Agency Information Collection Request; 60-Day Public Comment Request, 14491-14492 [2020-05023]
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Federal Register / Vol. 85, No. 49 / Thursday, March 12, 2020 / Notices
guidance as appropriate in response to
the comments. This guidance
supersedes ‘‘Implementation of Third
Party Programs Under the FDA
Modernization Act of 1997; Final
Guidance for Staff, Industry, and Third
Parties’’ issued on February 2, 2001, and
‘‘Guidance for Third Parties and FDA
Staff; Third Party Review of Premarket
Notifications’’ issued on September 28,
2004.
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 510(k) Third
Party Review 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.
III. Electronic Access
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. Persons
unable to download an electronic copy
of ‘‘510(k) Third Party Review Program’’
may send an email request to CDRH-
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. 3501–3521). The collections
of information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
Topic
807 ................................................................................................................................
Medical Devices: Third-Party Review
under FDAMA.
Premarket notification ...............................
CDRH Appeals Process ...........................
Q-submissions ..........................................
Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05080 Filed 3–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0419]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before May 11, 2020.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 795–7714.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0419 60D,
and project title for reference, to
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Guidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 17–028 to
identify the guidance you are
requesting.
21 CFR part or guidance
807, subpart E ..............................................................................................................
‘‘Center for Devices and Radiological Health (CDRH) Appeals Processes’’ ..............
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
VerDate Sep<11>2014
16:31 Mar 11, 2020
Jkt 250001
Sherrette Funn, the Reports Clearance
Officer, Sherrette.funn@hhs.gov, or call
202–795–7714.
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
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Acquisition
Regulation Clause Patent Rights and
Rights and Data.
Type of Collection: Extension.
OMB No. 0990–0419.
Abstract: The Department of Health
and Human Services; Office of the
Assistant Secretary for Financial
Resources and Office of Grants and
Acquisition Policy and Accountability,
Division of Acquisition is requesting an
approval by OMB for an extension of a
previously approved information
collection request, Acquisition
Regulation Clause Patent rights and
Rights in Data. HHS found that
systematically, over a period of several
PO 00000
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Fmt 4703
Sfmt 4703
14491
OMB control
No.
0910–0375
0910–0120
0910–0738
0910–0756
years, when Determination of
Exceptional Circumstances(DEC) were
executed, additional legal protection for
the patent and data rights of third
parties beyond those covered by FAR
27.306 were necessary A DEC is
executed consistent with the policy and
objectives of the Bayh-Dole Act, 35
U.S.C. 200, et seq., to ensure that subject
inventions made under contracts and
subcontracts (at all tiers) are used in a
manner to promote free competition and
enterprise without unduly encumbering
future research and discovery; to
encourage maximum participation of
small business firms in federally
supported research and development
efforts; to promote collaboration
between commercial concerns and
nonprofit organizations including
universities; to ensure that the
Government obtains sufficient rights in
federally supported inventions to meet
its needs; to protect the public against
nonuse or unreasonable use of
inventions; and in the case of fulfilling
the mission of the U.S. Department of
Health and Human Services, to
ultimately to benefit the public health.
Likely Respondents: Administrative,
technical, legal and management
personnel.
E:\FR\FM\12MRN1.SGM
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14492
Federal Register / Vol. 85, No. 49 / Thursday, March 12, 2020 / Notices
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Type of respondent and hours for each
Technical (4), Legal (2), Management (2) .......................................................
Technical (8), Legal (2), Management (2) .......................................................
Technical (8), Legal (3), Management (1) .......................................................
Technical (8), Legal (4), Management (2) .......................................................
Technical (6), Legal (2), Management (2) .......................................................
Technical (4), Legal (2), Management (2) .......................................................
Administrative (8) .............................................................................................
Administrative (2), Management (1) ................................................................
Technical (4), Legal (2), Management (2) .......................................................
Dated: March 6, 2020.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2020–05023 Filed 3–11–20; 8:45 am]
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute on
Aging Special Emphasis Panel, March
20, 2020, 8:00 a.m. to 6:00 p.m., Hyatt
Regency, Bethesda, Conference Room
Cabinet Suite, One Bethesda Metro
Center, 7400 Wisconsin Avenue,
Bethesda, MD 20814 which was
published in the Federal Register on
January 15, 2020, 85 FR 2431.
The meeting notice is amended to
change the Meeting Format from
Regular Meeting on March 20, 2020 to
a Teleconference Meeting on March 20,
2020. The meeting is closed to the
public.
