Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 9007 

FDA has based these estimates on 

conversations with industry and trade 

association representatives, and from 

internal review of the documents listed 

in tables 1 and 2 of this document. 

Dated: February 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3444 Filed 2–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0193] 

Guidance for Industry: Eligibility 

Determination for Donors of Human 

Cells, Tissues, and Cellular and 

Tissue-Based 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: Eligibility 

Determination for Donors of Human 

Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps),’’ dated 

February 2007. The guidance document 

assists establishments with making 

eligibility determinations for donors of 

human cells, tissues, and cellular and 

tissue-based products. The guidance 

announced in this document finalizes 

the draft guidance, ‘‘Guidance for 

Industry: Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps),’’ dated May 2004. This 

guidance also finalizes the draft 

guidance, ‘‘Guidance for Industry: 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps),’’

dated June 2002 (Docket No. 2002D–

0266). 

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 

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 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: 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 document entitled ‘‘Guidance for 

Industry: Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps),’’ dated February 2007. The 

guidance announced in this document 

assists HCT/P establishments with 

complying with the requirements under 

part 1271 (21 CFR part 1271), subpart C. 

These regulations require HCT/P 

establishments to perform an eligibility 

determination for most cell and tissue 

donors, based on donor testing and 

screening for relevant communicable 

disease agents and diseases. This 

guidance applies only to cells and 

tissues procured on or after the effective 

date of the regulations contained in part 

1271, subpart C (effective date May 25, 

2005). This guidance does not replace 

the guidance on 21 CFR part 1270, 

‘‘Guidance for Industry: Screening and 

Testing of Donors of Human Tissue 

Intended for Transplantation,’’ dated 

July 29, 1997, which continues to apply 

to certain tissues recovered before May 

25, 2005. 

In the Federal Register of June 25, 

2002 (67 FR 42789), FDA announced the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Preventive Measures to Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease (CJD) and 

Variant Creutzfeldt-Jakob Disease (vCJD) 

by Human Cells, Tissues, and Cellular 

and Tissue-Based Products (HCT/Ps),’’

dated June 2002. The draft guidance 

provides information intended to assist 

manufacturers of HCT/Ps in minimizing 

the risk of transmission of CJD and vCJD 

by HCT/P donors that have been 

possibly exposed to the agents of CJD 

and vCJD. 

In the Federal Register of May 25, 

2004 (69 FR 29835), FDA announced the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: 

Eligibility Determination for Donors of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps),’’ dated 

Ma 2004. The draft guidance provided 

to HCT/P establishments 

recommendations for the appropriate 

screening and testing of cell and tissue 

donors for relevant communicable 

disease agents and diseases, and 

recommendations for complying with 

the regulations for eligibility 

determination for donors of HCT/Ps. 

FDA issued these two draft guidances 

to assist manufacturers in minimizing 

the risk of communicable disease 

transmission by donors of HCT/Ps. FDA 

received numerous comments on the 

two draft guidances and those 

comments were considered as the 

guidance was finalized. Based on these 

comments and additional data, FDA has 

identified West Nile Virus, Sepsis, and 

Vaccinia as relevant communicable 

disease agents or diseases (RCDAD). On 

the other hand, FDA has not included 

severe acute respiratory syndrome 

(SARS-CoV) as an RCDAD in this 

guidance because there has been no 

laboratory-confirmed person-to-person 

transmission of SARS-CoV worldwide 

since July 2003. In addition, the 

guidance recommends nucleic acid 

amplification testing (NAT) for human 

immunodeficiency virus (HIV) and 

hepatitis C virus (HCV) for both living 

and cadaveric donors. The guidance 

also modifies and/or clarifies the 

following: 

• Recommendations for risk factors 

for vCJD; 

• Physical examination of a living 

HCT/P donor; 

• Exceptions to the requirement for 

determining donor eligibility and 

appropriate labeling; 

• Screening criteria for HIV–1 group 

O, viral hepatitis, syphilis, Chlamydia 

trachomatis and Neisseria gonorrhea; 

• Deferral criteria for receipt of 

human-derived clotting factors; 

• Procedures for communicable 

disease testing laboratories; 

• FDA’s approach to identifying new 

RCDADs; and 

• Use of gestational carriers or 

surrogates. 

