Federal Register / Vol. 75, No. 209 / Friday, October 29, 2010 / Notices 66767 

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, 

comments and recommendations must 

be submitted in one of the following 

ways by December 28, 2010: 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: October 26, 2010. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–27470 Filed 10–28–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Cancer Trials 

Support Unit (CTSU) Public Use Forms 

and Customer Satisfaction Surveys 

(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 July 13, 2010 (75 FR 39950) 

and allowed 60-days for public 

comment. There have been no public 

comments. Additionally, the 30-day 

Federal Register was published on 

September 13, 2010. The purpose of this 

notice is to allow an additional 30 days 

for public comment to the revisions. 

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: Cancer 

Trial Support Unit (CTSU). Type of 

Information Collection Request: Existing 

Collection in Use Without an OMB 

Number. Need and Use of Information 

Collection: CTSU collects annual 

surveys of customer satisfaction for 

clinical site staff using the CTSU Help 

Desk and the CTSU Web site. An 

ongoing user satisfaction survey is in 

place for the Oncology Patient 

Enrollment Network (OPEN). User 

satisfaction surveys are compiled as part 

of the project quality assurance 

activities and used to direct 

improvements to processes and 

technology. In addition, the CTSU 

collects standardized forms to process 

site regulatory information, changes to 

membership, patient enrollment data, 

and routing information for case report 

forms. This questionnaire adheres to 

The Public Health Service Act, Section 

413 (42 U.S.C. 285a–2) authorizes CTEP 

to establish and support programs to 

facilitate the participation of qualified 

investigators on CTEP-supported 

studies, and to institute programs that 

minimize redundancy among grant and 

contract holders, thereby reducing 

overall cost of maintaining a robust 

treatment trials program. Based on a 

conversation with the Office of 

Management and Budget on October 17, 

2010, the burden table has been revised 

to take into account future submissions 

of a generic data transmittal forms (see 

Attachment 1gg in the Table below). It 

was agreed that the generic forms will 

be finalized and submitted in the future 

as non-substantive change requests for 

OMB clearance as needed. Frequency of 

Response: The help desk and Web site 

survey are collected annually. The 

OPEN survey is ongoing. The form 

submissions vary depending on the 

purpose of the form and the activity of 

the local site. Affected Public: CTSU’s 

target audience is staff members at 

clinical sites and CTEP-supported 

programs. Respondent and burden 

estimates are listed in the Table below. 

The annualized burden is estimated to 

be 34,802 hours and the annualized cost 

to respondents is estimated to be $946, 

601. There are no Capital Costs, 

Operating Costs, and/or Maintenance 

Costs to report. 

Attach 

No. Section/form or survey title 

Use metrics/ 

month— 

# respond 

Estimated 

time for 

site to 

complete 

(minutes) 

Estimated 

burden 

(minutes/ 

hours) 

Frequency of 

response 

Total annual 

usage/annual 

burden hours 

Regulatory/Roster 

1a .......... CTSU IRB/Regulatory Approval Transmittal 

Form.

9,000 2 0.03 12.00 3,600 

1b .......... CTSU IRB Certification Form ........................... 8,500 10 0.17 12.00 17,000 

1c .......... CTSU Acknowledgement Form ........................ 500 5 0.08 12.00 500 

1d .......... Optional Form 1—Withdrawal from Protocol 

Participation Form.

50 5 0.08 12.00 50 

Roster Forms 

1e .......... CTSU Roster Update Form .............................. 50 2–4 0.07 12.00 40 

1f ........... CTSU Radiation Therapy Facilities Inventory 

Form.

20 30 0.50 12.00 120 

Drug shipment 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

66768 Federal Register / Vol. 75, No. 209 / Friday, October 29, 2010 / Notices 

Attach 

No. Section/form or survey title 

Use metrics/ 

month— 

# respond 

Estimated 

time for 

site to 

complete 

(minutes) 

Estimated 

burden 

(minutes/ 

hours) 

Frequency of 

response 

Total annual 

usage/annual 

burden hours 

1g .......... CTSU IBCSG Drug Accountability Form .......... 11 5–10 0.17 12.00 22 

1h .......... CTSU IBCSG Transfer of Investigational 

Agent Form.

