Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 57469 

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 applications 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 October 14, 

2010. 

A. Federal Reserve Bank of Kansas 

City (Dennis Denney, Assistant Vice 

President) 1 Memorial Drive, Kansas 

City, Missouri 64198–0001: 

1. GLAASS Financial, LLC; to become 

a bank holding company through the 

acquisition of 36.4 percent of the voting 

shares of EMSWATER Financial, LLC, 

both in Exeter, Nebraska. In connection 

with this application, Applicant also 

has applied to acquire EMSWATER 

Financial, LLC and First National 

Insurance Agency, Inc., both of Exeter, 

Nebraska pursuant to section 

225.28(b)(11)(A) of Regulation Y. 

Board of Governors of the Federal Reserve 

System, September 16, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–23522 Filed 9–20–10; 8:45 am] 

BILLING CODE 6210–01–S 

FEDERAL RESERVE SYSTEM 

Government in the Sunshine Act 

Meeting Notice 

AGENCY HOLDING THE MEETING: Board of 

Governors of the Federal Reserve 

System. 

TIME AND DATE: 12 p.m., Monday, 

September 20, 2010. 

The business of the Board requires 

that this meeting be held with less than 

one week’s advance notice to the public, 

and no earlier announcement of the 

meeting was practicable. 

PLACE: Marriner S. Eccles Federal 

Reserve Board Building, 20th and C 

Streets, NW., Washington, DC 20551. 

STATUS: Closed. 

Matters To Be Considered 

1. Implications of Dodd-Frank Reform 

Act for Board Organization and Staffing. 

FOR MORE INFORMATION PLEASE CONTACT: 

Michelle Smith, Director, or Dave 

Skidmore, Assistant to the Board, Office 

of Board Members at 202–452–2955. 

SUPPLEMENTARY INFORMATION: You may 

call 202–452–3206 beginning at 

approximately 5 p.m. two business days 

before the meeting for a recorded 

announcement of bank and bank 

holding company applications 

scheduled for the meeting; or you may 

contact the Board’s Web site at http:// 

www.federalreserve.gov for an electronic 

announcement that not only lists 

applications, but also indicates 

procedural and other information about 

the meeting. 

Dated: September 17, 2010. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2010–23669 Filed 9–17–10; 4:15 pm] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Guidance on Withdrawal of Subjects 

From Research: Data Retention and 

Other Related Issues 

AGENCY: Office for Human Research 

Protections, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), within the 

Office of the Assistant Secretary for 

Health, is announcing the availability of 

a guidance document entitled, 

‘‘Guidance on Withdrawal of Subjects 

From Research: Data Retention and 

Other Related Issues.’’ The guidance 

document provides OHRP’s first formal 

guidance on this topic. The document, 

which is available on the OHRP Web 

site at http://www.hhs.gov/ohrp/policy/ 

subjectwithdrawal.html or http:// 

www.hhs.gov/ohrp/policy/ 

subjectwithdrawal.pdf, is intended 

primarily for institutional review boards 

(IRBs), investigators, and funding 

agencies that may be responsible for the 

review or oversight of human subject 

research conducted or supported by the 

Department of Health and Human 

Services (HHS). The guidance document 

announced in this notice finalizes the 

draft guidance entitled, ‘‘Guidance on 

Important Considerations for When 

Participation of Human Subjects in 

Research is Discontinued,’’ that was 

made available for public comment 

through a notice in the Federal Register 

on December 1, 2008 (73 FR 72804). 

OHRP received comments on the draft 

guidance document from 30 individuals 

and organizations, and those comments 

were considered as the guidance was 

finalized. 

DATES: Comments on OHRP guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

a single copy of the guidance document 

entitled, ‘‘Guidance on Withdrawal of 

Subjects From Research: Data Retention 

and Other Related Issues,’’ to the 

Division of Policy and Assurances, 

Office for Human Research Protections, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–402–2071. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance document. 

Submit written comments to 

COMMENTS ON SUBJECT 

WITHDRAWAL GUIDANCE, Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. Comments also may be sent 

via e-mail to ohrp@hhs.gov or via 

facsimile at 240–402–2071. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, PhD, Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852, 240–453–6900; e-mail 

Irene.StithColeman@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

OHRP, Office of the Assistant 

Secretary for Health, is announcing the 

availability of a guidance document 

entitled, ‘‘Guidance on Withdrawal of 

Subjects From Research: Data Retention 

and Other Related Issues.’’ The guidance 

document provides OHRP’s first formal 

guidance on this topic. The document is 

intended primarily for IRBs, 

investigators, and funding agencies that 

may be responsible for the review or 

oversight of human subject research 

conducted or supported by HHS. 

The guidance document applies to 

non-exempt human subjects research 

conducted or supported by HHS. The 

guidance addresses the following six 

topics: 

(1) What does it mean when a subject 

withdraws from a research study? 


srobinson on DSKHWCL6B1PROD with NOTICES
57470 Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 

(2) May an investigator retain and 

analyze already collected data about a 

subject who withdraws from the 

research or whose participation is 

terminated by the investigator? 

(3) Can investigators honor subjects’ 

requests to have their data destroyed or 

excluded from any analysis? 

(4) Should the withdrawal of a subject 

from a research study be documented? 

(5) What is the relationship of this 

guidance to FDA’s guidance on this 

issue and to the HIPAA Privacy Rule? 

(6) When seeking the informed 

consent of subjects, what should 

investigators tell subjects about data 

retention in the event the subjects 

withdraw? 

