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 


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