Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification, 64711-64713 [E6-18553]
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mstockstill on PROD1PC68 with NOTICES
Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved information collection.
Title of Information Collection:
Indirect Medical Education (IME) and
Supporting Regulations 42 CFR 412.105;
Direct Graduate Medical Education
(GME) and Supporting Regulations in 42
CFR 413.75–413.73.
Use: The collection of information on
interns and residents (IR) is needed to
properly calculate Medicare program
payments to hospitals that incur
indirect and direct costs for medical
education. The agency’s Intern and
Resident Information System (IRIS) and
similar contractor systems use the
information for producing reports of
duplicate full-time equivalent IR counts
for IME and GME. The contractors also
use this information to ensure that
hospitals are properly reimbursed for
IME and GME, and help eliminate
duplicate reporting of IR counts which
inflate payments. The collection of this
information affects 1,215 hospitals
which participate in approved medical
education programs.
Form Number: CMS-R–64 (OMB#:
0938–0456).
Frequency: Recordkeeping and
Reporting—Annually.
Affected Public: Not-for-profit and
Business or other for-profit institutions.
Number of Respondents: 1,215.
Total Annual Responses: 1,215.
Total Annual Hours: 2,430.
2. Type of Information Collection
Request: Extension of a currently
approved information collection.
Title of Information Collection:
Intermediate Care Facility for the
Mentally Retarded or Persons with
Related Conditions ICF/MR Survey
Report Form and Supporting
Regulations at 42 CFR 442.30, 483.410,
483.420, 483.440, 483.50, and 483.460.
Use: The survey forms are needed to
ensure provider compliance. In order to
participate in the Medicaid program as
an ICF/MR, providers must meet
Federal standards. The survey report
form is used to record providers’ level
of compliance with the individual
standard requirements and report it to
the Federal government.
Form Number: CMS–3070G-I (OMB#:
0938–0062).
Frequency: Recordkeeping and
Reporting—Annually.
Affected Public: Business or other forprofit and Not-for-profit institutions.
Number of Respondents: 6,428.
Total Annual Responses: 6,428.
Total Annual Hours: 19,284.
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3. Type of Information Collection
Request: Extension of a currently
approved collection.
Title of Information Collection: Organ
Procurement Organization’s (OPOs)
Health Insurance Benefits Agreement
and Supporting Regulations at 42 CFR
486.301–486.348.
Use: The information provided on this
form serves as a basis for continuing the
agreements with CMS and the 58 OPOs
for participation in the Medicare and
Medicaid programs and for
reimbursement of service.
Form Number: CMS–576A (OMB#:
0938–0512.
Frequency: Reporting—Every 4 years
and as needed.
Affected Public: Business or other forprofit and Not-for-profit institutions.
Number of Respondents: 58.
Total Annual Responses: 58.
Total Annual Hours: 116.
4. Type of Information Collection
Request: Extension of a currently
approved information collection.
Title of Information Collection:
Reconciliation of State Invoice and Prior
Quarter Adjustment Statement.
Use: Section 1927 of the Social
Security Act requires drug labelers to
enter into and have in effect a rebate
agreement with CMS for States to
receive funding for drugs dispensed to
Medicaid recipients. Drug
manufacturers must complete and
submit to States the CMS–304 form to
explain any rebate payment adjustments
for the current quarter, and complete
and submit the CMS–304A form to
States to explain rebate payment
adjustments to any prior quarters. Both
forms are used to reconcile drug rebate
payments made by manufacturers with
the States invoices of rebates due.
Form Number: CMS–304/304A
(OMB#: 0938–0676).
Frequency: Recordkeeping and
Reporting—Quarterly.
Affected Public: Business or other forprofit.
Number of Respondents: 550.
Total Annual Responses: 3,740.
Total Annual Hours: 139,480.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
information collections must be mailed
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64711
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: October 24, 2006.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E6–18413 Filed 11–2–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0425]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification
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
premarket notification.
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.
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
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.
mstockstill on PROD1PC68 with NOTICES
SUPPLEMENTARY INFORMATION:
Premarket Notification—21 CFR Part
807; Subpart E—(OMB Control Number
0910–0120)
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) require a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3). If the device
is determined to be not substantially
equivalent to a legally marketed device,
it must have an approved premarket
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approval application (PMA), Product
Development Protocol or be reclassified
into class I or class II before being
marketed. The FDA makes the final
decision of whether a device is
equivalent or not equivalent.
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) added section
510(o) to the act to establish new
regulatory requirements for reprocessed
single-use devices (SUDs). MDUFMA
was signed into law on October 26,
2002.
Section 510(o) of the act requires that
FDA review the types of reprocessed
SUDs subject to premarket notification
requirements and identify which of
these devices require the submission of
validation data to ensure their
substantial equivalence to predicate
devices. Section 510(o) also requires
that FDA review critical and
semicritical reprocessed SUDs that are
currently exempt from premarket
notification requirements and determine
which of these devices require the
submission of premarket notifications to
ensure their substantial equivalence to
predicate devices.
