[Federal Register: October 3, 2003 (Volume 68, Number 192)]
[Notices]
[Page 57469-57470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc03-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 03N-0286]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
November 3, 2003.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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. 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), and the
Prescription Drug User Fee Amendments of 2002 (Public Law 107-188), 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 by FDA cannot begin until the fee is submitted. Form FDA
3397, the user fee cover sheet, 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 database system for fiscal year
(FY) 2002, there are an estimated 225 manufacturers of products subject
to PDUFA. However, not all manufacturers will have any submissions and
some may have multiple submissions in a given year. The total number of
annual responses is based on the average number of submissions received
by FDA in FY 2000 through 2002. CDER estimates 2,494 annual responses
that include the following submissions; 105 new drug applications;
1,557 chemistry supplements; 670 labeling supplements; and 162 efficacy
supplements. CBER estimates 737 annual responses that include the
following submissions; 11 biologics license applications; 640
manufacturing (chemistry) supplements; 72 labeling supplements; and 14
efficacy supplements. Based on previous estimates, the rate of
submissions is not expected to change significantly in the next few
years. 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 July 3, 2003 (68 FR 39954), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Annual
21 CFR No. of Frequency Total Hours per Total
Section Respondents per Annual Response Hours
Response Responses
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FDA 3397 225 14.36 3,231 0.30 969
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Total ............. .......... .......... ......... 969
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\1\There are no capital costs or operating and maintenance costs
associated with this collection of information.
[[Page 57470]]
Dated: September 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25043 Filed 10-2-03; 8:45 am]
BILLING CODE 4160-01-S