3 20 0.33 12.00 12 

Data Management 

1i ........... Site Initiated Data Update Form (generic) ....... 100 5–10 0.17 12.00 200 

1j ........... N0147 CTSU Data Transmittal Form ............... 1000 5–10 0.17 12.00 2,000 

1k .......... Site Intimated Data Update Form (DUF), Protocol: NCCTG N0147*.75 5–10 0.17 12.00 150 

1l ........... TAILORX/PACCT 1 CTSU Data Transmittal 

Form.

2100 5–10 0.17 12.00 4,200 

1m ......... Data Clarification Form ..................................... 650 15–20 0.33 12.00 2,600 

1n .......... Unsolicited Data Modification Form (UDM), 

Protocol: TAILORx/PACCT1.

75 5–10 0.17 12.00 150 

1o .......... Z4032 CTSU Data Transmittal Form ............... 50 5–10 0.17 12.00 100 

1p .......... Z1031 CTSU Data Transmittal Form ............... 50 5–10 0.17 12.00 100 

1q .......... Z1041 CTSU Data Transmittal Form ............... 50 5–10 0.17 12.00 100 

1r ........... Z6051 CTSU Data Transmittal Form ............... 75 5–10 0.17 12.00 150 

1s .......... RTOG 0834 CTSU Data Transmittal Form* .... 60 5–10 0.17 12.00 120 

1t ........... CTSU 7868 Data Transmittal Form ................. 50 5–10 0.17 12.00 100 

1u .......... Site Initiated Data Update Form, protocol 7868 10 5–10 0.17 12.00 20 

1v .......... MC0845(8233) CTSU Data Transmittal* .......... 50 5–10 0.17 12.00 100 

1w ......... 8121 CTSU Data Transmittal Form* ................ 100 5–10 0.17 12.00 200 

1x .......... Site Initiated Data Update Form, Protocol 

8121.

10 5–10 0.17 12.00 20 

1y .......... USMCI 8214/Z6091: CTSU Data Transmittal ..

*In Development ...............................................

50 5–10 0.17 12.00 100 

1z .......... USMCI 8214/Z6091 Crossover Request/ 

Checklist Transmittal Form.

5 5–10 0.17 12.00 10 

Patient Enrollment 

1aa ........ CTSU Patient Enrollment Transmittal Form ..... 600 5–10 0.17 12.00 1,200 

1bb ........ CTSU P2C Enrollment Transmittal Form ......... 30 5–10 0.17 12.00 60 

1cc ........ CTSU Transfer Form ........................................ 40 5–10 0.17 12.00 80 

Administrative 

1dd ........ CTSU System Account Request Form ............ 50 15–20 0.33 12.00 200 

1ee ........ CTSU Request for Clinical Brochure ............... 35 10 0.17 12.00 70 

1ff .......... CTSU Supply Request Form ............................ 130 5–10 0.17 12.00 260 

1gg ........ CTSU Generic Data Transmittal Form ............. 500 5–10 0.17 12.00 1000.00 

Surveys/Web Forms 

2 ............ CTSU Web Site Customer Satisfaction Survey 250 10–15 0.2500 1.00 63 

3 ............ CTSU Helpdesk Customer Satisfaction Survey 300 10–15 0.2500 1.00 75 

4 ............ CTSU OPEN Survey ........................................ 120 10–15 0.2500 1.00 30 

Annual Totals 

.......... 21,770 ............................................................... 34,802 

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. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Michael 

Montello, Pharm. D., CTEP, 6130 

Executive Blvd., Rockville, MD 20852, 

call non-toll-free number 301–435–9206 

or e-mail your request, including your 

address to: montellom@mail.nih.gov. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 209 / Friday, October 29, 2010 / Notices 66769 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: October 21, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–27330 Filed 10–28–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0378] 

Draft Compliance Policy Guide Sec. 

