Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance, 74926-74927 [E6-21167]
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74926
Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
No. of Responses
per Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Total Reporting Burden Hours
3,678.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Applications submitted under § 601.2.
3 Supplements submitted under § 601.12(f)(1) and (f)(2).
4 Annual reports submitted under § 601.12(f)(3).
Dated: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21132 Filed 12–12–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Denver Presley, Jr., Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarket
Surveillance
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
ACTION:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
[Docket No. 2006N–0382]
AGENCY:
Fax written comments on the
collection of information by January 12,
2007.
DATES:
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.
Postmarket Surveillance—21 CFR Part
822 (OMB No. 0910–0449)—Extension
Section 522(a) of the Federal Food,
Drug and Cosmetic Act (the act) (21
U.S.C. 360(l)) authorizes FDA to require
manufacturers to conduct postmarket
surveillance (PS) of any device that
meets the criteria set forth in the statute.
The PS regulation establishes
procedures that FDA uses to approve
and disapprove PS plans. The regulation
provides specific, clear, and flexible
instructions to manufacturers so they
know what information is required in a
PS plan submission. FDA reviews
submissions in accordance with part
822 (21 CFR part 822) in §§ 822.15 to
822.18 of the regulation, which describe
the grounds for approving or
disapproving a PS plan. If this
information is not collected, FDA would
not be able to ensure that the PS will
result in the collection of useful data
that could reveal unforeseen adverse
events or other information necessary to
protect the public health.
Respondents to this collection of
information are those manufacturers
who require PS of their products.
In the Federal Register of October 2,
2006 (71 FR 57973), 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
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
5
1
5
120
600
822.21
3
1
3
40
120
822.26
1
1
1
8
8
822.27
1
1
1
40
40
822.28
1
1
1
40
40
822.29
1
1
1
120
120
822.30
1
1
1
40
40
822.34
hsrobinson on PROD1PC76 with NOTICES
822.9, 822.10
1
1
1
20
20
822.38
10
2
20
120
2,400
Total
1There
3,338
are no capital costs or operating and maintenance costs associated with this collection of information.
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21:31 Dec 12, 2006
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74927
Federal Register / Vol. 71, No. 239 / Wednesday, December 13, 2006 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours per
Record
Total Hours
822.31
10
1
10
20
200
822.32
30
1
30
10
300
Total
hsrobinson on PROD1PC76 with NOTICES
1There
500
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that, based on current
staffing and resources and experience
with five actual PS actions over the past
3 years, five PS actions will be issued
for generic devices, comprised of
approximately five manufacturers. Each
manufacturer will be required to submit
a PS plan (§§ 822.9 and 822.10) and
interim and final reports on the progress
of the PS (§ 822.38). FDA anticipates
that, on a case-by-case basis, requests for
additional information may be made
from a manufacturer. FDA expects that
a small number of respondents will
propose changes to their PS plans
(§ 822.21), request a waiver of a specific
requirement of this regulation
(§ 822.29), or request exemption from
the requirement to conduct PS of their
device (§ 822.30). FDA’s experience has
shown that a few respondents will go
out of business (§ 822.26) or cease
marketing the device subject to PS
(§ 822.28) each year. In addition,
manufacturers must certify transfer of
records when ownership changes
(§ 822.34).
FDA expects that at least some of the
manufacturers will be able to satisfy the
PS requirement using information or
data they already have. For purposes of
calculating burden, however, FDA has
assumed that each PS order can only be
satisfied by a 3-year clinically-based PS
plan, using three investigators. These
estimates are based on FDA’s knowledge
and experience with limited
implementation of section 522 under
the Safe Medical Device Act of 1990.
Therefore, FDA would expect that the
recordkeeping requirements would
apply to a maximum of 10
manufacturers (3 to 4 added each year)
and 30 investigators (3 per PS plan).
After 3 years, FDA would expect these
numbers to remain level as the PS plans
conducted under the earliest orders
reach completion and new orders are
issued.
Dated: December 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–21167 Filed 12–12–06; 8:45 am]
BILLING CODE 4160–01–S
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21:31 Dec 12, 2006
Jkt 211001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) Los Angeles District, in
cooperation with the Society of Clinical
Research Associates (SoCRA), is
announcing a workshop on FDA clinical
trial statutory and regulatory
requirements. This 2-day workshop for
the clinical research community targets
sponsors, monitors, clinical
investigators, institutional review
boards, and those who interact with
them for the purpose of conducting
FDA-regulated clinical research. The
workshop will include both industry
and FDA perspectives on proper
conduct of clinical trials regulated by
FDA.
Date and Time: The public workshop
is scheduled for Wednesday, February
7, 2007, from 8:30 a.m. to 5 p.m. and
Thursday, February 8, 2007, from 8:30
a.m. to 4:30 p.m.
Location: The public workshop will
be held at the Wyndham San Diego at
Emerald Plaza, 400 West Broadway, San
Diego, CA 92101, 619–239–4500, FAX:
619–239–3274.
Contact: Marshalette Edwards, Food
and Drug Administration, 1431 Harbor
Bay Parkwy., Alameda, CA 94502, 510–
337–6794, FAX: 510–337–6703 e-mail:
MO.Edwards@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $575
(member), $650 (nonmember), $525
(Government employee nonmember) or
$450 (Government employee member)
to SoCRA , P.O. Box 101, Furlong, PA
18925. The registration fee for
nonmembers includes a 1-year
membership). The registration fee for
FDA employees is waived. Make the
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
registration fee payable to SoCRA.To
register via the Internet go to https://
www.socra.org/html/
FDAlConference.htm (FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register).
The registrar will also accept payment
by major credit cards. For more
information on the meeting, or for
questions on registration, contact 800–
SoCRA92 (800–762–7292), or 215–822–
8644, or via e-mail: socramail@aol.com.
Attendees are responsible for their own
accommodations. To make reservations
at the Wyndham San Diego at Emerald
Plaza at the reduced conference rate,
contact the hotel (see Location) before
January 7, 2007. The registration fee will
be used to offset the expenses of hosting
the conference, including meals,
refreshments, meeting rooms, and
materials.
Space is limited, therefore interested
parties are encouraged to register early.
Limited onsite registration may be
available. Please arrive early to ensure
prompt registration. If you need special
accommodations due to a disability,
please contact Marshalette Edwards (see
Contact) at least 7 days in advance of
the workshop.
The
workshop on FDA clinical trials
statutory and regulatory requirements
helps fulfill the Department of Health
and Human Services’ and FDA’s
important mission to protect the public
health by educating researchers on
proper conduct of clinical trials. Topics
for discussion include the following: (1)
FDA regulation of the conduct of
clinical research; (2) medical device,
drug, biological product and food
aspects of clinical research; (3)
investigator initiated research; (4) preinvestigational new drug application
meetings and the FDA meeting process;
(5) informed consent requirements; (6)
ethics in subject enrollment; (7) FDA
regulation of institutional review
boards; (8) electronic records
requirements; (9) adverse event
reporting; (10) how FDA conducts
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 71, Number 239 (Wednesday, December 13, 2006)]
[Notices]
[Pages 74926-74927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0382]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance
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 January
12, 2007.
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, 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.
Postmarket Surveillance--21 CFR Part 822 (OMB No. 0910-0449)--Extension
Section 522(a) of the Federal Food, Drug and Cosmetic Act (the act)
(21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct
postmarket surveillance (PS) of any device that meets the criteria set
forth in the statute.
The PS regulation establishes procedures that FDA uses to approve
and disapprove PS plans. The regulation provides specific, clear, and
flexible instructions to manufacturers so they know what information is
required in a PS plan submission. FDA reviews submissions in accordance
with part 822 (21 CFR part 822) in Sec. Sec. 822.15 to 822.18 of the
regulation, which describe the grounds for approving or disapproving a
PS plan. If this information is not collected, FDA would not be able to
ensure that the PS will result in the collection of useful data that
could reveal unforeseen adverse events or other information necessary
to protect the public health.
Respondents to this collection of information are those
manufacturers who require PS of their products.
In the Federal Register of October 2, 2006 (71 FR 57973), 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.9, 822.10 5 1 5 120 600
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.21 3 1 3 40 120
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.26 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.27 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.28 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.29 1 1 1 120 120
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.30 1 1 1 40 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.34 1 1 1 20 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.38 10 2 20 120 2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 3,338
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 74927]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.31 10 1 10 20 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
822.32 30 1 30 10 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that, based on current staffing and resources and
experience with five actual PS actions over the past 3 years, five PS
actions will be issued for generic devices, comprised of approximately
five manufacturers. Each manufacturer will be required to submit a PS
plan (Sec. Sec. 822.9 and 822.10) and interim and final reports on the
progress of the PS (Sec. 822.38). FDA anticipates that, on a case-by-
case basis, requests for additional information may be made from a
manufacturer. FDA expects that a small number of respondents will
propose changes to their PS plans (Sec. 822.21), request a waiver of a
specific requirement of this regulation (Sec. 822.29), or request
exemption from the requirement to conduct PS of their device (Sec.
822.30). FDA's experience has shown that a few respondents will go out
of business (Sec. 822.26) or cease marketing the device subject to PS
(Sec. 822.28) each year. In addition, manufacturers must certify
transfer of records when ownership changes (Sec. 822.34).
FDA expects that at least some of the manufacturers will be able to
satisfy the PS requirement using information or data they already have.
For purposes of calculating burden, however, FDA has assumed that each
PS order can only be satisfied by a 3-year clinically-based PS plan,
using three investigators. These estimates are based on FDA's knowledge
and experience with limited implementation of section 522 under the
Safe Medical Device Act of 1990. Therefore, FDA would expect that the
recordkeeping requirements would apply to a maximum of 10 manufacturers
(3 to 4 added each year) and 30 investigators (3 per PS plan). After 3
years, FDA would expect these numbers to remain level as the PS plans
conducted under the earliest orders reach completion and new orders are
issued.
Dated: December 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21167 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S
