Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices, 73938-73939 [E8-28695]
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73938
Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
Based on the submissions received,
FDA identified three other tiers of FCNs
that represent escalating levels of
burden required to collect information
(denoted as Categories C, D, and E in the
third, fourth, and fifth rows of table 1 of
this document). FDA estimated the
median number of hours necessary for
collecting information for each type of
notification within each of the three
tiers based on input from industry
sources. FDA estimates that five
respondents will submit two Category C
submissions annually, for a total of 10
responses. FDA estimates the reporting
burden to be 120 hours per response, for
a total burden of 1,200 hours. FDA
estimates that 33 respondents will
submit 2 Category D submissions
annually, for a total of 66 responses.
FDA estimates the reporting burden to
be 150 hours per response, for a total
burden of 9,900 hours. FDA estimates
that 30 respondents will submit 1
Category E submission annually, for a
total of 30 responses.
FDA estimates the reporting burden to
be 150 hours per response, for a total
burden of 4,500 hours.
FDA estimates that two respondents
will submit one indirect food additive
petition under § 171.1, for a total of two
responses. FDA estimates the reporting
burden to be 10,995 hours per response,
for a total burden of 21,990 hours.
FDA estimates that 10 respondents
will utilize the recommendations in the
guidance document entitled ‘‘Use of
Recycled Plastics in Food Packaging:
Chemistry Considerations,’’ to develop
the additional information for one such
submission annually, for a total of 10
responses. FDA estimates the reporting
burden to be 25 hours per response, for
a total burden of 250 hours.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28694 Filed 12–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on PROD1PC66 with NOTICES
[Docket No. FDA–2008–N–0607]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
17:35 Dec 03, 2008
Jkt 217001
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
reclassification petitions for medical
devices.
DATES: Submit written or electronic
comments on the collection of
information by February 2, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr.,Office Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
PO 00000
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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.
Reclassification Petitions for Medical
Devices—21 CFR Section 860.123 (OMB
Control Number 0910–0138)—Extension
FDA has responsibility under sections
513(e) and (f), 514(b), 515(b), and 520(l)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(e) and (f), 360d(b),
360e(b), and 360j(l)) and part 860 (21
CFR part 860), subpart C, to collect data
and information contained in
reclassification petitions. The
reclassification provisions of the act
allow any person to petition for
reclassification of a device from any one
of the three classes, i.e., I, II, and III, to
another class. The reclassification
content regulation (§ 860.123) requires
the submission of sufficient, valid
scientific evidence demonstrating that
the proposed reclassification will
provide a reasonable assurance of safety
and effectiveness of the device type for
its indications for use. Thus, the
reclassification provisions of the act
serve primarily as a vehicle for
manufacturers to seek reclassification
from a higher to a lower class, thereby
reducing the regulatory requirements
applicable to a particular device type or
to seek reclassification from a lower to
a higher class, thereby increasing the
regulatory requirements. The
reclassification petitions requesting
classification from class III to class II or
class I, if approved, provides an
alternative route to the market in lieu of
premarket approval for class III devices
or from class I or II to one or the other
class, which may increase requirements.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\04DEN1.SGM
04DEN1
73939
Federal Register / Vol. 73, No. 234 / Thursday, December 4, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
860.123
1There
6
Total Annual
Responses
1
Hours per
Response
6
Total Hours
500
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual
reclassification petitions received, FDA
anticipates that six petitions will be
submitted each year. The time required
to prepare and submit a reclassification
petition, including the time needed to
assemble supporting data, averages 500
hours per petition. This average is based
upon estimates by FDA administrative
and technical staff that are familiar with
the requirements for submission of a
reclassification petition, have consulted
and advised manufacturers on these
requirements, and have reviewed the
documentation submitted.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28695 Filed 12–3–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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 5,
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,
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 0910–0212. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Regulations Under the Federal Import
Milk Act—(OMB Control Number 0910–
0212—Extension)
[Docket No. FDA–2008–N–0453]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Regulations Under
the Federal Import Milk Act
AGENCY:
Annual Frequency
per Response
Food and Drug Administration,
HHS.
