Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority, 8799-8801 [E9-4137]
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Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Data collection mode
Hours per
response
Total burden
hours
Screening form ................................................................................
Self-administered questionnaire ......................................................
Focus group with parents of children <8 years of age (4 groups of
8 participants) ...............................................................................
Focus group with adults (4 groups of 8 participants) ......................
Semi-structured interviews with adolescents (13 to 20 years of
age) ..............................................................................................
Semi-structured interviews with primary care physicians ................
Semi-structured interviews with pharmacists ..................................
124
84
1
1
3/60
6/60
6
8
32
32
1
1
1.5
1.5
48
48
20
20
20
1
1
1
30/60
20/60
20/60
10
7
7
Total ..........................................................................................
332
............................
............................
134
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Data collection mode
Total burden
hours
Average hourly
wage rate*
Total cost burden
Screening form ................................................................................
Self-administered questionnaire ......................................................
Focus groups with parents of children <8 years of age (4 groups
of 8 participants) ..........................................................................
Focus groups with adults (4 groups of 8 participants) ....................
Semi-structured interviews with adolescents (13 to 20 years of
age) ..............................................................................................
Semi-structured interviews with primary care physicians ................
Semi-structured interviews with pharmacists ..................................
124
84
6
8
$10.30
10.30
$62
82
32
32
48
48
10.30
10.30
494
494
20
20
20
10
7
7
10.30
61.10
48.22
103
428
338
Total ..........................................................................................
332
134
............................
2,001
* Patient average hourly wage based on the average per capita income of $21,435 (computed into an hourly wage rate of $10.30) in Harris
County, Texas where the study will take place. Provider hourly wage based on the following estimates from National Compensation Survey: Occupational wages in the United States 2006, U.S. Department of Labor, Bureau of Labor Statistics: Primary care physician = $61.10/hour; pharmacist = $48.22/hour.
Estimates of Annualized Cost to the
Government
Exhibit 3 shows the estimated cost to
the Federal Government for this six
month project.
The total cost is $164,440. This
amount includes all direct and indirect
costs of the design, data collection,
analysis, and reporting phase of the
study.
EXHIBIT 3—ESTIMATED COST
Cost component
Total cost
Project Development ................
Data Collection Activities ..........
Data Processing and Analysis
Publication of Results ...............
Project Management ................
Overhead ..................................
$13,250
61,699
14,080
750
17,000
57,661
Total ...................................
164,440
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
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16:56 Feb 25, 2009
Jkt 217001
AHRQ health care research, quality
improvement and information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: February 17, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–3959 Filed 2–25–09; 8:45 am]
BILLING CODE 4160–90–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0631]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Recall Authority
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 March 30,
2009.
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,
E:\FR\FM\26FEN1.SGM
26FEN1
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Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0432. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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 Recall Authority—21
CFR Part 810 (OMB Control Number
0910–0432)—Extension
This collection of information
implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360h) and part 810
(21 CFR part 810) for the medical device
recall authority provisions. Section
518(e) of the act provides FDA with the
authority to issue an order requiring an
appropriate person, including
manufacturers, importers, distributors,
and retailers of a device, if FDA finds
that there is reasonable probability that
the device intended for human use
would cause serious adverse health
consequences or death to: (1)
Immediately cease distribution of such
device, (2) immediately notify health
professionals and device-user facilities
of the order, and (3) instruct such
professionals and facilities to cease use
of such device.
Further, the provisions under section
518 (e) of the act sets out a three- step
procedure for issuance of a mandatory
device recall order which are: (1) If
there is a reasonable probability that a
device intended for human use would
cause serious, adverse health
consequences or death, FDA may issue
a cease distribution and notification
order requiring the appropriate person
to immediately: (a) Cease distribution of
the device, (b) notify health
professionals and device user facilities
of the order, and (c) instruct those
professionals and facilities to cease use
of the device, (2) FDA will provide the
person named in the cease distribution
and notification order with the
opportunity for an informal hearing on
whether the order should be modified,
vacated, or amended to require a
mandatory recall of the device and, (3)
after providing the opportunity for an
informal hearing, FDA may issue a
mandatory recall order if the agency
determines that such an order is
necessary.
The information collected under the
recall authority provisions will be used
by FDA to: (1) Ensure that all devices
entering the market are safe and
effective, (2) accurately and
immediately detect serious problems
with medical devices, and (3) remove
dangerous and defective devices from
the market.
In the Federal Register of December
19, 2008 (73 FR 77719), 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
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
810.10(d)
2
1
2
8
16
810.11(a)
1
1
1
8
8
810.12(a-b)
1
1
1
8
8
810.14
2
1
2
16
32
810.15(a-c)
2
1
2
12
24
810.15(d)
2
1
2
4
8
810.15(e)
10
1
10
1
10
810.16(a-b)
2
12
24
40
960
810.17(a)
2
1
2
8
16
Total
1There
1,082
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECODKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
810.15(b)
1There
Annual Frequency
per Recordkeeping
2
Total Annual
Records
1
Hours per
Record
1
8
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
26FEN1
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Federal Register / Vol. 74, No. 37 / Thursday, February 26, 2009 / Notices
Explanation for Burden Estimates:
The burden estimates for tables I and
II of this document are based on FDA’s
experience with voluntary recalls under
part 810 of the regulations. FDA expects
no more than two mandatory recalls per
year, as most recalls are done
voluntarily. Since the last time this
collection of information was submitted
to OMB for renewal/approval, there
have been no mandatory recalls.
Dated: February 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4137 Filed 2–25–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Oral and
Dental: Small Business.
Date: March 5–6, 2009.
Time: 9 a.m. to 12 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: Tamizchelvi Thyagarajan,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4016K,
MSC 7814, Bethesda, MD 20892, 301–451–
1327, tthyagar@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Pathogens
and their Vectors.
Date: March 12, 2009.
Time: 10 a.m. to 5 p.m.
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Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: Richard G. Kostriken, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 301–402–
4454, kostrikr@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Quick Trials
on Imaging and Image-guided Intervention.
Date: March 12, 2009.
Time: 11 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: John Firrell, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5213,
MSC 7854, Bethesda, MD 20892, 301–435–
2598, firrellj@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Infectious
Agent Detection/Diagnosis, Food Safety,
Sterilization/Disinfection and
Bioremediation.
Date: March 13, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Guest Suites Santa
Monica, 1707 Fourth Street, Santa Monica,
CA 90401.
Contact Person: Fouad A. El-Zaatari, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3206,
MSC 7808, Bethesda, MD 20814–9692, (301)
435–1149, elzaataf@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Specials of
Genes, Genomes, and Genetics.
Date: March 13, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Michael A. Marino, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2216,
MSC 7890, Bethesda, MD 20892, (301) 435–
0601, marinomi@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, BTSS
Member Conflict.
Date: March 16, 2009.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: Roberto J. Matus, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7854, Bethesda, MD 20892, (301) 435–
2204, matusr@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Immune Mechanisms.
Date: March 19, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call).
Contact Person: Jian, Wang, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 4095D, MSC 7812, Bethesda,
MD 20892, (301) 435–2778,
wangjia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Health of
the Population SBIR–2.
Date: March 23, 2009.
Time: 12 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: Karin F. Helmers, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, 301–435–
1017, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Data
Ontologies and Sharing Data and Tools.
Date: March 24–25, 2009.
Time: 8 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting).
Contact Person: Alexander Gubin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm 5144, MSC
7812, Bethesda, MD 20892, 301–435–2902,
gubina@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Digestive Sciences.
Date: March 24–25, 2009.
Time: 8 a.m. to 6 p.m.
E:\FR\FM\26FEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 37 (Thursday, February 26, 2009)]
[Notices]
[Pages 8799-8801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0631]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device Recall
Authority
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 March
30, 2009.
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,
[[Page 8800]]
OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to oira_
submission@omb.eop.gov. All comments should be identified with the OMB
control number 0910-0432. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 Recall Authority--21 CFR Part 810 (OMB Control Number
0910-0432)--Extension
This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360h) and
part 810 (21 CFR part 810) for the medical device recall authority
provisions. Section 518(e) of the act provides FDA with the authority
to issue an order requiring an appropriate person, including
manufacturers, importers, distributors, and retailers of a device, if
FDA finds that there is reasonable probability that the device intended
for human use would cause serious adverse health consequences or death
to: (1) Immediately cease distribution of such device, (2) immediately
notify health professionals and device-user facilities of the order,
and (3) instruct such professionals and facilities to cease use of such
device.
Further, the provisions under section 518 (e) of the act sets out a
three- step procedure for issuance of a mandatory device recall order
which are: (1) If there is a reasonable probability that a device
intended for human use would cause serious, adverse health consequences
or death, FDA may issue a cease distribution and notification order
requiring the appropriate person to immediately: (a) Cease distribution
of the device, (b) notify health professionals and device user
facilities of the order, and (c) instruct those professionals and
facilities to cease use of the device, (2) FDA will provide the person
named in the cease distribution and notification order with the
opportunity for an informal hearing on whether the order should be
modified, vacated, or amended to require a mandatory recall of the
device and, (3) after providing the opportunity for an informal
hearing, FDA may issue a mandatory recall order if the agency
determines that such an order is necessary.
The information collected under the recall authority provisions
will be used by FDA to: (1) Ensure that all devices entering the market
are safe and effective, (2) accurately and immediately detect serious
problems with medical devices, and (3) remove dangerous and defective
devices from the market.
In the Federal Register of December 19, 2008 (73 FR 77719), 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
----------------------------------------------------------------------------------------------------------------
810.10(d) 2 1 2 8 16
----------------------------------------------------------------------------------------------------------------
810.11(a) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.12(a-b) 1 1 1 8 8
----------------------------------------------------------------------------------------------------------------
810.14 2 1 2 16 32
----------------------------------------------------------------------------------------------------------------
810.15(a-c) 2 1 2 12 24
----------------------------------------------------------------------------------------------------------------
810.15(d) 2 1 2 4 8
----------------------------------------------------------------------------------------------------------------
810.15(e) 10 1 10 1 10
----------------------------------------------------------------------------------------------------------------
810.16(a-b) 2 12 24 40 960
----------------------------------------------------------------------------------------------------------------
810.17(a) 2 1 2 8 16
----------------------------------------------------------------------------------------------------------------
Total 1,082
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recodkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
810.15(b) 2 1 1 8 8
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 8801]]
Explanation for Burden Estimates:
The burden estimates for tables I and II of this document are based
on FDA's experience with voluntary recalls under part 810 of the
regulations. FDA expects no more than two mandatory recalls per year,
as most recalls are done voluntarily. Since the last time this
collection of information was submitted to OMB for renewal/approval,
there have been no mandatory recalls.
Dated: February 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4137 Filed 2-25-09; 8:45 am]
BILLING CODE 4160-01-S
