47946 Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices 

Number of Respondents: 100,000; Total 

Annual Responses: 100,000; Total 

Annual Hours: 100,000. (For policy 

questions regarding this collection 

contact Kim McPhillips at 410–786– 

5374. 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, 

comments and recommendations must 

be submitted in one of the following 

ways November 17, 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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: September 11, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–22561 Filed 9–17–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Division of 

Extramural Research and Training; 

Submission for OMB Review; 

Comment Request; Hazardous Waste 

Worker Training—42 CFR Part 65 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of Environmental Health 

Sciences (NIEHS), 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 April 14, 2009, pages 

17195–17196, and allowed 60 days for 

public comment. No public comments 

were received. The purpose of this 

notice is to allow an additional 30 days 

for public comment. 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: Hazardous 

Waste Worker Training—42 CFR Part 

65. Type of Information Collection 

Request: Revision of OMB No. 0925– 

0348, expiration date September 30, 

2009. Need and Use of Information 

Collection: This request for OMB review 

and approval of the information 

collection is required by regulation 42 

CFR part 65(a)(6). The National Institute 

of Environmental Health Sciences 

(NIEHS) has been given major 

responsibility for initiating a worker 

safety and health training program 

under Section 126 of the Superfund 

Amendments and Reauthorization Act 

of 1986 (SARA) for hazardous waste 

workers and emergency responders. A 

network of non-profit organizations that 

are committed to protecting workers and 

their communities by delivering highquality, peer-reviewed safety and health 

curricula to target populations of 

hazardous waste workers and 

emergency responders has been 

developed. In twenty-one years (FY 

1987–2008), the NIEHS Worker Training 

program has successfully supported 20 

primary grantees that have trained more 

than 2.2 million workers across the 

country and presented over 130,250 

classroom and hands-on training 

courses, which have accounted for 

nearly 30 million contact hours of actual 

training. Generally, the grant will 

initially be for one year, and subsequent 

continuation awards are also for one 

year at a time. Grantees must submit a 

separate application to have the support 

continued for each subsequent year. 

Grantees are to provide information in 

accordance with S65.4(a), (b), (c) and 

65.6(b) on the nature, duration, and 

purpose of the training, selection 

criteria for trainees’ qualifications and 

competency of the project director and 

staff, cooperative agreements in the case 

of joint applications, the adequacy of 

training plans and resources, including 

budget and curriculum, and response to 

meeting training criteria in OSHA’s 

Hazardous Waste Operations and 

Emergency Response Regulations (29 

CFR 1910.120). As a cooperative 

agreement, there are additional 

requirements for the progress report 

section of the application. Grantees are 

to provide their information in hard 

copy as well as enter information into 

the WETP Grantee Data Management 

System. The information collected is 

used by the Director through officers, 

employees, experts, and consultants to 

evaluate applications based on technical 

merit to determine whether to make 

awards. Frequency of Response: 

Biannual. Affected Public: Non-profit 

organizations. Type of Respondents: 

Grantees. The annual reporting burden 

is as follows: Estimated Number of 

Respondents: 18; Estimated Number of 

Responses per Respondent: 2; Average 

Burden Hours Per Response: 14; and 

Estimated Total Annual Burden Hours 

Requested: 504. The annualized cost to 

respondents is estimated at: $16,380. 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) 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) 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) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to 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: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Joseph 

T. Hughes, Jr., Director, Worker 

Education and Training Program, 

Division of Extramural Research and 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 180 / Friday, September 18, 2009 / Notices 47947 

Training, NIEHS, P.O. Box 12233, 

Research Triangle Park, NC 27709 or 

call non-toll-free number (919) 541– 

0217 or E-mail your request, including 

your address to wetp@niehs.nih.gov. 

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: September 9, 2009. 

Christopher W. Long, 

NIEHS Deputy Associate Director for 

Management. 

