Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602), 63765-63766 [E6-18198]
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Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
ownership if devices are detained at a
place other than that of the appellant.
Under § 800.55(k), the owner or other
responsible person must supply records
about how the devices may have
become adulterated or misbranded, as
well as records of distribution of the
detained devices. These recordkeeping
requirements for administrative
detentions allow FDA to trace devices
for which the detention period expired
before a seizure is accomplished or
injunctive relief is obtained.
FDA also has the statutory authority
under section 516 of the act (21 U.S.C.
360f), to ban devices that present
substantial deception, or unreasonable
and substantial risk of illness or injury,
or unreasonable, direct, and substantial
danger to the health of individuals. The
final regulation for banned devices (part
895 (21 CFR part 895)), issued in the
Federal Register of May 18, 1979 (44 FR
29214), contained certain reporting
requirements (§§ 895.21(d) and
895.22(a)).
In the Federal Register of June 7, 2006
(71 FR 32987), FDA published a 60-day
notice requesting public comments 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
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
800.55(g)
Total Annual
Responses
Hours per
Response
Total Hours
1
1
25
25
26
895.21(d) and 895.22(a)
1
1
26
16
416
Total
441
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
800.55(k)
1There
1
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18190 Filed 10–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0426]
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.
cprice-sewell on PROD1PC66 with NOTICES
Total Annual
Records
1
Hours per
Record
1
Total Hours
20
20
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimate of the burden under
the administrative detention provision
is based on FDA’s discussion with the
last firm whose devices had been
detained. Historically, FDA has had
very few or no annual responses for this
information collection.
ACTION:
Annual Frequency
per Recordkeeper
Notice.
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
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
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 January 2, 2007.
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 the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
PO 00000
Frm 00015
Fmt 4703
Sfmt 4703
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
SUPPLEMENTARY INFORMATION:
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31OCN1
63766
Federal Register / Vol. 71, No. 210 / Tuesday, October 31, 2006 / Notices
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 through 43786), 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 (premarket
approval (PMA), product development
protocol (PDP), biologic license
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 a
guidance document entitled ‘‘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
No. of
Respondents
FDA Form Number
3602
Annual Frequency
per Response
2,000
Total Annual
Responses
1
Hours per
Response
2,000
1
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden is based on the number of
applications received in the last 3 years.
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18198 Filed 10–30–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0184]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance:
Food and Drug Administration,
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.
VerDate Aug<31>2005
15:25 Oct 30, 2006
Jkt 211001
Fax written comments on the
collection of information by November
30, 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:
Denver Presley, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
DATES:
SUPPLEMENTARY INFORMATION:
HHS.
cprice-sewell on PROD1PC66 with NOTICES
2,000
2,000
1 There
ACTION:
Total Hours
Investigational Device Exemptions
Reports and Records—21 CFR 812
(OMB Control Number 0910–0078)—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices, and
establishes rules under which new
PO 00000
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Fmt 4703
Sfmt 4703
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 added
section 520(g)(6) to the act and
permitted changes to be made to either
the investigational device or to the
clinical protocol without FDA approval
of an investigational device exemption
(IDE) supplement.
An IDE allows a device, which would
otherwise be subject to provisions of the
act, such as premarket notification or
premarket approval, to be used in
investigations involving human subjects
in which the safety and effectiveness of
the device is being studied. The purpose
of part 812 (21 CFR part 812) is to
encourage, to the extent consistent with
the protection of public health and
safety and with ethical standards, the
discovery and development of useful
devices intended for human use. The
IDE regulation is designed to encourage
the development of useful medical
devices, and allow investigators the
maximum freedom possible, without
jeopardizing the health and safety of the
public or violating ethical standards.
To do this, the regulation provides for
different levels of regulatory control
depending on the level of potential risk
the investigational device presents to
E:\FR\FM\31OCN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63765-63766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18198]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0426]
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.
ACTION: Notice.
-----------------------------------------------------------------------
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 January 2, 2007.
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 the
Chief Information Officer (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
[[Page 63766]]
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 through 43786),
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 (premarket approval (PMA), product
development protocol (PDP), biologic license 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 a guidance document entitled
``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 Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
FDA Form Number Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
3602 2,000 1 2,000 1 2,000
----------------------------------------------------------------------------------------------------------------
Total 2,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden is based on the number of applications received in the
last 3 years.
Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18198 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S
