Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act, 30724-30725 [2011-13058]
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30724
Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
Additionally, the evaluation will
capture information to describe the
quality of the implementation of the
various mentor-coaching approaches
including consistency of the mentorcoach implementation with the planned
approach, the frequency and content of
interactions between the mentorcoaches and the teaching staff, and
apparent changes in teaching staff
behavior, including their own
professional development. The
evaluation will also capture information
about the characteristics of those who
provided coaching, the characteristics of
teaching staff that were mentored, as
well as the characteristics of the settings
and the systems in which the mentorcoaching was embedded. Lastly, the
evaluation will document the factors
that appear to be most critical to
successful implementation and
implementation challenges.
The data collection will include a
census survey of all grantees; a census
survey of all mentor-coaches; telephone
interviews with a sub-sample of
administrators, mentor-coaches, and
teaching staff; and a mentor-coach
activity snapshot.
Respondents: Grantee and center
administrative staff, mentor-coaches,
teaching staff.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Grantee Census Survey ................................................................................
Mentor-Coach Census Survey ......................................................................
Administrator Telephone Interview ................................................................
Mentor-Coach Telephone Interview ..............................................................
Teaching Staff Telephone Interview ..............................................................
Mentor-Coach Activity Snapshot ...................................................................
Estimated Total Annual Burden
Hours: 579.
Additional Information: In
compliance with the requirements of
Section 3506(C)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
VerDate Mar<15>2010
20:04 May 25, 2011
Jkt 223001
Number of
responses per
respondent
Average burden
hours per
response
1
1
1
1
1
2
0.5
0.5
1.0
1.0
1.0
0.25
131
400
85
65
130
65
Dated: May 17, 2011.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. 2011–12787 Filed 5–25–11; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0153]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry and Food and Drug
Administration Staff: Food and Drug
Administration and Industry
Procedures for Section 513(g)
Requests for Information Under the
Federal Food, Drug, and Cosmetic Act
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
(the PRA).
DATES: Fax written comments on the
collection of information by June 27,
2011.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
ADDRESSES:
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
Total annual
burden hours
66
200
85
65
130
33
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–NEW and
title ‘‘Draft Guidance for Industry and
FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests
for Information Under the Federal Food,
Drug, and Cosmetic Act.’’ 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.
Draft Guidance for Industry and FDA
Staff: FDA and Industry Procedures for
Section 513(g) Requests for Information
under the Federal Food, Drug, and
Cosmetic Act—(OMB Control Number
0910–NEW)
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from 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
E:\FR\FM\26MYN1.SGM
26MYN1
30725
Federal Register / Vol. 76, No. 102 / Thursday, May 26, 2011 / Notices
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
before submitting the collection to OMB
for approval. To comply with this
requirement, in the Federal Register of
April 29, 2010 (75 FR 22599), FDA
published a notice of availability of the
draft guidance document providing a
60-day public comment period on the
proposed collection of information
provisions.
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.
Title: Draft Guidance for Industry and
FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests
for Information Under the Federal Food,
Drug, and Cosmetic Act.
Description: Section 513(g) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360c(g))
provides a means for obtaining the
Agency’s views about the classification
and regulatory requirements that may be
applicable to your particular device.
Section 513(g) provides that within 60
days of the receipt of a written request
of any person for information respecting
the class in which a device has been
classified or the requirements applicable
to a device under the FD&C Act, the
Secretary of Health and Human Services
shall provide such person a written
statement of the classification (if any) of
such device and the requirements of the
FD&C Act applicable to the device.
Section 513(g) of the FD&C Act
provides a means for obtaining FDA’s
views about the classification and the
regulatory requirements that may be
applicable to a particular device. The
purpose of this draft guidance is to
establish procedures for submitting,
reviewing, and responding to requests
for information respecting the class in
which a device has been classified or
the requirements applicable to a device
under the FD&C Act that are submitted
in accordance with section 513(g) of the
FD&C Act. FDA does not review data
related to substantial equivalence or
safety and effectiveness in a 513(g)
request for information. FDA’s
responses to 513(g) requests for
information are not device classification
decisions and do not constitute FDA
clearance or approval for marketing.
Classification decisions and clearance or
approval for marketing require
submissions under different sections of
the FD&C Act. Additionally, the FD&C
Act, as amended by the FDA
Amendments Act of 2007 (Pub. L. 110–
85), requires FDA to collect user fees for
513(g) requests for information.