[FR Doc. E9–22567 Filed 9–17–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice of Availability of Draft Policy 

Documents for Comment 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: This is a Notice of Availability 

and request for comments on a draft 

Agency Guidance (‘‘Policy Information 

Notices’’ (PINs)) to convey and clarify 

statutory and regulatory governance 

requirements for federally-funded 

health centers and Federally Qualified 

Health Center (FQHC) Look-Alikes. The 

PIN, ‘‘Health Center Governance 

Requirements and Expectations’’ is 

available on the Internet at http:// 

bphc.hrsa.gov/draftsforcomment/ 

governance/draftgovernancepin.htm. 

DATES: Comments must be received by 

October 26, 2009. 

ADDRESSES: Comments should be 

submitted to <OPPDGeneral@hrsa.gov> 

by close of business October 26, 2009. 

SUMMARY: HRSA believes that 

community input is valuable to the 

development of policies and policy 

documents related to the 

implementation of HRSA programs, 

including the Health Center Program. 

Therefore, we are requesting comments 

on the PIN referenced above. Comments 

will be reviewed and analyzed, and a 

summary and general response will be 

published as soon as possible after the 

deadline for receipt of comments. 

Background: HRSA administers the 

Health Center Program, which supports 

more than 7,500 health care delivery 

sites, including community health 

centers, migrant health centers, health 

care for the homeless centers, and 

public housing primary care centers. 

Health centers serve medically 

underserved communities, delivering 

preventive and primary care services to 

patients regardless of their ability to 

pay. The purpose of the recently 

published draft PIN is (a) To convey and 

clarify HRSA’s policy regarding Health 

Center Program statutory and regulatory 

governance requirements for all Health 

Center Program grantees (e.g., health 

centers funded under section 330(e), (g), 

(h) and (i) of the Public Health Service 

(PHS) Act, as amended) and FQHC 

Look-Alikes (per section 1905(l)(2)(B) 

and section 1861(aa)(4) of the Social 

Security Act.); (b) provide clarification 

regarding board requirements for public 

centers under co-applicant 

arrangements, including public centers 

funded or designated solely under 

sections 330(g), 330(h) and/or 330(i) of 

the PHS Act, as amended to serve 

special populations; and (c) outline the 

eligibility and qualifying expectations 

for HRSA approval of a governance 

waiver for the fifty-one percent 

consumer/patient majority governance 

requirement for eligible section 330 

grantees and FQHC Look-Alikes. The 

PIN eliminates the monthly meeting 

requirement from waiver consideration. 

FOR FURTHER INFORMATION CONTACT: For 

questions regarding this notice, please 

contact the Office of Policy and Program 

Development, Bureau of Primary Health 

Care, HRSA, at 301–594–4300. 

Dated: September 11, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–22444 Filed 9–17–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0427] 

Draft Guidance for Industry: Clinical 

Considerations for Therapeutic Cancer 

Vaccines; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Clinical 

Considerations for Therapeutic Cancer 

Vaccines’’ dated September 2009. The 

draft guidance document provides 

recommendations to sponsors who wish 

to submit an Investigational New Drug 

application (IND) for a therapeutic 

cancer vaccine on critical clinical 

considerations for investigational 

studies of these products. The draft 

guidance applies to therapeutic cancer 

vaccines that are intended to be 

administered to patients with an 

existing cancer for the purpose of 

treatment. The draft guidance does not 

apply to products intended to be 

administered to patients to prevent or 

decrease the incidence of cancer and 

does not apply to adoptive 

immunotherapeutic products such as T 

cell or NK cell products. 

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 December 17, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit written comments on the 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. 

FOR FURTHER INFORMATION CONTACT: Lori 

Jo Churchyard, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Clinical Considerations for 

Therapeutic Cancer Vaccines’’ dated 

September 2009. The draft guidance 

document provides recommendations to 

sponsors who wish to submit an IND for 

a therapeutic cancer vaccine on critical 

clinical considerations for early and late 

phase investigational studies intended 

to support a biologics license 

application. Development of a 

therapeutic cancer vaccine can present 

different considerations for clinical trial 

design than development of a traditional 

cytotoxic drug or biological product, 

due to differences in the proposed 


erowe on DSK5CLS3C1PROD with NOTICES