Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Notices 42309 

comments and recommendations must 

be submitted in one of the following 

ways by October 20, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number (CMS–10198), Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: August 14, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–20128 Filed 8–20–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0391] 

Clinical Investigator Training Course 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Office of 

Critical Path Programs and the Clinical 

Trials Transformation Initiative (CTTI) 

are co-sponsoring a 3-day training 

course for clinical investigators on 

scientific, ethical, and regulatory 

aspects of clinical trials. This training 

course is intended to provide 

investigators with expertise in the 

design, conduct, and analysis of clinical 

trials; improve the quality of clinical 

trials; and enhance the safety of trial 

participants. Senior FDA staff will 

communicate directly with clinical 

investigators on issues of greatest 

importance for successful clinical 

research. 

DATES: The training course will be held 

on November 16 and 17, 2009, from 8 

a.m. to 5 p.m. and on November 18, 

2009, from 8 a.m. to 3:30 p.m. 

ADDRESSES: The course will be held at 

the National Labor College, 10000 New 

Hampshire Ave., Silver Spring, MD 

20903. 

FOR FURTHER INFORMATION CONTACT: 

Devota DeMarco, Office of Critical Path 

Programs (HF–18), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3605, 

Devota.DeMarco@fda.hhs.gov; or 

Nancy Stanisic, Office of Critical Path 

Programs (HF–18), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1660, 

Nancy.Stanisic@fda.hhs.gov. 

Registration: Register by November 2, 

2009, at the registration/information 

Web site at https://www.trials

transformation.org/fda-clinicalinvestigator-training-course/ or by fax at 

919–660–1769. 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 $300 per person. The 

fee includes course materials and onsite 

lunch. Early registration is 

recommended because seating is 

limited. There will be no onsite 

registration. If you need special 

accommodations due to a disability, 

please contact one of the persons listed 

in the FOR FURTHER INFORMATION

CONTACT section of this document. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 course will cover 

a wide variety of key topics, including 

material on novel safety concerns, 

adverse event monitoring, compliance 

with the legal and ethical obligations of 

clinical research, and acceptable 

scientific and analytic standards in the 

design and conduct of clinical studies. 

The faculty will include a diverse 

representation of senior FDA staff, 

enabling FDA to communicate directly 

with clinical investigators on issues of 

greatest importance for successful 

clinical research. 

II. Description of the Training Course 

A. Purpose 

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; and 

• The ethical considerations and 

regulatory requirements for clinical 

trials. 

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. 

B. Proposed Agenda 

The course will be conducted over 3 

days and will comprise approximately 

26 lectures, each lasting between 30 and 

45 minutes. Two sessions of case 

studies will be included for which 

participants will be expected to do 

preparatory reading and answer 

questions. The course will be presented 

mainly by senior FDA staff, with guest 

lecturers presenting selected topics. 

On day one, 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. Day two 

will include discussions of scientific, 

statistical, ethical, and regulatory 

aspects of clinical studies. Day three 

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 

the role of personalized medicine and 

new scientific techniques in medical 

product development. 


srobinson on DSKHWCL6B1PROD with NOTICES
42310 Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Notices 

C. Target Audience 

The course is targeted at healthcare 

professionals responsible for, or 

involved in, the conduct and/or design 

of clinical trials. 

Dated: August 14, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20084 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0395] 

Draft Guidance for Industry, User 

Facilities, and Food and Drug 

Administration Staff; eMDR— 

Electronic Medical Device Reporting; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘eMDR—Electronic Medical 

Device Reporting.’’ The draft guidance 

document addresses general issues 

related to the submission of postmarket 

medical device reports (MDRs) in 

electronic format. Elsewhere in this 

issue of the Federal Register, FDA is 

publishing a proposed rule to require 

that manufacturers, importers, and user 

facilities submit most MDRs to the 

agency in electronic format. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115 (g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by November 19, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘eMDR—Electronic 

Medical Device Reporting’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

, Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Building 

66, rm. 4613, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your request, or fax your request to 301– 

847–8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Howard Press, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Building 66, rm. 3320, Silver 

Spring, MD 20993–0002, 301–796–6087. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The draft guidance document 

provides information related to the 

submission of postmarket MDRs in 

electronic format, including technical 

information. The information provided 

in the draft guidance document is 

intended to help reporters prepare the 

MDR for electronic submission in a way 

that would satisfy the requirements of 

FDA’s proposed electronic Medical 

device reporting regulation that is 

published elsewhere in this issue of the 

Federal Register. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on electronic medical device reporting 

(eMDR). It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive an electronic 

copy of ‘‘eMDR—Electronic Medical 

Device Reporting’’ you may either send 

an e-mail request to dsmica@fda.hhs.gov 

or send a fax request to 240–276–3151 

to receive a hard copy. Please use the 

document number 1679 to identify the 

guidance you are requesting. 

The Center for Devices and 

Radiological Health (CDRH) maintains 

an entry on the Internet for easy access 

to information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http:// 

www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to proposed 

collections of information described in 

FDA’s proposed rule on medical device 

reporting, electronic submission 

requirements, published elsewhere in 

this issue of the Federal Register. The 

proposed collections of information in 

the proposed rule are subject to review 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520). In accordance with the 

proposed medical device regulation, 

medical device manufacturers, 

importers, and user facilities would be 

required to submit MDRs to FDA, to 

maintain records, and may also seek 

exemption or variance from these 

requirements. Manufacturers, importer, 

and user facilities are currently 

submitting paper MDR reports on FDA 

Form 3500 A, for which the existing 

information collection requirements 

under 21 CFR part 803 are approved 

under OMB control number 0910–0437. 

The changes to the burden associated 

with this proposed rule have been sent 

to OMB as a revision to OMB control 

number 0910–0437 for review under 

section 307(d) of the PRA. 

V. 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. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19681 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 


srobinson on DSKHWCL6B1PROD with NOTICES