[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Notices]
[Page 51195-51196]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au06-42]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0203]
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
September 28, 2006.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (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), and the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, which includes 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 FDA 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) 2005, there are an estimated 243 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 number of submissions received by FDA
in FY 2005. CDER estimates 3,085 annual responses that include the
following submissions: 101 new drug applications; 3 biologics license
applications; 1,915 manufacturing supplements; 921 labeling
supplements; and 145 efficacy supplements. CBER estimates 676 annual
responses that include the following submissions: 6 biologics license
applications, 614 manufacturing supplements, 46 labeling supplements,
and 10 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 May 25, 2006 (71 FR 30144), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per
Form No. of Respondents Response Total Annual Responses Hours per Respondent Total Hours
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FDA 3397 243 15.48 3,761 0.30 1,128
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 51196]]
Dated: August 22, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14266 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S