58972 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of Guidance/Reporting 

Activity 

No. of 

Respondents 

Annual Frequency per 

Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

4.4.1.2. Sponsor notification to 

the DMC regarding waivers 1 1 1 .25 .25 

4.4.3.2. DMC reports of meeting 

minutes to the sponsor 370 2 740 1 740 

5. Sponsor reporting to FDA on 

DMC recommendations related 

to safety 37 1 37 .5 18.5 

Total 758.75 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Recordkeeping Activity No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours Per 

Record Total Hours 

4.1. and 6.4 SOPs for DMCs 37 1 37 8 296 

4.4.3.2. DMC meeting records 370 1 370 2 740 

Total 1,036 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

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: September 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23833 Filed 10–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; Information Program on 

Clinical Trials: Maintaining a Registry 

and Results Databank 

SUMMARY: In compliance with the 

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

the Paperwork Reduction Act of 1995 to 

provide opportunity for public comment 

on proposed data collection projects, the 

National Library of Medicine (NLM), the 

National Institutes of Health (NIH) 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: 

Information Program on Clinical Trials: 

Maintaining a Registry and Results 

Databank; Type of Information 

Collection Request: Revision of 

currently approved collection [OMB No. 

0925–0586, expiration date 01/31/2009], 

Form Number: NA; Need and Use of 

Information Collection: The National 

Institutes of Health is modifying the 

clinical trial registry databank 

established under previous law 

[FDAMA, Section 113] to comply with 

provisions of Title VIII of Public Law 

110–85 (Food and Drug Administration 

Amendments Act of 2007). The 

databank collects specified registration 

and results information on certain 

clinical trials identified in the law, with 

the objective of enhancing patient 

enrollment and providing a mechanism 

for tracking subsequent progress of 

clinical trials, to the benefit of public 

health. The databank is widely used by 

patients, physicians, and medical 

researchers; in particular those involved 

in clinical research studies. Public Law 

110–85 expands the scope of clinical 

trials that must be registered in 

ClinicalTrials.gov, increases the clinical 

trial information that must be submitted 

as part of each registration, and requires 

the submission of basic results 

information for registered trials of 

approved drugs, biologics and devices. 

Frequency of Response: Responsible 

parties must submit the required 

registration information not later than 

21 days after enrolling the first subject. 

Results information is to be reported not 

later than 12 months after the 

completion date (as defined in the law), 

but can be delayed under certain 

circumstances. Updates to submitted 

information are required at least once a 

year, unless there are no changes to 

report. Changes in recruitment status 

and completion of a trial must be 

reported not later than 30 days after 

such events. Description of 

Respondents: Respondents are referred 

to in the law as ‘‘responsible parties,’’ 

and are defined as: (1) The sponsor of 

the clinical trial (as defined in 21 CFR 

50.3) or (2) the principal investigator of 

such clinical trial if so designated by a 

sponsor, grantee, contractor, or awardee, 

provided that ‘‘the principal investigator 

is responsible for conducting the trial, 

has access to and control over the data 

from the clinical trial, has the right to 

publish the results of the trial, and has 

the ability to meet all of the 

requirements’’ for submitting 

information under the law. Estimate of 

Burden: The burden associated with this 

information collection consists of two 

parts: the burden associated with 

registration of clinical trials; and the 

burden associated with the reporting of 

results information. In both cases, the 

burden includes the time necessary to 

extract information from the study 

protocol or results record, reformat it, 

enter it into the databank, and provide 

necessary updating over the course of 

the study. It is estimated that 

registration information will be required 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices 58973 

for 3,000 trials of drugs and biologics 

and 445 trials of medical devices each 

year. Each initial registration is 

estimated to take 7 hours and each of 

the subsequent 8 updates to the record 

are estimated to take 2 hours, resulting 

in an annual burden of 79,235 hours. It 

is estimated that there will be voluntary 

submissions of registration information 

for 6,000 trials of drugs and biologics, 

545 trials of devices, and 5,280 trials of 

other types of medical interventions. 

