Agency Information Collection Activities; Proposed Collection; Public Comment Request, 48359-48360 [2019-19857]
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48359
Federal Register / Vol. 84, No. 178 / Friday, September 13, 2019 / Notices
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
On March 20, 1998, FDA issued the
guidance document, ‘‘The New 510(k)
Paradigm: Alternate Approaches to
Demonstrating Substantial Equivalence
in Premarket Notifications,’’ which
established the Special 510(k) Program.
By establishing the Special 510(k)
Program, FDA sought to create an
efficient review process for certain
changes subject to 510(k) submission
requirements by leveraging design
control requirements. The Special
510(k) Program allows manufacturers
that are intending to change their own
legally marketed device to utilize risk
analysis and verification and validation
activities to facilitate submission,
review, and clearance of the change.
While FDA intends to review Special
510(k)s within 30 days, the Special
510(k) Program does not alter any
statutory or regulatory requirements
related to the 510(k) process under
sections 510 and 513 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360 and 360c) and 21 CFR part 807,
subpart E.
To improve the efficiency of 510(k)
review, FDA has updated the Special
510(k) Program to both clarify existing
policy and the types of changes
appropriate for the program. This
guidance explains the factors FDA uses
when considering whether a 510(k) is
appropriate for review as a Special
510(k). In general, a change to an
existing device may be appropriate for
a Special 510(k) when: (1) The proposed
change is submitted by the
manufacturer legally authorized to
market the existing device; (2)
performance data are unnecessary, or if
performance data are necessary, wellestablished methods are available to
evaluate the change; and (3) all
performance data necessary to support
substantial equivalence can be reviewed
in a summary or risk analysis format.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of September 28,
2018 (83 FR 49097). FDA revised the
guidance as appropriate in response to
the comments. This document
supersedes the Special 510(k) content in
‘‘The New 510(k) Paradigm: Alternate
Approaches to Demonstrating
Substantial Equivalence in Premarket
Notifications,’’ issued on March 20,
1998.
III. Electronic Access
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘The Special 510(k)
Program.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. 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.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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 the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..........................................................................
801 ............................................................................................
820 ............................................................................................
Premarket Notification ..............................................................
Medical Device Labeling Regulations ......................................
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Q-submissions ..........................................................................
‘‘Requests for Feedback and Meetings for Medical Device
Submissions: The Q Submission Program and Meetings
with Food and Drug Administration Staff’’.
Dated: September 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Persons unable to download
an electronic copy of ‘‘The Special
510(k) Program’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 18008 and complete title of the
guidance in the request to identify the
guidance you are requesting.
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
ACTION:
Office of the Secretary, HHS.
Notice.
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Comments on the ICR must be
received on or before November 12,
2019.
DATES:
[Document Identifier: OS–0990–XXXX]
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services (HHS), is
publishing the following summary of a
proposed collection for public
comment.
SUMMARY:
Submit your comments to
Sherette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
ADDRESSES:
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OMB control No.
0910–0120
0910–0485
0910–0073
0910–0756
requesting information, please include
the document identifier 0990–New–60D
and project title for reference to
Sherrette.funn@hhs.gov, or call the
Reports Clearance Officer.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 84, No. 178 / Friday, September 13, 2019 / Notices
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
0990–XXXX—Subpart C Research
Certification Form.
Abstract: Assistant Secretary for
Health, Office for Human Research
Protections is requesting a new
information collection, on the Subpart C
Research Certification Form. The
purpose of the IRB Registration Form is
to provide a simplified, standardized
procedure for institutions to submit
subpart C research certifications to
OHRP in order to obtain authorization
to include prisoners in human subjects
research as required in 45 CFR
46.305(c).
Likely Respondents: Institutions or
Organizations operating IRBs that have
enrolled or are planning to enroll
prisoners in human subject research
conducted or supported by HHS.
ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
Number of
respondents
Form name
Total burden
hours
Subpart C Certification Form .......................................................................................................
80
1
80
Total ......................................................................................................................................
........................
........................
