62902 Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Notices 

that a collection of information entitled 

‘‘Requirements for Collection of Data 

Relating to the Prevention of Medical 

Gas Mixups at Health Care Facilities; 

Survey’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 24, 2004 (69 FR 

35379), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0548. The 

approval expires on March 31, 2006. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets.

Dated: October 22, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24113 Filed 10–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for Reproductive 

Health Drugs; Notice of Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public.

Name of Committee: Advisory 

Committee for Reproductive Health 

Drugs.

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues.

Date and Time: The meeting will be 

held on December 2, 2004, from 8 a.m. 

to 5:30 p.m.

Location: Hilton, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD.

Contact Person: Teresa Watkins, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

watkinst@cder.fda.gov or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512537. Please call the Information 

Line for up-to-date information on this 

meeting.

Agenda: The committee will discuss 

new drug application (NDA) 21–769, 

Testosterone Transdermal System 

(proposed tradename, Intrinsa) by 

Procter and Gamble, indicated for the 

treatment of hypoactive sexual desire 

disorder in surgically menopausal 

women receiving concomitant estrogen 

therapy. Background materials for this 

meeting when available will be posted 

on the Internet 1 business day before the 

meeting at: http://www.fda.gov/ohrms/

dockets/ac/acmenu.htm. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person by November 17, 2004. Oral 

presentations from the public will be 

scheduled between approximately 11 

a.m. and 12 noon. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before November 17, 2004, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Teresa 

Watkins at least 7 days in advance of the 

meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: October 21, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–24068 Filed 10–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D–0584]

‘‘Guidance for Industry: Use of Nucleic 

Acid Tests on Pooled and Individual 

Samples From Donors of Whole Blood 

and Blood Components (Including 

Source Plasma and Source 

Leukocytes) to Adequately and 

Appropriately Reduce the Risk of 

Transmission of Human 

Immunodeficiency Virus Type 1 and 

Hepatitis C Virus;’’ Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (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 (Including 

Source Plasma and Source Leukocytes) 

to Adequately and Appropriately 

Reduce the Risk of Transmission of 

HIV–1 and HCV,’’ dated October 2004. 

The guidance provides 

recommendations to all establishments 

that manufacture Whole Blood and 

blood components (including Source 

Plasma and Source Leukocytes) on the 

implementation of licensed nucleic acid 

tests (NAT) to identify human 

immunodeficiency virus type 1 (HIV–1) 

ribonucleic acid (RNA), and hepatitis C 

virus (HCV) RNA in donations of Whole 

Blood and blood components to reduce 

the risk of transmission of these agents; 

and the reporting to FDA of such 

implementation. 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.

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

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