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from the draft guidance document that 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draft guidance document has been 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
Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 57471 

Clinical Center patients, family 

members of Clinical Center patients, 

visitors to the Clinical Center, NIH 

intramural collaborators, private 

physicians or organizations who refer 

patients to the Clinical Center, 

volunteers, vendors and collaborating 

commercial enterprises, small 

businesses, regulators, and other 

organizations. The annual reporting 

burden is as follows: 

FY 2010 

Customer Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Clinical Center Patients ................................................................................... 5000 1 .5 2500 

Family Members of Patients ............................................................................ 2000 1 .5 1000 

Visitors to the Clinical Center .......................................................................... 1000 1 .17 170 

NIH Intramural Collaborators ........................................................................... 2000 1 .17 340 

Vendors and Collaborating Commercial Enterprises ...................................... 2500 1 .33 833 

Professionals and Organizations Referring Patients ....................................... 2000 1 .33 833 

Regulators ........................................................................................................ 30 1 .33 10 

Volunteers ........................................................................................................ 275 1 .5 138 

Total .......................................................................................................... 14,805 ........................ ........................ 5,824 

FY 2011 

Customer Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Clinical Center Patients ................................................................................... 5000 1 .5 2500 

Family Members of Patients ............................................................................ 3000 1 .5 1500 

Visitors to the Clinical Center .......................................................................... 1500 1 .17 255 

NIH Intramural Collaborators ........................................................................... 1500 1 .25 375 

Vendors and Collaborating Commercial Enterprises ...................................... 1000 1 .25 250 

Professionals and Organizations Referring Patients ....................................... 3000 1 .33 1000 

Regulators ........................................................................................................ 30 1 .33 10 

Volunteers ........................................................................................................ 275 1 .33 92 

Total .......................................................................................................... 15,305 ........................ ........................ 5,982 

FY 2012 

Customer Number of respondents 

Frequency of 

response 

Average time 

per response 

Annual hour 

burden 

Clinical Center Patients ................................................................................... 5000 1 .5 2500 

Family Members of Patients ............................................................................ 2000 1 .5 1000 

Visitors to the Clinical Center .......................................................................... 1000 1 .17 170 

NIH Intramural Collaborators ........................................................................... 1000 1 .17 170 

Vendors and Collaborating Commercial Enterprises ...................................... 2500 1 .25 625 

Professionals and Organizations Referring Patients ....................................... 3000 1 .33 1000 

Regulators ........................................................................................................ 25 1 .25 6 

Volunteers ........................................................................................................ 300 1 .25 75 

Total .......................................................................................................... 14,825 ........................ ........................ 5,546 

Estimated costs to the respondents 

consists of their time; time is estimated 

using a rate of $10.00 per hour for 

patients and the public; $30.00 for 

vendors, regulators, organizations and 

$55.00 for health care professionals. The 

estimated annual costs to respondents 

for each year for which the generic 

clearance is requested is $127,885 for 

2010, $126,895 for 2011, and $120,730 

for 2012. Estimated Capital Costs are 

$7,000. Estimated Operating and 

Maintenance costs are $75,000. 

Requests for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

Clinical Center and the agency, 

including whether the information shall 

have practical utility; (2) The accuracy 

of the agency’s estimate of the burden of 

the proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project, or to obtain a copy of 

the data collection plans and 

instruments, contact: Dr. David K. 

Henderson, Deputy Director for Clinical 

Care, National Institutes of Health 

Clinical Center, Building 10, Room 6– 

1480, 10 Center Drive, Bethesda, 

Maryland 20892, or call non-toll free: 

301–496–3515, or e-mail your request or 

comments, including your address to: 

dkh@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 


srobinson on DSKHWCL6B1PROD with NOTICES
57472 Federal Register / Vol. 75, No. 182 / Tuesday, September 21, 2010 / Notices 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 6, 2010. 

David K. Henderson, 

Deputy Director for Clinical Care, CC National 

Institutes of Health. 

[FR Doc. 2010–23526 Filed 9–20–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee (BCCEDCAC): Notice of 

Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the 

BCCEDCAC, HHS, has been renewed for 

a 2-year period through September 12, 

2012. 

