80 FR 12642 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 46 (March 10, 2015)

Page Range		12642-12643
FR Document		2015-05506

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.

Federal Register, Volume 80 Issue 46 (Tuesday, March 10, 2015)

[Federal Register Volume 80, Number 46 (Tuesday, March 10, 2015)]
[Notices]
[Pages 12642-12643]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-05506]

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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.

-----------------------------------------------------------------------

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 May 11, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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

[[Page 12643]]

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 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.
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 ``General Device Classification Questionnaire,'' Form FDA
3429. Both forms contain a series of questions concerning the safety
and effectiveness of the device type.
In the Federal Register of March 25, 2014 (79 FR 16252), FDA issued
a proposed rule that would eliminate the need for Forms FDA 3427 and
FDA 3429. However, because the proposed rule has not been finalized, we
continue to include the forms in the burden estimate for this
information collection.
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 Average
Activity FDA Form Nos. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition........... .............. 6 1 6 497 2,982
Supplemental Data Sheet................................. 3427 6 1 6 1.5 9
General Device Classification Questionnaire............. 3429 6 1 6 1.5 9
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on reclassification petitions received in the last 3 years,
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.
This document refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 814, subparts A through E have been approved
under OMB control number 0910-0231.

Dated: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05506 Filed 3-9-15; 8:45 am]
BILLING CODE 4164-01-P

12642 Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices

DEPARTMENT OF HEALTH AND Room 5B01, Bethesda, MD 20892–9304, (301) Dated: March 4, 2015.
HUMAN SERVICES 435–6680, skandasa@mail.nih.gov. Michelle Trout,
(Catalogue of Federal Domestic Assistance Program Analyst, Office of Federal Advisory
National Institutes of Health Program Nos. 93.864, Population Research; Committee Policy.
93.865, Research for Mothers and Children; [FR Doc. 2015–05455 Filed 3–9–15; 8:45 am]
National Cancer Institute; Amended 93.929, Center for Medical Rehabilitation BILLING CODE 4140–01–P
Notice of Meeting Research; 93.209, Contraception and
Notice is hereby given of a change in Infertility Loan Repayment Program, National
the meeting of the National Cancer Institutes of Health, HHS imposed by the DEPARTMENT OF HEALTH AND
Institute Special Emphasis Panel, March review and funding cycle.) HUMAN SERVICES
24, 2015 01:00 p.m. to March 24, 2015, Dated: March 4, 2015.
05:00 p.m., National Cancer Institute Food and Drug Administration
Michelle Trout,
Shady Grove, 9609 Medical Center [Docket No. FDA–2011–N–0776]
Program Analyst, Office of Program Advisory
Drive, Rockville, MD, 20850 which was Committee Policy.
published in the Federal Register on Agency Information Collection
[FR Doc. 2015–05452 Filed 3–9–15; 8:45 am]
February 03, 2015, 80FR5767. Activities; Proposed Collection;
The meeting notice is amended to BILLING CODE 4140–01–P Comment Request; Reclassification
change the title from NCI/R01/U54 Petitions for Medical Devices
Review to NCI P01/R01/U54 Review.
DEPARTMENT OF HEALTH AND AGENCY: Food and Drug Administration,
The meeting is closed to the public.
HUMAN SERVICES HHS.
Dated: March 4, 2015. ACTION: Notice.
Melanie J. Gray, National Institutes of Health
Program Analyst, Office of Federal Advisory SUMMARY: The Food and Drug
Committee Policy. National Heart, Lung, and Blood Administration (FDA) is announcing an
[FR Doc. 2015–05456 Filed 3–9–15; 8:45 am] Institute: Notice of Closed Meeting opportunity for public comment on the
BILLING CODE 4140–01–P proposed collection of certain
Pursuant to section 10(d) of the information by the Agency. Under the
Federal Advisory Committee Act, as Paperwork Reduction Act of 1995 (the
DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is PRA), Federal Agencies are required to
HUMAN SERVICES hereby given of the following meeting. publish notice in the Federal Register
concerning each proposed collection of
National Institutes of Health The meeting will be closed to the information, including each proposed
public in accordance with the extension of an existing collection of
Eunice Kennedy Shriver National provisions set forth in section information, and to allow 60 days for
Institute of Child Health and Human 552b(c)(6), Title 5 U.S.C., as amended. public comment in response to the
Development; Notice of Closed The grant applications and the notice. This notice solicits comments on
Meeting discussions could disclose confidential the information collection requirements
Pursuant to section 10(d) of the trade secrets or commercial property for reclassification petitions for medical
Federal Advisory Committee Act, as such as patentable material, and devices.
amended (5 U.S.C. App.), notice is personal information concerning DATES: Submit either electronic or
hereby given of the following meeting. individuals associated with the grant written comments on the collection of
The meeting will be closed to the applications, the disclosure of which information by May 11, 2015.
public in accordance with the would constitute a clearly unwarranted ADDRESSES: Submit electronic
provisions set forth in sections invasion of personal privacy. comments on the collection of
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: National Heart, Lung, information to http://
as amended. The contract proposals and and Blood Institute Special Emphasis Panel; www.regulations.gov. Submit written
the discussions could disclose NHLBI CLTR SEP Review. comments on the collection of
confidential trade secrets or commercial Date: March 30, 2015. information to the Division of Dockets
property such as patentable material, Time: 10 a.m. to 1 p.m. Management (HFA–305), Food and Drug
and personal information concerning Agenda: To review and evaluate grant Administration, 5630 Fishers Lane, Rm.
individuals associated with the contract applications. 1061, Rockville, MD 20852. All
proposals, the disclosure of which Place: National Institutes of Health, 6701 comments should be identified with the
would constitute a clearly unwarranted Rockledge Drive, Room 7188, Bethesda, MD docket number found in brackets in the
invasion of personal privacy. 20892 (Telephone Conference Call). heading of this document.
Name of Committee: National Institute of Contact Person: Chang Sook Kim, Ph.D., FOR FURTHER INFORMATION CONTACT: FDA
Child Health and Human Development Scientific Review Officer, Office of Scientific PRA Staff, Office of Operations, Food
Special Emphasis Panel. Review/DERA National Heart, Lung, and and Drug Administration, 8455
Date: April 3, 2015. Blood Institute, 6701 Rockledge Drive, Room
Time: 9 a.m. to 5 p.m.
Colesville Rd., COLE–14526, Silver
7188, Bethesda, MD 20892–7924, 301–435– Spring, MD 20993–0002, PRAStaff@
Agenda: To review and evaluate contract 0287, carolko@mail.nih.gov. fda.hhs.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES

proposals.
Place: National Institutes of Health, 6100 (Catalogue of Federal Domestic Assistance
SUPPLEMENTARY INFORMATION: Under the
Executive Boulevard, Rockville, MD 20852, Program Nos. 93.233, National Center for
PRA (44 U.S.C. 3501–3520), Federal
(Telephone Conference Call). Sleep Disorders Research; 93.837, Heart and
Contact Person: Sathasiva B. Kandasamy,
Agencies must obtain approval from the
Vascular Diseases Research; 93.838, Lung
Ph.D., Scientific Review Administrator, Office of Management and Budget
Diseases Research; 93.839, Blood Diseases
Division of Scientific Review, National and Resources Research, National Institutes
(OMB) for each collection of
Institute of Child Health and Human of Health, HHS)
information they conduct or sponsor.
Development, 6100 Executive Boulevard, ‘‘Collection of information’’ is defined

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Federal Register / Vol. 80, No. 46 / Tuesday, March 10, 2015 / Notices 12643

in 44 U.S.C. 3502(3) and 5 CFR respondents, including through the use Form FDA 3427, and a ‘‘General Device
1320.3(c) and includes Agency requests of automated collection techniques, Classification Questionnaire,’’ Form
or requirements that members of the when appropriate, and other forms of FDA 3429. Both forms contain a series
public submit reports, keep records, or information technology. of questions concerning the safety and
provide information to a third party. effectiveness of the device type.
Reclassification Petitions for Medical
Section 3506(c)(2)(A) of the PRA (44 In the Federal Register of March 25,
Devices—21 CFR 860.123 (OMB Control
U.S.C. 3506(c)(2)(A)) requires Federal 2014 (79 FR 16252), FDA issued a
Number 0910–0138)—Extension
Agencies to provide a 60-day notice in proposed rule that would eliminate the
the Federal Register concerning each Under sections 513(e) and (f), 514(b), need for Forms FDA 3427 and FDA
proposed collection of information, 515(b), and 520(l) of the Federal Food, 3429. However, because the proposed
including each proposed extension of an Drug, and Cosmetic Act (FD&C Act) (21 rule has not been finalized, we continue
existing collection of information, U.S.C. 360c(e) and (f), 360d(b), 360e(b), to include the forms in the burden
before submitting the collection to OMB and 360j(l)) and part 860 (21 CFR part estimate for this information collection.
for approval. To comply with this 860), subpart C, FDA has responsibility The reclassification provisions of the
requirement, FDA is publishing notice to collect data and information FD&C Act serve primarily as a vehicle
of the proposed collection of contained in reclassification petitions. for manufacturers to seek
information set forth in this document. The reclassification provisions of the reclassification from a higher to a lower
With respect to the following FD&C Act allow any person to petition class, thereby reducing the regulatory
collection of information, FDA invites for reclassification of a device from any requirements applicable to a particular
comments on these topics: (1) Whether of the three classes, i.e., I, II, and III, to device type, or to seek reclassification
the proposed collection of information another class. The reclassification from a lower to a higher class, thereby
is necessary for the proper performance content regulation (§ 860.123) requires increasing the regulatory requirements
of FDA’s functions, including whether the submission of valid scientific applicable to that device type. If
the information will have practical evidence demonstrating that the approved, petitions requesting
utility; (2) the accuracy of FDA’s proposed reclassification will provide a classification from class III to class II or
estimate of the burden of the proposed reasonable assurance of safety and class I provide an alternative route to
collection of information, including the effectiveness of the device type for its market in lieu of premarket approval for
validity of the methodology and indications for use. class III devices. If approved, petitions
assumptions used; (3) ways to enhance The reclassification procedure requesting reclassification from class I
the quality, utility, and clarity of the regulation requires the submission of or II, to a different class, may increase
information to be collected; and (4) specific data when a manufacturer is requirements.
ways to minimize the burden of the petitioning for reclassification. This FDA estimates the burden of this
collection of information on includes a ‘‘Supplemental Data Sheet,’’ collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
FDA Form Number of Total annual
Activity responses per burden per Total hours
Nos. respondents responses
respondent response

Supporting data for reclassification peti-
tion ........................................................ ........................ 6 1 6 497 2,982
Supplemental Data Sheet ........................ 3427 6 1 6 1.5 9
General Device Classification Question-
naire ...................................................... 3429 6 1 6 1.5 9

Total .................................................. ........................ ........................ ........................ ........................ ........................ 3,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on reclassification petitions review by the Office of Management and DEPARTMENT OF HEALTH AND
received in the last 3 years, FDA Budget (OMB) under the Paperwork HUMAN SERVICES
anticipates that six petitions will be Reduction Act of 1995 (44 U.S.C. 3501–
submitted each year. The time required 3520). The collections of information in National Institutes of Health
to prepare and submit a reclassification 21 CFR part 807, subpart E have been
petition, including the time needed to National Institute on Aging; Notice of
approved under OMB control number
assemble supporting data, averages 500 Closed Meeting
0910–0120 and the collections of
hours per petition. This average is based information in 21 CFR part 814, Pursuant to section 10(d) of the
upon estimates by FDA administrative subparts A through E have been Federal Advisory Committee Act, as
and technical staff who: (1) Are familiar approved under OMB control number amended (5 U.S.C. App.), notice is
with the requirements for submission of 0910–0231. hereby given of the following meeting.
a reclassification petition, (2) have
mstockstill on DSK4VPTVN1PROD with NOTICES

Dated: March 4, 2015. The meeting will be closed to the
consulted and advised manufacturers on public in accordance with the
these requirements, and (3) have Leslie Kux,
provisions set forth in sections
reviewed the documentation submitted. Associate Commissioner for Policy.
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
This document refers to previously [FR Doc. 2015–05506 Filed 3–9–15; 8:45 am]
as amended. The grant applications and
approved collections of information BILLING CODE 4164–01–P the discussions could disclose
found in FDA regulations. These confidential trade secrets or commercial
collections of information are subject to property such as patentable material,

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Document Created: 2018-02-21 09:34:57
Document Modified: 2018-02-21 09:34:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 11, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 12642

80 FR 12642 - Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 46 (March 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration