42308 Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Notices 

prescription drugs under the Medicare 

Part D benefit to Medicare beneficiaries. 

The data is used primarily for payment, 

and is used for claim validation as well 

as for other legislated functions such as 

quality monitoring, program integrity 

and oversight. 

Form Number: CMS–10174 (OMB#: 

0938–0982). 

Frequency: Reporting—Monthly. 

Affected Public: Business or other forprofits and not-for-profit institutions. 

Number of Respondents: 747. 

Total Annual Responses: 947,881,770. 

Total Annual Hours: 1896. 

(For policy questions regarding this 

collection contact Bobbie Knickman at 

410–786–4161. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: New collection. 

Title of Information Collection: 

Medicare Quality of Care Complaint 

Form. 

Use: In accordance with Section 

1154(a)(14) of the Social Security Act, 

Quality Improvement Organizations 

(QIOs) are required to conduct 

appropriate reviews of all written 

complaints submitted by beneficiaries 

concerning the quality of care received. 

The Medicare Quality of Care Complaint 

Form will be used by Medicare 

beneficiaries to submit quality of care 

complaints. This form will establish a 

standard form for all beneficiaries to 

utilize and ensure pertinent information 

is obtained by QIOs to effectively 

process these complaints. 

Form Number: CMS–10287 (OMB#: 

0938–New). 

Frequency: Reporting—on occasion. 

Affected Public: Individuals or 

households. 

Number of Respondents: 3,500. 

Total Annual Responses: 3,500. 

Total Annual Hours: 583. 

(For policy questions regarding this 

collection contact Tom Kessler at 410– 

786–1991. For all other issues call 410– 

786–1326.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection. 

Title of Information Collection: 

External Quality Review Protocols. 

Use: The results of Medicare reviews, 

Medicare accreditation services, and 

Medicaid external quality reviews will 

be used by States in assessing the 

quality of care provided to Medicaid 

beneficiaries by managed care 

organizations and to provide 

information on the quality of care 

provided to the general public upon 

request. 

Form Number: CMS–R–305 (OMB#: 

0938–0786). 

Frequency: Reporting—Yearly. 

Affected Public: State, Local or Tribal 

Governments. 

Number of Respondents: 40. 

Total Annual Responses: 40. 

Total Annual Hours: 520,000. 

(For policy questions regarding this 

collection contact Gary B. Jackson at 

410–786–1218. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on September 21, 2009: 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: August 14, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–20127 Filed 8–20–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10198] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Creditable 

Coverage Disclosure to CMS On-Line 

Form and Instructions; Use: Most 

entities that currently provide 

prescription drug benefits to any 

Medicare Part D eligible individual 

must disclose to the CMS whether the 

prescription drug benefit that they offer 

is creditable. The disclosure is required 

to be provided annually and upon any 

change that affects whether the coverage 

is creditable prescription drug coverage. 

CMS released a Disclosure to CMS 

Guidance Paper and a disclosure to 

CMS notification on-line form in 

January 2006. 

Section 1860D–1 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) and 

implementing regulations at 42 CFR 

423.56 requires that entities that offer 

prescription drug benefits under any of 

the types of coverage described in 42 

CFR 423.56(b) provide a disclosure of 

creditable coverage to CMS informing us 

whether such coverage meets the 

actuarial requirements specified in 

guidelines provided by CMS. Form 

Number: CMS–10198 (OMB#: 0938– 

1013); Frequency: Reporting—Yearly 

and Semi-annually; Affected Public: 

Federal Government, Business or other 

for-profits and not-for-profit 

institutions, and State, Local, or Tribal 

Governments; Number of Respondents: 

87,500; Total Annual Responses: 

87,500; Total Annual Hours: 7,291.7. 

(For policy questions regarding this 

collection contact James Mayhew at 

410–786–9244. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 


srobinson on DSKHWCL6B1PROD with NOTICES
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