Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 10253 

Management and Budget Paperwork 

Reduction Project. Fax: 202–395–6974. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 4, 2009. 

Brendan C. Kelly, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–4926 Filed 3–9–09; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Help America Vote Act (HAVA) 

Voting Access Application and Annual 

Report. 

OMB No.: 0970–0327. 

Description: This is a revision to 

include the application for the 

previously cleared Help America Vote 

Act (HAVA) Annual report, Payments to 

States and Units of Local Government, 

(42 U.S.C. 15421). 

The Help America Vote Act (HAVA) 

application to States and Units of Local 

Government is required by Federal 

statute and regulation. Each State or 

Unit of Local Government must prepare 

an application to receive funds under 

the Help America Vote Act (HAVA), 

Public Law 107–252, Title II, Subtitle D, 

Part 2, Sections 261 to 265, Payments to 

States and Units of Local Government to 

Assure Access for Individuals with 

Disabilities (42 U.S.C. 15421–25). The 

application is provided in writing to the 

Administration for Children and 

Families, Administration on 

Developmental Disabilities. 

An annual report is required by 

Federal statute (the Help America Vote 

Act (HAVA) of 2002, Public Law 107– 

252, Section 261, Payments to States 

and Units of Local Government, 42 

U.S.C. 15421). Each State or Unit of 

Local Government must prepare and 

submit an annual report at the end of 

every fiscal year. The report addresses 

the activities conducted with the funds 

provided during the year. The 

information collected from the annual 

report will be aggregated into an annual 

profile of how States have utilized the 

funds and establish best practices for 

election officials. It will also provide an 

overview of the State election goals and 

accomplishments and permit the 

Administration on Developmental 

Disabilities to track voting progress to 

monitor grant activities. 

Respondents: Secretaries of State, 

Directors, State Election Boards, State 

Chief Election officials. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Help America Vote Act (HAVA) Voting Access Annual Report ...................... 50 1 24 1,200 

Help America Vote Act (HAVA) Voting Access Application ............................ 55 1 50 2,750 

Estimated Total Annual Burden 

Hours: 3,950 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: March 5, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–4992 Filed 3–9–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0521] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Clinical Trial Sponsors: Establishment 

and Operation of Clinical Trial Data 

Monitoring Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 9, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0581. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto,Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

10254 Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 

Guidance for Clinical Trial Sponsors: 

Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees—(OMB Control Number 

0910–0581)—Extension 

Sponsors are required to monitor 

studies evaluating new drugs, biologics, 

and devices (21 CFR 312.50 and 312.56 

for drugs and biologics and 21 CFR 

812.40 and 812.46 for devices). Various 

individuals and groups play different 

roles in clinical trial monitoring. One 

such group is a Data Monitoring 

Committee (DMC), appointed by a 

sponsor to evaluate the accumulating 

outcome data in some trials. A clinical 

trial DMC is a group of individuals with 

pertinent expertise that reviews on a 

regular basis accumulating data from an 

ongoing clinical trial. The DMC advises 

the sponsor regarding the continuing 

safety of current participants and those 

yet to be recruited, as well as the 

continuing validity and scientific merit 

of the trial. 

FDA’s guidance document is intended 

to assist sponsors of clinical trials in 

determining when a DMC is needed for 

monitoring a study, and how such 

committees should operate. The 

guidance addresses the roles, 

responsibilities, and operating 

procedures of DMCs and describes 

certain reporting and recordkeeping 

responsibilities, including the 

following: (1) Sponsor notification to 

the DMC regarding waivers, (2) DMC 

reports of meeting minutes to the 

sponsor, (3) sponsor reports to FDA on 

DMC recommendations related to safety, 

(4) standard operating procedures 

(SOPs) for DMCs, and (5) DMC meeting 

records. 

1. Sponsor Notification to the DMC 

Regarding Waivers 

The sponsor must report to FDA 

serious unexpected adverse events in 

drugs and biologics trials (§ 312.32 (21 

CFR 312.32)) and unanticipated adverse 

events in the case of device trials under 

(§ 812.150(b)(1) (21 CFR 812.150(b)(1))). 

The agency recommends in the 

guidance that sponsors notify DMCs 

about any waivers granted by FDA for 

expedited reporting of certain serious 

events. 

2. DMC Reports of Meeting Minutes to 

the Sponsor 

The agency recommends in the 

guidance that the DMC issue a written 

report to the sponsor based on the DMC 

meeting minutes. Reports to the sponsor 

should include only those data 

generally available to the sponsor. The 

sponsor may convey the relevant 

information in this report to other 

interested parties, such as study 

investigators. Meeting minutes or other 

information that include discussion of 

confidential data would not be provided 

to the sponsor. 

3. Sponsor Reporting to FDA on DMC 

Recommendations Related to Safety 

The requirement of the sponsor to 

report DMC recommendations related to 

serious adverse events in an expedited 

manner in clinical trials of new drugs 

(§ 312.32(c)) would not apply when the 

DMC recommendation is related to an 

excess of events not classifiable as 

serious. Nevertheless, the agency 

recommends in the guidance that 

sponsors inform FDA about all 

recommendations related to the safety of 

the investigational product whether or 

not the adverse event in question meets 

the definition of ‘‘serious.’’ 

