[Federal Register: December 5, 2000 (Volume 65, Number 234)]
[Notices]
[Page 75942-75943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de00-65]
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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