Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices, 54392-54393 [05-18221]
Download as PDF
<![CDATA[
54392
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0554]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Irradiation in the Production,
Processing, and Handling of Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Irradiation in the Production,
Processing, and Handling of Food’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
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 the
Federal Register of March 29, 2005 (70
FR 15863), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0549. The
approval expires on June 30, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18165 Filed 9–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0350]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<18>2005
16:17 Sep 13, 2005
Jkt 205001
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 November 14, 2005.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 860.123 (OMB Control
Number 0910–0138)—Extension
FDA has the responsibility under
sections 513(e), 513(f), 514(b), 515(b),
and 520(l) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
360c(e), 360c(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, II, and III) to
another class. The reclassification
content regulation (§ 860.123) requires
the submission of sufficient, valid
scientific evidence demonstrating that
the proposed classification will provide
a reasonable assurance of safety and
effectiveness of the device for its
intended use. 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. The reclassification petitions
requesting classification from class III to
class II or class I, if approved, provide
an alternative route to the market in lieu
of premarket approval for class III
devices.
Respondents are device
manufacturers seeking reclassification.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\14SEN1.SGM
14SEN1
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices
54393
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
860.123
1There
6
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 current trends 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.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18221 Filed 9–13–05; 8:45 am]
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket No. 2004D–0251]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Requests for Inspection by an
Accredited Person Under the
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
Notice.
16:17 Sep 13, 2005
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0186]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Requests for Inspection by an
Accredited Person Under the Inspection
by Accredited Persons Program’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management
Programs (HFA–250), Food and Drug
VerDate Aug<18>2005
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1223.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 7, 2005 (70 FR
33179), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0569. The
approval expires on August 31, 2008. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18222 Filed 9–13–05; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total Annual
Responses
Jkt 205001
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 October 14,
2005.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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 written
comments be faxed to the Office of
Information and 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.
ADDRESSES:
State Enforcement Notifications—21
CFR 100.2(d) (OMB Control Number
0910–0275)—Extension
Section 310(b) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 337(b)) authorizes States to
enforce certain sections of the act in
their own names, but provides that
States must notify FDA before doing so.
Section 100.2(d) (21 CFR 100.2(d)) sets
forth the information that a State must
provide to FDA in a letter of notification
when it intends to take enforcement
action under the act against a particular
food located in the State. The
information required under § 100.2(d)
will enable FDA to identify the food
against which the State intends to take
action and advise the State whether
Federal action has been taken against it.
With certain narrow exceptions, Federal
enforcement action precludes State
action under the act.
In the Federal Register of June 20,
2005 (70 FR 35446), FDA published a
60-day notice requesting public
comment on the information collection
provisions. FDA received no comments.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\14SEN1.SGM
14SEN1
]]>Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Notices]
[Pages 54392-54393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18221]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0350]
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 November 14, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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 860.123 (OMB
Control Number 0910-0138)--Extension
FDA has the responsibility under sections 513(e), 513(f), 514(b),
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360c(e), 360c(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, 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 classification will provide a
reasonable assurance of safety and effectiveness of the device for its
intended use. 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. The reclassification petitions
requesting classification from class III to class II or class I, if
approved, provide an alternative route to the market in lieu of
premarket approval for class III devices.
Respondents are device manufacturers seeking reclassification.
FDA estimates the burden of this collection of information as
follows:
[[Page 54393]]
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 current trends 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.
Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18221 Filed 9-13-05; 8:45 am]
BILLING CODE 4160-01-S
