[Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices, 39105-39106 [2018-16983]
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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 314 for
submitting NDAs and abbreviated new
drug applications, including
supplemental applications and annual
reports, have been approved under OMB
control number 0910–0001. The
collections of information in 21 CFR
parts 211 and 212 (current good
manufacturing practices) have been
approved under OMB control numbers
0910–0139 and 0910–0667.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Reclassification Petitions for Medical
Devices
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0776]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
SUMMARY:
VerDate Sep<11>2014
22:37 Aug 07, 2018
Jkt 244001
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
[FR Doc. 2018–16984 Filed 8–7–18; 8:45 am]
ACTION:
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
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
7, 2018.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0138. Also
include the FDA docket number found
in brackets in the heading of this
document.
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 the
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 (§ 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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
39105
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 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.
In the Federal Register of March 07,
2018 (83 FR 9743), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received one
comment.
The comment supports continued use
of Forms FDA 3427 and FDA 3429.
Specifically, the commenter is
addressing the issue of discontinuing
the forms as previously referenced,
wherein FDA issued a proposed rule (79
FR 16252) to eliminate the need for the
forms. Because FDA is not
discontinuing use of the forms at this
time, and this comment relates to the
proposed rule (79 FR 16252) and not to
the information collection itself, we
make no changes to this information
collection based on the comment.
The Center for Devices and
Radiological Health (CDRH) has
continually maintained contact with
industry. Informal communications
concerning the importance and effect of
reclassification are provided primarily
through trade organizations, and via
CDRH’s website (https://www.fda.gov/
MedicalDevices/default.htm).
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\08AUN1.SGM
08AUN1
39106
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
form No.
Activity/21 CFR section
Supporting data for reclassification petition—21 CFR 860.123 .........................
Supplemental Data Sheet ........................
General Device Classification Questionnaire ......................................................
Total ..................................................
1 There
Number
of responses
per respondent
Number of
respondents
Total
annual
responses
Average
burden per
response
Total
hours
........................
3427
6
6
1
1
6
6
497
1.5
2,982
9
3429
6
1
6
1.5
9
........................
........................
........................
........................
........................
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
560, Rockville, MD 20852, (240) 276–
9567.
560, Rockville, MD 20852, (240) 276–
9567.
Correction
The meeting will be held on
September 21, 2018, from 9:00 a.m. to
12:30 p.m.
ADDRESSES: Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Room 800, Washington, DC 20201.
Correction
In the Federal Register of July 27,
2018, in FR Vol. 83 No. 145, on page
35662, in the second column, correct
the DATES and ADDRESSES captions to
read:
DATES: The meeting will be held on
September 21, 2018, from 9:00 a.m. to
12:30 p.m.
ADDRESSES: Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Room 800, Washington, DC 20201.
Dated: August 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Dated: August 1, 2018.
Holli M. Richmond,
Executive Director, Office of the President’s
Council on Sports, Fitness, and Nutrition,
U.S. Department of Health and Human
Services.
Dated: August 1, 2018.
Holli M. Richmond,
Executive Director, Office of the President’s
Council on Sports, Fitness, and Nutrition,
U.S. Department of Health and Human
Services.
[FR Doc. 2018–16983 Filed 8–7–18; 8:45 am]
[FR Doc. 2018–16970 Filed 8–7–18; 8:45 am]
[FR Doc. 2018–16969 Filed 8–7–18; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4150–35–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the President’s Council on
Sports, Fitness, and Nutrition;
Correction
Meeting of the President’s Council on
Sports, Fitness, and Nutrition;
Correction
National Institutes of Health
AGENCY:
Office of the Assistant
Secretary for Health, President’s Council
on Sports, Fitness, and Nutrition, Office
of the Secretary, Department of Health
and Human Services.
ACTION: Notice of meeting; correction.
AGENCY:
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health, President’s Council on Sports,
Fitness, and Nutrition.
ACTION: Notice of meeting; correction.
The Department of Health and
Human Services published a document
in the Federal Register of July 27, 2018,
concerning the upcoming annual
meeting of the President’s Council on
Sports, Fitness, and Nutrition (PCSFN).
The document contained an incorrect
location and time.
FOR FURTHER INFORMATION CONTACT: Ms.
Holli M. Richmond, Executive Director,
Office of the President’s Council on
Sports, Fitness, and Nutrition, Tower
Building, 1101 Wootton Parkway, Suite
SUMMARY:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Nursing Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
Based on reclassification petitions
received in the past 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.
The burden estimate for this
information collection has not changed
since the past OMB approval.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:37 Aug 07, 2018
Jkt 244001
In the Federal Register of July 27,
2018, in FR Vol. 83 No. 145, on page
35662, in the second column, correct
the DATES and ADDRESSES captions to
read:
DATES:
BILLING CODE 4150–35–P
The Department of Health and
Human Services published a document
in the Federal Register of July 27, 2018,
concerning the upcoming annual
meeting of the President’s Council on
Sports, Fitness, and Nutrition (PCSFN).
The document contained an incorrect
location and time.
FOR FURTHER INFORMATION CONTACT: Ms.
Holli M. Richmond, Executive Director,
Office of the President’s Council on
Sports, Fitness, and Nutrition, Tower
Building, 1101 Wootton Parkway, Suite
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
National Institute of Nursing Research;
Notice of Meeting
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39105-39106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16983]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0776]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 7, 2018.
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 emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0138.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
Reclassification Petitions for Medical Devices
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 the 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
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.
In the Federal Register of March 07, 2018 (83 FR 9743), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
The comment supports continued use of Forms FDA 3427 and FDA 3429.
Specifically, the commenter is addressing the issue of discontinuing
the forms as previously referenced, wherein FDA issued a proposed rule
(79 FR 16252) to eliminate the need for the forms. Because FDA is not
discontinuing use of the forms at this time, and this comment relates
to the proposed rule (79 FR 16252) and not to the information
collection itself, we make no changes to this information collection
based on the comment.
The Center for Devices and Radiological Health (CDRH) has
continually maintained contact with industry. Informal communications
concerning the importance and effect of reclassification are provided
primarily through trade organizations, and via CDRH's website (https://www.fda.gov/MedicalDevices/default.htm).
FDA estimates the burden of this collection of information as
follows:
[[Page 39106]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section FDA form No. Number of responses per Total annual burden per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting data for reclassification petition--21 CFR .............. 6 1 6 497 2,982
860.123................................................
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 past 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.
The burden estimate for this information collection has not changed
since the past OMB approval.
Dated: August 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16983 Filed 8-7-18; 8:45 am]
BILLING CODE 4164-01-P
