[Federal Register Volume 65, Number 161 (Friday, August 18, 2000)]
[Notices]
[Pages 50540-50541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1440]


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

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 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 October 17, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Submit written comments on the collection 
of information to the Dockets Management Branch (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: 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 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: (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

[[Page 50541]]

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 (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.
    FDA estimates the burden of this collection of information as 
follows:

                                 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               0.30         876
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 11, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-21011 Filed 8-17-00; 8:45 am]
BILLING CODE 4160-01-F