29768 Federal Register / Vol. 75, No. 102 / Thursday, May 27, 2010 / Notices 

• Cancer industry is predicted to 

expand to $85.3 billion by 2010. 

Inventors: Hui Han and John E. 

Niederhuber (NCI). 

Patent Status: U.S. Provisional 

Application No. 61/253,617 filed 21 Oct 

2009 (HHS Reference No. E–303–2009/ 

0–US–01). 

Licensing Status: Available for 

licensing. 

Licensing Contact: Jennifer Wong; 

301–435–4633; wongje@mail.nih.gov. 

Dated: May 20, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–12790 Filed 5–26–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–1997–D–0008] (formerly 

Docket No. 1997D–0318) 

Guidance for Industry: Revised 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease 

(vCJD) by Blood and Blood Products; 

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: Revised 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Blood and Blood Products’’ dated 

May 2010. The guidance announced in 

this notice provides blood collecting 

establishments and manufacturers of 

plasma derivatives with comprehensive 

FDA recommendations intended to 

minimize the possible risk of 

transmission of CJD and vCJD from 

blood and blood products. This 

guidance document amends the January 

2002 guidance document of the same 

title by: Incorporating donor deferral 

recommendations for donors who have 

received a transfusion of blood or blood 

components in France since 1980, 

providing updated scientific 

information on CJD and vCJD, revising 

labeling recommendations for Whole 

Blood and blood components intended 

for transfusion, and recognizing AABB’s 

full Donor History Questionnaire 

Version 1.3 as an acceptable mechanism 

for collection of donor history 

information. The guidance announced 

in this notice supersedes the guidance 

document entitled ‘‘Guidance for 

Industry: Revised Preventive Measures 

to Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and 

Blood Products’’ dated January 2002 

(2002 guidance), and the draft guidance 

document entitled ‘‘Draft Guidance for 

Industry: Amendment (Donor Deferral 

for Transfusion in France Since 1980) to 

‘‘Guidance for Industry: Revised 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Blood and Blood Products’’’ dated 

August 2006 (2006 draft guidance). 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the 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 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 guidance 

document. 

Submit electronic or written 

comments on the guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Denise Sa ́nchez, 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 document entitled ‘‘Guidance for 

Industry: Revised Preventive Measures 

to Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and 

Blood Products’’ dated May 2010. This 

guidance amends the 2002 FDA 

guidance of the same title by 

incorporating donor deferral 

recommendations as to donors in France 

(as announced in the 2006 draft 

guidance), providing updated scientific 

information on CJD and vCJD, revising 

labeling recommendations for Whole 

Blood and blood components intended 

for transfusion, and recognizing the use 

of AABB’s full Donor History 

Questionnaire Version 1.3 as an 

acceptable mechanism that is consistent 

with FDA requirements and 

recommendations for collecting donor 

history information. 

In the Federal Register of January 16, 

2002 (67 FR 2226), FDA announced the 

availability of a guidance entitled 

‘‘Guidance for Industry: Revised 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Blood and Blood Products’’ dated 

January 2002 (the 2002 guidance). The 

2002 guidance finalized 

recommendations to all blood collecting 

establishments and manufacturers of 

plasma derivatives for deferral of donors 

with possible exposure to the CJD and 

vCJD agents. In the Federal Register of 

August 14, 2006 (71 FR 46484), FDA 

announced the availability of a draft 

guidance entitled ‘‘Draft Guidance for 

Industry: Amendment (Donor Deferral 

for Transfusion in France Since 1980) to 

‘Guidance for Industry: Revised 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Blood and Blood Products’’’ (the 2006 

draft guidance). The 2006 draft guidance 

was intended to amend the 2002 

guidance by adding a donor deferral 

recommendation for donors who have 

received a transfusion of blood or blood 

components in France since 1980. 

