[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