690.800 Salmonella in Animal Feed; 

Availability; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

December 31, 2010, the comment period 

for a notice of availability of a draft 

compliance policy guide (CPG) that 

appeared in the Federal Register of 

August 2, 2010 (75 FR 45130). In the 

document, FDA requested comments on 

its proposal that certain criteria should 

be considered in recommending 

enforcement action against animal feed 

or feed ingredients that are adulterated 

due to the presence of Salmonella. The 

Agency is taking this action in response 

to requests for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: Submit either electronic or 

written comments by December 31, 

2010. 

ADDRESSES: Submit electronic 

comments on the draft CPG to http:// 

www.regulations.gov. Submit written 

comments on the draft CPG to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: Kim 

Young, Center for Veterinary Medicine 

(HFV–230), Food and Drug 

Administration, 7519 Standish Pl., 

MPN–4, rm. 106, Rockville, MD 20855, 

240–276–9200, e-mail: 

Kim.young@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 2, 

2010 (75 FR 45130), FDA published a 

notice of availability of a draft CPG with 

a 90-day comment period to request 

comments on its proposal that certain 

criteria should be considered in 

recommending enforcement action 

against animal feed or feed ingredients 

that are adulterated due to the presence 

of Salmonella. The Agency has received 

a request for a 60-day extension of the 

comment period for the draft CPG. The 

request conveyed concern that the 

current 90-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the draft CPG. FDA has considered the 

request and is extending the comment 

period for the draft CPG for 60 days, 

until December 31, 2010. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments 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: October 26, 2010. 

Dara Corrigan, 

Associate Commissioner for Regulatory 

Affairs. 

[FR Doc. 2010–27448 Filed 10–28–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Board on Radiation and 

Worker Health (ABRWH or Advisory 

Board), National Institute for 

Occupational Safety and Health 

(NIOSH) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), and pursuant to the 

requirements of 42 CFR 83.15(a), the 

Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting of the 

aforementioned committee: 

Board Public Meeting Times and Dates 

(All Times Are Mountain Time) 

8:15 a.m.–5:15 p.m., November 16, 

2010. 

8:15 a.m.–5:15 p.m., November 17, 

2010. 

8:15 a.m.–12 p.m., November 18, 2010 

Public Comment Times and Dates (All 

Times Are Mountain Time) 

5:30 p.m.–7 p.m.,* November 16, 

2010. 

5:30 p.m.–6:30 p.m.,* November 17, 

2010. 

*Please note that the public comment 

periods may end before the times 

indicated, following the last call for 

comments. Members of the public who 

wish to provide public comments 

should plan to attend public comment 

sessions at the start times listed. 

Place: Hilton Santa Fe Historic Plaza, 

100 Sandoval Street, Santa Fe, New 

Mexico; Phone: 505–988–2811; Fax: 

505–986–6439. Audio Conference Call 

via FTS Conferencing. The USA toll-free 

dial-in number is 1–866–659–0537 with 

a pass code of 9933701. 

Status: Open to the public, limited 

only by the space available. The meeting 

space accommodates approximately 150 

people. 

Background: The Advisory Board was 

established under the Energy Employees 

Occupational Illness Compensation 

Program (EEOICP) Act of 2000 to advise 

the President on a variety of policy and 

technical functions required to 

implement and effectively manage the 

new compensation program. Key 

functions of the Advisory Board include 

providing advice on the development of 

probability of causation guidelines 

which have been promulgated by the 

Department of Health and Human 

Services (HHS) as a final rule, advice on 

methods of dose reconstruction which 

have also been promulgated by HHS as 

a final rule, advice on the scientific 

validity and quality of dose estimation 

and reconstruction efforts being 

performed for purposes of the 

compensation program, and advice on 

petitions to add classes of workers to the 

Special Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the Advisory 

Board to HHS, which subsequently 

delegated this authority to the CDC. 

NIOSH implements this responsibility 

for CDC. The charter was issued on 

August 3, 2001, renewed at appropriate 

intervals, and will expire on August 3, 

2011. 

Purpose: This Advisory Board is 

charged with (a) Providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES