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Federal Register / Vol. 73, No.

28 / Monday, February 11, 2008 / Notices 7747

Office of Communication, Training, and detect microbiological surrogates. This Electronic submissions will be accepted
Manufacturers Assistance (HFM–40), draft guidance focuses on RMMs with by FDA through FDMS only.
Center for Biologics Evaluation and qualitative results (i.e., detection of
IV. Electronic Access
Research (CBER), Food and Drug microorganisms). If the RMM does not
Administration, 1401 Rockville Pike, have the capability to speciate Persons with access to the Internet
suite 200N, Rockville, MD 20852–1448. microorganisms, an additional method may obtain the draft guidance at either
Send one self-addressed adhesive label for speciation will be needed for
to assist the office in processing your investigation of detected contaminants. or
requests. The draft guidance may also be Early discussions with product review default.htm.
obtained by mail by calling CBER at 1– staff at CBER are encouraged for Dated: January 29, 2008.
800–835–4709 or 301–827–1800. See individuals intending to use or develop Jeffrey Shuren,
the SUPPLEMENTARY INFORMATION section an RMM at any time in the product
Assistant Commissioner for Policy.
for electronic access to the draft lifecycle using growth-based, viability-
[FR Doc. E8–2398 Filed 2–8–08; 8:45 am]
guidance document. based, surrogate-based, or RMMs that
Submit written comments on the draft provide quantitative results.
guidance to the Division of Dockets The draft guidance is being issued
Management (HFA–305), Food and Drug consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). DEPARTMENT OF HEALTH AND
Administration, 5630 Fishers Lane, rm. HUMAN SERVICES
1061, Rockville, MD 20852. Submit The draft guidance, when finalized, will
electronic comments to http:// represent FDA’s current thinking on this Food and Drug Administration topic. It does not create or confer any
rights for or on any person and does not Hemoglobin Based Oxygen Carriers:
operate to bind FDA or the public. An Current Status and Future Directions;
E. Levine, Jr. Center for Biologics alternative approach may be used if
Evaluation and Research (HFM–17), Public Workshop
such approach satisfies the requirement
Food and Drug Administration, 1401 of the applicable statutes and AGENCY: Food and Drug Administration,
Rockville Pike, suite 200N,Rockville, regulations. HHS.
MD 20852–1448, 301–827–6210. ACTION: Notice of public workshop.
SUPPLEMENTARY INFORMATION: II. Paperwork Reduction Act of 1995
This draft guidance refers to The Food and Drug Administration
I. Background (FDA) is announcing a public workshop
previously approved collections of
FDA is announcing the availability of information found in FDA Regulations. entitled: Hemoglobin Based Oxygen
a draft document entitled ‘‘Guidance for These collections of information are Carriers: Current Status and Future
Industry: Validation of Growth-Based subject to review by the Office of Directions. The purpose of the public
Rapid Microbiological Methods for Management and Budget (OMB) under workshop is to discuss the safety of
Sterility Testing of Cellular and Gene the Paperwork Reduction Act of 1995 hemoglobin-based oxygen carriers
Therapy Products,’’ dated February (44 U.S.C. 3501–3520). The collections (HBOCs) as related to a variety of
2008. This draft guidance applies to of information to which this draft potential uses of these investigational
somatic cellular therapy and gene guidance refers are covered by 21 CFR products. We are having this discussion
therapy products. This draft guidance parts 601 (on BLAs) and 312 (on INDs), because clinical and nonclinical studies
does not apply directly to human cells, and were approved under OMB Control of HBOCs, as either blood substitutes or
tissues, and cellular and tissue products No. 0910–0338 and 0910–0014, as resuscitation fluids, have raised
(HCT/Ps) which are regulated solely respectively. questions about the safety of these
under section 361 of the Public Health products as a group. The public
Service Act as described under 21 CFR III. Comments workshop will feature presentations and
1271.10, or HCT/Ps which are regulated The draft guidance is being roundtable discussions led by experts
as medical devices under 21 CFR part distributed for comment purposes only from academic institutions, government,
820. Such products are not subject to and is not intended for implementation and industry.
the sterility testing provision in § 610.12 at this time. Interested persons may Date and Time: The public workshop
(21 CFR 610.12), or to the requirement submit to the Division of Dockets will be held on April 29, 2008, from
in 21 CFR 610.9 to demonstrate that an Management (see ADDRESSES) written or 8:30 a.m. to 5 p.m. and April 30, 2008,
alternative RMM is equivalent to the electronic comments regarding the draft from 8:30 a.m. to 5 p.m.
sterility method specified in the guidance. Submit a single copy of Location: The public workshop will
regulations. However, HCT/P and electronic comments or two paper be held at the Lister Hill Center
device establishments seeking to copies of any mailed comments, except Auditorium, Building 38A, National
validate an RMM may find these that individuals may submit one paper Institutes of Health, 8800 Rockville
recommendations useful. copy. Comments are to be identified Pike, Bethesda, MD 20894.
The principles of RMM validation with the docket number found in the Contact Person: Rhonda Dawson,
described in this draft guidance apply brackets in the heading of this Center for Biologics Evaluation and
only to growth-based RMMs. Growth- document. A copy of the draft guidance Research (HFM–302), Food and Drug
based RMMs, like traditional methods of and received comments are available for Administration, 1401 Rockville Pike,
detecting viable microorganisms as public examination in the Division of suite 200N, Rockville, MD 20852–1448,
described in § 610.12, rely on the ability Dockets Management between 9 a.m. 301–827–6129, FAX: 301–827–2843, e-
to recover and detect organisms from and 4 p.m., Monday through Friday. mail:
rwilkins on PROD1PC63 with NOTICES

the product and demonstrate their Please note that on January 15, 2008, Registration: Mail or fax your
viability by multiplication in liquid the FDA Web site transitioned to the registration information (including
media. The specific recommendations Federal Dockets Management System name, title, firm name, address, and
in this document may not be applicable (FDMS). FDMS is a Government-wide, telephone and fax numbers) to the
for non-growth-based RMMs which electronic docket management system. contact person by April 11, 2008. There

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7748 Federal Register / Vol. 73, No. 28 / Monday, February 11, 2008 / Notices

is no registration fee for the public Dated: February 4, 2008. D of the Public Health Service Act. The
workshop. Early registration is Jeffrey Shuren, ACICBL prepares an annual report
recommended because seating is limited Assistant Commissioner for Policy. describing the activities conducted
to 175 attendees. Registration on the day [FR Doc. E8–2397 Filed 2–8–08; 8:45 am] during the fiscal year, identifying
of the public workshop will be provided BILLING CODE 4160–01–S findings and developing
on a space available basis beginning at recommendations to enhance Title VII
7:30 a.m. Interdisciplinary, Community-Based
If you need special accommodations DEPARTMENT OF HEALTH AND Training Grant Programs. The Annual
HUMAN SERVICES Report is submitted to the Secretary of
due to a disability, please contact
the U.S. Department of Health and
Rhonda Dawson at least 7 days in Health Resources and Services Human Services, and ranking members
advance of the workshop. Administration of the Committee on Health, Education,
SUPPLEMENTARY INFORMATION: FDA; the Labor and Pensions of the Senate, and
National Heart, Lung, and Blood Advisory Committee on the Committee on Energy and
Institute, National Institutes of Health; Interdisciplinary, Community-Based Commerce of the House of
Linkages; Notice of Request for Representatives.
and the Department of Health and
Human Services’ Office of the Secretary The Department of Health and Human
and Office of Public Health and Science AGENCY: Health Resources and Services Services is requesting a total of five (5)
are co-sponsoring this public workshop. Administration, HHS. nominations for voting members of the
The primary goal of the workshop is to ACTION: Notice. ACICBL from schools that have
discuss what is known about the safety administered or are currently
of HBOCs, and possible paths forward SUMMARY: The Health Resources and administering awards from the
for development of these products. Services Administration (HRSA) is following programs: Allied Health—one
Topics to be discussed on April 29, requesting nominations to fill five (5) (1) nominee, Geriatric Education and
2008, will include: (1) Introduction to upcoming vacancies on the Advisory Training Programs—one (1) nominee,
the issues and unmet needs surrounding Committee on Interdisciplinary, and Health Education and Training
HBOC development, (2) overview of the Community-Based Linkages (ACICBL). Centers (HETCs)—one (1) nominee.
physiology and chemistry of Authority: 42 U.S.C. 294f, section 756 Nominations are also requested for two
hemoglobin in HBOCs, (3) nitric oxide of the PHS Act, as amended. The (2) students, residents, and/or fellow
Advisory Committee is governed by representatives.
physiology and pathophysiology related
provisions of Public Law (Pub. L.) 92–
to HBOCs, (4) review of nonclinical The legislation governing this
463, as amended (5 U.S.C. Appendix 2)
studies of HBOCs, (5) risk-benefit Committee requires a fair balance of