Under the Federal Import Milk Act
(FIMA) (21 U.S.C. 141–149), milk or
cream may be imported into the United
States only by the holder of a valid
import milk permit (21 U.S.C. 141).
Before such permit is issued: (1) All
cows from which import milk or cream
is produced must be physically
examined and found healthy; (2) if the
milk or cream is imported raw, all such
cows must pass a tuberculin test; (3) the
dairy farm and each plant in which the
milk or cream is processed or handled
must be inspected and found to meet
certain sanitary requirements; (4)
bacterial counts of the milk at the time
of importation must not exceed
specified limits; and (5) the temperature
of the milk or cream at time of
importation must not exceed 50° F (21
U.S.C. 142).
FDA’s regulations in part 1210 (21
CFR part 1210) implement the
provisions of FIMA. Sections 1210.11
and 1210.14 require reports on the
sanitary conditions of, respectively,
dairy farms and plants producing milk
and/or cream to be shipped to the
United States. Section 1210.12 requires
reports on the physical examination of
herds, while § 1210.13 requires the
reporting of tuberculin testing of the
herds. In addition, the regulations in
part 1210 require that dairy farmers and
plants maintain pasteurization records
(§ 1210.15) and that each container of
milk or cream imported into the United
States bear a tag with the product type,
permit number, and shipper’s name and
address (§ 1210.22). Section 1210.20
requires that an application for a permit
to ship or transport milk or cream into
the United States be made by the actual
shipper. Section 1210.23 allows permits
to be granted based on certificates from
accredited officials.
In the Federal Register of August 25,
2008 (73 FR 50031), 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
mstockstill on PROD1PC66 with NOTICES
21 CFR Section
No. of
Respondents
Form No.
Annual
Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
1210.11
FDA 1996/Sanitary inspection of
dairy farms
8
200
1,600
1.5
2,400
1210.12
FDA 1995/Physical examination of
cows
1
1
1
0.5
0.5
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17:35 Dec 03, 2008
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PO 00000
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E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73938-73939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28695]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0607]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reclassification Petitions for Medical Devices
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 reclassification petitions for
medical devices.
DATES: Submit written or electronic comments on the collection of
information by February 2, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr.,Office Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3793.
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.
Reclassification Petitions for Medical Devices--21 CFR Section 860.123
(OMB Control Number 0910-0138)--Extension
FDA has responsibility under sections 513(e) and (f), 514(b),
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and part 860 (21
CFR part 860), subpart C, to collect data and information contained in
reclassification petitions. The reclassification provisions of the act
allow any person to petition for reclassification of a device from any
one of the three classes, i.e., I, II, and III, to another class. The
reclassification content regulation (Sec. 860.123) requires the
submission of sufficient, valid scientific evidence demonstrating that
the proposed reclassification will provide a reasonable assurance of
safety and effectiveness of the device type for its indications for
use. Thus, the reclassification provisions of the act serve primarily
as a vehicle for manufacturers to seek reclassification from a higher
to a lower class, thereby reducing the regulatory requirements
applicable to a particular device type or to seek reclassification from
a lower to a higher class, thereby increasing the regulatory
requirements. The reclassification petitions requesting classification
from class III to class II or class I, if approved, provides an
alternative route to the market in lieu of premarket approval for class
III devices or from class I or II to one or the other class, which may
increase requirements.
FDA estimates the burden of this collection of information as
follows:
[[Page 73939]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.123 6 1 6 500 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the last 3 years, and actual reclassification petitions
received, FDA anticipates that six petitions will be submitted each
year. The time required to prepare and submit a reclassification
petition, including the time needed to assemble supporting data,
averages 500 hours per petition. This average is based upon estimates
by FDA administrative and technical staff that are familiar with the
requirements for submission of a reclassification petition, have
consulted and advised manufacturers on these requirements, and have
reviewed the documentation submitted.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28695 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S
