Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, 90857-90858 [2016-30113]
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90857
Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm,
https://www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
GuidancesInformationSheetsandNotices
/ucm219433.htm, https://www.fda.gov/
ScienceResearch/SpecialTopics/
RunningClinicalTrials/Proposed
RegulationsandDraftGuidances/
default.htm, https://www.hhs.gov/ohrp/
newsroom/rfc/, or https://
www.regulations.gov.
Leslie Kux,
Assistant Commissioner for Policy, Food and
Drug Administration.
Karen B. DeSalvo,
Acting Assistant Secretary for Health,
Department of Health and Human Services.
[FR Doc. 2016–30146 Filed 12–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0795]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Third-Party Review Under the Food
and Drug Administration
Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 January 17,
2017.
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 0910–0375. Also
include the FDA 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, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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.
SUMMARY:
Medical Devices; Third-Party Review
Under the Food and Drug
Administration Modernization Act—
OMB Control Number 0910–0375—
Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360m), directing FDA to
accredit persons in the private sector to
review certain premarket notifications
(510(k)s). Participation in this thirdparty review program by accredited
persons is entirely voluntary. A third
party wishing to participate will submit
a request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation, to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices. Respondents to
this information collection are
businesses or other for-profit
organizations.
FDA receives an average of one
application for accreditation for thirdparty review per year. According to
FDA’s data, the number of 510(k)s
submitted for third-party review is
approximately 260 annually, which is
26 annual reviews per each of the 10
accredited reviewers. Third-party
reviewers are required to keep records
of their review of each submission.
In the Federal Register of July 8, 2016
(81 FR 44627), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Requests for accreditation ...................................................
510(k) reviews conducted by accredited third parties .........
1
10
1
26
1
260
24
40
24
10,400
Total ..............................................................................
........................
........................
........................
........................
10,424
rmajette on DSK2TPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
510(k) reviews ......................................................................
10
26
260
10
2,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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90858
Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Notices
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–30113 Filed 12–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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
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.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
Date: February 23, 2017.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, Suite 920, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Manana Sukhareva, Ph.D.,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 959, Bethesda,
MD 20892, (301) 451–3397, sukharem@
mail.nih.gov.
Dated: December 8, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30075 Filed 12–14–16; 8:45 am]
BILLING CODE 4140–01–P
rmajette on DSK2TPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
VerDate Sep<11>2014
15:19 Dec 14, 2016
Jkt 241001
hereby given of a meeting of the
National Advisory Council for
Biomedical Imaging and Bioengineering.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering.
Date: January 24, 2017.
Open: 8:30 a.m. to 12:00 p.m.
Agenda: Report from the Institute Director,
other Institute Staff and scientific
presentation.
Place: The William F. Bolger Center,
Franklin Building, Classroom 15/16, 9600
Newbridge Drive, Potomac, MD 20854.
Closed: 1:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: The William F. Bolger Center,
Franklin Building, Classroom 15/16, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: David T. George, Ph.D.,
Acting Associate Director, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 920,
Bethesda, MD 20892.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nibib1.nih.gov/about/NACBIB/
NACBIB.htm, where an agenda and any
additional information for the meeting will
be posted when available.
Dated: December 8, 2016.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30074 Filed 12–14–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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
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.
Name of Committee: Center for Scientific
Review, Special Emphasis Panel;
Applications in Biobehavioral Regulation,
Learning, and Ethology.
Date: December 21, 2016.
Time: 11:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, 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.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 8, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–30072 Filed 12–14–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
E:\FR\FM\15DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90857-90858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30113]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0795]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Third-Party Review Under the Food and Drug Administration Modernization
Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 January
17, 2017.
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 0910-0375.
Also include the FDA 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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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.
Medical Devices; Third-Party Review Under the Food and Drug
Administration Modernization Act--OMB Control Number 0910-0375--
Extension
Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360m), directing FDA to accredit persons in the private
sector to review certain premarket notifications (510(k)s).
Participation in this third-party review program by accredited persons
is entirely voluntary. A third party wishing to participate will submit
a request for accreditation to FDA. Accredited third-party reviewers
have the ability to review a manufacturer's 510(k) submission for
selected devices. After reviewing a submission, the reviewer will
forward a copy of the 510(k) submission, along with the reviewer's
documented review and recommendation, to FDA. Third-party reviewers
should maintain records of their 510(k) reviews and a copy of the
510(k) for a reasonable period of time, usually a period of 3 years.
This information collection will allow FDA to continue to implement
the accredited person review program established by FDAMA and improve
the efficiency of 510(k) review for low- to moderate-risk devices.
Respondents to this information collection are businesses or other for-
profit organizations.
FDA receives an average of one application for accreditation for
third-party review per year. According to FDA's data, the number of
510(k)s submitted for third-party review is approximately 260 annually,
which is 26 annual reviews per each of the 10 accredited reviewers.
Third-party reviewers are required to keep records of their review of
each submission.
In the Federal Register of July 8, 2016 (81 FR 44627), FDA
published a 60-day notice requesting public comment on the proposed
collection of information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation...... 1 1 1 24 24
510(k) reviews conducted by 10 26 260 40 10,400
accredited third parties.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,424
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews..................................................... 10 26 260 10 2,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 90858]]
Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30113 Filed 12-14-16; 8:45 am]
BILLING CODE 4164-01-P
