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comments regarding the draft guidance.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the draft guidance and received 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may obtain the draft guidance at either 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: 

13214 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section 741(d) of the Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

741(d)—Minor Use or Minor Species 

Fee Waiver & Reduction Requests 9 1 9 2 18 

Request for Reconsideration; CVM 

AGDUFA Waiver Officer2 1 1 1 1 1 

Request for Review; CVM AGDUFA 

Appeals Officer 1 1 1 1 1 

Request for Review; FDA User Fee 

Appeals Officer 1 1 1 1 1 

Total 21 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 CVM means Center for Veterinary Medicine. 

Appeals for reconsideration or review 

of AGDUFA user fee waiver decisions 

will be very rare. Waivers are granted 

only for user fees involving minor use 

or minor species as defined by the 

Minor Use and Minor Species Act of 

2008 (MUMS). Decisions on waivers of 

user fees based on minor species do not 

allow for agency discretion as ‘‘minor 

species’’ is defined specifically in the 

MUMS statute. As to minor use in a 

major species, FDA, under MUMS, 

determines that a new animal drug is for 

minor use in a major species at the time 

that the pioneer new animal drug 

application is submitted. This 

determination carries over to the 

abbreviated (generic) new animal drug 

application. Therefore, we do not 

anticipate that there will be more than 

one request for review or 

reconsideration for either the ‘‘minor 

use’’ or ‘‘minor species’’ waivers or 

reductions under AGDUFA per year. 

Fee Waiver or Reduction Requests: 

For those who, after reading the 

guidance, decide to apply for a waiver 

or reduction of one or more of the fees 

they were assessed, the time to complete 

the information required for their 

waiver application, based on the 

guidance provided, is estimated to be 2 

hours or less. 

Based on FDA’s database system, 

there are an estimated 50 sponsors of 

products subject to AGDUFA. However, 

not all sponsors will have submissions 

in a given year. CVM estimates nine 

waiver requests that include minor use 

or minor species. The estimated hours 

per response are based on past FDA 

experience with the various waiver 

requests in CVM. The hours per 

response listed in table 1 of this 

document are based on the average of 

these estimates. 

Dated: March 19, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6724 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–0664] 

Joint Meeting of the Pediatric Advisory 

Committee and the Oncologic Drugs 

Advisory Committee; 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: Pediatric 

Advisory Committee and Oncologic 

Drugs Advisory Committee. 

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 Monday, April 27, 2009, from 

8 a.m. to 6 p.m. 

Addresses: Washington DC North/ 

Gaithersburg Hilton, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Carlos Pen ̃ a, Office of 

the Commissioner (HF–33), Food and 

Drug Administration, 5600 Fishers Lane 

(for express delivery, rm. 14B–08), 

Rockville, MD 20857, 301–827–3340, or 

by e-mail: carlos.pen ̃ a@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

8732310001. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On Monday, April 27, 2009, 

the Pediatric Advisory Committee and 

the Oncologic Drugs Advisory 

Committee will meet to discuss the 

scientific and ethical issues involved in 

obtaining and using brain biopsy 

specimens to evaluate gene expression 

patterns in children with diffuse 

pontine gliomas. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2009 and scroll down to the 

appropriate advisory committee link. 

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 on or before April 13, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief