Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices 1695 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/oc/op/ 

goodreprint.html or http:// 

www.regulations.gov. 

Dated: January 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–452 Filed 1–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0674] 

Participation of Certain Population 

Subsets in Clinical Drug Trials; 

Request for Comment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is seeking 

information and comments on issues 

related to the enrollment of certain 

populations in clinical drug trials. 

Particularly, we are requesting 

information and comments from 

medical product manufacturers, 

institutional review boards (IRBs), 

patient groups, universities, researchers, 

community groups, and other interested 

parties. This request is related to FDA’s 

implementation of the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) section 901, which 

requires recommendations be included 

in a report to Congress addressing best 

practice approaches on increasing the 

participation of elderly populations, 

children, racially and ethnically diverse 

communities, and medically 

underserved populations in clinical 

drug trials. FDA requests that those with 

information on possible approaches to 

increase participation of these groups in 

clinical drug trials submit comments. 

DATES: Submit written or electronic 

comments by February 27, 2009. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Brenda Evelyn, Office of Special Health 

Issues, Office of the Commissioner, 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–4460. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 901 of FDAAA requires that 

FDA submit a report to Congress that 

includes ‘‘recommendations regarding 

impediments to the participation of 

elderly populations, children, racially 

and ethnically diverse communities and 

medically underserved populations in 

clinical drug trials’’ and 

recommendations that address ‘‘best 

practice approaches for increasing the 

inclusion of such subsets of the general 

population’’ in clinical drug trials 

(FDAAA, section 901(d)(5)). In 

developing this report, FDA seeks 

comments that may help to develop 

these recommendations. 

Participation of all segments of the 

population in medical research is 

critical to public health. The ability to 

develop drugs that are safe and effective 

for diverse groups hinges on the 

availability of clinical drug trial 

participants from these same groups. 

Some researchers and public health 

experts argue that inconsistent 

representation of certain communities 

can potentially lead to health disparities 

and insufficient data for risk 

assessment. FDA has previously 

identified the need for inclusion of 

children, both sexes, the elderly, 

racially and ethnically diverse 

communities, and other populations in 

clinical trials so that data are available 

to evaluate the potential differences 

among these subgroups (63 FR 6854, 

February 11, 1998). According to the 

Department of Health and Human 

Services (HHS) Office of Minority 

Health, in a recent prostate cancer 

study, only 8 percent of the 18,000 

participants were minorities 

(www.omhrc.gov/templates/ 

content.aspx?ID=5147). Increased 

participation from all of these subgroups may help assure that data 

relevant to the entire treatment 

population are obtained. 

In addition, statutory mandates and 

incentives such as the Pediatric 

Research Equity Act (PREA) (Public Law 

No. 108–155 as amended by FDAAA) 

and the Best Pharmaceuticals for 

Children Act (BPCA) (Public Law No. 

107–109 as amended by FDAAA) 

require and encourage medical research 

to consider implications for pediatric 

populations. 

For over 20 years, FDA has worked to 

encourage broad participation of all 

groups in clinical drug trials. Under 

FDA regulations (21 CFR 312.33), all 

investigational new drug (IND) 

applications must include in annual 

reports the number of patients tabulated 

by age, gender, and race, and under 21 

CFR 314.50(d)(5)(v) and (d)(5)(vi), new 

drug applications (NDA) are required to 

include analyses of efficacy and safety 

by demographic subgroups. Biologics 

license applications typically include 

analyses of efficacy and safety by 

demographic subgroups. The 

International Conference on 

Harmonization (ICH) guidance on the 

common technical document also calls 

for such analyses (see M4E: The CTD— 

Efficacy (August 2001) available at 

http://www.fda.gov/cber/gdlns/ 

m4ectd.pdf.). 

FDA has issued labeling 

recommendations for specific subpopulations (Guidance for Industry: 

Content and Format of the Adverse 

Reactions Section of Labeling for 

Human Prescription Drugs and 

Biological Products, January 2006, 

available at http://www.fda.gov/cber/ 

gdlns/cfadvers.htm) and guidelines for 

studying gender differences in clinical 

drug studies (Guideline for the Study 

and Evaluation of Gender, July 1993, 

available at http://www.fda.gov/cder/ 

Guidance/old036fn.pdf). FDA has made 

recommendations for minimum 

standards for the collection and use of 

race and ethnicity information to assist 

in the reporting of the summary of 

safety and effectiveness data by 

demographic subgroups (age, gender, 

race), as well as an analysis of whether 

modifications of dose or dosage 

intervals are needed for specific 

subgroups. (Guidance for Industry: 

Collection of Race and Ethnicity Data in 

Clinical Trials, September 2005, 

available at http://www.fda.gov/CBER/ 

gdlns/racethclin.htm; see, also ICH E–7 

Guideline for Industry, Studies in 

Support of Special Populations: 

Geriatrics (August 1994) available at 

1696 Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices 

http://www.fda.gov/cder/guidance/ 

iche7.pdf and Reviewer Guidance: 

Conducting a Clinical Safety Review of 

a New Product Application and 

Preparing a Report on the Review 

(February 2005) available at http:// 

www.fda.gov/cder/guidance/ 

3580fnl.pdf.) 

