Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Providing Information About Pediatric Uses of Medical Devices, 14224-14225 [2017-05302]
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Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
submitter may request status reports
every 30 days following the initial status
request. To obtain a 510(k) status report,
the submitter should complete the
status request form, Form FDA 3541,
and fax it to the Center for Devices and
Radiological Health office identified on
the form.
In the Federal Register of November
18, 2016 (81 FR 81772), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Activity and 21 CFR part/section
Form FDA No.
510(k) submission (807 subpart E) ......
Summary cover sheet (807.87) ............
Status request (807.90(a)(3)) ...............
Standards (807.87(d) and (f)) ...............
510(k) statement (807.93) ....................
........................
3514
3541
3654
........................
3,900
1,956
218
2,700
225
1
1
1
1
10
3,900
1,956
218
2,700
2,250
79 .....................
.5 (30 minutes)
.25 (15 minutes)
10 .....................
10 .....................
308,100
978
55
27,000
22,500
Total ...............................................
........................
........................
........................
........................
...........................
358,633
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0762. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2017–05300 Filed 3–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 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.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2013–D–0117]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing
Information About Pediatric Uses of
Medical Devices
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 April 17,
2017.
SUMMARY:
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:
ADDRESSES:
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Jkt 241001
Providing Information About Pediatric
Uses of Medical Devices Under Section
515A of the Federal Food, Drug, and
Cosmetic Act
OMB Control Number 0910–0762—
Extension
The guidance document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff’’ suggests that
applicants who submit certain medical
device applications include, if readily
available, pediatric use information for
diseases or conditions that the device is
being used to treat, diagnose, or cure
that are outside the device’s approved or
proposed indications for use, as well as
an estimate of the number of pediatric
patients with such diseases or
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Sfmt 4703
conditions. The information submitted
will allow FDA to identify pediatric
uses of devices outside their approved
or proposed indication for use to
determine areas where further pediatric
device development could be useful.
This recommendation applies to
applicants who submit the following
applications: (1) Any request for a
humanitarian device exemption
submitted under section 520(m) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(m)); (2)
any premarket approval application
(PMA) or supplement to a PMA
submitted under section 515 of the
FD&C Act (21 U.S.C. 360e); and (3) any
product development protocol
submitted under section 515 of the
FD&C Act.
Respondents are permitted to submit
information relating to uses of the
device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A of
the FD&C Act will choose to submit this
information and that it will take 30
minutes for them to do so.
In the Federal Register of December 5,
2016 (81 FR 87575), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
14225
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Description
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Uses outside approved indication .....................................
148
1
148
0.5 (30 minutes)
74
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05302 Filed 3–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, notice
is hereby given that a meeting is
scheduled for the National Advisory
Committee on Rural Health and Human
Services (NACRHHS). This meeting will
be open to the public. Information about
NACRHHS and the agenda for this
meeting can be obtained by accessing
the following Web site: https://
www.hrsa.gov/advisorycommittees/
rural.
DATES:
April 10, 2017, 9:00 a.m.–5:00 p.m. EDT
April 11, 2017, 8:30 a.m.–5:00 p.m. EDT
April 12, 2017, 9:00 a.m.–11:00 a.m.
EDT
ADDRESSES: This meeting will be held
in-person at the Hyatt Place Hotel. The
address for the meeting is 400 E Street
SW., Washington, DC 20024. The
meeting will also be held in-person at
the Hubert H. Humphrey Building,
located at 200 Independence Avenue
SW., Washington, DC, on April 11.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, Administrative
Coordinator, NACRHHS, HRSA, 5600
Fishers Lane, Room 17W41C, Rockville,
Maryland 20857, telephone (301) 443–
0835, fax (301) 443–2803 or by email at
shirsch@hrsa.gov.
Persons interested in attending any
portion of the meeting, including the
April 11 portion at the Hubert H.
Humphrey Building, should contact
Adam Cohen at the Federal Office of
Rural Health Policy before April 7, 2017
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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20:02 Mar 16, 2017
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by telephone at (301) 443–0445 or by
email at acohen@hrsa.gov.
