[Federal Register: October 3, 2003 (Volume 68, Number 192)]
[Page 57469-57470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0286]

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.


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 
November 3, 2003.

ADDRESSES:  The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. 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: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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--

    Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 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.
    In the Federal Register of July 3, 2003 (68 FR 39954), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

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

[[Page 57470]]

    Dated: September 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25043 Filed 10-2-03; 8:45 am]