Other agencies have also issued 

guidelines for the participation of 

diverse groups in clinical trials. For 

example, the National Institutes of 

Health (NIH) requires the inclusion of 

women and minority groups in NIHfunded trials unless an exception is 

warranted (NIH Policy on the Inclusion 

of Women and Minorities as Subjects in 

Clinical Research as amended October 

2001, information is available at http:// 

grants.nih.gov/grants/funding/ 

women_min/ 

guidelines_amended_10_2001.htm). 

NIH also has issued guidelines for 

inclusion of children as research 

subjects (March 1998 NIH Policy and 

Guidelines on the Inclusion of Children 

as Participants in Research Involving 

Human Subjects, available at http:// 

grants.nih.gov/grants/guide/notice-files/ 

not98-024.html). 

Currently, healthcare professional 

organizations, various universities, 

foundations, and industries are taking 

steps to encourage broad participation 

of all populations in clinical drug trials. 

Since 1998, the National Medical 

Association has administered Project 

IMPACT, a program initially funded by 

HHS designed to train African American 

physicians on being clinical 

investigators and to increase knowledge 

and raise awareness about clinical trials 

among African American physicians 

and consumers. (Information is 

available at http://www.omhrc.gov/ 

assets/pdf/checked/Project%

20IMPACT--Increasing%20Minority%

20Participation%

20and%20Awareness%

20of%20Clinical%20Trials.pdf.) The 

program is currently being funded by 

AstraZeneca and has expanded to 

include the Interamerican College of 

Physicians and Surgeons, an Hispanic 

health professional organization. 

(Information is available at http:// 

www.astrazeneca-us.com/communitysupport/?itemId=1338629.) Further, 

some foundations have supported 

studies and programs designed to 

increase participation (e.g., the Lance 

Armstrong Foundation’s support of the 

Education Network to Advance Clinical 

Cancer Trials, intended ‘‘to foster 

awareness about cancer clinical trials, 

enhance their acceptability and improve 

access to them.’’ Information is available 

at http://www.livestrong.org/site/ 

c.khLXK1PxHmF/b.2662065/k.C0D9/ 

ENACCT.htm). Industry has partnered 

with academia to fund similar programs 

(e.g., Genentech’s and Baylor College of 

Medicine’s research initiative with the 

Intercultural Cancer Council, ‘‘Project 

addresses underrepresentation of 

minorities, underserved patients in 

clinical studies.’’ Information is 

available at http://www.bcm.edu/news/ 

item.cfm?newsID=420). 

We are seeking information to 

determine if additional approaches are 

necessary to increase participation of 

certain subsets of the general population 

(elderly populations, children, racially 

and ethnically diverse communities, 

and medically underserved populations) 

in drug clinical trials. 

II. Request for Comments and 

Information 

In providing comments, we are 

particularly interested in responses to 

the following questions regarding the 

participation of certain population 

subsets in clinical drug trials. 

A. Communication and Knowledge 

Barriers 

1. To what extent do differences in 

native language, educational level, and 

literacy interfere with members of some 

populations’ participation in clinical 

trials: 

• Finding out about the existence of 

trials and how to enroll 

• Understanding informed consent 

documents and procedures 

• Adhering to clinical trial 

instructions and drug regimens 

• Completing clinical trials 

2. To what extent do limitations in 

access to technology and to medical care 

in general decrease the chance that 

members of some populations will 

know about the existence of clinical 

trials and how to participate in them? 

• Are these subsets of populations 

aware of www.ClinicalTrials.gov? 

3. What proven methods, i.e., best 

practices, are available to address the 

impact of these potential barriers to 

communication about the existence of, 

and how to participate in, clinical drug 

trials? 

4. To what extent are health care 

providers aware of 

www.ClinicalTrials.gov? 

B. Trust and Cultural Sensitivity 

1. To what extent do culturally-bound 

beliefs or traditions, or trust or 

stereotypes about the medical research 

community, interfere with group 

members’ willingness to participate in 

clinical drug trials? 

• Are particular populations 

significantly more or less trusting of 

those who conduct medical research? 

2. What approaches to address 

cultural sensitivity and trust issues, 

including increased collaboration with 

community-based organizations, have 

been shown to increase successful 

clinical trial participation? 

