Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement, 821-823 [05-109]
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Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices
existing paperwork clearance for the
rule.2
Deceptive lending cases at the FTC
and elsewhere suggest that consumers
who do not understand the terms of
their mortgages can be subject to
deception, that deception can occur
even when consumers receive the
disclosures required by the Truth-inLending Act, 15 U.S.C. 1601 et seq.
(TILA), and that deception about
mortgage terms can result in substantial
consumer injury.
Despite a long history of mortgage
disclosure requirements and many
legislative and regulatory proposals
regarding disclosures, little empirical
evidence exists to document the effect
of current disclosures on consumer
understanding of mortgage terms,
consumer mortgage shopping behavior,
or consumer mortgage choice.
The Mortgage Disclosure Study will
examine: (1) How consumers search for
and choose mortgages; (2) how
consumers use and understand
information about mortgages, including
required disclosures; and (3) whether
improved disclosures might improve
consumer understanding, consumer
mortgage shopping, and consumers’
ability to avoid deception. The research
also may assist the targeting of the FTC’s
enforcement actions by identifying areas
most prone to consumer
misunderstanding and lender deception
and may help refine disclosure remedies
imposed on deceptive lenders.
1. Description of the Collection of
Information and Proposed Use
The FTC is conducting this study in
two phases: (1) A qualitative research
phase; and (2) a quantitative research
phase. The qualitative research phase
includes two focus groups and 36 indepth interviews. The quantitative
research will include copy tests of
current and alternative disclosures.
Results from the first phase will be used
to refine the design of the second phase.
The two focus groups and 25 of the
in-depth interviews have been
completed under the current PRA
clearance and are not part of this
extension request.3 Eleven of the in2 In its September 28, 2004 Federal Register
Notice, the FTC indicated it was seeking to extend
the current PRA clearance through December 31,
2005. The FTC staff expect the consumer research
for the Mortgage Disclosure Survey to be completed
by that date, but is now seeking to extend the
current PRA clearance through December 31, 2006,
to allow for any unanticipated delays.
3 The September 28, 2004 Federal Register Notice
included all of the in-depth interviews in the
extension request; 25 of those interviews were
subsequently completed under the current
clearance and are not a part of this extension
request.
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17:49 Jan 04, 2005
Jkt 205001
depth interviews have not yet been
conducted. Accordingly, this extension
request covers information collection for
the 11 in-depth interviews that remain
for the qualitative phase and the copy
tests for the quantitative phase.
The remaining in-depth interviews
will be conducted with 11 consumers
who have recently completed a
mortgage transaction. Respondents will
be asked to bring their loan documents
to the interview. Some of the interviews
will be with consumers who obtained
their mortgage from a prime lender and
some will be with consumers who
obtained their mortgage from a
subprime lender. The purpose of the
interviews is to gain in-depth
knowledge of the extent to which
consumers use, search for, and
understand mortgage information—
including information about their own
recent loans.
The quantitative research phase will
consist of copy test interviews of 800
consumers who entered into a mortgage
transaction within the previous two
years. If possible, approximately half of
the respondents will be consumers who
obtained their mortgage from a prime
lender and half will be consumers who
obtained their mortgage from a
subprime lender. The purpose of the
copy tests will be to examine whether
alternative disclosures can improve
consumer understanding of mortgage
terms and help to reduce potential
deception about mortgage offers. The
findings from the focus groups and indepth interviews will be used to refine
the alternative disclosures used in the
copy tests.
All information will be collected on a
voluntary basis. The FTC has contracted
with two consumer research firms (one
each for the qualitative and quantitative
phases) to recruit respondents, conduct
the interviews, and write a brief
methodological report. The results will
assist the FTC in determining how
required disclosures and other
information affect consumers’ ability to
understand the cost and features of
mortgages. This understanding will
further the FTC’s mission of protecting
consumers and competition in this
important market.
2. Estimated Hours Burden
Qualitative Research
The qualitative phase is complete
except for 11 in-depth interviews. If all
respondents for those interviews are
single decision makers, this would
amount to an 11 hour burden. However,
some of the interviews may include
couples. Assuming that about half of the
interviews include couples, the hours
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Sfmt 4703
821
burden for the in-depth interviews
would increase to 17 hours ((6 × 2
hours) + (5 × 1 hour)).
Quantitative Research
Approximately 800 consumers who
engaged in a mortgage transaction
during the previous two years will
participate in the quantitative phase of
the research. Each copy test interview
will take roughly 20–30 minutes. The
estimated hours burden for the
quantitative phase ranges from 267
hours (800 respondents × 1⁄3 hour per
respondent) to 400 hours (800
respondents × 1⁄2 hour per respondent).
Total
The total estimated hours burden for
both phases of the study ranges from
278 hours (11 hours + 267 hours) to 417
hours (17 hours + 400 hours).
