Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act, 57801-57802 [2010-23633]
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57801
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
about both risks and benefits, and no
additional information) in three
different promotional offers (money
back guarantee and two others) in a
medium prevalence medical condition
(defined previously). This supplemental
study will be conducted online. One
type of offer examined will be money
back guarantee; we will choose the other
two types of promotional offers based
on the results of the main study. The
exact wording of the qualifying context
to be examined will be determined
through pretesting. This study is
experimental in method: Participants
will be randomly assigned to condition.
Supplementary Study Design
Type of Offer
Type of Context
(examples)
Money Back
Guarantee
Offer 2
To be determined
Offer 3
To be determined
Additional information about risk
Additional information about efficacy
Additional information about efficacy and risk
Control: No Context
Interviews are expected to last no
more than 20 minutes. A total of 10,000
participants will be involved in the
pretesting and two phases of the study.
This will be a one time (rather than
annual) collection of information.
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
Pretests
1,000
1
1,000
.33
330
Main study: online
3,750
1
3,750
.33
1,238
Main study: mall intercept
2,250
1
2,250
.33
743
Supplementary study
3,000
1
3,000
.33
990
Total
10,000
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23632 Filed 9–21–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0447]
emcdonald on DSK2BSOYB1PROD with NOTICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices
Third-Party Review Under the Food
and Drug Administration
Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
3,301
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
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18:32 Sep 21, 2010
Jkt 220001
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 information collection in ‘‘Medical
Devices Third-Party Review under the
Food and Drug Administration
Modernization Act of 1997.’’
DATES: Submit either electronic or
written comments on the collection of
information by November 22, 2010.
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
PO 00000
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comments should be identified with the
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.,
Rockville, MD 20850, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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22SEN1
57802
Federal Register / Vol. 75, No. 183 / Wednesday, September 22, 2010 / Notices
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 Third-Party Review
Under the Food and Drug
Administration Modernization Act—
Section 523 of the Federal Food, Drug,
and Cosmetic Act (OMB Control
Number 0910–0375)—Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360m), directing
FDA to accredit persons in the private
sector to review certain premarket
notifications [510(k)s]. Participation in
this third-party review program by
accredited persons is entirely voluntary.
A third party wishing to participate will
submit a request for accreditation to
FDA. Accredited third-party reviewers
have the ability to review a
manufacturer’s 510(k) of the act (21
U.S.C. 360) submission for selected
devices. After reviewing a submission,
the reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Section 523 of the Act
Annual Frequency
per Response
Requests for Accreditation
Total Annual
Respondents
Hours per
Response
Total Hours
1
1
24
24
10
510(k) reviews conducted by accredited third parties
1
26
260
40
10,400
Totals
10,424
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Section 523 of the Act
No. of
Recordkeepers
510(k) reviews
1 There
10
Total Annual
Records
26
Hours per
Record
260
Total Hours
10
2,600
are no capital costs or operating and maintenance costs associated with this collection of information.
I. Reporting
510(k) reviews conducted by accredited
third parties
According to FDA’s data in 2009, the
agency has experienced that the number
of 510(k)’s submitted for third-party
review is approximately 260 annually,
which is 26 annual reviews per each of
the 10 accredited reviewers.
emcdonald on DSK2BSOYB1PROD with NOTICES
Annual Frequency
per Recordkeeping
II. Recordkeeping
Third party reviewers are required to
keep records of their review of each
submission. According to FDA’s in
2009, the agency anticipates
approximately 260 submissions of
510(k)’s for third-party review per year.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–23633 Filed 9–21–10; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Income Withholding for
Support (IWO).
OMB No.: 0970–0154.
Description
Use of the OMB-approved Income
Withholding for Support form falls
under the authority of section 466 of the
Act, 42 U.S.C. 666. Section
466(b)(6)(A)(ii) of the Act requires that
the notice given to the employer for
income withholding in IV–D cases shall
be in a standard format prescribed by
the Secretary, and contain only such
information as may be necessary for the
PO 00000
Frm 00067
Fmt 4703
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employer to comply with the
withholding order for all IV–D cases.
Section 466(a)(8)(B)(iii) of the Act
requires that section 466(b)(6)(A)(ii) of
the Act be applicable also to non-IV–D
income withholding orders. These
provisions clearly require all
individuals and entities to use a form
developed by the Secretary of HHS to
notify employers of the income
withholding order for child support in
all IV–D and non-IV–D cases.
OCSE requires States’ automated
systems to be able to automatically
generate and download data to the OMB
approved income withholding form. If
child support orders are established by
the child support agency, necessary
information is already contained within
the automated system for downloading
into income withholding orders. If a
court or other tribunal has issued a
child support order, then agency staff
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]]>Agencies
[Federal Register Volume 75, Number 183 (Wednesday, September 22, 2010)]
[Notices]
[Pages 57801-57802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23633]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0447]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices Third-Party Review Under the Food and
Drug Administration Modernization Act
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 information collection in ``Medical Devices Third-
Party Review under the Food and Drug Administration Modernization Act
of 1997.''
DATES: Submit either electronic or written comments on the collection
of information by November 22, 2010.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@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
[[Page 57802]]
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 Third-Party Review Under the Food and Drug
Administration Modernization Act--Section 523 of the Federal Food,
Drug, and Cosmetic Act (OMB Control Number 0910-0375)--Extension
Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in
the private sector to review certain premarket notifications [510(k)s].
Participation in this third-party review program by accredited persons
is entirely voluntary. A third party wishing to participate will submit
a request for accreditation to FDA. Accredited third-party reviewers
have the ability to review a manufacturer's 510(k) of the act (21
U.S.C. 360) submission for selected devices. After reviewing a
submission, the reviewer will forward a copy of the 510(k) submission,
along with the reviewer's documented review and recommendation to FDA.
Third-party reviewers should maintain records of their 510(k) reviews
and a copy of the 510(k) for a reasonable period of time, usually a
period of 3 years.
This information collection will allow FDA to continue to implement
the accredited person review program established by FDAMA and improve
the efficiency of 510(k) review for low- to moderate-risk devices.
Respondents to this information collection are businesses or other
for-profit organizations.
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
Section 523 of the Act Respondents per Response Respondents Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Accreditation 1 1 1 24 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews conducted by accredited third parties 10 26 260 40 10,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals 10,424
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Section 523 of the Act Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews 10 26 260 10 2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
I. Reporting
510(k) reviews conducted by accredited third parties
According to FDA's data in 2009, the agency has experienced that
the number of 510(k)'s submitted for third-party review is
approximately 260 annually, which is 26 annual reviews per each of the
10 accredited reviewers.
II. Recordkeeping
Third party reviewers are required to keep records of their review
of each submission. According to FDA's in 2009, the agency anticipates
approximately 260 submissions of 510(k)'s for third-party review per
year.
Dated: September 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23633 Filed 9-21-10; 8:45 am]
BILLING CODE 4160-01-S