which sets forth standards for the
considerations in clinical trials of formation and use of advisory health professionals who represent the
HBOCs, (6) proposed clinical committees. general population with regard to a
indications for HBOCs, and (7) broad geographic distribution and an
industry’s experience with HBOC DATES:The Agency must receive evenness of urban and rural areas, along
clinical trials. Panel deliberations on the nominations on or before March 12, with professionals who are women and
safety and efficacy of HBOCs in various 2008. minorities. As such, the pool of
clinical settings and potential ADDRESSES: All nominations are to be appropriately qualified nominations
mechanisms of effects on organs will be submitted by mail to Louis D. should reflect these requirements to the
the main topics of discussion on April Coccodrilli, Designated Federal Official, degree possible.
30, 2008. We also will discuss future ACICBL, Bureau of Health Professions Interested individuals may nominate
development pathways with a focus on (BHPr), HRSA, Parklawn Building, multiple qualified professionals for
the use and development of animal Room 9–05, 5600 Fishers Lane; membership to the ACICBL to allow the
models, biochemical redesign Rockville, MD 20857. Secretary a diverse listing of highly
approaches, and alternative clinical FOR FURTHER INFORMATION CONTACT: qualified potential candidates.
designs where benefit exceeds risk. Adriana Guerra, Public Health Fellow, Nominees willing to serve as members
Please note that on January 15, 2008, Division of Medicine and Dentistry, by of the ACICBL should not have an
the FDA Web site transitioned to the e-mail or telephone, appearance of a conflict of interest that
(301) 443–6194. would preclude their participation.
Federal Dockets Management System
(FDMS). FDMS is a Government-wide, SUPPLEMENTARY INFORMATION: Under the Potential candidates will be asked to
electronic docket management system. authorities that established the ACICBL, provide detailed information concerning
Electronic submissions will be accepted the Federal Advisory Committee Act of consultancies, research grants, or
by FDA through FDMS only. October 6, 1972 (Pub. L. 92–463), and contracts to permit an evaluation of
section 2119 of the Act, 42 U.S.C. 00aa– possible sources of conflicts of interest.
Transcripts: Transcripts of the public 19, as added by Pub. L. 99–660 and In addition, a curriculum vitae and a
workshop may be requested in writing amended, HRSA is requesting statement of interest will be required of
from the Freedom of Information Office nominations for five (5) voting the nominee to support experience
(HFI–35), Food and Drug members. working with Title VII Interdisciplinary,
Administration, 5600 Fishers Lane, rm. The ACICBL provides advice and Community-Based Training Grant
6–30, Rockville, MD 20857, recommendations to the Secretary and Programs, expertise in the field, and
approximately 15 working days after the to the Congress concerning policy, personal desire in participating on a
rwilkins on PROD1PC63 with NOTICES

public workshop at a cost of 10 cents program development and other matters National Advisory Committee. Qualified
per page. A transcript of the public of significance related to candidates will be invited to serve a two
workshop will be available on the interdisciplinary, community-based or three-year term. All nominations
Internet at training grant programs authorized must be received no later than March
minutes/workshop-min.htm. under sections 751–756, Title VII, Part 12, 2008.

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