SUPPLEMENTARY INFORMATION:
NACRHHS provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas.
The meeting on Monday, April 10,
will be called to order at 9:00 a.m. by
the Chairperson of the Committee, the
Honorable Ronnie Musgrove. The
Committee will examine the current
delivery of health care and human
services in rural areas. The day will
conclude with a period of public
comment at approximately 5:00 p.m.
The Committee will visit the Hubert
H. Humphrey Building on Tuesday,
April 11. The day will conclude with a
period of public comment at
approximately 5:00 p.m.
The Committee will meet to
summarize key findings and develop a
work plan for the next quarter and its
future meeting on Wednesday, April 12,
at 9:00 a.m., at the Hyatt Place Hotel.
The Hubert H. Humphrey Building
requires a security screening on entry.
To facilitate your access to the building,
please contact Adam Cohen before April
7, 2017 at (301) 443–0445. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify Adam
Cohen by telephone at (301) 443–0445
or by email at acohen@hrsa.gov at least
10 days prior to the meeting.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2017–05298 Filed 3–16–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Board of Scientific Advisors,
March 21, 2017, 08:30 a.m. to 05:00
p.m., National Institutes of Health, 31
PO 00000
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Fmt 4703
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Center Drive, Building 31, Conference
Room 10, Bethesda, MD, 20892 which
was published in the Federal Register
on March 3, 2017, 82 FR 12459.
The meeting notice is amended to
change the meeting start and end time
to 9:00 a.m. to 4:30 p.m. The date and
location remain the same. The meeting
is open to the public.
Dated: March 14, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–05391 Filed 3–16–17; 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.
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 Human
Genome Research Institute Special Emphasis
Panel; Gabriella Miller Kids First.
Date: April 24, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Grand Thomas Boardroom,
2350 M Street NW., Washington, DC 20037.
Contact Person: Barbara J. Thomas, Ph.D.,
Scientific Review Officer Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 5635
Fishers Lane, Ste. 4076, MSC 9306, Bethesda,
MD 20892–9306, 301–402–0838,
barbara.thomas@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
E:\FR\FM\17MRN1.SGM
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Agencies
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14224-14225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0117]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Providing Information
About Pediatric Uses of Medical Devices
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 April
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 0910-0762.
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 10A-12M, 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.
Providing Information About Pediatric Uses of Medical Devices Under
Section 515A of the Federal Food, Drug, and Cosmetic Act
OMB Control Number 0910-0762--Extension
The guidance document entitled ``Providing Information About
Pediatric Uses of Medical Devices--Guidance for Industry and Food and
Drug Administration Staff'' suggests that applicants who submit certain
medical device applications include, if readily available, pediatric
use information for diseases or conditions that the device is being
used to treat, diagnose, or cure that are outside the device's approved
or proposed indications for use, as well as an estimate of the number
of pediatric patients with such diseases or conditions. The information
submitted will allow FDA to identify pediatric uses of devices outside
their approved or proposed indication for use to determine areas where
further pediatric device development could be useful. This
recommendation applies to applicants who submit the following
applications: (1) Any request for a humanitarian device exemption
submitted under section 520(m) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360j(m)); (2) any premarket approval
application (PMA) or supplement to a PMA submitted under section 515 of
the FD&C Act (21 U.S.C. 360e); and (3) any product development protocol
submitted under section 515 of the FD&C Act.
Respondents are permitted to submit information relating to uses of
the device outside the approved or proposed indication if such uses are
described or acknowledged in acceptable sources of readily available
information. We estimate that 20 percent of respondents submitting
information required by section 515A of the FD&C Act will choose to
submit this information and that it will take 30 minutes for them to do
so.
In the Federal Register of December 5, 2016 (81 FR 87575), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 14225]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Description Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Uses outside approved indication............. 148 1 148 0.5 (30 minutes)..................... 74
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05302 Filed 3-16-17; 8:45 am]
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