Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 53822-53823 [2020-19092]
Download as PDF
<![CDATA[
53822
Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Principles for Selecting,
Developing, Modifying, and Adapting
Patient-Reported Outcome Instruments
for Use in Medical Device Evaluation.’’
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.
II. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by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 ‘‘Principles for
Selecting, Developing, Modifying, and
Adapting Patient-Reported Outcome
Instruments for Use in Medical Device
Evaluation’’ may send an email request
to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the
document. Please use the document
number 18042 to identify the guidance
you are requesting.
III. Paperwork Reduction Act of 1995
This draft guidance refers to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. 3501–3521). The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
814, subparts A through E ..........................................................
814, subpart H ............................................................................
812 ..............................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic
Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
800, 801, and 809 .......................................................................
Premarket notification ................................................................
Premarket approval ....................................................................
Humanitarian Device Exemption ...............................................
Investigational Device Exemption ..............................................
De Novo classification process ..................................................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Q-submissions ...........................................................................
0910–0756
Medical Device Labeling Regulations ........................................
0910–0485
Dated: August 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–N–3657; FDA–
2019–N–6085; FDA–2017–N–6381; FDA–
2017–N–0084; FDA–2013–N–0731; FDA–
2019–N–5971; FDA–2014–N–1021; and
FDA–2019–N–3018]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
SUMMARY:
[FR Doc. 2020–19094 Filed 8–28–20; 8:45 am]
AGENCY:
Notice.
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. 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.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
khammond on DSKJM1Z7X2PROD with NOTICES
Title of collection
Accreditation Scheme for Conformity Assessment Pilot Program ..........................................................................
General Administrative Practice and Procedures ...................................................................................................
Records and Reports Concerning Experience With Approved New Animal Drugs ...............................................
Adverse Event Program for Medical Devices (Medical Product Safety Network ...................................................
Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice ...................................................................
Recommendations to Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood
Components; Agency Guidance ..........................................................................................................................
Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods ............................................................
VerDate Sep<11>2014
19:30 Aug 28, 2020
Jkt 250001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\31AUN1.SGM
31AUN1
Date approval
expires
0910–0889
0910–0191
0910–0284
0910–0471
6/30/2023
7/31/2023
7/31/2023
7/31/2023
0910–0543
7/31/2023
0910–0681
0910–0817
7/31/2023
8/31/2023
53823
Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB control
number
Title of collection
Healthcare Provider Perception of Boxed Warning Information Survey .................................................................
Dated: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
[FR Doc. 2020–19092 Filed 8–28–20; 8:45 am]
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2019–E–2091 and FDA–2019–E–2092
For ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; POTELIGEO.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–2091 and FDA–
2019–E–2092]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; POTELIGEO
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for POTELIGEO and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by October 30, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 1, 2021. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 30,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of October 30, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:30 Aug 28, 2020
Jkt 250001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0890
8/31/2023
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday
240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53822-53823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19092]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2019-N-3657; FDA-2019-N-6085; FDA-2017-N-6381; FDA-
2017-N-0084; FDA-2013-N-0731; FDA-2019-N-5971; FDA-2014-N-1021; and
FDA-2019-N-3018]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. 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.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection number expires
------------------------------------------------------------------------
Accreditation Scheme for Conformity 0910-0889 6/30/2023
Assessment Pilot Program...............
General Administrative Practice and 0910-0191 7/31/2023
Procedures.............................
Records and Reports Concerning 0910-0284 7/31/2023
Experience With Approved New Animal
Drugs..................................
Adverse Event Program for Medical 0910-0471 7/31/2023
Devices (Medical Product Safety Network
Human Cells, Tissues, and Cellular and 0910-0543 7/31/2023
Tissue-Based Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice...................
Recommendations to Reduce the Risk of 0910-0681 7/31/2023
Transfusion-Transmitted of Infection in
Whole Blood and Blood Components;
Agency Guidance........................
Food Labeling; Gluten-Free Labeling of 0910-0817 8/31/2023
Fermented or Hydrolyzed Foods..........
[[Page 53823]]
Healthcare Provider Perception of Boxed 0910-0890 8/31/2023
Warning Information Survey.............
------------------------------------------------------------------------
Dated: August 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19092 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P
