Federal Register / Vol. 72, No. 171 / Wednesday, September 5, 2007 / Notices 50965 

use by public safety, (4) cost of user 

devices and network equipment of 

emergency communications networks 

(e.g., unit cost, maintenance/upgrade 

cost, etc.), and the cost of operations 

and operations systems (including 

feature upgrades) for emergency 

communications networks and services, 

(5) deployment of user devices, network 

equipment, and operations processes 

and equipment of emergency 

communications systems (e.g., type of 

systems deployed or to be deployed), 

number of units deployed/sold, etc.), (6) 

standardization of user devices, network 

equipment, and operations interfaces of 

emergency communications systems 

(e.g., standard/proprietary, standard 

activities, etc.), (7) interoperability (i.e., 

the ability of communications among 

different systems, devices and groups) 

of user groups, user devices, network 

equipment, and operations processes 

and equipment of emergency 

communications systems (e.g., 

interoperability among first responders 

within a jurisdiction, among 

jurisdictions using the same and 

different network technologies), (8) 

spectrum usage of user devices and 

network equipment of emergency 

communications systems (e.g., 

frequencies of operation, shared/ 

dedicated spectrum, etc.), (9) 

applications and application 

requirements for end users and the 

technical requirements for such 

applications including bandwidth 

needs, (10) operations systems features 

and operations processes supporting 

emergency network operation during an 

emergency, (11) service capabilities 

(e.g., voice, data, video, mobile to 

mobile communications, etc.), (12) 

evolutionary trend of user devices, 

network equipment, and operations of 

emergency communications systems 

(e.g., next generation, migration path, 

etc.), (13) backhaul connectivity of 

network equipment and facilities (e.g., 

commercial/private, wired/wireless, 

capacity, etc.), (14) description of 

network technology and architecture 

(e.g., whether the network design 

accommodates access to emergency 

responders from other jurisdictions, 

capability of architecture to support 

resiliency in disaster situations, etc.), 

(15) operations budget for the network, 

(16) responsibilities of the organizations 

operating the networks, including 

service provisioning, traffic 

management and network maintenance, 

especially during an emergency, (17) 

plans, if any, for restoring emergency 

communication services or reverting to 

backup networks in the event that a 

primary emergency communications 

network is damaged or destroyed, (18) 

ability of existing emergency 

communications networks to back up or 

complement the communication 

resources of other emergency 

communications networks, (19) ability 

to rapidly increase emergency 

communication network capacity in the 

event that the capacity limits of the 

network are exceeded in a major 

disaster, (20) a description of the role of 

‘‘core services’’ such as authentication 

and agency locator services, whether 

and how they are implemented in 

existing and planned networks, and 

their costs, (21) a description of the 

processes and systems used or planned 

to connect emergency responders to a 

back-up network in an emergency, and 

(22) plans to restore emergency 

communications services if the network 

over which they are provided is 

damaged, destroyed, or sufficiently 

congested to be impaired or unusable 

(e.g., changes in operations staffing in 

emergency conditions, dynamic 

bandwidth allocation to users or 

networks, back-up communications for 

other emergency communications 

services or networks), other 

administrative or planning issues 

associated with the deployment and 

maintenance of such backup national 

emergency communications 

capabilities. 

Federal Communications Commission. 

William F. Caton, 

Deputy Secretary. 

[FR Doc. E7–17507 Filed 9–4–07; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL RESERVE SYSTEM 

Formations of, Acquisitions by, and 

Mergers of Bank Holding Companies 

The companies listed in this notice 

have applied to the Board for approval, 

pursuant to the Bank Holding Company 

Act of 1956 (12 U.S.C. 1841 et seq.) 

(BHC Act), Regulation Y (12 CFR Part 

225), and all other applicable statutes 

and regulations to become a bank 

holding company and/or to acquire the 

assets or the ownership of, control of, or 

the power to vote shares of a bank or 

bank holding company and all of the 

banks and nonbanking companies 

owned by the bank holding company, 

including the companies listed below. 

