Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification, 48696-48697 [2010-19746]
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48696
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
firms 4 hours per review each quarter,
the total burden of this activity, for
firms that choose to review their plans
annually, is 2,320 (145 x 4 x 4) hours
per year. This annual burden is shown
in row 6 of table 1 of this document.
Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: ORR Requirements for Refugee
Cash Assistance; and Refugee Medical
Assistance (45 CFR Part 400).
OMB No.: 0970–0036.
Description: As required by section
412(e) of the Immigration and
Nationality Act, the Administration for
Children and Families (ACF), Office of
Refugee Resettlement (ORR), is
requesting the information from Form
ORR–6 to determine the effectiveness of
[FR Doc. 2010–19747 Filed 8–10–10; 8:45 am]
BILLING CODE 4160–01–S
the State cash and medical assistance,
child welfare, social services, and
targeted assistance programs. State-byState Refugee Cash Assistance (RCA)
and Refugee Medical Assistance (RMA)
utilization rates derived from Form
ORR–6 are calculated for use in
formulating program initiatives,
priorities, standards, budget requests,
and assistance policies. ORR regulations
require that State Refugee Resettlement
and Wilson-Fish agencies, and local and
Tribal governments complete Form
ORR–6 in order to participate in the
above-mentioned programs.
Respondents: State Refugee
Resettlement and Wilson-Fish Agencies,
local, and Tribal governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ORR–6 .............................................................................................................
sroberts on DSKD5P82C1PROD with NOTICES
Instrument
50
3
3.88
582
Estimated Total Annual Burden
Hours: 582.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project.
Fax: 202–395–7285.
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: August 5, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–19748 Filed 8–10–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0198]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 September
10, 2010.
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:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0120. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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.
Premarket Notification—(OMB Control
Number 0910–0120)—Extension
Section 510(k) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360(k)) and the implementing
regulation under part 807 (21 CFR part
807, subpart E) requires a person who
intends to market a medical device to
submit a premarket notification
submission to FDA at least 90 days
before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
equivalent to a legally marketed device,
as defined in § 807.92(a)(3). If the device
is determined to be not substantially
equivalent to a legally marketed device,
it must have an approved premarket
approval application (PMA), Product
Development Protocol, Humanitarian
Device Exemption (HDE), Petition for
Evaluation of Automatic Class III
Designation (de novo) or be reclassified
E:\FR\FM\11AUN1.SGM
11AUN1
Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices
into class I or class II before being
marketed. FDA makes the final decision
of whether a device is substantially
equivalent or not equivalent.
Section 807.81 states when a
premarket notification is required. A
premarket notification is required to be
submitted by a person who is:
• Introducing a device to the market
for the first time;
• Introducing a device into
commercial distribution for the first
time by a person who is required to
register; and
• Introducing or reintroducing a
device which is significantly changed or
modified in design, components,
method of manufacturer, or the
intended use that could affect the safety
and effectiveness of the device.
Section 807.87 specifies information
required in a premarket notification
submission.
Section 204 of the Food and Drug
Administration Modernization Act
(FDAMA) amended section 514 of the
act (21 U.S.C. 360d). Amended section
514 allows FDA to recognize consensus
standards developed by international
and national organizations for use in
satisfying portions of device premarket
review submissions including
premarket notifications or other
requirements. FDA has published and
updated the list of recognized standards
regularly since enactment of FDAMA
48697
available within 30 days of a request, all
information included in the submitted
premarket notification on safety and
effectiveness. This information will be
provided to any person within 30 days
of a request if the device described in
the 510(k) submission is determined to
be substantially equivalent. The
information provided will be a
duplicate of the 510(k) submission
including any safety and effectiveness
information, but excluding all patient
identifiers and trade secret and
commercial confidential information.
According to § 807.90, submitters may
request information on their 510(k)
review status 90 days after the initial
log-in date of the 510(k). Thereafter, the
submitter may request status reports
every 30 days following the initial status
request. To obtain a 510(k) status report,
the submitter should complete the
status request form, Form FDA 3541,
and fax it to the Center for Devices and
Radiological Health office identified on
the form. The most likely respondents to
this information collection will be
specification developers and medical
device manufacturers.
In the Federal Register of May 5, 2010
(75 FR 24708), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
and has allowed 510(k) submitters to
certify conformance to recognized
standards to meet the requirements of
§ 807.87. FDA Form FDA 3654, the
510(k) Standards Data Form,
standardizes the format for submitting
information on consensus standards that
a 510(k) submitter chooses to use as a
portion of their premarket notification
submission (The Form FDA 3654 is not
for declarations of conformance to a
recognized standard). FDA believes that
use of this form will simplify the 510(k)
preparation and review process for
510(k).
Form FDA 3514, a summary
coversheet form, assists respondents in
categorizing administrative 510(k)
information for submission to FDA. This
form also assists respondents in
categorizing information for other FDA
medical device programs such as PMAs,
investigational device exemptions, and
HDEs. Under § 807.87(h), each 510(k)
submitter must include in the 510(k)
either a summary of the information in
the 510(k) as required by § 807.92
(510(k) summary) or a statement
certifying that the submitter will make
available upon request the information
in the 510(k) with certain exceptions as
per § 807.93 (510(k) statement). If the
510(k) submitter includes a 510(k)
statement in the 510(k) submission,
§ 807.93 requires that the official
correspondent of the firm make
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
Form
Number
No. of
Respondents
807 subpart E
Annual Frequency
per Response
Total Annual
Responses
3,800
1
Hours per
Response
3,800
Total Hours
79
300,200
807.87
FDA Form 3514
1,956
1
1,956
807.90
(a)(3)
FDA Form 3541
218
1
218
807.87(d)
and (f)
FDA Form 3654
1,500
1
1,500
10
15,000
2,000
10
2,000
10
20,000
807.92 and
807.93
0.5
0.25
Total
sroberts on DSKD5P82C1PROD with NOTICES
1 There
978
55
336,233
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19746 Filed 8–10–10; 8:45 am]
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Agencies
[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48696-48697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19746]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0198]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification
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
September 10, 2010.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0120.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Premarket Notification--(OMB Control Number 0910-0120)--Extension
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) requires a person who intends to market a
medical device to submit a premarket notification submission to FDA at
least 90 days before proposing to begin the introduction, or delivery
for introduction into interstate commerce, for commercial distribution
of a device intended for human use. Based on the information provided
in the notification, FDA must determine whether the new device is
substantially equivalent to a legally marketed device, as defined in
Sec. 807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), Product Development Protocol,
Humanitarian Device Exemption (HDE), Petition for Evaluation of
Automatic Class III Designation (de novo) or be reclassified
[[Page 48697]]
into class I or class II before being marketed. FDA makes the final
decision of whether a device is substantially equivalent or not
equivalent.
Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
Introducing a device to the market for the first time;
Introducing a device into commercial distribution for the
first time by a person who is required to register; and
Introducing or reintroducing a device which is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device.
Section 807.87 specifies information required in a premarket
notification submission.
Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions including premarket
notifications or other requirements. FDA has published and updated the
list of recognized standards regularly since enactment of FDAMA and has
allowed 510(k) submitters to certify conformance to recognized
standards to meet the requirements of Sec. 807.87. FDA Form FDA 3654,
the 510(k) Standards Data Form, standardizes the format for submitting
information on consensus standards that a 510(k) submitter chooses to
use as a portion of their premarket notification submission (The Form
FDA 3654 is not for declarations of conformance to a recognized
standard). FDA believes that use of this form will simplify the 510(k)
preparation and review process for 510(k).
Form FDA 3514, a summary coversheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and HDEs. Under Sec. 807.87(h), each 510(k) submitter must
include in the 510(k) either a summary of the information in the 510(k)
as required by Sec. 807.92 (510(k) summary) or a statement certifying
that the submitter will make available upon request the information in
the 510(k) with certain exceptions as per Sec. 807.93 (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
510(k) submission, Sec. 807.93 requires that the official
correspondent of the firm make available within 30 days of a request,
all information included in the submitted premarket notification on
safety and effectiveness. This information will be provided to any
person within 30 days of a request if the device described in the
510(k) submission is determined to be substantially equivalent. The
information provided will be a duplicate of the 510(k) submission
including any safety and effectiveness information, but excluding all
patient identifiers and trade secret and commercial confidential
information. According to Sec. 807.90, submitters may request
information on their 510(k) review status 90 days after the initial
log-in date of the 510(k). Thereafter, the submitter may request status
reports every 30 days following the initial status request. To obtain a
510(k) status report, the submitter should complete the status request
form, Form FDA 3541, and fax it to the Center for Devices and
Radiological Health office identified on the form. The most likely
respondents to this information collection will be specification
developers and medical device manufacturers.
In the Federal Register of May 5, 2010 (75 FR 24708), FDA published
a 60-day notice requesting public comment on the proposed collection of
information. 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 Form Number Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807 subpart E .................. 3,800 1 3,800 79 300,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87 FDA Form 3514 1,956 1 1,956 0.5 978
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.90 (a)(3) FDA Form 3541 218 1 218 0.25 55
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87(d) and (f) FDA Form 3654 1,500 1 1,500 10 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.92 and 807.93 .................. 2,000 10 2,000 10 20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 336,233
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S