80
Terry Clark,
Office of the Secretary, Asst Paperwork
Reduction Act Reports Clearance Officer.
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from:
COMMANDANT (CG–612), ATTN:
PAPERWORK REDUCTION ACT
MANAGER, U.S. COAST GUARD, 2703
MARTIN LUTHER KING JR. AVE. SE,
STOP 7710, WASHINGTON, DC 20593–
7710.
FOR FURTHER INFORMATION CONTACT: Mr.
Anthony Smith, Office of Information
Management, telephone 202–475–3532,
or fax 202–372–8405, for questions on
these documents.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–19857 Filed 9–12–19; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2019–0748]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0028
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0028, Course Approval and
Records for Merchant Marine Training
Schools; without change. Our ICR
describes the information we seek to
collect from the public. Before
submitting this ICR to OIRA, the Coast
Guard is inviting comments as
described below.
DATES: Comments must reach the Coast
Guard on or before November 12, 2019.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2019–0748] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
SUMMARY:
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Average
burden per
response
(in hours)
VerDate Sep<11>2014
17:09 Sep 12, 2019
Jkt 247001
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. chapter 35, as amended. An
ICR is an application to OIRA seeking
the approval, extension, or renewal of a
Coast Guard collection of information
(Collection). The ICR contains
information describing the Collection’s
purpose, the Collection’s likely burden
on the affected public, an explanation of
the necessity of the Collection, and
other important information describing
the Collection. There is one ICR for each
Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) The practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
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the Collection on respondents,
including the use of automated
collection techniques or other forms of
information technology. Consistent with
the requirements of Executive Order
13771, Reducing Regulation and
Controlling Regulatory Costs, and
Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast
Guard is also requesting comments on
the extent to which this request for
information could be modified to reduce
the burden on respondents.
In response to your comments, we
may revise the this ICR or decide not to
seek an extension of approval for the
Collection. We will consider all
comments and material received during
the comment period.
We encourage you to respond to this
request by submitting comments and
related materials. Comments must
contain the OMB Control Number of the
ICR and the docket number of this
request, [USCG–2019–0748], and must
be received by November 12, 2019.
Submitting Comments
We encourage you to submit
comments through the Federal
eRulemaking Portal at https://
www.regulations.gov. If your material
cannot be submitted using https://
www.regulations.gov, contact the person
in the FOR FURTHER INFORMATION
CONTACT section of this document for
alternate instructions. Documents
mentioned in this notice, and all public
comments, are in our online docket at
https://www.regulations.gov and can be
viewed by following that website’s
instructions. Additionally, if you go to
the online docket and sign up for email
alerts, you will be notified when
comments are posted.
We accept anonymous comments. All
comments received will be posted
without change to https://
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[Federal Register Volume 84, Number 178 (Friday, September 13, 2019)]
[Notices]
[Pages 48359-48360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-XXXX]
Agency Information Collection Activities; Proposed Collection;
Public Comment Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services (HHS), is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before November 12,
2019.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 795-7714.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-New-60D and
project title for reference to [email protected], or call the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and
[[Page 48360]]
(4) the use of automated collection techniques or other forms of
information technology to minimize the information collection burden.
Information Collection Request Title: 0990-XXXX--Subpart C Research
Certification Form.
Abstract: Assistant Secretary for Health, Office for Human Research
Protections is requesting a new information collection, on the Subpart
C Research Certification Form. The purpose of the IRB Registration Form
is to provide a simplified, standardized procedure for institutions to
submit subpart C research certifications to OHRP in order to obtain
authorization to include prisoners in human subjects research as
required in 45 CFR 46.305(c).
Likely Respondents: Institutions or Organizations operating IRBs
that have enrolled or are planning to enroll prisoners in human subject
research conducted or supported by HHS.
Estimate Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
Average burden
Form name Number of per response Total burden
respondents (in hours) hours
----------------------------------------------------------------------------------------------------------------
Subpart C Certification Form.................................... 80 1 80
----------------------------------------------------------------------------------------------------------------
Total....................................................... .............. .............. 80
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Asst Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2019-19857 Filed 9-12-19; 8:45 am]
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