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

Federal Register: June 8, 2009 (Volume 74, Number 108)          
                  Page 27145-27146

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 August 7, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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 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 (the FD&C 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), 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), and most recently by the Food 
and Drug Administration

[[Page 27146]]

Amendments Act of 2007 (Public Law 110-85), 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 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) 2008, there are an estimated 255 manufacturers of products subject 
to the user fee provisions of 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 2008. CDER received 3,107 annual 
responses that include the following submissions: 147 new drug 
applications; 13 biologics license applications; 1,813 manufacturing 
supplements; 987 labeling supplements; and 147 efficacy supplements. 
CBER received 810 annual responses that include the following 
submissions: 9 biologics license applications; 743 manufacturing 
supplements; 48 labeling supplements; and 10 efficacy supplements. 
Based on the previous submissions that were received, the rate of these 
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 the average is 30 minutes.
    FDA is revising Form FDA 3397 in the following ways: (1) By 
including an additional question regarding redemption of a priority 
review voucher; (2) by deleting the exclusion for certain applications 
submitted under section 505(b)(2) of the FD&C Act (21 U.S.C. 
355(b)(2)); and (3) by making several minor editorial changes.
    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                      255                 15.36              3,917                0.5              1,959
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 1, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13276 Filed 6-5-09; 8:45 am]

BILLING CODE 4160-01-S