4. SOPs for DMCs 

In the guidance, we recommend that 

sponsors establish procedures to do the 

following things: 

• Assess potential conflicts of interest 

of proposed DMC members; 

• Ensure that those with serious 

conflicts of interest are not included in 

the DMC; 

• Provide disclosure to all DMC 

members of any potential conflicts that 

are not thought to impede objectivity 

and, thus, would not preclude service 

on the DMC; 

• Identify and disclose any 

concurrent service of any DMC member 

on other DMCs of the same, related or 

competing products; 

• Ensure separation, and designate a 

different statistician to advise on the 

management of the trial, if the primary 

study statistician takes on the 

responsibility for interim analysis and 

reporting to the DMC; and 

• Minimize the risks of bias that arise 

when the primary study statistician 

takes on the responsibility for interim 

analysis and reporting to the DMC, if it 

appears infeasible or highly impractical 

for any other statistician to take over 

responsibilities related to trial 

management. 

5. DMC Meeting Records 

The agency recommends in the 

guidance that the DMC or the group 

preparing the interim reports to the 

DMC maintain all meeting records. This 

information should be submitted to FDA 

with the clinical study report 

(§ 314.50(d)(5)(ii) (21 CFR 

314.50(d)(5)(ii))). 

Description of Respondents: The 

submission and data collection 

recommendations described in this 

document affect sponsors of clinical 

trials and DMCs. 

Burden Estimate: Table 1 of this 

document provides the burden estimate 

of the annual reporting burden for the 

information to be submitted in 

accordance with the guidance. Table 2 

of this document provides the burden 

estimate of the annual recordkeeping 

burden for the information to be 

maintained in accordance with the 

guidance. 

Reporting and Recordkeeping Burdens 

Based on information from FDA 

review divisions, FDA estimates there 

are approximately 740 clinical trials 

with DMCs regulated by the Center for 

Biologics Evaluation and Research, the 

Center for Drug Evaluation and 

Research, and the Center for Devices 

and Radiological Health. FDA estimates 

that the average length of a clinical trial 

is 2 years, resulting in an annual 

estimate of 370 clinical trials. Because 

FDA has no information on which to 

project a change in the use of DMCs, 

FDA estimates that the number of 

clinical trials with DMCs will not 

change significantly in the next few 

years. For purposes of this information 

collection, FDA estimates that each 

sponsor is responsible for 

approximately 10 trials, resulting in an 

estimated 37 sponsors that are affected 

by the guidance annually. 

Based on information provided to 

FDA by sponsors that have typically 

used DMCs for the kinds of studies for 

which this guidance recommends them, 

FDA estimates that the majority of 

sponsors have already prepared SOPs 

for DMCs, and only a minimum amount 

of time is necessary to revise or update 

them for use for other clinical studies. 

FDA receives very few requests for 

waivers regarding expedited reporting of 

certain serious events; therefore, FDA 

has estimated one respondent per year 

to account for the rare instance a request 

may be made. FDA estimates that the 

DMCs would hold two meetings per 

year per clinical trial resulting in the 

issuance of two DMC reports of meeting 

minutes to the sponsor. One set of both 

of the meeting records should be 

maintained per clinical trial. Based on 

FDA’s experience with clinical trials 

using DMCs, FDA estimates that the 

sponsor on average would issue two 

interim reports per clinical trial to the 

DMC. FDA estimates that the DMCs 

would hold two meetings per year per 

clinical trial resulting in the issuance of 

two DMC reports of meeting minutes to 

the sponsor. One set of both meeting 

records should be maintained per 

clinical trial. 

The ‘‘Hours per Response’’ and 

‘‘Hours per Record’’ are based on FDA’s 

experience with comparable 

recordkeeping and reporting provisions 

applicable to FDA regulated industry. 

The ‘‘Hours per Response’’ include the 

time the respondent would spend 

reviewing, gathering, and preparing the 

Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 10255 

information to be submitted to the DMC, 

FDA, or the sponsor. The ‘‘Hours per 

Record’’ include the time to record, 

gather, and maintain the information. 

The information collection provisions 

in the guidance for §§ 312.30 (21 CFR 

312.30), 312.32, 312.38 (21 CFR 312.38), 

312.55 (21 CFR 312.55), and 312.56 

have been approved under OMB control 

no. 0910–0014; § 314.50 has been 

approved under OMB control no. 0910– 

0001; and §§ 812.35 (21 CFR 812.35) 

and 812.150 have been approved under 

OMB control no. 0910–0078. 

In the Federal Register of October 8, 

2008 (73 FR 58970), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

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. 

Dated: March 3, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4971 Filed 3–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0650] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; General 

Administrative Procedures: Citizen 

Petitions; Petition for Reconsideration 

or Stay of Action; Advisory Opinions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by April 9, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0183. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

General Administrative Procedures: 

Citizen Petitions; Petition for 

Reconsideration or Stay of Action; 

Advisory Opinions—(OMB Control 

Number 0910–0183)—Extension 

The Administrative Procedures Act (5 

U.S.C. 553(e)) provides that every 

agency shall give an interested person 

the right to petition for issuance, 

amendment, or repeal of a rule. Section 

10.30 (21 CFR 10.30) sets forth the 

format and procedures by which an 

interested person may submit to FDA, in 

accordance with Sec. 10.20 (21 CFR 

10.20) (submission of documents to 

Division of Dockets Management), a 

citizen petition requesting the 

Commissioner of Food and Drugs (the 

Commissioner) to issue, amend, or 

revoke a regulation or order, or to take 

or refrain from taking any other form of 

administrative action. 

The Commissioner may grant or deny 

such a petition, in whole or in part, and 

may grant such other relief or take other 

action as the petition warrants. 

Respondents are individuals or 

households, State or local governments, 

not-for-profit institutions and 

businesses or other for-profit 

institutions or groups.