The applications listed below, as well 

as other related filings required by the 

Board, are available for immediate 

inspection at the Federal Reserve Bank 

indicated. The application also will be 

available for inspection at the offices of 

the Board of Governors. Interested 

persons may express their views in 

writing on the standards enumerated in 

the BHC Act (12 U.S.C. 1842(c)). If the 

proposal also involves the acquisition of 

a nonbanking company, the review also 

includes whether the acquisition of the 

nonbanking company complies with the 

standards in section 4 of the BHC Act 

(12 U.S.C. 1843). Unless otherwise 

noted, nonbanking activities will be 

conducted throughout the United States. 

Additional information on all bank 

holding companies may be obtained 

from the National Information Center 

website at www.ffiec.gov/nic/. 

Unless otherwise noted, comments 

regarding each of these applications 

must be received at the Reserve Bank 

indicated or the offices of the Board of 

Governors not later than September 28, 

2007. 

1. Federal Reserve Bank of Atlanta 

(David Tatum, Vice President) 1000 

Peachtree Street, NE., Atlanta, Georgia 

30309: 

1. Community First, Inc., Columbia, 

Tennessee; to acquire 100 percent of the 

voting shares of First National Bank of 

Centerville, Centerville, Tennessee. 

Board of Governors of the Federal Reserve 

System, August 30, 2007. 

Jennifer J. Johnson, 

Secretary of the Board. 

[FR Doc. E7–17489 Filed 9–4–07; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RETIREMENT THRIFT 

INVESTMENT BOARD 

Sunshine Act; Notice of Meeting 

TIME AND DATE: 9 a.m. (Eastern Time), 

September 17, 2007. 

PLACE: 4th Floor Conference Room, 

1250 H Street, NW., Washington, DC 

20005. 

STATUS: Parts will be open to the public 

and parts closed to the public. 

Matters To Be Considered 

Parts Open to the Public 

1. Approval of the minutes of the 

August 20, 2007 Board member 

meeting. 

2. Thrift Savings Plan activity report by 

the Executive Director. 

a. Monthly Participant Activity 

Report. 

b. Monthly Investment Performance 

Report. 

c. Legislative Report. 

3. Increasing Decimal Places in Fund 

Prices. 

4. Business Assurance and IT 

Infrastructure. 

5. Annual Budget Report. 


rfrederick on PROD1PC67 with NOTICES
50966 Federal Register / Vol. 72, No. 171 / Wednesday, September 5, 2007 / Notices 

aThe National Human Research Protections 

Advisory Committee has been disbanded and 

replaced by the Secretary’s Advisory Committee on 

Human Research Protections. 

a. Fiscal Year 2007 Results. 

b. Fiscal Year 2008 Budget. 

c. Fiscal Year 2009 Estimate. 

Parts Closed to the Public 

6. Personnel. 

CONTACT PERSON FOR MORE INFORMATION: 

Thomas J. Trabucco, Director, Office of 

External Affairs, (202) 942–1640. 

Dated: August 31, 2007. 

Thomas K. Emswiler, 

Secretary to the Board, Federal Retirement 

Thrift Investment Board. 

[FR Doc. 07–4350 Filed 8–31–07; 11:45 am] 

BILLING CODE 6760–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Information and 

Comments on Research That Involves 

Adult Individuals With Impaired 

Decision-making Capacity 

AGENCY: Office for Human Research 

Protections, Office of Public Health and 

Science, Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

Public Health and Science is seeking 

information and comments about 

whether guidance or additional 

regulations are needed to adequately 

protect adult individuals with impaired 

decision-making capacity who are 

potential subjects in research. This 

request for information and comments 

stems from the recommendation of an 

HHS working group, generated in 

response to the report published by the 

National Bioethics Advisory 

Commission (NBAC) entitled ‘‘Research 

Involving Persons With Mental 

Disorders That May Affect Decisionmaking Capacity’’ (December 1998), and 

from subsequent recommendations by 

the National Human Research 

Protections Advisory Committee 

(NHRPAC).a

In addition, as part of its charge to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services (the 

Secretary) and the Assistant Secretary 

for Health on issues and topics 

pertaining to or associated with the 

protection of human subjects, the 

Secretary’s Advisory Committee on 

Human Research Protections (SACHRP) 

has formed a Subcommittee on 

Inclusion of Individuals with Impaired 

Decision-Making in Research. This 

SACHRP subcommittee is currently 

considering whether guidance or 

additional regulations are needed for 

research involving individuals with 

impaired decision-making capacity. The 

information and comments submitted in 

response to this notice will be shared 

with SACHRP to inform the 

Committee’s recommendations to the 

Secretary and Assistant Secretary for 

Health. 