Dated: March 6, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05039 Filed 3–11–20; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Sep<11>2014
16:31 Mar 11, 2020
Jkt 250001
1
1
3
3
1
1
3
3
3
8
12
12
14
10
8
8
3
8
504
756
2,268
2,646
630
504
1,512
567
1,512
........................
........................
........................
10,899
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neuropharmacology.
Date: April 2, 2020.
Time: 12:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Telephone Conference Call).
Contact Person: Richard D. Crosland,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4190,
MSC 7850, Bethesda, MD 20892, 301–694–
7084, crosland@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: AIDS and Related Research.
Date: April 3, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: Barna Dey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
Bethesda, MD 20892, 301–451–2796 bdey@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Endocrinology, Metabolism,
Nutrition and Reproductive Science.
Date: April 3, 2020.
Time: 10:30 a.m. to 5:00 p.m.
Frm 00041
Fmt 4703
Total
burden hours
63
63
63
63
63
63
63
63
63
amended, notice is hereby given of the
following meetings.
The meetings 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
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Average
burden per
response
(hours)
Number of
responses per
respondent
Sfmt 4703
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: Antonello Pileggi, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6166,
Bethesda, MD 20892, (301) 402–6297,
pileggia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Biobehavioral Applications in
Substance Abuse and Pain Management.
Date: April 3, 2020.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Telephone Conference Call).
Contact Person: Andrea B. Kelly, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7770, Bethesda, MD 20892, (301) 455–
1761, kellya2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–18–
669: SPF Macaque Colonies.
Date: April 3, 2020.
Time: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Telephone Conference Call).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Epilepsy
and Neuroprotective Drug Development.
Date: April 6, 2020.
Time: 10:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892, (Telephone Conference Call).
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 85, Number 49 (Thursday, March 12, 2020)]
[Notices]
[Pages 14491-14492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05023]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0419]
Agency Information Collection Request; 60-Day 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, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before May 11, 2020.
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 0990-0419 60D, and
project title for reference, to Sherrette Funn, the Reports Clearance
Officer, [email protected], or call 202-795-7714.
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 (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Acquisition Regulation Clause Patent
Rights and Rights and Data.
Type of Collection: Extension.
OMB No. 0990-0419.
Abstract: The Department of Health and Human Services; Office of
the Assistant Secretary for Financial Resources and Office of Grants
and Acquisition Policy and Accountability, Division of Acquisition is
requesting an approval by OMB for an extension of a previously approved
information collection request, Acquisition Regulation Clause Patent
rights and Rights in Data. HHS found that systematically, over a period
of several years, when Determination of Exceptional Circumstances(DEC)
were executed, additional legal protection for the patent and data
rights of third parties beyond those covered by FAR 27.306 were
necessary A DEC is executed consistent with the policy and objectives
of the Bayh-Dole Act, 35 U.S.C. 200, et seq., to ensure that subject
inventions made under contracts and subcontracts (at all tiers) are
used in a manner to promote free competition and enterprise without
unduly encumbering future research and discovery; to encourage maximum
participation of small business firms in federally supported research
and development efforts; to promote collaboration between commercial
concerns and nonprofit organizations including universities; to ensure
that the Government obtains sufficient rights in federally supported
inventions to meet its needs; to protect the public against nonuse or
unreasonable use of inventions; and in the case of fulfilling the
mission of the U.S. Department of Health and Human Services, to
ultimately to benefit the public health.
Likely Respondents: Administrative, technical, legal and management
personnel.
[[Page 14492]]
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent and hours for each Number of responses per per response Total burden
respondents respondent (hours) hours
----------------------------------------------------------------------------------------------------------------
Technical (4), Legal (2), Management (2)........ 63 1 8 504
Technical (8), Legal (2), Management (2)........ 63 1 12 756
Technical (8), Legal (3), Management (1)........ 63 3 12 2,268
Technical (8), Legal (4), Management (2)........ 63 3 14 2,646
Technical (6), Legal (2), Management (2)........ 63 1 10 630
Technical (4), Legal (2), Management (2)........ 63 1 8 504
Administrative (8).............................. 63 3 8 1,512
Administrative (2), Management (1).............. 63 3 3 567
Technical (4), Legal (2), Management (2)........ 63 3 8 1,512
---------------------------------------------------------------
.............. .............. .............. 10,899
----------------------------------------------------------------------------------------------------------------
Dated: March 6, 2020.
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2020-05023 Filed 3-11-20; 8:45 am]
BILLING CODE 4150-04-P