FDA has identified the reprocessed
SUDs that require the submission of
validation data to date. The requirement
to submit validation data for certain
reprocessed SUDs has been
incorporated into the premarket
notification program. As with all other
devices, new premarket notifications for
reprocessed SUDs will be required as
new manufacturers enter the market or
manufacturers with cleared premarket
notifications make significant changes
to their device. The burden estimates
below include the burden for submitting
premarket notifications for reprocessed
SUDs with the burden for all other
devices. FDA may amend the lists of
reprocessed SUDs that require the
submission of premarket notifications
with validation data as necessary.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is:
• Introducing a device to the market
for the first time;
• Introducing or reintroducing a
device which is significantly changed or
modified in design, components,
method of manufacturer, or the
intended use that could affect the safety
and effectiveness of the device.
Section 807.87 specifies information
required in a premarket notification
submission.
Section 204 of the Food and Drug
Administration Modernization Act
(FDAMA) amended section 514 of the
act (21 U.S.C. 360d). Amended section
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Fmt 4703
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514 allows FDA to recognize consensus
standards developed by international
and national organizations for use in
satisfying portions of device premarket
review submissions including
premarket notifications or other
requirements. FDA has published and
updated the list of recognized standards
regularly since enactment of FDAMA
and has allowed 510(k) submitters to
certify conformance to recognized
standards to meet the requirements of
§ 807.87. Certification of conformance to
a recognized standard may allow a
manufacturer to submit an abbreviated
510(k). FDA is now seeking approval of
a form (Form FDA 3654) that will
standardize certification of conformance
to a recognized standard. FDA believes
that use of this form will simplify the
certification process for 510(k)
submitters and the review process for
FDA.
Form FDA 3514, a summary cover
sheet form, has been created to assist
respondents in categorizing 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, and
humanitarian device exemptions. The
total burden (1,000 hours) for Form FDA
3514 has been included in this
information collection. Form FDA 3654
is used in the following information
collections: 0910–0078, 0910–0231, and
0910–0332, but the burden is approved
under this information collection (0910–
0120).
Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) (510(k) summary) or a
statement certifying that the submitter
will make available upon request the
information in the 510(k) (510(k)
statement). If the 510(k) submitter
includes a 510(k) statement in the
submission, § 807.93 requires that the
official correspondent of the firm make
available within 30 days of a request all
information included in the submitted
premarket notification on safety and
effectiveness. This information will be
provided to any person within 30 days
of a request if the device described in
the premarket notification submission is
determined to be substantially
equivalent. The information provided
will be a duplicate of the premarket
notification submission including any
safety and effectiveness information, but
excluding all patient identifiers and
trade secret and confidential
information.
The most likely respondents to this
information collection will primarily be
medical device manufacturers including
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Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices
reprocessors of SUDs, and initial
importers of devices.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Form FDA
Number
No. of
Respondents
807, subpart E
(807.81 and
807.87/510(k))
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
3,700
1
3,700
80
296,000
3514
2,000
1
2,000
0.5
1,000
3654
150
1
150
1
150
Totals
297,150
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
Form FDA
Number
No. of
Recordkeepers
807.93
Annual Frequency
per Recordkeeping
2,000
Total Annual
Records
10
Hours per
Recordkeeper
20,000
0.5
Total
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on
conversations with industry and trade
association representatives, and from
internal review of the documents listed
in tables 1 and 2.
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18553 Filed 11–2–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0247]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Medical Device User Fee Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC68 with NOTICES
10,000
10,000
1 There
ACTION:
Total Hours
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 December
4, 2006.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
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15:24 Nov 02, 2006
Jkt 211001
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, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
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.
Medical Device User Fee Cover Sheet;
Form FDA 3601 (OMB Control Number
0910–0511)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the
Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250), authorizes FDA
to collect user fees for certain medical
device applications. Under this
authority, companies pay a fee for
certain new medical device applications
or supplements submitted to the agency
for review. Because the submission of
user fees concurrently with applications
and supplements is required, the review
of an application cannot begin until the
fee is submitted. Form FDA 3601, the
‘‘Medical Device User Fee Cover Sheet,’’
is designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, determine the amount of
the fee required, and account for and
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Frm 00035
Fmt 4703
Sfmt 4703
track user fees. The form provides a
cross-reference of the fees 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
Devices and Radiological Health
(CDRH), and the Center for Biologics
Evaluation and Research (CBER) to
initiate the administrative screening of
new medical device applications and
supplemental applications.
