public comment will be 

limited to no more than three minutes 

per speaker. Pre-registration is required 

for both public attendance and 

comment. Individuals who plan to 

attend and need special assistance, such 

as accommodation for hearing 

impairment or other reasonable 

accommodations, should notify the 

designated contact person at least one 

week prior to the meeting. 

Any members of the public who wish 

to have printed material distributed to 

NVAC should submit materials to the 

Executive Secretary, NVAC, through the 

contact person listed above prior to 

close of business one week before each 

meeting (conference call). A draft 

agenda and any additional materials 

will be posted on the NVAC Web site 

(http://www.hhs.gov/nvpo/nvac/) prior 

to the meeting. 

Dated: June 29, 2009. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office. 

[FR Doc. E9–15782 Filed 7–2–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

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

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276– 

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Cross-community 

Evaluation of the Native Aspirations 

Project—NEW 

The Substance Abuse and Mental 

Health Services Administration’s 

(SAMHSA), Center for Mental Health 

Services (CMHS) will conduct the 

Cross-Community Evaluation of the 

Native Aspirations Project. The crosscommunity evaluation has two tiers. 

Community-specific activities (Tier 1) 

are tied to key components of a 

community plan developed in each 

participating community that guides 

program planning and local evaluation 

through data-driven frameworks and 

inquiry. Tier I activities will include 

process and impact evaluation activities 

to determine the stage of readiness of 

communities to implement programs, 

how accurately community plans reflect 

the needs and characteristics of each 

community, how well local resources 

for American Indian/Alaska Native (AI/ 

AN) youth are mobilized, the experience 

and impact of the Gathering of Native 

Americans (GONA), and the impact of 

the Native Aspirations program on the 

community. Core cross-community data 

collection activities (Tier II) are crosscommunity and include process and 

impact indicators such as communitylevel knowledge and awareness of 

suicide, violence, bullying, and 

substance abuse; pro-social and helpseeking behaviors among Native youth; 

and the provision of services specific to 

Native youth through existing service 

systems. Tier II activities are directly 

tied to the primary objectives of the 

Native Aspirations Project and are 

designed to augment data collection 

through the collection of communityand systems-level change measurement. 

Activities include the Service Provider 

Focus Groups and the Community 

Knowledge, Awareness and Behavior 

Survey (C–KABS). 

Data will be collected from Native 

adults and youth involved in the 

Community Mobilization Plan (CMP) 

meeting and the Gathering of Native 

Americans (GONA), key program 

stakeholders, Native youth service 

providers (e.g., teachers, mental health 

providers, case workers, juvenile justice 

providers), and other community 

members (Native youth and adults). 

Data collection will take place in 25 AI/ 

AN communities across three cohorts. 

Data collection for the Native 

Aspirations Cross-community 

Evaluation will occur over a 3-year 

period of grant funding for each cohort. 

Clearance is requested for a 3-year 

period of data collection that spans FY 

2009 through FY 2012 during which 

Cohorts 3 and 4 will receive 3 years of 

data collection and Cohort 5 will receive 

2 years of data collection with the final 

year to be submitted in an OMB renewal 

package. The following describes the 

specific data collection activities and 

the 9 data collection instruments to be 

used, followed by a summary table of 

respondents and respondent burden. 

Community Specific Data Collection 

Activities—Tier I 

• GONA—Baseline Interviews (1 

Version). Each participating community 

will have the opportunity to hold a 

GONA focused on youth violence, 

bullying, substance abuse, and suicide 

concerns. Community GONAs follow 

four themes that correspond to 

indigenous values and are core 

resiliency factors for Native people. 

These values—belonging, mastery, 

mstockstill on PROD1PC66 with NOTICES