Using the same hour estimates as for 

mandatory registration, the burden 

associated with voluntary registrations 

is estimated at 271,975 hours, bringing 

the total registration burden to 351,210 

hours. In the first year of operation, it 

is estimated that there will be an 

additional burden of 84,150 hours 

associated with the updating of 

information for 7,000 trials of drugs and 

biologics and 650 trials of medical 

devices that were previously registered 

in the databank and ongoing as of 

December 26, 2007 (90 days after 

enactment). It is estimated that such 

trials will require one update of 3 hours 

to bring them into compliance with the 

new law (FDAAA) and 4 subsequent 

updates of 2 hrs each. Results reporting 

is required only for those applicable 

clinical trials of drugs, biologics, and 

devices that are subject to the 

mandatory registration requirements of 

FDAAA and for which the product(s) 

under study have been approved or 

cleared by the FDA. It is estimated that 

results reporting will be required for 

1,645 trials of drugs and biologics and 

375 trials of medical devices each year. 

Initial submission of results information 

is estimated to require 10 hours, and 

each result submission is expected to 

require two updates that take 5 hours 

each. The total burden for results 

reporting is therefore estimated at 

40,400 hours per year. There are no 

capital costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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. 

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: David Sharlip, 

National Library of Medicine, Building 

38A, Room B2N12, 8600 Rockville Pike, 

Bethesda, MD 20894, or call non-toll 

free number 301–402–9680 or E-mail 

your request to sharlipd@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 30, 2008. 

Betsy L. Humphreys, 

Deputy Director, National Library of 

Medicine, National Institutes of Health. 

[FR Doc. E8–23790 Filed 10–7–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Refugee Resettlement 

Replacement Grant Award 

CFDA#: 93.576. 

AGENCY: Office of Refugee Resettlement, 

ACF, DHHS. 

ACTION: Notice to award a replacement 

grant to Catholic Charities of Tennessee, 

Inc. 

SUMMARY: In Fiscal Year 2005, in an 

effort to assist local school systems that 

were being strained by the arrivals of 

large numbers of refugee children, The 

Office of Refugee Resettlement (ORR) 

awarded, through competition, a 

Refugee School Impact grant to the 

Tennessee Department of Human 

Services, Nashville, TN, for a project 

period of August 15, 2005 through 

August 14, 2010. The Tennessee 

Department of Human Services served 

as the fiscal sponsor and legal entity for 

the project. As of June 30, 2008, the 

Tennessee Department of Human 

Services relinquished the grant. Catholic 

Charities of Tennessee, Inc., Nashville, 

TN, is now awarded a non-competitive 

replacement grant to continue to 

provide services under the Refugee 

School Impact project. Services 

provided under the grant to Catholic 

Charities of Tennessee, Inc., are within 

the scope and operation of the original 

award. Under the award, Catholic 

Charities of Tennessee, Inc., is eligible 

apply for a non-competitive 

continuation award for the period of 

August 15, 2009 through August 14, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Pamela Green-Smith, Director, Division 

of Refugee Assistance, Office of Refugee 

Resettlement, 370 L’Enfant Promenade, 

SW., Washington, DC 20447. Telephone: 

202–401–4531. E-mail: 

Pamela.Greensmith@acf.hhs.gov 

SUPPLEMENTARY INFORMATION: 

Legislative Authority: This program is 

authorized by Section 412 (c)(1)(A)(iii), 

as amended of the Immigration and 

Nationality Act (8 U.S.C. 1522 

(c)(1)(A)(iii)) and covers the following 

Services: (1) English as a Second 

Language instruction (2) After-school 

tutorials focused on helping students 

understand and complete programs that 

encourage high school completion and 

full participation in school activities (3) 

After-school summer programs that 

support remedial work or promote 

school readiness (4) Parental 

involvement programs (5) Interpreter 

services for parent/teacher meetings and 

conferences and (6) Bi-lingual/bicultural counselors and aides. 

Amount of Award: $224,834.76. 

Project Period: August 15, 2008— 

August 14, 2010. 

Dated: October 1, 2008. 

Pamela Green-Smith, 

Director, Division of Refugee Assistance, 

Office of Refugee Resettlement. 

[FR Doc. E8–23774 Filed 10–7–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2008–1006] 

National Offshore Safety Advisory 

Committee; Meeting 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The National Offshore Safety 

Advisory Committee (NOSAC) will 

meet, in New Orleans, LA, to discuss 

various issues relating to offshore safety 

and security. The meeting will be open 

to the public. 

DATES: NOSAC will meet on Thursday, 

November 13, 2008, from 9 a.m. to 3 

p.m. The meeting may close early if all 

business is finished. Written material 

and requests to make oral presentations 

should reach the Coast Guard on or 

before October 30, 2008. Requests to 


jlentini on PROD1PC65 with NOTICES