[Federal Register: July 3, 2003 (Volume 68, Number 128)]
[Page 39954-39955]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0286]

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 Form FDA 3397, User Fee Cover 
Sheet that must be submitted along with certain drug and biologic 
product applications and supplements.

DATES: Submit written or electronic comments on the collection of 
information by September 2, 2003.

ADDRESSES: Submit electronic comments to http://www.fda.gov/dockets/ecomments.
 Submit written comments 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: JonnaLynn P. 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 comment on: (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

[[Page 39955]]

on respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 

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

    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 
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 the agency 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) 2002, there are an estimated 225 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 average number of submissions received 
by FDA in FY 2000 through 2002. CDER estimates 2,494 annual responses 
that include the following submissions: 105 new drug applications; 
1,557 chemistry supplements; 670 labeling supplements; and 162 efficacy 
supplements. CBER estimates 737 annual responses that include the 
following submissions: 11 biologics license applications; 640 
manufacturing (chemistry) supplements; 72 labeling supplements; and 14 
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 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                 Annual Frequency per       Total Annual
                  Form                     No. of Respondents          Response              Responses         Hours per Response        Total Hours
FDA 3397                                         225                     14.36               3,231                     0.30                969
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16791 Filed 7-2-03; 8:45 am]