Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices 7747 

Office of Communication, Training, and 

Manufacturers Assistance (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 The draft guidance may also be 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: Paul 

E. Levine, Jr. 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: Validation of Growth-Based 

Rapid Microbiological Methods for 

Sterility Testing of Cellular and Gene 

Therapy Products,’’ dated February 

2008. This draft guidance applies to 

somatic cellular therapy and gene 

therapy products. This draft guidance 

does not apply directly to human cells, 

tissues, and cellular and tissue products 

(HCT/Ps) which are regulated solely 

under section 361 of the Public Health 

Service Act as described under 21 CFR 

1271.10, or HCT/Ps which are regulated 

as medical devices under 21 CFR part 

820. Such products are not subject to 

the sterility testing provision in § 610.12 

(21 CFR 610.12), or to the requirement 

in 21 CFR 610.9 to demonstrate that an 

alternative RMM is equivalent to the 

sterility method specified in the 

regulations. However, HCT/P and 

device establishments seeking to 

validate an RMM may find these 

recommendations useful. 

The principles of RMM validation 

described in this draft guidance apply 

only to growth-based RMMs. Growthbased RMMs, like traditional methods of 

detecting viable microorganisms as 

described in § 610.12, rely on the ability 

to recover and detect organisms from 

the product and demonstrate their 

viability by multiplication in liquid 

media. The specific recommendations 

in this document may not be applicable 

for non-growth-based RMMs which 

detect microbiological surrogates. This 

draft guidance focuses on RMMs with 

qualitative results (i.e., detection of 

microorganisms). If the RMM does not 

have the capability to speciate 

microorganisms, an additional method 

for speciation will be needed for 

investigation of detected contaminants. 

Early discussions with product review 

staff at CBER are encouraged for 

individuals intending to use or develop 

an RMM at any time in the product 

lifecycle using growth-based, viabilitybased, surrogate-based, or RMMs that 

provide quantitative results. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’s current thinking on this 

topic. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA Regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information to which this draft 

guidance refers are covered by 21 CFR 

parts 601 (on BLAs) and 312 (on INDs), 

and were approved under OMB Control 

No. 0910–0338 and 0910–0014, 

respectively. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cber/guidelines.htm 

or http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: January 29, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2398 Filed 2–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Hemoglobin Based Oxygen Carriers: 

Current Status and Future Directions; 

Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: Hemoglobin Based Oxygen 

Carriers: Current Status and Future 

Directions. The purpose of the public 

workshop is to discuss the safety of 

hemoglobin-based oxygen carriers 

(HBOCs) as related to a variety of 

potential uses of these investigational 

products. We are having this discussion 

because clinical and nonclinical studies 

of HBOCs, as either blood substitutes or 

as resuscitation fluids, have raised 

questions about the safety of these 

products as a group. The public 

workshop will feature presentations and 

roundtable discussions led by experts 

from academic institutions, government, 

and industry. 

Date and Time: The public workshop 

will be held on April 29, 2008, from 

8:30 a.m. to 5 p.m. and April 30, 2008, 

from 8:30 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Lister Hill Center 

Auditorium, Building 38A, National 

Institutes of Health, 8800 Rockville 

Pike, Bethesda, MD 20894. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov. 

Registration: Mail or fax your 

registration information (including 

name, title, firm name, address, and 

telephone and fax numbers) to the 

contact person by April 11, 2008. There 


rwilkins on PROD1PC63 with NOTICES
7748 Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices 

is no registration fee for the public 

workshop. Early registration is 

recommended because seating is limited 

to 175 attendees. Registration on the day 

of the public workshop will be provided 

on a space available basis beginning at 

7:30 a.m. 

If you need special accommodations 

due to a disability, please contact 

Rhonda Dawson at least 7 days in 

advance of the workshop. 

SUPPLEMENTARY INFORMATION: FDA; the 

National Heart, Lung, and Blood 

Institute, National Institutes of Health; 

and the Department of Health and 

Human Services’ Office of the Secretary 

and Office of Public Health and Science 

are co-sponsoring this public workshop. 

The primary goal of the workshop is to 

discuss what is known about the safety 

of HBOCs, and possible paths forward 

for development of these products. 