Specifically, in the 2006 draft guidance, 

we stated that we intended to 

incorporate the new donor deferral 

recommendation after receiving 

comments on the draft guidance and 

reissue the revised 2002 guidance as a 

level 2 guidance document for 

immediate implementation (71 FR 

46484, August 14, 2006). Upon further 

consideration, however, we believe it 

appropriate to issue the guidance 

announced in this notice as a level 1 

guidance document. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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 


wwoods2 on DSK1DXX6B1PROD with NOTICES
Federal Register / Vol. 75, No. 102 / Thursday, May 27, 2010 / Notices 29769 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This 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 in 

21 CFR 601.12 have been approved 

under OMB control number 0910–0338; 

the collections of information in 21 CFR 

606.100 have been approved under 

OMB control number 0910–0116; and 

the collections of information in 21 CFR 

Part 600.14 and 606.171 have been 

approved under OMB control number 

0910–0458. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) electronic 

or written comments regarding the 

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 

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 guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: May 18, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12696 Filed 5–26–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Notice of Meetings 

In accordance with section 10(d) of 

the Federal Advisory Committee Act as 

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

Agency for Healthcare Research and 

Quality (AHRQ) announces meetings of 

scientific peer review groups. The 

subcommittees listed below are part of 

the Agency’s Health Services Research 

Initial Review Group Committee. 

The subcommittee meetings will be 

closed to the public in accordance with 

the Federal Advisory Committee Act, 

section 10(d) of 5 U.S.C., Appendix 2 

and 5 U.S.C. 552b(c)(6). Grant 

applications are to be reviewed and 

discussed at these meetings. These 

discussions are likely to involve 

information concerning individuals 

associated with the applications, 

including assessments of their personal 

qualifications to conduct their proposed 

projects. This information is exempt 

from mandatory disclosure under the 

above-cited statutes. 

1. Name of Subcommittee: Health Care 

Technology and Decision Sciences. 

Date: June 15–17, 2010 (Open from 8 a.m. 

to 8:15 a.m. on June 15 and closed for 

remainder of the meeting) 

Place: Crowne Plaza Hotel, 3 Research 

Court, Conference Room TBD, Rockville, MD 

20852. 

2. Name of Subcommittee: Health Systems 

Research. 

Date: June 16–18, 2010 (Open from 8 a.m. 

to 8:15 a.m. on June 16 and closed for 

remainder of the meeting) 

Place: Sheraton Rockville Hotel, 920 King 

Farm Boulevard, Conference Room TBD, 

Rockville, MD 20852. 

3. Name of Subcommittee: Health Care 

Research Training. 

Date: June 17–18, 2010 (Open from 8 a.m. 

to 8:15 a.m. on June 17 and closed for 

remainder of the meeting) 

Place: Hyatt Regency Hotel, 7400 

Wisconsin Avenue, 1 Bethesda Metro Center, 

Conference Room TBD, Bethesda, Maryland 

20814. 

4. Name of Subcommittee: Health Care 

Quality and Effectiveness Research. 

Date: June 22–24, 2010 (Open from 8:30 

a.m. to 8:45 a.m. on June 22 and closed for 

remainder of the meeting) 

Place: Hilton Rockville Executive Meeting 

Center, 1750 Rockville Pike, Conference 

Room TBD, Rockville, Maryland 20850. 

Contact Person: Anyone wishing to obtain 

a roster of members, agenda or minutes of the 

nonconfidential portions of the meetings 

should contact Mrs. Bonnie Campbell, 

Committee Management Officer, Office of 

Extramural Research, Education and Priority 

Populations, AHRQ, 540 Gaither Road, Suite 

2000, Rockville, Maryland 20850, Telephone 

(301) 427–1554. 

Agenda items for these meetings are 

subject to change as priorities dictate. 

Dated: May 13, 2010. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2010–12547 Filed 5–26–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Integrating 

Patient-Reported Outcomes in Hospice and 

Palliative Care Practices. 

Date: June 1, 2010. 

Time: 11 a.m. to 2 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Cancer Institute, 6116 

Executive Blvd., Room 8018, Bethesda, MD 

20892 (Telephone Conference Call). 

Contact Person: Shamala K. Srinivas, PhD, 

Scientific Review Officer, Research Programs 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Boulevard, Room 8123, 

Bethesda, MD 20892, 301–594–1224, 

ss537t@nih.gov. 

This notice is being published less than 30 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; 

Development of Anticancer Agents. 

Date: June 2, 2010. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room 8018, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Joyce C. Pegues, B.S., B.A., 

PhD, Scientific Review Officer, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Boulevard, 

Room 7149, Bethesda, MD 20892–8329, 

301–594–1286, peguesj@mail.nih.gov. 

This notice is being published less than 30 

days prior to the meeting due to scheduling 

conflicts. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 


wwoods2 on DSK1DXX6B1PROD with NOTICES