Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397, 51195-51196 [E6-14266]
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Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
Board of Governors of the Federal Reserve
System, August 25, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 06–7253 Filed 8–25–06; 1:17 pm]
BILLING CODE 6210–01–S
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.
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 crossreference of the fee submitted for an
application with the actual application
by using a unique number tracking
51195
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 BURDEN1
Form
No. of Respondents
FDA 3397
jlentini on PROD1PC65 with NOTICES
1There
Annual Frequency per
Response
243
Total Annual
Responses
15.48
Hours per Respondent
3,761
0.30
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
17:07 Aug 28, 2006
Jkt 208001
PO 00000
Frm 00013
Fmt 4703
Sfmt 4703
E:\FR\FM\29AUN1.SGM
29AUN1
Total Hours
1,128
51196
Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0327]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee and Modernization Act Small
Business Qualification Certification
(Form FDA 3602)
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
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
the proposed collection of information
that will permit an applicant to certify
that it qualifies as a ‘‘small business’’
within the meaning of the Medical
Device User Fee and Modernization Act
(MDUFMA).
DATES: Submit written or electronic
comments on the collection of
information by October 30, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (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:
Denver Presley, Jr., Office of
Management Programs (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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
comments on these topics: (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 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.
MDUFMA Small Business Qualification
Certification (Form FDA 3602)—(OMB
Control Number 0910–0508)—Extension
MDUFMA amends the Federal Food,
Drug, and Cosmetic Act to provide for
user fees for certain medical device
applications. FDA published a Federal
Register notice on August 2, 2006 (71
FR 43784), announcing fees for fiscal
year (FY) 2007. To avoid harming small
businesses, MDUFMA provides for
reduced or waived fees for applicants
who qualify as a ‘‘small business.’’ This
means there are two levels of fees, a
standard fee, and a reduced or waived
small business fee.
For FY 2006, you can qualify for a
small business fee discount under
MDUFMA if you reported gross receipts
or sales of no more than $100 million
on your Federal income tax return for
the most recent tax year. If you have any
affiliates, partners, or parent firms, you
must add their gross receipts or sales to
yours and the total must be no more
than $100 million. If your gross receipts
or sales are no more than $30 million
(including all of your affiliates, partners,
and parent firms), you will also qualify
for a waiver of the fee for your first
(ever) premarket application (PMA,
product development protocol (PDP),
biologics licensing application (BLA), or
Premarket Report). An applicant must
pay the full standard fee unless it
provides evidence demonstrating to
FDA that it meets the ‘‘small business’’
criteria. The evidence required by
MDUFMA is a copy of the most recent
Federal income tax return of the
applicant, and any affiliate, partner, or
parent firm. FDA will review these
materials and decide whether an
applicant is a ‘‘small business’’ within
the meaning of MDUFMA.
Form FDA 3602 is available in
guidance document, ‘‘Guidance for
Industry and FDA: FY 2006 MDUFMA
Small Business Qualification Worksheet
and Certification.’’ This guidance
describes the criteria FDA will use to
decide whether an entity qualifies as a
MDUFMA small business and will help
prospective applicants understand what
they need to do to meet the small
business criteria for FY 2006 and
subsequent fiscal years.
Description of Respondents:
Respondents will be businesses or other
for-profit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
jlentini on PROD1PC65 with NOTICES
FDA Form Number
No. of
Respondents
3602
Annual Frequency
per Response
2,000
Total Annual
Responses
1
Hours per
Response
2,000
1
Total Hours
1There
2,000
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Aug<31>2005
Total Hours
17:07 Aug 28, 2006
Jkt 208001
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Pages 51195-51196]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14266]
=======================================================================
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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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
Form No. of Respondents Response Total Annual Responses Hours per Respondent Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3397 243 15.48 3,761 0.30 1,128
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