Topics to be discussed on April 29, 

2008, will include: (1) Introduction to 

the issues and unmet needs surrounding 

HBOC development, (2) overview of the 

physiology and chemistry of 

hemoglobin in HBOCs, (3) nitric oxide 

physiology and pathophysiology related 

to HBOCs, (4) review of nonclinical 

studies of HBOCs, (5) risk-benefit 

considerations in clinical trials of 

HBOCs, (6) proposed clinical 

indications for HBOCs, and (7) 

industry’s experience with HBOC 

clinical trials. Panel deliberations on the 

safety and efficacy of HBOCs in various 

clinical settings and potential 

mechanisms of effects on organs will be 

the main topics of discussion on April 

30, 2008. We also will discuss future 

development pathways with a focus on 

the use and development of animal 

models, biochemical redesign 

approaches, and alternative clinical 

designs where benefit exceeds risk. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA through FDMS only. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/cber/ 

minutes/workshop-min.htm. 

Dated: February 4, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–2397 Filed 2–8–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on 

Interdisciplinary, Community-Based 

Linkages; Notice of Request for 

Nominations 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill five (5) 

upcoming vacancies on the Advisory 

Committee on Interdisciplinary, 

Community-Based Linkages (ACICBL). 

Authority: 42 U.S.C. 294f, section 756 

of the PHS Act, as amended. The 

Advisory Committee is governed by 

provisions of Public Law (Pub. L.) 92–

463, as amended (5 U.S.C. Appendix 2) 

which sets forth standards for the 

formation and use of advisory 

committees. 

DATES: The Agency must receive 

nominations on or before March 12, 

2008. 

ADDRESSES: All nominations are to be 

submitted by mail to Louis D. 

Coccodrilli, Designated Federal Official, 

ACICBL, Bureau of Health Professions 

(BHPr), HRSA, Parklawn Building, 

Room 9–05, 5600 Fishers Lane; 

Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: 

Adriana Guerra, Public Health Fellow, 

Division of Medicine and Dentistry, by 

e-mail aguerra@hrsa.gov or telephone, 

(301) 443–6194. 

SUPPLEMENTARY INFORMATION: Under the 

authorities that established the ACICBL, 

the Federal Advisory Committee Act of 

October 6, 1972 (Pub. L. 92–463), and 

section 2119 of the Act, 42 U.S.C. 00aa–

19, as added by Pub. L. 99–660 and 

amended, HRSA is requesting 

nominations for five (5) voting 

members. 

The ACICBL provides advice and 

recommendations to the Secretary and 

to the Congress concerning policy, 

program development and other matters 

of significance related to 

interdisciplinary, community-based 

training grant programs authorized 

under sections 751–756, Title VII, Part 

D of the Public Health Service Act. The 

ACICBL prepares an annual report 

describing the activities conducted 

during the fiscal year, identifying 

findings and developing 

recommendations to enhance Title VII 

Interdisciplinary, Community-Based 

Training Grant Programs. The Annual 

Report is submitted to the Secretary of 

the U.S. Department of Health and 

Human Services, and ranking members 

of the Committee on Health, Education, 

Labor and Pensions of the Senate, and 

the Committee on Energy and 

Commerce of the House of 

Representatives. 

The Department of Health and Human 

Services is requesting a total of five (5) 

nominations for voting members of the 

ACICBL from schools that have 

administered or are currently 

administering awards from the 

following programs: Allied Health—one 

(1) nominee, Geriatric Education and 

Training Programs—one (1) nominee, 

and Health Education and Training 

Centers (HETCs)—one (1) nominee. 

Nominations are also requested for two 

(2) students, residents, and/or fellow 

representatives. 

The legislation governing this 

Committee requires a fair balance of 

health professionals who represent the 

general population with regard to a 

broad geographic distribution and an 

evenness of urban and rural areas, along 

with professionals who are women and 

minorities. As such, the pool of 

appropriately qualified nominations 

should reflect these requirements to the 

degree possible. 

Interested individuals may nominate 

multiple qualified professionals for 

membership to the ACICBL to allow the 

Secretary a diverse listing of highly 

qualified potential candidates. 

Nominees willing to serve as members 

of the ACICBL should not have an 

appearance of a conflict of interest that 

would preclude their participation. 

Potential candidates will be asked to 

provide detailed information concerning 

consultancies, research grants, or 

contracts to permit an evaluation of 

possible sources of conflicts of interest. 

In addition, a curriculum vitae and a 

statement of interest will be required of 

the nominee to support experience 

working with Title VII Interdisciplinary, 

Community-Based Training Grant 

Programs, expertise in the field, and 

personal desire in participating on a 

National Advisory Committee. Qualified 

candidates will be invited to serve a two 

or three-year term. All nominations 

must be received no later than March 

12, 2008. 


rwilkins on PROD1PC63 with NOTICES