3. To what extent do the beliefs of 

clinical trial personnel about the 

commitment or ability of members of 

some populations to follow through 

with a protocol influence willingness to 

recruit and enroll such individuals in 

clinical drug trials? 

4. What approaches, i.e. best 

practices, have been shown to improve 

trust between potential participants and 

clinical drug trial researchers and 

healthcare providers who can provide 

referrals? 

C. Costs of Clinical Trial Participation 

Note: The term ‘‘cost’’ may vary from 

participant to participant and is 

intended to include time lost (i.e. wages, 

childcare, etc), effort expended, and 

other sacrifices that may be necessary to 

participate in clinical drug trials. 

1. To what extent do data show that 

the ‘‘costs’’ of participation, to either 

potential participants or to those who 

conduct clinical drug trials, prohibit 

participation or enrollment of particular 

populations? 

2. To what extent do data address the 

following? 

• Do particular populations 

understand the potential public benefit 

from participating in clinical drug trials 

as compared to the ‘‘cost’’ to the 

participant? 

• Is the belief that there is a public 

benefit from participating in clinical 

drug trials a sufficient incentive for 

participation for some populations? 

3. To what extent do data show that 

limited health insurance coverage is an 

impediment to clinical drug trial 

participation? 

4. To what degree is the geographical 

accessibility to clinical trials a 

significant cost that affects the 

participation of some populations? 

5. What are the ‘‘costs’’ of 

participating in clinical drug trials that 

are most relevant to some populations? 

How might these be reduced? 

6. What approaches, i.e. best 

practices, have been shown to decrease 

‘‘costs’’ with resulting increased 

participation in clinical drug trials? 

D. Other 

1. Please describe any other barriers, 

or best practice approaches, that HHS 

should consider in striving to increase 

participation of certain population 

subsets in clinical drug trials. 

Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices 1697 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: January 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–450 Filed 1–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Follow-up of 

Kidney Cancer Patients From the 

Central European Multicenter CaseControl Study (CEERCC) (NCI) 

SUMMARY: Under the provisions of 

section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on November 3, 2008 (Volume 

73, No. 213, p. 65387) and allowed 60 

days for public comment. There was one 

public comment received which 

questioned why U.S. tax dollars are 

being spent on a study located in 

Europe. The investigator responded 

directly to the comment on 12/19/08 

stating that this study costs less money 

to conduct in central Europe than in the 

U.S. since previous data has already 

been collected. Additionally, since this 

region has the highest rates of kidney 

cancer in the world a study in this area 

would provide a wealth of data in terms 

of the causes of kidney cancer. The 

purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: Follow-up 

of Kidney Cancer Patients from the 

Central European Multicenter CaseControl Study (NCI). Type of 

Information Collection Request: New. 

Need and Use of Information Collection: 

The purpose of this questionnaire is to 

obtain information on the 5-year 

survival status of kidney cancer patients 

that were previously enrolled in a 

Central European Case-Control Study of 

Kidney Cancer that was conducted from 

2001 to 2004. The aim is to assess 

survival, the prevalence of recurrent 

disease and progression, and to 

investigate patient, tumor and genetic 

determinants of survival among cases. 

The questionnaire will collect 

information on patient related factors, 

tumor related factors that were not 

collected during the initial study, and 

the type of treatment(s) received since 

the patients were last contacted for the 

case-control study. This questionnaire 

adheres to The Public Health Service 

Act, section 412 (42 U.S.C. 285a–1) and 

section 413 (42 U.S.C. 285a–2), which 

authorizes the Division of Cancer 

Epidemiology and Genetics of the 

National Cancer Institute (NCI) to 

establish and support programs for the 

detection, diagnosis, prevention and 

treatment of cancer; and to collect, 

identify, analyze and disseminate 

information on cancer research, 

diagnosis, prevention and treatment. 

Frequency of Response: Once. Affected 

Public: Individuals. Type of 

Respondents: Individuals that 

participated in the Central European 

Renal Cancer Case-Control Study 

between 2001–2004 and physician 

abstractors. The estimated total annual 

burden hours requested is 296. The 

annualized cost to respondents is 

estimated at $5174. The data will be 

collected within a two-year period. 

There are no additional capital costs, 

operating costs, and/or maintenance 

costs to report. 

ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Number of 

respondents 

Frequency 

of response 

Average 

time per 

response 

(Minutes/ 

Hour) 

Annual 

burden 

hours 

Patients ............................................................................................................................ 200 1 40/60 133.33 

Families (NOK) ................................................................................................................ 240 1 40/60 160.00 

Physicians ........................................................................................................................ 10 1 15/60 2.50 

Totals ........................................................................................................................ 450 .................... .................... 295.83 

Request 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 function of the 

agency, including whether the 

information will 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 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology.