Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking, 22991-22993 [2014-09467]
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Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
[FR Doc. 2014–09288 Filed 4–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–1466–N]
Medicare Program: Notice of Two
Membership Appointments to the
Advisory Panel on Hospital Outpatient
Payment
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice announces two
new membership appointments to the
Advisory Panel on Hospital Outpatient
Payment (the Panel). The two new
appointments to the Panel will each
serve a 4-year period. The new members
will have terms that begin on February
16, 2014 and continue through February
15, 2018. The purpose of the Panel is to
advise the Secretary of the Department
of Health and Human Services and the
Administrator of the Centers for
Medicare & Medicaid Services
concerning the clinical integrity of the
Ambulatory Payment Classification
groups and their relative payment
weights. The Panel also addresses and
makes recommendations regarding
supervision of hospital outpatient
services. The advice provided by the
Panel will be considered as we prepare
the annual updates for the hospital
outpatient prospective payment system.
FOR FURTHER INFORMATION CONTACT: For
additional information on the Panel
meeting dates, agenda topics, copy of
the charter, as well as updates to the
Panel’s activities, search our Internet
Web site: https://www.cms.gov/
Regulations-and-Guidance/Guidance/
FACA/AdvisoryPanelonAmbulatory
PaymentClassificationGroups.html. For
other information regarding the Panel,
contact Carol Schwartz, the Designated
Federal Officer (DFO) at CMS, Center for
Medicare, Hospital and Ambulatory
Policy Group, Division of Outpatient
Care, 7500 Security Boulevard, Mail
Stop C4–05–17, Baltimore, MD 21244–
1850, phone (410) 786–3985.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
I. Background
The Department of Health and Human
Services (the Secretary) is required by
section 1833(t)(9)(A) of the Social
Security Act (the Act) (42 U.S.C.
1395l(t)(9)(A)) and section 222 of the
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Public Health Service Act (PHS Act) (42
U.S.C. 217a) to consult with an expert
outside advisory panel on the clinical
integrity of the Ambulatory Payment
Classification groups and relative
payment weights, which are major
elements of the Medicare Hospital
Outpatient Prospective Payment System
(OPPS), and the appropriate supervision
level for hospital outpatient services.
The Panel is governed by the provisions
of the Federal Advisory Committee Act
(FACA) (Pub. L. 92–463), as amended (5
U.S.C. Appendix 2), which sets forth
standards for the formation and use of
advisory panels. The Panel Charter
provides that the Panel shall meet up to
3 times annually. We consider the
technical advice provided by the Panel
as we prepare the proposed and final
rules to update the OPPS for the
following calendar year.
The Panel shall consist of a chair and
up to 19 members who are full-time
employees of hospitals, hospital
systems, or other Medicare providers.
The Secretary or a designee selects the
Panel membership based upon either
self-nominations or nominations
submitted by Medicare providers and
other interested organizations. New
appointments are made in a manner that
ensures a balanced membership under
the FACA guidelines.
The Panel presently consists of the
following members and a Chair.
• Edith Hambrick, M.D., J.D., Chair,
CMS Medical Officer.
• Karen Borman, M.D., FACS.
• Kari S. Cornicelli, C.P.A., FHFMA.
• Brian D. Kavanagh, M.D., MPH.
• Scott Manaker, M.D., Ph.D.
• John Marshall, CRA, RCC, CIRCC,
RT(R), FAHRA.
• Jim Nelson, M.B.A., C.P.A., FHFMA.
• Leah Osbahr, M.A., MPH.
• Jacqueline Phillips.
• Traci Rabine.
• Michael Rabovsky, M.D.
• Marianna V. Spanaki-Varela, MD,
Ph.D., M.B.A.
• Gale Walker.
• Kris Zimmer.
II. Provisions of the Notice
We published a notice in the Federal
Register on November 1, 2013, entitled
‘‘Medicare Program; Solicitation of Five
Nominations to the Advisory Panel on
Hospital Outpatient Payment (HOP, the
Panel)’’ (78 FR 65660). The notice
solicited nominations for five new
members to fill the vacancies on the
Panel beginning September 30, 2013. As
a result of that notice, we are
announcing two new members to the
Panel. The Panel currently consists of
15 members. The two new Panel
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22991
members appointments are for 4-year
terms beginning on February 16, 2014.
New Appointments to the Panel
The two new members of the Panel
with terms beginning on February 16,
2014 and continuing through February
15, 2018 are as follows:
• Wendy Resnick, FHFMA.
• Johnathan Pregler, M.D.
III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 35).
Dated: April 17, 2014.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2014–09289 Filed 4–24–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0555]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
information collection requirements for
the tracking of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 24, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
SUMMARY:
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Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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.
Medical Devices; Device Tracking—21
CFR Part 821 (OMB Control Number
0910–0442)—Extension
Section 211 of the Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) became
effective on February 19, 1998. FDAMA
amended the previous medical device
tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360i(e)(1) and (e)(2)) that
were added by the Safe Medical Devices
Act of 1990 (SMDA) (Pub. L. 101–629).
Unlike the tracking provisions under
SMDA, which required tracking of any
medical device meeting certain criteria,
FDAMA allows FDA discretion in
applying tracking provisions to medical
devices meeting certain criteria and
provides that tracking requirements for
medical devices can be imposed only
after FDA issues an order. In the Federal
Register of February 8, 2002 (67 FR
5943), FDA issued a final rule that
conformed existing tracking regulations
to changes in tracking provisions
effected by FDAMA under part 821 (21
CFR part 821).
Section 519(e)(1) of the FD&C Act, as
amended by FDAMA, provides that
FDA may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; (4)
records and inspection requirements; (5)
confidentiality; and (6) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
615,380 hours per year. The burden
estimates cited in tables 1, 2, and 3 of
this document are based on the number
of device tracking orders issued in the
last 3 years.
This regulation also refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by Office of
Management and Budget under the PRA
(44 U.S.C. 3501–3520). The collections
of information found in §§ 821.2(b),
821.25(e), and 821.30(e) have been
approved under OMB control number
0910–0183.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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Number of
responses per
respondent
Number of
respondents
Activity/21 CFR Part
Total
annual
responses
Average
burden per
response
Total hours
Discontinuation of business—821.1(d) ................................
Exemption or variance—821.2 and 821.30(e) .....................
Notification of failure to comply—821.25(d) ........................
Multiple distributor data—821.30(c)(2) ................................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
4
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR Part
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Tracking information—821.25(a) .........................................
Record of tracking data—821.25(b) ....................................
Standard operating procedures—821.25(c) 2 ......................
Manufacturer data audit—821.25(c)(3) ................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
12
12
12
12
1
46,260
1
1,124
12
555,120
12
13,488
76
1
63
1
912
555,120
756
13,488
22,000
1
22,000
1
22,000
Total ..............................................................................
........................
........................
........................
........................
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/21 CFR Part
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) .............................................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
Total ..............................................................................
........................
........................
........................
........................
23,100
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–09467 Filed 4–24–14; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Preparation for International
Cooperation on Cosmetics Regulation;
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA or we) is announcing a public
meeting entitled, ‘‘International
Cooperation on Cosmetics Regulation
(ICCR)—Preparation for ICCR–8
Meeting.’’ The purpose of the meeting is
to invite public input on various topics
pertaining to the regulation of
cosmetics. We may use this input to
help us prepare for the ICCR–8 meeting
that will be held in Canada from July 8
to 10, 2014.
Date and Time: The meeting will be
held on June 4, 2014, from 2 p.m. to 4
p.m.
Location: The meeting will be held at
the Food and Drug Administration,
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16:57 Apr 24, 2014
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Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Pkwy.,
Wiley Auditorium (first floor), College
Park, MD 20740.
Contact Person: If you intend to
participate in the meeting, you should
register with Maria Rossana (Rosemary)
Cook, Office of Cosmetics and Colors,
Food and Drug Administration, 4300
River Rd., College Park, MD 20740,
email: maria.cook@fda.hhs.gov or FAX:
301–436–2975.
Registration and Requests for Oral
Presentations: Send registration
information (including your name, title,
firm name, address, telephone number,
fax number, and email address), written
material, and requests to make an oral
presentation, to the contact person by
May 20, 2014.