According to the FDA database
system, there are an estimated 4,600
manufacturers of products subject to
MDUFMA. However, not all
manufacturers will have any cover sheet
submissions in a given year and some
may have multiple cover sheet
submissions. The total number of
annual responses is based on the
number of coversheet submissions
received by FDA in fiscal year (FY)
2005. CDRH received 4,436 annual
responses that included the following:
43 premarket approval applications,
4,071 premarket notifications, 22
modular premarket applications, 1
product development protocol, 1
premarket report, 15 panel track
supplements, 174 real-time
supplements, and 109 180-day
supplements. CBER received 106 annual
responses that included the following: 2
premarket approval applications, 16
biologics license applications, 84
premarket notifications, 1 modular
premarket application, 2 180-day
supplements, and 1 real-time
supplement. The number of received
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]]>Agencies
[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64711-64713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18553]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0425]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification
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 premarket notification.
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.
[[Page 64712]]
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.
Premarket Notification--21 CFR Part 807; Subpart E--(OMB Control Number
0910-0120)
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) require a person who intends to market a
medical device to submit a premarket notification submission to FDA at
least 90 days before proposing to begin the introduction, or delivery
for introduction into interstate commerce, for commercial distribution
of a device intended for human use. Based on the information provided
in the notification, FDA must determine whether the new device is
substantially equivalent to a legally marketed device, as defined in
Sec. 807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), Product Development Protocol or
be reclassified into class I or class II before being marketed. The FDA
makes the final decision of whether a device is equivalent or not
equivalent.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250) added section 510(o) to the act to establish new
regulatory requirements for reprocessed single-use devices (SUDs).
MDUFMA was signed into law on October 26, 2002.
Section 510(o) of the act requires that FDA review the types of
reprocessed SUDs subject to premarket notification requirements and
identify which of these devices require the submission of validation
data to ensure their substantial equivalence to predicate devices.
Section 510(o) also requires that FDA review critical and semicritical
reprocessed SUDs that are currently exempt from premarket notification
requirements and determine which of these devices require the
submission of premarket notifications to ensure their substantial
equivalence to predicate devices.
FDA has identified the reprocessed SUDs that require the submission
of validation data to date. The requirement to submit validation data
for certain reprocessed SUDs has been incorporated into the premarket
notification program. As with all other devices, new premarket
notifications for reprocessed SUDs will be required as new
manufacturers enter the market or manufacturers with cleared premarket
notifications make significant changes to their device. The burden
estimates below include the burden for submitting premarket
notifications for reprocessed SUDs with the burden for all other
devices. FDA may amend the lists of reprocessed SUDs that require the
submission of premarket notifications with validation data as
necessary.
Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
Introducing a device to the market for the first time;
Introducing or reintroducing a device which is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device.
Section 807.87 specifies information required in a premarket
notification submission.
Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions including premarket
notifications or other requirements. FDA has published and updated the
list of recognized standards regularly since enactment of FDAMA and has
allowed 510(k) submitters to certify conformance to recognized
standards to meet the requirements of Sec. 807.87. Certification of
conformance to a recognized standard may allow a manufacturer to submit
an abbreviated 510(k). FDA is now seeking approval of a form (Form FDA
3654) that will standardize certification of conformance to a
recognized standard. FDA believes that use of this form will simplify
the certification process for 510(k) submitters and the review process
for FDA.
Form FDA 3514, a summary cover sheet form, has been created to
assist respondents in categorizing 510(k) information for submission to
FDA. This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and humanitarian device exemptions. The total burden (1,000
hours) for Form FDA 3514 has been included in this information
collection. Form FDA 3654 is used in the following information
collections: 0910-0078, 0910-0231, and 0910-0332, but the burden is
approved under this information collection (0910-0120).
Under Sec. 807.87(h), each 510(k) submitter must include in the
510(k) either a summary of the information in the 510(k) (510(k)
summary) or a statement certifying that the submitter will make
available upon request the information in the 510(k) (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
submission, Sec. 807.93 requires that the official correspondent of
the firm make available within 30 days of a request all information
included in the submitted premarket notification on safety and
effectiveness. This information will be provided to any person within
30 days of a request if the device described in the premarket
notification submission is determined to be substantially equivalent.
The information provided will be a duplicate of the premarket
notification submission including any safety and effectiveness
information, but excluding all patient identifiers and trade secret and
confidential information.
The most likely respondents to this information collection will
primarily be medical device manufacturers including
[[Page 64713]]
reprocessors of SUDs, and initial importers of devices.
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
21 CFR Section Form FDA Number Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807, subpart E (807.81 and 807.87/ ................. 3,700 1 3,700 80 296,000
510(k))
--------------------------------------------------------------------------------------------------------------------------------------------------------
3514 2,000 1 2,000 0.5 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
3654 150 1 150 1 150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 297,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Form FDA Number Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.93 ................. 2,000 10 20,000 0.5 10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on conversations with industry and
trade association representatives, and from internal review of the
documents listed in tables 1 and 2.
Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18553 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S
