[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51195-51196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0203]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; User Fee Cover Sheet; 
Form FDA 3397

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

DATES: Fax written comments on the collection of information by 
September 28, 2006.

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.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

User Fee Cover Sheet; Form FDA 3397--(OMB Control Number 0910-0297)--
Extension

    Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379g and 379h), the Prescription Drug User Fee Act of 
1992 (PDUFA) (Public Law 102-571), as amended by the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), and the 
Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002, which includes the Prescription Drug User Fee Amendments of 
2002 (Public Law 107-188), FDA has the authority to assess and collect 
user fees for certain drug and biologics license applications and 
supplements. Under this authority, pharmaceutical companies pay a fee 
for certain new human drug applications, biologics license 
applications, or supplements submitted to FDA for review. Because the 
submission of user fees concurrently with applications and supplements 
is required, review of an application by FDA cannot begin until the fee 
is submitted. Form FDA 3397, the user fee cover sheet, is designed to 
provide the minimum necessary information to determine whether a fee is 
required for review of an application, to determine the amount of the 
fee required, and to account for and track user fees. The form provides 
a cross-reference of the fee submitted for an application with the 
actual application by using a unique number tracking system. The 
information collected is used by FDA's Center for Drug Evaluation and 
Research (CDER) and Center for Biologics Evaluation and Research (CBER) 
to initiate the administrative screening of new drug applications, 
biologics license applications, and supplemental applications.
    Respondents to this collection of information are new drug and 
biologics manufacturers. Based on FDA's database system for fiscal year 
(FY) 2005, there are an estimated 243 manufacturers of products subject 
to PDUFA. However, not all manufacturers will have any submissions, and 
some may have multiple submissions in a given year. The total number of 
annual responses is based on the number of submissions received by FDA 
in FY 2005. CDER estimates 3,085 annual responses that include the 
following submissions: 101 new drug applications; 3 biologics license 
applications; 1,915 manufacturing supplements; 921 labeling 
supplements; and 145 efficacy supplements. CBER estimates 676 annual 
responses that include the following submissions: 6 biologics license 
applications, 614 manufacturing supplements, 46 labeling supplements, 
and 10 efficacy supplements. Based on previous estimates, the rate of 
submissions is not expected to change significantly in the next few 
years. The estimated hours per response are based on past FDA 
experience with the various submissions, and range from 5 to 30 
minutes. The hours per response are based on the average of these 
estimates.
    In the Federal Register of May 25, 2006 (71 FR 30144), 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\
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                                                            Annual Frequency per
               Form                   No. of Respondents          Response         Total Annual  Responses   Hours per Respondent       Total Hours
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FDA 3397                                              243                  15.48                     3,761                   0.30                  1,128
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 51196]]

    Dated: August 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14266 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S