Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728, 27802 [E9-13716]

Download as PDF 27802 Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: June 8, 2009. Janean Chambers, Reports Clearance Officer. [FR Doc. E9–13684 Filed 6–10–09; 8:45 am] BILLING CODE 4184–01–P In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0572] Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728—21 U.S.C. 379j-21 (OMB Control Number 0910– 0632)—Extension Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 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 review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by July 13, 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 0910–0632. 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. This collection of information is currently approved under the emergency processing provisions of the PRA for 180 days. FDA is now seeking a 3-year clearance. Section 741 of the act (21 U.S.C. 379j21), establishes three different kinds of user fees: (1) Fees for certain types of abbreviated applications for generic new animal drugs, (2) annual fees for certain generic new animal drug products, and (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. Because the submission of user fees concurrently with applications is required, the review of an application cannot begin until the fee is submitted. Form FDA 3728, the Animal Generic Drug User Fee Cover Sheet, is designed to provide the minimum necessary information in order to do the following: (1) Determine whether a fee is required for review of an application, (2) determine the amount of fee required, and (3) account for and track user fees. In the Federal Register of March 11, 2009 (74 FR 10596), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 U.S.C. 379j-21 Form FDA 3728 jlentini on PROD1PC65 with NOTICES 1 There Annual Frequency per Response No. of Respondents 20 Total Annual Responses 2 Hours per Response 40 Total Hours .08 are no capital costs or operating and maintenance costs associated with this collection of information. Respondents to this collection of information are generic animal drug applicants. Based on FDA’s database system, there are an estimated 20 sponsors of new animal drugs potentially subject to the Animal Generic Drug User Fee Act of 2008. Dated: June 3, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–13716 Filed 6–10–09; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Submission for OMB Review; Comment Request Administration for Children and Families Title: Performance Progress Report. OMB No.: 0970–0334. VerDate Nov<24>2008 16:37 Jun 10, 2009 Jkt 217001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\11JNN1.SGM 11JNN1 3.2

Agencies

[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Page 27802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13716]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0572]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Implementation of the 
Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 
3728

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 review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 
13, 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 0910-0632. 
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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Implementation of the Animal Generic Drug User Fee Act of 2008; User 
Fee Cover Sheet Form FDA 3728--21 U.S.C. 379j-21 (OMB Control Number 
0910-0632)--Extension

    This collection of information is currently approved under the 
emergency processing provisions of the PRA for 180 days. FDA is now 
seeking a 3-year clearance.
    Section 741 of the act (21 U.S.C. 379j-21), establishes three 
different kinds of user fees: (1) Fees for certain types of abbreviated 
applications for generic new animal drugs, (2) annual fees for certain 
generic new animal drug products, and (3) annual fees for certain 
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs. Because 
the submission of user fees concurrently with applications is required, 
the review of an application cannot begin until the fee is submitted. 
Form FDA 3728, the Animal Generic Drug User Fee Cover Sheet, is 
designed to provide the minimum necessary information in order to do 
the following: (1) Determine whether a fee is required for review of an 
application, (2) determine the amount of fee required, and (3) account 
for and track user fees.
    In the Federal Register of March 11, 2009 (74 FR 10596), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Annual Frequency per
        21 U.S.C. 379j-21             No. of Respondents            Response          Total Annual Responses     Hours per Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3728                                           20                        2                       40                      .08                3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents to this collection of information are generic animal 
drug applicants. Based on FDA's database system, there are an estimated 
20 sponsors of new animal drugs potentially subject to the Animal 
Generic Drug User Fee Act of 2008.

    Dated: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13716 Filed 6-10-09; 8:45 am]
BILLING CODE 4160-01-S
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