If you need special accommodations
due to a disability, please contact Maria
Rossana (Rosemary) Cook (see Contact
Person) by May 28, 2014.
SUPPLEMENTARY INFORMATION: You may
present proposals for future ICCR
agenda items, data, information, or
views orally or in writing, on issues
pending at the public meeting. Time
allotted for oral presentations may be
limited to 10 minutes or less for each
presenter. If you wish to make an oral
presentation, you should notify the
contact person by May 20, 2014, and
submit a brief statement of the general
nature of the evidence or arguments that
you wish to present, your name,
address, telephone number, fax number,
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and email address, and indicate the
approximate amount of time you need
to make your presentation.
Transcripts: As soon as a transcript is
available, it will be accessible at
https://www.regulations.gov. It also may
be viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20850. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. You
should send written requests for a
hardcopy or CD–ROM transcript to the
Division of Freedom of Information,
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
The Purpose of the Multilateral
Framework on the ICCR: The purpose of
the multilateral framework on the ICCR
is to pave the way for the removal of
regulatory obstacles to international
trade while maintaining global
consumer protection.
ICCR is a voluntary international
group of cosmetics regulatory
authorities from the United States,
Japan, the European Union, and Canada.
These regulatory authority members
will enter into constructive dialogue
with their relevant cosmetics industry
trade associations and public advocacy
groups. Currently, the ICCR members
are: Health Canada; the European
Directorate General for Health and
Consumers; the Ministry of Health,
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]]>Agencies
[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22991-22993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09467]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0555]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking
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 information collection
requirements for the tracking of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by June 24, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of
[[Page 22992]]
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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.
Medical Devices; Device Tracking--21 CFR Part 821 (OMB Control Number
0910-0442)--Extension
Section 211 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) became effective on February 19, 1998. FDAMA
amended the previous medical device tracking provisions under section
519(e)(1) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360i(e)(1) and (e)(2)) that were added by the Safe
Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629). Unlike the
tracking provisions under SMDA, which required tracking of any medical
device meeting certain criteria, FDAMA allows FDA discretion in
applying tracking provisions to medical devices meeting certain
criteria and provides that tracking requirements for medical devices
can be imposed only after FDA issues an order. In the Federal Register
of February 8, 2002 (67 FR 5943), FDA issued a final rule that
conformed existing tracking regulations to changes in tracking
provisions effected by FDAMA under part 821 (21 CFR part 821).
Section 519(e)(1) of the FD&C Act, as amended by FDAMA, provides
that FDA may require by order that a manufacturer adopt a method for
tracking a class II or III medical device, if the device meets one of
the three following criteria: (1) The failure of the device would be
reasonably likely to have serious adverse health consequences, (2) the
device is intended to be implanted in the human body for more than 1
year (referred to as a ``tracked implant''), or (3) the device is life-
sustaining or life-supporting (referred to as a ``tracked l/s-l/s
device'') and is used outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary) use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; (4) records and inspection requirements; (5)
confidentiality; and (6) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 615,380 hours per year. The burden
estimates cited in tables 1, 2, and 3 of this document are based on the
number of device tracking orders issued in the last 3 years.
This regulation also refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by Office of Management and Budget under the PRA
(44 U.S.C. 3501-3520). The collections of information found in
Sec. Sec. 821.2(b), 821.25(e), and 821.30(e) have been approved under
OMB control number 0910-0183.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Discontinuation of business-- 1 1 1 1 1
821.1(d).......................
Exemption or variance--821.2 and 1 1 1 1 1
821.30(e)......................
Notification of failure to 1 1 1 1 1
comply--821.25(d)..............
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...................
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Total....................... .............. .............. .............. .............. 4
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 22993]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR Part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information--821.25(a). 12 1 12 76 912
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)......................
Standard operating procedures-- 12 1 12 63 756
821.25(c) \2\..................
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...................
Multiple distributor data and 22,000 1 22,000 1 22,000
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 592,276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Part Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked devices 22,000 1 22,000 1 22,000
and final distributor data--
821.30(a) and (b)..............
Multiple distributor data and 1,100 1 1,100 1 1,100
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 23,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09467 Filed 4-24-14; 8:45 am]
BILLING CODE P