Of particular importance, the 

guidance document clarifies that when 

a subject chooses to withdraw from (i.e., 

discontinue his or her participation in) 

an ongoing research study, or when an 

investigator terminates a subject’s 

participation in such a research study 

without regard to the subject’s consent, 

the investigator may retain and analyze 

already collected data relating to that 

subject, even if that data includes 

identifiable private information about 

the subject. 

The guidance document announced 

in this notice finalizes the draft 

guidance entitled, ‘‘Guidance on 

Important Considerations for When 

Participation of Human Subjects in 

Research is Discontinued,’’ that was 

made available for public comment 

through a notice in the Federal Register 

on December 1, 2008 (73 FR 72804). 

OHRP received comments on the draft 

guidance document from 30 individuals 

and organizations, and those comments 

were considered as the guidance was 

finalized. 

In addition to the change in the title, 

the final guidance document differs 

from the draft guidance document that 

was made available for public comment 

in the following three key ways: 

(1) All content regarding 

biospecimens that was included in the 

draft guidance document has been 

removed from the final guidance 

document. This change makes the final 

guidance document more harmonious 

with the Food and Drug 

Administration’s (FDA’s) corresponding 

guidance entitled, ‘‘Guidance for 

Sponsors, Clinical Investigators, and 

IRBs: Data Retention When Subjects 

Withdraw from FDA-Regulated Clinical 

Trials,’’ which also focuses on data 

retention when subjects withdraw from 

research and is silent on issues related 

to biospecimens. Furthermore, research 

involving the banking and use of 

biospecimens for research purposes is a 

complex, evolving area of research. 

OHRP believes that guidance on the use 

of biospecimens obtained from subjects 

who subsequently withdraw from 

research should be addressed in the 

future by a more comprehensive 

guidance document that addresses more 

broadly research involving 

biospecimens. In the meantime, 

individuals with questions regarding 

how to handle biospecimens obtained 

from subjects who subsequently 

withdraw from a research study should 

contact OHRP by telephone at 240–453– 

6900 or 866–447–4777 or by e-mail at 

ohrp@hhs.gov. 

(2) The final guidance document 

includes more examples of social and 

behavioral research activities in order to 

emphasize that the guidance applies to 

such research, in addition to its 

applicability to biomedical research. 

(3) The final guidance includes a 

recommendation that investigators plan 

for the possibility that subjects will 

withdraw from research and that they 

include a discussion of what 

withdrawal will mean and how it will 

be handled in their research protocols 

and informed consent documents. 

Furthermore, the final guidance 

addresses the question of what 

investigators, when seeking the 

informed consent of subjects, should tell 

the subjects about data retention in the 

event the subjects withdraw. 

For HHS-conducted or supported 

research that is regulated by FDA, FDA’s 

guidance on this issue also should be 

consulted. FDA’s guidance entitled, 

‘‘Guidance for Sponsors, Clinical 

Investigators, and IRBs: Data Retention 

When Subjects Withdraw from FDARegulated Clinical Trials’’ can be found 

at http://www.fda.gov/OHRMS/

DOCKETS/98fr/FDA–2008–D–0576-gdl.

pdf. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document on 

OHRP’s Web site at http://www.hhs.gov/ 

ohrp/policy/subjectwithdrawal.html or 

http://www.hhs.gov/ohrp/policy/subject

withdrawal.pdf. 

III. Comments 

Interested persons may submit 

comments regarding this guidance 

document to OHRP at any time. Please 

see the ADDRESSES section for 

information on where to submit written 

comments. 

Dated: September 15, 2010. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2010–23517 Filed 9–20–10; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Proposed Collection; 

Comment Request; Customer and 

Other Partners Satisfaction Surveys 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995 

for the opportunity for public comment 

on the proposed data collection projects, 

the National Institutes of Health Clinical 

Center (CC) will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: Customer 

and Other Partners Satisfaction Surveys. 

Type of Information Collection Request: 

Extension request. Need and Use of 

Information Collection: The information 

collected in these surveys will be used 

by Clinical Center personnel: (1) To 

evaluate the satisfaction of various 

Clinical Center customers and other 

partners with Clinical Center services; 

(2) to assist with the design of 

modifications of these services, based 

on customer input; (3) to develop new 

services, based on customer need; and 

(4) to evaluate the satisfaction of various 

Clinical Center customers and other 

partners with implemented service 

modifications. These surveys will 

almost certainly lead to quality 

improvement activities that will 

enhance and/or streamline the Clinical 

Center’s operations. The major 

mechanisms by which the Clinical 

Center will request customer input is 

through surveys and focus groups. The 

surveys will be tailored specifically to 

each class of customer and to that class 

of customer’s needs. Surveys will either 

be collected as written documents, as 

faxed documents, mailed electronically 

or collected by telephone from 

customers. Information gathered from 

these surveys of Clinical Center 

customers and other partners will be 

presented to, and used directly by, 

Clinical Center management to enhance 

the services and operations of our 

organization. Frequency of Response: 

The participants will respond yearly. 

Affected public: Individuals and 

households; businesses and other for 

profit, small businesses and 

organizations. Types of respondents: 

These surveys are designed to assess the 

satisfaction of the Clinical Center’s 

major internal and external customers 

with the services provided. These 

customers include, but are not limited 

to, the following groups of individuals: 


srobinson on DSKHWCL6B1PROD with NOTICES