[Federal Register Volume 71, Number 101 (Thursday, May 25, 2006)]
[Notices]
[Pages 30144-30146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7985]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0203]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; User Fee Cover Sheet; Form FDA 3397

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on User Fee Cover Sheet; Form FDA 
3397 that must be submitted along with

[[Page 30145]]

certain drug and biologic product applications and supplements.

DATES: Submit written or electronic comments on the collection of 
information by July 24, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(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, including 
each proposed extension of an existing 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 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.

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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                         Form                              Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3397                                                              243                 15.48              3,761               0.30              1,128
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 30146]]

    Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7985 Filed 5-24-06; 8:45 am]
BILLING CODE 4160-01-S