[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Notices]
[Pages 7420-7421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No.97N-0438]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the information collection by March 
16, 1998.

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: 
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 section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collections of information to OMB for review and 
clearance.

User Fee Cover Sheet; Form FDA 3397--(OMB Control Number 0910-
090297)--Reinstatement)

    Under section 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379g and 379h), FDA has the authority to assess and 
collect user fees for certain drug and biologic product applications 
and supplements. Under this authority, pharmaceutical companies pay a 
fee for each new drug application, biologic product license 
application, biologic license application, or supplement submitted 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 
utilizing a unique number tracking system. The information collected is 
used by FDA, Center for Drug Evaluation and Research (CDER), and Center 
for Biologics Evaluation and Research (CBER) to initiate the 
administrative screening of new drug applications, new biologic product 
license applications, and supplemental applications.
    Respondents to this collection of information are drug and biologic 
product applicants.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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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                              200               9.44        1,888                .15          283       
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There are no capital costs or operating and maintenance costs associated with this collection.                  


[[Page 7421]]

    Based on the agency's experience of 4 years, FDA estimates there 
are approximately 200 manufacturers of products subject to the 
Prescription Drug User Fee Act. Of the 200 manufacturers, CDER 
estimates 141 are drug manufacturers, and CBER estimates 59 are 
biologics manufacturers. CDER estimates there are 1,721 annual 
responses that include the following: 125 new drug applications, 1,098 
chemistry supplements, 400 labeling supplements, and 98 efficacy 
supplements. CBER estimates there are 167 annual responses that include 
the following: 157 annual product supplements, and 10 original license 
applications.

    Dated: February 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3707 Filed 2-12-98; 8:45 am]
BILLING CODE 4160-01-F