William E. Kovacic,
General Counsel.
[FR Doc. 05–176 Filed 1–4–05; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0437]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Third-Party Review Under the Food
and Drug Administration
Modernization Act, Third-Party
Premarket Submission Review, and
Quality System Inspections Under the
United States/European Community
Mutual Recognition Agreement
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 February 4,
2005.
ADDRESSES: 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 comments be
faxed to the Office of Information and
E:\FR\FM\05JAN1.SGM
05JAN1
822
Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices
Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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 Devices; Third-Party Review
Under FDAMA, Third-Party Premarket
Submission Review, and Quality
System Inspections Under U.S./E.C.
Mutual Recognition Agreement (OMB
Control Number 0910–0378)—Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360m), directing
FDA to accredit persons in the private
sector to review certain premarket
applications and notifications.
Participation in this third-party review
program by accredited persons is
entirely voluntary. A third party
wishing to participate will submit a
request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
submission under section 510(k) of the
act (21 U.S.C. 360(k)) for selected
devices. After reviewing a submission,
the reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation to FDA. Third-party
reviews should maintain records of their
510(k) reviews and a copy of the 510(k)
for a reasonable period of time, usually
a period of 3 years. This information
collection will allow FDA to continue to
implement the accredited person review
program established by FDAMA and
improve the efficiency of 510(k) review
for low-to-moderate risk devices.
The third-party program under the
U.S/European Community (E.C.) Mutual
Recognition Agreement (MRA) is
intended to implement that part of the
U.S./E.C. MRA that covers the exchange
of quality system evaluation reports for
all medical devices and premarket
evaluation reports for selected low-tomoderate risk devices. Under the MRA,
firms may apply to become designated
as a U.S. conformity assessment body
(CAB). Firms who are designated will be
qualified to conduct quality system
evaluations for all classes of devices and
product type evaluations and
verifications for selected devices based
on European Union (EU) requirements
under the voluntary third-party program
authorized by MRA. Firms designated as
EU CABs could conduct quality system
evaluations for all classes of devices and
premarket 510(k) evaluations for
selected devices based on FDA’s
requirements. Under the voluntary
third-party program, reports of these
evaluations would be submitted by the
EU CABs to FDA. The EU CABs would
also be required to maintain copies of
their evaluation reports for a period of
no less than 3 years.
In the Federal Register of October 14,
2004 (69 FR 61021), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Requests for accreditation
15
1
15
24
360
510(k) reviews conducted by accredited
third parties
15
14
210
40
8,400
Premarket reports by EU CABs
9
5
45
40
1,800
Quality system reports by EU CABs
9
4
36
32
1,152
Item
Total
1 There
11,712
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.–ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency
per Recordkeeper
Total Annual
Records
Hours per Recordkeeper
Total Hours
510(k) reviews
15
14
210
10
2,100
Premarket reports by EU CABs
9
5
45
10
450
Quality system reports by EU CABs
9
4
36
10
360
Item
Total
1 There
2,910
are no capital costs or operating and maintenance costs associated with this collection of information.
The burdens are explained as follows:
I. Reporting
A. Requests for Accreditation
Under the agency’s third-party review
pilot program, the agency received 37
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17:49 Jan 04, 2005
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applications for recognition as thirdparty reviewers, of which the agency
recognized 7. In the past 3 years,
however, the agency has averaged
receipt of 15 applications for
recognition of third-party review
PO 00000
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Fmt 4703
Sfmt 4703
accredited persons, and 9 EU CABS.
The agency has accredited 15 of the
applicants to conduct third-party
reviews, and 9 EU CABs.
E:\FR\FM\05JAN1.SGM
05JAN1
Federal Register / Vol. 70, No. 3 / Wednesday, January 5, 2005 / Notices
B. 510(k) Reviews Conducted by
Accredited Third Parties
In the 18 months under the thirdparty review pilot program, FDA
received only 22 total 510(k)s that
requested and were eligible for review
by third parties. Because the third-party
review program is not as limited in time
as the pilot program, and is expanded in
scope, the agency anticipates that the
number of 510(k)s submitted for thirdparty review will remain the same as
they were during the last OMB approval
in 2001. The agency has experienced
that the number of 510(k)s submitted by
accredited persons for third-party
review since the last OMB approval in
2001 has been approximately 210
annually, which is 14 annual reviews
per each of the estimated 15 accredited
reviewers.
1. Premarket Reports
Under this program, EU CABs will be
able to perform third-party evaluations
for certain products produced in Europe
for export to the United States. EU CABs
would be required to submit to FDA
reports of their evaluations. Based upon
information gathered since this
collection was last reviewed in 2001,
the agency has experienced that nine
European manufacturers have not
received any third-party requests for
review annually. The agency estimates,
based on dialog with EU officials and
actual experience, nine firms will be
designated to act as EU CABs.
2. Quality System Reports
Under this program, EU CABs will be
able to perform third-party evaluations
of the quality systems established by
manufacturers of European products
produced for export to the United
States. EU CABs would be required to
submit to FDA reports of their
evaluations. Based upon information
gathered during the negotiation of the
U.S./E.C. MRA and actual experience
since the collection was last approved
by OMB in 2001, the agency anticipates
that European manufacturers will
request third-party audits for
approximately 36 medical device
products annually. The agency
estimates that nine EU CABs will
perform these evaluations.
II. Recordkeeping
Third-party reviewers are required to
keep records of their review of each
submission. The agency anticipates
approximately 210 annual submissions
of 510(k)s for third-party review.
As stated previously, firms designated
as EU CABs will be able to perform
third-party evaluations of quality
systems and premarket submissions for
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17:49 Jan 04, 2005
Jkt 205001
certain products produced for export to
the United States. Such review will be
conducted consistent with FDA’s
regulatory requirements, and FDA will
require the reviewers to keep, in their
records, a copy of the report that they
submit to FDA for each review. The
agency anticipates that 45 premarket
reports and 36 quality system reports
will be generated and required to be
maintained by EU CABs annually. The
agency further estimates that each
reviewer will require no more than 10
hours (2 hours per recordkeeping per
report) for each to maintain such
records annually.
Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–109 Filed 1–4–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2004D–0377 and 2004D–0378]
International Conference on
Harmonisation; Draft Guidances on
E14 Clinical Evaluation of QT/QTc
Interval Prolongation and
Proarrhythmic Potential for NonAntiarrhythmic Drugs and S7B
Nonclinical Evaluation of the Potential
for Delayed Ventricular Repolarization
(QT Interval Prolongation) by Human
Pharmaceuticals; Availability;
Reopening of Comment Periods
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of comment
periods.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
February 18, 2005, the comment periods
for the draft guidances entitled ‘‘E14
Clinical Evaluation of QT/QTc Interval
Prolongation and Proarrhythmic
Potential for Non-Antiarrhythmic
Drugs’’ and ‘‘S7B Nonclinical
Evaluation of the Potential for Delayed
Ventricular Repolarization (QT Interval
Prolongation) by Human
Pharmaceuticals.’’ The draft guidances
were prepared under the auspices of the
International Conference on
Harmonisation (ICH) of Technical
Requirements for Registration of
Pharmaceuticals for Human Use. FDA
published notices of availability of the
draft guidances in the Federal Register
of September 13, 2004 (69 FR 55163 and
69 FR 55164, respectively). FDA is
taking this action in response to
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
823
requests to extend the comment periods
for both draft guidances.
DATES: Submit written or electronic
comments on the draft guidances by
February 18, 2005. General comments
on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written comments
on the draft guidances to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.fda.gov/dockets/ecomments.
Submit written requests for single
copies of the draft guidances to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Office of
Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send two
self-addressed adhesive labels to assist
the office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidances.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance entitled ‘‘E14
Clinical Evaluation of QT/QTc
Interval Prolongation and
Proarrhythmic Potential for NonAntiarrhythmic Drugs’’: Douglas C.
Throckmorton, Center for Drug
Evaluation and Research (HFD–1),
Food and Drug Administration,
5600 Fishers Lane,Rockville MD,
20857, 301–594–5400.
Regarding the guidance entitled ‘‘S7B
Nonclinical Evaluation of the
Potential for Delayed Ventricular
Repolarization (QT Interval
Prolongation) by Human
Pharmaceuticals’’: John Koerner,
Center for Drug Evaluation and
Research (HFD–110), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–
594–5338.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September
13, 2004, FDA announced the
availability of the following two draft
guidances prepared under the auspices
of the ICH:
E:\FR\FM\05JAN1.SGM
05JAN1
]]>Agencies
[Federal Register Volume 70, Number 3 (Wednesday, January 5, 2005)]
[Notices]
[Pages 821-823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-109]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0437]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Third-Party Review Under the Food and Drug Administration Modernization
Act, Third-Party Premarket Submission Review, and Quality System
Inspections Under the United States/European Community Mutual
Recognition Agreement
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
February 4, 2005.
ADDRESSES: 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 comments be faxed to the
Office of Information and
[[Page 822]]
Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX:
202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 Devices; Third-Party Review Under FDAMA, Third-Party Premarket
Submission Review, and Quality System Inspections Under U.S./E.C.
Mutual Recognition Agreement (OMB Control Number 0910-0378)--Extension
Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in
the private sector to review certain premarket applications and
notifications. Participation in this third-party review program by
accredited persons is entirely voluntary. A third party wishing to
participate will submit a request for accreditation to FDA. Accredited
third-party reviewers have the ability to review a manufacturer's
submission under section 510(k) of the act (21 U.S.C. 360(k)) for
selected devices. After reviewing a submission, the reviewer will
forward a copy of the 510(k) submission, along with the reviewer's
documented review and recommendation to FDA. Third-party reviews should
maintain records of their 510(k) reviews and a copy of the 510(k) for a
reasonable period of time, usually a period of 3 years. This
information collection will allow FDA to continue to implement the
accredited person review program established by FDAMA and improve the
efficiency of 510(k) review for low-to-moderate risk devices.
The third-party program under the U.S/European Community (E.C.)
Mutual Recognition Agreement (MRA) is intended to implement that part
of the U.S./E.C. MRA that covers the exchange of quality system
evaluation reports for all medical devices and premarket evaluation
reports for selected low-to-moderate risk devices. Under the MRA, firms
may apply to become designated as a U.S. conformity assessment body
(CAB). Firms who are designated will be qualified to conduct quality
system evaluations for all classes of devices and product type
evaluations and verifications for selected devices based on European
Union (EU) requirements under the voluntary third-party program
authorized by MRA. Firms designated as EU CABs could conduct quality
system evaluations for all classes of devices and premarket 510(k)
evaluations for selected devices based on FDA's requirements. Under the
voluntary third-party program, reports of these evaluations would be
submitted by the EU CABs to FDA. The EU CABs would also be required to
maintain copies of their evaluation reports for a period of no less
than 3 years.
In the Federal Register of October 14, 2004 (69 FR 61021), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Respondents to this information collection are 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
Item Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for accreditation 15 1 15 24 360
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews conducted by accredited third parties 15 14 210 40 8,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket reports by EU CABs 9 5 45 40 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality system reports by EU CABs 9 4 36 32 1,152
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 11,712
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Record- Annual Frequency Total Annual Hours per Record-
Item keepers per Recordkeeper Records keeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews 15 14 210 10 2,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Premarket reports by EU CABs 9 5 45 10 450
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality system reports by EU CABs 9 4 36 10 360
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 2,910
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burdens are explained as follows:
I. Reporting
A. Requests for Accreditation
Under the agency's third-party review pilot program, the agency
received 37 applications for recognition as third-party reviewers, of
which the agency recognized 7. In the past 3 years, however, the agency
has averaged receipt of 15 applications for recognition of third-party
review accredited persons, and 9 EU CABS. The agency has accredited 15
of the applicants to conduct third-party reviews, and 9 EU CABs.
[[Page 823]]
B. 510(k) Reviews Conducted by Accredited Third Parties
In the 18 months under the third-party review pilot program, FDA
received only 22 total 510(k)s that requested and were eligible for
review by third parties. Because the third-party review program is not
as limited in time as the pilot program, and is expanded in scope, the
agency anticipates that the number of 510(k)s submitted for third-party
review will remain the same as they were during the last OMB approval
in 2001. The agency has experienced that the number of 510(k)s
submitted by accredited persons for third-party review since the last
OMB approval in 2001 has been approximately 210 annually, which is 14
annual reviews per each of the estimated 15 accredited reviewers.
1. Premarket Reports
Under this program, EU CABs will be able to perform third-party
evaluations for certain products produced in Europe for export to the
United States. EU CABs would be required to submit to FDA reports of
their evaluations. Based upon information gathered since this
collection was last reviewed in 2001, the agency has experienced that
nine European manufacturers have not received any third-party requests
for review annually. The agency estimates, based on dialog with EU
officials and actual experience, nine firms will be designated to act
as EU CABs.
2. Quality System Reports
Under this program, EU CABs will be able to perform third-party
evaluations of the quality systems established by manufacturers of
European products produced for export to the United States. EU CABs
would be required to submit to FDA reports of their evaluations. Based
upon information gathered during the negotiation of the U.S./E.C. MRA
and actual experience since the collection was last approved by OMB in
2001, the agency anticipates that European manufacturers will request
third-party audits for approximately 36 medical device products
annually. The agency estimates that nine EU CABs will perform these
evaluations.
II. Recordkeeping
Third-party reviewers are required to keep records of their review
of each submission. The agency anticipates approximately 210 annual
submissions of 510(k)s for third-party review.
As stated previously, firms designated as EU CABs will be able to
perform third-party evaluations of quality systems and premarket
submissions for certain products produced for export to the United
States. Such review will be conducted consistent with FDA's regulatory
requirements, and FDA will require the reviewers to keep, in their
records, a copy of the report that they submit to FDA for each review.
The agency anticipates that 45 premarket reports and 36 quality system
reports will be generated and required to be maintained by EU CABs
annually. The agency further estimates that each reviewer will require
no more than 10 hours (2 hours per recordkeeping per report) for each
to maintain such records annually.
Dated: December 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-109 Filed 1-4-05; 8:45 am]
BILLING CODE 4160-01-S
