Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 13211 

DATES: Submit a written or electronic 

request for participation in this program 

by April 27, 2009. You should include 

the following information in your 

request: contact name, contact phone 

number, e-mail address, name of the 

establishment, address, and license 

number (if applicable). 

ADDRESSES: If you are interested in 

participating in this program, you 

should submit a request to participate in 

the program to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic requests to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Lore 

Fields, Center for Biologics Evaluation 

and Research (HFM–375), Food and 

Drug Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852– 

1448, 301–827–6143, Fax: 301–827– 

3534, or e-mail: lore.fields@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CBER regulates certain biological 

products, including blood and blood 

products, and is committed to 

advancing the public health through 

innovative activities that help ensure 

the safety, effectiveness and timely 

delivery of these products to patients. 

Further, CBER seeks to continuously 

enhance and update review efficiency 

and quality, and the quality of its 

regulatory efforts and interactions, by 

providing CBER staff and industry with 

improved processes. In support of this 

goal, CBER has participated in the FDA 

development of a computer-assisted 

automated BLA/BLS submission 

program called eSubmitter to improve 

the process for providing certain 

regulatory submissions to FDA. The 

eSubmitter will include programs to 

submit applications for licensure, 

supplements to an approved license, 

and amendments to pending 

applications or supplements. 

II. The eSubmitter Pilot Evaluation 

Program Expectations 

The eSubmitter pilot evaluation 

program is expected to last 

approximately 6 months. During this 

period of time, participants will 

complete BLA/BLS regulatory 

submissions using the eSubmitter 

template developed at CBER for use by 

Source Plasma establishments. The 

eSubmitter was developed using the 

same review criteria for applications for 

these products as currently used in the 

BLA/BLS review process at CBER. 

During the BLA/BLS submission 

process, the participants will enter the 

requested information into the 

eSubmitter tool and attach requested 

documents as an Adobe document (pdf 

format). This information will be saved 

onto a CD–ROM and mailed to CBER for 

review. Paper copies of submissions 

will not be required. CBER will review 

the information provided on the CD– 

ROM and the attachments according to 

current managed review procedures. 

During the BLA/BLS submission 

process, CBER staff will be available to 

answer any questions or concerns that 

may arise. As each submission is 

completed, the users will be asked to 

comment on the eSubmitter program. 

These discussions will assist CBER in 

the final development and release of 

this electronic tool for use by industry. 

III. Requests for Participation 

Requests to participate in the 

eSubmitter pilot are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Once requests for 

participation are received, FDA will 

contact interested establishments to 

discuss the pilot program. 

Dated: March 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6687 Filed 3–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0137] 

Draft Guidance for Industry: Use of 

Serological Tests to Reduce the Risk 

of Transmission of Trypanosoma cruzi 

Infection in Whole Blood and Blood 

Components for Transfusion and 

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 draft document entitled 

‘‘Guidance for Industry: Use of 

Serological Tests to Reduce the Risk of 

Transmission of Trypanosoma cruzi 

Infection in Whole Blood and Blood 

Components for Transfusion and 

Human Cells, Tissues, and Cellular and 

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

March 2009. The draft guidance 

document notifies establishments that 

manufacture Whole Blood and blood 

components intended for use in 

transfusion, and establishments that 

make eligibility determinations for 

donors of HCT/Ps about FDA approval 

of a biologics license application for an 

enzyme-linked immunosorbent assay 

(ELISA) test system for the detection of 

antibodies to Trypanosoma cruzi (T. 

cruzi). The draft guidance also notifies 

establishments that make donor 

eligibility determinations for HCT/P 

donors that FDA has determined T. 

cruzi to be a relevant communicable 

disease under current regulations. In 

addition, the guidance provides 

recommendations for using a licensed 

test for antibodies to T. cruzi to test 

individual human donors, including 

donors of Whole Blood and blood 

components for transfusion and HCT/P 

donors (living and cadaveric (non-heart 

beating)), for antibodies to T. cruzi in 

plasma and serum samples. The 

guidance document does not apply to 

Source Plasma. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 24, 2009. Submit 

written comments on the information 

collection burden by May 26, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft 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 draft guidance 

document. 

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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, 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 draft document entitled ‘‘Guidance for 

13212 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 

Industry: Use of Serological Tests to 

Reduce the Risk of Transmission of 

Trypanosoma cruzi Infection in Whole 

Blood and Blood Components for 

Transfusion and Human Cells, Tissues, 

and Cellular and Tissue-Based Products 

(HCT/Ps)’’ dated March 2009. The draft 

guidance document notifies 

establishments that manufacture Whole 

Blood and blood components intended 

for use in transfusion, and 

establishments that make eligibility 

determinations for donors of HCT/Ps 

about FDA approval of a biologics 

license application for an ELISA test 

system for the detection of antibodies to 

T. cruzi. The test is intended for use as 

a donor screening test to reduce the risk 

of transmission of T. cruzi infection by 

detecting antibodies to T. cruzi in 

plasma and serum samples from 

individual human donors, including 

donors of Whole Blood and blood 

components intended for transfusion, 

and HCT/P donors. 

In addition, FDA is providing 

establishments that manufacture Whole 

Blood and blood components intended 

for use in transfusion with 

recommendations for unit and donor 

management, labeling of Whole Blood 

and blood components, and procedures 

for reporting implementation of a 

licensed T. cruzi test at their facilities or 

contract testing laboratories, as required 

for blood establishments under title 21 

of the Code of Federal Regulations (CFR) 

§ 601.12 (21 CFR 601.12). FDA is 

notifying establishments that make 

donor eligibility determinations for 

HCT/P donors, that it has determined T. 

cruzi to be a relevant communicable 

disease under 21 CFR 1271.3(r)(2), and 

is providing them with 

recommendations for screening and 

antibody testing of HCT/P donors. 

The guidance document applies to 

Whole Blood and blood components 

intended for transfusion and donors of 

HCT/Ps. The guidance document does 

not apply to Source Plasma. The 

recommendations made in the guidance 

with respect to HCT/Ps are in addition 

to recommendations made in the 

document entitled ‘‘Guidance for 

Industry: Eligibility Determination for 

Donors of Human Cells, Tissues, and 

Cellular and Tissue-Based Products 

(HCT/Ps)’’ dated August 2007. 

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 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 requirement 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

The draft guidance document 

contains information collection 

provisions that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (the PRA) (44 U.S.C. 3501– 

3520). Under the PRA, Federal agencies 

must obtain approval from OMB for 

each collection of information they 

conduct or sponsor. ‘‘Collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comment on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Draft Guidance for Industry: Use of 

Serological Tests to Reduce the Risk of 

Transmission of Trypanosoma cruzi 

Infection in Whole Blood and Blood 

Components for Transfusion and 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps) 

The draft guidance would implement 

the FDA approved donor screening 

ELISA test system for the detection of 

antibodies to T. cruzi. The use of the 

donor screening test is to reduce the risk 

of transmission of T. cruzi infection by 

detecting antibodies to T. cruzi in 

plasma and serum samples from 

individual human donors, including 

donors of Whole Blood and blood 

components intended for use in 

transfusion. The draft guidance 

recommends establishments that 

manufacture Whole Blood and blood 

components intended for use in 

transfusion to notify consignees of all 

previously collected in-date blood and 

blood components to quarantine and 

return the blood components to 

establishments or to destroy them 

within 3 calendar days after a donor 

tests repeatedly reactive by a licensed 

test for T. cruzi antibody. The draft 

guidance also recommends that when 

establishments identify a donor who is 

repeatedly reactive by a licensed test for 

T. cruzi antibodies and for whom there 

is additional information indicating risk 

of T. cruzi infection, such as 

geographical risk for exposure in an 

endemic area, or medical diagnostic 

testing of the donor, the establishment 

notify consignees of all previously 

distributed blood and blood 

components collected during the 

lookback period and, if blood or blood 

components were transfused, encourage 

consignees to notify the recipient’s 

physician of record of a possible 

increased risk of T. cruzi infection. 

Description of Respondents: The 

reporting recommendations described in 

the draft guidance affect establishments 

that manufacture Whole Blood and 

blood components intended for use in 

transfusion. 

Burden Estimate: We believe that the 

information collection provisions for 

consignee notification and consignees to 

notify the recipient’s physician in the 

draft guidance do not create a new 

burden for respondents and are part of 

usual and customary business practice. 

Since the end of January 2007, a number 

of blood centers representing a large 

proportion of U.S. blood collections 

have been testing donors using this 

licensed assay. We believe these 

establishments have already developed 

standard operating procedures for 

notifying consignees and the consignees 

to notify the recipient’s physician. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 

§ 601.12 have been approved under 

OMB control no. 0910–0338; the 

collections of information in 21 CFR 

606.100, 606.121, 606.122, 

606.160(b)(ix), 606.170(b), and 630.6 

have been approved under OMB control 

no. 0910–0116; the collections of 

information in 21 CFR 606.171 have 

been approved under OMB control no. 

0910–0458. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. We recognize that recent 

Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 13213 

scientific information obtained from 

screening of donors may affect the 

recommendations for implementation in 

the guidance. In particular, we welcome 

comments on potential strategies for 

selective donor testing for T. cruzi 

infection. Also, we recognize that 

lookback studies conducted using the 

licensed ELISA test suggest that the risk 

of transmission of this agent by 

transfusion of a seropositive unit in the 

United States may be much lower than 

previously thought, and we welcome 

comments in that regard. Additionally, 

we encourage you to submit comments 

to the docket regarding the value of 

performing recipient notification on 

prior collections from a donor who is 

repeatedly reactive on a currently 

licensed T. cruzi antibody test, and a 

prior collection had a licensed test 

result with a signal to cutoff ratio greater 

than 0.75 (i.e., a grey zone result), but 

for whom there may not be additional 

information indicating risk of infection. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the 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. 

IV. 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.regulations.gov. 

Dated: March 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6684 Filed 3–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0149] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Guidance for Industry: Animal 

Generic Drug User Fees and Fee 

Waivers and Reductions 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). The proposed collection of 

information concerns the burden hours 

required to implement the new statutory 

requirements for the user fees and fee 

waivers reductions provisions of the 

Animal Generic Drug User Fee Act of 

2008 (AGDUFA) (Federal Food, Drug, 

and Cosmetic Act (the act)). 

DATES: Fax written comments on the 

collection of information provisions by 

March 31, 2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Guidance for Industry: Animal 

Generic Drug Fees and Fee Waivers 

Reduction; Emergency Request.’’ Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710); Food and Drug 

Administration 5600 Fishers Lane 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j) and 5 CFR 1320.13). 

Section 741(d) of the act (21 U.S.C. 

379k(d)), as amended by AGDUFA, 

authorizes FDA to collect user fees for 

certain: (1) Abbreviated applications for 

generic new animal drugs, (2) new 

animal drug products, and (3) sponsors 

of such abbreviated applications for 

generic new animal drugs and/or 

investigational submissions of new 

animal drugs. However, AGDUFA also 

provides FDA with the authorization to 

grant a waiver from or a reduction of 

those fees in certain circumstances. To 

provide guidance, FDA has developed 

the guidance entitled ‘‘Animal Generic 

Drug User Fees and Fee Waivers and 

Reductions,’’ which is crucial to firms 

understanding whether they might 

qualify for the waiver or reduction, and 

if so, how to apply for it. 

With respect to the following 

collection of information FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry: Animal Generic 

Drug User Fees and Fee Waivers and 

Reductions (Section 741(d) of the 

Federal Food, Drug, and Cosmetic Act); 

Emergency Request 

AGDUFA requires FDA to collect user 

fees for certain: (1) Abbreviated 

applications for a generic new animal 

drug, (2) generic new animal drug 

products, and (3) sponsors of such 

abbreviated applications for generic new 

animal drugs and/or investigational 

submissions for generic new animal 

drugs. AGDUFA also contains a specific 

provision under which a fee waiver or 

reduction may be requested for any or 

all of these fees. The type of fee waiver 

and reduction requests to be submitted 

is: Minor Use or Minor Species. FDA 

seeks OMB approval for this summary 

of information required for a fee waiver 

or reduction request. 

Respondents to the proposed 

collection of information will likely be 

private industry. Requests for a waiver 

or reduction may be submitted by a 

person paying any of the generic new 

animal drug user fees assessed— 

application fees, product fees, or 

sponsor fees. 

FDA estimates the burden of this 

collection of information as follows: