Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Notices 62903

Administration, suite 200N, 1401 

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive 

label to assist the office in processing 

your requests. The guidance may also be 

obtained by mail by calling 1–800–835–

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance.

Submit written comments on the 

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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Nathaniel L. Geary, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Use of Nucleic Acid Tests on 

Pooled and Individual Samples From 

Donors of Whole Blood and Blood 

Components to Adequately and 

Appropriately Reduce the Risk of 

Transmission of HIV–1 and HCV,’’

dated October 2004. FDA’s final rule (66 

FR 31146, June 11, 2001) entitled 

‘‘Requirements for Testing Human 

Blood Donors for Evidence of Infection 

Due to Communicable Diseases’’ became 

effective on December 10, 2001. The 

regulations under § 610.40(b) (21 CFR 

610.40(b)) require that establishments 

that collect or manufacture Whole Blood 

and blood components ‘‘must perform 

one or more screening tests to 

adequately and appropriately reduce the 

risk of transmission of communicable 

disease agents’’ (66 FR 31146 at 31162). 

As we noted in the preamble to the final 

rule, the standard for adequate and 

appropriate testing will change as new 

testing technology is approved by FDA. 

We explained, ‘‘* * * we intend to 

regularly issue guidance describing 

those tests that we believe would 

adequately and appropriately reduce the 

risk of transmission of communicable 

disease agents’’ (66 FR 31146 at 31149).

The guidance announced in this 

notice finalizes the draft guidances 

entitled ‘‘Use of Nucleic Acid Tests on 

Pooled Samples From Source Plasma 

Donors to Adequately and 

Appropriately Reduce the Risk of 

Transmission of HIV–1 and HCV,’’

dated December 2001, and ‘‘Use of 

Nucleic Tests on Pooled and Individual 

Samples From Donors of Whole Blood 

and Blood Components for Transfusion 

to Adequately and Appropriately 

Reduce the Risk of Transmission of 

HIV–1 and HCV,’’ dated March 2002. 

This guidance recommends that 

establishments implement these 

recommendations as soon as feasible, 

but not later than 6 months after 

publication of this notice.

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’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 requirements of the 

applicable statutes and regulations.

II. The Paperwork Reduction Act of 

1995

This guidance contains information 

collection provisions that 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 in 

21 CFR 601.12 and § 610.40 of this 

guidance were approved under OMB 

control numbers 0910–0315 and 0910–

0472.

III. Comments

Interested persons may, at any time, 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES) regarding this 

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 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.

IV. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cber/guidelines.htm or 

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

default.htm.

Dated: October 20, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24067 Filed 10–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0462]

Draft Guidance for Industry: Criteria 

for Safety and Efficacy Evaluation of 

Oxygen Therapeutics as Red Blood 

Cell Substitutes; 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 entitled Criteria 

for Safety and Efficacy Evaluation of 

Oxygen Therapeutics as Red Blood Cell 

Substitutes’’ dated October 2004. The 

draft guidance provides sponsors or 

investigators, with criteria for testing the 

efficacy and safety of oxygen 

therapeutics as substitutes for red blood 

cells, and guidance on the design of 

clinical trials to assess risk/benefit ratio 

of such use. The draft guidance, when 

finalized, would supercede the ‘‘Points 

to Consider on the Safety Evaluation of 

Hemoglobin-Based Oxygen Carriers,’’

dated August 27, 1990, and replaces the 

draft ‘‘Guidance for Industry: Efficacy 

Evaluation of Hemoglobin- and 

Perfluorocarbon-Based Oxygen Carriers’’

dated September 1997.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 26, 2005 to ensure their 

adequate consideration in preparation of 

the final guidance. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

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 the CBER Voice 

Information System at 1–800–835–4709 

or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance.

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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Nathaniel L. Geary, Center for Biologics 

62904 Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Notices 

Evaluation and Research (HFM–17), 

Food and Drug Administration, suite 

200N, 1401 Rockville Pike, Rockville, 

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry entitled Criteria for Safety and 

Efficacy Evaluation of Oxygen 

Therapeutics as Red Blood Cell 

Substitutes’’ dated October 2004. The 

draft guidance, when finalized, would 

supercede the ‘‘Points to Consider on 

the Safety Evaluation of HemoglobinBased Oxygen Carriers,’’ dated August 

27, 1990, and replaces the draft 

‘‘Guidance for Industry: Efficacy 

Evaluation of Hemoglobin- and 

Perfluorocarbon-Based Oxygen Carriers’’

dated September 1997. The draft 

guidance provides you, as a sponsor or 

investigator, with criteria for testing the 

efficacy and safety of oxygen 

therapeutics as substitutes for red blood 

cells, and guidance on the design of 

clinical trials to assess risk/benefit ratio 

of such use. While the draft guidance is 

restricted to use of oxygen therapeutics 

as substitutes for red blood cells, this 

may not be the only indication being 

evaluated for these investigational new 

drugs. The draft guidance should not 

discourage innovation in the 

development of appropriate endpoints 

for and the design of clinical trials for 

other uses of oxygen therapeutics.

The draft guidance was revised based 

on, in part, presentations and 

discussions obtained at a workshop 

entitled ‘‘Criteria for Safety and Efficacy 

Evaluation of Oxygen Therapeutics as 

Red Cell Substitutes’’ held on 

September 27 and 28, 1999, and public 

comments received on the September 

1997 draft guidance. The workshop was 

sponsored by CBER, FDA, and cosponsored by the National Heart, Lung, 

and Blood Institute, National Institute of 

Health, the Department of Defense, U.S. 

Army Medical and Material Command, 

and the Armed Services Blood Program 

Office.

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 the agency’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. 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 this 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.

III. 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: October 20, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24066 Filed 10–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting:

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: November 17, 2004, 9 

a.m. to 5 p.m.; November 18, 2004, 9 a.m. to 

5 p.m. 

Place: Adam’s Mark Denver, 1550 Court 

Place, Denver, Colorado 80202, Phone: (800) 

444–2326; Fax: (303) 626–2544. 

Status: The meeting will be open to the 

public. 

Agenda: The agenda includes an overview 

of the Council’s general business activities. In 

addition, the Council will hear presentations 

from experts on farmworker issues, including 

the status of farmworker health at the local 

and national level. 

The Council meeting is being held in 

conjunction with the 14th Annual Midwest 

Farmworker Stream Forum sponsored by the 

National Center for Farmworker Health, Inc., 

which is being held in Denver, Colorado, 

during the same period of time. 

Agenda items are subject to change as 

priorities indicate. 

For Further Information Contact: Anyone 

requiring information regarding the Council 

should contact Gladys Cate, Office of 

Minority and Special Populations, staff 

support to the National Advisory Council on 

Migrant Health, Bureau of Primary Health 

Care, Health Resources and Services 

Administration, 4350 East-West Highway, 

Bethesda, Maryland 20814, Telephone (301) 

594–0367.

Dated: October 20, 2004. 

Steven A. Pelovitz, 

Associate Administrator, Office of 

Administration and Financial Management.

[FR Doc. 04–24069 Filed 10–27–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commerical 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel 

Services Conflicts 3. 

Date: November 2, 2004. 

Time: 3:30 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Marina Broitman, PhD, 

Scientific Review Administrator, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6153, MSC 9608, 

Bethesda, MD 20892–9608, 301–402–8152, 

mbroitma@mail.nih.gov.

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel 

Advanced Centers for MH Disparities 

Research (SEP II). 

Date: November 30, 2004. 

Time: 9 a.m. to 5 p.m.