[Federal Register Volume 62, Number 218 (Wednesday, November 12, 1997)]
[Notices]
[Pages 60720-60721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 reinstatement 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 comments on the collection of information by 
January 12, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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 
Information Resources Management (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 reinstatement

[[Page 60721]]

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 listed 
below.
    With respect to the following collection of information, FDA 
invites comments 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 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)--Reinstatement

    Under sections 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.                  

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

    Dated: November 3, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-29710 Filed 11-10-97; 8:45 am]
BILLING CODE 4160-01-F