The guidance announced in this 

document finalizes the previously 

described draft guidances dated June 

2002 and May 2004. 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 


sroberts on PROD1PC70 with NOTICES
9008 Federal Register / Vol. 72, No. 39 / Wednesday, February 28, 2007 / Notices 

approach may be used if such approach 

satisfies the 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 

part 1271, subpart C have been 

approved under OMB Control No. 0910–

0543. The collections of information in 

part 1271, subpart D have been 

approved under OMB Control No. 0910–

0559. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance announced in this document. 

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 guidance at either http:// 

www.fda.gov/cber/guidelines.htmor 

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

default.htm. 

Dated: February 21, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–3445 Filed 2–27–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0021] 

Draft Guidance for Industry on 

Advisory Committee Meetings: 

Preparation and Public Availability of 

Information Given to Advisory 

Committee Members; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Advisory Committee 

Meetings—Preparation and Public 

Availability of Information Given to 

Advisory Committee Members.’’ This 

guidance is intended to provide 

information to industry sponsors, 

applicants, and petitioners on the 

development, preparation, or 

submission of briefing materials that 

will be given to advisory committee 

members as background information 

prior to open FDA advisory committee 

meetings. The guidance will help 

sponsors develop, organize, and submit 

advisory committee briefing materials 

for public release and should help 

minimize the time and resources spent 

in preparing these materials for public 

availability. The guidance also describes 

the process FDA intends to follow when 

we make briefing materials available to 

the public. 

DATES: Submit written or electronic 

comments on the draft guidance 

document by April 30, 2007. General 

comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to 

Office of Policy (HF–11), Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist the 

office in processing your request. 

Submit written comments on the draft 

guidance to 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. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Poppy Kendall, Food and Drug 

Administration (HF–11), 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, FAX: 301–594–6777, e-mail: 

poppy.kendall@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Advisory Committee Meetings—

Preparation and Public Availability of 

Information Given to Advisory 

Committee Members.’’ This guidance 

will help sponsors develop, prepare, 

and submit advisory committee briefing 

materials and should help minimize the 

time and resources spent in preparing 

these materials for public availability. 

The guidance also describes the process 

FDA intends to follow when we make 

briefing materials available to the 

public. The term ‘‘briefing materials’’ is 

used to describe the package of 

information that we provide to advisory 

committee members before a meeting, 

and that usually contains information 

prepared by us and/or the sponsor (if 

the meeting involves an application or 

particular product). In addition, the 

Appendices to the draft guidance 

provide timelines for preparing and 

submitting briefing materials to FDA. 

For open advisory committee 

meetings for which the briefing 

materials may contain information that 

under certain circumstances could be 

considered to be exempt from disclosure 

under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), we intend to post 

the publicly available version of the 

briefing materials on our Web site at 

least 2 full business days before the 

advisory committee meeting is 

scheduled to occur. With respect to 

meetings for which the briefing 

materials do not contain information 

that could be considered exempt from 

disclosure under FOIA, we will 

probably make the briefing materials 

available on our Web site more than 2 

full business days before the advisory 

committee meeting is schedule to occur. 

In the latter case, we anticipate that 

meetings subject to this timeline will 

normally address general matters such 

as guidance documents and policy 

issues related to FDA-regulated 

products. 

This draft guidance, which will 

harmonize the preparation and public 

availability of information given to 

advisory committee members for all 

products regulated by FDA, replaces 

three previously issued draft guidances: 

(1) ‘‘Disclosing Information Provided to 

Advisory Committees in Connection 

With Open Advisory Committee 

Meetings Related to the Testing or 

Approval of New Drugs and Convened 

by the Center for Drug Evaluation and 

Research, Beginning on January 1, 

2000;’’ (2) ‘‘Disclosing Information 

Provided to Advisory Committees in 

Connection With Open Advisory 

Committee Meetings Related to the 

Testing or Approval of Biologic 

Products and Convened by the Center 

for Biologics Evaluation and Research;’’

and (3) ‘‘Availability of Information 

Given to Advisory Committee Members 

in Connection With the Center for 

Devices and Radiological Health Open 

Public Panel Meetings.’’ An important 

goal of this guidance is to help ensure 

that briefing materials are made 

available to the public as provided 

under section 10(b) of the Federal 


sroberts on PROD1PC70 with NOTICES