DATES: Submit written or electronic 

information and comments by December 

4, 2007. 

ADDRESSES: Submit written comments 

to REQUEST FOR INFORMATION ON 

RESEARCH THAT INVOLVES ADULT 

INDIVIDUALS WITH IMPAIRED 

DECISION-MAKING CAPACITY, Office 

for Human Research Protections, The 

Tower Building, 1101 Wootton 

Parkway, Suite 200, Rockville, MD 

20852. Comments also may be sent via 

e-mail to 

impairedcapacityohrp@hhs.gov, or via 

facsimile at 301–402–2071. Comments 

received within the comment period, 

including any personal information 

provided, will be made available to the 

public upon request. 

FOR FURTHER INFORMATION CONTACT: Julie 

Kaneshiro, Office for Human Research 

Protections, Department of Health and 

Human Services, The Tower Building, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852; 240–453–6900; 

e-mail julie.kaneshiro@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Department of Health and Human 

Services (HHS) regulates research 

involving human subjects conducted or 

supported by HHS through regulations 

codified at 45 CFR part 46 which are 

administered by OHRP. The HHS 

regulations stipulate that in order to 

approve research covered by the 

regulations, an institutional review 

board (IRB) shall determine that when 

some or all of the subjects are likely to 

be vulnerable to coercion or undue 

influence, such as children, prisoners, 

pregnant women, mentally disabled 

persons, or economically or 

educationally disadvantaged persons, 

additional safeguards have been 

included in the study to protect the 

rights and welfare of these subjects. 45 

CFR 46.111(b). Apart from this broad 

requirement regarding vulnerable 

populations, the HHS regulations do not 

contain specific additional standards for 

the participation of adults with 

impaired decision-making capacity in 

research, nor do they define who should 

be considered as part of this population. 

In response to the recommendations by 

the National Commission for the 

Protection of Human Subjects of 

Biomedical and Behavioral Research 

(National Commission) that pertained to 

research involving individuals who are 

institutionalized as mentally infirm, in 

1978, the Department of Health, 

Education, and Welfare (now HHS), 

issued proposed regulations on research 

involving those institutionalized as 

mentally disabled. However, these 

proposed regulations were never 

finalized or adopted due to a lack of 

consensus on the proposed regulatory 

provisions, and a judgment that the 

general HHS regulations governing 

human subjects’ participation in 

research were sufficient to address the 

National Commission’s 

recommendations. 

The impetus for this request for 

information and comments stems from a 

number of different sources. HHS is 

aware that some research currently 

conducted or supported by HHS 

involves adults with impaired decisionmaking capacity. HHS believes that 

research involving adults with impaired 

decision-making capacity is important 

and necessary in order to improve the 

health and well-being of such 

individuals. HHS and others have long 

recognized the potential vulnerability of 

these subjects, and that research 

involving this population needs to be 

conducted with adequate safeguards. At 

this time HHS believes it is appropriate 

to solicit the views of the public on 

whether the current human subject 

protection regulations are adequate in 

safeguarding these individuals. This 

request for information and comments 

also stems from recommendations of an 

HHS working group (HHS WG), 

generated in response to the report 

published by the former NBAC entitled 

‘‘Research Involving Persons with 

Mental Disorders That May Affect 

Decision-making Capacity’’ (December 

1998), and from subsequent 

recommendations by the former 

NHRPAC. 

A. NBAC Report 

In its December 1998 report, the full 

text of which can be found on the 

Internet at http:// 

bioethics.georgetown.edu/nbac, NBAC 

defined decisional impairment as a 

limitation or incapacity that is not part 

of normal growth and development. 

NBAC’s report contained 

recommendations for helping to ensure 

adequate protections for people with 

decisional impairment who participate 

in research, but referred only to research 

involving persons with mental disorders 


rfrederick on PROD1PC67 with NOTICES