In the Federal Register of April 29,
2010, 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
Number of
respondents
FD&C Act 513(g)
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
responses
Total hours
Center for Devices and Radiological Health (CDRH) .........
Center for Biologics Evaluation and Research (CBER) ......
110
4
1
1
110
4
12
12
1,320
48
Total ..............................................................................
........................
........................
........................
........................
1,368
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
mstockstill on DSK4VPTVN1PROD with NOTICES
Respondents to this collection of
information are mostly device
manufacturers; however, anyone may
submit a 513(g) request for information.
The total number of annual responses is
based on the average number of 513(g)
requests received each year by the
Agency. FDA based its estimates on the
number of 513(g) requests for
information received by both CDRH and
CBER from 2007 to 2009.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0320]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Experimental
Study on Consumer Responses to
Whole Grain Labeling Statements on
Food Packages
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2011–13058 Filed 5–25–11; 8:45 am]
ACTION:
BILLING CODE 4160–01–P
SUMMARY:
VerDate Mar<15>2010
20:04 May 25, 2011
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
Jkt 223001
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a study entitled: ‘‘Experimental Study
on Consumer Responses to Whole Grain
Labeling Statements on Food Packages.’’
Submit either electronic or
written comments on the collection of
information by July 25, 2011.
DATES:
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
ADDRESSES:
E:\FR\FM\26MYN1.SGM
26MYN1
]]>Agencies
[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Notices]
[Pages 30724-30725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0153]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for
Industry and Food and Drug Administration Staff: Food and Drug
Administration and Industry Procedures for Section 513(g) Requests for
Information Under the Federal Food, Drug, and Cosmetic Act
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 (the PRA).
DATES: Fax written comments on the collection of information by June
27, 2011.
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-NEW and
title ``Draft Guidance for Industry and FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests for Information Under the
Federal Food, Drug, and Cosmetic Act.'' 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.
Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures
for Section 513(g) Requests for Information under the Federal Food,
Drug, and Cosmetic Act--(OMB Control Number 0910-NEW)
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain
approval from 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
[[Page 30725]]
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 before submitting the collection to OMB for approval. To
comply with this requirement, in the Federal Register of April 29, 2010
(75 FR 22599), FDA published a notice of availability of the draft
guidance document providing a 60-day public comment period on the
proposed collection of information provisions.
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.
Title: Draft Guidance for Industry and FDA Staff: FDA and Industry
Procedures for Section 513(g) Requests for Information Under the
Federal Food, Drug, and Cosmetic Act.
Description: Section 513(g) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining
the Agency's views about the classification and regulatory requirements
that may be applicable to your particular device. Section 513(g)
provides that within 60 days of the receipt of a written request of any
person for information respecting the class in which a device has been
classified or the requirements applicable to a device under the FD&C
Act, the Secretary of Health and Human Services shall provide such
person a written statement of the classification (if any) of such
device and the requirements of the FD&C Act applicable to the device.
Section 513(g) of the FD&C Act provides a means for obtaining FDA's
views about the classification and the regulatory requirements that may
be applicable to a particular device. The purpose of this draft
guidance is to establish procedures for submitting, reviewing, and
responding to requests for information respecting the class in which a
device has been classified or the requirements applicable to a device
under the FD&C Act that are submitted in accordance with section 513(g)
of the FD&C Act. FDA does not review data related to substantial
equivalence or safety and effectiveness in a 513(g) request for
information. FDA's responses to 513(g) requests for information are not
device classification decisions and do not constitute FDA clearance or
approval for marketing. Classification decisions and clearance or
approval for marketing require submissions under different sections of
the FD&C Act. Additionally, the FD&C Act, as amended by the FDA
Amendments Act of 2007 (Pub. L. 110-85), requires FDA to collect user
fees for 513(g) requests for information.
In the Federal Register of April 29, 2010, 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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
FD&C Act 513(g) respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Center for Devices and 110 1 110 12 1,320
Radiological Health (CDRH).....
Center for Biologics Evaluation 4 1 4 12 48
and Research (CBER)............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,368
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents to this collection of information are mostly device
manufacturers; however, anyone may submit a 513(g) request for
information. The total number of annual responses is based on the
average number of 513(g) requests received each year by the Agency. FDA
based its estimates on the number of 513(g) requests for information
received by both CDRH and CBER from 2007 to 2009.
Dated: May 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13058 Filed 5-25-11; 8:45 am]
BILLING CODE 4160-01-P
