[Federal Register Volume 65, Number 234 (Tuesday, December 5, 2000)]
[Notices]
[Pages 75942-75943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1440]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; User Fee Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 4, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (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), 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 cannot begin until the fee is submitted. Form FDA 3397 
is the user fee cover sheet, which 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 data base system, there are an 
estimated 208 manufacturers of products subject to PDUFA. However, not 
all manufacturers will have any submissions in a given year and some 
may have multiple submissions. The total number of annual responses is 
based on the number of submissions received by FDA in fiscal year 1999. 
CDER estimates 2,478 annual responses that include the following: 125 
new drug applications, 1,458 chemistry supplements, 755 labeling 
supplements, and 140 efficacy supplements. CBER estimates 443 annual 
responses that include the following: 8 biologics license applications, 
396 manufacturing (chemistry) supplements, 29 labeling supplements, and 
10 efficacy supplements. 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 August 18, 2000 (65 FR 50540), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 75943]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
              Form                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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FDA 3397                              208              14.4         2,921                .30         876
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30829 Filed 12-4-00; 8:45 am]
BILLING CODE 4160-01-F