Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices, 70460-70461 [2011-29255]
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70460
Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
30-Day notice of submission of
information collection approval from
the Office of Management and Budget
and request for comments.
ACTION:
As part of a Federal
Government-wide effort to streamline
the process to seek feedback from the
public on service delivery, the
Administration for Children and
Families has submitted a Generic
Information Collection Request (Generic
ICR): ‘‘Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery’’ to OMB for
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.).
DATES: Comments must be submitted by
December 14, 2011.
ADDRESSES: Written comments may be
submitted 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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. Email address:
infocollection@acf.hhs.gov.
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SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The information collection
activity will garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
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generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: The
target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
The Agency received no comments in
response to the 60-day notice published
in the Federal Register of December 22,
2010 (75 FR 80542).
Below we provide the Administration
for Children and Families projected
average estimates for the next three
years:
Current Actions: New collection of
information.
Type of Review: New Collection.
Affected Public: Non-profit
organizations, Individuals and
Households, Businesses and
Organizations, State, Local or Tribal
Government.
Average Expected Annual Number of
activities: 5.
Respondents: 300.
Annual responses: 300.
Frequency of Response: Once per
request.
Average minutes per response: 30.
Burden hours: 150 hours.
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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
Office of Management and Budget
control number.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–29281 Filed 11–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0776]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
the information collection requirements
for reclassification petitions for medical
devices.
DATES: Submit either electronic or
written comments on the collection of
information by January 13, 2012.
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., PI50–
400B, 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
SUMMARY:
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Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices
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
Under sections 513(e) and (f), 514(b),
515(b), and 520(l) of the Federal Food,
Drug, and Cosmetic Act (FD&C 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, FDA has responsibility
to collect data and information
contained in reclassification petitions.
The reclassification provisions of the
FD&C Act allow any person to petition
for reclassification of a device from any
of the three classes, i.e., I, II, and III, to
another class. The reclassification
procedure regulation requires the
submission of specific data when a
manufacturer is petitioning for
reclassification. This includes a
‘‘Supplemental Data Sheet,’’ Form FDA
3427, and a ‘‘Classification
70461
Questionnaire,’’ Form FDA 3429. Both
forms contain a series of questions
concerning the safety and effectiveness
of the device type. Further, the
reclassification content regulation
(§ 860.123) requires the submission of
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 FD&C
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 applicable to
that device type. If approved, petitions
requesting classification from class III to
class II or class I provide an alternative
route to market in lieu of premarket
approval for class III devices. If
approved, petitions requesting
reclassification from class I or II, to a
different class, may increase
requirements.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of respondents
Number of responses per
respondent
Total annual
responses
Average
burden per 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.
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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 who: (1) Are familiar
with the requirements for submission of
a reclassification petition, (2) have
consulted and advised manufacturers on
these requirements, and (3) have
reviewed the documentation submitted.
Dated: November 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29255 Filed 11–10–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0015]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Orphan Drugs; Common European
Medicines Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product Designation
(Food and Drug Administration Form
3671)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Orphan Drugs; Common European
Medicines Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product Designation
SUMMARY:
PO 00000
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Fmt 4703
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(FDA Form 3671)’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On June
29, 2011, the Agency submitted a
proposed collection of information
entitled ‘‘Orphan Drugs; Common
European Medicines Agency/Food and
Drug Administration Application Form
for Orphan Medicinal Product
Designation (FDA Form 3671)’’ 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
E:\FR\FM\14NON1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70460-70461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29255]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0776]
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 the information collection
requirements for reclassification petitions for medical devices.
DATES: Submit either electronic or written comments on the collection
of information by January 13, 2012.
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.,
PI50-400B, 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
[[Page 70461]]
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
Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the
Federal Food, Drug, and Cosmetic Act (FD&C 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, FDA has responsibility to collect data and information
contained in reclassification petitions. The reclassification
provisions of the FD&C Act allow any person to petition for
reclassification of a device from any of the three classes, i.e., I,
II, and III, to another class. The reclassification procedure
regulation requires the submission of specific data when a manufacturer
is petitioning for reclassification. This includes a ``Supplemental
Data Sheet,'' Form FDA 3427, and a ``Classification Questionnaire,''
Form FDA 3429. Both forms contain a series of questions concerning the
safety and effectiveness of the device type. Further, the
reclassification content regulation (Sec. 860.123) requires the
submission of 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 FD&C 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 applicable
to that device type. If approved, petitions requesting classification
from class III to class II or class I provide an alternative route to
market in lieu of premarket approval for class III devices. If
approved, petitions requesting reclassification from class I or II, to
a different class, may increase requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 who: (1) Are familiar with
the requirements for submission of a reclassification petition, (2)
have consulted and advised manufacturers on these requirements, and (3)
have reviewed the documentation submitted.
Dated: November 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29255 Filed 11-10-11; 8:45 am]
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