For information, contact Ms. Jameka 

Blackmon, Designated Federal Officer, 

BCCEDCAC, CDC, 1600 Clifton Road, 

NE., M/S K57, Atlanta, Georgia, 30333, 

telephone (770) 488–4740; fax (770) 

488–3230. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: September 14, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–23588 Filed 9–20–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0456] 

Clinical Investigator Training Course 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of Critical 

Path Programs, in cosponsorship with 

the Clinical Trials Transformation 

Initiative (CTTI), is announcing a 3-day 

training course for health care 

professionals responsible for, or 

involved in, the conduct and/or design 

of clinical trials (clinical investigators). 

This course is intended to assist clinical 

investigators in understanding what 

preclinical and clinical information is 

needed to support the investigational 

use of medical products, as well as the 

scientific, regulatory, and ethical 

considerations involved in the conduct 

of clinical trials. 

DATES: The training course will be held 

on November 8 and 9, 2010, from 8 a.m. 

to 5 p.m. and on November 10, 2010, 

from 8 a.m. to 3 p.m. 

ADDRESSES: The training course will be 

held at the National Labor College, 

10000 New Hampshire Ave., Silver 

Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Masiello, Office of Critical Path 

Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 4166, Silver Spring, 

MD 20993–0002, 301–796–8498, 

Nancy.Masiello@fda.hhs.gov. 

Registration: Register by November 1, 

2010, at the registration/information 

Web site at https://www.trials

transformation.org/fda-clinicalinvestigator-training-course/. 

Registration materials, payment 

procedures, accommodation 

information, and a detailed description 

of the course can be found at the 

registration/information Web site. The 

registration fee is $350 per person. The 

fee includes course materials and onsite 

lunch. Early registration is 

recommended because seating is 

limited. There will be no onsite 

registration. Persons attending the 

course are advised that FDA is not 

responsible for providing access to 

electrical outlets. If you need special 

accommodations due to a disability, 

please contact Nancy Masiello at least 7 

days in advance. 

SUPPLEMENTARY INFORMATION: Clinical 

trial investigators play a critical role in 

the development of medical products. 

They bear the responsibility for 

ensuring the safe and ethical treatment 

of study subjects and for acquiring 

adequate and reliable data to support 

regulatory decisions. This course is 

intended to assist clinical investigators 

in understanding what preclinical and 

clinical information is needed to 

support the investigational use of 

medical products, as well as the 

scientific, regulatory, and ethical 

considerations involved in the conduct 

of clinical trials. 

The training course is designed to 

provide clinical investigators with an 

overview of the following topics: 

• The essential toxicological, 

pharmacological, and manufacturing 

data to support investigational use in 

humans; 

• Fundamental issues in the design 

and conduct of clinical trials; 

• Statistical and analytic 

considerations in the interpretation of 

trial data; 

• Appropriate safety evaluation 

during studies; 

• The ethical considerations and 

regulatory requirements for clinical 

trials; and 

• Application and compliance issues. 

In addition, the course should: 

• Foster a cadre of clinical 

investigators with knowledge, 

experience, and commitment to 

investigational medicine; 

• Promote communication between 

clinical investigators and FDA; 

• Enhance investigators’ 

understanding of FDA’s role in 

experimental medicine; and 

• Improve the quality of data while 

enhancing subject protection in the 

performance of clinical trials. 

On November 8, 2010, the course will 

address the role of FDA in clinical 

studies, regulatory considerations for 

clinical trials, and review of the material 

generally appearing in an ‘‘investigator’s 

brochure,’’ i.e., the preclinical 

information (toxicology, animal studies, 

and chemistry/manufacturing 

information) that supports initial 

clinical trials in humans. Presentations 

will also discuss the role of clinical 

pharmacology in early clinical studies 

and how this information is used in the 

design of subsequent studies. On 

November 9, 2010, the course will 

include discussions of scientific, 

statistical, ethical, and regulatory 

aspects of clinical studies. On 

November 10, 2010, the course will 

include discussions of safety assessment 

in clinical trials, including hepatic and 

cardiovascular safety, approaches to 

special populations (e.g., pregnant 

women and pediatrics), and breakout 

sessions to discuss how to put together 

an application, including related 

compliance issues. 

Dated: September 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–23493 Filed 9–20–10; 8:45 am] 

BILLING CODE 4160–01–S 


srobinson on DSKHWCL6B1PROD with NOTICES